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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study. Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months. At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ≥0.35 µg/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ≥1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ≥0.15 µg/mL (difference, 1.5%; CI, -7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ≥1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ≥2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ≥5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups. A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated. Output:
{'conditions': 'Vaccines, Pneumococcal', 'interventions': 'Biological: 13-valent Pneumococcal Conjugate Vaccine|Biological: 7vPnC|Biological: Pediacel|Biological: NeisVac-C|Biological: Menitorix'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study. Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months. At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ≥0.35 µg/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ≥1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ≥0.15 µg/mL (difference, 1.5%; CI, -7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ≥1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ≥2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ≥5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups. A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Episodic therapy of genital herpes is usually recommended for patients with infrequent symptomatic recurrences and where transmission is not a concern. While shorter courses are as effective as standard 5-day regimens, it is unknown whether abbreviated therapy has detrimental effects on natural history and the development of antiviral resistance. To assess time to next recurrence and development of antiviral resistance in patients with recurrent genital herpes treated with either single-day famciclovir (1 g twice-daily) or 3-day valacyclovir (500 mg twice-daily). Longer-term, follow-up data on the time to next recurrence and antiviral sensitivity were collected from a previously reported multicenter, multinational, double-blind, parallel group study in which 1179 immunocompetent adults were randomized 1 : 1 to receive either single-day famciclovir or 3-day valacyclovir. Treatment was self-initiated within 6 hours of a recurrence. Swabs for viral culture and sensitivity testing were collected for two sequential recurrences. The median time to next recurrence from treatment initiation was 33.5 days for famciclovir and 38.0 days for valacyclovir. No drug resistance to penciclovir, the active metabolite of famciclovir, was observed at baseline nor did any develop by the time of the next recurrence. The study had no placebo arm, typing of viral isolates was not performed and viral resistance testing was restricted to penciclovir only. Treatment with single-day famciclovir for recurrent genital herpes did not shorten the time to the next recurrence. Drug resistance to penciclovir continues to be a rare event in immunocompetent patients. Output:
{'conditions': 'Genital Herpes', 'interventions': 'Drug: Famciclovir|Drug: Valacyclovir|Drug: Placebo matching famciclovir|Drug: Placebo matching valacyclovir'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Episodic therapy of genital herpes is usually recommended for patients with infrequent symptomatic recurrences and where transmission is not a concern. While shorter courses are as effective as standard 5-day regimens, it is unknown whether abbreviated therapy has detrimental effects on natural history and the development of antiviral resistance. To assess time to next recurrence and development of antiviral resistance in patients with recurrent genital herpes treated with either single-day famciclovir (1 g twice-daily) or 3-day valacyclovir (500 mg twice-daily). Longer-term, follow-up data on the time to next recurrence and antiviral sensitivity were collected from a previously reported multicenter, multinational, double-blind, parallel group study in which 1179 immunocompetent adults were randomized 1 : 1 to receive either single-day famciclovir or 3-day valacyclovir. Treatment was self-initiated within 6 hours of a recurrence. Swabs for viral culture and sensitivity testing were collected for two sequential recurrences. The median time to next recurrence from treatment initiation was 33.5 days for famciclovir and 38.0 days for valacyclovir. No drug resistance to penciclovir, the active metabolite of famciclovir, was observed at baseline nor did any develop by the time of the next recurrence. The study had no placebo arm, typing of viral isolates was not performed and viral resistance testing was restricted to penciclovir only. Treatment with single-day famciclovir for recurrent genital herpes did not shorten the time to the next recurrence. Drug resistance to penciclovir continues to be a rare event in immunocompetent patients. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. To evaluate the efficacy and tolerability of brimonidine purite 0.1% in comparison to brinzolamide 1% when used as adjunctive therapy to latanoprost 0.005% in patients with glaucoma or ocular hypertension. Randomized, single-center, investigator-masked, parallel-group clinical study. Patients with IOP >or= 18 mmHg while on once-daily latanoprost were randomized to adjunctive treatment with brimonidine purite TID (n = 20) or brinzolamide TID (n = 20) for 3 months. Intraocular pressure (IOP) was measured at 8 a.m., 10 a.m., and 4 p.m. at latanoprost-treated baseline and after 1 and 3 months of latanoprost and adjunctive therapy. A patient questionnaire was administered to evaluate the tolerability of eye drop instillation. Baseline mean diurnal IOP (+/- standard deviation, mmHg) on latanoprost was comparable between groups (brimonidine purite: 19.6 +/- 2.94; brinzolamide: 19.8 +/- 3.25; p = 0.846). Mean diurnal IOP at Month 3 was 16.3 +/- 2.63 mmHg with brimonidine purite and 17.8 +/- 2.19 mmHg with brinzolamide (p = 0.028). Adjunctive use of brimonidine purite provided greater IOP lowering than brinzolamide at 10 a.m. (p < 0.001) and 4 p.m. (p = 0.050) and equivalent IOP lowering to brinzolamide at 8 a.m. (p = 0.716). Blurred vision at Month 1 and bitter taste at Months 1 and 3 were more common upon instillation of brinzolamide eye drops. Brimonidine purite 0.1% provided significantly lower IOP compared with brinzolamide 1% when used as adjunctive therapy to latanoprost. Both adjunctive therapies were well tolerated. Limitations of this study include the use of a single site and the sample size. Additional studies are needed to further evaluate these drugs as adjunctive therapy to prostaglandin analogs. Output:
{'conditions': 'Glaucoma|Ocular Hypertension', 'interventions': 'Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops|Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. To evaluate the efficacy and tolerability of brimonidine purite 0.1% in comparison to brinzolamide 1% when used as adjunctive therapy to latanoprost 0.005% in patients with glaucoma or ocular hypertension. Randomized, single-center, investigator-masked, parallel-group clinical study. Patients with IOP >or= 18 mmHg while on once-daily latanoprost were randomized to adjunctive treatment with brimonidine purite TID (n = 20) or brinzolamide TID (n = 20) for 3 months. Intraocular pressure (IOP) was measured at 8 a.m., 10 a.m., and 4 p.m. at latanoprost-treated baseline and after 1 and 3 months of latanoprost and adjunctive therapy. A patient questionnaire was administered to evaluate the tolerability of eye drop instillation. Baseline mean diurnal IOP (+/- standard deviation, mmHg) on latanoprost was comparable between groups (brimonidine purite: 19.6 +/- 2.94; brinzolamide: 19.8 +/- 3.25; p = 0.846). Mean diurnal IOP at Month 3 was 16.3 +/- 2.63 mmHg with brimonidine purite and 17.8 +/- 2.19 mmHg with brinzolamide (p = 0.028). Adjunctive use of brimonidine purite provided greater IOP lowering than brinzolamide at 10 a.m. (p < 0.001) and 4 p.m. (p = 0.050) and equivalent IOP lowering to brinzolamide at 8 a.m. (p = 0.716). Blurred vision at Month 1 and bitter taste at Months 1 and 3 were more common upon instillation of brinzolamide eye drops. Brimonidine purite 0.1% provided significantly lower IOP compared with brinzolamide 1% when used as adjunctive therapy to latanoprost. Both adjunctive therapies were well tolerated. Limitations of this study include the use of a single site and the sample size. Additional studies are needed to further evaluate these drugs as adjunctive therapy to prostaglandin analogs. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. The study objective was to investigate the safety and tolerability of up-titration to high doses of taspoglutide, a once-weekly human glucagon-like peptide-1 analogue, in subjects with Type 2 diabetes inadequately controlled on metformin alone. In this double-blind phase II trial, subjects were randomized to placebo or taspoglutide (20 mg; three separate groups) administered once weekly by subcutaneous injection for 4 weeks. This was followed by dose maintenance at 20 mg, or titration to 30 mg (20/30) or 40 mg (20/40) once weekly with matched placebo for an additional 4 weeks. Subjects were monitored for adverse events (AEs) throughout the study and 4-week follow-up. One hundred and twenty-nine subjects were randomized and treated [mean age 57 years, mean baseline glycated haemoglobin (HbA(1c)), 7.9%]. The most frequently reported AEs were nausea and vomiting. The number of patients reporting gastrointestinal AEs did not increase following titration to higher doses of taspoglutide or when continuing the initial 20 mg regimen. Three subjects were withdrawn from the study as a result of gastrointestinal AEs (one before and two after titration to higher doses). Although not designed to investigate efficacy, improvement in glycaemic control was observed in all active arms of the study. The proportion of subjects achieving HbA(1c) < 7.0% after 8 weeks of treatment was 72, 53 and 70% in the 20/20-, 20/30- and 20/40-mg arms, respectively, vs. 19% for placebo. Taspoglutide was safe, well tolerated at high doses and efficacious for lowering HbA(1c). Up-titration of dose was not associated with a worsening AE profile. Output:
{'conditions': 'Diabetes Mellitus, Type 2', 'interventions': 'Drug: GLP-1 analogue|Drug: GLP-1 analogue|Drug: GLP-1 analogue|Drug: Placebo'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. The study objective was to investigate the safety and tolerability of up-titration to high doses of taspoglutide, a once-weekly human glucagon-like peptide-1 analogue, in subjects with Type 2 diabetes inadequately controlled on metformin alone. In this double-blind phase II trial, subjects were randomized to placebo or taspoglutide (20 mg; three separate groups) administered once weekly by subcutaneous injection for 4 weeks. This was followed by dose maintenance at 20 mg, or titration to 30 mg (20/30) or 40 mg (20/40) once weekly with matched placebo for an additional 4 weeks. Subjects were monitored for adverse events (AEs) throughout the study and 4-week follow-up. One hundred and twenty-nine subjects were randomized and treated [mean age 57 years, mean baseline glycated haemoglobin (HbA(1c)), 7.9%]. The most frequently reported AEs were nausea and vomiting. The number of patients reporting gastrointestinal AEs did not increase following titration to higher doses of taspoglutide or when continuing the initial 20 mg regimen. Three subjects were withdrawn from the study as a result of gastrointestinal AEs (one before and two after titration to higher doses). Although not designed to investigate efficacy, improvement in glycaemic control was observed in all active arms of the study. The proportion of subjects achieving HbA(1c) < 7.0% after 8 weeks of treatment was 72, 53 and 70% in the 20/20-, 20/30- and 20/40-mg arms, respectively, vs. 19% for placebo. Taspoglutide was safe, well tolerated at high doses and efficacious for lowering HbA(1c). Up-titration of dose was not associated with a worsening AE profile. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. To assess the efficacy and safety of varenicline (a licensed cigarette smoking cessation aid) in helping users of smokeless tobacco to quit. Double blind, placebo controlled, parallel group, multicentre, randomised controlled trial. Medical clinics (mostly primary care) in Norway and Sweden. Men and women aged ≥18 who used smokeless tobacco at least eight times a day, with no abstinence period over three months within one year before screening, who wanted to quit all tobacco use. Participants were excluded if they used any other form of tobacco (except smokeless tobacco) or medication to stop smoking within three months of screening or had any pre-existing medical or psychiatric condition. Varenicline 1 mg twice daily (titrated during the first week) or placebo for 12 weeks, with 14 weeks' follow-up after treatment. The primary end point was the four week continuous abstinence rate at the end of treatment (weeks 9-12) confirmed with cotinine concentration. A secondary end point was continuous abstinence rate for weeks 9-26. Safety and tolerability were also evaluated. 431 participants (213 varenicline; 218 placebo) were randomised and received at least one dose of study drug. Participants' demographics and baseline use of smokeless tobacco were similar (89% (189) and 90% (196), respectively, were men; mean age in both groups was 43.9; participants used smokeless tobacco products about 15 times a day, and about 80% first used smokeless tobacco within 30 minutes after awakening). Continuous abstinence rate at week 9-12 was higher in the varenicline group than the placebo group (59% (125) v 39% (85); relative risk 1.60, 95% confidence interval 1.32 to 1.87, P<0.001; risk difference 20%; number needed to treat 5). The advantage of varenicline over placebo persisted through 14 weeks of follow-up (continuous abstinence rate at week 9-26 was 45% (95) v 34% (73); relative risk 1.42, 1.08 to 1.79, P=0.012; risk difference 11%; number needed to treat 9). The most common adverse events in the varenicline group compared with the placebo group were nausea (35% (74) v 6% (14)), fatigue (10% (22) v 7% (15)), headache (10% (22) v 9% (20)), and sleep disorder (10% (22) v 7% (15)). Few adverse events led to discontinuation of treatment (9% (19) and 4% (9), respectively), and serious adverse events occurred in two (1%) and three (1%) participants, respectively. Varenicline can help people to give up smokeless tobacco and has an acceptable safety profile. The response rate in the placebo group in this study was high, suggesting a population less resistant to treatment than smokers. NCT00717093. Output:
{'conditions': 'Tobacco Use Cessation', 'interventions': 'Drug: Varenicline Tartrate|Drug: Placebo'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. To assess the efficacy and safety of varenicline (a licensed cigarette smoking cessation aid) in helping users of smokeless tobacco to quit. Double blind, placebo controlled, parallel group, multicentre, randomised controlled trial. Medical clinics (mostly primary care) in Norway and Sweden. Men and women aged ≥18 who used smokeless tobacco at least eight times a day, with no abstinence period over three months within one year before screening, who wanted to quit all tobacco use. Participants were excluded if they used any other form of tobacco (except smokeless tobacco) or medication to stop smoking within three months of screening or had any pre-existing medical or psychiatric condition. Varenicline 1 mg twice daily (titrated during the first week) or placebo for 12 weeks, with 14 weeks' follow-up after treatment. The primary end point was the four week continuous abstinence rate at the end of treatment (weeks 9-12) confirmed with cotinine concentration. A secondary end point was continuous abstinence rate for weeks 9-26. Safety and tolerability were also evaluated. 431 participants (213 varenicline; 218 placebo) were randomised and received at least one dose of study drug. Participants' demographics and baseline use of smokeless tobacco were similar (89% (189) and 90% (196), respectively, were men; mean age in both groups was 43.9; participants used smokeless tobacco products about 15 times a day, and about 80% first used smokeless tobacco within 30 minutes after awakening). Continuous abstinence rate at week 9-12 was higher in the varenicline group than the placebo group (59% (125) v 39% (85); relative risk 1.60, 95% confidence interval 1.32 to 1.87, P<0.001; risk difference 20%; number needed to treat 5). The advantage of varenicline over placebo persisted through 14 weeks of follow-up (continuous abstinence rate at week 9-26 was 45% (95) v 34% (73); relative risk 1.42, 1.08 to 1.79, P=0.012; risk difference 11%; number needed to treat 9). The most common adverse events in the varenicline group compared with the placebo group were nausea (35% (74) v 6% (14)), fatigue (10% (22) v 7% (15)), headache (10% (22) v 9% (20)), and sleep disorder (10% (22) v 7% (15)). Few adverse events led to discontinuation of treatment (9% (19) and 4% (9), respectively), and serious adverse events occurred in two (1%) and three (1%) participants, respectively. Varenicline can help people to give up smokeless tobacco and has an acceptable safety profile. The response rate in the placebo group in this study was high, suggesting a population less resistant to treatment than smokers. NCT00717093. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Lapaquistat acetate is a squalene synthase inhibitor investigated for the treatment of hypercholesterolemia. This report summarizes the phase 2 and 3 results from the lapaquistat clinical program, which was halted at an advanced stage as a result of potential hepatic safety issues. Efficacy and safety data were pooled from 12 studies (n=6151). These were 6- to 96-week randomized, double-blind, parallel, placebo- or active-controlled trials with lapaquistat monotherapy or coadministration with other lipid-altering drugs in dyslipidemic patients, including a large (n=2121) 96-week safety study. All studies included lapaquistat 100 mg daily; 5 included 50 mg; and 1 included 25 mg. The main outcome measures were the percent change in low-density lipoprotein cholesterol, secondary lipid/metabolic parameters, and overall safety. Lapaquistat 100 mg significantly decreased low-density lipoprotein cholesterol by 21.6% in monotherapy and by 18.0% in combination with a statin. It also reduced other cardiovascular risk markers, such as C-reactive protein. Total adverse events were higher for lapaquistat than placebo, although individual events were generally similar. At 100 mg, there was an increase in alanine aminotransferase value ≥3 times the upper limit of normal on ≥2 consecutive visits (2.0% versus 0.3% for placebo in the pooled efficacy studies; 2.7% versus 0.7% for low-dose atorvastatin in the long-term study). Two patients receiving lapaquistat 100 mg met the Hy Law criteria of alanine aminotransferase elevation plus increased total bilirubin. Squalene synthase inhibition with lapaquistat acetate, alone or in combination with statins, effectively lowered low-density lipoprotein cholesterol in a dose-dependent manner. Elevations in alanine aminotransferase, combined with a rare increase in bilirubin, presented potential hepatic safety issues, resulting in termination of development. The lapaquistat experience illustrates the current challenges in lipid-altering drug development. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00487994, NCT00143663, NCT00143676, NCT00864643, NCT00263081, NCT00286481, NCT00249899, NCT00249912, NCT00813527, NCT00256178, NCT00268697, and NCT00251680. Output:
{'conditions': 'Hyperlipidemias', 'interventions': 'Drug: Lapaquistat acetate and fenofibrate|Drug: Fenofibrate'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Lapaquistat acetate is a squalene synthase inhibitor investigated for the treatment of hypercholesterolemia. This report summarizes the phase 2 and 3 results from the lapaquistat clinical program, which was halted at an advanced stage as a result of potential hepatic safety issues. Efficacy and safety data were pooled from 12 studies (n=6151). These were 6- to 96-week randomized, double-blind, parallel, placebo- or active-controlled trials with lapaquistat monotherapy or coadministration with other lipid-altering drugs in dyslipidemic patients, including a large (n=2121) 96-week safety study. All studies included lapaquistat 100 mg daily; 5 included 50 mg; and 1 included 25 mg. The main outcome measures were the percent change in low-density lipoprotein cholesterol, secondary lipid/metabolic parameters, and overall safety. Lapaquistat 100 mg significantly decreased low-density lipoprotein cholesterol by 21.6% in monotherapy and by 18.0% in combination with a statin. It also reduced other cardiovascular risk markers, such as C-reactive protein. Total adverse events were higher for lapaquistat than placebo, although individual events were generally similar. At 100 mg, there was an increase in alanine aminotransferase value ≥3 times the upper limit of normal on ≥2 consecutive visits (2.0% versus 0.3% for placebo in the pooled efficacy studies; 2.7% versus 0.7% for low-dose atorvastatin in the long-term study). Two patients receiving lapaquistat 100 mg met the Hy Law criteria of alanine aminotransferase elevation plus increased total bilirubin. Squalene synthase inhibition with lapaquistat acetate, alone or in combination with statins, effectively lowered low-density lipoprotein cholesterol in a dose-dependent manner. Elevations in alanine aminotransferase, combined with a rare increase in bilirubin, presented potential hepatic safety issues, resulting in termination of development. The lapaquistat experience illustrates the current challenges in lipid-altering drug development. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00487994, NCT00143663, NCT00143676, NCT00864643, NCT00263081, NCT00286481, NCT00249899, NCT00249912, NCT00813527, NCT00256178, NCT00268697, and NCT00251680. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. To evaluate the efficacy of combining the dual endothelin receptor antagonist, bosentan, and the phosfodiesterase-5-inhibitor, sildenafil, in patients with Eisenmenger syndrome. The study was a randomized, placebo-controlled, double-blinded, cross-over design. Patients with Eisenmenger syndrome (n = 21) were treated open label with bosentan for 9 months. After 3 months, sildenafil/placebo was added for 3 months, and a cross-over was performed for the last 3 months. At baseline and after 3, 6, and 9 months, patients were examined with 6 min walk test, oxygen saturations, N-terminal pro-brain natriuretic peptide, New York Heart Association (NYHA) classification, cardiac catheterization, and magnetic resonance imaging. The primary endpoint was changed in 6 min walk distance (MWD). Bosentan improved the 6 MWD (377 vs. 414 m, P = 0.001), pulmonary vascular resistance (PVR) (28 vs. 22 wood, P = 0.01), and pulmonary blood flow (2.6 vs. 3.5 L/min, P = 0.01). Adding sildenafil to bosentan did not improve the 6 MWD significantly (21 vs. 8 m, P = 0.48), but increased saturation at rest (2.9 vs. -1.8%, P < 0.01). In Eisenmenger syndrome, treatment with bosentan significantly improved walking distance, pulmonary blood flow, and PVR. Adding sildenafil to bosentan did not significantly improve walking distance but did increase saturation at rest. http://www.ClinicalTrial.gov: NCT00303004. Output:
{'conditions': 'Eisenmenger Syndrome', 'interventions': 'Drug: Bosentan and Sildenafil'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. To evaluate the efficacy of combining the dual endothelin receptor antagonist, bosentan, and the phosfodiesterase-5-inhibitor, sildenafil, in patients with Eisenmenger syndrome. The study was a randomized, placebo-controlled, double-blinded, cross-over design. Patients with Eisenmenger syndrome (n = 21) were treated open label with bosentan for 9 months. After 3 months, sildenafil/placebo was added for 3 months, and a cross-over was performed for the last 3 months. At baseline and after 3, 6, and 9 months, patients were examined with 6 min walk test, oxygen saturations, N-terminal pro-brain natriuretic peptide, New York Heart Association (NYHA) classification, cardiac catheterization, and magnetic resonance imaging. The primary endpoint was changed in 6 min walk distance (MWD). Bosentan improved the 6 MWD (377 vs. 414 m, P = 0.001), pulmonary vascular resistance (PVR) (28 vs. 22 wood, P = 0.01), and pulmonary blood flow (2.6 vs. 3.5 L/min, P = 0.01). Adding sildenafil to bosentan did not improve the 6 MWD significantly (21 vs. 8 m, P = 0.48), but increased saturation at rest (2.9 vs. -1.8%, P < 0.01). In Eisenmenger syndrome, treatment with bosentan significantly improved walking distance, pulmonary blood flow, and PVR. Adding sildenafil to bosentan did not significantly improve walking distance but did increase saturation at rest. http://www.ClinicalTrial.gov: NCT00303004. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. A recent trial involving predominantly Caucasian subjects with Parkinson Disease (PD) showed switching overnight from an oral dopaminergic agonist to the rotigotine patch was well tolerated without loss of efficacy. However, no such data have been generated for Korean patients. This open-label multicenter trial investigated PD patients whose symptoms were not satisfactorily controlled by ropinirole, at a total daily dose of 3 mg to 12 mg, taken as monotherapy or as an adjunct to levodopa. Switching treatment from oral ropinirole to transdermal rotigotine was carried out overnight, with a dosage ratio of 1.5:1. After a 28-day treatment period, the safety and tolerability of switching was evaluated. Due to the exploratory nature of this trial, the effects of rotigotine on motor and nonmotor symptoms of PD were analyzed in a descriptive manner. Of the 116 subjects who received at least one treatment, 99 (85%) completed the 28-day trial period. Dose adjustments were required for 11 subjects who completed the treatment period. A total of 76 treatment-emergent adverse events (AEs) occurred in 45 subjects. No subject experienced a serious AE. Thirteen subjects discontinued rotigotine prematurely due to AEs. Efficacy results suggested improvements in both motor and nonmotor symptoms and quality of life after switching. Fifty-two subjects (46%) agreed that they preferred using the patch over oral medications, while 31 (28%) disagreed. Switching treatment overnight from oral ropinirole to transdermal rotigotine patch, using a dosage ratio of 1.5:1, was well tolerated in Korean patients with no loss of efficacy. This trial is registered with the ClincalTrails.gov Registry (NCT00593606). Output:
{'conditions': "Parkinson's Disease", 'interventions': 'Drug: Rotigotine'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. A recent trial involving predominantly Caucasian subjects with Parkinson Disease (PD) showed switching overnight from an oral dopaminergic agonist to the rotigotine patch was well tolerated without loss of efficacy. However, no such data have been generated for Korean patients. This open-label multicenter trial investigated PD patients whose symptoms were not satisfactorily controlled by ropinirole, at a total daily dose of 3 mg to 12 mg, taken as monotherapy or as an adjunct to levodopa. Switching treatment from oral ropinirole to transdermal rotigotine was carried out overnight, with a dosage ratio of 1.5:1. After a 28-day treatment period, the safety and tolerability of switching was evaluated. Due to the exploratory nature of this trial, the effects of rotigotine on motor and nonmotor symptoms of PD were analyzed in a descriptive manner. Of the 116 subjects who received at least one treatment, 99 (85%) completed the 28-day trial period. Dose adjustments were required for 11 subjects who completed the treatment period. A total of 76 treatment-emergent adverse events (AEs) occurred in 45 subjects. No subject experienced a serious AE. Thirteen subjects discontinued rotigotine prematurely due to AEs. Efficacy results suggested improvements in both motor and nonmotor symptoms and quality of life after switching. Fifty-two subjects (46%) agreed that they preferred using the patch over oral medications, while 31 (28%) disagreed. Switching treatment overnight from oral ropinirole to transdermal rotigotine patch, using a dosage ratio of 1.5:1, was well tolerated in Korean patients with no loss of efficacy. This trial is registered with the ClincalTrails.gov Registry (NCT00593606). Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers. Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double-blind, cross-over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine-maintained injection drug users (IDUs). Intravenous heroin users (n = 12) lived in the hospital for 8-9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions. Intravenous buprenorphine/naloxone was self-administered less frequently than buprenorphine or heroin (P < 0.0005). Participants were most likely to self-administer drug intravenously when maintained on the lowest sublingual buprenorphine dose. Subjective ratings of 'drug liking' and 'desire to take the drug again' were lower for buprenorphine/naloxone than for buprenorphine or heroin (P = 0.0001). Participants reported that they would pay significantly less money for buprenorphine/naloxone than for buprenorphine or heroin (P < 0.05). Seven adverse events were reported; most were mild and transient. These data suggest that although the buprenorphine/naloxone combination has intravenous abuse potential, that potential is lower than it is for buprenorphine alone, particularly when participants received higher maintenance doses and lower buprenorphine/naloxone challenge doses. Buprenorphine/naloxone may be a reasonable option for managing the risk for buprenorphine misuse during opioid dependence treatment. Output:
{'conditions': 'Opioid-related Disorders', 'interventions': 'Drug: heroin, naloxone, buprenorphine, buprenorphine/naloxone'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers. Sublingual buprenorphine is an effective maintenance treatment for opioid dependence, yet intravenous buprenorphine misuse occurs. A buprenorphine/naloxone formulation was developed to mitigate this misuse risk. This randomized, double-blind, cross-over study was conducted to assess the intravenous abuse potential of buprenorphine/naloxone compared with buprenorphine in buprenorphine-maintained injection drug users (IDUs). Intravenous heroin users (n = 12) lived in the hospital for 8-9 weeks and were maintained on each of three different sublingual buprenorphine doses (2 mg, 8 mg, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intravenous placebo, naloxone, heroin and low and high doses of buprenorphine and buprenorphine/naloxone were examined. Every participant received each test dose under the three buprenorphine maintenance dose conditions. Intravenous buprenorphine/naloxone was self-administered less frequently than buprenorphine or heroin (P < 0.0005). Participants were most likely to self-administer drug intravenously when maintained on the lowest sublingual buprenorphine dose. Subjective ratings of 'drug liking' and 'desire to take the drug again' were lower for buprenorphine/naloxone than for buprenorphine or heroin (P = 0.0001). Participants reported that they would pay significantly less money for buprenorphine/naloxone than for buprenorphine or heroin (P < 0.05). Seven adverse events were reported; most were mild and transient. These data suggest that although the buprenorphine/naloxone combination has intravenous abuse potential, that potential is lower than it is for buprenorphine alone, particularly when participants received higher maintenance doses and lower buprenorphine/naloxone challenge doses. Buprenorphine/naloxone may be a reasonable option for managing the risk for buprenorphine misuse during opioid dependence treatment. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Aprepitant was shown previously to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving an anthracycline and cyclophosphamide (AC)-based regimen. This study assessed aprepitant in patients receiving a broad range of MEC regimens with a variety of tumor types. This phase III, randomized, gender-stratified, double-blind trial enrolled patients with confirmed malignancies, naïve to MEC or highly emetogenic chemotherapy, who were scheduled to receive a single dose of at least one MEC agent. Patients received an aprepitant triple-therapy regimen (aprepitant, ondansetron, and dexamethasone) or a control regimen (ondansetron and dexamethasone) administered orally. Primary and key secondary efficacy endpoints were proportions of patients with no vomiting and complete response (no vomiting and no rescue medication), respectively, during the 120 h post-chemotherapy. Of 848 randomized patients, 77% were female, and 52% received non-AC-based antineoplastic regimens. Significantly, more patients in the aprepitant group achieved no vomiting and complete response, regardless of whether they received AC or non-AC regimens, in the 120 h after chemotherapy. Overall, the incidences of adverse events were generally similar in the aprepitant (62.8%) and control groups (67.2%). The aprepitant regimen provided superior efficacy in the treatment of CINV in a broad range of patients receiving MEC (non-AC or AC) in both no vomiting and complete response endpoints. Aprepitant was generally well tolerated. These results show the benefit of including aprepitant as part of the standard antiemetic regimen for cancer patients receiving MEC. Output:
{'conditions': 'Chemotherapy-Induced Nausea and Vomiting', 'interventions': 'Drug: aprepitant|Drug: Comparator: ondansetron|Drug: Comparator: dexamethasone|Drug: Comparator: fosaprepitant dimeglumine|Drug: Comparator; Placebo (unspecified)|Drug: Comparator; Placebo (unspecified)'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Aprepitant was shown previously to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving an anthracycline and cyclophosphamide (AC)-based regimen. This study assessed aprepitant in patients receiving a broad range of MEC regimens with a variety of tumor types. This phase III, randomized, gender-stratified, double-blind trial enrolled patients with confirmed malignancies, naïve to MEC or highly emetogenic chemotherapy, who were scheduled to receive a single dose of at least one MEC agent. Patients received an aprepitant triple-therapy regimen (aprepitant, ondansetron, and dexamethasone) or a control regimen (ondansetron and dexamethasone) administered orally. Primary and key secondary efficacy endpoints were proportions of patients with no vomiting and complete response (no vomiting and no rescue medication), respectively, during the 120 h post-chemotherapy. Of 848 randomized patients, 77% were female, and 52% received non-AC-based antineoplastic regimens. Significantly, more patients in the aprepitant group achieved no vomiting and complete response, regardless of whether they received AC or non-AC regimens, in the 120 h after chemotherapy. Overall, the incidences of adverse events were generally similar in the aprepitant (62.8%) and control groups (67.2%). The aprepitant regimen provided superior efficacy in the treatment of CINV in a broad range of patients receiving MEC (non-AC or AC) in both no vomiting and complete response endpoints. Aprepitant was generally well tolerated. These results show the benefit of including aprepitant as part of the standard antiemetic regimen for cancer patients receiving MEC. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. To evaluate the efficacy, tolerability, and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia. Patients meeting the American College of Rheumatology criteria for fibromyalgia were randomized to receive esreboxetine at dosages of 4 mg/day (n=277), 8 mg/day (n=284), or 10 mg/day (n=283) or matching placebo (n=278) for 14 weeks. The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Questionnaire (FIQ) total score at week 14. Secondary efficacy measures included scores for the Patient's Global Impression of Change (PGIC) scale, the Global Fatigue Index (GFI), and the 36-item Short-Form health survey (SF-36; physical function scale only) at week 14. The safety profile of esreboxetine was evaluated based on adverse events and other safety measures. Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score (P≤0.025), the FIQ score (P≤0.023), and the PGIC score (P≤0.007) compared with patients in the placebo group. Additionally, patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo (P=0.001). No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine (any dosage) and those receiving placebo. Adverse events were mostly mild to moderate in severity; insomnia, constipation, dry mouth, nausea, dizziness, hot flush, headache, hyperhidrosis, and palpitations were reported most frequently. Esreboxetine was generally well tolerated and was associated with significant improvements in pain, FIQ, PGIC, and fatigue scores compared with placebo. The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure. Output:
{'conditions': 'Fibromyalgia', 'interventions': 'Drug: [S,S]-Reboxetine|Drug: Placebo|Drug: [S,S]-Reboxetine|Drug: [S,S]-Reboxetine'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. To evaluate the efficacy, tolerability, and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia. Patients meeting the American College of Rheumatology criteria for fibromyalgia were randomized to receive esreboxetine at dosages of 4 mg/day (n=277), 8 mg/day (n=284), or 10 mg/day (n=283) or matching placebo (n=278) for 14 weeks. The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Questionnaire (FIQ) total score at week 14. Secondary efficacy measures included scores for the Patient's Global Impression of Change (PGIC) scale, the Global Fatigue Index (GFI), and the 36-item Short-Form health survey (SF-36; physical function scale only) at week 14. The safety profile of esreboxetine was evaluated based on adverse events and other safety measures. Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score (P≤0.025), the FIQ score (P≤0.023), and the PGIC score (P≤0.007) compared with patients in the placebo group. Additionally, patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo (P=0.001). No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine (any dosage) and those receiving placebo. Adverse events were mostly mild to moderate in severity; insomnia, constipation, dry mouth, nausea, dizziness, hot flush, headache, hyperhidrosis, and palpitations were reported most frequently. Esreboxetine was generally well tolerated and was associated with significant improvements in pain, FIQ, PGIC, and fatigue scores compared with placebo. The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Clozapine is associated with significant weight gain and metabolic disturbances. This multicentre, randomized study comprised a double-blind, placebo-controlled treatment phase of 16 wk, and an open-label extension phase of 12 wk. Outpatients who met DSM-IV-TR criteria for schizophrenia, who were not optimally controlled while on stable dosage of clozapine for > or =3 months and had experienced weight gain of > or =2.5 kg while taking clozapine, were randomized (n=207) to aripiprazole at 5-15 mg/d or placebo, in addition to a stable dose of clozapine. The primary endpoint was mean change from baseline in body weight at week 16 (last observation carried forward). Secondary endpoints included clinical efficacy, body mass index (BMI) and waist circumference. A statistically significant difference in weight loss was reported for aripiprazole vs. placebo (-2.53 kg vs. -0.38 kg, respectively, difference=-2.15 kg, p<0.001). Aripiprazole-treated patients also showed BMI (median reduction 0.8 kg/m(2)) and waist circumference reduction (median reduction 2.0 cm) vs. placebo (no change in either parameter, p<0.001 and p=0.001, respectively). Aripiprazole-treated patients had significantly greater reductions in total and low-density lipoprotein (LDL) cholesterol. There were no significant differences in Positive and Negative Syndrome Scale total score changes between groups but Clinical Global Impression Improvement and Investigator's Assessment Questionnaire scores favoured aripiprazole over placebo. Safety and tolerability were generally comparable between groups. Combining aripiprazole and clozapine resulted in significant weight, BMI and fasting cholesterol benefits to patients suboptimally treated with clozapine. Improvements may reduce metabolic risk factors associated with clozapine treatment. Output:
{'conditions': 'Schizophrenia', 'interventions': 'Drug: aripiprazole|Drug: Placebo'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Clozapine is associated with significant weight gain and metabolic disturbances. This multicentre, randomized study comprised a double-blind, placebo-controlled treatment phase of 16 wk, and an open-label extension phase of 12 wk. Outpatients who met DSM-IV-TR criteria for schizophrenia, who were not optimally controlled while on stable dosage of clozapine for > or =3 months and had experienced weight gain of > or =2.5 kg while taking clozapine, were randomized (n=207) to aripiprazole at 5-15 mg/d or placebo, in addition to a stable dose of clozapine. The primary endpoint was mean change from baseline in body weight at week 16 (last observation carried forward). Secondary endpoints included clinical efficacy, body mass index (BMI) and waist circumference. A statistically significant difference in weight loss was reported for aripiprazole vs. placebo (-2.53 kg vs. -0.38 kg, respectively, difference=-2.15 kg, p<0.001). Aripiprazole-treated patients also showed BMI (median reduction 0.8 kg/m(2)) and waist circumference reduction (median reduction 2.0 cm) vs. placebo (no change in either parameter, p<0.001 and p=0.001, respectively). Aripiprazole-treated patients had significantly greater reductions in total and low-density lipoprotein (LDL) cholesterol. There were no significant differences in Positive and Negative Syndrome Scale total score changes between groups but Clinical Global Impression Improvement and Investigator's Assessment Questionnaire scores favoured aripiprazole over placebo. Safety and tolerability were generally comparable between groups. Combining aripiprazole and clozapine resulted in significant weight, BMI and fasting cholesterol benefits to patients suboptimally treated with clozapine. Improvements may reduce metabolic risk factors associated with clozapine treatment. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. The influence of dietary fiber on determinants of metabolic syndrome is controversial. The objective of this study was to determine the effects of NUTRIOSE supplementation on insulin resistance and the determinants of metabolic syndrome in overweight men. In this double-blind, randomized, placebo-controlled study, we supplemented the diets of overweight Chinese men with 250 mL of fruit juice that contained NUTRIOSE (Test group: n = 60, age = 30.4 ± 4.3 years, body mass index (BMI) = 24.5 ± 0.2 kg·m-2) or a maltodextrin placebo ( n = 60, age = 31.6 ± 4.1 years, BMI = 24.5 ± 0.3 kg·m-2) at a dosage of 17 g twice daily for 12 weeks. Daily caloric intake, body composition, blood chemistry, and blood pressure were evaluated every 4 weeks during the trial. Test subjects consumed fewer calories per day and had greater reductions in body weight, BMI, body fat percentage, and waist circumference than Control subjects. All markers of glucose metabolism improved in the Test group, with increases in adiponectin and reductions in glucose, insulin, homeostasis model assessment-estimated insulin resistance, glycosylated hemoglobin, and glycated albumin (all p < 0.01). Similarly, all lipid measures improved with increases in high-density lipoprotein cholesterol and reductions in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides (all p < 0.01). No changes were observed in systolic blood pressure between groups. Most components of glucose metabolism and the lipid profile were significantly better in the Test than in the Control subjects. No adverse events or gastrointestinal complaints were reported in either group. Supplementation with NUTRIOSE for 12 weeks is well tolerated, lowers insulin resistance, and improves determinants of metabolic syndrome in overweight men. Output:
{'conditions': 'Overweight|Metabolic Syndrome X', 'interventions': 'Dietary Supplement: NUTRIOSE|Dietary Supplement: Placebo'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. The influence of dietary fiber on determinants of metabolic syndrome is controversial. The objective of this study was to determine the effects of NUTRIOSE supplementation on insulin resistance and the determinants of metabolic syndrome in overweight men. In this double-blind, randomized, placebo-controlled study, we supplemented the diets of overweight Chinese men with 250 mL of fruit juice that contained NUTRIOSE (Test group: n = 60, age = 30.4 ± 4.3 years, body mass index (BMI) = 24.5 ± 0.2 kg·m-2) or a maltodextrin placebo ( n = 60, age = 31.6 ± 4.1 years, BMI = 24.5 ± 0.3 kg·m-2) at a dosage of 17 g twice daily for 12 weeks. Daily caloric intake, body composition, blood chemistry, and blood pressure were evaluated every 4 weeks during the trial. Test subjects consumed fewer calories per day and had greater reductions in body weight, BMI, body fat percentage, and waist circumference than Control subjects. All markers of glucose metabolism improved in the Test group, with increases in adiponectin and reductions in glucose, insulin, homeostasis model assessment-estimated insulin resistance, glycosylated hemoglobin, and glycated albumin (all p < 0.01). Similarly, all lipid measures improved with increases in high-density lipoprotein cholesterol and reductions in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides (all p < 0.01). No changes were observed in systolic blood pressure between groups. Most components of glucose metabolism and the lipid profile were significantly better in the Test than in the Control subjects. No adverse events or gastrointestinal complaints were reported in either group. Supplementation with NUTRIOSE for 12 weeks is well tolerated, lowers insulin resistance, and improves determinants of metabolic syndrome in overweight men. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Efficacy of an Internet-based behavioral intervention for adults with insomnia. Insomnia is a major health problem with significant psychological, health, and economic consequences. However, availability of one of the most effective insomnia treatments, cognitive behavioral therapy, is significantly limited. The Internet may be a key conduit for delivering this intervention. To evaluate the efficacy of a structured behavioral Internet intervention for adults with insomnia. Forty-five adults were randomly assigned to an Internet intervention (n = 22) or wait-list control group (n = 23). Forty-four eligible participants (mean [SD] age, 44.86 [11.03] years; 34 women) who had a history of sleep difficulties longer than 10 years on average (mean [SD], 10.59 [8.89] years) were included in the analyses. The Internet intervention is based on well-established face-to-face cognitive behavioral therapy incorporating the primary components of sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. The Insomnia Severity Index and daily sleep diary data were used to determine changes in insomnia severity and the main sleep variables, including wake after sleep onset and sleep efficiency. Intention-to-treat analyses showed that scores on the Insomnia Severity Index significantly improved from 15.73 (95% confidence interval [CI], 14.07 to 17.39) to 6.59 (95% CI, 4.73 to 8.45) for the Internet group but did not change for the control group (16.27 [95% CI, 14.61 to 17.94] to 15.50 [95% CI, 13.64 to 17.36]) (F(1,42) = 29.64; P < .001). The Internet group maintained their gains at the 6-month follow-up. Internet participants also achieved significant decreases in wake after sleep onset (55% [95% CI, 34% to 76%]) and increases in sleep efficiency (16% [95% CI, 9% to 22%]) compared with the nonsignificant control group changes of wake after sleep onset (8% [95% CI, -17% to 33%) and sleep efficiency (3%; 95% CI, -4% to 9%). Participants who received the Internet intervention for insomnia significantly improved their sleep, whereas the control group did not have a significant change. The Internet appears to have considerable potential in delivering a structured behavioral program for insomnia. clinicaltrials.gov Identifier: NCT00328250. Output:
{'conditions': 'Sleep Initiation and Maintenance Disorders', 'interventions': 'Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Efficacy of an Internet-based behavioral intervention for adults with insomnia. Insomnia is a major health problem with significant psychological, health, and economic consequences. However, availability of one of the most effective insomnia treatments, cognitive behavioral therapy, is significantly limited. The Internet may be a key conduit for delivering this intervention. To evaluate the efficacy of a structured behavioral Internet intervention for adults with insomnia. Forty-five adults were randomly assigned to an Internet intervention (n = 22) or wait-list control group (n = 23). Forty-four eligible participants (mean [SD] age, 44.86 [11.03] years; 34 women) who had a history of sleep difficulties longer than 10 years on average (mean [SD], 10.59 [8.89] years) were included in the analyses. The Internet intervention is based on well-established face-to-face cognitive behavioral therapy incorporating the primary components of sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. The Insomnia Severity Index and daily sleep diary data were used to determine changes in insomnia severity and the main sleep variables, including wake after sleep onset and sleep efficiency. Intention-to-treat analyses showed that scores on the Insomnia Severity Index significantly improved from 15.73 (95% confidence interval [CI], 14.07 to 17.39) to 6.59 (95% CI, 4.73 to 8.45) for the Internet group but did not change for the control group (16.27 [95% CI, 14.61 to 17.94] to 15.50 [95% CI, 13.64 to 17.36]) (F(1,42) = 29.64; P < .001). The Internet group maintained their gains at the 6-month follow-up. Internet participants also achieved significant decreases in wake after sleep onset (55% [95% CI, 34% to 76%]) and increases in sleep efficiency (16% [95% CI, 9% to 22%]) compared with the nonsignificant control group changes of wake after sleep onset (8% [95% CI, -17% to 33%) and sleep efficiency (3%; 95% CI, -4% to 9%). Participants who received the Internet intervention for insomnia significantly improved their sleep, whereas the control group did not have a significant change. The Internet appears to have considerable potential in delivering a structured behavioral program for insomnia. clinicaltrials.gov Identifier: NCT00328250. Output:<end_of_turn> <start_of_turn>model
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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Two randomized trials of linaclotide for chronic constipation. Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase C receptor. In two trials, we aimed to determine the efficacy and safety of linaclotide in patients with chronic constipation. We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation. Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks. The primary efficacy end point was three or more complete spontaneous bowel movements (CSBMs) per week and an increase of one or more CSBMs from baseline during at least 9 of the 12 weeks. Adverse events were also monitored. For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all comparisons of linaclotide with placebo). Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups. The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups. In these two 12-week trials, linaclotide significantly reduced bowel and abdominal symptoms in patients with chronic constipation. Additional studies are needed to evaluate the potential long-term risks and benefits of linaclotide in chronic constipation. (Funded by Ironwood Pharmaceuticals and Forest Research Institute; ClinicalTrials.gov numbers, NCT00765882 and NCT00730015.). Output:
{'conditions': 'Chronic Constipation', 'interventions': 'Drug: Matching Placebo|Drug: Linaclotide'}
1
No
<start_of_turn>user Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below. ```TypeScript { // Information on the clinical trial characteristics from the abstract conditions: string // The condition or disease being treated in the clinical trial drug_or_intervention: string // The drug or intervention used in the clinical trial } ``` Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags. Input:Two randomized trials of linaclotide for chronic constipation. Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase C receptor. In two trials, we aimed to determine the efficacy and safety of linaclotide in patients with chronic constipation. We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation. Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks. The primary efficacy end point was three or more complete spontaneous bowel movements (CSBMs) per week and an increase of one or more CSBMs from baseline during at least 9 of the 12 weeks. Adverse events were also monitored. For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all comparisons of linaclotide with placebo). Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups. The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups. In these two 12-week trials, linaclotide significantly reduced bowel and abdominal symptoms in patients with chronic constipation. Additional studies are needed to evaluate the potential long-term risks and benefits of linaclotide in chronic constipation. (Funded by Ironwood Pharmaceuticals and Forest Research Institute; ClinicalTrials.gov numbers, NCT00765882 and NCT00730015.). Output:<end_of_turn> <start_of_turn>model
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