bioihbjkbjnl/mcl2 huggingface dataset:
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
Condition: Migraine With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A previously published, placebo-controlled, head-to-head comparator study found eletriptan to
      have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack.
      The goal of the current study was to extend the findings of that study by examining the
      efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to
      evaluate the comparative efficacy of eletriptan and sumatriptan across additional important
      clinical outcomes. In particular, early response (at 1 hour), sustained response (without
      need for additional treatment) at 24 hours, and consistency of response across multiple
      attacks were examined.
    


Intervention name(s): Placebo; Eletriptan 40 mg; Eletriptan 80 mg; Sumatriptan 50 mg; Sumatriptan 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): matching placebo; 40mg oral; 80mg oral; 50mg oral; 100mg oral
Intervention MeSH terms: Sumatriptan; Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tolcapone in Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone
      in 20 people (ages 18-65). The study will be divided into an initial 2 week phase and a
      second 2 week phase, with one of the 2 week phases consisting of active treatment with
      tolcapone, and the other 2 week phase consisting of inactive placebo treatment. There will be
      a one-week wash-out phase between the 2-week treatment phases. Participants will be
      randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1
      basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
    

Detailed description: 
      The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in adults
      with obsessive compulsive disorder (OCD). The hypothesis to be tested is that tolcapone will
      be more effective and well tolerated in adults with OCD compared to placebo. The proposed
      study will provide needed data on the treatment of a disabling disorder where current
      treatments are often ineffective.

      The primary aim of this application is to conduct a randomized placebo-controlled
      pharmacotherapy trial using tolcapone in 20 participants with OCD. The study will consist of
      two phases: a 2 week active treatment phase with tolcapone, a one-week wash-out phase, and a
      2 week placebo phase. The subjects will be randomized to either receive tolcapone or placebo
      treatment in the first 2 weeks, and the other during the remaining 2 week phase.

      This will be one of few studies assessing the use of pharmacotherapy for the treatment of OCD
      in adults. Assessing the efficacy and safety of tolcapone will help inform clinicians about
      additional treatment options for adults suffering from this disorder.
    

Intervention name(s): Tolcapone 200 MG
Intervention type(s): Drug
Intervention description(s): All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.
Other intervention name(s): No other names
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the immunologic effects and safety of 60-day treatment of the Standardized
      Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass
      pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
    


Intervention name(s): Phleum pratense grass pollen allergen extract; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days; placebo tablet given once daily over 60 days
Other intervention name(s): GRAZAX/GRASTEK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: GRAZAX
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The experimental model is a semi-acute, over-night, study where the purpose is to evaluate
      food factors related to colonially derived regulation and satiety in healthy subjects.
    


Intervention name(s): High levels of indigestible carbohydrates; Low levels of indigestible carbohydrates
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Respiration rate is a critical vital sign that provides early detection of respiratory
      compromise and patient distress. Continuous monitoring of respiration rate is performed in
      patients under different clinical conditions, including post-surgery or different respiratory
      diseases. Clinician observation, pulse oximetry, and capnography are used individually or in
      combination to monitor ventilation during sedation and on post-surgical patients. The
      American Society of Anesthesiologists mandates the monitoring of respiration by measuring end
      tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques
      for respiration rate measurement include different technologies such as acoustic respiratory
      rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain
      respiratory conditions.
    


Intervention name(s): Radical-7; Nellcor™ Bedside Respiratory Patient Monitoring System; Capnostream 20p
Intervention type(s): Device; Device; Device
Intervention description(s): Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time.
Radical-7- measures respiratory rate according to acoustic respiratory rate (RRa).; Comparison between 3 different monitors that measure repiratory rate. The participant is connected to 3 monitors at the same time.
Nellcor™ Bedside Respiratory Patient Monitoring System - measures respiratory rate according to oximetry respiration rate (RRoxi).; Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream 20p- measures respiratory rate according to Capnography (RRetco2).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Respiratory Conditions for Adults
Palatability and Postprandial Sensations
Condition: Healthy
Study type: Interventional

Summary: 
      Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and
      emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses
      to conventional (potato and cheese cream followed by vanilla cream) versus unconventional
      test meals (mixture of both creams) with identical composition (350 Kcal) and physical
      characteristics (colour, texture, consistency, temperature) but distinctively different
      palatability will be studied on a cross over-design. The responses to the meals will be
      tested on 2 different days.

      Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day
      before, to consume a standard breakfast at home after overnight fast, and to report to the
      laboratory, where the test meal will be administered 5 h after breakfast. Studies will be
      conducted in a quiet, isolated room with participants sitting on a chair. Perception will be
      measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals
      up to 60 min after the probe meal.
    


Intervention name(s): Mixed meal; Combined meal
Intervention type(s): Other; Other
Intervention description(s): Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.; Combined meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: meal ingestion; palatability; postprandial responses; hedonic response
Effect of Resistance and Aerobic Exercise in CIDP or MMN
Condition: Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional

Summary: 
      Resistance and aerobic exercise has been shown to be effective for maintenance of muscle
      strength in patients with neuromuscular diseases.

      Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes
      in muscle strength during high intensive resistance training and changes in maximal oxygen
      consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in
      maintenance therapy with subcutaneous immunoglobulin.

      The hypotheses are that muscle strength and VO2-max are significantly increased during the
      training sessions.
    


Intervention name(s): Resistance training; Aerobic training
Intervention type(s): Other; Other
Intervention description(s): Participants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training:
Week 0-4: 70-80 % of 1-RM
Week 5-8: 75-86 % of 1-RM
Week 9-12: 80-92% of 1-RM
Participants trains unilateral, the opposite site serves as reference.
MMN patients train elbow (flexion/extension) and wrist (flexion/extension)
CIDP patients train knee (flexion/extension) and elbow (flexion/extension); Participants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well.
Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Resistance training; Aerobic exercise; Isokinetic muscle strength; Bicycle ergometry test; Subcutaneous immunoglobulin
N-Acetyl Cysteine in Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of
      trichotillomania
    

Detailed description: 
      The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine
      (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks
      of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and
      well tolerated in patients with trichotillomania compared to placebo. The proposed study will
      provide needed data on the treatment of a disabling disorder that currently lacks a clearly
      effective treatment.
    

Intervention name(s): Placebo; N-Acetyl Cysteine
Intervention type(s): Drug; Drug
Intervention description(s): daily; 600mg capsules in varying doses for 12 weeks.
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trichotillomania; Hair-pulling
Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope
Condition: Mammoplasty
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the feasibility and outcome of performing dual plane
      breast augmentation with assistant of endoscope by axillary approach.
    

Detailed description: 
      Dual plane augmentation mammoplasty is a logical approach to realize the benefits of
      retromammary and partial retropectoral implant placement while minimizing the tradeoffs of
      other pocket locations. Traditionally, dual plane augmentation has been performed using
      transareolar or inframammary fold approach. However, the approach is unacceptable to Chinese
      patients because of the front scar formation. For aesthetic reasons, the axillary incision is
      more acceptable approach for augmentation mammoplasty.

      The endoscope assistant technique has been widely used in transaxillary breast augmentation.
      It provides the feasibility to perform dual plane breast augmentation by axillary approach.

      In this research, at least 40 patients with light degree of glandular ptotic and constricted
      lower pole breasts are selected to receive soft cohesive gel microtextured anatomic style
      silicone implants. Portions of the pectoralis major muscle is split without its release from
      the costal margin with the help of a 10mm, 30°endoscope and endoscopic diathermy scissors
      through a 4-cm incision in the axilla each side. Bleeding during surgery is kept to the
      minimum. The results of outcomes, operative time, bleeding volume, drainage volume,
      complications are observed.
    

Intervention name(s): Transaxillary dual plane technique
Intervention type(s): Procedure
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: augmentation mammoplasty; Dual plane; Endoscope; Transaxillary incision
PUFA Augmentation in Treatment of Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up
      response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major
      Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.
    

Detailed description: 
      As per brief summary
    

Intervention name(s): Polyunsaturated Fatty Acids (PUFA); Citalopram
Intervention type(s): Drug; Drug
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: depression; citalopram; Celexa; Polyunsaturated Fatty Acids; omega-3; EPA; antidepressants
Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450
      inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects.
      Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1
      and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in
      1 part only.
    

Detailed description: 
      This study will consist of 4 parts. Each part has two periods. The parts may be conducted in
      any order. Subjects may participate in 1 part only.

      Each subject will participate in a screening phase, a baseline phase in each study period, a
      treatment phase in each study period and a follow-up telephone call. Subjects will be
      screened for eligibility. Eligible subjects will return to the study center on Day -1 of
      Period 1 and will remain at the study center until the last day of Period 2.

      Part 1: On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On
      Day 1 of each study period, each subject will receive 1 of 2 treatments according to the
      sequence in which he or she is randomized.

      In Part 2, subjects will receive a single dose of CC-122 in Period 1 and, following an
      appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-122
      in Period 2.

      In Part 3, subjects will receive a single dose of CC-122 in Period 1 and, following an
      appropriate washout, multiple doses of fluvoxamine plus one dose of fluvoxamine with CC-122
      in Period 2.

      In Part 4, subjects will receive a single dose of CC-122 in Period 1 and, following an
      appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-122 in
      Period 2.
    

Intervention name(s): CC-122; Itraconazole; Fluvoxamine; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CC-122; CYP3A Inhibitor; CYP1A2 Inhibitor; CYP3A Inducer
Intervention MeSH terms: Itraconazole; Rifampin; Fluvoxamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; CC-122; Adult; Phase 1; CYTOCHROME P450
Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis
Condition: Radiation Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the effects of CSMed® for preventing and managing radiation dermatitis in
      patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
    

Detailed description: 
      A prospective study was conducted at the University Hospital Medical Center. The patient
      received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record
      the difference between the part of the skin with dressing and undressed skin for each
      patient. The severity of acute radiation dermatitis was graded using the RTOG clinical
      scoring standard. From the beginning of the treatment to 4 weeks after the end of the
      treatment, skin pain, itching, local fever and tightness, as well as skin healing time were
      collected every week.
    

Intervention name(s): CSMed Dressing
Intervention type(s): Drug
Intervention description(s): Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
Condition: Hepatic Cirrhosis; Ascites
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 1

Summary: 
      For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics,
      pharmacology, and safety of the drug under fasting condition.
    

Detailed description: 
      This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and
      safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in
      Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis
      (accompanied by ascites).

      Trial Design:

        1. Open, single-center, multi-dose pharmacokinetics study

        2. Study population:

           Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis
           (accompanied by ascites)

        3. Dosage and mode of administration of investigational product:

           Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from
           day 1 of treatment.

        4. Study duration:

      Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day
    

Intervention name(s): tolvaptan
Intervention type(s): Drug
Intervention description(s): Drug: tolvaptan
tablet, 15mg, Qd, for 7 days.
Other intervention name(s): SAMSCA
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic cirrhosis patients with ascites
Quantification of Micro-RNA 146-a in Chronic Periodontitis and Coronary Heart Disease Subjects
Condition: Periodontal Diseases; Coronary Disease
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      The expression and quantification of Micro-RNA 146-a, was analyzed in the subgingival plaque
      samples of generalized chronic periodontitis patients with and without coronary heart
      disease. The demographic variables and periodontal parameters were assessed and correlated
      with expression of micro-RNA 146-a. The quantification of levels of micro-RNA 146-a was done
      using Real time Polymerase chain reaction. ( RT-PCR)
    

Detailed description: 
      The quantification of the levels of MicroRNA 146-a was analyzed in subgingival plaque samples
      of generalized chronic periodontitis subjects with and without coronary heart disease and
      compared them with the healthy subject.A total of 90 subjects were selected for the study and
      assigned to 3 groups based on inclusion and exclusion criteria. Group I comprised of 30
      subjects with Generalized chronic periodontitis diagnosed with coronary heart disease.Group
      II comprised of 30 subjects with Generalized chronic periodontitis without coronary heart
      disease and Group III comprised of 30 systemically healthy volunteers with no chronic
      periodontitis or coronary heart disease. Demographic variables such as age, weight,height,BMI
      and income and clinical parameters such as plaque index, bleeding on probing, probing pocket
      depth and clinical attachement levels were recorded. Subgingival plaque samples were
      collected from all the 3 groups. The collected samples were subject to further molecular
      analysis for micro-RNA expression and quantification using RT-PCR.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All male patients within the age group of 35-65 years. The subjects were from South Indian
        population.
      
Keywords: Micro-RNA; Chronic periodontitis