bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether nocturnal environmental control with
      Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients
      with perennial allergic asthma.
    

Detailed description: 
      Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical,
      chemical and combined methods aiming to reduce airborne allergen levels have shown little or
      no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims
      and objectives: This study aims to investigate treatment with Temperature controled Laminar
      Airflow (TLA) with a very low particle concentration directed to the breathing zone in
      subjects with allergic asthma during night sleep. The hypothesis is that the decreased
      allergen exposure during the night will have an effect on quality of life and bronchial
      inflammation.

      Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing
      active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active
      and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion
      and randomization, during which the patient shall get familiar with the use of the patient
      asthma diary and to adhere to the requirements of the study participation. First 12 weeks an
      unchanged maintenance medication will be kept and week 13-52 medication will be modified to
      obtain asthma control according to international guidelines (GINA). After inclusion, run-in,
      randomization and baseline measurements active/placebo treatment with AA will be implemented
      over 52 weeks.
    

Intervention name(s): Temperature controlled Laminar Airflow (TLA); Placebo TLA
Intervention type(s): Device; Device
Intervention description(s): Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).; Placebo TLA (without filtration and TLA function)
Other intervention name(s): Protexo; TLA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Temperature controlled Laminar Airflow; TLA; Perennial allergy; Quality of life; Environmental control
Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Condition: Gastritis Associated With Helicobacter Pylori
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan
      20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg
      bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1
      week. Success or failure of eradication was determined by the 13C-urea breath test performed
      at 1 month after the therapy.
    

Detailed description: 
      Patients infected with H. pylori were enrolled and invited to the study.

      Patients who have never undergone the H. pylori eradication therapy are randomly assigned to
      the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the
      triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg
      bid for 1 week.

      Patients who have ever failed in the eradication of H. pylori by the triple therapy
      containing clarithromycin are randomly assigned to the dual therapy with vonoprazan 20 mg bid
      and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid,
      amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week.

      Success or failure of eradication was determined by the 13C-urea breath test performed at 1
      month after the therapy.
    

Intervention name(s): vonoprazan 20 mg bid; Amoxicillin 500 mg tid; Amoxicillin 750 mg bid; Clarithromycin 200 mg bid; Metronidazole 250 mg bid
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.; Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.; Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.; Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.; Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.
Other intervention name(s): takecab® 20 mg bid; Sawacillin® 500 mg tid; Sawacillin® 750 mg bid; Claris® 200 mg bid; fragile 250 mg bid
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pylori
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Condition: Anovulation; Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of
      Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
    


Intervention name(s): Clomiphene; clomiphene and paroxetine; clomiphene and clarithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): clomiphene once 100 mg oral; clomiphene 100mg and paroxetine 3x40mg; clomiphene 100mg and clarithromycin 9x500mg
Intervention MeSH terms: Clarithromycin; Paroxetine; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetic; clomiphene; CYP2D6 polymorphisms; inhibition of CYP2D6 and CYP3A4
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics (including dose proportionality
      assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising
      dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus
      the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI
      1181181 (Bioavailability/Food effect (BA/FE) part)
    


Intervention name(s): BI 1181181; BI 1181181, R; BI 1181181, T2; Placebo to BI 1181181; BI 1181181, T1
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose (low to high dose); powder for oral solution; tablet, fasted; Placebo to BI 1181181; tablet, fed
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after
      treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of
      tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the
      systemic exposure following inhalation of the free combination (Treatment B) of tiotropium
      (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered
      once-daily over 21 days via Respimat(R) (RMT).

      The secondary objectives are:

      to compare the systemic exposure to tiotropium and CD 1857 after single dose administration
      of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to
      BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the
      free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium
      and BI 54903 when administered as FDC and as free dose combination, respectively
    


Intervention name(s): Tiotropium; Tiotropium; BI 54903; BI 54903
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Medium dose of oral inhalation; Medium dose of oral inhalation; Medium dose of oral inhalation; Medium dose of oral inhalation
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
Condition: Binge Drinking; HIV
MeSH terms: Binge Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of
      naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially
      diverse participants will be recruited using Respondent Driven Sampling as well as active
      field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug
      dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys
      will be completed monthly.
    


Intervention name(s): Placebo; Naltrexone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Naltrexone
Vinblastine and Temsirolimus in Pediatrics With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
Condition: Recurrent Lymphoma; Refractory Lymphoma; Solid Tumours; Central Nervous System
MeSH terms: Lymphoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the best dose of vinblastine that can be given with
      a new drug, temsirolimus.
    

Detailed description: 
      Vinblastine is already approved in the treatment of some types of cancer in children and
      temsirolimus is already used to treat some adult cancers in Canada. Temsirolimus has been
      shown to slow the growth of tumours in animals but it is not known if it can also slow tumour
      growth in children. Laboratory studies suggest that giving both vinblastine and temsirolimus
      may offer better results than giving vinblastine alone.
    

Intervention name(s): Vinblastine; Temsirolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors; Vinblastine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases
Condition: Respiratory System
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize variability and extent of the deposition of
      ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with
      chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg
      active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be
      evaluated. In this study the radiolabeled substance will be administered and scintigraphy
      imaging techniques will be used to demonstrate the lung deposition visually. In the healthy
      subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly
      based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a
      separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The
      latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in
      the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block).
      Safety investigations will focus on local tolerability in the lung.

      Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the
      study drug.

      Results from this study will be used to show how the drug is distributed in the human lung.
    


Intervention name(s): Ciprofloxacin (Cipro Inhale, BAYQ3939); Ciprofloxacin (Cipro Inhale, BAYQ3939); Ciprofloxacin (Cipro Inhale, BAYQ3939); Ciprofloxacin (Cipro Inhale, BAYQ3939)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects; 50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block; 50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients; 50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung; Scintigraphy; Pharmacokinetics; Inhalation; Ciprofloxacin
Antiarrhythmic Effects of N-3 Fatty Acids
Condition: Arrhythmia; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation
MeSH terms: Heart Diseases; Tachycardia; Ventricular Fibrillation; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted
      defibrillators.
    

Detailed description: 
      BACKGROUND:

      Ventricular tachycardia (VT) and ventricular fibrillation (VF) are common causes of the
      300,000 sudden deaths occurring in the United States each year. Most of these victims have
      associated heart disease, most commonly coronary artery disease. Populations consuming
      considerable quantities of fish and marine mammals have lower than expected mortality rates
      from coronary disease. Interventional and observational trials have indicated that fatty fish
      consumption decreases the death rate from coronary artery disease, in part by reducing the
      number of sudden deaths. Animal and tissue culture studies both support the hypothesis that
      these beneficial effects are from the antiarrhythmic properties of n-3 long chained
      polyunsaturated fatty acids (eicosapentaenoic and docosahexaenoic acids).

      DESIGN NARRATIVE:

      Prospective, randomized, double blinded trial. Survivors of VT and VF with an implantable
      defibrillator were randomized, 100 to dietary supplementation with n-3 polyunsaturated fatty
      acids(PUFA) or 100 to a placebo. Adherence to the supplement were assessed by measurements of
      plasma, red cell, and adipose tissue n-3 fatty acid concentrations. The primary outcome
      variable was the incidence of recurrent VT or VF, but secondary variables were also assessed
      using serial implantable cardioverter defibrillator (ICD) assessment, correlation of the
      rhythms with the biochemical measurements of n-3 fatty acids, hospitalization rates and
      quality of life. The (ICD) was the best protection available to patients and stored rhythm
      electrograms which allowed documentation of rhythm endpoints.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): dietary n-3 polyunsaturated fatty acids
Intervention type(s): Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)
      and compare their effects on tumor response and associated side effects, to determine if one
      therapy is better than the other for people diagnosed with relapsed or persistent
      neuroblastoma.
    


Intervention name(s): 131I-MIBG; Vincristine; Irinotecan; Vorinostat
Intervention type(s): Radiation; Drug; Drug; Drug
Other intervention name(s): 131I-Metaiodobenzylguanidine; Iobenguane sulfate; m-Iodobenzylguanidine sulfate; MIBG; Zolinza
Intervention MeSH terms: Irinotecan; Vincristine; Vorinostat; 3-Iodobenzylguanidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn if aripiprazole is safe and effective in the treatment
      of psychosis associated with dementia of the Alzheimer's type.
    


Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Primary purpose: Treatment
Keywords: Psychosis associated with dementia of the Alzheimer's type
D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
Condition: Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder NOS
MeSH terms: Autism Spectrum Disorder; Autistic Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of D-cycloserine for improving
      social impairment in child with pervasive developmental disorders (PDD).
    

Detailed description: 
      This study will evaluate the efficacy of D-Cycloserine given 30 minutes prior to each of 10
      weekly Social Skills Training Sessions for the treatment of social impairment in children
      (ages 5-11 years) with PDD during a randomized placebo-controlled trial. This will examine
      our central hypothesis that D-cycloserine will enhance learning of social skills in children
      with PDD's.
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions; Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions
Other intervention name(s): Seromycin; Sugar pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; D-cycloserine; Social Skills Training
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male
      volunteers. Subjects will be randomized in cohorts to receive single oral doses of either
      bitopertin or placebo.
    


Intervention name(s): bitopertin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and
      sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to
      placebo. The primary objective of this study is to evaluate the percentage change in body
      weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week
      24).
    

Detailed description: 
      This is a randomized, 24-week, placebo-controlled, double-blind study to evaluate the effects
      of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of
      leucine, sildenafil and metformin compared to placebo. Subjects meeting all the inclusion
      criteria and no exclusion criteria will be randomized to one of five study arms.

      The primary objective of this study is to evaluate the percentage change in body weight in
      subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24)
      receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose
      combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives
      will also assess changes in absolute body weight, percentage of patients with ≥5% body weight
      loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in
      blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and
      changes in in C-reactive protein. In addition this study will evaluate the safety and
      tolerability of NS-0200 and NS-0300.

      Patients will have one screening visits which will determine their eligibility based on lab
      tests. Once qualified, patients will be randomly assigned to either one of the treatment
      groups or the placebo control group and monitored for a total of 24 weeks. Patients will
      return to the clinic each month for lab tests, and routine examinations.
    

Intervention name(s): Leu Sil 1.0mg; Leu Sil 4.0mg; Leu Met Sil 1.0mg; Leu Met Sil 4.0mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Leu 1100 mg + 1mg Sil BID; Leu 1100 mg + 4mg Sil BID; Leu 1100 mg + Met 500mg + 1mg Sil BID; Leu 1100 mg + Met 500mg + 4mg Sil BID; Placebo
Other intervention name(s): NS-0300-1.0; NS-0300-4.0; NS-0200-1.0; NS-0200-4.0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment