bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
Condition: Seasonal Allergic Rhinitis; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ
      Grass.

      The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the
      optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements
      of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis
      (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during
      the peak grass pollen season (GPS).
    

Detailed description: 
      Multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to
      confirm the efficacy and safety of the optimal effective dose of PQ Grass (27600 SU).

      Randomized study subjects, in a randomisation ratio of 1:1, will receive either treatment
      with 6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially)
      to achieve a cumulative nominal dose of 27600 SU, or 6 injections of placebo prior to the
      onset of the grass pollen season (GPS).

      The aim of the study is to confirm the efficacy and safety of the optimal effective dose of
      the PQ Grass 27600 SU dose. Efficacy will be determined through the measurements of the
      effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis
      and the use of relief medications to control these symptoms during the peak GPS.
    

Intervention name(s): PQ Grass; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Suspension for Injection; Solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
Condition: HIV-infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study to assess safety and tolerability of VM-1500 and to determine main
      pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy
      subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, phase Ib study in healthy volunteers
      with dose escalation to identify the optimal dosing schedule of VM-1500.

      A total of 36 subjects will be treated with the VM-1500 or placebo for 14 days with further
      follow-up for four weeks. Subjects will be randomized into 3 cohorts with 3:1 drug/placebo
      ratio:

      Cohort 1 (n=12): 10 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 2 (n=12):
      20 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 3 (n=12): 30 mg VM-1500 for
      9 volunteers, Placebo for 3 volunteers; Decision to escalate to the next (higher) dose will
      be made by the Independent Safety Review Board (ISRB), established specifically for this
      study. ISRB will base its decision on both the safety data obtained during drug
      administration in each cohort and analysis of clinical and lab data obtained within the
      course of the study.

      Study time lines:

        -  Screening period - up to 30 days

        -  Treatment period - 14 days dosing (Day 1-14)

        -  2 hospitalizations: Day 1-3, Day 13-15

        -  28 PK samples in plasma: Day1 - predose, 0,25; 0,5; 1; 1,5; 2; 3; 4; 8; 12 hours Day 3,
           Day 5, Day 7, Day 9, Day 11, Day 13 - before dosing Day 14 (feed condition) - before
           dosing, 0,5; 1; 2; 4; 8; 12h Day 16, Day 23, Day 30, Day 37, Day 44 PK in blood cells -
           Day 1 (predose, 4h, 8h), Day 3, 5,7, 9, 11, 13, 14

        -  Post treatment follow-up period 30 days.
    

Intervention name(s): VM-1500; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VM-1500; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?
Condition: COPD
Study type: Observational

Summary: 
      The purpose of our study is to assess the impact of pulmonary rehabilitation on objective
      sleep quality in COPD patients.
    

Detailed description: 
      COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and
      respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation
      between altered sleep quality and low activity levels have been shown in this population. In
      primary insomnia, it is well established that physical activity has a positive impact on
      sleep quality.

      The purpose of our study is to assess the impact of pulmonary rehabilitation on objective
      sleep quality in COPD patients.
    

Intervention name(s): pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients physically able to follow a pulmonary rehabilitation program
      
Keywords: COPD; pulmonary rehabilitation; insomnia; sleep quality; physical activity
Mid-Urethral Sling Tensioning Trial
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Prospective randomized clinical trial comparing two methods of intra-operative tensioning of
      retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of
      abnormal bladder function. Secondary outcomes include validated quality of life scores,
      physical exam findings, and rates of immediate post operative voiding dysfunction.
    


Intervention name(s): Retropubic Midurethral Sling
Intervention type(s): Device
Other intervention name(s): Tension free Vaginal Tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tension-Free Vaginal Tape; Suburethral Slings; Midurethral Slings; Mid-urethral sling; urinary retention
A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825
      in healthy volunteers.
    


Intervention name(s): MAS825; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose i.v. and s.c.; single dose i.v. and s.c.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
Condition: Social Anxiety Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in
      response to deviations from the embedded contingency in attention bias modification treatment
      (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and
      clinical improvement.

      ***As of September 2017, recruitment of SAD participants has concluded.
    

Detailed description: 
      all participants, suffering from either social anxiety disorder or generalized anxiety
      disorder, will receive 6 sessions of ABMT, adapted for an oddball paradigm. two of the
      sessions will also include simultaneous EEG measurement. the goal of the study is to
      determine the emergence of vMMN in response to trials deviating the embedded contingency and
      to examine the correlation between vMMN emergence and clinical improvement of anxiety
      symptoms.
    

Intervention name(s): ABMT
Intervention type(s): Behavioral
Intervention description(s): Participants will be trained with a dot-probe task including angry-neutral faces. The task will be adapted for the oddball paradigm, such that in 80% of trials the probe will appear in place of the neutral face, and in 20% of trials in place of the angry face.
Other intervention name(s): attention bias modification
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABMT; social anxiety; generalized anxiety
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study's primary goals are to test the safety and effectiveness of Tobramycin for
      Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of
      age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already
      been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung
      fluid will be examined for bacteria before and after the 28-day treatment. The amount of
      bacteria before and after treatment will be compared. This will indicate whether the
      antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients
      will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the
      patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr
      but contains no medication).
    


Intervention name(s): Tobramycin for Inhalation
Intervention type(s): Drug
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema
Condition: Pulmonary Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional

Summary: 
      The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin
      quantitative and functional deficiency in an adult French population presenting with
      pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative
      and/or functional deficiency will be displayed.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the efficacy and safety of 4 doses of BI
      1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in
      patients with asthma in comparison to placebo.
    


Intervention name(s): Placebo; Olodaterol (BI 1744) high; Olodaterol (BI 1744) medium; Olodaterol (BI 1744) very low; Formoterol 12 mcg; Olodaterol (BI 1744) low
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler; Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat; Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat; Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat; Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups; Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Intervention MeSH terms: Formoterol Fumarate; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
Condition: Overweight; Obesity; Sedentary Lifestlye
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The aim of the current study is to demonstrate that a commercial weight management diet (i.e.
      low energy density) influences satiation, hunger and satiety and leads to lower energy intake
      during ad-libitum meals and over a full day. We further seek to demonstrate the
      sustainability of this effect following 12- week weight loss on the weight management
      program.

        -  We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater
           fullness and reduced desire to eat compared to standard meals.

        -  We hypothesise that the commercial weight management program will lead to greater weight
           loss compared to control program.

        -  We hypothesise that formulated meals (high consumer acceptance) will improve hedonic
           control over eating (lower wanting for high fat food)

        -  We hypothesise that the commercial weight management program will improve hedonic
           control over eating (reduced experience food cravings)
    


Intervention name(s): Weight management program
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to determine the specificity and sensitivity of the combined growth
      hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly
      probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.
    

Detailed description: 
      The randomisation was carried out before the first test was performed. In order to be
      informed of the subject's randomisation group, the investigator phoned the access number
      given to him/her. The subject's allocation to a given randomisation arm was determined on the
      basis of a centralised randomisation (answering service), balanced per group of subjects with
      a minimisation on 2 criteria: age and BMI.

      This was a centralised randomisation using a Interactive Voice Response System (IVRS) which
      was balanced in each of the following 3 categories of subjects:

        -  Category A = healthy volunteers,

        -  Category B = subjects with a strong probability of deficit in GH,

        -  Category C = subjects with a low probability of deficit in GH.

      In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined
      by the following randomisation group:

        -  Group 1: GHRH+Arg, GHRH+Arg, ITT or

        -  Group 2: ITT, ITT, GHRH+Arg.
    

Intervention name(s): GHRH+Arg, GHRH+Arg, ITT; ITT, ITT, GHRH+Arg.
Intervention type(s): Other; Other
Intervention description(s): GHRH+Arg repeatability test (2 tests) + comparison with one IT test; IT repeatability test (2 tests) + comparison with one GHRH+Arg test
Intervention MeSH terms: Growth Hormone-Releasing Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GH secretion tests; adverse effects; adult growth hormone deficiency; growth-hormone releasing hormone and arginine test; insulin tolerance test; GHRH + Arginine test
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
Condition: Advanced Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the tolerability and efficacy of the addition of
      rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous
      infusion of gemcitabine in combination with cisplatin in the treatment of patients affected
      by advanced non-small cell lung cancer.
    

Detailed description: 
      The primary end-points of the GECO study

        -  To evaluate the tolerability of three innovative schedules of treatment for advanced
           NSCLC

        -  To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the
           treatment of patients affected by advanced NSCLC

        -  To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with
           the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30
           minutes, in combination with cisplatin, in the treatment of patients affected by
           advanced NSCLC

      Four treatment arms are planned.

        -  ARM A standard treatment : cisplatin + gemcitabine

        -  ARM B cisplatin + gemcitabine + rofecoxib

        -  ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute)

        -  ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib

      The phase II part of the study for experimental arms B, C and D will be conducted to evaluate
      tolerability in the three treatment arms.

      The phase III study for efficacy has been designed according to a factorial 2x2 model with
      the planned comparison of

        -  The efficacy of rofecoxib: A + C (arms without rofecoxib) vs B+D (arms with rofecoxib)

        -  The efficacy of p.c.i. gemcitabine: A + B (arms with standard infusion of gemcitabine)
           vs C+ D (arms with p.c.i gemcitabine)
    

Intervention name(s): gemcitabine; prolonged continuous infusion gemcitabine; cisplatin; rofecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Rofecoxib; Gemcitabine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prolonged continuous infusion; Cox-2 inhibitors
Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial
      to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as
      measured by hemoglobin A1c (HbA1c).
    


Intervention name(s): Exenatide (AC2993); Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks; subcutaneous injection, once daily; forced titration to target blood glucose level
Other intervention name(s): Byetta; Lantus
Intervention MeSH terms: Insulin Glargine; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Insulin glargine; comparator; Amylin; Lilly
Physical Training Per se
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The investigators aimed to evaluate the health benefits of physical training per se, weight
      loss per se and exercise-induced weight loss in young, overweight men. The investigators
      hypothesized that physical training would have independent effects on various health
      parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass,
      waist circumference, blood pressure and key muscle proteins), and that a concomitant weight
      loss from physical activity would increase the effect.
    

Detailed description: 
      At baseline, during the intervention and in the week following the intervention participants
      underwent a panel of tests:

        -  Cardio respiratory fitness

        -  blood pressure

        -  anthropometric measures

      At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to
      asses insulin sensitivity.

      Tissue and blood samples were also collected for further analysis:

        -  Total-protein analysis of selected proteins

        -  Fasting plasma glucose, insulin and free fatty acids
    

Intervention name(s): 12 weeks of lifestyle change
Intervention type(s): Behavioral
Intervention description(s): Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Impact of Distress on the IVF Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment,
      and it may have a detrimental impact on pregnancy rates, yet there is minimal published
      research on the efficacy of structured skills-based psychological interventions with assisted
      reproductive technology (ART) patients. The objective of this study is to determine if women
      who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will
      have higher pregnancy rates than controls (C).

      This is a randomized, controlled prospective study conducted at a private
      academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled
      to undergo their first IVF cycle. Subjects are randomized via computer generated random
      numbers table to a 10 session mind/body program or a control group and followed for two IVF
      cycles. The primary outcome measure is clinical pregnancy rate.
    


Intervention name(s): Mind/Body Program; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten week group mind/body program; Spa gift certificates
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF, Mind/Body