bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects
Condition: Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.
    


Intervention name(s): TQ-B3101
Intervention type(s): Drug
Intervention description(s): TQ-B3101 oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of XSurge Supplementation on Biomarkers and Performance From High Intensity Resistance Exercise
Condition: Exercise Performance Recovery
Study type: Interventional

Summary: 
      Part one of this study will consist of baseline (BL) testing, 28 days of daily
      supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists
      of five visits, of which, the first visit will consist of maximal strength testing. The
      remaining visits will consist of performance testing and muscle evaluation.

      Phase two of this study will consist of six weeks of supervised resistance training along
      with supplementation of XSurge. Following the six weeks of training, subjects will complete a
      second acute exercise protocol. Measures to be evaluated will consist of performance testing
      and muscle evaluation.
    


Intervention name(s): XSurge; Placebo: Microcrystalline Cellulose; Control: No supplementation
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): During part one of the study, 28 days of supplementation with XSurge will be provided. During the second part of the study 6 weeks of supplementation with XSurge will accompany a training program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine
      compared with placebo in outpatients with binge eating disorder
    


Intervention name(s): lisdexamfetamine; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): oral; 20-70mg/day; 20-70mg; oral
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vasoconstriction Trial With LEO 90100 Aerosol Foam
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Vasoconstriction study with LEO 90100
    

Detailed description: 
      This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone
      ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching
      test
    

Intervention name(s): LEO 90100 aerosol foam; Dermoval®/Dermovate®; Diprosone; Elocon; Locoid; LEO 90100 foam vehicle
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Clobetasol; Betamethasone-17,21-dipropionate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Biomarkers of Meats and Potatoes Intake
Condition: Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      This cross-over meal study is a four-way intervention with 12 volunteers randomized at the
      same time to four meals with fried meats (beef, pork, chicken and amino-acid matched non-meat
      control) and to four meals with potato products (boiled, chips, fries, and a control with
      boiled white rice) to search for biomarkers of intake.
    

Detailed description: 
      In a two-dimensional, cross-over meal study, 12 healthy volunteers consumed in a randomized
      sequence four test meals: chicken, pork, beef, and a control made of egg white and pea. At
      the same time they were independently randomized to four starchy foods to be consumed
      together with the meats: boiled potatoes, fried potatoes, potato crisps or boiled white rice.
      Fasting and postprandial urine samples were collected to cover 48 h after each meal and
      samples were profiled by untargeted LC-ESI-qTOF-MS metabolomics. The profiles following the
      meal challenges were explored by univariate and multivariate analyses and single and combined
      markers of intake identified chemically by MS/MS fragmentation experiments and statistically
      by ROC curves and error rates as well as FDR statistics.
    

Intervention name(s): Meat arm; Starchy foods arm
Intervention type(s): Other; Other
Intervention description(s): Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination; Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Subjects were randomised to four meals with meats and starchy foods in such a way that all volunteers had each meat and each starchy food once and so that all combinations of meats and starchy foods were equally common. Each volunteer was also randomised to the sequence of the meals.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Biomarkers of food intake
Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Condition: Central Serous Chorioretinitis
MeSH terms: Chorioretinitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the study is to evaluate the effect of spironolactone on 16 patients
      presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate
      whether spironolactone can resolve sub retinal fluid in these patients.

      CSCR is a major cause of visual loss in the young population. It is characterized by sub
      retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes
      of the disease remain unknown but a choroidopathy has been suggested. Moreover,
      corticotherapy and stress are known risk factors of CSCR.

      Our preclinical studies have demonstrated that the mineralocorticoid pathway could be
      involved in the control of choroidal blood flow.

      The investigators propose to evaluate the mineralocorticoid receptors antagonist
      spironolactone in the treatment of CSCR.

      Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint:
      visual acuity gain ≥ 15 EDTRS letters
    

Detailed description: 
      This is a prospective placebo controlled cross over study including 16 patients
    

Intervention name(s): Spironolactone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg tablet once a day for 1 month; one tablet once a day for 1 month
Other intervention name(s): aldactone
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: retina
A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 Radio-labeled SRT2104 in Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the absolute bioavailability of SRT2104
      as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.

      The secondary objective of this study is to assess the potential systemic metabolite burden
      of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and
      identification.
    

Detailed description: 
      This will be a single centre, combined IV and oral single dose, open-label study in healthy
      male volunteers.

      Each subject will receive the following formulations on a single study day:

        1. Regimen A: A single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension
           formulation;

        2. Regimen B: A single intravenous dose of 10 mL containing 100 µg (not more than 250 nCi,
           9.25 kBq) Carbon-14 radio-labeled SRT2104 , administered by IV infusion over 15 minutes,
           starting 2 hours and 45 minutes after the oral dose.
    

Intervention name(s): 250 mg SRT2104 Suspension; Carbon-14 radio-labeled SRT2104
Intervention type(s): Drug; Drug
Intervention description(s): Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation.; Single 10 mL IV dose containing 100 microgram (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104, administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose is administered.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Headstrong Intervention for Pediatric Headache
Condition: Chronic Headaches
MeSH terms: Headache Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is
      effective in helping children cope with chronic headaches.
    

Detailed description: 
      Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM
      program or the Headstrong CD-ROM program. We anticipate that those assigned to the active
      (Headstrong) program group will have significantly greater reductions in headache frequency,
      duration, and severity and improvements in mood and quality of life.
    

Intervention name(s): Educational CD-rom; Headstrong CD-rom
Intervention type(s): Other; Other
Intervention description(s): Educational CD-Rom; Headstrong CD-rom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; tension headaches; chronic daily headaches
Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With CF, PCD and Healthy Children
Condition: Primary Ciliary Dyskinesia; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Ciliary Motility Disorders; Dyskinesias; Fibrosis
Study type: Observational

Summary: 
      The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise
      capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.
    

Detailed description: 
      The impaired airway clearence and pulmonary functions, exercise intolerance, low physical
      activity level and decreased peripheral muscle strength make physiotherapy approaches
      important in the management of CF and PCD.
    

Intervention name(s): Measurement of functional capacity; pulmonary function test; Functional capacity; Peripheral muscle strength; Respiratory muscle strength
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Functional capacity of participants will be measured with six-minute walk test.; It will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75; Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test; Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.; Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children diagnosed with cystic fibrosis and primary ciliary dyskinesia and age matched
        healthy volunteers who do not have any diagnosed chronic diseases
      
Keywords: respiratory functions; exercise capacity; muscle strength
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Gates MRI-RSM01-101 is a Phase 1, randomized, double-blind, placebo-controlled,
      dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence
      of ADA, and assessment of neutralizing antibody against RSV after administration of single
      intravenous or intramuscular doses of RSM01 to healthy adults.
    

Detailed description: 
      Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract
      infection (LRTI) among infants and young children, resulting in annual epidemics worldwide.

      RSM01, a monoclonal antibody targeting RSV, may potentially provide an effective method to
      protect infants from RSV disease based on its potency and an extended half-life that is
      expected to support once-per-RSV-season administration.

      This study is a first-in-human evaluation of RSM01 in healthy male and female adults with the
      goal of characterizing the safety and tolerability of a range of single doses of RSM01 to
      enable determination of appropriate dose(s) to be administered to infants in a future study.
      Enrollment is planned at a single study center in the United States. Approximately 56
      participants will be enrolled; 48 participants to receive RSM01 and 8 participants to
      received placebo. Participants will be followed for approximately 5 months (151 days) after
      dosing.
    

Intervention name(s): RSM01; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cohort 1: RSM01 300 mg IV
Cohort 2: RSM01 300 mg IM
Cohort 3: RSM01 1000 mg IV
Cohort 4: RSM01 3000 mg IV
Cohort 5: RSM01 ≥ 300 mg - ≤ 600 mg IM; Cohort 1: Placebo IV
Cohort 2: Placebo IM
Cohort 3: Placebo IV
Cohort 4: Placebo IV
Cohort 5: Placebo IM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled study of RSM01. The study will be conducted in 2 parts: A Dose Escalation Phase (28 participants) with 4 dosing cohorts, followed by an Expansion Phase (28 participants) with a single cohort.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cranial Osteopathy in Functional Disorders of the Newborn
Condition: Newborn Complication
Study type: Interventional

Summary: 
      To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction
      of the hyper irritability of the newborn and the improvement of the postural abnormalities
    


Intervention name(s): cranial osteopathy; comfort massage
Intervention type(s): Other; Other
Intervention description(s): two sessions at three weeks intervals; manipulation, comfort massage, standardized and not affecting the skull
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: osteopathy; cranial
Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects
Condition: Symptomatic Neurogenic Orthostatic Hypertension; nOH
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in
      healthy subjects.
    

Detailed description: 
      A single-center, randomized, double-blind, placebo controlled, positive controlled, multiple
      dose, parallel group study will be conducted in healthy male and female subjects. Subjects
      will be randomized to one of 3 groups:

      Subjects in Group 1a (n=18) will be administered moxifloxacin placebo on Day 1, ampreloxetine
      placebo from Day 1 to Day 15, and moxifloxacin <Dose A> on Day 15.

      Subjects in Group 1b (n=18) will be administered a single oral dose of moxifloxacin <Dose A>
      on Day 1, ampreloxetine placebo from Day 1 to Day 15 and moxifloxacin placebo on Day 15.

      Subjects in Group 2 (n=36) will be administered moxifloxacin placebo on Day 1 and on Day 15,
      and ampreloxetine <Dose A> from Day 1 to Day 7, ampreloxetine <Dose B> from Day 8 to Day 14,
      and ampreloxetine placebo on Day 15.
    

Intervention name(s): Ampreloxetine <Dose A>; Ampreloxetine <Dose B>; Ampreloxetine Placebo; Moxifloxacin; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ampreloxetine <Dose A> will be administered as 1 tablet of <Dose A> and 3 tablets of Ampreloxetine Placebo.; Ampreloxetine <Dose B> will be administered as 4 tablets of <Dose A>; Ampreloxetine Placebo will be administered as 4 tablets of placebo. The placebo tablet will match (in appearance) the ampreloxetine <Dose A> tablet.; Moxifloxacin will be administered orally as a single tablet.; Moxifloxacin placebo will be administered orally as a single tablet. The placebo tablet will match (in appearance) the moxifloxacin tablet.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic neurogenic orthostatic hypertension; nOH; Thorough QT; Symptomatic nOH
A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand the effects of liver functional impairment on the
      study medicine (PF-07081532). People with liver functional impairment may process the study
      medicine differently from healthy people.

      We are seeking participants who:

        -  Are between 18 and 70 years of age;

        -  Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight
           >50 kg (110 lbs.).

      Participants will take the study medicine as a tablet once at the study clinic, and then will
      stay onsite for about 7 days. During this time, the study team will monitor their treatment
      experience and take some blood samples to test the level of PF-07081532. This will help us
      understand if certain level of liver functional impairment could affect the study medicine
      being processed in the body.
    


Intervention name(s): PF-07081532
Intervention type(s): Drug
Intervention description(s): PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic impairment; Healthy volunteers
Enhancing Physical Activity and Healthy Aging Among Recent Retirees
Condition: Exercise; Aging; Retirement
Study type: Interventional

Summary: 
      The purpose of REACT project is to provide cost-effective way to promote physical activity
      and reduce sedentary time among older adults. This is done by examining the efficacy of
      activity tracker based intervention on wake-time physical activity, sedentary time, sleep and
      other health outcomes among recent retirees. REACT study will be the first randomized
      physical activity trial targeted to time window right after retirement.
    


Intervention name(s): Polar Loop 2 activity tracker
Intervention type(s): Device
Intervention description(s): The participants were instructed to aim to reach the daily activity goal, initially set at stage 1 as per the goals set by the trackers' manufacturer. The daily activity goal was based on user's typical daily activities, gender and age. The stage 1 daily activity goal corresponded to ~1h/day of jogging or ~2h/day of walking or ~7h/day household activities or a combination of these activities. The tracker gave an inactivity alert as a vibration and text "it's time to move" on the screen of the tracker if the user has been still for 55 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical activity; Sedentary time; Intervention; Retiree
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this research study is to compare the pregnancy rates for two different types of
      progesterone supplementation after in-vitro fertilization (IVF).
    

Detailed description: 
      The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing
      an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect
      to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular
      progesterone).
    

Intervention name(s): Crinone 8% Vaginal Gel; Intramuscular Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.; Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
Other intervention name(s): IVF-ET; Pregnancy; luteal phase support; Crinone; Intramuscular progesterone; vaginal progesterone; Other Names:; IVF-ET; Pregnancy; luteal phase support; Crinone; vaginal progesterone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; In vitro fertilization; Embryo transfer; Crinone; Intramuscular Progesterone; Progesterone support
Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children
Condition: Allergic Asthma
Study type: Observational

Summary: 
      The purpose of the study is to investigate, whether the FeNO concentration of asthmatic
      children is influenced differently by inhaled corticosteroid compared to inhaled
      corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO
      concentration is more decreased in patients with a combination therapy compared to those with
      a corticosteroid mono therapy.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Allergic asthmatics
A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics
      of ALKS 5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Sublingual tablet given alone and in conjunction with Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; Samidorphan; ALKS 5461; Healthy Volunteer; Pharmacokinetics