bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on
           Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the
           morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours
           interval in healthy male and female subjects

      Secondary Objectives:

        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when
           clopidogrel is given either alone alone in the morning, or in association with
           omeprazole in the evening at a 12-hours interval
    

Detailed description: 
      The total study duration per subjects is 8-9 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing

        -  Period clopidogrel/placebo: 7 days including 5 days treatment

        -  Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment

        -  Washout between periods: at least 14 days period after last dosing respect to
           clopidogrel treatment

        -  End of study: at 7 to 10 days after the last dosing
    

Intervention name(s): clopidogrel; Placebo; omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: matching tablet
Route of administration: oral; Pharmaceutical form: delayed-release capsule
Route of administration:oral
Other intervention name(s): SR25990
Intervention MeSH terms: Omeprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
Condition: Asthenozoospermia
MeSH terms: Asthenozoospermia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in
      asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve
      it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds
      which are susceptible to oxidation and production of free oxygen radicals.
    


Intervention name(s): vitamin E; DHA; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      We will evaluate the bioavailability of naproxen 375 mg in two formulations
    


Intervention name(s): PN400; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): naproxen 375 mg / esomeprazole 20 mg; naproxen 375 mg
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of CLA Supplements on Body Weight and Fat Oxidation
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural
      sources. When given to small animals, decreases of body fat have been noted.. Although weight
      loss is the best treatment for overweight and obesity, it is difficult to maintain the loss
      in the long term. Because of this, treatment emphasis has turned to small weight losses
      obtained through non-restrictive diets and prevention of weight regain. This is a study to
      determine if 6 months of consumption a purified form of CLA will result in greater loss of
      body fat than control and to determine whether CLA consumption increases total fat oxidation,
      which would help explain why the weight loss occurs.
    

Detailed description: 
      Subjects were screened and then underwent baseline evaluation. The substudy evaluation
      measured 24-h energy expenditure and substrate utilization by using a whole-room indirect
      calorimeter. Dietary fat oxidation was measured by mixing [1-13C]oleate and D31-palmitate
      into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end
      products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers
      (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo
      as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.
    

Intervention name(s): conjugated linoleic acid
Intervention type(s): Drug
Intervention description(s): 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to evaluate the safety, tolerability and immunogenicity of
      ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60
      years or older who are healthy or who have stable, chronic underlying medical conditions.
      This study will also provide preliminary safety and immunogenicity data to support concurrent
      dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a
      dose previously assessed in the Phase 1a study.
    

Detailed description: 
      A Phase 1b, double-blind, randomized, controlled cohort escalation study evaluating the
      safety, tolerability and immunogenicity of MEDI7510.

      Approximately 264 subjects will be enrolled at approximately 5 study centers in the US and
      randomized by cohort (Cohort 1 [4:1]; Cohorts 2 and 3 [8:8:3]; Cohort 4 [5:1]) to receive a
      single intramuscular dose of 1 study vaccine (Cohorts 1 and 4) or a single intramuscular dose
      of each of 2 study vaccines (Cohorts 2 and 3) administered in contralateral arms.

      Cohort 1: MEDI7510 formulation (n = 40) or IIV (n = 10) Cohort 2: MEDI7510 formulation and
      placebo (n = 40) or MEDI7510 formulation and IIV (n = 40) or placebo and IIV (n = 15) Cohort
      3: MEDI7510 formulation and placebo (n = 40) or MEDI7510 formulation and IIV (n = 40) or
      placebo and IIV (n = 15) Cohort 4: MEDI7510 formulation (n = 20) or IIV (n = 4)
    

Intervention name(s): MEDI7510; IIV
Intervention type(s): Biological; Biological
Intervention description(s): RSV sF antigen plus adjuvant; Marketed Inactivated Influenza Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV; Older adults; MEDI7510; Vaccine
Safety and Efficacy Study of EPI-743 in Children With Leigh Syndrome
Condition: Leigh Syndrome
MeSH terms: Leigh Disease; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of EPI-743 in children with Leigh
      syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity
      and mortality and disease associated biomarkers.
    

Detailed description: 
      The purpose of this study is to evaluate the effects of EPI-743 in patient with Leigh
      syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity
      and mortality and biomarkers associated with the disease.

      This study is a six month prospective randomized double-blind, placebo-controlled trial with
      a six month extension phase of two dose levels of EPI743. The planned enrollment is for
      approximately 30 children with genetically confirmed Leigh syndrome. After 6 months of
      treatment, those children that were randomized to the placebo treatment arm will be
      re-randomized to one of the 2 active treatment arms.
    

Intervention name(s): Placebo; EPI-743 15 mg/kg; EPI-743 5 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ubiquinone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EPI743; Leigh syndrome; respiratory chain disease; mitochondrial disorders
Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Capecitabine is active in metastatic breast cancer but the conventional schedule (1250
      mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in
      up to 50% of patients leading to those reductions. There are theoretical reasons to
      administer S-phase specific agents in continuous, protracted rather than intermittent
      schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks
      on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter
      administer approximately the same cumulative dose of capecitabine as the standard schedule.
      The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from
      50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor
      activity in both arms.
    

Detailed description: 
      Capecitabine is active in metastatic breast cancer but the conventional schedule (1250
      mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in
      up to 50% of patients leading to those reductions. Some authors have tested continuous
      administration schedules of capecitabine, showing better tolerance and apparently similar
      antitumor activity. Capecitabine is a pro-drug of 5-FU and mimics an i.v. continuous infusion
      administration of this antimetabolite. On the other hand, there are theoretical reasons to
      administer S-phase specific agents in continuous, protracted rather than intermittent
      schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks on, one week
      off)with a continuous administration schule (800 mg/m2/12hr). The latter schedule administer
      approximately the same cumulative dose of capecitabine as the standard one. The study
      hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50%
      (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity
      in both arms.
    

Intervention name(s): Capecitabine
Intervention type(s): Drug
Other intervention name(s): xeloda
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capecitabine; schedule; breast cancer
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Condition: Moderate to Severe Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2b study is designed to have all subjects go into a 12 week induction period to
      compare different doses of study drug against placebo. After induction is complete all
      subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
    


Intervention name(s): Induction- PF-06480605 50 mg SC Q4W; Induction- PF-06480605 150 mg SC Q4W; Induction- PF-06480605 450 mg SC Q4W; Induction- Placebo SC Q4W; Chronic- PF-06480605 50 mg SC Q4W; Chronic- PF-06480605 150 mg SC Q4W; Chronic- PF-06480605 450 mg SC Q4W
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug; Drug
Intervention description(s): PF-06480605; PF-06480605; PF-06480605; 0 mg Placebo; PF-06480605; PF-06480605; PF-06480605
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
Condition: Kidney Failure, Chronic
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to compare the single dose pharmacokinetics of
      alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of
      matched healthy subjects. The secondary objective was to evaluate the safety and tolerability
      of a single dose of alisporivir when administered to subjects with ESRD.
    


Intervention name(s): Alisporivir
Intervention type(s): Drug
Intervention description(s): Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
Other intervention name(s): DEB025
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether wheelchair handrail compensator plus
      rehabilitation training could do better than ordinary wheelchair plus rehabilitation training
      in relieving pain and improving daily life activity, upper limb motor function and quality of
      life for patients with hemiplegic shoulder pain.
    

Detailed description: 
      The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb
      position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board
      supports has been used to prevent shoulder pain and could be recommended for wheelchair users
      to keep normal position. Therefore, the investigators designed the equipment wheelchair
      handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using
      of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement
      of upper limb function and increase of the quality of life.The aim of this study was to
      evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation
      training for people with hemiplegic shoulder pain.
    

Intervention name(s): Wheelchair handrail compensator; Ordinary wheelchair
Intervention type(s): Device; Device
Intervention description(s): Patients were treated by wheelchair handrail compensator for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks. The handrail compensator would help the paralysis upper limb kept the shoulder joint stretch forward, the elbow joint extend, the forearm in pronation, the wrist in flection and the fingers extend.; Patients were treated by ordinary wheelchair for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks.The ordinary handrail could prevent the disable arm from sinking, but could not help the upper limp keep a normal position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemiplegia; shoulder pain; wheelchair; stroke; rehabilitation
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
Condition: Malaria; Anaemia
MeSH terms: Malaria; Anemia
Study type: Interventional

Summary: 
      Although the risk of malaria is greatest in early childhood, significant numbers of
      schoolchildren remain at risk from malaria infection, clinical illness and death. By the time
      they reach school, many children have already acquired some clinical immunity and the ability
      to limit parasite growth, and thus most infections are asymptomatic and will go undetected
      and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and
      learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage
      may bring education, as well as health, benefits.

      Intermittent parasite clearance (IPC) delivered through schools is a simple intervention,
      which can be readily integrated into broader school health programmes, and may usefully
      supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a
      policy of universal coverage of nets.

      This study seeks to establish whether intermittent parasite clearance undertaken once a year
      at the end of the malaria transmission season can reduce malaria parasite carriage and
      anaemia amongst school-going children already using insecticide-treated nets, and its
      consequent impact on school attendance and performance, in order to assess its suitability
      for inclusion as a standard intervention in school health programmes in areas of seasonal
      malaria transmission.
    


Intervention name(s): Intermittent parasite clearance; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days; Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: malaria; anaemia; cognition; intermittent preventive treatment; children; schools; insecticide-treated nets
A Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, blinded, randomized, placebo controlled, dose escalation study. Up
      to 9 healthy male volunteers will participate in the study. This study is designed to
      investigate the use of delayed release tablets for colonic delivery of Brilacidin.
    

Detailed description: 
      Brilacidin is a fully synthetic, non-peptidic, host defense protein mimetic, and has been
      shown to demonstrate anti-inflammatory and antibacterial activities.

      Two prototype tablets have been developed to contain 50 mg or 100 mg of Brilacidin. Matching
      placebo tablets have also been developed. In this Phase 1 study, the delayed release
      prototype tablets will be tested to confirm efficient and specific target release of
      Brilacidin in the colon and to assess the safety, tolerability and the pharmacokinetics of
      Brilacidin administered directly to the colon.

      Three subjects will be enrolled into each cohort of the study. Each subject will receive one
      treatment at one Assessment Visit. In each cohort, two subjects will receive a Brilacidin
      containing dose, and one subject will receive placebo.

      Cohort 1: 50 mg Brilacidin or Placebo; Cohort 2: 100 mg Brilacidin or Placebo; Cohort 3: 200
      mg Brilacidin (as 2 x 100 mg Brilacidin tablets) or 2 x Placebo.

      Each treatment (drug and placebo) will be radiolabelled with technetium-99m (99mTc). The
      radiopharmaceutical, 99mTc-DTPA, does not enter the systemic circulation and is routinely
      used for investigations of this type. In Cohort 1 and 2 each tablet, including placebo, will
      be radiolabelled to contain approximately 4 MBq 99mTc-DTPA at time of dosing. In Cohort 3
      each individual tablet, active or placebo, will be radiolabelled with 2 MBq 99mTc-DTPA to
      give a total dose of 4 MBq per treatment.

      Each tablet will be taken orally with 200 mL room temperature water with subjects in the
      fasted state. The gastrointestinal transit and release behavior of the tablets will be
      studied using gamma scintigraphy. Blood samples will be taken at pre-defined times to allow
      pharmacokinetic (PK) evaluation of drug absorption with respect to time and location of
      tablet release.
    

Intervention name(s): Brilacidin; Placebo; 4Mq 99mTc-DTPA
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Brilacidin; Placebo; 4Mq technetium-99m (99mTc), complexed with diethylenetriaminepentaacetic acid (DTPA) which prevents absorption of the radioisotope from the gastrointestinal tract
Intervention MeSH terms: Brilacidin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the
      dopamine receptor occupancy of LB-102 at various doses and timepoints.
    

Detailed description: 
      This is a Phase 1, open label study designed to evaluate the dopamine receptor occupancy in
      healthy subjects. There will be 4 cohorts consisting of 4 subjects each. Eligible subjects
      will receive 1 or 2 doses of LB-102 on Day 1: subjects in the final cohort will be dosed for
      5 days BID (ie twice/day) on an inpatient basis. This will be an open label study. Blood
      samples for pharmacokinetic (PK) and safety assessments will be collected at screening,
      immediately pre-dose, and during/before/after PET scan. Subjects enrolled in the inpatient
      cohort will be monitored daily. Follow-up after discharge will consist of a phone call the
      evening of discharge and the next day to check on subjects. This will be an adaptive study
      and doses in cohorts 2-4 will be determined after PET data from Cohort 1 are obtained.
    

Intervention name(s): LB-102
Intervention type(s): Drug
Intervention description(s): (N-Methyl amisulpride)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-121 is being developed for use in the treatment of autistic disorder (AD).

      This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over
      single-site Phase I study.

      The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121
      in subjects ages 15 to 45 years with AD.

      Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in
      order to inform later stage trials.
    


Intervention name(s): SB-121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB-121 is a formulation of L. reuteri; Placebo oral formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lactobacillus reuteri; autistic disorder; microbiome