bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants
Condition: Low Birth Weight; Perinatology; Iron Status; Cord Clamping
MeSH terms: Body Weight; Birth Weight
Study type: Interventional

Summary: 
      Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min
      after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron
      status until six months after birth, without increasing the risk of polycythaemia or other
      adverse events. We hypothesize that this intervention will also benefit low birth weight
      infants in South Africa.
    


Intervention name(s): Cord clamping
Intervention type(s): Procedure
Intervention description(s): Early vs Delayed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Beta-2 Microglobulin and Serum Cytokines x HAART
Condition: HIV Patients
Study type: Observational

Summary: 
      Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines
      TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy
      (HAART) failure.
    

Detailed description: 
      Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ,
      IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure
      Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals
      were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART
      for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART
      without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with
      TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic,
      clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α,
      IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+
      lymphocytes tests were performed.

      Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic
      failure, genotyping.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu
        School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.
      
Keywords: B-2 microglobulin; Serum cytokines; HIV-1; Resistance; HAART; Therapeutic failure; Genotyping.
A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose pharmacokinetics of rilpivirine (RPV)
      after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV-LA)
      and 'aged' RPV-LA, in healthy adult participants.
    

Detailed description: 
      This is a phase 1 randomized (study medication is assigned by chance), open-label (all people
      know the identity of the intervention), parallel-group, sequential study in healthy adult
      participants to investigate the effect of different storage conditions for RPV-LA on the
      single-dose pharmacokinetics of rilpivirine (RPV) after intramuscular injection. A total of
      60 healthy adult participants will be enrolled in this study. The study will consist of 2
      treatment sessions in a fixed sequential order : session 1 of up to day 8, all participants
      will receive a single oral dose of rilpivirine 25 milligram (mg) tablet on day 1, session 2
      will consists of 2 treatment groups. The participants will be randomized in session 2 on Day
      1 in a 1:1 ratio to Treatments A and B. Each treatment group will receive one IM injection of
      RPV LA on Day 1 of session 2. Session 1 and 2 will be separated by a washout period of at
      least 14 days. The total study duration for each participant will be approximately 6.5
      months. Safety will be monitored throughout the study.
    

Intervention name(s): Rilpivirine (RPV); Rilpivirine Long-Acting Parenteral Formulation (RPV-LA); Aged RPV-LA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive one oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1.; Participants will receive one intramuscular (IM) injection of rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.; Participants will receive one intramuscular (IM) injection of aged rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.
Intervention MeSH terms: Rilpivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rilpivirine; Healthy participants
Understanding Everyday Stress
Condition: Stress; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is being done to better understand how people experience stress in
      everyday life and how that stress may relate to sleep and physical activity. We are also
      testing stress management approaches that are intended to reduce stress responses in everyday
      life.
    

Detailed description: 
      This research study is being done to better understand how people experience stress in
      everyday life and how that stress may relate to sleep and physical activity. We are also
      testing stress management approaches that are intended to reduce stress responses in everyday
      life.

      This study asks participants to carry and use a study-provided smartphone to answer brief
      surveys during daily life for several weeks. On these surveys, participants will self-report
      their stress, mood, thoughts, physical activity, and sleep patterns, as well as a few other
      questions about where they are and what they are doing at each survey. Study participants
      will also wear two commercial devices on their person; one that tracks physical activity and
      the other sleep. Information about stress management will also be provided to participants on
      the study smartphone. At the end of the study, participants will be asked to return the
      smartphone and devices and will receive compensation for their time and effort.

      The overall aim of this study is to determine the effectiveness of two stress management
      interventions, both delivered via the study smartphone, on the outcomes of stress responses,
      sleep, and physical activity.
    

Intervention name(s): Self-monitoring and personalized stress management; Self-monitoring and general stress management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Self-monitoring and personalized stress management education and materials.; Self-monitoring and general stress management education and materials.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress; Stress Management; Health Behaviors; Experimental Medicine; Science of Behavior Change
Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the
      safety and immunogenicity of a 2-injection vaccine Chikungunya virus (CHIKV) virus-like
      particle vaccine (CHIKV VLP) in healthy adults.
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, placebo-controlled, double-blind study to
      evaluate the safety and immunogenicity of a 2-injection vaccine regimen (Day 0 and 28) with
      Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP, VRC-CHKVLP059-00-VP) in
      healthy adults ages 18-60 years old that reside in CHIKV endemic regions.

      The hypothesis is that the vaccine regimen is safe and induces a neutralizing antibody
      response to CHIKV. The primary objectives are to evaluate safety and tolerability of a
      2-injection investigational vaccine regimen of VRC-CHKVLP059-00-VP at 20 mcg compared to
      placebo (PBS) in healthy adults in CHIKV endemic areas. The secondary objective is to
      evaluate neutralizing antibody response in vaccine recipients. The exploratory objectives
      relate to assessing incidence of CHIKV infection in vaccine and placebo recipients, as well
      as antigen-specific humoral and cellular immune responses during the study.

      The expected study duration per subject is approximately 72 weeks with intramuscular (IM)
      injections scheduled at Day 0 and Day 28.
    

Intervention name(s): VRC-CHKVLP059-00-VP; VRC-PBSPLA043-00-VP
Intervention type(s): Biological; Other
Intervention description(s): VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).; VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antibody Response; Immune Response; Healthy Volunteer; Vaccine-Mediated Protection; Chikungunya Virus; Vaccines, Virus-like Particles
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of
      CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor
      fluctuations (OFF episodes). All patients will receive active treatment, but patients will be
      blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study
      for those patients who participated in that study and remain eligible for this study. In
      addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009
      (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as
      CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
    


Intervention name(s): CVT-301
Intervention type(s): Drug
Other intervention name(s): Inhaled levodopa
Intervention MeSH terms: Levodopa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes
Neuromuscular Training in Female Youth Soccer
Condition: Injury;Sports
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      The goal of this clinical trial is to analyze the effectiveness of an NMT-based, injury
      prevention training program ('FIFA 11+ for Kids') in pre-adolescent (Ages 8 to 11) elite
      female soccer players by measuring neuromuscular control and motor coordination through
      pre-intervention and post-intervention testing. As well as monitoring the incidence of injury
      throughout a soccer season.
    

Detailed description: 
      This study will recruit females aged between 8-11 from several teams within a large,
      competitive elite soccer club. Whole teams will be assigned to either the intervention group
      or an age-matched control group. Participants will be informed which group they will be
      placed in prior to participation in the research study. As directed by their respective
      coaches, the intervention group will receive neuromuscular training (NMT) through an already
      established, validated protocol (FIFA 11+ Kids); whilst the control group will perform their
      standard warm-up during soccer practice sessions. The program will last for the duration of
      the spring soccer season (January - May 2023; 5 months). All study participants will be
      required to attend two evaluation sessions (pre-intervention and post-intervention) in order
      to measure performance in speed, agility, hop testing, dynamic balance and strength.
    

Intervention name(s): Neuromuscular Training
Intervention type(s): Other
Intervention description(s): This intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups for this study. The control group performs their standard warm-up during soccer practice sessions and the experimental group performs neuromuscular training (NMT) in the form of the FIFA 11+ Kids program as their warm up.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).
Condition: Skin Androgenization
MeSH terms: Virilism
Study type: Interventional
Phase: Phase 1

Summary: 
      Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum
      excretion rates will be measured before and after 6 weeks of treatment.
    


Intervention name(s): testosterone gel; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks; transdermal placebo gel for 6 weeks
Other intervention name(s): AndroGel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Biomarkers of Skin Androgenization
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the general safety and tolerability of the administration of the 3-dose
      regimen of the MRKAd5+6 trigene vaccine
    


Intervention name(s): V526; Comparator: Placebo to V526
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.; 0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; HIV Seronegativity; Preventive Vaccine
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      Vitamin D deficiency is common after bariatric surgery. This study is designed to determine
      if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin
      D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high
      dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a
      significant rise in serum vitamin D levels compared to the subjects taking only the usual
      vitamin D protocol.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        bariatric surgery
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
Condition: Constipation; Parkinson Disease
MeSH terms: Parkinson Disease; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled
      study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with
      approximately 54 patients allocated to receive the active investigational product and
      approximately 18 patients allocated to receive placebo.

      - Study Update-

      Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized
      1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each
      group.
    

Detailed description: 
      The study will be conducted on an out-patient basis. Each patient will have 6 visits to the
      clinic: a screening visit, a randomization visit, 3 follow up visits, and 1 end of study
      visit.

      Patient randomization will be stratified based upon the baseline weekly complete spontaneous
      bowel movement rate (CSBM) established during the screening period. Patients will be allowed
      to adjust their dosing, based upon protocol specifications. Rescue medications will be
      provided to all patients to ensure they move their bowels on a regular basis.

      Patients will also be asked to participate in up to 2 sub-studies: a pk study and/or a stool
      microbiome study. The first 20 patients to consent to the pk study will have additional blood
      samples taken at randomization and at 2 follow up visits. The first 20 patients to consent to
      the stool microbiome study will provide stool samples at randomization and at 2 follow up
      visits.
    

Intervention name(s): Active Investigational Treatment ENT-01; Placebo Treatment
Intervention type(s): Drug; Drug
Intervention description(s): ENT-01 will be administered in tablet form, once daily.; Placebo will be administered in tablet form, once daily.
Other intervention name(s): ENT-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Weight Gain Management in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Weight Gain; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with
      schizophrenia who have been under treatment with olanzapine for at least two months and
      evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent
      adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
    


Intervention name(s): Olanzapine Hydrochloride; Nizatidine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine; Nizatidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it
      presents as subacute monocular visual loss that develops over several days.

      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term
      beneficial effect on vision.

      There are a number of factors that contribute to nerve fibre damage including increased level
      of sodium, so blocking sodium entry could help to protect them against damage.

      The main objective of the study is determine whether phenytoin (which blocks sodium entry)
      can protect nerve fibre and improve final visual function after optic neuritis.
    


Intervention name(s): Phenytoin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.; 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
Other intervention name(s): epanutin
Intervention MeSH terms: Phenytoin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      One of the urgent priorities in the field of pediatric neuro-rehabilitation is the
      development of efficient early motor interventions for children with cerebral palsy (CP).
      Animal studies suggest that early intensive interventions are likely to have a significant
      impact on the organization of the brain and corticospinal tracts, reducing motor impairments
      and their medium and long-term consequences in children with cerebral palsy. Although most of
      the growth, development and cortical organization takes place in the time course of the first
      2 years of life, most studies investigating the effectiveness of intensive rehabilitation and
      associated neurophysiological mechanisms have been conducted in school-aged children (> 6
      years). In addition, the vast majority of these studies were conducted in children with
      unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is
      therefore a priority to investigate the effectiveness of early interventions on the overall
      motor function of children with CP, especially in children with bilateral form of CP.

      Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it
      possible to apply the concepts of structured motor learning and intensive treatment to both
      the upper limbs and the lower limbs and demonstrated improvements at both levels in
      school-aged children with unilateral CP and bilateral and then at all three International
      Classification of Functioning and Disability levels. The principles and content of HABIT-ILE
      can be applied to pre-school children and this method is promising for early
      neuro-rehabilitation.
    

Detailed description: 
      The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of
      early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with
      bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity
      including usual rehabilitation (control group).
    

Intervention name(s): MRI; Electro-Encephalography-High Density; 3D and EMG analysis; care and classic activities
Intervention type(s): Other; Other; Other; Other
Intervention description(s): MRI at baseline and J90; Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90; 3D and EMG analysis at baseline and J90; physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: cerebral palsy (CP); pre-school children with bilateral CP