bioihbjkbjnl/mcl2 huggingface dataset:
NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass
Condition: Healthy
Study type: Interventional

Summary: 
      this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an
      intermediate profile, rich in leucines and other essential amino acids, can significantly
      enhance muscle mass gain during strength training. This study will compare the efficacy of
      NUTRALYS® to a reference product. If the results of the study demonstrate a significant
      improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be
      considered as an alternative to sports nutrition products, to which many people are
      intolerant.
    


Intervention name(s): oral powder in sachet
Intervention type(s): Other
Other intervention name(s): Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
A Food Effect Study of Apatinib Mesylate in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the effect of high-fat and low-fat meal on
      the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects.

      The secondary objective of the study was to assess the safety of apatinib mesylate
      administered in adult healthy subjects.
    


Intervention name(s): Apatinib Mesylate
Intervention type(s): Drug
Intervention description(s): Single dose of apatinib mesylate after high-fat meal, low fat meal and fast
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV
Condition: Human Immunodeficiency Virus
MeSH terms: Tuberculosis; Acquired Immunodeficiency Syndrome; HIV Infections; Mycobacterium Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination
      in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus
      infection (HIV).
    


Intervention name(s): M72/AS01E Mycobacterium tuberculosis vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive an intramuscular dose of M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29; Participants will receive an intramuscular dose of saline (0.9% NaCl), on Day 1 and Day 29
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mycobacterium tuberculosis; M72/AS01E Vaccine; Antiretroviral therapy; Mtb; HIV; TB vaccine
Milk Ingredients and Resistance Against E-coli-induced GastroEnteritis (MIRAGE)
Condition: Bacterial Infection; Diarrhea; Gastroenteritis
MeSH terms: Bacterial Infections; Gastroenteritis; Diarrhea
Study type: Interventional

Summary: 
      Background: The incidence of gastrointestinal infections is very high. In Western countries
      at least 30% of the population suffers from at least one food-borne infection per year.
      Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of
      infections. One of the possibilities is to strengthen human resistance to gut infections by
      consumption of milk ingredients.

      Aim: To study whether a milk protein concentrate rich in phospholipids improves the
      resistance of humans to enterotoxigenic E. coli (ETEC).

      Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks
      intervention with a milk protein concentrate rich in phospholipids in healthy subjects of
      18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich
      in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain
      their usual pattern of physical activity and their habitual food intake, but to standardize
      their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally
      infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food
      research; dose will be 1010 CFU). Before and after infection, an online diary will be kept to
      record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The
      diary will also be used for daily recording of bowel habits and frequency and severity of
      gastrointestinal complaints.

      The following biological samples will be collected: 4x10 ml venous blood, a single fecal
      bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and
      the fecal samples are collected to quantify several infection- and immune system markers and
      to verify dietary calcium intake. Saliva is sampled three times before and after infection to
      quantify immune system markers.

      Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output
      per day).

      Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and
      gastrointestinal complaints, relative fecal wet weight.
    


Intervention name(s): Milk protein; Milk protein rich in phospholipids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bacterial infection; Dairy; Diarrhea; Diet; E.Coli; Gastroenteritis; Milk; Stool consistency
Cardiac and Respiratory Function With Non-invasive Ventilation
Condition: OHS; Hypercapnic Respiratory Failure
MeSH terms: Respiratory Insufficiency; Hypercapnia
Study type: Observational

Summary: 
      To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output
      measurements and markers of neural respiratory drive (EMGpara) prior to, during and after
      non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The
      investigators hypothesize that the improvement in cardiac function and/or respiratory
      mechanics over time are associated with ongoing improvements in oxygenation, quality of life
      and exercise capacity.
    

Detailed description: 
      Respiratory failure is characterized by the incapacity of the respiratory system to maintain
      the normal arterial blood gas homeostasis. Specifically, the overlap of hypoxaemia and
      hypercapnia (PaCO2 >6 kPa) is referred to as Hypercapnic Respiratory Failure (HRF). HRF is
      one of the most common causes for hospital admission with high re-admission rates, therefore
      constitute a major burden on healthcare systems. Non Invasive Ventilation (NIV) is a well
      established treatment in patients with hypercapnic respiratory failure who frequently suffer
      with associated pulmonary hypertension (PH). NIV helps to increase arterial oxygenation and
      reduces hypercapnia. It is used in patients with hypercapnic respiratory failure caused by
      Obesity Hypoventilation Syndrome (OHS). The associated degree of PH can lead to an increased
      afterload of the right ventricle (RV) that causes progressive remodelling of the right heart.
      RV dysfunction is correlated with a reduced long term prognosis in respiratory conditions. In
      literature NIV is shown as effective method to treat acute hypercapnic respiratory failure in
      OHS.

      It has not been described how NIV impacts on cardiac function and NRD in OHS.
    

Intervention name(s): Parasternal EMG (EMGpara) and Transthoracic Echocardiography
Intervention type(s): Other
Intervention description(s): OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting with a confirmed diagnosis of OHS and Overlap Syndrome and hypercapnic
        respiratory failure with the clinical intervention to commence on NIV will be invited to
        participate in the trial.
Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, three-period sequential dosing study being conducted to
      determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy
      adults.
    

Detailed description: 
      This is a Phase 1, open-label, three-period sequential dosing study being conducted primarily
      to determine the pharmacokinetics of Triferic iron administered intravenously to healthy
      adults.. Participation will be up to 5 weeks total duration including Screening, Baseline,
      Treatment Period, and Follow-up. Following Screening, subjects will be admitted to the clinic
      on Day -1, prior to Baseline (Day 1). During the Treatment Period, subjects will receive two
      doses of Triferic. Each subject will receive a single 6-mg dose of Triferic administered IV
      over 3 hours (hr) on one day (Day 2), and a single 35-µg/kg dose of Triferic administered IV
      push the following day (Day 3). On Day 4, subjects will be discharged from the clinic and
      will return approximately one week later for their final Follow-up visit.
    

Intervention name(s): Triferic
Intervention type(s): Drug
Intervention description(s): Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Other intervention name(s): ferric pyrophosphate citrate; FPC
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; healthy adult volunteer
A Study of Definitive Therapy to Treat Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of treating men with oligometastatic prostate cancer with the following
      therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant
      androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control
      with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic
      radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen
      deprivation. Androgen blockade will be the same throughout the course of treatment.
    

Detailed description: 
      Neoadjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months
      of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel
      therapy, patients with a prostate-specific antigen response of at least a 50% decrease from
      baseline, will proceed to maximum consolidative therapy.

      Surgery and Radiation (month 7 though ~11): After completion of neoadjuvant therapy, the men
      will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant
      radiation therapy (RT). After definitive local therapy, patients will be treated with
      consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.

      Follow up: Patients will continue on androgen deprivation for a total of 1 year. They will be
      followed clinically and monitored with serum testosterone and prostate-specific antigen until
      2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen blockade
      will be the same throughout the course of treatment.
    

Intervention name(s): Leuprolide Acetate; Bicalutamide; Docetaxel; Prostatectomy; Radiation
Intervention type(s): Drug; Drug; Drug; Procedure; Radiation
Intervention description(s): 22.5mg by intramuscular (IM) injection every 3 months; bicalutamide (Casodex) 50mg by mouth daily; Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.; Removal of the entire prostate gland, plus some surrounding tissue.; 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
Other intervention name(s): Lupron Deport; Casodex; Texotere; Radical prostatectomy
Intervention MeSH terms: Docetaxel; Leuprolide; Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupron; Bicalutamide; Docetaxel
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Condition: Epicondylitis of the Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients
      with lateral and medial epicondylitis and compare it to Naproxen sodius.
    

Detailed description: 
      The objective of this single center is to evaluate the safety and efficacy of Synera ® in
      lateral and medial epicondylitis . This is an open-label, comaparative study study where the
      subjects will be randomized to one of the following groups:

        1. Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart
           to the medial or lateral side of the index elbow

        2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of
           the index elbow

        3. Naproxen Sodium: 500mg bid
    

Intervention name(s): Naproxen; Synera patch twice daily; Synera patch for 12hrs/day; Naproxen; Synera; Synera
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Naproxen 500mg BID for the first 2 weeks; 1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks; 1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks; 500mg bid; Topical appication of single patch to elbow for 12hrs/day; Single patch applied to elbow for 4hrs/twice daily
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epicondylitis
Feasibility of the Portable YouGrabber System
Condition: Cerebral Palsy; Stroke; Traumatic Brain Injury; Meningomyelocele; Central Nervous System Diseases
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Nervous System Diseases; Central Nervous System Diseases; Meningomyelocele; Spina Bifida Cystica
Study type: Interventional

Summary: 
      The aim of the study is to determine the feasibility of the portable version of the
      YouGrabber® system in children with central motor disorders.
    

Detailed description: 
      In a feasibility trial with the portable version of the YouGrabber® system it will be
      determined if the technique and equipment are ready to be used in a home setting where
      children with central motor disorders train with assistance of caregivers but without a
      therapist. Furthermore, it will be examined if children and adolescents with central motor
      disorders accept this home-based system and if they are motivated for using it.
    

Intervention name(s): YouGrabber
Intervention type(s): Device
Intervention description(s): 2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Rehabilitation; Telerehabilitation; Upper limb therapy
Cardiac Resynchronization Therapy in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      This study is being conducted to determine whether patients with advanced pulmonary
      hypertension when treated with cardiac resynchronization therapy improve hemodynamically
      and/or receive clinical benefit.
    

Detailed description: 
      This study aims to determine whether stimulating earlier activation of the failing right
      ventricle in pulmonary hypertension reduces the effects of interventricular dependence in
      human subjects, thereby improving overall cardiac function and symptoms in patients with
      pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.
    

Intervention name(s): Cardiac Resynchronization Therapy (CRT)
Intervention type(s): Device
Intervention description(s): A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Achilles Pain Block
Condition: Achilles Tendon Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to better understand how the peripheral and central nervous
      system interact to produce the sensation of pain and motor patterns in patients with achilles
      tendinopathy (AT). These findings will motivate the development of future clinical studies
      that incorporate knowledge about pain processing and movement strategies in patients with
      tendinopathy. Participants with achilles tendinopathy will receive an anesthetic injection to
      the achilles tendon in order to examine how reduced pain, detected by the peripheral nervous
      system, alters task performance and perception of pain. We hypothesize that there are factors
      within the central nervous system that contribute to continued pain and disability in
      patients with chronic AT.
    

Detailed description: 
      Twenty three people with Achilles tendinopathy (AT) and 23 people without AT will participate
      in this single visit clinical study. Participants will rate their pain with pressure to the
      heel, leg and elbow, climb stairs and perform a novel task in a motion capture system, and
      complete questionnaires on how pain affects their daily life. All subjects will complete
      these measures twice, and for participants with AT they will complete this battery of tests
      before and after an anesthetic injection to the area of pain. This study has 2 aims:

      Specific Aim 1 compares measures of altered central processing in patients with chronic AT to
      adults without chronic pain; we hypothesize that patients with chronic AT will demonstrate
      signs of altered central processing, including central sensitization (lower pressure pain
      threshold), psychosocial factors (higher kinesiophobia), and/or altered motor control (lower
      ankle power during stair ascent).

      Specific Aim 2 determines which indicators of altered central processing persist after a
      local anesthetic injection to the Achilles tendon in patients with chronic AT; we hypothesize
      chronic AT pain is perpetuated by altered central processing that persists in the absence of
      continued peripheral nociception.
    

Intervention name(s): Ropivacaine injection
Intervention type(s): Drug
Intervention description(s): single dose, subcutaneous injection
Intervention MeSH terms: Ropivacaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: In this mechanistic study, the Achilles tendinopathy group receives an anesthetic injection. The healthy control group does not receive an injection.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Human; Pain; Biomechanics; Anesthetics
Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging
Condition: Lung Cancer With Mediastinal Lymph Node Involvement
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue.
      The purpose of this study is to determine whether the assessment of the hypermethylation
      level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a
      contribution to lung cancer staging.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar lymph nodes
      
Keywords: Lung cancer; EBUS-TBNA; Epigenetics; shox2 protein, human
Anti-CD20 in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of rituximab
      (anti-CD20) in treating systemic lupus erythematosus (SLE).

      White blood cells in the body called B cells give off substances that are active in promoting
      SLE disease. Researchers have found that anti-CD20 can block production of these substances
      in another disease. This study explores whether anti-CD20 will also be safe in people with
      SLE and whether it may be effective in treating SLE.
    

Detailed description: 
      B cells clearly play an essential role in the pathogenesis of SLE since they produce
      autoantibodies. Clinical observations support the contention that intervening in the
      production of autoantibodies by the B lymphocyte will be effective therapy. Current approved
      therapy for B-cell non-Hodgkin's lymphoma includes anti-CD20. The results of anti-CD20
      administration in SLE are anticipated to be similar to those in lymphoma patients. The
      current proposal explores the mechanisms and applicability of B-cell depletion as a potential
      treatment for SLE.

      Participants receive 4 weekly infusions of study medication. Each participant is enrolled in
      the study for a total of 1 year with protocol visits weekly for the first 3 months, then
      every other week for the next 2 months, every month for the next 4 months, and every other
      month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15,
      19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments
      for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity
      measure (SLAM) score are performed. Participants complete a health questionnaire and a health
      survey and laboratory parameters are evaluated.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
Other intervention name(s): Rituxan®
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; SLE; B-Lymphocytes; anti-CD20; rituximab