bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Safety and Tolerability of a Probioitc
Condition: Healthy Volunteers; Tolerability; Safety
Study type: Interventional

Summary: 
      The rationale for the current study is to initially evaluate the safety and tolerability of a
      novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.
    

Detailed description: 
      Probiotics are live microorganisms, which when administered in adequate amounts, confer a
      health benefit on the host. Probiotics have been studied for decades for their potential
      health benefits of non-pathogenic microorganisms. The species Limosilactobacillus reuteri (L.
      reuteri), formerly Lactobacillus reuteri, is currently used in probiotic products.

      The design of the study is based on the aim to study the safety and tolerability of a novel
      strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in a limited number of
      healthy volunteers.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Other; Other
Intervention description(s): The study product is a probiotic strain; The study product is a placebo to the probiotic strain
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomised, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label single arm, multicenter, phase II study designet To assess the
      progression free survival (PFS) of cabozantinib in patients pretreated with one
      immunocheckpoint inhibitor (CPI) in monotherapy or in combination
    


Intervention name(s): Cabometyx
Intervention type(s): Drug
Intervention description(s): cabozantinib 60 mg orally once daily
Other intervention name(s): cabozantinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Prognosis in HIV Infection
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess the safety of probiotics in cART-treated
      immunologic non-responder (INR) patients with chronic HIV infection.

      The secondary objectives are to i) explore the biological effects of probiotics in combined
      antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii)
      investigate differences between cART-treated HIV-infected INR and non-INR patients with
      regards to gut microbial composition and mucosal barrier function.
    


Intervention name(s): Probiotic compound
Intervention type(s): Dietary Supplement
Intervention description(s): Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Probiotics; Microbiota; Mucosal immunology; Gut biopsy
A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect
      scan. This study requires the participant to make 4 visits to the GCRC in the Charlton
      building but no overnight stays.
    

Detailed description: 
      A screening interview and symptoms assessment by the Bowel Disease Questionnaire (BDQ) and
      consent will be obtained prior to the studies at the testing facility (General Clinical
      Research Center, 7th floor, Charlton Building, Mayo Clinic). Smoking status will be recorded.
      Vitals and an electrocardiogram will be obtained. Following an initial screening, subjects
      will be randomized to itopride or identical placebo.

      Day 1: The participant will report in a fasting condition (10 hours) to the study center
      early in the morning. All participants will undergo the nutrient drink test to assess maximum
      tolerated volume and postprandial symptoms PRIOR to ingesting any medication.

      Day 2-7: The patients will take the study medication as prescribed that is a tablet 30
      minutes before meals, three times per day. On days 6, 7 and 8, the morning and midday dose of
      the medication intake will occur in the clinical research center under supervision of the
      study staff.

      Day 6: The participant will return fasting for 10 hours to the study center early in the
      morning. Scintigraphic gastric and small bowel transit measurement will be performed, with
      medication ingested at standard times (30 min prior to meal), and the 99mTc-sulfur colloid
      labeled egg meal ingested 30 minutes after the morning dose of study medication. Imaging will
      be taken for 6 hours. Vitals and an electrocardiogram will be obtained Day 7: All
      participants will undergo a repeat nutrient drink test to assess postprandial symptoms at
      maximal satiety and 30 minutes after drug ingestion. The satiety study will be completed once
      a maximum tolerated volume is achieved, and the 30 minute post-meal questionnaire will be
      completed.

      Day 8: The participant will return fasting to the study center early in the morning.
      Participants will undergo SPECT imaging to evaluate fasting gastric volume starting 30
      minutes after ingestion of study medication. The participant will then ingest 300 ml of the
      nutrient drink Ensure", and postprandial gastric volumes will be calculated as described
      previously (41-46). Vitals will be obtained.
    

Intervention name(s): Itopride
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4
      consecutive weeks as an iv infusion along with a nutritional supplement administered two
      hours before the methotrexate. One hour before the methotrexate treatment the patients will
      be administered the first infusion of the day of either TK112690 or placebo depending on
      randomization. Five hours after the methotrexate treatment the patients will be administered
      the second treatment of either TK112690 or placebo depending on randomization. The TK112690
      dose will be 45 mg/kg.
    

Detailed description: 
      Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4
      consecutive weeks as an iv infusion along with a nutritional supplement administered two
      hours before the methotrexate. One hour before the methotrexate treatment the patients will
      be administered the first infusion of the day of either TK112690 or placebo depending on
      randomization infusion. Five hours after the methotrexate treatment the patients will be
      administered the second treatment of either TK112690 or placebo depending on randomization.
      The TK112690 dose will be 45 mg/kg.

        -  A total of 22 patients will be enrolled into one of 2 different dose groups: TK-112690
           treated or placebo treated.

        -  Screening must be within 15 days of subject enrollment.

        -  Patients will remain for observation at the clinical site for a minimum of 25 hours post
           initial TK112690 or placebo dose.

        -  Study follow-up will occur on Week 6, two weeks after the last dosing of methotrexate.

        -  Blinding: The study will be partially blinded. The patient and investigator will be
           blinded as to whether TK112690 or placebo is administered. The CRO, sponsor, and site
           pharmacist will know whether the patient was administered active drug or placebo.
    

Intervention name(s): TK-112690; Placebo TK-112690
Intervention type(s): Drug; Drug
Intervention description(s): TK112690 treatment pre-methotrexate treatment; Placebo
Other intervention name(s): Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 22 patients will be enrolled into one of 2 different: TK112690 treated or placebo treated.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Mucositis; Methotrexate; Uridine Phosphorylase Inhibitor; Head and Neck Cancer
Comprehensive Program for Youth Mental Health
Condition: Depression; Suicide; Anxiety
MeSH terms: Suicide
Study type: Interventional

Summary: 
      The majority of addiction and mental health problems seen in adults present first in youth.
      There is strong evidence that prevention and early identification during childhood can
      mitigate some of these risks. Students who screen at risk for the development of mental
      illness will be offered online intervention programs with personal guidance from a trained
      coach. In addition, lessons revolving around resiliency will be provided to all students.

      The objectives of this study are:

        -  Decreased rates of depression and suicide (as well as rates of suicide attempts)

        -  Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits
           such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer

        -  Decreased school drop-out rates Decreased rates of interactions with the justice system

        -  Decreased costs across a range of ministries (health, education, justice, human
           services), both for youth as well as their families who have been involved in this
           program
    


Intervention name(s): Smart, Positive, Active, Realistic X-factor thoughts (SPARX); Breaking Free; This Way Up; Resiliency Training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Cognitive Behavioral Therapy based online intervention for depression; Online based intervention for Drug and Alcohol Use; Cognitive Behavioral Therapy online intervention for Depression and Anxiety; Op Volle Kracht (OVK)
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tele-Exercise for Male Elite Fencers
Condition: Sports Physical Therapy; Athletic Performance
Study type: Interventional

Summary: 
      Tele-exercise has been used to enhance athletic performance among athletes. Physical
      performance indicators such as lunge distance, speed, reaction time, coordination, and
      balance control during stationary jumps can be used to measure the effectiveness of
      tele-exercise programs for fencing athletes.

      The objective of this study was to examine the effectiveness of tele-exercise programs on
      lunge distance, speed, reaction time, coordination, and balance control during stationary
      jumps among male elite fencers.
    


Intervention name(s): Tele-exercise program; Conventional Fencing Exercise
Intervention type(s): Other; Other
Intervention description(s): The tele-exercise program focused on lunge movement with additional strengthening abdominal and lumbopelvic muscle training while maintaining neuromuscular control. The difficulty of training was adjusted every week according to the five-step mastery program; The conventional exercise was based on 'displacement', a basic footwork training in fencing. The Displacement is also basic footwork to approach the opponent. The Displacement consisted of seven movements including 'Marche', 'Retraite & Rompre', 'Passe avant', 'Passe arrière', 'Bond en avant', 'Bond en arrière', and 'Balestra'.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sports Physical Therapy; Athletic Performance; Fencing; Tele-exercise
Aerobic Exercises for Multiple Sclerosis
Condition: Multiple Sclerosis, Primary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central
      nervous system (CNS) .It is the most common neurological disorders affecting young
      adults.Multiple sclerosis is an autoimmune disease that results in progressive neural
      degeneration. Cytokines play an important role in the pathogenesis and treatment of MS.
    

Detailed description: 
      This research aims to evaluate the effect of aerobic exercises on the immune system
      anti-inflammatory (IL-10) and pro inflammatory (IL-17) cytokines and its consequences on the
      functional status in the Multiple Sclerosis patients.

      Aerobic exercises are a term to describe planned, structured and repetitive physical activity
      undertaken over a prolonged period to maintain or improve physical fitness and functional
      capacity .
    

Intervention name(s): aerobic exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study group (GA) and control group (GB) in addition to normal matched subjects (GC).The control group (GB)was treated by the disease modifying drug (interferon beta-1a) "Rebif", (GA) treated by the same drug in addition to a physical therapy program of aerobic exercises for 40 min included bicycle ergometry training
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Aerobic exercises; cytokine IL-10; cytokine IL-17
Inspiratory Muscle Training and Hospital Complications
Condition: Muscle Weakness
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and
      athletes, your goal is to recondition the respiratory muscles, providing optimization of lung
      capacity, either for high performance sport as to support metabolic wear caused by illness.
      It is generally agreed the positive impact of the application of a TMI Protocol on maximal
      inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from
      mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or
      pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the
      muscle; the specificity of training; the reversibility of the gain and muscle atrophy.
    

Detailed description: 
      This prospective double-blind (patient and evaluator) randomised controlled trial compared
      the efficacy of inspiratory muscle training and inspiratory muscle training. The study
      protocol for this trial was described elsewhere. This study was conducted in accordance with
      Consolidated Standards of Reporting Trials recommendations. The trial was performed at the
      Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the
      institutional hospital ethics committee (approval reference number 03/2014). Before
      enrolment, written informed consent was obtained from participants or their legal guardians.
    

Intervention name(s): Powerbreathe; Physiotherapy
Intervention type(s): Device; Other
Intervention description(s): Respiratory equipment for physiotherapy, offering to load muscles inspiratory; This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
Other intervention name(s): MODEL: CLASSIC LIGHT RESISTANCE; ANVISA: CLASS I 81001390001; MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM; Concurrent training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Muscles; Muscle Weakness; Hospitalization; Length of Stay; Mortality
Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
Condition: Relapse Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the add-on effect of oral minocycline in subjects treated with daily
      injection of Copaxone. Copaxone and minocycline are thought to have differential modes of
      actions that may complement each other in treating MS symptoms.
    


Intervention name(s): glatiramer acetate with minocycline; Glatiramer acetate with placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg; Subcutaneous injection glatiramer acetate 20mg, with oral placebo
Other intervention name(s): Copaxone®; Copaxone®
Intervention MeSH terms: Minocycline; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
Condition: Muscle Spasm; Back Pain
MeSH terms: Muscle Cramp; Spasm; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of Eperisone HCl in the treatment of
      Acute Musculoskeletal spasm associated with Low-Back Pain.
    

Detailed description: 
      This is a multi-center trial, which will be conducted in a total of 240 patients (120
      patients in each treatment group). Patients attending the out-patient setting of traumatology
      and orthopedic departments of the study centers will be screened for lumbar pain and spasm by
      clinical and radiological examination for inclusion. In this study, it has been planned to
      enroll a total of 240 patients with 120 patients in each group. The total duration of
      treatment will be 14 days. Patients will be screened for baseline parameters and will then be
      randomized, as per the predetermined randomization schedule, into two groups. Patients will
      be treated with either Eperisone-HCl (Myonal) or placebo for a period of 14 days. After the
      baseline-screening visit (Day 1), the patients would be asked to follow up on day 3, day 7,
      and day 14. During each visit, a complete general examination and clinical evaluation of
      efficacy parameters would be done. Adverse events would be monitored during the study period
      and would be recorded in the Case Report Form (CRF). At the end of the treatment, Global
      Assessment of Response to Therapy by Physicians and Patients (PGART) would be done for
      efficacy and tolerability separately.
    

Intervention name(s): Eperisone
Intervention type(s): Drug
Intervention MeSH terms: Eperisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle; Spasm; Back; Pain
Effective Methods of Reducing Lower Back, Neck and Shoulder Pain Among Office Workers
Condition: Musculoskeletal Pain; Low Back Pain
MeSH terms: Musculoskeletal Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder
      areas, are some of the most common issues among office workers. The Social Security
      Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a
      maximum of 10,000 per year.

      Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a
      sample of office workers; 2. Test effective methods of reducing lower back, neck and shoulder
      pain in this sample by training exercise, or ergonomics modification, or both of them; and 3.
      Assess discomfort scores and the range of motion of the lower back, neck and shoulder muscles
      among the office workers after undertaking the different methods for a period of 6 months.

      Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and
      forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from
      3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups
      (receiving training exercise, receiving modified ergonomics, receiving a combination of
      exercise and ergonomics modification) and a control group (receiving none of these
      interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal
      discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of the
      interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were measured by
      a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived exertion of
      training exercises. The rapid office strain assessment (ROSA) questionnaire was used to
      assess the strain associated with office work. Height and weight were also measured to
      calculate the body mass index (BMI).
    

Detailed description: 
      It is expected that, 6 months intervention including exercise training, ergonomic
      modification and mixture of these 2 intervention, maybe can decrease the severity of pain in
      lower back, neck and shoulder among office workers.
    

Intervention name(s): office exercise training; ergonomic modification; Exercise and ergonomic; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The exercise group, did 6 months office exercise training.; The ergonomic modification group, followed 6 months modified office ergonomic modification.; The mixture group, did 6 months exercise training and also followed 6 months modified office ergonomic modification.; Control group did not do any exercise and did not follow any ergonomic modification.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Exercise