bioihbjkbjnl/mcl2 huggingface dataset:
Acute Study on Muscle Soreness, Damage, and Performance
Condition: Soreness, Muscle; Performance Enhancing Product Use; Damage Muscle
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient
      supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants
      will complete one enrollment visit, in which they will sign a consent form and complete a
      health history questionnaire. Participants will complete two interventions, with three visits
      each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric
      placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes
      post-exercise, in random order. Total time from enrollment to completion will be at least 14
      days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery
      and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.
    


Intervention name(s): Pre-workout plus and protein recovery plus; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Study products consumed prior and after exercise; Placebo product consumed prior and after exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of a HIV DNA vaccine after it is injected into your muscle
      using an electroporation device (TriGrid™ Delivery System made by Ichor Medical Systems), and
      will test the ability of the vaccine to help your body make antibodies and T-Cells.

      In this study, we would like to learn about the effects that electroporation of the HIV DNA
      has on you and your immune system.
    

Detailed description: 
      Over 40 million people worldwide are currently infected with HIV, the virus that causes AIDS
      (Acquired Immune Deficiency Syndrome). The number of new cases continues to rise at an
      alarming rate. Other infectious diseases, such as smallpox or poliomyelitis, have been
      controlled, or even eliminated, by vaccination programs. Many experts believe that an HIV
      vaccine offers the best hope for controlling the epidemic.

      Many different possible HIV vaccines are currently being developed and tested.

      The ADVAX vaccine which you will receive is one vaccine that has been tested. To date, one to
      three doses of the ADVAX vaccine have been given to 45 individuals in a study that took place
      between December 2003 and October 2005 at the Rockefeller University and the University of
      Rochester and it appears to be safe. The difference between this ADVAX study and the previous
      one is that you will only receive two doses of the vaccine or placebo by either standard
      intramuscular injection or by "electroporation."

      This study is part of a broader research effort to see if changes in the way vaccines are
      given can make vaccines more effective.

      The results of other studies suggest that using regular needles may not be the most potent
      way to inject this type of vaccine. This is why we are studying a new method of injection
      called electroporation.

      Electroporation uses a device that injects substances into muscle along with small amounts of
      electricity. This device has been used to a limited extent in human subjects and has been
      shown to be more effective than regular needles and safe when tested in animals. Devices
      similar to this have been used in many studies to deliver chemotherapy directly into
      patients' tumors.
    

Intervention name(s): TriGrid™ Delivery System; conventional intramuscular injection
Intervention type(s): Device; Device
Intervention description(s): Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.; administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV vaccine; HIV; AIDS; prevention; HIV/AIDS; HIV Preventative Vaccine; HIV Seronegativity
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy, safety, and tolerability of different
      dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during
      maintenance treatment in adult and adolescent participants with schizophrenia. The study will
      include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis
      of schizophrenia, are clinically stable, and are eligible for risperidone treatment
    


Intervention name(s): TV-46000; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TV-46000 will be administered per dose and schedule specified in the arm.; Placebo matching to TV-46000 will be administered per schedule specified in the arm.
Other intervention name(s): Risperidone
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol
      rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients
      with constipation.
    


Intervention name(s): Glycerine; Docusate sodium and sorbitol rectal solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sorbitol; Bismuth subsalicylate; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients
Condition: Rectal Cancer; Prognosis
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      We explored the relationship between NLR and grade 3 or higher treatment related small bowel
      toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and
      concurrent intensity modulated radiotherapy (IMRT).
    

Detailed description: 
      Gender, age, stage of disease, and pathologic factors were retrospectively obtained from
      electronic patient records. Staging was determined according to the classification
      established by the American Joint Committee on Cancer (AJCC, 7th edition).Pelvic magnetic
      resonance imaging (MRI) were used for pretreatment staging. All patients enrolled in this
      study were treated with intensity modulated radiotherapy (IMRT) concurrent with capecitabine
      (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection.
      The mean radiation dose was 50 Gy with daily fraction of 2.0 Gy.

      Acute treatment toxicity was scored according to the National Cancer Institute Common
      Terminology Criteria for Adverse Events (CTCAE; version 3.0) and late toxicity was classified
      according to the Late Effects in Normal Tissue-Subjective, Objective, Management and Analytic
      (LENT-SOMA) system.

      After the whole treatment procedure, all patients were subjected to a follow-up every three
      months for the first two years, every six months for the next three years, and every year
      thereafter. Physical examinations, routine blood test, serum carcinoembryonic antigen (CEA)
      and Cancer Antigen 19-9 (CA-199) level were checked at each follow up. Chest, abdominal CT
      scan and total colonoscopy were performed annually except the suspicion of tumor recurrence.

      Overall survival (OS) time was defined from the date of completion of treatment to death from
      any cause and progression-free survival (PFS) time was defined as the time from the date of
      completion of therapy to the date of local recurrence or distant metastasis or death. Patient
      follow-up was lasted until death or the cutoff date of January 2017.Blood sampling reports
      from each enrolled patient were obtained within seven days before treatment. White blood cell
      count, neutrophil, lymphocyte and platelet counts were examined. The NLR was calculated as
      the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood
      test results.
    

Intervention name(s): capecitabine and concurrent intensity modulated radiotherapy
Intervention type(s): Radiation
Intervention description(s): patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
Intervention MeSH terms: Capecitabine
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with rectal cancer undergoing capecitabine and concurrent intensity modulated
        radiotherapy
Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue
Condition: Neoplasms; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the
      PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus
      a supervised resistance program. The primary objective is improvement of cancer-related
      fatigue.
    

Detailed description: 
      Patients should have finalized their oncological treatment in the previous 5 years. The
      sample size (32 patients) was calculated to improve the perception of fatigue score from an
      anticipated initial 38 to a post-intervention 48.

      The control arm consist of supervised strength training in two sessions per week with
      non-supervised international recommendations for aerobic exercise. The experimental arm will
      consist of supervised strength + resistance training in two sessions per week.

      After evaluating the weekly physical activity through accelerometer, body composition through
      DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training
      according to a randomized assignment.

      Secondary objectives include:

        1. cardiorespiratory fitness,

        2. quality of life;

        3. adherence to the training program;

        4. adherence to international recommendations,

        5. body composition,

        6. employment status
    

Intervention name(s): Vigorous aerobic training
Intervention type(s): Behavioral
Intervention description(s): Supervised vigorous aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer survivors; training; exercise; cancer-related fatigue
Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
Condition: Severe Uncontrolled Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This pilot study will use novel technologies to collect information about the patient
      experience before and early after starting Fasenra (benralizumab) as standard of care for
      severe uncontrolled asthma in a real-world setting, to determine how the experience changes
      over time. Any detection of an early, subjective first-dose effect in this pilot study will
      be further validated in a larger follow-up study.
    

Detailed description: 
      PRIMARY OBJECTIVE: Explore the use of novel technologies to detect early changes in quality
      of life (QoL) within the first 4 weeks after first dose of Fasenra for the treatment of
      severe uncontrolled asthma.

      ENDPOINTS: Improvement in QoL measures, and physical and mental well-being as assessed by an
      increase in positive facial expressions, positive keywords, and quality of life biomarkers,
      with a decrease in asthma symptoms and improvement in FEV1 and PEF within the first 4 weeks
      after beginning Fasenra.

      TARGET POPULATION: Individuals aged 18-75 years with severe asthma uncontrolled (ACQ >=1.5)
      on current medications (HD-ICS/LABA with/without other maintenance therapies except
      biologics). Patients beginning Fasenra asstandard of care as specified by NICE guidelines.

      STUDY DURATION: The study duration per patient will be approximately 6 weeks from the
      enrolment visit to end of recorded data. Subjects will record data for 2 weeks prior to their
      first injection with Fasenra and then for 4 more weeks post-injection. PROCEDURESPatients
      will be required to visit the study site 3 times (enrolment and onboarding visit, Fasenra
      injection visit, last visit), and perform daily tasks at home in between site visits
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals aged 18-75 years with severe asthma uncontrolled (ACQ >=1.5) on current
        medications (HD-ICS/LABA with/without other maintenance therapies except biologics) who are
        beginning Fasenra treatment as standard of care.
Vitamin D Supplementation and PTH Response Among Malaysian Adults
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical trial was designed to determine the efficacy of vitamin D supplementation on
      plasma 25-hydroxyvitamin D [25(OH)D] and intact parathyroid hormone (PTH) concentrations of
      Malaysian female adults of child-bearing age after daily intake of vitamin D supplements
      containing either 0 IU, 600 IU, 1200 IU or 4000 IU vitamin D for 16 weeks.
    

Detailed description: 
      After being informed regarding the study protocol and requirements, participants given
      informed consent were interviewed using a questionnaire for collection of background data and
      medical history as a screening process. Eligible participants were randomly assigned in a
      double-blind manner to receive daily 500 mg of calcium with either 0, 600 IU, 1200 IU or 4000
      IU vitamin D supplement for 16 weeks. Questionnaires and anthropometric measurements were
      collected at baseline and post 16 weeks supplementation trial. Primary outcomes of plasma
      25(OH)D and intact PTH were measured via fasting intravenous blood samples at baseline and
      post 16 weeks trial.
    

Intervention name(s): Placebo, 500 mg calcium; 600 IU vitamin D + 500 mg calcium; 1200 IU vitamin D + 500 mg calcium; 4000 IU vitamin D + 500 mg calcium
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Berry flavoured sachet powder (500 mg calcium); Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium); Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium); Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
An Ascending Dose Study to Assess Safety, Tolerability, PK/PD of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction
Condition: Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to provide pertinent information to enable decisions regarding
      the developability of LHW090 for use in patients with chronic renal insufficiency, including
      a comparison of the potential risk-benefit ratio of several doses of the study drug to enable
      optimal doses to be tested in later studies.
    


Intervention name(s): LHW090; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg, 12.5 mg, 100 mg capsules; Matching placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy volunteers and patients,; renal insufficiency,
Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults
Condition: Diarrhea; Vomit; Fever; Nausea; Irritability
MeSH terms: Nausea; Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for
      Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
    

Detailed description: 
      Rotavirus (RV) is the most important cause of acute gastroenteritis in children worldwide. In
      Vietnam rotavirus causes an estimated 122,000-140,000 hospitalizations and 2900-5400 deaths
      per year among children under 5 years of age (1). Over the past 13 years, sentinel hospital
      surveillance identified rotavirus in 44%-62% of children admitted for the treatment of acute
      diarrhea in Vietnam (2-4). Such a high burden of disease justified accelerated development of
      a new and locally manufactured vaccine against rotavirus in Vietnam. It is estimated that if
      a vaccine was introduced in the current childhood immunization schedule, it could reduce
      severe rotavirus disease by about 60% or more given current vaccine efficacies and coverage
      (5).

      The Government of Vietnam has pursued a policy to encourage local vaccine production so the
      country could be self-reliant with affordable vaccines for its population (6). Over the past
      decades, several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis,
      and Diphtheria-Pertussis-Tetanus have contributed to the reduction in the prevalence of these
      diseases and to the eradication of polio over the past decade. While two commercial rotavirus
      vaccines, RotarixTM (GSK, Belgium) and RotaTeq® (Merck), have both been tested in Vietnam,
      neither is currently available at an affordable cost for the national program. Therefore, the
      candidate vaccine, Rotavin-M1, was developed in order to fill this need for a more affordable
      vaccine for Vietnamese children (6). This vaccine is similar to RotarixTM, and was developed
      by selecting a common G1P[8] strain and attenuating it through serial
    

Intervention name(s): Rotavin
Intervention type(s): Drug
Intervention description(s): Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses
Other intervention name(s): Rotavin-M1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: blood cell counts; BUN; ALT; AST; diarrhea; fever; vomit; nausea; loss of appetite; irritability
Effectiveness of Progressive Muscle Relaxation on Sleep Disturbance in Athletes
Condition: Sleep Disturbance in Athletes
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Literature supports that athletes have so many reasons for sleep disturbance in their day to
      day practice and during competition. This study is aimed to build familiarity with the
      significance of sleep for greatest athletic execution as well as providing Progressoive
      Muscle Relaxation(PMR),(A technique proposed by Jackobson to improve sleep and degrease the
      anxiety) as strategy to improve sleep prior to a significant competition during tournament
    

Detailed description: 
      Adequate sleep is necessary to accomplish ideal athletic performance, cognitive functioning
      and overall well-being. Inadequate sleep is likewise connected to slow reaction time, delayed
      perception which can prompt impaired performance and increase risk of injury. A few
      investigations on sleep and athlete performance have additionally shown that sleep quality
      can be disturb for so many reasons.

      A range of interventions are available that may be beneficial or are commonly utilized in
      athletes to enhance sleep quantity and quality in athletes. Drug strategies and hypnotics are
      related with side effects, for example, drug resistance and withdrawal symptoms. Thus, there
      has been increase in utilization of non-drug strategies for further developing sleep quality.
      Among such strategies are relaxation methods. It has been considered as one of the cost
      effective and simple methods for easing sleep. Progressive Muscle Relaxation (PMR) is a
      method that involved efficiently relaxing global muscles of body with the objective of mental
      and physical relaxation. PMR is widely used previously to improve sleep in general population
      however there is currently no evidence to support PMR to improve sleep quality during a
      competition/tournament as a non-pharmacological method to improve participating athlete's
      sleep.

      The aim of this study is to build familiarity with the significance of sleep for greatest
      athletic execution as well as providing PMR as strategy to improve sleep prior to a
      significant competition during tournament.
    

Intervention name(s): Progressive muscle relaxation; control
Intervention type(s): Behavioral; Other
Intervention description(s): Progressive Muscle Relaxation (PMR): This method involved efficiently relaxing global muscles of body with the objective of mental and physical relaxation.; control group will not receive any intervention
Other intervention name(s): simple Range of Motion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Mild To Moderate Erectile Dysfunction Study
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile
      dysfunction
    


Intervention name(s): Viagra (Sildenafil Citrate) 100 mg
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose
      Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II
      Diabetes under usual care. It is also to investigate and analyze the exploratory influential
      factor of ipragliflozin treatment on clinical efficacy and safety.
    


Intervention name(s): Ipragliflozin (SGLT2 inhibitor)
Intervention type(s): Drug
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic and hospital