bioihbjkbjnl/mcl2 huggingface dataset:
Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities With Blood Flow Restriction
Condition: Exercise
Study type: Interventional

Summary: 
      Introduction: Studies on resistance training (RT) associated with blood flow restriction
      (BFR) have emerged as an alternative method of gaining strength and hypertrophy; however, the
      cardiovascular and autonomic repercussion of BFR at different intensities is unknown. Thus,
      it becomes relevant to investigate this type of training in post-exercise. Objective:
      investigate and compare autonomic and hemodynamic responses of acute eccentric RT with
      different intensities associated or not to BFR in healthy youngsters. Method: This is a
      randomized clinical trial including 60 healthy men aged 18-35 years, divided into four groups
      according to exercise intensity and BFR: 80% without BFR, 40% without BFR, 80% with BFR and
      40% with BFR. Exercise intensity will be determined by the peak of excentric torque on the
      dinamometer isokinetic method and by the BFR, as being 40% of the intensity required for the
      complete examination of the blood flow evaluated by Doppler. Participants will do an
      eccentric femoral quadriceps muscle exercise session on the isokinetic dynamometer according
      to the previously randomized group. For recovery analyzes, the recovery heart rate (HRR) in
      the 1st (HRR1) and 2nd (HRR2) minute, rMSSD of 30 seconds, the hemodynamic parameters (heart
      rate, systolic and diastolic blood pressure, respiratory rate, peripheral oxygen saturation
      and rate pressure product) and heart rate variability (HRV) indices analyzed in the time
      domain (mean HR, rMSSD and SDNN), frequency domain (LF and HF [nu and ms2]) and Poincaré plot
      (SD1 and SD2). The analysis will be occur on baseline, immediately e after the excentric
      exercise and in the post exercise period for 60 minutes. Descriptive statistics method and
      comparison of HRV indices and hemodynamic parameters between moments and groups will be
      performed with the aid of the analysis of variance technique for the repetitive measures
      model without the schema of two sets of tests to follow . The level of significance will be p
      <0.05.
    


Intervention name(s): eccentric exercise with blood flow restriction
Intervention type(s): Other
Intervention description(s): High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: resistance training; vascular occlusion; hemodynamics, cardiovascular system; autonomic nervous system; heart rate; recovery of physiological function
A Crossover Trial of Chitosan Oligosaccharide on Post Prandial Glucose Control in Subjects With Normal, IFG and IGT
Condition: Normal; Impaired Fasting Glucose; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      It is well known that Chitosan oligosaccharide is low molecular weight and water soluble and
      chitosan oligosaccharide has been shown to reduce blood cholesterol and blood pressure,
      increase immunity, and enhance antitumor properties. the effect of chitosan oligosaccharide
      (GO2KA1) supplementation on glucose control in subjects with normal blood glucose, impaired
      fasting glucose and impaired glucose tolerance.
    

Detailed description: 
      A randomized, double-blinded, controlled, cross-over trial was conducted to verify the
      effects of chitosan oligosaccharide (GO2KA1). forty healthy male and female subjects aged
      20-75 years with normal blood glucose, impaired fasting glucose and impaired glucose
      tolerance were recruited. The subjects visited the research site twice over with a seven-day
      interval after an overnight fast at least 12 hr. On the screening visit, the participants
      were the 2-hr oral glucose tolerance test (OGTT) was conducted. And they were separated
      normal blood glucose, impaired fasting glucose and impaired glucose tolerance. On the first
      visit, the participants were randomly assigned to consume a test or placebo product [test
      product: chitosan oligosaccharide powder 500mg (GO2KA1); placebo product: white egg powder
      500mg] and ingested the assigned product. On the second visit, the participants consumed the
      other product that they did not eat on the first visit. On both visit day, the 2-hr oral
      sucrose tolerance test (OSTT) was conducted and started at 8:00 in the morning; venous blood
      samples were collected before (0 hr) and after ingestion (0.5, 1 and 2 hr) of the products.
    

Intervention name(s): Chitosan Oligosaccharide (GO2KA1); White egg
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.; White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chitosan Oligosaccharide; diabetes mellitus; blood glucose; fasting blood sugar; normal blood glucose; impaired fasting glucose; Impaired Glucose Tolerance
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
Condition: Microbiota; Constipation; Candida
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, double-blind study will determine the effect of daily
      supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a
      single investigational center in Northeast Ohio (i.e., The Center for Applied Health
      Sciences).

      Subjects will attend three study visits. During Visit 1, subjects will be screened for
      participation [i.e., medical history, routine blood work, background baseline diet]. During
      Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal
      health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency).
      Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation,
      respectively, with the probiotic dietary supplement or placebo.
    


Intervention name(s): 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase
Intervention type(s): Dietary Supplement
Intervention description(s): A multi-strain probiotic blend
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in The United States of America. The aim of this trial is to
      investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the
      body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
    


Intervention name(s): NNC0194-0499; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an
      adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1,
      2, 3, and 4.
    

Detailed description: 
      Volunteers will be screened up to 42 days before vaccination (up to 90 days for Ad35
      neutralizing antibody) and will be followed for 12 months after the last vaccination (16
      months total participation).

      It is estimated that it will take approximately 5 months to complete enrolment.
    

Intervention name(s): Adjuvanted GSK investigational HIV vaccine formulation 1; Adjuvanted GSK investigational HIV vaccine formulation 2; Ad35 investigational HIV vaccine; Adjuvanted GSK investigational HIV vaccine formulation 2; Adjuvanted GSK investigational HIV vaccine formulation 2; Ad35 investigational HIV vaccine; Ad35 investigational HIV vaccine; Placebo (saline)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Receive at Months 0 and 1; Receive at Months 0 and 1; Receive at Month 0; Receive at Months 3 and 4; Receive at Months 0, 1, and 4; Receive at Month 4; Receive at Months 0, 1, and 4; (Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
Dysfunctional Hemoglobin
Condition: Elevated Levels of Carboxyhemoglobin and Methemoglobin
Study type: Observational

Summary: 
      The purpose of the study is to determine if a new pulse oximeter accurately detects
      carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
    


Intervention name(s): Elevated levels of carboxyhemoglobin
Intervention type(s): Other
Intervention description(s): Comparison of pulse co-oximeters
Other intervention name(s): Elevated levels of methemoglobin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Adult volunteers
Cognitive Effects of 500mg Trans-resveratrol
Condition: Cognitive Performance; Mood
Study type: Interventional

Summary: 
      This study investigated the potentially cognitive enhancing effects of 500mg
      trans-resveratrol in healthy, young humans.
    


Intervention name(s): Trans-resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.; In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.
Other intervention name(s): Pharmaceutical grade silica
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Long Term Safety Assessment of SER120 in Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic
      patients.
    


Intervention name(s): SER120
Intervention type(s): Drug
Intervention description(s): once a day treatment of nocturia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: decrease in the number of nocturic episodes for patients with nocturia
The Effect of Using a Birth Ball and Squatting Position During Labor
Condition: Labor Pain; Labor Fast; Satisfaction, Patient
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of using the birth ball and squatting
      position during labor on labor pain, duration of labor and satisfaction. The research is a
      randomized controlled experimental study. The sample of the study consisted of a total of 159
      pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53
      in the control group, who met the criteria for inclusion in the study.
    


Intervention name(s): Birth ball; Squatting
Intervention type(s): Other; Other
Intervention description(s): Exercises for childbirth; Exercises for childbirth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Labor Pain; Birth ball; Squatting; Duration of labor; Satisfaction
A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study how the body processes digoxin and the effect of
      dulaglutide on how digoxin is processed by the body. Information about any side effects that
      may occur will also be collected.

      This study is for research purposes only and is not intended to treat any medical condition.
      This research study requires that a blood sample be obtained and stored for future research
      involving genetic analysis.
    


Intervention name(s): Digoxin; Dulaglutide
Intervention type(s): Drug; Biological
Intervention description(s): Administered orally; Administered as subcutaneous injection
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide; Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Energy Intake, Exercise and Constitutional Leanness
Condition: Anorexia Nervosa; Constitutional Leanness
MeSH terms: Anorexia; Thinness; Anorexia Nervosa
Study type: Interventional

Summary: 
      The aim of this study will be to identify the physical and dietary profile of adult women
      presenting constitutional leanness (CL), comparatively with normal-weight peers and
      BMI-matched women with anorexia nervosa. After an evaluation of their daily energy intake,
      physical activity level, body composition, aerobic capacities and muscle strength, women from
      the normal weight and CL groups will be asked to realized laboratory sessions to evaluate
      their energy intake and appetite feelings responses to acute exercise
    

Detailed description: 
      Body composition (using X-ray absorptiometry), muscle strength (biodex), daily energy intake
      (dietary record), food preferences (Leeds Food Preference Questionnaire) and physical
      activity level (GT3X accelerometers) will be assessed among women with constitutional
      leanness normal weight women and women with anorexia nervosa. The CT and NW groups will then
      be asked to randomly realized three experimental session: i) a rest session with an fixed
      lunch meal; a rest session with an ad libitum meal ; iii) an exercise session with an ad
      libitum meal. Their ad libitum energy intake will be assessed during the two last sessions.
      Appetite feelings will be assessed at regular intervals and their food reward in response to
      the lunch will also be assessed.
    

Intervention name(s): REST-Fixed; REST-AdLib; EX-AdLib
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive a fixed meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; condition with an acute exercise set 30 minutes before the lunch meal that will be served ad libitum This will be a 30-minute exercise set at 65% of their capacities (cycling), 30 minutes before lunch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: all participants receive the same intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appetite control; leanness; physical fitness
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as
      ARISTADA, ALKS 9070).
    


Intervention name(s): Aripiprazole Lauroxil
Intervention type(s): Drug
Intervention description(s): Monthly IM injection
Other intervention name(s): ARISTADA
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; ARISTADA; Aripiprazole Lauroxil; Schizophrenia
Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Critical Illness Associated Polyneuropathy / or Polymyopathy (CIP/M)
Condition: Polyneuropathy; Polymyopathy
MeSH terms: Polyneuropathies; Critical Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA
      delivers assist to spontaneous breathing based on the detection of the electrical activity of
      the diaphragm. We study the effect of NAVA in patients with critical illness associated
      polyneuropathy / polymyopathy (CIP/M)
    


Intervention name(s): Neurally adjusted ventilatory assist (NAVA)
Intervention type(s): Device
Intervention description(s): NAVA for 72 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: critical associated illness polyneuropathy or polymyopathy (CIP/M)
Therapy of Pain Syndromes According to McGill's Method in Physiotherapy
Condition: Vertebrogenic Pain Syndrome
MeSH terms: Syndrome; Back Pain
Study type: Interventional

Summary: 
      The goal of this study is to determine the applicability of McGill ́s method to patients with
      diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the
      measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in
      the Czech Republic.
    

Detailed description: 
      This is a pilot experimental research involving 10 probands diagnosed with Vertebrogenic
      Algic syndrome in the cervical spine, 10 probands diagnosed with Vertebrogenic Algic syndrome
      in the thoracic spine and 10 probands diagnosed with Vertebrogenic Algic syndrome in the
      lumbar spine. Each participant undergo a kinesiological examination according to the McGill
      ́s principles together with an SF-36 questionnaire. Measured values are compared and provided
      a basis for testing the hypotheses. The study uses methods of research, observation, querying
      and comparison of collected data.
    

Intervention name(s): Cervical pain; Thoracic pain; Lumbar pain
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise program for cervical spine according to McGill's approach.; Exercise program for thoracic spine according to McGill's approach.; Exercise program for lumbar spine according to McGill's approach.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain syndrome; efficiency; stabilization; McGill method
Safety and Immunogenicity of Typhax, a Typhoid Vaccine
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, double-blind, ascending dose study conducted at a single clinical
      research center.
    

Detailed description: 
      Healthy adult subjects aged 18 to 55 years were assigned to 3 ascending dose cohorts of
      Typhax (0.5, 2.5 or 10 mcg Vi antigen). Groups of 15 subjects in each dose cohort were
      randomized to receive Typhax, Typhim Vi (25 mcg Vi antigen) or placebo (saline) in a ratio of
      3:1:1, respectively. Typhax and placebo (saline) was administered as two dose regimen (Days 0
      and 28), and Typhim Vi was given as a single dose (Day 0) with matching placebo on Day 28.
      All doses were administered by a unblinded third-party as 0.5 mL by intramuscular (IM)
      injection. Safety and reactogenicity endpoints was assessed at 14 and 28 days after the first
      Typhax vaccination and 14 days after the second vaccination. Immunogenicity was assessed
      using an enzyme-linked immunosorbent assay (ELISA) to measure anti-Vi antibody serum titers
      on days 0, 14, 28, 42 and 180. A positive immune response (seroconversion) by ELISA is
      defined as at least a 4-fold increase over baseline in the Vi-specific ELISA.
    

Intervention name(s): Typhax (investigational typhoid fever candidate vaccine); Placebo; Active Comparator Typhim Vi
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Placebo is administered to the control group on Day 0 and 28; A single dose of commercial typhoid fever vaccine Typhim Vi is administered on Day 0, followed by placebo control on Day 28
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, Ascending Dose
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200
      mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on
      cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).
    

Detailed description: 
      The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus
      matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use
      among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and
      inclusion into the study, participants will be randomized to receive a 12-week course of NAC
      1200 mg or matched placebo twice daily. All participants will concurrently participate in a
      twice-weekly contingency management (CM) intervention. Medication management will be
      conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing
      will occur at all visits, and will be used as the primary determinant of cannabis use.
      Participants will return approximately four weeks after treatment conclusion for evaluation
      of adverse events with medication discontinuation and sustained treatment effects.
    

Intervention name(s): N-Acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.; Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment