bioihbjkbjnl/mcl2 huggingface dataset:
Taurine as a Possible Anti-aging Therapy?
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      Among the strategies that can improve the body's ability to counteract oxidative stress, the
      use of nutritional antioxidants has been investigated. Taurine is a "semi-essential" amino
      acid, also called a nitrogen compound, which has been used as an effective antioxidant due to
      its ability to neutralize hypochlorous acid, an extremely toxic oxidant produced by
      leukocytes in the inflammatory process in humans.
    

Detailed description: 
      Objective: To evaluate the oxidative parameters of women aged 55 to 70 years after 16 weeks
      of taurine supplementation.

      Methods: Twenty-four women age 55 to 70 will be randomly assigned to two groups: control
      group (GC), supplemented with placebo (1.5 g of starch); and taurine group (GTAU),
      supplemented with taurine (1.5 g), for 16 weeks. Anthropometry, functional capacity test,
      taurine, and levels of oxidative stress markers will be determined in pre and post
      intervention plasma samples. Food consumption will be assessed before, during, and after the
      intervention. The results will be analyzed by an ANOVA two-way repeated measures mixed model,
      with the Sidak post hoc (p < 0.05).
    

Intervention name(s): Taurine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 gram/day; Placebo supplementation in capsules of 500 grams of starch powder, total dosage: 1.5 gram/day
Other intervention name(s): Taurine supplementation in capsules of 500 grams of taurine powder, total dosage: 1.5 grams/day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aging; Oxidative Stress; Taurine; Nutritional Supplementation; Therapeutic Strategy
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine whether adding the drug risperidone (Risperdal®) is more effective
      than placebo in treating schizophrenic patients who are taking the drug clozapine.
    

Detailed description: 
      Clozapine is the only antipsychotic drug that has been approved for treatment resistant
      patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to
      respond and continue to exhibit clinically significant residual positive and negative
      symptoms and cognitive impairments. An emerging trend in treatment is the addition of a
      second antipsychotic drug. This study will determine if risperidone when given as adjunctive
      treatment is more effective than placebo in treating schizophrenic patients failing clozapine
      therapy.

      Participants are randomly assigned to add either adjunctive risperidone or placebo to their
      current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative
      symptoms, cognitive impairments, side effects of the treatment, anxiety, depression,
      hostility symptoms, and quality of life are assessed. Neurological tests, self administered
      questionnaires, and interviews are used to assess patients.
    

Intervention name(s): Placebo; Risperdal
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule daily for 16 weeks; Risperdal 4 mg per day for 16 weeks
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
Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
Condition: Subclinical Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional

Summary: 
      Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal
      subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome
      and cognitive function in the children.
    

Detailed description: 
      The investigators conducted a single-blinded trial in which pregnant women at a gestation of
      less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of
      thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned
      to a screening group in PUMCH (in which measurements were obtained immediately) or a control
      group in HMCHH (in which serum was stored and measurements were obtained shortly after
      delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings
      in the screening group were given individualized levothyroxine treatment and regular
      follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with
      subclinical hypothyroidism between two groups.
    

Intervention name(s): thyroid screening
Intervention type(s): Other
Intervention description(s): The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: antenatal thyroid screening; subclinical hypothyroidism; thyroid function; thyroid antibody; pregnancy outcome; childhood cognitive function
Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 3

Summary: 
      This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to
      moderate vascular dementia in a more reasonable design.
    

Detailed description: 
      This study is a 24-weeks, multicenter, randomized, double-blind, double- placebo, parallel
      controlled phase III trial being carried out in 23 centers around China. The study population
      includes mild to moderate VaD patients (planned a total of 630) aged 45-85 in both gender.
      Participants will be randomly allocated to TZK (15g/d) and placebo identified to donepezil,
      donepezil (5mg/d) and placebo identified to TZK, or placebo identified to TZK and placebo
      identified to donepezil for a 24-weeks double-blind treatment period . The primary outcome
      measure is change from baseline in the Vascular Dementia Assessment Scale-Cognitive Subscale
      and Clinician's Interview-Based Impression of Change-Plus carer Interview. The secondary
      outcomes are changes from baseline in the Mini-Mental State Examination, Activity of Daily
      Living Scale, Clock Drawing Test, Trail Making Test and Neuropsychiatric Inventory. Safety is
      being assessed by observing side effects and adverse reaction during the entire treatment
      period. Statistical analysis will be conducted according to per-protocol population and
      intend-to-treat population and the safety will be analyzed in safety set.
    

Intervention name(s): Tianzhi granule and placebo identified to donepezil; Donepezil and placebo identified to Tianzhi granule; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks; donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks; placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vascular dementia; Tianzhi granule; Herbal medicine; Randomized controlled trial; Three arms
Phase 1 Study of URC102 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the
      food effect on PK.
    


Intervention name(s): URC102; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Condition: Hand Dermatoses
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Study type: Interventional
Phase: Phase 3

Summary: 
      Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has
      skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in
      occupational dermatoses is limited. Coconut oil is one of traditional substance that is used
      as a skin care. There is study shows that coconut oil is effective for atopic dermatitis
      treatment in children. Other studies are needed to assess the effectivity coconut oil
      mosturizer cream to overcome occupational hand dermatitis.
    

Detailed description: 
      The aim of this study is to measure the effectivenes of coconut oil cream for batik workers
      who suffer from occupational hand dermatitis. The gloves that used as a protective equipment
      are made from rubber which have its own limitations. Therefore other interventions are needed
      to improve barrier skin.
    

Intervention name(s): Cocos Nucifera Whole; Cocos Nucifera Whole
Intervention type(s): Drug; Drug
Intervention description(s): Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance; For dermatopharmacokinetic evaluation using tape/ skin stripping
Other intervention name(s): Coconut Oil Cream; Coconut Oil Cream
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Batik traditional workers with occupational hand dermatitis using emolient for prevention
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders
Condition: Poor Ovarian Reserve
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG
      and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in
      patients with poor ovarian reserve seeking IVF/ICSI treatment.
    

Detailed description: 
      Women with POR (Bologna criteria) manifest a very low follicular response to controlled
      ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of
      oocyte maturation was shown to improve follicle collection yield and oocyte maturation in
      women with predicted normal ovarian response. These benefits have been attributed to the
      GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion.
      The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for
      final oocyte maturation improve oocyte collection and maturation rate
    

Intervention name(s): Dual trigger; hCG (standard)
Intervention type(s): Drug; Drug
Intervention description(s): Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once); human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)
Other intervention name(s): Dual ovulation trigger (Choriomon and Triptorelin); human Chorionic Gonadotropin
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening
Condition: Blood Flow Restriction; draw-in Maneuver; Transverse Abdominis
Study type: Interventional

Summary: 
      This study expects to provide a new alternative way to improve the muscle activation,
      strength and activation of transverse abdominis in abdominal draw-in maneuver combined with
      blood flow restriction.
    

Detailed description: 
      The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal
      wall and also known as a significant component of core stability. Abdominal draw-in maneuver
      (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation
      of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with
      low intensity exercise that produces similar results to high intensity training. However,
      there is few evidences for BFR training on core muscles.

      Healthy adults (age ranged 18-34 years and BMI between 18.5~24.99) were randomly recruited in
      the study. For the intervention group, an inflatable cuff (14 cm in width * 84 cm in length)
      is warped around abdominal muscles below ribs which may cause to at least 60% restriction of
      blood flow detected by Power Doppler ultrasonography. All participants are instructed to
      perform ADIM both condition of BFR and BFR-free twice a week, for six weeks. Outcome
      measurements include Double leg lowering test (DLLT) for muscle strength, brightness mode
      ultrasound (USD) for muscle hypertrophy and electromyography (EMG) muscle activation. The
      same physical therapist will do the measurement at first week, third week and the sixth week.
    

Intervention name(s): blood flow restriction; sham blood flow restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform abdominal draw-in maneuver.; an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs without inflation. All participants are instructed to perform abdominal draw-in maneuver.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers
Condition: Phase I Study in Healthy Volunteers to Evaluate ECG Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluating ECG effects, safety, tolerability and
      pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers
    

Detailed description: 
      An adaptive randomised, double-blind, single-centre, placebo-controlled Phase I study
      evaluating ECG effects, safety, tolerability and PK of single ascending doses of Modufolin®
      for Injection, 100 mg in healthy male volunteers. Thirty-three (33) eligible and consenting
      subjects will be included in 3 cohorts, 11 subjects in each cohort. Within each cohort,
      subjects will be randomised to receive either placebo (3 subjects) or Modufolin® for
      Injection, 100 mg (8 subjects). There will be 3 pre-defined ascending dose-levels. Additional
      dose levels may be considered if recommended by the internal Safety Review cCommittee. There
      will be an interval between each dose level to allow time for safety data to be analyzed and
      evaluated by the iSRC. The iSRC will have the choice to decide to escalate the dose as
      planned, reduce or increase the dose escalation step, repeat the dose, reduce the dose or
      terminate the study. The total study duration for the subjects will be approximately 5 weeks
      and there will be in total 3 visits to the clinic. Subjects will be screened for eligibility
      according to study-specific inclusion/exclusion criteria within 4 weeks prior to start of
      stud treatment (Visit 1; Screening visit). The subjects will be confined to the research
      clinic from the evening before dosing (Day -1) until 24 hrs post dose (Days 1 and 2). The
      subjects should be fasting overnight (8 hrs) before IMP/placebo administration until 4 hrs
      post-dose. A Follow-up Visit will be performed 5 to 10 days after dose administration of for
      each cohort.
    

Intervention name(s): Modufolin (arfolitixorin)
Intervention type(s): Drug
Intervention description(s): Thirty-three eligible and consenting subjects will be included in 3 cohorts, 11 subjects in each cohort, Within each cohort, subjects will be randomized to receive either placebo (3 subjects) or Modufolin® for injection, 100mg (8 subjects)
Other intervention name(s): arfolitixorin
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: An adaptive, randomized, double-blind, single-center, placebo-controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
Condition: Infections, Human Immunodeficiency Virus and Herpesviridae; Infection, Human Immunodeficiency Virus
MeSH terms: Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, two part, open-label, crossover study in healthy adult
      subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet
      formulations manufactured by three different processes relative to the GSK2248761 WBM capsule
      formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the
      selected WBM tablet formulation (Part B).
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): GSK2248761 WBM Capsule; GSK2248761 WBM Tablet Formulation 1; GSK2248761 WBM Tablet Formulation 2; GSK2248761 WBM Tablet Formulation 3; GSK2248761 WBM Tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg GSK2248761 WBM capsule (reference) 2 X100mg; GSK2248761 WBM Tablet 200mg manufacturing process 1; GSK2248761 WBM Tablet 200mg manufacturing process 2; GSK2248761 WBM Tablet 200mg manufacturing process 3; GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: formulation; bioavailability; pharmacokinetics; GSK2248761
Warm Water for Unsedated Colonoscopy
Condition: Colonoscopy
Study type: Interventional

Summary: 
      Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of
      drug-related side effects, although it may be painful for the patient. Based on recent
      reports, the investigators designed this randomized controlled trial hypothesizing that the
      use of water irrigation versus air insufflation during the insertion phase of colonoscopy
      might increase the global tolerability of the examination and the proportion of patients
      undergoing complete colonoscopy without sedation.
    


Intervention name(s): warm water irrigation; air insufflation
Intervention type(s): Procedure; Procedure
Intervention description(s): warm water irrigation during insertion phase of colonoscopy; air insufflation during the insertion phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: sedation; warm water
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with
      placebo in the treatment of patients with schizophrenia.

      This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses
      of RBP-7000 compared with placebo over an 8-week treatment period.
    


Intervention name(s): RBP-7000; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).
Other intervention name(s): risperidone in Atrigel; Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone
A Single Dose Study In Japanese And Western Healthy Subjects To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-04991532
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the safety, tolerability and pharmacokinetics of single
      ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is
      to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532
      in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western
      healthy subjects.
    

Detailed description: 
      Safety/Tolerability and Pharmacokinetics
    

Intervention name(s): PF-04991532; Placebo; PF-04991532
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.; Single dose administration of matching placebo in tablet formulation at the fasted state; Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.
Intervention MeSH terms: Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: PF-04991532; safety and tolerability; PK; Japanese and Western population