bioihbjkbjnl/mcl2 huggingface dataset:
BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,
      Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of
      Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22
      days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets
      containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test
      Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets
      containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg
      (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.
    

Intervention name(s): Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets; Tribenzor of Daichi Sankyo Inc. USA
Intervention type(s): Drug; Drug
Intervention description(s): oral, crossover; oral, crossover
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome
Condition: Sturge-Weber Syndrome
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex)
      for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).
    

Detailed description: 
      The investigators hope to gain an understanding of the utility of pharmaceutical grade CBD
      used for the treatment of cognitive impairments in SWS in this open-label study. Anecdotal
      evidence from a phase I trial investigating the use of CBD for medically refractory seizures
      suggests CBD may also have a beneficial effect on cognition, mood, and behavior. The
      investigators hypothesize that CBD/ Epidiolex will improve SWS brain function resulting in
      improved cognitive function, social interactions, mood, motor function and behavior, as well
      as reduced migraines. This is an open-label prospective oral drug trial of Epidiolex in 10
      subjects. Assessments will be done at baseline and repeated after 6 months on study drug.
    

Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.
Other intervention name(s): Epidiolex; CBD
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sturge-Weber Syndrome; SWS; Cognitive impairments
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial investigates the effects of FE 999049 compared to placebo.
    


Intervention name(s): Follitropin delta; Placebo
Intervention type(s): Drug; Other
Intervention description(s): FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 12 µg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 µg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 µg, and the maximum daily dose was 24 µg.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early ovarian hyperstimulation syndrome (OHSS) with the exception of gonadotropin-releasing hormone (GnRH) agonist for triggering of final follicular maturation, was not allowed.; Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed.
Other intervention name(s): FE 999049; Rekovelle
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain
      at the end of the study will be greater in the Wet Cupping Treatment group than in the
      Waiting Control group.
    


Intervention name(s): Wet Cupping; Acetaminophen
Intervention type(s): Device; Drug
Intervention description(s): Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25); Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.
Other intervention name(s): Disposable wet cupping cup, Seongho trade & company, Korea
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Persistent Non-specific Low Back Pain; wet cupping; cupping; Numerical Rating Scale
Effect of Exercise on Prevention of Weight Gain
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss; Weight Gain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the dose-response of exercise on prevention of weight
      gain in overweight adults.
    


Intervention name(s): behavioral exercise intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Nurses' Negative Words and Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Psychological implications expressed pivotal effects on daily activities. Postoperative pain
      management is always encountered varying influence from the ambience of surgical wards,
      especially the nurses. We hypothesized that nurses' negative or positive words would produce
      unexpected role in pain management, which might be a strong factor resulting in the failure
      of postoperative analgesia.
    


Intervention name(s): No Words; Positive words; Partially Negative Words; Totally Negative Words
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Without any words was given during pain management; Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.; Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.; Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
Other intervention name(s): NW; PW; PNW; TNW
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Psychological Tests; Pain, Postoperative; Nurses
Reversing Corticosteroid Induced Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Medically stable outpatients receiving chronic oral corticosteroid therapy were enrolled in a
      48-week randomized, double-blind, placebo-controlled, parallel-group, trial of lamotrigine.
    

Detailed description: 
      Stress and corticosteroid exposure are associated with changes in both the human and animal
      hippocampus. An extensive literature suggests that corticosteroid-induced changes in the
      hippocampus are, in part, mediated through increases in extracellular glutamate. In animals,
      agents that decrease glutamate release prevent dendritic changes in the hippocampus secondary
      to stress or corticosterone. We have developed a research program using patients receiving
      prescription corticosteroids (e.g., prednisone) to explore the effects of corticosteroids on
      the human hippocampus. Our research program is translational in focus, with a goal of
      exploring whether the reported effects of corticosteroids on the animal hippocampus are also
      found in humans. A current focus of our research is examining glutamate release inhibitors in
      patients taking corticosteroids. We have both open-label and placebo-controlled pilot data
      suggesting that the glutamate release inhibitor lamotrigine is associated with significant
      improvement in declarative memory (a measure of hippocampal performance) in this population.
      A definitive study examining declarative memory in corticosteroid-dependent patients
      receiving lamotrigine vs. placebo is proposed. Neuroimaging and mood will also be assessed.
    

Intervention name(s): Lamotrigine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine will be initiated at 25 mg/day and upwardly titrated to a dose of 400 mg/day over 10 weeks.
Other intervention name(s): Lamictal
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      In a controlled, parallel, double-blind intervention study over 6 months, the investigators
      investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium
      bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and
      compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured
      in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at
      the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry
      (DXA) at baseline and at 6 months.
    


Intervention name(s): Placebo; CaCO3; Kefir
Intervention type(s): Other; Other; Other
Intervention description(s): Placebo daily for 6 months; CaCO3 daily for 6 months; Kefir daily for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Set Your Goal: Engaging Go/No-Go Active Learning
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will test a computational model reinforcement learning in depression and anxiety
      and test the extent to which the computational model predicts response to an adapted version
      of behavioral activation psychotherapy. The model will be based on a data from a computer
      task of reinforcement learning during 3T functional magnetic resonance imaging at baseline.
    

Detailed description: 
      The dysfunction of reinforcement learning is emerging as a transdiagnostic dimension of mood
      and anxiety. Computational models of reinforcement learning may expedite our ability to
      identify predictors of response, thereby improving efficacy rates. We will will, first,
      examine the neural substrates of reinforcement learning in depression and anxiety, and,
      second, test a computational model of reinforcement learning as a predictor of response to an
      adapted version of behavioral activation psychotherapy. Subjects (N=10) will be enrolled in a
      two week evaluation, followed with a nine week weekly intervention program. Assessments will
      be conducted at baseline, and during the intervention as the 3-, 6-, 9-week follow-ups.
      Reinforcement learning will be measured using 3T magnetic resonance imaging during a computer
      task. All other measures include structured clinical interviews, questionnaires, and computer
      tasks.
    

Intervention name(s): Go/No-Go Active Learning (GOAL)
Intervention type(s): Behavioral
Intervention description(s): Behavioral Activation psychotherapy adapted to engage go/no-go learning
Intervention model: Single Group Assignment
Intervention model description: Adapted version of Behavioral Activation psychotherapy designed to optimize decision making and learning.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reinforcement learning; computational models; neuroimaging
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.
Condition: Human Papillomavirus (HPV) Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000
      new cases are reported each year worldwide, from which 83% occur in developing countries. The
      incidence of cervical cancer varies depending on the region of the world. Africa has some of
      the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7
      and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8
      per 100 000; Middle Africa 28.0 and 23.0 per 100 000).

      As in the majority of developing countries, organization of cervical cancer screening
      programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic
      vaccination could therefore clearly and efficiently decrease the incidence of cervical
      cancer. The current study is designed to assess the immunogenicity and safety of GSK
      Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in
      Africa.

      Ideally, HPV vaccination should be performed before onset of sexual activity, since studies
      have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will
      therefore be performed in subjects aged 10 to 25 years of age.
    


Intervention name(s): Cervarix; Placebo Al(OH)3
Intervention type(s): Biological; Drug
Intervention description(s): The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.; Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
Other intervention name(s): GlaxoSmithKline Biologicals' HPV vaccine GSK580299; HPV-16/18 L1 AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Human Papillomavirus (HPV) vaccine
Visanne Study to Assess Safety in Adolescents
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical trial which was designed to demonstrate the safety and efficacy of Visanne
      (approved in endometriosis for adults) in the adolescent population.
    


Intervention name(s): Dienogest (Visanne, BAY86-5258)
Intervention type(s): Drug
Intervention description(s): Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
Intervention MeSH terms: Dienogest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometriosis; DEXA; Adolescent; Safety; Efficacy; Post-menarche
Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
Condition: Cardiovascular Risk
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But
      it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron
      emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation
      within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.

      The investigators are examining this association in normal and impaired glucose tolerance
      patients groups.
    

Detailed description: 
      We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired
      glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum
      blood-normalized standardized uptake value (SUV), known as the target-to-background ratio
      (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular
      inflammation by FDG-PET scan.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subjects underwent routine health checkups at Korea University Guro Hospital. Patients
        with DM or gestational diabetes were not included.
      
Keywords: atherosclerosis; inflammation; hsCRP; Framingham risk score; positron emission tomography; inflammation in FDG-PET
Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy
Condition: Change of Image Quality of CLE
Study type: Observational

Summary: 
      Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most
      commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein
      is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning
      microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within
      the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in
      clinical examination,there are no data on contrast dynamics and image quality over time after
      injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human
      being.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients without any disease of heart,liver or kidney;patients without serious gastritis
        and other serious stomach lesions.
Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. It is not yet known whether fludarabine is more effective than
      chlorambucil in treating chronic lymphocytic leukemia.

      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as
      first-line therapy compared to chlorambucil in treating older patients with previously
      untreated chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the overall and progression-free survival of older patients with previously
           untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.

        -  Compare the duration of remission in patients treated with these regimens.

      Secondary

        -  Compare the incidence of toxicity, especially infections, in patients treated with these
           regimens.

        -  Compare the quality of life in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for
           up to 6 courses.

        -  Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for
           up to 12 months.

      PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
    

Intervention name(s): Fludarabine; Chlorambucil
Intervention type(s): Drug; Drug
Intervention description(s): Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles; Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month
Intervention MeSH terms: Fludarabine; Chlorambucil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Condition: Cicatrix; Scar Prevention
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of a single
      intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that
      will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo
      on scarring at these incision sites will be evaluated visually and histologically.
    


Intervention name(s): RXI-109; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intradermal injection of RXI-109 at incision sites; Single intradermal injection of placebo at incision sites
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scar; Scar prevention; Fibrosis