bioihbjkbjnl/mcl2 huggingface dataset:
Learning Yoga to eNhance Cancer Survivorship
Condition: Cancer
Study type: Interventional

Summary: 
      This study aims to conduct a single-arm pilot test of online yoga classes for young adult
      cancer survivors (YACS). Study hypotheses are that LYNC will be feasible (enrollment of > 50%
      of eligible) and acceptable (75% attendance at all sessions). In addition, analyses of
      preliminary efficacy outcomes will examine whether participants report potential improvements
      in psychosocial and physical wellbeing.
    

Detailed description: 
      This study will recruit YACS (n=30) for an 8-week course (75-minute yoga classes delivered
      once per week) delivered online via videoconferencing software such as Zoom or Bluejeans.
      During yoga classes, all participants will be able to see one another, to simulate the group
      experience of being in an in-person class. Participants will complete patient-reported
      outcomes of physical and psychosocial wellbeing at baseline (prior to class 1) and
      post-intervention (after class 8), as well as post-intervention measures of
      feasibility/acceptability (e.g., ease of accessing online classes, satisfaction with yoga
      classes, helpfulness of online yoga, barriers/dislikes associated with online yoga). All
      surveys will be administered via REDCap. In addition, the investigators will compute rates of
      retention (% of consenting subjects who complete post-intervention assessment) and adherence
      (# of yoga classes attended).
    

Intervention name(s): Yoga Intervention
Intervention type(s): Other
Intervention description(s): Weekly 75-minute yoga classes.
Other intervention name(s): Yoga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Young Adult; Cancer Survivor
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
Condition: Growth Hormone Disorder; Pituitary Dwarfism
MeSH terms: Dwarfism; Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). This is a 12 month study to
      determine if Norditropin is safe and effective in children with IGF deficiency.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth Hormone Disorder
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in
      subjects with iron deficiency anemia.
    


Intervention name(s): Placebo; Iron alone; Low-dose 5-aminolevulinic acid with iron; Medium-dose 5-aminolevulinic acid with iron; High-dose 5-aminolevulinic acid with iron
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo; once/day; for 12 weeks; Iron (3 mg); once/day; for 12 weeks; 5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks; 5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks; 5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
Intervention MeSH terms: Iron; Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy
Condition: NSAID Induced Gastropathy
MeSH terms: Stomach Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry
      surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with
      Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who
      become symptomatic during NSAID treatment, to compare the proportion of patients with
      positive treatment effects using the Likert scale. Third objective: To compare the proportion
      of patients with positive treatment effects as determined by Modified Lanza scoring between
      the two groups.
    


Intervention name(s): Rebamipide and Esomeprazole
Intervention type(s): Drug
Intervention description(s): Rebamipide 100mg TID for 12 weeks
Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks
Intervention MeSH terms: Esomeprazole; Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
Condition: Dental Caries
MeSH terms: Dental Caries; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative hypersensitivity (POH) is a problem for many patients as determined by the
      recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following
      occlusal caries restoration. The objectives of this two-armed randomized comparative
      effectiveness research trial (RCERT) are to determine whether adding a resin modified glass
      ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC)
      restorations, and to identify other factors (putative risk factors) that are associated with
      increased POH.

      The primary outcome of this study is the reduction/elimination of restoration POH as measured
      by clinical assessment (air stream) and patient-reports.

      Outcomes will be ascertained via the following specific aims:

      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical
      measurement (air drying) and by patient-reported outcomes among the two treatment groups at
      three points in time: prior to restoration and at one and four weeks postrestoration.

      Specific Aim 2: To identify putative risk factors for POH (or factors associated with
      differences in POH) including: preoperative caries stage measured by the proposed American
      Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the
      preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation
      depth, and patient sleep bruxism status.
    


Intervention name(s): Restoration with a dentin bonding agent (DBA); Restoration with a resin modified glass ionomer liner (RMGI)
Intervention type(s): Procedure; Procedure
Intervention description(s): Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.; Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental caries; Resin based composite; Hypersensitivity; Teeth; Dentistry; Practice-based research network
Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India and the corresponding
      Reference Product: Coreg® (Carvedilol Tablets) 12.5 mg Tablets of M/s GlaxoSmithKline, under
      fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 42 healthy adult subjects. In each study period, a single 12.5
      mg dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Carvedilol Tablets USP 12.5 mg; Carvedilol
Intervention type(s): Drug; Drug
Intervention description(s): 12.5mg tablet once a day; 12.5mg tablet once a day
Other intervention name(s): Test Product; Coreg®
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This three-part study will be performed with participants on chronic hemodialysis.

        -  Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a
           single dose of powder in bottle (PIB) or tablet formulations of DS2330b

        -  Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day
           repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer
           carbonate three times a day

        -  Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated
           oral doses of DS-2330b tablets when given with sevelamer carbonate

      After screening, participants should expect the study to last about 21 days for Part A, and
      46 days for Parts B and C.
    


Intervention name(s): DS-2330b PIB; Placebo; Sevelamer; DS-2330b Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DS-2330b as powder in bottle with stock solution (PIB); Placebo matching stock solution in bottle; Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.; DS-2330b as tablet formulation
Other intervention name(s): Sevelamer carbonate
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A has a 2-period, open-label, randomized, 2-way crossover design with a single dose of Treatments A1 and A2
Part B participants are randomized with a 2:3:3:3 ratio to Treatment B1, B2, B3, and B4, respectively, using a double-blind, repeated dose, parallel design
Part C is an optional, single-arm, open label, repeated dose design
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic hemodialysis; Investigational drug
FRIENDS as an Indicative Prevention Program in Norway
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this pilot-study is to evaluate a cognitive behavioral program, the
      Friends-program, as indicated prevention for anxious youth. The youths are recruited by
      school nurses who will also lead the intervention groups applying the Friends-manual.
    


Intervention name(s): The Friends program
Intervention type(s): Behavioral
Intervention description(s): The Friends program is a ten weeks group interventions based on principles from Cognitive Behavioural Therapy aimed at ameliorating symptoms of anxiety and depression in children and adolescents. There are age-specific versions of the manual, one for children 8-12 years and one for adolescents 12-15 years.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Open trial; Indicative prevention; Youth anxiety; Cognitive behavioral therapy
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see
      whether enough calories from glucose are excreted in the urine to cause weight loss.
    


Intervention name(s): GW869682
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hunger; obesity; sodium-dependent glucose transporter; GW869682; body composition; SGLT2 inhibitor; weight loss
Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on
      Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other
      half received placebo.
    

Detailed description: 
      In China, the herbal formulas have been used in the treatment of diabetes for centuries.
      Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula
      used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of
      Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali
      (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori
      Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of
      Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and
      their constituents have therapeutic effects on the metabolic disorders.

      This randomized, double-blind, placebo-controlled trial was conducted in a community hospital
      of Shanghai, China. 60 adult participants were metabolic disorder patients according with at
      least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others).
      During 3-month treatment, participants were randomly divided in to two groups assigned to
      take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals
      with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride
      (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density
      lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.
    

Intervention name(s): AMP-1915; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A traditional Chinese Formula extract from Astragalus, Radix Puerariae and Cortex Mori is mixed into instant noodles. Patients are treated with AMP-1915 as meal.; Instant noodles without drug
Other intervention name(s): Huangqi San
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; hyperlipidemia; hyperglycemia
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to look at the safety and tolerability of the experimental
      drug, how people process the drug, how the drug affects people, and to identify a dose or
      doses to study in subsequent future studies.
    

Detailed description: 
      The purposes of this trial are to determine if administration of INS50589 Intravenous
      Infusion is well tolerated, to determine the pharmacological effects of INS50589 at different
      doses, and to identify an appropriate dose for later efficacy studies. More specifically, the
      objectives are to:

        -  Evaluate safety and tolerability

        -  Evaluate pharmacokinetics of INS50589 and its major metabolite(s)

        -  Evaluate effects of INS50589 on platelet function at various dose levels

        -  Evaluate potential relationship between plasma concentrations of INS50589 and various
           pharmacodynamic endpoints

        -  Identify one or more dose levels of INS50589 for future studies
    

Intervention name(s): INS50589 Intravenous Infusion
Intervention type(s): Drug
Intervention MeSH terms: INS 50589
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bleeding; blood transfusion; surgeries
Effects of Anticipation of Pain Relief on Brain Mechanisms
Condition: Pain
Study type: Interventional

Summary: 
      This study will use brain imaging technology to examine chemical systems in the brain that
      suppress pain and stress when an individual has an expectation of pain relief.
    

Detailed description: 
      Evidence suggests that the expectation of pain relief, even if a person receives only a
      placebo, can provide actual therapeutic benefits. The µ-opioid receptor system, located in
      the brain, is activated during anticipation of pain relief; this activation suppresses stress
      and pain responses. This study will use brain imaging technology to examine the effects of a
      placebo intervention on µ-opioid neurotransmitters. Examination of the factors that regulate
      these placebo-activated neurotransmitter responses will clarify the overall neurobiology
      underlying variations in the responses to placebos, as well as pain and other stressful
      conditions, ultimately leading to the optimization of medical and psychological
      interventions.

      This study will last several hours during one study visit. Participants will receive both a
      painful and a painless injection while undergoing positron emission tomography (PET) brain
      imaging. The painful injection will consist of small amounts of hypertoninc saline
      (concentrated saline that causes cell shrinkage) in the jaw muscle over a 20-minute period.
      Several minutes after participants receive hypertonic saline, they will receive an injection
      with isotonic saline not associated with pain in the opposite jaw muscle. After participants
      receive the injections, they will either be told or not be told about a pain relief
      intervention. PET imaging will continue as participants either anticipate or do not
      anticipate pain relief. Participants will be asked about their pain levels repeatedly
      throughout the study; their responses will be entered into a computer-controlled system which
      will modulate rates of saline infusion.
    

Intervention name(s): Hypertonic saline; Isotonic saline
Intervention type(s): Procedure; Procedure
Intervention description(s): To elicit pain; Non-painful control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Hypertonic saline is a challenge to activate endogenous opioid systems as assessed with positron emission tomography. There is no treatment involved. Isotonic saline is the control.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Positron-Emission Tomography; Endorphins; Pain Relief; Opioid Receptors; Stress; Analgesia
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
Condition: Breast Cancer; Breast Carcinoma; Breast Neoplasms; Breast Tumors; Cancer of Breast
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this clinical study is to describe the patient population, breast cancer
      treatment, and breast cancer treatment results of adult female patients who have received
      palbociclib combination treatments for advanced or metastatic breast cancer in India.

      There are two groups of patients this study will describe. The first group of patients will
      have received palbociclib in combination with aromatase inhibitor (as prescribed by the
      Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as
      initial endocrine-based therapy for their metastatic disease. The second group of patients
      will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or
      metastatic breast cancer in combination with fulvestrant in women with disease progression
      following endocrine therapy.
    


Intervention name(s): Palbociclib plus hormonal treatment - first line treatment; Palbociclib plus hormonal treatment - second line treatment
Intervention type(s): Drug; Drug
Intervention description(s): Palbociclib plus hormonal treatment; Palbociclib plus hormonal treatment
Intervention MeSH terms: Palbociclib
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult menopausal women with confirmed metastatic or advanced breast cancer in India
      
Keywords: Hormone receptor positive / human epidermal growth factor 2 negative (HR+/HER2-); Advanced Breast Cancer; Metastatic Breast Cancer; Palbociclib; aromatase inhibitor; fulvestrant