bioihbjkbjnl/mcl2 huggingface dataset:
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine if high dose supplementation with the omega-3 fatty
      acids EPA and DHA, when added to a weight loss program, is well tolerated in the study
      population and if there is an increase in the favorable change in blood and tissue breast
      cancer risk factors when compared to weight loss alone.
    

Detailed description: 
      Subjects will all participate in a 6-month weight loss intervention. Subjects will be
      randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.
    

Intervention name(s): Omega-3 Fatty Acids; Placebo Capsule; Diet and Exercise
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA); Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
Other intervention name(s): Eicosapentaenoic Acid (EPA); Docosahexaenoic Acid (DHA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast cancer risk; DHA; Omega-3 Fatty Acids; EPA; Weight Loss
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Assessed.
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional

Summary: 
      To evaluate and compare the relative bioavailability and therefore the bioequivalence of
      fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman
      Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/850mg tablets
      manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects
      under Fed Conditions.
    


Intervention name(s): Metformin and Vildagliptin 850/50 mg
Intervention type(s): Drug
Intervention description(s): 50 mg Vildagliptin + 850 mg Metformin as single-dose per study period
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pilot Behavioral Support Intervention After Bariatric Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral
      support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all
      surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight
      Management compared to 40 usual care patients.
    

Detailed description: 
      Bariatric surgery patients may experience significant psychosocial changes after surgery, but
      little psychological support is available beyond support groups postoperatively. Psychosocial
      changes after surgery, including mood fluctuations, interpersonal issues and substance use,
      have the potential to lower quality of life and interfere with adherence to the postoperative
      diet and lifestyle, diminishing weight loss outcomes.

      This prospective randomized pilot trial will evaluate the effect of a postoperative support
      program targeting quality of life, psychosocial functioning and adherence to behavior change
      in Geisinger Health System (GHS) bariatric surgery patients.

      In this study there will be two arms. The intervention arm will include forty bariatric
      surgery patients (all procedure types) from the GHS Center for Nutrition and Weight
      Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral
      support program to address psychosocial changes after surgery, strategies for postoperative
      diet and adherence and preventing weight regain. The control arm will include 40 usual care
      (UC) patients from the same center that completed bariatric surgery within one year.

      Both groups will complete two sets of surveys. The first set will be administered at study
      initiation. The second set will be administered upon completion of the 8 sessions for the
      intervention group. The control group will also complete surveys during this same timeframe
      (approximately 4-6 months after baseline survey completion).

      Upon study completion, control group members will be afforded an opportunity to participate
      in the same postoperative behavioral support program offered to the intervention group.

      The primary endpoint of this study will be quality of life with secondary endpoints including
      differences in psychosocial functioning (mood, eating behaviors) and adherence (diet,
      physical activity, appointments) as well as patient satisfaction, treatment feasibility and
      attrition.
    

Intervention name(s): Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
B. Lactis B94 Effects of Gastrointestinal Function
Condition: Quality of Life
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of daily consumption of Bifidobacterium
      animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit
      time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75
      years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled,
      crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a
      4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants
      will complete daily questionnaires about stool frequency and stool form (transit). Dietary
      intake will also be assessed. A total of 5 stools (one in each period) will be collected for
      exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase
      stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms
    

Detailed description: 
      Probiotics have been shown to improve symptoms of constipation by decreasing gastrointestinal
      transit time, increasing stool frequency, and normalizing stool form. A 20-week randomized,
      double-blinded, placebo-controlled crossover study will be carried out. Participants will
      complete a 4-week baseline period during which stool frequency, stool consistency (transit
      time), and gastrointestinal symptoms will be collected by paper questionnaire, and
      participants will collect a single stool. Dietary intake data (3-day) will be obtained during
      the baseline period. Participants will be randomized on or about day 29 and will consume
      Bifidobacterium animalis ssp lactis B94 (B. lactis B94) or placebo for 4 weeks, followed by a
      4-week washout, 4 weeks on the alternative, and second 4-week washout. Participants will be
      randomized by sealed envelope method, prepared by a UF faculty member not affiliated with the
      study.

      During the intervention and washout periods, participants will complete daily questionnaires
      to assess stool frequency and form (Bristol Stool Form Scale). Furthermore, they will
      complete Gastrointestinal Symptom Rating Scale (GSRS) at weeks 4, 8, 12, 16 and 20(± 3 days).
      During these same weeks (± 3 days) dietary intake data (28-day record) and stools will be
      collected (1 per period). Participants' height and weight will be taken at baseline, and
      weight during weeks 4, 8, 12, 16 and 20.
    

Intervention name(s): B. lactis B94; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A probiotic dose of 15 billion per capsule.; Placebo capsule
Other intervention name(s): Bifidobacterium animalis ssp lactis B94; Placebo capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to optimize calcineurin immunosuppressive regimens and evaluate
      immunological and non-immunological markers that may explain mechanistic differences in these
      agents and their effects.
    

Detailed description: 
      One of the major challenges in transplantation over the past two decades has been managing
      long-term renal function. Serum creatinine is the most commonly used serum marker of renal
      function. However serum creatinine is insensitive for detecting small decreases in glomerular
      filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al
      concluded that cystatin C is superior to serum creatinine as a marker of kidney function
      since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in
      GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe
      acute rejection and better lipid profiles than cyclosporine-treated patients.

      Cardiovascular disease is the primary cause of premature death in renal and other transplant
      recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk
      factors such as hypertension, hyperlipidemia, obesity and diabetes.

      This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best
      possible long-term outcomes after renal transplantation.
    

Intervention name(s): cyclosporine; Prograf (Tacrolimus)
Intervention type(s): Drug; Drug
Intervention description(s): Maintain on cyclosporine at target trough level of 50-250 ng/mL.; Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
Other intervention name(s): Cyclosporine/Neoral®/Sandimmune®/Gengraf®; Tacrolimus/Prograf®/FK506
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Transplantation; Immunosuppressive Agents
Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional

Summary: 
      Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief
      than placebo in patients with chronic pancreatitis.

      Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom
      that brings the patient to clinical attention. Pain in chronic pancreatitis is
      multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension,
      inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical
      allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for
      pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized
      controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage
      gated calcium channel blocking agent) can result in significant reduction of pain in CP.

      In this study, the investigators will study the efficacy of the combination of antioxidants
      and pregabalin in reducing pain and compare that with placebo. The investigators will
      randomize patients with documented chronic pancreatitis with recurrent/persistent pain after
      undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants +
      pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the
      secondary outcomes will be change in the number of painful days, analgesic requirements,
      quality of life and depression scale. Pain score will be quantified by the Izbicki pain score
      and visual analog scale; while quality of life and depression will be measured by the EORTC
      QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B
      will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively
      and analysis will be done on a intention to treat and per protocol basis. With an expected
      improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10%
      drop out rate, the required sample size in each group will be at least 40.
    


Intervention name(s): Placebo; Antioxidant plus Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): This group will include placebo.; This group will contain combination of antioxidant cocktail and pregabalin
Intervention MeSH terms: Pregabalin; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic pancreatitis; pregabalin; antioxidant
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Condition: Acellular Pertussis; Tetanus; Hepatitis B; Diphtheria; Haemophilus Influenzae Type b; Poliomyelitis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Booster and immune memory study
    

Detailed description: 
      Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent
      polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK
      Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bevacizumab in Treating Young Patients With Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of bevacizumab in treating
      young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can
      locate tumor cells and either kill them or deliver tumor-killing substances to them without
      harming normal cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a
      maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion,
      every 2 weeks to children with refractory solid tumors.

      II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given
      on this schedule.

      III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory
      cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of bevacizumab within the confines of a
      phase I study.

      II. To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF,
      and parallel angiogenic markers V-CAM-1, ICAM-1, bFGF, and TSP-1 at baseline and at time
      points post therapy.

      III. To explore the biologic effect of bevacizumab on circulating endothelial cells (CECs)
      and circulating endothelial cell precursors (CECPs).

      IV. To determine in archival tumor tissue the expression of VEGF by immunohistochemistry
      and/or real time PCR.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every
      28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.
    

Intervention name(s): bevacizumab
Intervention type(s): Biological
Intervention description(s): Given IV
Other intervention name(s): anti-VEGF humanized monoclonal antibody; anti-VEGF monoclonal antibody; Avastin; rhuMAb VEGF
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to examine the effect of a single IV dose of ketamine (0.5
      mg/kg) on laboratory-induced stress in healthy participants.
    

Detailed description: 
      Stress exposure is one of the greatest risk factors for psychiatric illnesses like major
      depressive disorder (MDD) and post-traumatic stress disorder (PTSD). Stress resilience is the
      ability to experience stress without developing psychopathology. Enhancing stress resilience
      in at-risk populations could potentially protect against the development of stress-induced
      psychiatric disorders. Despite this, no resilience-enhancing pharmaceuticals have been
      identified yet. Pre-clinical studies showed that the administration of the glutamate
      N-methyl-D-aspartate (NMDA) receptor antagonist ketamine one week before an acute stress
      prevents the developing of depressive-like behavior in animals. In this project the study
      team proposes a pilot study to test if this stress prophylactic effect of ketamine applies
      also to humans. Ketamine will be compared to an active placebo control condition, the
      anesthetic midazolam, in a sample of healthy volunteers. The specific aims of this project
      are to test the effect of ketamine administered 1-week prior a laboratory-induced stress (1)
      on the positive and negative affect as measured with the Profile of Mood States (POMS) -
      Bipolar and (2) on the hypothalamic-pituitary-adrenal axis (HPA axis),
      adrenaline-noradrenaline axis (ANS axis), and self-reports of anxiety. The study team expects
      that subjects treated with ketamine, compared to midazolam, will experience reduced symptoms
      of negative affect and anxiety and a blunted hormonal response to an acute stress.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): administered 1 week prior to a laboratory-induced stress; administered 1 week prior to a laboratory-induced stress
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two groups in parallel during the duration of the study: the ketamine arm or the midazolam arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ketamine; Resilience; Stress; Healthy Volunteers
An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in
      Adults with pain due to osteoarthritis of the knee.
    

Detailed description: 
      A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of
      two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis
      of the knee.

      The primary trial objective is to evaluate whether there is greater efficacy of 10 mL Ampion™
      versus 10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in
      improving knee pain, when applied to patients suffering from OA of the knee.

      The secondary trial objective include: the evaluation of the safety of an intra-articular
      injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of
      the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function
      when applied to patients suffering from OA of the knee and evaluation of responder status
      defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research
      Society International (OMERACT-OARSI) Criteria.
    

Intervention name(s): 4 mL injection of Ampion; 10 mL Injection of Ampion; 4 mL Injection of Placebo; 10 mL Injection of Placebo
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 4 mL Injection of Ampion; 10 mL Injection of Ampion; 4 mL Injection of Placebo; 10 mL Injection of Placebo
Other intervention name(s): Saline; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; osteoarthritis of the knee