bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Measure if There is Any Difference in How the Body Breaks Down or Inactivates Either Fluoxetine or LY2216684 When Both of These Medicines Are Given Together.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure if there is any difference in how the body breaks
      down or inactivates either fluoxetine or LY2216684 when both of these medicines are given
      together. This study will look at how fluoxetine might affect LY2216684 and how giving
      LY2216684 might affect fluoxetine in the body.

      The duration of study participation in this study is approximately 36 days not including the
      screening appointment. This study requires 1 research unit confinement of 29 days/28 nights
      followed by 1 outpatient appointment. A screening appointment is required within 30 days
      prior to the start of the study.
    


Intervention name(s): LY2216684; Fluoxetine
Intervention type(s): Drug; Drug
Intervention description(s): LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27; Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized trial is determining the role of antibiotic prophylaxis in the prevention of
      the infectious complications in patients carrying out totally implantable venous access
      device.
    


Intervention name(s): cefazolin Sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): cefazolin Sodium 1g i.v. before operation; placebo
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: implantable catheters; Indwelling Catheters; infection; cefazolin sodium; prophylactic; antibiotic; totally implantable venous access device; cancer patients
Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Main objective of this study is to assess BMS-986165 plasma PK following single and multiple
      oral doses of BMS-986165 in healthy Chinese subjects.
    


Intervention name(s): BMS-986165; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dose 1 or Dose 2 on Day 1, and from Days 5-19'; Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two dose groups. Once the safety and tolerability up to discharge (Day 24) of Group 1, has been assessed and deemed safe; dosing for Group 2 will begin.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to assess the immunogenicity and safety of one booster vaccination with
      45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young
      adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1
      influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).
    


Intervention name(s): Recombinant Influenza HA Vaccine (H5N1)
Intervention type(s): Biological
Intervention description(s): one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
Other intervention name(s): UMN-0501
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Avian influenza, H5N1, pandemic, recombinant HA vaccine
The Efficacy of Fenugreek Supplementation on Men's Health
Condition: Aging; Testosterone Deficiency
Study type: Interventional

Summary: 
      1. The problem: There is limited research on the use of herbal supplements in general, and
           fenugreek specifically, to improve male health, particularly to increase testosterone
           levels. As well, no located studies have examined the effects of fenugreek
           supplementation on healthy men's health-related quality of life, anxiety levels, and
           body composition.

        2. Relevant research examined the effects of fenugreek supplementation with healthy men
           aged between 43 and 70 years of age. The researchers found that both total serum
           testosterone and free testosterone increased compared to placebo after 12 weeks of
           active treatment. The researchers concluded that fenugreek supplementation was a safe
           and effective treatment for reducing symptoms of possible androgen deficiency, improves
           sexual function and increases serum testosterone in healthy middle-aged to older men.
           Another study found that fenugreek supplementation improved aging male symptoms and
           testosterone levels remained in a normal range in healthy men aged 25 to 45 years.

        3. The importance of this study: The importance of this study is to help determine if
           fenugreek supplementation affects testosterone levels, body composition, health-related
           quality of life, anxiety, and aging symptoms in healthy men aged 21 - 45 years.
    


Intervention name(s): AlphaFen fenugreek 400 mg; AlphaFen fenugreek 500 mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.; A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.; rice flour in a vegetable/ cellulose capsule
Intervention MeSH terms: Fenugreek seed meal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will complete 3 assessments during the study at Day 0, Week 4, and Week 8. At each assessment, they complete the following: self-report inventories (e.g., Aging Male Symptoms Questionnaire, Trait Anxiety Inventory, Health-related Quality of Life), body composition via BOD POD, heart rate, blood pressure, and blood draws. The subjects will be randomized to one of the following three conditions: (1) AlphaFenTM fenugreek (400 mg/d), (2) AlphaFenTM fenugreek (500 mg/d), or (2) placebo control. The subjects will be asked to take one capsule of the fenugreek supplement or placebo daily for eight weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fenugreek; Aging Male Symptoms; Testosterone; Supplementation; Double Blind; Body Composition
Relative Bioavailability of Pimasertib in Cancer Patients
Condition: Neoplasms
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over
      trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in
      cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial
      extension phase).
    


Intervention name(s): Pimasertib Capsule (Part A); Pimasertib Tablet (Part A); Pimasertib Tablet (Part A); Pimasertib Capsule (Part A); Pimasertib Capsule (Part B and trial extension phase)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.; Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.; Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.; Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.; Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
Other intervention name(s): AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B
Intervention MeSH terms: Niacinamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasms; Pimasertib; Cancer
Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
Condition: Concussion
Study type: Interventional
Phase: Phase 4

Summary: 
      Concussions are a common injury among athletes in the United States. The annual incidence of
      sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8
      million, and the likelihood of an athlete in a contact sport experiencing a concussion is as
      high as 20 percent per season. Even mild traumatic brain injury, including concussion, can
      cause long-term cognitive problems that affect a person's ability to perform daily activities
      and to return to school or work. Far more concerning is the mounting body of evidence that
      concussions are not just transient injuries - but have cumulative effects. It has been well
      established in animal models that progesterone has neuroprotective benefits. Animal studies
      using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema,
      reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral
      outcomes. To date, there have been no studies to assess whether or not progesterone will be
      effective for the treatment of concussions. This double-blind placebo controlled trial will
      assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the
      duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize
      that athletes treated with progesterone will have faster resolution of their concussive
      symptoms. The investigators believe this study may be the first clinical trial to show an
      effective treatment for concussion.
    


Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Standard placebo
Other intervention name(s): Prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion
Drug Interaction Study of MGL-3196 With Pioglitazone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the single-dose pharmacokinetics (AUC) of
      pioglitazone are affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects.
    


Intervention name(s): MGL-3196; Pioglitazone 15mg
Intervention type(s): Drug; Drug
Intervention description(s): MGL-3196 100 mg tablet administered orally in the morning for 13 days; Pioglitazone 15 mg tablet administered orally on 2 separate days, initially on one day alone and again after MGL-3196 has been dosed to steady-state
Intervention MeSH terms: Pioglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
Condition: Healthy Participants
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat
      between the coadministration of the mini-tablet formulations in applesauce or chocolate
      pudding followed by water and the coadministration of atazanavir oral powder in applesauce
      and cobicistat oral tablet followed by water in healthy adult participants.
    


Intervention name(s): Atazanavir; Cobicistat; Atazanavir/Cobicistat Mini-tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): ATV; Reyataz; COBI; Tybost; Evotaz
Intervention MeSH terms: Atazanavir Sulfate; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Participants; Atazanavir; Cobicistat; Reyataz; Tybost; Evotaz
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to evaluate the safety and tolerability of multiple
      doses of BIIB061 administered to healthy adults. The secondary objective is to determine the
      multiple-dose PK profile of BIIB061 in this study population.
    


Intervention name(s): BIIB061; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants receive BIIB061; Matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of
      a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal
      function. The renal function will be calculated by the estimated glomerular filtration rate
      (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.
    


Intervention name(s): Glepaglutide
Intervention type(s): Drug
Intervention description(s): Single dose of Glepaglutide 10 mg
Other intervention name(s): ZP1848
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: If only Part A will be conducted total subjects of 16 will be enrolled if Part B also will be conducted up to 48 subjects will be enrolled.
Masking: None (Open Label)
Primary purpose: Other
Infant & Toddler Short Gut Feeding Outcomes Study
Condition: Short Bowel Syndrome; Intestinal Failure; Home Parenteral Nutrition
MeSH terms: Short Bowel Syndrome; Intestinal Failure
Study type: Observational

Summary: 
      The purpose of this study is to better understand why children with short gut develop feeding
      problems.
    

Detailed description: 
      We seek to identify characteristics of our patients' histories that are associated with
      feeding problems in the context of availability of early prophylactic occupational therapy.
      We plan to review our most recent four years' experience in children with short gut syndrome
      with onset in early infancy who initially required home parenteral nutrition to identify risk
      factors or clusters of risk factors associated with food aversion.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients seen in home-TPN clinic and subjects who meet the inclusion criteria will be
        invited to participate.
      
Keywords: Short Gut; Short Bowel Syndrome; Intestinal Failure; Home parenteral nutrition; Feeding Behavior; Enteral Nutrition; Parent-Child Relations; Parenteral Nutrition; Digestive System Diseases
Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
Condition: Athletic Injuries; Physical Therapies
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus
      diathermy in combination with high-intensity laser therapy for pain relief in male
      professional soccer players with muscle injuries. The main questions it intends to answer
      are:

      • Is this combination of treatments effective in these patients in terms of pain relief?

      Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy
      and high intensity laser. Researchers will compare the group of participants, called the
      treatment group, with a control group to see if:

      • Is the combined treatment of cryoultrasound therapy and high intensity laser more effective
      in these patients than the combination of diathermy and high intensity laser?
    


Intervention name(s): Cryoultrasound therapy plus high-intensity laser therapy; diathermy plus high-intensity laser therapy
Intervention type(s): Other; Other
Intervention description(s): Group A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy.; Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in
      patients with acute heart failure.
    


Intervention name(s): Shenfu Zhusheye; 5% glucose injection
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
Condition: Cholesterol
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and
      simvastatin given alone on intestinal cholesterol absorption.
    

Detailed description: 
      Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week
      treatment periods.
    

Intervention name(s): ezetimibe; Comparator: Placebo (unspecified); simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.; matching placebo tablet. Duration of Treatment 31 Weeks.; simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
Other intervention name(s): MK0653; MK0733
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is
      a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low
      HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade
      chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.

      This study will investigate the effect of a 12 week intervention with canola oil versus the
      typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS
      parameters. CVD risk will be assessed based on the profile of lipids and other factors in the
      blood as well using specialized equipment for non-invasive monitoring of blood vessel
      function.
    

Detailed description: 
      The current, worldwide obesity epidemic is significantly increasing the number of individuals
      with Metabolic Syndrome (MetS), an early stage combination of risk factors which predisposes
      individuals to cardiovascular disease (CVD) and other chronic diseases. While it has been
      shown that modification of dietary fat intake can play an important role in prevention and
      management of CVD there is an absence of dietary intervention studies focusing on dietary
      oils and early stage modification of MetS components, particularly those affecting
      progression to CVD.

      The composition of canola oil is considered healthy. However, there is a lack of
      scientifically sound clinical studies directly comparing canola oil with other fats in the
      diet. Given that much of the evidence for current dietary recommendations for type and
      amounts of fatty acids is based on heart disease, the proposed research will contribute to
      the knowledge base for dietary fat recommendations for individuals with MetS.

      Specifically, this study will investigate the effect of a 12 week intervention with canola
      oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function
      and MetS parameters. CVD risk will be assessed based on the profile of lipids and other
      factors in the blood as well using specialized equipment for non-invasive monitoring of blood
      vessel function.
    

Intervention name(s): Canola Oil 25 g/d; Non-Canola Oil Mixture 25 g/d
Intervention type(s): Other; Other
Intervention description(s): Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.; Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Canola Oil; Metabolic Syndrome; Serum LDL cholesterol