bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open label, randomized, crossover trial to investigate the relative
      bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized
      to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference,
      test. The reference treatment refers to the current Phase II film-coated tablet (5 * 100
      milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III
      film-coated tablet (1 * 500 mg film-coated tepotinib tablet).
    


Intervention name(s): Tepotinib test (Treatment Period 1); Tepotinib reference (Treatment Period 2); Tepotinib reference (Treatment Period 1); Tepotinib test (Treatment Period 2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 * 500 mg tablet) in Treatment period 1 (Day 1); Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 * 100 mg tablet) in Treatment period 2 (Day 22); Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 * 100 mg tablet) in Treatment period 1 (Day 1); Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 * 500 mg tablet) in Treatment period 2 (Day 22)
Intervention MeSH terms: Tepotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; Tepotinib; Mesenchymal-epithelial transition factor; Translocated promoter region
Beta Glucosylceramide for Treatment of NASH
Condition: Compliance Behavior
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oral administration of betaglucosylceramide was shown effective in reducing inflammation in
      animal models and was found safe in humans.
    

Detailed description: 
      Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver
      biopsy.
    

Intervention name(s): Beta Glucosylceramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Beta Glucosylceramide; normal saline
Other intervention name(s): normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the effects of St. John's wort, a common herbal remedy, on
      metabolism of the female contraceptive hormone levonorgestrel.
    

Detailed description: 
      In the last decade, St. John's wort has become one of the most commonly used botanicals.
      Levonorgestrel is a form of progesterone, a female hormone involved in conception. It can be
      given as both a pill and an injection and is used for contraception and for the treatment of
      endometriosis. However, evidence suggests that St. John's wort may reduce the effectiveness
      of the contraceptive hormone levonorgestrel. This study will determine whether interactions
      between St. John's wort and levonorgestrel reduce the effectiveness of the hormone. This
      study will also determine whether a higher dose of levonorgestrel will override the effects
      of St. John's wort.

      All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their
      first menstrual cycle after entering this study. Blood and urine collection will occur
      immediately after the levonorgestrel is given and every week until participants' next
      menstrual cycle to determine the levels of reproductive hormones in participants' bodies.

      At the beginning of participants' next menstrual cycle, they will be randomly assigned to one
      of four groups and receive either St. John's wort or placebo for 6 weeks. Group 1 will
      receive a placebo; Groups 2 and 3 will receive a standard dose of St. John's wort (900 mg per
      day); and Group 4 will receive an increased dose of St. John's wort (1500 mg per day). After
      6 weeks, Groups 1, 2, and 4 will receive 150 mcg levonorgestrel; and Group 3 will receive 225
      mcg levonorgestrel. Blood and urine collection will occur immediately after levonorgestrel is
      given and every week until participants' next menstrual cycle.
    

Intervention name(s): Placebo Control (Placebo Herb); St. John's Wort; Levonorgestrel
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Placebo herb three times daily (ground cellulose) for 4-6 weeks; St. John's Wort (Hypericum perforatum) orally or 4-6 weeks; Levonorgestrel in a single oral dose
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Menstruation; Complementary Therapies; Pharmacokinetics; Hypericum; St. John's wort; Levonorgestrel; Women
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or
      ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
    


Intervention name(s): ALKS 9072; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular (IM) injection, 441 mg or 882 mg given monthly; Placebo for IM injection, given monthly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; schizophrenia; ALKS 9072; ALKS 9070; aripiprazole lauroxil
Effects of Energy Density on Self-served Snacks in Preschool Children
Condition: Eating Behavior
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether the energy density of snack foods affects
      the amounts that preschool children serve themselves and then consume. We will serve snacks
      that vary in energy density to preschool children in their childcare centers and measure the
      amount they serve themselves and consume. The results will have implications for guidance
      about the provision of snacks for preschool children and may help in identifying strategies
      for the prevention of obesity in children.
    


Intervention name(s): Snack with energy density less than 1.5 kcal/g; Snack with energy density greater than 1.5 kcal/g
Intervention type(s): Other; Other
Intervention description(s): Snack meal with snack food having energy density less than 1.5 kcal/g; Snack meal with snack food having energy density greater than 1.5 kcal/g
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Optimizing the Management of Acute Diarrhoeal Disease
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have
      viral gastroenteritis and so not treated with antibiotics - but they may indeed have a
      treatable cause for their illness. The investigators will conduct a randomized trial to see
      if rapid testing using novel methods to identify potentially treatable causes of diarrhoea
      leads to improved outcomes. The investigators will also be randomizing children to
      Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of
      care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a
      large multi-centre trial following the previous pilot trial.
    


Intervention name(s): Rapid diagnostics; Probiotic; Placebo
Intervention type(s): Other; Biological; Other
Intervention description(s): Participants will have enteric specimens obtained using a flocked rectal swab, which will be transported in 2 mL Cary Blair medium. These will be tested using the BioMerieux BioFire FilmArray GI panel.; The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.; The placebo will be the vegetable oil vehicle and look identical to the probiotic.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhoea; gastroenteritis; rapid diagnostics; probiotics
A Study to Test Different Doses of BI 456906 in Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Main objective is to investigate the tolerability of different titration schemes of BI 456906
      in otherwise healthy patients with obesity/overweight, and to determine a titration scheme
      for future studies.
    


Intervention name(s): BI 456906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection; solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
InBody Validation Study
Condition: Validation Study
Study type: Observational

Summary: 
      With, one in three Americans now having a body mass index (BMI) greater than 30, and the
      fastest growing segment of the population having a BMI greater than 40, it is paramount to
      conduct validation of approaches to measure body composition. Currently the dual-energy x-ray
      absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is
      often difficult to perform since it is limited to specific height, weight and BMI's. InBody
      is a tool which uses bio electric impedance to measure the body composition. This study will
      compare both approaches. Validation is necessary as it is clinically quite pertinent to
      accurately assess a patients' body fat percentage, fat free mass, and total body water and
      changes that are occurring with nutritional support.
    

Detailed description: 
      This study will use a stratified design. Eligible participants will be categorized with BMI
      category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1
      of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥
      35. Within these arms, the 44 participants will participate in an InBody 770® body
      composition measure as well as an iDXA body composition measure.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.
      
Keywords: Body Mass Index; BMI; InBody; iDXA; validation
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to
      receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will
      receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

      All subjects will be followed for 6 months after the last vaccination to assess safety and
      tolerability.
    


Intervention name(s): rLP2086 vaccine; control
Intervention type(s): Biological; Biological
Intervention description(s): 120 mcg, 3 doses, at month 0, 2, and 6.; HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: phase 3 safety study; 5700 healthy subjects; 3 vaccine doses at month 0; 2; and 6; control HAV/saline/HAV
Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
Condition: Antibiotic Therapy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is randomized, double-blind, placebo controlled, single centre; 21 days phase II
      clinical trial on healthy volunteers. Following baseline visit at the day of randomization,
      treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic
      treatment subjects will also receive the study treatment, either probiotic or placebo. Daily
      Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect
      fecal samples for microbiological examination. The primary objective of the study is to
      evaluate the maintenance of intestinal microbiota composition during antibiotic treatment
      with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects
      associated with antibiotic use.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic capsule once daily; Placebo capsule once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy
      for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and
      long lasting pain relief for up to six months with a single IA injection.
    


Intervention name(s): Hydros; Hydros-TA; Triamcinolone Acetonide
Intervention type(s): Device; Device; Drug
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee
Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery
Condition: Cervical Disc Prolapse
MeSH terms: Intervertebral Disc Displacement; Prolapse
Study type: Interventional

Summary: 
      Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted
      as moderate in severity, often needing oral opioid analgesics. In addition, these patients
      are more prone for postoperative respiratory complication due to airway edema secondary to
      surgical retraction or wound hematoma. Opioid analgesics provide good pain control but
      postoperative nausea and vomiting and respiratory depression are undesirable in these
      patients who are at risk for postoperative wound hematoma and airway edema The use of
      multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after
      ambulatory procedures at most surgery centers throughout the world . The purpose of this
      study is to determine whether superficial cervical plexus block will improve the
      postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire
      (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.
    

Detailed description: 
      Anterior cervical discectomy and fusion is increasingly being done as a day surgery or short
      stay surgery. Postoperative pain is the leading cause of unplanned hospital admissions
      following day surgery, a major source of dissatisfaction and often impairs the quality of
      recovery. Opioid analgesics alone are not always effective and may also worsen the
      postoperative nausea and vomiting and in turn the postoperative recovery. This study is
      designed to find out if an injection of freezing on the side of neck around the nerves
      (superficial cervical plexus block) improves the quality of recovery from anesthesia and
      surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery.

      Primary Outcome Measure The primary outcome measure is the global QoR-40 aggregate score at
      24 hours after surgery.

      Secondary Outcome Measures

        -  Postoperative pain scores (first 24 hours)

        -  Total analgesic consumption (first 24 hours)

        -  Time for first opioid administration

        -  Postop Nausea and vomiting (first 24 hours)

        -  Post operative sedation (first 24 hours)
    

Intervention name(s): Superficial cervical plexus block for experimental group
Intervention type(s): Other
Intervention description(s): 15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: superficial cervical plexus block; quality of recovery
Breathing Interventions for Relaxation: Dosing Through Extended Exhale
Condition: Healthy Adults; Stress
Study type: Interventional

Summary: 
      Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S.
      use breathing exercises for health purposes. The aim of this project is to examine if
      different slow breathing has different physiological and psychological effects.
    


Intervention name(s): Slow breathing
Intervention type(s): Behavioral
Intervention description(s): Slow breathing techniques from yoga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: slow breathing; yoga; mind-body practicers
CalFitness Smartphone-Delivered Physical Activity Intervention With Messaging
Condition: Sedentary Lifestyle; Physical Activity
Study type: Interventional

Summary: 
      The overall goal of this study is to test personalized mobile phone-based physical activity
      interventions among students at the University of California, Berkeley. Most physical fitness
      applications for smartphones and activity trackers use a constant goal for the number of
      steps each day. However, if the step goals are dynamically adjusted according to past
      behavior, then the corresponding goals may encourage individuals to increase their physical
      activity level. This study consists of a randomized controlled trial in which we are
      assessing the efficacy of four different algorithms for calculating personalized goals for
      the number of steps each day and for determining which motivational messages to send each
      day.
    


Intervention name(s): Step Goal Delivery by Smartphone; Message Delivery by Smartphone
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Step Goal Delivery by Smartphone; Message Delivery by Smartphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicentre randomized controlled trial to evaluate the optimal treatment for patients who
      developed an iron deficiency after Roux-en-Y Gastric bypass.
    

Detailed description: 
      Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are
      still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y
      Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.

      Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency
      occurs in 14-66% in the first two years after surgery. Worldwide there are three most used
      options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and
      intravenous injection of Ferinject.

      Our goal is to determine which treatment is the most effective to normalize ferritin values
      in the blood and which treatment is the most cost-effective one after a RYGB.
    

Intervention name(s): Ferrous fumarate; Ferrous gluconate; Iron(III)carboxymaltose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured; treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured; treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
Other intervention name(s): Losferron; Ferinject
Intervention MeSH terms: Ferrous fumarate; Ferrous gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kidney Awareness Registry and Education
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility and acceptability of two different
      interventions aimed at improving health outcomes among patients with chronic kidney disease
      (CKD), who are at high risk of CKD progression. Specifically, this study will examine how
      best to implement a provider-level intervention (access to a CKD-registry) and a
      patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on
      patient health outcomes, with a 2x2 factorial design.
    


Intervention name(s): CKD Registry; ATSM + Health Coach; Usual care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Primary care providers (PCPs) will have access to a Chronic Kidney Disease (CKD) registry for patient care. The registry will:
identify patients with CKD
notify PCPs of a patients' CKD status
provide PCP outreach with NKDEP guidelines and patient educational materials; Patients with CKD will participate in an Automated Telephone Self Management (ATSM) program, which blends automated phone calls with live targeted call-backs from a health coach. Patients will receive bi-weekly automated calls for 52 weeks in their native language, consisting of pre-recorded queries pertaining to CKD management, preventive services, and lifestyle changes. Patients will interact with the system using a touch-tone keypad; Out-of-range values or invalid responses will prompt a live call-back within 24-48 hours by a health coach.; Primary care providers will manage their patients with CKD per usual care.
Patients will receive usual care.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: CKD; Automated Telephone Self Management; Registry; CKD awareness; Self efficacy