bioihbjkbjnl/mcl2 huggingface dataset:
Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training
Condition: Contraception Behavior
Study type: Interventional

Summary: 
      The purpose of the study is to measure whether an education and training intervention for
      clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will
      result in greater use of the methods among contraceptive patients.
    

Detailed description: 
      Unintended pregnancy is extremely high in the United States among young women, and use of
      contraceptives with top-tier effectiveness, intrauterine contraception and implants, is low.
      Contraceptive providers in the US have low knowledge of current scientific evidence on LARC
      methods, and do not routinely include these methods in counseling patients at highest risk of
      unintended pregnancy. This intervention provides evidence-based education and hands-on
      training to clinicians and contraceptive educators in Planned Parenthood affiliated Title X
      clinics throughout the US on LARC methods.
    

Intervention name(s): LARC education and training
Intervention type(s): Behavioral
Intervention description(s): A CME/CEU accredited Grand Rounds education and training session will be given to clinicians and contraceptive educators practicing in clinics assigned to the intervention arm. Clinicians will have hands-on training as well. The half-day session emphasizes evidence-based contraceptive counseling and provision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Long-acting reversible contraception; Intrauterine contraception; Intrauterine devices; Single-rod implant; Hormonal contraception
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
Condition: Ischemic Heart Disease; Coronary Arteriosclerosis; Cardiovascular Disease; Coronary Disease; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived
      Stem & Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not
      revascularizable and have demonstrated reversible ischemia.
    

Detailed description: 
      Subjects who have coronary artery disease that cannot be revascularized and demonstrate
      reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be
      evaluated for eligibility in this study. Eligible subjects will undergo standard
      pre-operative testing after admission to the hospital, and then will undergo liposuction
      under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to
      randomization subjects will receive either ADRCs or placebo.

      The outcomes of this trial will be based on assessment of primary and secondary endpoints at
      6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36
      months after the procedure.
    

Intervention name(s): Direct injection of ADRCs into the Left Ventricle; Direct injection of placebo into the Left Ventricle
Intervention type(s): Other; Other
Intervention description(s): Dose escalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADRC; Stem Cells; chronic ischemia; heart disease; coronary artery disease; inducible reversible ischemia
A Multicenter Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors
Condition: Neuroendocrine Tumors; Liver Metastases
MeSH terms: Neoplasm Metastasis; Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      By improved kidney dosimetry including biological effective dose and taking into account
      potential risk factors (especially for kidney toxicity), it might be possible to give an
      optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic
      neuroendocrine tumor.
    


Intervention name(s): 177Lu-DOTA-TATE
Intervention type(s): Drug
Intervention description(s): 177Lu-DOTA-TATE given as intravenous infusion given during 3-5 treatments. Evaluation is performed after every single cycle. Further more, evaluation is made after last cycle, and delivered cumulative dose to kidneys should be 27 Gy.
Patients with stable disease or partial response, and without pronounced toxicity will continue treatment to a step 2, where additional 3-5 treatment cycles are given, with a cumulative dose to kidneys to 40 Gy.
Intervention MeSH terms: Lutetium Lu 177 dotatate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroendocrine tumor; Liver metastases; 177Lu-DOTA-TATE; Safety; Kidney dosimetry; Dose escalation; Neuroendocrine tumors, with liver metastases.
Plyometric and Complex Training in Male Cricket Players
Condition: Physical Functional Performance
Study type: Interventional

Summary: 
      The complex training starts with a high load of resistance training that is succeeded by
      plyometric training. This combination aims at improving the efficacy of the plyometric
      training stimulus, thus increasing the neuromuscular response, explosive strength, and power.
      This response might further be improved by making appropriate variations in the dosage
      parameters of complex training. Previously available literature reports conflicting evidence,
      with some studies supporting the effectiveness of complex training for improving power output
      in sports, whereas others contradict this rationale. There is a paucity of research evidence
      that directly compares the efficacy of plyometric and complex training for the outcomes of
      physical performance in cricket players.
    


Intervention name(s): Complex training exercises; Plyometric training exercises
Intervention type(s): Other; Other
Intervention description(s): Squats and drop jumps, Barbell step-ups and hops, Bench press and plyometric press-up, Barbell lunge and box jumps were performed.; Drop Jumps, Hops, Plyometric press-up, Box Jumps were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized control study with a pretest-posttest design.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Muscle strength; Fitness; Athletes; Exercise; Power
Multicenter Worksite Nutrition Study
Condition: Diabetes; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to study the potential benefits of low fat vegan diet in a
      randomized, controlled and multi-centered workplace setting, the investigators will enroll
      participants from 10 worksites of Government Employee Insurance Company (GEICO). After
      randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study.
      The vegan sites will receive low fat vegan diet instructions and weekly group sessions
      starting from year 1. no intervention is done to the control sites until the week 18 when the
      identical program will be given. At various time points, health measurements will be give to
      all participants.
    

Detailed description: 
      The purpose of this study is to study the weight loss and other potential benefits of low fat
      vegan diet as compared to the standard American diet in a randomized, controlled and
      multi-centered workplace setting.

      The 10 months study involves 5 vegan sites and 5 control sites generated through a random
      process after recruitment. The vegan sites will receive low fat vegan diet instructions and
      weekly group sessions starting from the January, 2011. The control sites will also receive
      identical instructions starting from the 5th month and lasting for 18 weeks.

      For each participant at baseline and week 18 a blood test will be conducted, along with blood
      pressure, weight, hip and waist measurements. A questionnaire will also be administered
      during these time points to assess dietary intake, work productivity, quality of life, and
      healthcare utilization. At the end of one year, information about health insurance
      utilization will be obtained from Health Maintenance Organization(HMO) or Preferred Provider
      Organization(PPO) for each participant.
    

Intervention name(s): vegan instruction and food accessibility; control
Intervention type(s): Other; Other
Intervention description(s): weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria; no intervention in until June 2011. The control group start vegan diet in July 2011.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: vegan; diet; diabetes; overweight; workplace; nutrition; diabetes and/or overweight
Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
Condition: Placenta, Retained; Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage; Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage); Pregnancy Related; Hysteroscopy / Methods; Retrospective Studies; Vacuum Curettage
MeSH terms: Placenta, Retained; Hemorrhage
Study type: Observational

Summary: 
      Collection of relevant data form patients who were treated in the Ghent University Hospital
      in the context of a placental remnant lager than 4 cm, performing statistical analyzes on the
      collected data, reviewing the literature on the subject and formulation of a recommendation
      for treatment of these large placental remnants.
    


Intervention name(s): kind of surgery
Intervention type(s): Procedure
Intervention description(s): hysteroscopy, curettage, other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a placental remnant in medical history.
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Condition: Cow's Milk Protein Allergy; Eosinophilic Gastrointestinal Disorders; Malabsorption/Maldigestion; Short Bowel Syndrome; Multiple Food Allergies
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Short Bowel Syndrome; Malabsorption Syndromes; Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
Study type: Observational [Patient Registry]

Summary: 
      To assess the frequency and nature of adverse events in infants fed a free amino acid based
      infant formula.
    

Detailed description: 
      Prospective, post-market surveillance program to be conducted in the United States (US).
      Infant will be invited to enroll by their healthcare provider who recommends the use of a
      free amino acid based infant formula
    

Intervention name(s): Free amino acid infant formula
Intervention type(s): Other
Intervention description(s): Patients who will be fed a free amino acid based infant formula
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The intent of the program is to enroll infants consuming a free amino acid based infant
        formula identified in the US
A First-Time-In-Human Study in Healthy Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-time-in-human study. The overall purpose of the study is to assess whether
      the drug is safe and well tolerated after single, increasing doses. The blood levels of the
      drug after different doses will be measured and the effect of the drug on pleasurable eating
      behaviour will be assessed.
    

Detailed description: 
      The human body naturally produces substances known as opioids and the pleasurable (or
      hedonic) response to eating highly sugary or fatty foods is increased by opioids. The drug to
      be tested in this study attaches to specific binding sites in the brain, known as mu-opioid
      receptors. This may stop the natural effect of opioids and therefore reduce the pleasurable
      response to food. We predict that this in turn may help patients with obesity to lose weight
      more effectively. The study is divided into three parts:

      Part A: This part of the study will start with a very low dose of study drug, which will then
      be gradually increased in subesquent doses. This is known as dose-rising and is the way to
      assess safety and tolerability (any side effects that make taking the drug unpleasant).
      Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4
      groups of 6-9 healthy male or female volunteers will be enrolled in this part of the study.

      Part B: A dose selected from Part A that was well tolerated will be used to check if there is
      a difference in the blood levels of the study drug when taken without food in liquid form,
      without food as a capsule, or with a high fat meal as a capsule. One group of 12 healthy male
      or female volunteers will be enrolled in this part of the study.

      Part C: A well tolerated dose selected from Parts A & B will be used to test whether the drug
      has an effect on preferences for sugary and high fat food, when compared to placebo. Up to 32
      healthy overweight male volunteers will be enrolled in this part of the study.
    

Intervention name(s): GSK1521498 or placebo
Intervention type(s): Drug
Intervention description(s): GSK1521498 is a mu-opioid receptor inverse agonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Food Effect; Pharmacokinetics; First-Time-In-Humans; Pharmacodynamics; Healthy Volunteers
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to demonstrate the non-inferiority of the antibody
      responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal
      assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or
      equal to [>=] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with
      Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given
      alone.

      The secondary objectives were to compare the hSBA antibody response in terms of geometric
      mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate
      vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was
      given alone in the second year of life; to describe the hSBA and serum bactericidal assay
      using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C,
      W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months
      of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13
      months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence
      against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate
      vaccine administered at 3 months of age for Group 1 and Group 2.
    

Detailed description: 
      Study duration per participant was approximately 11 to 12 months.
    

Intervention name(s): Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine; Meningococcal group B vaccine; Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine; Human rotavirus RIX4414 strain vaccine; Pneumococcal 13-valent polysaccharide conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL; Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL; Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL; Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL; Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Other intervention name(s): MenACYW Conjugate vaccine; Bexsero®; Infanrix hexa®; Rotarix®; Prevenar 13®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Efficacy and Safety of AD-208
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of AD-208.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients
      with androgenetic alopecia.
    

Intervention name(s): AD-208; AD-2081; placebo of AD-208; placebo of AD-2081
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PO, Once daily(QD), 24weeks; PO, Once daily(QD), 24weeks; PO, Once daily(QD), 24weeks; PO, Once daily(QD), 24weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Novel Neuroimage Study in Tauopathies With Parkinsonism
Condition: Parkinsonism
MeSH terms: Parkinsonian Disorders; Tauopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this study are: 18F-THK5351 PET(Positron Emission Tomography) can defect the tau
      burden in PSP(Progressive Supranuclear Palsy) and CBS (Corticobasal syndrome)correlating with
      the known NFT(neurofibrillary tangles) topology of those diseases, 18F-THK5351 PET will
      differentiate subjects with suspected tauopathy due to PSP and CBS from subjects with
      suspected synucleinopathy due to idiopathic PD(Parkinson's disease). The distribution of
      PHF(paired helical filament) tau burden will correlate with specific motor and cognitive
      features of PSP and CBS; and regional PHF tau burden will be associated with cortical
      thinning. Together, these efforts will establish the potential for developing 18F-THK5351 PET
      imaging as a biomarker and diagnostic tool for the parkinsonian tauopathies.
    


Intervention name(s): F-18
Intervention type(s): Drug
Intervention description(s): Totally 60 subjects age 20-80 including 20 subjects with a diagnosis of PD,PSP,and CBS. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
Other intervention name(s): F-18 THK-5351; F-18 AV-45
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-THK5351 PET; Tauopathies
Virtual Reality Analgesia for Pediatric Burn Survivors
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Many children with large severe burns report severe pain during burn wound cleaning. The
      current study explores whether adjunctive immersive Virtual Reality distraction may help
      reduce the intensity of pain experienced by children during burn wound cleaning by taking the
      patient's mind off their pain.
    

Detailed description: 
      All patients always receive their usual pain medications. Using a within-subjects,
      within-wound care design, in the current study, pediatric patients being treated for severe
      burn injuries will receive music distraction during some portions of their wound care (active
      comparator condition), and they will receive what we predict will be an unusually strong
      distraction, immersive virtual reality (the experimental treatment) during other comparable
      portions of the same wound cleaning sessions. During virtual reality, each patient will look
      into virtual reality goggles, and will play a simple cartoon-like virtual reality game
      SnowWorld during burn wound cleaning. After each wound care session, the patient will rate
      how much pain they experienced during wound care during No VR (music only) compared to how
      much pain they experienced during wound care during virtual reality, on each study day, for
      up to 10 study days per patient. Treatment order randomized.
    

Intervention name(s): virtual reality distraction (Yes VR); music distraction (No VR)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within-subject design with repeated measures, with random assignment to initial treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality pain; opioid; pediatric burn; wound care
Benefit of IQP-AO-101 for Sleep
Condition: Insomnia, Nonorganic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with
      respect to sleep-promoting effects in subjects with sleep complaints.
    


Intervention name(s): IQP-AO-101; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 dose (sachet) to be consumed 30 - 60 mins before bedtime; 1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Effects of Gun Massager and Transverse Friction Massage in Patients With Plantar Fasciitis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      to compare the effects of massage gun and transverse friction massage on management of pain
      and disability in patients with plantar fasciitis.
    


Intervention name(s): gun massager; transverse friction massage
Intervention type(s): Other; Other
Intervention description(s): 15 to 20 minutes along with hot pack.; 15 to 20 minutes along with hot pack.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plantar fasciitis; foot and ankle disability index; numeric pain scale; deep friction massage; gun massager