bioihbjkbjnl/mcl2 huggingface dataset:
Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the effects of different therapies in ovulation induction in
      Intrauterine Insemination Cycles.
    


Intervention name(s): Meropur 150 a day; Gonal-f 150 plus Luveris 150
Intervention type(s): Drug; Drug
Intervention description(s): one subcutaneous injection a day; one subcutaneous injection a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
Condition: Healthy; Contraception; Contraceptive Usage; Women
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I single-center, two-arm, open-label, randomized study in healthy
      HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated
      with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg
      Levonorgestrel.
    

Detailed description: 
      This 26 week study will be conducted at one site. The site will enroll 24 subjects. Subjects
      will be randomized to 1 of 2 treatment regimens:

      Regimen A: vaginal ring used continuously for approximately 90 days Regimen B: vaginal ring
      used cyclically for approximately 90 days: used for ~28 days, then removed,washed and stored
      for 2 days. The same ring will be used for 2 additional cycles in a similar fashion.
    

Intervention name(s): VR: 200 mg DPV + 320 mg LNG
Intervention type(s): Drug
Intervention description(s): One silicone elastomer vaginal ring (VR) containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Women; Contraception; Vaginal Ring; dapivirine; Levonorgestrel
Mindful Self-Regulation fMRI Pilot Study
Condition: Psychiatric Problem; Depression; Anxiety; Neuroimaging; Self-Control
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care
      (see study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A
      Pilot Study") engages self-regulation targets such as emotion regulation, attention, and
      interoceptive awareness; and 2) changes brain activation in neuroimaging tasks before
      compared to after the training. Neuroimaging fMRI tasks probe mechanisms related to
      self-regulation, such as attention/inhibition, emotion regulation, self-compassion,
      interoception and pain regulation.

      The study will also look at whether chronic disease self-management and successful engagement
      of self-report and behavioral self-regulation targets (emotion regulation, attention, and
      interoceptive awareness) relates to the observed brain activation changes after compared to
      before the mindfulness intervention.
    

Detailed description: 
      This study aims to test brain activation changes related to self-regulation targets of
      attention, emotion regulation, self-compassion, interoception and pain regulation that are
      influenced by mindfulness training within primary care (compare MINDFUL-PC study).

      The study will also look at whether successful chronic disease self-management relates to the
      observed brain activation changes after compared to before the mindfulness intervention.

      The study will examine the relationship between mindfulness training within primary care and
      medical regimen adherence (initiation and maintenance) as well as the underlying neural
      correlates associated with changes in self-regulation.

      This is a single-arm pilot trial, recruiting from a randomized controlled trial (see
      MINDFUL-PC study). .
    

Intervention name(s): Mindfulness Training for Primary Care (MTPC)
Intervention type(s): Behavioral
Intervention description(s): For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetes Mellitus
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects
      with Type II Diabetes and painful peripheral neuropathy.
    

Detailed description: 
      This study is designed with 4 periods: screening, baseline/day 0, outpatient treatment, and
      safety follow-up. Site visits take place At -30 days, -7 days, Day 0, Week 3 (phone
      assessment), 6, 9 (phone assessment) and 12/end of study [EOS]. There is also a Week 14 phone
      call for a safety review with the subject. The purpose of this early phase 2 trial is to
      evaluate the overall safety and tolerability of both the active topical solution and the
      placebo also called the 'vehicle' formulated as a topical solution that penetrates the skin
      of the lower legs and tops of the feet. There are also secondary and exploratory objectives
      to determine if this active has efficacy properties during the 12-week treatment period as
      hypothesized. Even though pirenzepine is approved and used for another indication
      systemically, the sponsor believes the active in a topical solution to be effective in
      treating painful peripheral neuropathy commonly found in diabetic patients.

      There are both objective and subjective tests being introduced in this trial due to the
      unique nature of the study, and lack of defined and standardized efficacy parameters.
    

Intervention name(s): Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution; Placebo: WST-057 4mL topical solution
Intervention type(s): Drug; Drug
Intervention description(s): WST-057; Placebo
Intervention MeSH terms: Pirenzepine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 ratio, Active (4% WST-057 topical solution): Placebo (matching placebo solution)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Type 2 DM; US; WST-057
Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
Condition: Zika Virus
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of a
      single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of
      previous flavivirus infection.
    

Detailed description: 
      This study will evaluate the safety, reactogenicity, and immunogenicity of a single dose of
      the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous
      flavivirus infection.

      Participants will be randomly assigned to receive a single dose of either rZIKV/D4Δ30-713 or
      placebo at study entry (Day 0).

      Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, and 180.
      Visits may include a physical examination; blood, urine, saliva, nasopharyngeal (NP) or
      midturbinate swab, vaginal secretions, and semen collection; and pregnancy testing.

      SARS-CoV-2 PCR (nasopharyngeal or mid-turbinate swab) will be performed during screening and
      on days 0, 8, and 14.
    

Intervention name(s): rZIKV/D4Δ30-713 (Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection); Placebo; rZIKV/D4Δ30-713 (Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection).
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection; Administered by subcutaneous injection.; Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zika virus; Vaccine
KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation
      protocol in treating traumatized children in Sri Lanka when applied by locally trained
      teacher counsellors.
    


Intervention name(s): KIDNET; Meditation-Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events; a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
Allocation: Randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-traumatic Stress disorder (PTSD)
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
Condition: Postmenopause
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone
      versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months
      and to investigate the bleeding pattern over a treatment period of one year
    


Intervention name(s): continuous combined estradiol and dydrogesterone; continuous combined estradiol and dydrogesterone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone; 1 Mg Estradiol and 5 Mg Dydrogesterone; Placebo
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hormone replacement; vasomotoric symptoms; bleeding pattern
Vascular Inflammation in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to find out if diabetes damages the blood vessels of adolescents
      with good diabetes control compared to adolescents with less optimal control.
    

Detailed description: 
      Many published studies reveal that adult patients with T1DM can have early, silent and more
      advanced vessel wall thickness than normal subjects. This is influenced by the degree of
      their blood sugar control. If this is happening in adolescents, we want to know what
      proportion of adolescent children with type 1 diabetes show signs of early blood vessel
      damage. We also want to learn if these signs of damage are linked to other factors such as
      how long someone has had diabetes, blood sugar control or individual differences because of a
      difference in genetic make-up.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric Endocrinology clinic
      
Biospecimen description: 
      Whole blood
Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether a 4-month period of
      supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel
      capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one
      or more cognitive measures of attention, memory, processing speed, and error rate in healthy
      children 4 years of age.

      The secondary objectives are to measure the safety and tolerability of the DHA dose
      administered and to measure blood DHA levels before and after supplementation.
    

Detailed description: 
      DHA is the primary omega-3 fatty acid present in the brain and retina and plays crucial
      structural and functional roles in these issues. The primary dietary source of DHA is fatty
      fish (e.g., salmon, herring, tuna). The American diet provides one of the lowest levels of
      omega-3 fatty acids of most industrialized nations. Children between the ages of 1 and 5
      years consume only 30 to 50 mg DHA per day despite high requirements for this nutrient to
      support growth and tissue turnover.

      Studies with human infants have reported visual and cognitive benefits of DHA supplementation
      in early life. Reported benefits include significant improvements on tests of visual acuity
      during infancy, psychomotor or mental development in the first two years of life, and
      problem-solving and sustained attention around 5 years of age.

      Few studies have evaluated the effect that DHA supplementation has on the cognitive function
      of older children. Studies that considered DHA supplementation in children 4-12 years of age
      with attention-deficit/hyperactivity disorder (ADHD) or other developmental disorders have
      shown improvements on several measures of attention, behavior, and executive function.

      Given the estimated high requirements of DHA to support growth and maintenance of the brain,
      the low consumption of DHA by American children, and the evidence from human and animal
      studies that DHA status affects the functional capacity of the central nervous system, there
      is a reasonable expectation that DHA supplementation administered to preschool-aged children
      will improve performance on tests of attention, memory, processing speed, and error rate.
    

Intervention name(s): DHA; placebo
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: DHA supplementation; Cognitive function; Preschool children; Attention and behavior; Healthy Children
REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

      To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are
      overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled
      HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti
      Diabetic medications - Metformin (Met) and Sulfonylurea (SU).

      Secondary:

      To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid
      measures, Other measures and changes in quality of life
    


Intervention name(s): Rimonabant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast; Matching placebo tablets. Once daily before breakfast
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
Condition: Healthy Control Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators want to see if healthy people who are given 2 doses of a medication called
      anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then
      exposed to a form of air pollution, called Endotoxin, have less inflammation with the
      medication. Endotoxin is believed to be one of the causes of asthma attacks.
    


Intervention name(s): Anakinra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.; Injection of NS
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy volunteer; endotoxin
Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
Condition: Anesthesia
Study type: Interventional

Summary: 
      Perioperative fluid management is crucial for patients' outcome. Muller et al developed a
      "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The
      investigators design the study to investigate the effectiveness of mini-fluid challenge test
      in prone position surgery.
    

Detailed description: 
      Perioperative fluid management is crucial for patients' outcome. Series of studies have
      indicated that adequate fluid management optimizes the cardiac out put, improves tissue
      perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a
      "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best
      of our knowledge, the efficacy of the test was not discussed in the perioperative care in
      prone position surgery. The investigators design the study to investigate the effectiveness
      of mini-fluid challenge test in prone position surgery.
    

Intervention name(s): Mini-fluid challenge
Intervention type(s): Other
Intervention description(s): Mini-fluid challenge test with 100mL colloid infusion in 1 min
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Boost Study 21270 (Cognition)
Condition: Cognitive Function Abnormal
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is designed to to test the technical feasibility of encouraging interaction with a
      mobile smartphone software package (mHealth app) for training aspects of executive function
      and cognition.
    

Detailed description: 
      The purpose of this human subjects study is to test the technical feasibility of interaction
      with a mobile smartphone software package (mHealth app) for training in aspects of executive
      function and cognition. The study participants are healthy subjects recruited online, with
      consent secured at the time of screening, and with enrollees assigned to High or Low groups
      on the basis of initial screening task scores. Subjects are requested to participate for at
      least 150 min per week in app interaction activities for up to 8 weeks with measures
      primarily evaluating feasibility of app package task completion, and secondarily evaluating
      the cognitive effect of these activities.
    

Intervention name(s): mHealth application (custom)
Intervention type(s): Behavioral
Intervention description(s): Smartphone based application designed to engage user executive functions
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognition
Cortisol and the Formation of Intrusive Memories
Condition: Intrusive Memories
Study type: Interventional

Summary: 
      Intrusive memories of traumatic events are core features of posttraumatic stress disorder
      (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this
      study was to determine whether cortisol levels during an intrusion-inducing stressor
      influence subsequent intrusive memories.
    

Detailed description: 
      The investigators conducted an experimental, double-blind, placebo-controlled study in 60
      healthy women. Prior to watching an established trauma film paradigm that induces short
      lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or
      placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the
      intrusions and the mean degree of distress evoked by the intrusions were assessed during the
      following seven days. Salivary cortisol and alpha-amylase were collected at seven time points
      prior to, and after the trauma film.
    

Intervention name(s): Stress Film; Hydrocortisone; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Film scene with severe physical and sexual violence.; 10mg
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
Condition: HIV; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures
      of systemic and vascular inflammation and endothelial function (all indicators of
      cardiovascular risk) in treated and suppressed HIV infected individuals This study will
      assess the safety and effects of canakinumab on endothelial function (assessed by
      flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by
      FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk
      (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163),
      D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 10
      individuals will receive a single dose of 150mg canakinumab with follow-up for 12 weeks. In
      the second part of the study, 100 participants will be randomized (2:1 - canakinumab to
      placebo) and will be followed by for 36 weeks.
    


Intervention name(s): Canakinumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150mg Canakinumab received subcutaneously; 150mg Placebo received subcutaneously
Other intervention name(s): IL--1β
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment