bioihbjkbjnl/mcl2 huggingface dataset:
E4Relief (Response to Estetrol in Life Improvement for MEnopausal-associated Hot Flushes)
Condition: Hot Flushes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for
      the treatment of vasomotor symptoms (VMS) in post-menopausal women.
    

Detailed description: 
      Oestrogen therapy is the most consistently effective treatment used in the US and Europe for
      menopausal VMS. Following the safety issues reported in the primary Women's Health Initiative
      publications and with continued subject requests for treatment, a challenge to clinicians has
      been to identify the lowest effective dose of oestrogen for alleviating menopausal symptoms.
      In addition, it is a challenge to develop a safer oestrogen than those currently used.

      For this purpose, the minimum effective dose (MED) of E4 has to be defined for the treatment
      of menopausal symptoms. The present study is intended to evaluate changes in frequency and in
      severity of moderate to severe VMS in order to define the MED.

      Subjects will be randomly allocated to either treatment group (2.5 mg E4, 5 mg E4, 10 mg E4,
      15 mg E4, or placebo) in a 1:1:1:1:1 ratio. All treatments (E4 or Placebo) will be
      administered once daily (QD) per os for at least 12 consecutive weeks until the last
      biological assessments (Day 90 maximum) have been performed.
    

Intervention name(s): Estetrol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All treatments (E4 [2.5 mg, 5 mg, 10 mg, 15 mg] capsule) will be administered once daily (QD) per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.; 1 capsule will be administered QD per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.
Other intervention name(s): E4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Estetrol; Vasomotor symptoms; Menopause
Ganaxolone Treatment in Children With Fragile X Syndrome
Condition: Fragile x Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,
      crossover study to investigate ganaxolone treatment in children with fragile x syndrome
      (FXS). The objective of the study is to assess the safety, tolerability and efficacy of
      ganaxolone in the treatment of anxiety and attention in subjects with FXS.
    

Detailed description: 
      This is a single center study conducted at University of California Davis (UCD) MIND
      Institute. Children with FXS between the ages of 6-17 years, inclusive will be randomized at
      a 1:1 ratio to receive ganaxolone or placebo treatment for 6 weeks, discontinue treatment and
      washout for 2 weeks, and then cross over to the opposite treatment for another 6 weeks.
    

Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, given in 3 divided doses; oral suspension, given in 3 divided doses
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fragile x syndrome; ganaxolone; anxiety; attention; pediatric
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
Condition: Glenohumeral Joint Degeneration
Study type: Interventional

Summary: 
      The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker
      ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere
      with either a +2 mm or a +6 mm offset.
    


Intervention name(s): ReUnion System with a Large-Diameter Glenosphere +2 mm offset; ReUnion System with a Small-Diameter Glenosphere +2 mm offset; ReUnion System with a Large-Diameter Glenosphere +6 mm offset; ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
Condition: Pediatric Obesity; Dyslipidemia; Hypertension; Diabetes; Quality of Life
MeSH terms: Hypertension; Overweight; Dyslipidemias; Pediatric Obesity
Study type: Interventional

Summary: 
      In the present study the effect of a community-based treatment of overweight and obese
      children is analyzed. The treatment-method is based on the principals and the method used in
      the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by
      the change in body mass index standard deviation score, change in blood pressure standard
      deviation score, quality of life and concentration of fasting blood lipids and glucose during
      one year of treatment.
    

Detailed description: 
      In the present study the effect of a community-based treatment of overweight and obese
      children is analyzed. The treatment-method is based on the principals and the method used in
      the Children Obesity Clinic in the Pediatric department i Holbaek and the care providers in
      each of the eight municipalities included are thought thoroughly to use this method.

      The treatment effect is evaluated after one year, and the effect is assessed by the change in
      body mass index standard deviation score, change in blood pressure standard deviation score,
      quality of life (PedsQL), body composition and concentration of fasting blood lipids and
      glucose.
    

Intervention name(s): Community-based treatment of overweight and obesity
Intervention type(s): Behavioral
Intervention description(s): Community based treatment of overweight and obese children using the "Holbaek-method".
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pediatric obesity; Community-based treatment; dyslipidemia; hypertension; diabetes
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Condition: Transient Tachypnea
MeSH terms: Tachypnea; Transient Tachypnea of the Newborn
Study type: Interventional

Summary: 
      Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid
      and a common cause of admission of full term infants and late pre term infants (34 to 36
      weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at
      delivery, and mode of delivery are considered risk factors for TTN. The investigators
      hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based
      infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the
      incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot
      study to evaluate the prophylactic administration of CPAP in the Delivery Room towards
      prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a
      randomized control trial after obtaining informed consents from the parents of eligible
      infants. Infants will be randomized to receive either experimental treatment (prophylactic
      CPAP) or standardized care.
    


Intervention name(s): Prophylactic CPAP Administration
Intervention type(s): Other
Intervention description(s): EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)
CONTROL GROUP: Provision of standard care in the Delivery Room
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Transient Tachypnea of the Newborn; Elective Cesarean section; Late preterm; CPAP; Delivery Room
Treatment of Multiple Attacks of Acute Migraine (0462-025)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine
      compared to placebo.
    


Intervention name(s): rizatriptan benzoate; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache; Placebo to Rizatriptan, Oral Tablet
Other intervention name(s): MK0462
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption (the way the drug enters the
      body), metabolism (the way the drug is broken down in the body), and excretion (the way drug
      leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single
      dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of
      canagliflozin will also be assessed.
    

Detailed description: 
      This study will be an open label (all volunteers and study staff know the identity of the
      assigned treatment), single dose, single center study to investigate the absorption,
      metabolism, and excretion of canagliflozin (a drug currently being investigated for the
      treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening
      phase, an open-label treatment phase, and an end-of study (or follow-up) phase. On Day 1, all
      volunteers will receive a single oral dose of radiolabeled 14C-canagliflozin which contains
      196 mg of canagliflozin and approximately 40 microcurie (1480kBq) of radioactivity. The
      International Commission on Radiological Protection considers this amount of radioactivity to
      be acceptable for this type of study. The radioactivity allows the amount of canagliflozin
      and its metabolites (break-down products) to be more precisely measured in blood, plasma,
      urine, and feces samples, which will be collected from each volunteer. The total duration of
      the study is approximately 5 weeks (including screening and follow-up); this time will be
      increased by 6 days in volunteers who have a slower rate of excretion of canagliflozin.
    

Intervention name(s): Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)
Intervention type(s): Drug
Intervention description(s): A single oral dose of 196 mg radiolabeled 14C-canagliflozin (14C-JNJ-28431754) liquid suspension containing approximately 40 microcurie (1480 kBq) of 14C radioactivity will be administered on Day 1.
Other intervention name(s): 14C-JNJ-28431754
Intervention MeSH terms: Canagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Male; Canagliflozin (JNJ-28431754); Radiolabeled 14C-canagliflozin; Absorption; Metabolism; Excretion; Radioactivity
Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this series of challenge studies is to examine the impact of menstrual cycle
      phase on cortical GABA response to administration of agents with either direct
      (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While
      the impact of these agents on cortical GABA levels in women with premenstrual dysphoric
      disorder (PMDD) is of interest, this study is designed primarily for those women without a
      psychiatric illness.
    


Intervention name(s): Fluoxetine; Zolpidem; Progesterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.; Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.; Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.
Other intervention name(s): Prozac; Ambien; Prometrium
Intervention MeSH terms: Zolpidem; Fluoxetine; Progesterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: menses; women; healthy controls; Healthy females with regular menstrual cycles
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Observational

Summary: 
      Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
    

Detailed description: 
      This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The
      Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek
      system and the laboratory reference method. This preliminary study is intended to help
      familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an
      indicator as to whether some of the variables. Evaluation Phase consists of testing seventy
      (70) patient samples with the CoaguChek XS system and with the laboratory method.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        70 Warfarin teated patients
      
Keywords: PT; DVT
Memantine for Spasticity in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Participants (n=20) will be identified at routine care visits performed at the Rochester
      Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will
      have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity
      muscle group. Participants will be seen at screening, one, and three months, and will be
      evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual
      muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The
      type and severity of any adverse events will be recorded using standard definitions.
      Participants will be instructed to call between visits to inform the investigators regarding
      any adverse events they experience. Follow-up will continue until all adverse events resolve
      or stabilize.
    

Detailed description: 
      This is a randomized, placebo controlled, double-blind, parallel group trial of memantine in
      patients with MS and spasticity. Participants will be identified at routine care visits at
      the Rochester Multiple Sclerosis Center. After obtaining informed consent, patients will
      undergo screening, which will include a physical/neurologic exam and an assessment of the
      Expanded Disability Status Scale, spasticity, and functional abilities. Eligible patients
      will return for a baseline evaluation, will initiate their randomly assigned study
      medication, and will return after one and three months for re-evaluation. The type and
      severity of any adverse events will be recorded using standard definitions. Participants will
      be instructed to call between visits to inform the investigators regarding any adverse events
      they experience. Follow-up will continue until all adverse events resolve or stabilize.
    

Intervention name(s): placebo; memantine
Intervention type(s): Drug; Drug
Intervention description(s): matched tablets bid; 10 mg bid
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
Condition: Secondary Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men
      with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm
      Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
    


Intervention name(s): Androxal 12.5 mg/25 mg; Placebo Capsules; AndroGel 1.62%; Placebo Gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Enclomiphene; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Testosterone
Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
Condition: Psychosis; Sleep
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      Randomized control trial assessing supplemental melatonin for youth with at-risk or psychotic
      symptoms.
    

Detailed description: 
      Context: Sleep disturbances and circadian dysrhythmias have been associated with psychotic
      symptom severity in Psychosis Spectrum (PS) youths. Supplemental melatonin is a safe
      over-the-counter dietary supplement, and several studies have found that melatonin improves
      sleep across several childhood neuropsychiatric disorders.

      Objectives: Investigators seeks to determine whether supplemental melatonin improves sleep
      and circadian alignment in PS youth. Investigators will also investigate whether supplemental
      melatonin affects psychotic symptoms, neurocognition, and peripheral inflammatory and
      oxidative stress markers.

      Study Design: Parallel group, double-blind, randomized, placebo-controlled trial
      Setting/Participants: 40 PS youths ages 11-30 years old (throughout the protocol we use
      "youth" to describe this age group) with sleep disturbances will be recruited from an extant
      cohort of PS youths followed by our lab in the Philadelphia Neurodevelopmental Cohort (PNC),
      Children's Hospital of Philadelphia (CHOP), University of Pennsylvania (UPenn), and the
      surrounding community. The study will be conducted at CHOP and UPenn.

      Study Interventions and Measures: Youths will be randomized to receive pill placebo or oral
      melatonin. Participants will take melatonin (or placebo) at the same time every evening for 2
      weeks (final dose range 2.5-10 mg nightly). Outcomes will be assessed at 1 week, 2 weeks, and
      6-months. Primary outcomes will be changes in self-reported sleep and actigraph-measured
      sleep and circadian rhythm. Secondary outcomes will be psychotic symptoms, neurocognition,
      and peripheral blood markers of inflammation and oxidative stress.
    

Intervention name(s): oral melatonin tablets (NatureMade brand); Placebo
Intervention type(s): Drug; Other
Intervention description(s): melatonin tablets; pill placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Randomized, double-blind, placebo controlled parallel group, multi center study in subjects
      with moderate-severe osteoarthritis.
    

Detailed description: 
      This will be a randomized, double blind, placebo controlled, parallel group, multi-center
      study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid
      250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio.
      Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit
      subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects
      will then continue on the study for an additional 12 weeks.

      Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse
      events and cost of all aspects of medical care related directly or indirectly to
      osteoarthritis.

      Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the
      12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at
      baseline and the 12 week visit and the synovial fluid archived for study of intra-articular
      inflammatory markers.
    

Intervention name(s): Naproxen; flavocoxid 250 mg; flavocoxid 500 mg
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): nonsteroidal anti-inflammatory drug; flavonoid mixture; flavonoid mixture
Other intervention name(s): naprosyn; Limbrel 250 mg; limbrel 500 mg
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment