bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of long-term therapy
      with retigabine administered as adjunctive therapy in adult epilepsy patients with
      partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of
      long-term treatment with retigabine and patient quality of life will also be assessed.
    

Detailed description: 
      This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind
      VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet
      inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an
      adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.
      Treatment will be continued until retigabine is commercially available, or until the program
      is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada,
      Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with
      retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset
      seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine
      and patient quality of life will be assessed.
    

Intervention name(s): Ezogabine: USAN Retigabine (International Nonproprietary Name)
Intervention type(s): Drug
Intervention description(s): Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
Other intervention name(s): GKE-841; D-23129; GW582892X
Intervention MeSH terms: Ezogabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Partial Seizures; Potassium Channels; Anticonvulsant; Complex Partial Seizures; Epilepsies, Partial; RTG115098
First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, open-label, multicentre phase II study evaluating the safety and
      efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line
      treatment of metastatic colorectal cancer.
    


Intervention name(s): Bevacizumab; Irinotecan; Oxaliplatin; 5-fluorouracil/leucovorin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Teenagers After London Terrorist Attack
Condition: Adolescent Development; Post Traumatic Stress Disorder; Terrorism
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational [Patient Registry]

Summary: 
      -  Context: Since March 2012, several terrorist attacks have been perpetrated in France
           (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims
           in a terrorist attack in London (Westminster Bridge).

        -  Main goal = to estimate the psycho-traumatic impact and to describe cares and management
           of high school students, victims of the terrorist attack in London on 2017, March the
           22nd.

        -  3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or
           other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding
           care); 3) Preventive and therapeutic.
    

Detailed description: 
      Inclusion criterion: 53 teenagers of Saint-Joseph high school (Concarneau, France) directly
      exposed to the terrorist attack.

      Methodology: self questionnaires and heterogenous questionnaires; descriptive statistics
      (means +/- standard deviations; search for a significant difference according to traumatic
      symptomatology)
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): 2-hour clinical observation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  53 Teenagers;

          -  Saint-Joseph high school (29)

          -  Directly exposed.
      
Keywords: Adolescent; Post Traumatic Stress Disorder; Terrorist Attack
Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical benefits that can be expected by the
      Embryo transfert procedure with hypnosis to the usual embryo transfer procedure
    


Intervention name(s): hypnosis during embryo transfer or usual transfer procedure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypnosis embryo transfer IVF ICSI
Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg
      tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in
      healthy adult subjects under fed conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of tizanidine Hydrochloride 4mg tablets and
      zanaflex® 4mg tablets administered As 1 x 4mg tablet in healthy adult subjects under fed
      conditions
    

Intervention name(s): Tizanidine
Intervention type(s): Drug
Intervention description(s): Tizanidine HCl Tablets 4 mg
Other intervention name(s): Zanaflex 4 mg
Intervention MeSH terms: Tizanidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to compare the clinical performance of ProClear 1-Day versus
      1-Day Acuvue Moist each for one week of daily disposable wear.
    

Detailed description: 
      The purpose of this cross-over study is to evaluate the clinical performance of the
      ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus
      on lens wearing comfort.
    

Intervention name(s): omafilcon A; etafilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): Proclear 1 Day (omafilcon A); 1-Day Acuvue Moist (etafilcon A)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study
Condition: Pregnancy
Study type: Interventional

Summary: 
      Prenatal care is defined as preventive healthcare characterized by regular check-ups by
      doctors or midwives to treat and prevent potential health problems throughout the course of
      the pregnancy. The investigators propose that a mobile app for prenatal care has the
      potential to provide patient-tailored, risk-appropriate prenatal educational content and may
      facilitate vital sign and weight checks between visits. The investigators describe the
      methods used to develop and test the effectiveness of a mobile app for prenatal care to
      safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of
      care.
    

Detailed description: 
      This is a protocol for a multi-center quasi-randomized controlled trial to compare an
      intervention group receiving a prenatal care app, to a control group receiving usual care.
      The trial is being conducted at two diverse outpatient obstetric practices that are part of a
      single academic department of obstetrics in Washington, DC. Women who are between 18 and 40,
      who are visiting their OB for a first trimester routine visit, who have a confirmed desired
      pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based
      smart phone that they use regularly will be eligible for enrollment. The Investigators will
      measure the effect of a mobile app for prenatal care on:

        1. the number of in-person OB visits during pregnancy;

        2. patient satisfaction with prenatal care;

        3. gestational weight gain;

        4. maternal and fetal outcomes; and

        5. clinician satisfaction.

      To capture these outcomes, the investigators will administer patient surveys via telephone
      every 4 weeks during gestation and the immediate post-partum period, review the electronic
      medical record, and conduct in-depth interviews with a representative subset of patients
      after delivery.
    

Intervention name(s): Babyscripts Prenatal App; Placebo
Intervention type(s): Device; Device
Intervention description(s): The use of a mobile digital app to facilitate certain aspects of standard prenatal care.; No Mobile App, Usual care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This report assesses the effect of supplementation with gamma-aminobutyric acid on blood
      pressure among people with mild hypertension. Overall, "Beauty Drink" consumption for 8 weeks
      could successfully reduce mean diastolic and systolic BP through the suppression of ACE
      linked to downstream suppression of angiotensin II formation, which further decreases the
      sympathetic outflow leads to hypertension.
    

Detailed description: 
      This report assesses the effect of supplementation with gamma-aminobutyric acid on blood
      pressure among people with mild hypertension. Fifty subjects with systolic blood pressure
      (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg
      were randomized to ingest 2 bottles of "Beauty Drink" or placebo per day for 8 weeks of a
      stage. In addition, anthropometric measurements (blood pressure, body weight, body fat) and
      blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol
      (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT
      were examined every four weeks.
    

Intervention name(s): Beauty Drink; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects receive two bottles of "Beauty Drink" per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.; Subjects receive two bottles of placebo of similar appearance per day for 8 weeks of a stage. In addition, anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: gamma-aminobutyric acid; blood pressure; clinical trial; angiotensin converting enzyme; Beauty Drink
Vascular Inflammation Stratified by Body Size Phenotype
Condition: Atherosclerosis; Obesity; Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Observational

Summary: 
      -  Vascular Inflammation is a key factor in both the pathogenesis and outcome of
           atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying
           vascular inflammation within atherosclerotic plaque

        -  Recently, unique subsets of obese individuals, such as metabolically obese but normal
           weight (MONW) and metabolically healthy obese (MHO), have been getting an attention

        -  Therefore, the purpose of this study is to examine the relationship of vascular
           inflammation,measured by FDG-PET, with various body sized phenotypes
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers who underwent a medical health check in the health promotion center in
        Korea University Guro Hospital
Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.
Condition: Tetanus; Diphtheria; Acellular Pertussis
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals'
      dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.
    


Intervention name(s): Boostrix
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: uncontrolled
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30
      minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.
      On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be
      administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen
      is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be
      administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given
      orally for 2 days following chemotherapy.
    

Detailed description: 
      In order to decrease this delayed CINV, the investigators have developed a unique schedule of
      antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In
      this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30
      minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.
      On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be
      administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen
      is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be
      administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given
      orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic
      schedule will significantly reduce the delayed CINV compared to historical controls
    

Intervention name(s): Palonosetron; ondansetron; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO; Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV; Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Other intervention name(s): Aloxi; zofran; Dex
Intervention MeSH terms: Dexamethasone; Ondansetron; Palonosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Autologous stem cell transplant; BEAM; Oral busulfan; Cyclophosphamide; Etoposide; Carboplatin; melphalan
Prebiotics and Stress Reduction in Women
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      In modern life, many people state to experience stress. Women compared to men report more and
      higher levels of stress. Recent research found that supplementation of
      galactose-oligosaccharides (GOS) resulted in reduced anxiety levels in British female
      students with higher anxiety scores at baseline in self-reported trait anxiety. Moreover,
      supplementation of probiotics in germ-free rodents resulted in reduced levels of circulating
      corticosterone (cortisol in humans). These findings illustrate the potential of prebiotic
      supplementation, through the microbiota-gut-brain (MGB) axis, to improve mental health and
      wellbeing.

      The present study aims to study the effect of oligosaccharides on self-perceived stress.
    


Intervention name(s): Relax+; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotics, daily administered; Placebo, daily administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of the study drug gets into the
      bloodstream and how long it takes the body to get rid of it. This study has two parts. It
      will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive
      substance C14 will be incorporated into the study drug, to investigate the study drug and its
      breakdown products, to find out how much of these pass from blood into urine, feces and
      expired air. The study will last about 4 weeks. Screening is required within 28 days prior to
      the start of the study and follow up is required approximately 7 days after discharge.
    


Intervention name(s): [¹⁴C]-LY3484356; LY3484356; [¹⁴C]-LY3484356 (IV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered IV.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metabolism; Absolute Bioavailability; Disposition
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
Condition: Gastroesophageal Reflux; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain
      model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the
      esophagus.
    


Intervention name(s): PPC-5650; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.; A 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux
Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes
Condition: Myasthenic Syndromes, Congenital
MeSH terms: Lambert-Eaton Myasthenic Syndrome; Myasthenic Syndromes, Congenital; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover
      study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients
      (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open label
      (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.
    

Detailed description: 
      Each patient will participate in an open-label unblinded drug escalation/treatment run-in
      phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is
      achieved for 7 days. After this phase, blinded treatment effect will be assessed in a
      randomized fashion of continuation or cessation of drug (Placebo) starting with Period I
      (duration 7 days). Following experimental Period 1, patients will be returned to the stable
      dose administered at the end of the open-label run-in period for approximately 2 weeks,
      followed by cross over treatment in Period 2 dosing for 7 days. After completion of Period 2,
      patients will be eligible for expanded access with restoration of open-label amifampridine
      phosphate at the same dose and frequency as established in the run in phase of the study.
    

Intervention name(s): amifampridine phosphate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.; A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate.
Other intervention name(s): 3,4 diaminopyridine phosphate, Firdapse™
Intervention MeSH terms: Amifampridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of SER120 nasal spray formulations in patients with
      nocturia
    


Intervention name(s): SER120 750 ng; SER120 1500 ng; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SER120 750 ng; SER120 1500 ng; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment