bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate safety and tolerability of treatment with atogepant for the
      prevention of episodic migraine over the course of one year.
    


Intervention name(s): Standard of Care (SOC) Migraine Preventive Medication; Atogepant
Intervention type(s): Drug; Drug
Intervention description(s): Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.; Atogepant tablets taken orally, once daily for 52 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Versartis International Trial in Adults With Long-Acting Growth Hormone
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for
      five months in adults with GHD.
    

Detailed description: 
      A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing
      regimen in adults with GHD. This is an open-label, international, multicenter study with
      VRS-317 treatment for five months. This treatment period will include monthly dose titrations
      until a subject's mean IGF-I SDS value is within a target range for two consecutive months.
      Subjects will be stratified into three cohorts based on sensitivity to rhGH.
    

Intervention name(s): somavaratan
Intervention type(s): Drug
Intervention description(s): Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other intervention name(s): VRS-317
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VRS-317; Long Acting Growth Hormone; Versartis; somavaratan; Growth Hormone Deficiency; Adult Growth Hormone Deficiency; AGHD; Growth Hormone Replacement; Growth Hormone Replacement Therapy; XTEN
Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A number of diseases lead to a so called systemic inflammatory response syndrome (SIRS). This
      excessive response is self-destructive and leads to major complications of the initial
      disease: dysfunction of the microcirculation, systemic vasodilation, and increased capillary
      leakage and oedema. Animal studies have shown that pre-treatment with endotoxin
      (lipopolysaccharide or LPS) suppress the excessive immune response and when rechallenged, the
      animal survive a normally lethal dose of endotoxin.

      Besides a diminished cytokine response, an increased production of leucocytes in the bone
      marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The
      combination of these factors: diminished systemic inflammatory response and increased
      cellular immunity makes that endotoxin tolerance is a useful tool for preventing the
      complications after an excessive inflammatory response.

      Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive
      more after induction of a normally lethal fungal infection. Endotoxin tolerance is also
      protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known
      about endotoxin tolerance in human.

      The purpose of this study is to induce a state of tolerance through 2 different
      administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory
      cytokines, other inflammatory parameters and different proteins involved in the signalling
      pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the
      effect of tolerance on ischemia-reperfusion injury will be investigated.
    

Detailed description: 
      See protocol
    

Intervention name(s): repeated injections of endotoxin during 5 days
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endotoxin tolerance; humans; cross-tolerance; pro and anti-inflammatory cytokines
Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome
Condition: Chronic Prostatitis
MeSH terms: Prostatitis; Pelvic Pain
Study type: Interventional

Summary: 
      The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT
      vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group
      sham-controlled clinical study.
    


Intervention name(s): Dornier Aries 2 device; Dornier Aries 2 device; Dornier Aries 2 device
Intervention type(s): Device; Device; Device
Intervention description(s): • Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.; LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7); LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85
      years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination
      schedules. The study will assess the safety and tolerability of the vaccine as well as the
      subjects' immune response to the vaccine. One year after the third dose subjects that did not
      receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up
      to 4 years after their third vaccination.
    


Intervention name(s): Clostridium difficile Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection.; 0.5 mL intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clostridium difficile, Vaccine.
Allogeneic Stem Cell Transplantation (SCT) After Dose-reduced Conditioning for Myelofibrosis Patients
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a reduced intensity conditioning regimen
      followed by allogeneic stem cell transplantation is a feasible and effective treatment for
      patients with primary myelofibrosis.
    

Detailed description: 
      The purpose of this study is to determine whether a reduced intensity conditioning regimen
      followed by allogeneic stem cell transplantation from related or unrelated donors is a
      feasible and effective treatment for patients with primary myelofibrosis.
    

Intervention name(s): Allogeneic Stem Cell Transplantation
Intervention type(s): Procedure
Intervention description(s): Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cell Transplantation
Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
Condition: Negative Symptoms of Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate the efficacy and safety of roluperidone in adult
      schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of
      roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12
      weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome
      Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.
    


Intervention name(s): Placebo Oral Tablet; Roluperidone 32 mg; Roluperidone 64 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo administered as a single dose once daily; Roluperidone administered as a single dose once daily; Roluperidone administered as a single dose once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
London Underground Study - Health Effects of Particulate Matter
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      An average of 4.8 million journeys are made on the London Underground every day and as the
      'Tube' has elevated airborne particulate matter concentrations compared to ambient air, this
      raises concern about the potential health impact of this environment. This study explores the
      health effects of particulate matter from the London Underground on patients with COPD and
      healthy volunteers.

      Patients with COPD and healthy participants will be invited to undertake a set 90 min journey
      on the London Underground, and on a separate occasion (3-8 weeks apart), a 90 min journey on
      the London Overground (as a proxy for a clean air London area while maintaining other aspects
      of a train journey). A series of clinical, physiological and inflammatory data will be
      collected before, during and after (at different time points) each of the sessions in order
      to compare their response in relation to exposure and/or to disease status.
    


Intervention name(s): Exposure to London Underground ambient particulate matter; Exposure to London air ambient particulate matter
Intervention type(s): Other; Other
Intervention description(s): Exposure to particulate matter on the London Underground; Exposure to ambient particulate matter on the London Overground (as a proxy as a proxy for a clean air London area while maintaining other aspects of a train journey)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Particulate matter; London Underground
Mean Systemic Filling Pressure Trends in Liver Transplant Recipients
Condition: Liver Transplant; Complications; Liver Diseases; Hemodynamic Instability
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Patients with end stage liver disease undergoing liver transplantation have varying degrees
      of intraoperative haemodynamic unstability during various phases of transplantation. It is
      difficult to determine the cause for hemodynamic instability in these patients and to predict
      the best treatments. Currently, cardiovascular resuscitation options are triggered by
      arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of
      the circulation. The primary determinants of cardiac output reside on the venous side. Veins
      are 30-50 times more compliant than arteries and contain approximately 75% of the total blood
      volume. Mean systemic filling pressure provides vital information on this venous side of the
      circulation. Mean systemic filling pressure , which is defined as the pressure equal to the
      pressure which would be measured if the heart should suddenly stop pumping and all (arterial
      and venous) the pressures in the entire circulatory system should be brought to equilibrium
      instantaneously, is a good, complete and reliable reflection of the total intravascular fluid
      compartment. We would study the Mean systemic filling pressure in liver transplant recipients
      and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data
      for 7 days for respiratory, cardiac and renal complications will be collected, along with
      hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure
      and these outcomes will be analyzed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with liver diseases undergoing liver transplantation
      
Keywords: liver transplantation; mean systemic filling pressure; advanced hemodynamic monitoring; liver cirrhosis
A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
Condition: ASD; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Sleep problems are very common in children with ASD, with a prevalence rate as high as 78%,
      and often pose significant challenges and stress to the families. Sleep problems in children
      with ASD are strongly associated with the exacerbation of daytime symptoms, and poor parental
      sleep quality and mental health. The present study is a randomised controlled trial to
      compare the effects of a parent-based sleep intervention for children with ASD (aged 3-6).
      Eligible participants will be randomised to either intervention (three consultation sessions
      and four follow-up phone calls) or waiting-list control condition. Assessments will be
      conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).
    


Intervention name(s): Sleep hygiene practices and behavioural intervention
Intervention type(s): Behavioral
Intervention description(s): The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem. The second and third session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. Follow-up phone calls provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep; ASD; Insomnia; Behavioral Intervention
Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
Condition: Obesity; Diabetes; Heart Failure; Insulin Resistance
MeSH terms: Heart Failure; Insulin Resistance
Study type: Observational

Summary: 
      An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic
      profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post
      bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only
      15 patients completed 24 month evaluations due to 28 patients unwilling to return.

      The overarching purpose appears to have been not only evaluation of weightloss, but
      normalization of metabolic profile over time.
    


Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female, adult patients with clinically severe obesity who have undergone elective
        bariatric surgery.
      
Biospecimen description: 
      Skeletal muscle biopsies, plasma
    
Keywords: Obesity; Insulin Resistance; Free Fatty Acids; Heart Failure
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
Condition: Brain Injuries; Post-Concussive Symptom; Post-Concussive Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this open trial is to investigate the feasibility, acceptability, and effect
      of metacognitive therapy in patients with prolonged post-concussive symptoms after mild
      traumatic brain injury.
    


Intervention name(s): Metacognitive therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotherapy
Rivastigmine Bioequivalence Trial With Multiple Applications of Transdermal Patches (9.5 mg/24 h)
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The present clinical trial will be conducted in order to compare the bioavailability of
      rivastigmine and to assess bioequivalence at steady-state of the marketed Test product
      Rivastigmine twice-weekly 9,5 mg/24 h transdermal patch (Manufacturer: Luye Pharma AG,
      Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermal patch
      (Manufacturer: LTS Lohmann Therapie-Systeme AG, Germany) after multiple patch applications.
      Each of both treatments will last for 11 days with a washout period of at least 14
      treatment-free days between the treatments.
    


Intervention name(s): Rivastigmine twice-weekly 9,5 mg/24 h; Exelon® 9.5 mg/24 h
Intervention type(s): Drug; Drug
Intervention description(s): 3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period; 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Paracervical Block Versus No Paracervical Block During IUD Insertion
Condition: Analgesia; IUD Insertion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the pain level and level of discomfort with
      paracervical block versus no analgesia in women who present to the University of Texas (UT)
      Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and
      the UT Physicians Women's Center- Bellaire for IUD insertion.
    


Intervention name(s): Lidocaine; No analgesia; Intrauterine device (IUD)
Intervention type(s): Drug; Other; Device
Intervention description(s): Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.; IUD placement without analgesia.; IUD placement with or without paracervical block with 1% lidocaine.
Other intervention name(s): xylocaine, lignocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The study analyzes the consequences of weight bearing after an HTO in a population of young
      patient with medial osteoarthritis (immediate weight bearing versus two month weight
      bearing). The two options are usually used so the protocol belongs to the intermediate care
      evaluation category.

      The IKS (International Knee Society) score at one year follow up is the first outcome. The
      aim of the study is to highlight that the option early weight bearing (immediately in
      postoperative) is equal to the option delayed weight bearing.
    


Intervention name(s): Early weight bearing; Delayed weight bearing
Intervention type(s): Procedure; Procedure
Intervention description(s): Weight bearing performed immediately after surgery; Weight bearing performed 2 months after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Osteotomy; Weight bearing; Opening wedge
This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailabilities of
      digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail
      together with the following drug transporter inhibitors:

      Part 1: verapamil (P-gp) and rifampin (OATP1B1/1B3) Part 2: cimetidine (OCT2/MATE) Part 3:
      probenecid (OAT1/3) The secondary objective is to investigate other potential changes in
      pharmacokinetics (e.g. in clearance, volume of distribution, etc.) of digoxin, furosemide,
      metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the
      inhibitors describe above.
    


Intervention name(s): Digoxin; Furosemide; Metformin; Rosuvastatin; Verapamil; Rifampin; Cimetidine; Probenecid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Oral solution; Oral solution; Film-coated tablet; Film-coated tablet; Film-coated tablet; Tablet; Tablet
Intervention MeSH terms: Metformin; Rifampin; Probenecid; Digoxin; Verapamil; Furosemide; Cimetidine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test whether Rifampin affects blood levels of istradefylline
      in humans. Rifampin could possibly decrease istradefylline levels.
    


Intervention name(s): Istradefylline 40 mg; Rifampin 300mg BID + istradefylline 40mg Day 8 only
Intervention type(s): Drug; Drug
Intervention description(s): On Day 1, istradefylline 1 × 40-mg tablet administered alone; On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
Other intervention name(s): KW-6002; rifadin
Intervention MeSH terms: Rifampin; Istradefylline
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PD