bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical trial is to compare the efficacy and safety of an initial
      triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral
      treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve
      patients with pulmonary arterial hypertension.
    


Intervention name(s): Macitentan; Tadalafil; Selexipag
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.; Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.; Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.
Intervention MeSH terms: Selexipag; Tadalafil; Macitentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
Condition: Diabetes Mellitus; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased
      steadily in recent years. This has resulted in the increasing incidence of contrast-induced
      acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes
      mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs,
      hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning
      that in a patient with CKD it amplifies the risk of CIAKI.

      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether
      statins treatment during the perioperative period would reduce the risk of CIAKI in a
      high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing
      coronary angiography or noncoronary angiography, and evaluate the influence of such potential
      benefit on short-term outcome.
    


Intervention name(s): rosuvastatin
Intervention type(s): Drug
Intervention description(s): rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: diabetes mellitus; chronic kidney disease; contrast induced acute kidney injury; angiography
Exercise and Nutrition on Obese Microbiome
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects nine weeks of intense exercise training
      will have on weight, inflammation, and intestinal bacteria composition of overweight and
      obese adults.
    


Intervention name(s): Exercise Protocol; Calorie-Restrictive Low Carbohydrate Diet (CR-LC); Ancestral Diet (AD)
Intervention type(s): Other; Other; Other
Intervention description(s): The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise. Exercises are performed in person as a group with other participating subjects and lead by certified instructors. Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.; Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. CR-LC consists of caloric and macronutrient restrictions. Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure. Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).; Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. AD consists of consuming only whole foods and avoiding processed foods. Emphasis will be on food quality with no caloric or macronutrient restrictions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to
      assess the effect of challenges with dactylis glomerata pollen in an environmental challenge
      chamber on dermal symptoms in patients suffering from atopic dermatitis.

      After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for
      biomarker assessments. The severity of atopic dermatitis will be rated with the "SCORing
      Atopic Dermatitis" (SCORAD), with the objective SCORAD and with the assessment of itch and
      sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on
      each day including baseline assessments.
    


Intervention name(s): Grass pollen : Dactylis glomerata; Challenge with clean air
Intervention type(s): Other; Other
Intervention description(s): The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen.; The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
Condition: Osteoporosis, Management Care, Fracture
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care
      of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists,
      primary care physicians and osteoporosis experts into which the fracture patient disappears".

      The most effective way to achieve this goal is through implementation of coordinator-based
      post fracture models of care. Exemplar models have been refered to as "Fracture Liaison
      Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator
      Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).

      The objective of this trial is to assess efficacy of a new coordinator-based post-fracture
      program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after
      fracture thanks to an optimal recommendations practice to reduce the incidence of secondary
      fractures.

      Men and women are included aged over 45 years with fragility wrist and hip fractures.

      Evaluation criteria are based on the evidence-based assessment (stratify risk, identify
      secondary causes of osteoporosis, fracture evaluation), the medication adherence, others
      prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number
      of falls.

      Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6
      months
    


Intervention name(s): Coordinator-based post fracture program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Condition: HCV Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics
      and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype
      1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the
      clinic for the initial 5 days of the study.
    


Intervention name(s): GS-5885; Placebo; GS-5885; Placebo; GS-5885; Placebo; GS-5885; Placebo; GS-5885; Placebo; GS-5885; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet, oral, 3 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, 10 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, 30 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, up to 90 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, up to 90 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, up to 90 mg once daily for 3 days; tablet, oral, once daily for 3 days
Intervention MeSH terms: Ledipasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV RNA; multiple ascending dose; NS5A; GS-5885; chronic genotype 1 HCV infection
Insomnia and Cognitive Performance in Chronic Pain
Condition: Chronic Pain; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Interventional

Summary: 
      The aim of the present study is to examine cognitive function in a patient population with
      complex chronic pain to test the hypothesis that insomnia severity on its own predicts
      objective cognitive function, and that a correlation is not better explained by comorbid
      depression or anxiety, morphine equivalent daily dose, or the level of pain itself.
    

Detailed description: 
      Almost 20 % of the adult European population suffers from chronic pain of moderate to severe
      intensity, and clinical insomnia has been reported in 53-73% of chronic pain patients.
      Insomnia seems to be correlated with small to moderate impairments in several cognitive
      functions involved in working and episodic memory and in attention tasks, and chronic pain
      has been shown to be associated with objective deficits in memory and executive functioning.
      The aim of the present study is to examine cognitive function in a patient population with
      complex chronic pain to test the hypothesis that insomnia severity on its own predicts
      objective cognitive function, and that a correlation is not better explained by comorbid
      depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

      Inividuals with complex chronic pain are assessed with a neuropsychological test battery
      examining different aspects of memory and executive functioning:

      The Digit Span subtest from Wechsler's Adult Intelligence Scale III (WAIS-III): Verbal
      working memory.

      Claeson-Dahl Inventory of Learning and Memory (CD): Verbal retention. The Rey Complex Figure
      Test (RCFT): Visuospatial retention. The Wisconsin Card Sorting Test (WCST): Cognitive
      flexibility. The Trail-Making Test (TMT): Sustained attention.

      The presence of insomnia is examined with the Bergen Insomnia Scale (BIS) , and insomnia
      severity with the Insomnia Severity Index (ISI). Present pain level at the time of the
      neuropsychological assessment is quantified using the Visual Analogue Scale (VAS). Pain
      medication is transformed to the morphine equivalent daily dose (MEDD). Anxiety and
      depression are assessed with the Hospital Anxiety and Depression Scale.
    

Intervention name(s): Neuropsychological assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cognitive Impairment
Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of
      active, moderate to severe ulcerative colitis in patients who have failed conventional
      therapy using mesalamine or steroids
    


Intervention name(s): AEB071; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis; immunosuppressive therapy; AEB071; Modified Baron score; Partial Mayo score
Biomagnetic Signals of Intestinal Ischemia II
Condition: Ischemia
MeSH terms: Ischemia
Study type: Observational

Summary: 
      The lack of blood flow to the small intestine causes mesenteric ischemia. Using a
      Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the
      small intestine, we are hoping to identify abnormalities without surgical intervention.
    

Detailed description: 
      The electrical activity of the small intestine may contain important information that will
      help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of
      mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome
      before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to
      the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic
      field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients
      with mesenteric ischemia, the investigators hope to identify abnormal disease states without
      surgery.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: Blood supply; Mesentery
Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      The currently available stock of smallpox vaccine would be insufficient in the face of an
      incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are
      urgently needed because previous manufacturing methods using calf lymph are no longer
      acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea
      has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by
      infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,
      and immunogenicity of CJ-50300.
    


Intervention name(s): smallpox vaccine CJ-50300
Intervention type(s): Drug
Intervention description(s): Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Other intervention name(s): CJ-53300
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smallpox vaccine efficacy
Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterise pharmacokinetics and assess the relative bioavailability of two new oral
      formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and
      Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg
    


Intervention name(s): Lasolvan tablet; Lasolvan tablet; Lasolvan tablet; Lasolvan tablet; Lasolvan effervescent tablet; Lasolvan effervescent tablet; Lasolvan effervescent tablet; Lasolvan prolonged-release hard capsule; Lasolvan prolonged-release hard capsule; Lasolvan prolonged-released capsules; Lasolvan tablet; Lasolvan tablet; Lasolvan prolonged-release hard capsule; Lasolvan effervescent tablet; Lasolvan prolonged-release hard capsule; Lasolvan prolonged-release hard capsule; Lasolvan effervescent tablet; Lasolvan effervescent tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One Lasolvan tablet 30 mg twice daily for 5 days.; One Lasolvan tablet 30 mg twice daily for 5 days.; One Lasolvan tablet 30 mg twice daily for 5 days.; One Lasolvan tablet 30 mg twice daily for 5 days.; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One Lasolvan tablet 30 mg twice daily for 5 days.; One Lasolvan tablet 30 mg twice daily for 5 days.; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.; One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Chronic gynaecological pain is a major medical problem that affects 20-30% of women at
      different moments of their life. This largely neglected issue has a significant impact on the
      sexual and conjugal life of women suffering from it as well as on their psychological health.
      Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally
      ignored. Also, treatment is limited and not extensively studied. This study aims at better
      understanding and treating gynaecological pain. The focus of the study will be provoked
      vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor
      physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The
      treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from
      provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital,
      Royal-Victoria Hospital, CHUM St-Luc).
    

Detailed description: 
      This is a randomised controlled trial comparing the impact of multimodal physiotherapy
      treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first
      treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation
      techniques, stretching and pelvic floor muscle control exercises. The second treatment is a
      night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then
      evaluate women's pain and sexual function right after the treatment and 6 months later.
    

Intervention name(s): Multimodal physiotherapy; lidocaine
Intervention type(s): Procedure; Drug
Intervention description(s): 10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.; 10 weeks of daily topical 5% lidocaine application
Other intervention name(s): Xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: provoked vestibulodynia; multimodal physiotherapy; lidocaine
CONtrolled Focal Fibrous Band Release Method Study
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the
      appearance of cellulite.
    

Detailed description: 
      Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli
      device in reducing the appearance of cellulite.
    

Intervention name(s): Avéli device
Intervention type(s): Device
Intervention description(s): Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants were treated with the Avéli device.
Masking: None (Open Label)
Primary purpose: Treatment