bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects
      with moderate to severe atopic dermatitis (AD).
    

Detailed description: 
      This is a placebo controlled study where subjects with moderate to severe atopic dermatitis
      will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once
      daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month
      open-label extension study (OLE). There will be a 4-week follow up period for subjects not
      participating in the OLE study. This study will also characterize the pharmacokinetics and
      pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects
      who consent.
    

Intervention name(s): ASN002; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose of ASN002 for 12 weeks; Placebo of ASN002 for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eczema
Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
Condition: Mitral Stenosis
MeSH terms: Mitral Valve Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and
      effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.
    


Intervention name(s): Ivabradine; Atenolol
Intervention type(s): Drug; Drug
Intervention description(s): Ivabradine 5 mg BId for 4 weeks; 50 mg od for 4 weeks
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
Condition: Asthma; Chest Syndrome; Clinical Anxiety; Clinical Depression; Lung Function; Quality of Life; Eosinophilia; Nitric Oxide; Airway Responsiveness; Induced Sputum
MeSH terms: Asthma; Eosinophilia
Study type: Observational

Summary: 
      Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that
      threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of
      breath, chest tightness and cough, usually occurring at night or early morning. However,
      there are still some patients with only persistent clinical manifestations of chest
      tightness. Concerned about this group of patients, we presented a subgroup of bronchial
      asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks
      asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and
      therefore often misdiagnosed for a long time. In order to further understand the clinical
      characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national
      multicenter observation study to further understand CTVA. Finally, we plan to clarify whether
      CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and
      perform an appropriate treatment of CTVA.
    


Intervention name(s): Treat patient according to Global Initiative for Asthma (GINA) guideline
Intervention type(s): Drug
Intervention description(s): Treat patient according to Global Initiative for Asthma (GINA) guideline
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with only symptom of chest tightness and bronchial provocation test positive
        according to eligibility criteria.
A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the surgical and clinical outcomes of patients
      receiving total knee replacement with the same implant using two different types of cutting
      guides during surgery:

        1. Standard knee cutting guides;

        2. MRI generated patient specific custom cutting guides.

      Both types of cutting guides used in this study are registered with the U.S. Food and Drug
      Administration (FDA) and are routinely used for knee replacement surgery. However, it is
      unknown if one type of cutting guide has risks or benefits over the other.
    


Intervention name(s): Instrument
Intervention type(s): Other
Intervention description(s): Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
Other intervention name(s): Vanguard® Knee System; Signature™ Custom Guides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fed
      condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA,
      under fed condition in healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 500 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 10 days including washout period of 7
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Tablets USP 500mg; Etodolac Tablets USP 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet once a day; 500 mg tablet once a day
Other intervention name(s): Test Product; Reference Product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Imaging of Cannabinoid Receptors
Condition: Cannabis Use Disorder; Cannabis Dependence, Continuous
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Early Phase 1

Summary: 
      All participants will be healthy volunteers and all procedures will be completed for research
      purposes only. Two groups will be recruited, females who use cannabis (marijuana, MJ), and
      female who do not use cannabis (controls). Female MJ users will be enrolled in a protocol
      that includes an outpatient drug administration session and a 4-day/3-night inpatient stay on
      the Johns Hopkins Bayview Clinical Research Unit (CRU). During outpatient visits, MJ users
      will have an MRI, and complete MJ self-administration and cognitive performance sessions. MJ
      users will then reside on the CRU,and complete MJ abstinence, and self-report instruments for
      withdrawal discomfort. A positron emission tomography (PET) scan of brain cannabinoid type 1
      receptors will also be completed. Non-users will complete MRI, PET imaging and cognitive
      testing under an outpatient protocol (no MJ administration).
    

Detailed description: 
      The primary goals of this project are to examine whether use of cannabis alters brain
      cannabinoid type 1 receptor (CB1R) availability in females, and if severity of cannabis
      withdrawal is correlated with CB1 receptor availability. CB1R are widely distributed in the
      human brain and can be quantified using PET imaging with the radiotracer 11C-OMAR
      (Carbon-11-OMAR). The effects MJ use on brain CB1R have not been studied in females. The
      current study will enroll 10 female MJ users in an inpatient protocol that includes
      administration of smoked MJ, followed by monitored abstinence with daily behavioral
      assessments, and PET imaging with 11C-OMAR. PET data will collected in 10 matched controls
      for comparison. The proposed study is an important first step to determine whether localized
      CB1R changes in female MJ users help explain, and provide a neurobiological target for
      intervention. Results will increase knowledge of cannabinoid mechanisms of cannabis use and
      severity of dependence in females, an understudied population.
    

Intervention name(s): 11C-OMAR; Cannabis
Intervention type(s): Drug; Drug
Intervention description(s): 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.; Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
Other intervention name(s): JHU75528; Marijuana
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups will be recruited. Female cannabis users and nonusers.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Marijuana; cannabis; cannabinoid receptor
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Condition: Sudden Sensorineural Hearing Loss (SSNHL)
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 2

Summary: 
      Compare hearing outcomes between treatment with dexamethasone versus prednisone in
      participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing
      loss).
    

Detailed description: 
      Sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 per 100,000 persons
      with spontaneous recovery seen in 32% to 65%. Many different treatments have been
      investigated in attempt to improve hearing outcomes, with oral corticosteroids having some
      success. Steroid regimens are highly variable, however, retrospective data has suggested
      greater improvement in hearing outcomes with the use of high dose oral steroids
      (dexamethasone) in the setting of unilateral sudden sensorineural hearing loss compared to
      traditional medical therapy with lower dose oral prednisone. The investigators hypothesize
      that patients with unilateral SSNHL who are randomized to treatment with high doses of oral
      dexamethasone will show better hearing outcomes than patients who are randomized to the more
      common standard clinical practice treatment with lower doses of oral prednisone.
    

Intervention name(s): Dexamethasone; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.; All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
Other intervention name(s): dexamethasone sodium phosphate; Deltasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Prednisone; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
Masking: None (Open Label)
Primary purpose: Treatment
CART Therapy in GUCY2C-positive Digestive Tract Tumors
Condition: Malignant Neoplasms of Digestive Organs
MeSH terms: Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted
      therapy in patients with advanced gastrointestinal tumors.
    

Detailed description: 
      The primary objective of phase 1 is to evaluate the safety of CART regimens. The primary
      objective of phase 2 is to evaluate the efficacy of CART, as measured by objective response
      rate in subjects with colorectal cancer. Secondary objectives will include assessing the
      safety and tolerability of CART and additional efficacy endpoints.
    

Intervention name(s): gucy2c cart cells
Intervention type(s): Biological
Intervention description(s): Patients with advanced malignant gastrointestinal tumors were injected with CART cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cart; gucy2c; Digestive tract tumor
Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet
      and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged
      population, and if the diet-induced modulation of the gut microbiota mediates changes in
      metabolic risk markers.

      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in
      the gut microbiota composition and to affect markers for insulin sensitivity, lipid
      metabolism and inflammation. The investigators hypothesize that the effect of both
      interventions on the metabolic risk markers will be partly mediated by the diet-induced
      changes in the gut microbiota composition.
    


Intervention name(s): Wheat bran extract; Fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).; Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine
      over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed
      8-week acute treatment.
    


Intervention name(s): Vortioxetine (Lu AA21004)
Intervention type(s): Drug
Intervention description(s): 2.5, 5, or 10 mg/day; tablets; orally
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Long-term; Safety; Open-label
Liraglutide Hospital Discharge Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications and death. Improved glucose control with insulin
      injections may improve clinical outcome and prevent some of the hospital complications.
      Increasing evidence indicates that incretin-based agents are safe and effective for the
      hospital management of patients with type 2 diabetes (T2D).

      Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the
      treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous
      insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food
      intake and body weight and improve ß-cell function when administered subcutaneously.
      Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma
      glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy.
      When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable
      reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective
      studies; however, have compared the efficacy and safety of liraglutide in the hospital
      setting or after hospital discharge.

      The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus
      glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas,
      nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in
      medicine patients with T2D after hospital discharge.
    

Detailed description: 
      Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in
      similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared
      to treatment with glargine (Lantus®) in patients with T2D after hospital discharge. Patients
      with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents or
      low dose insulin naïve (0.4u/kg/day) prior to admission will be randomized to liraglutide or
      glargine in combination to OADs at hospital discharge.
    

Intervention name(s): Liraglutide + OADs; Glargine + OADs
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide subcutaneously daily; Glargine once daily subcutaneously
Other intervention name(s): Victoza® + OADs; Glargine (Lantus®) + OADs
Intervention MeSH terms: Insulin Glargine; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incretins; Liraglutide; Glargine; Randomized controlled trial; basal insulin; hospital discharge; inpatient diabetes
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate the drug-drug interaction between LC15-0444 and
      metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy
      male subjets after oral administration concomitantly and each alone.
    


Intervention name(s): LC15-0444; Metformin; LC15-0444+Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LC15-0444 50mg qd (8 days once daily); Metformin 1000 mg bid (8 days twice daily); LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Condition: Bruxism, Sleep-Related
MeSH terms: Bruxism; Sleep Bruxism
Study type: Interventional

Summary: 
      There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over
      teeth, muscles and articulation of the jaw are important.

      This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism
      in ambulatory evaluation.
    


Intervention name(s): BRUXENSE occlusal splint
Intervention type(s): Device
Intervention description(s): Patients participating will put the BRUXENSE occlusal splint each night. During the night the device will collect data potentially related to bruxism. After each night the device will be cleaned with water and toothpaste and charged. This routine will be conducted over 10 consecutive nights.
Intervention MeSH terms: Salicylic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Condition: Osteoporotic Vertebral Compression Fractures
MeSH terms: Fractures, Compression
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty
      for the treatment of painful, osteoporotic vertebral compression fractures.
    


Intervention name(s): Kyphoplasty
Intervention type(s): Procedure
Intervention description(s): kyphoplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of tDCS on Motor Performance and Cortical Excitability
Condition: Cortical Excitability; Motor Performance; tDCS
Study type: Interventional

Summary: 
      In this study the effect of tDCS intensity on motor performance and corticospinal (CS)
      excitability is evaluated. The investigators expect that a positive relationship between
      current intensity and motor performance/CS excitability.
    


Intervention name(s): transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)
Intervention type(s): Device
Intervention description(s): The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.
Other intervention name(s): NeuroConn DC-stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Portal Vein Pulsatility Flow in Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      This study is to investigate if portal vein pulsatility fraction can be measured in pregnancy
      and if it increases during the course of pregnancy as would be expected by the physiologic
      increase in blood volume that happens during pregnancy. Portal vein pulsatility fraction is
      measured in non-pregnant controls and in women in the 1st, 2nd and 3rd trimester of
      pregnancy.
    


Intervention name(s): ultrasound
Intervention type(s): Other
Intervention description(s): portal vein pulsatility fraction (percent) measured with ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women attending either the anaesthetic preassessment clinic or the obstetric
        ultrasound clinic at University Hospital Basel.

        Non-pregnant healthy females fulfilling the inclusion criteria will be recruited by
        published advertisement at the University Hospital Basel.
      
Keywords: portal vein pulsatility; physiologic volume overload
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      The hypotheses for this study is that there is no transfer of testosterone from male (donor)
      subjects to female (recipient) subjects when contact is made 2 hours post application of 2%
      Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.
    


Sampling method: Non-Probability Sample
Study population: 
        Healthy male and female volunteers
      
Keywords: Open label, single dose, pharmacokinetic study