bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of alitretinoin in the
      treatment of severe chronic hand eczema that does not respond to treatment with potent
      topical steroids.
    

Detailed description: 
      Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for
      dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from
      labour market. Conventional treatments, including highly potent topical steroids, yield often
      unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin,
      a retinoid, in patients who have not responded to avoidance of causative factors, such as
      contact allergens and skin irritants, non-medicated skin care and highly potent topical
      steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.
    

Intervention name(s): alitretinoin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks; Patients receive matching placebo for up to 24 weeks
Intervention MeSH terms: Alitretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: retinoid treatment; fingertip dermatitis; hyperkeratotic hand eczema; vesicular hand eczema; pompholyx
Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Condition: Stable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      There are few data regarding anti-anginal effects between beta-blockers with and without
      vasodilating property. Beta-blocker without vasodilating property is generally known to have
      unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared
      carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina
      pectoris.
    

Detailed description: 
      Previous studies have demonstrated that beta-blockers are effective in reducing not only
      ischemia but also cardiovascular mortality following myocardial infarction. And, recent
      guidelines have suggested the potential for use of beta-blockers as first-line agents in
      chronic stable angina. However, beta-blockers are a diverse class with different mechanisms
      of action and physiological effects. Various pharmacologic properties that characterize
      beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant
      vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal
      efficacies. In addition, traditional beta-blockers, particularly nonvasodilating
      beta-blockers, have been reported to have negative metabolic effects, including
      hyperglycemia, insulin resistance, and dyslipidemia. These unfavorable effects of
      beta-blockers should be considered in patients with stable angina pectoris, because the
      pathophysiology of coronary artery disease is associated with abnormalities in glucose and
      lipid metabolism. Carvedilol, a newer vasodilating beta-blocker, has been shown to differ
      from traditional beta-blockers in terms of metabolic effects in patients with hypertension
      and diabetes. However, few data regarding comparative anti-anginal and metabolic effects
      between beta-blockers with and without vasodilating property have been reported, particularly
      in patients with angina pectoris. In this study, we simultaneously compared anti-anginal and
      metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.
    

Intervention name(s): Carvedilol; Atenolol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Beta-blockers; Anti-anginal effect; Lipid metabolism; Glucose metabolism
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
Condition: Primary Hypertension; Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The research of clinical effectiveness assessment is to explore the causal relationship
      between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment,
      the research takes the Resistant Hypertension (RH) as example to study the causal inference
      methods under real world.
    

Detailed description: 
      Background: Syndrome differentiation is one of the substantial characteristics in Traditional
      Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of
      causal relationship between treatment and clinial effect under real-word study may help.

      Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome
      differentiation method in treating resistant hypertension and explore causal inference in the
      real-world study.

      Research design and methods: It is a multi-center,prospective,two-arm,cohort study including
      200 patients with resistant hypertension (doctors' diagnosis based on the American Heart
      Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure
      >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and
      Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents
      for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and
      nonpharmacological recommendations were initiated in the observational group and the control
      group received the same interventions without Chinese herbs.

      Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood
      pressure reductions and changes in symptoms and signs.Cardiac event and death incident will
      be the secondary outcomes.Possible side effects and adverse reactions arising from the
      treatment like diarrhea will be recorded.

      Discussion: This is a rigorous methodology pilot study and 200 patients are enough to
      calculate sample size in later formal trial.
    

Intervention name(s): Herbs; Antihypertensive drugs
Intervention type(s): Drug; Drug
Intervention description(s): Herbs 180ml by mouth every 12 hours for 8 weeks; Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
Other intervention name(s): recipe of removing both phlegem and blood stasis; Thiazide diuretics and ACE inhibitor and β-blocker
Intervention MeSH terms: Antihypertensive Agents; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistant hypertension; causal inference; a chorot study; recipe of removing both phlegm and blood stasis
Radioimmunoimaging of Light Chain (AL) Amyloidosis
Condition: AL Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive
      monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by
      PET/CT imaging in patients with AL amyloidosis.
    

Detailed description: 
      To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis
      without significant cardiac (New York Heart Association class IV) disease and not be on
      kidney dialysis. Additionally, after testing, their blood must not contain antibodies to
      mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the
      radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days
      after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks
      after the antibody infusion.
    

Intervention name(s): Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Intervention type(s): Biological
Intervention description(s): Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radioimmunoimaging; AL Amyloidosis; PET/CT
Comparative Study of Three Common Bile Duct Closure Techniques
Condition: Common Bile Duct Closure
Study type: Interventional

Summary: 
      This study evaluates the efficacy and safety of three different methods of CBD repair after
      common bile duct exploration and provides more evidence for selecting the optimal duct
      closure after choledocholithotomy.
    

Detailed description: 
      At present, the commonest available options for CBD closure include repair over T-tube drain,
      primary closure, and repair after antegrade biliary stenting. All three methods present
      speciﬁc technical performance features, require different postoperative management protocols,
      and are charged with speciﬁc morbidity related to the procedure and therefore should not be
      considered the same procedure in the context of CBDE.

      Repair over T-tube is the traditional surgical technique. It has many advantages as
      post-operative distal CBD decompression, trans-tubal cholangiography, and availability of
      retained CBD stones extraction. However, it has several potential complications up to 10% of
      patients. The most frequent complications are bile leakage, tract infection, T-tube
      dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure
      from dehydration due to inadequate water ingestion. It also causes discomfort and persistent
      pain to the patient along with increased hospital admission and thus the economic burden to
      the country. Primary closure of CBD has been described in the literature to overcome these
      adverse consequences of the T-tube. However, it has many potential complications as a
      potential bile leak and CBD stricture, which may occur due to papillary edema and
      insufficient bile duct expansion. There are conflicting results regarding significant
      differences in the morbidity and mortality between primary closure and T-tube drainage. There
      is no conclusive evidence displaying whether primary closure is better or worse than T-tube
      drainage after CBD exploration.

      Using a biliary stent in primary closure is an effective method to decrease the two
      complications, which can reduce biliary pressure without bile loss. Although there are some
      available drainage options after CBDE, a consensus on the optimal drainage is yet to be
      reached.
    

Intervention name(s): T tube drainage; Primary closure; Antegrade stenting
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): closure of common bile duct over T tube; Primary closure of common bile duct; Closure of common bile duct over antegrade plastic biliary stent
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: choledocholithiasis; T-tube; primary repair; biliary stenting
Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Graft-Versus-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical trial to see if the addition of etanercept to standard preventative
      medicines helps in preventing two major complications of hematopoietic stem cell
      transplantation (HSCT): decrease the rate of acute graft-vs-host disease (GVHD) and the risk
      of death.
    

Detailed description: 
      This is a clinical trial to see if the addition of etanercept helps in preventing two major
      complications of hematopoietic stem cell transplantation (HSCT). The main objective will be
      to see whether the addition of etanercept to standard preventative medicines will decrease
      the rate of acute graft-vs-host disease (GVHD) and the risk of death by 100 days following
      allogeneic HSCT from volunteer donors.

      GVHD is a common complication following a bone marrow transplant from another donor. GVHD
      occurs after transplant when the donor's blood cells recognize parts of the body as foreign.
      During this process, chemicals called cytokines are released that may damage certain body
      tissues, including the gut, liver and skin. Some of the main effects can include red skin
      rash, diarrhea, sometimes with blood, and yellow jaundice. It can range from mild to life
      threatening and often requires admission to the hospital for treatment. The standard
      treatment for acute GVHD is a combination of steroids and another drug that suppress the
      immune system, such as tacrolimus or cyclosporine.

      Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing
      damage to your tissue. The purpose of etanercept is to help improve the response to standard
      treatment for GVHD. Previous studies have shown that less than 50% of patients respond fully
      to GVHD treatment. Without a good response, patients often have a prolonged treatment for
      this disease, often involving hospitalization and sometimes even death. Etanercept (Enbrel)
      will be added to the standard treatment to see if we can lower the rate of GVHD and the risk
      of death from GVHD by blocking TNF.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant.
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem Cell Transplantation; Graft-Versus-Host Disease; prophylaxis
Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity
Condition: Cardiovascular Diseases; Glucose Metabolism Disorders
MeSH terms: Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on
      vascular reactivity and metabolic profile. Participants, divided in six groups, will receive
      one of these breakfast integrations for 14 days:

      group 1) 30 g peeled hazelnuts;

      group 2) 30 g unpeeled hazelnuts;

      group 3) snack with 30 g peeled hazelnuts;

      group 4) snack with 2.5 g cocoa powder;

      group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;

      group 6) empty snack, control group.
    

Detailed description: 
      In the last few years, the prevalence of overweight and obesity has increased in all age
      groups. The European Food Safety Authority stated "cocoa flavanols help maintain
      endothelium-dependent vasodilation, which contributes to normal blood flow". Several studies
      reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease.
      The hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet
      integrations on vascular reactivity and endocrine-metabolic parameters.
    

Intervention name(s): Hazelnut; Cocoa; No hazelnuts / No cocoa; Cream; Snack
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): This dietary supplement contains 30 g of hazelnut.; This dietary supplement contains 2.5 g of cocoa powder.; This dietary supplement does not contain hazelnut nor cocoa powder.; This dietary supplement is just a cream obtained by grinding hazelnuts.; This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hazelnut; Cocoa; Flavonoid; Lipids; Vascular Reactivity
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the effectiveness of prolonged exposure therapy versus active
      psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.
    

Detailed description: 
      PTSD is an anxiety disorder that can develop after exposure to an event in harm to the life
      or physical integrity of oneself or others has occurred or was threatened. People with PTSD
      have persistent frightening thoughts and memories of their ordeal and often feel emotionally
      numb, especially with people to whom they were once close. Effective treatments for
      post-traumatic stress disorder are available, and research is yielding new, improved
      therapies that can help reduce symptoms of PTSD. Prolonged exposure (PE) therapy is a brief
      cognitive behavioral therapy that has been effective in treating symptoms of PTSD in adults.
      However, no treatments have been proven effective for the treatment of PTSD in adolescents.
      This study will compare the effectiveness of PE therapy versus non-trauma directed active
      psychotherapy in reducing the symptoms of PTSD in adolescents. In addition, this study aims
      to refine the existing PE treatment protocol for adolescents with PTSD.

      Participants in this single-blind study will be randomly assigned to receive either PE
      therapy or AP. All participants will receive 12 to 18 therapy sessions, which will be
      conducted weekly. Assessments of PTSD symptoms, depression, and overall functioning will be
      conducted at baseline, immediately post-treatment, and 3 months post-treatment.
    

Intervention name(s): Prolonged Exposure Therapy; Active Psychotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Prolonged exposure therapy includes a trauma focused protocol and cognitive behavioral treatment for PTSD. Cognitive behavioral treatment includes psychoeducation, in vivo exposures, and imaginal exposures.; Active psychotherapy includes non-trauma focused therapy, based on time-limited psychodynamic treatment, which includes a formulation of a central issue and open-associative sessions exploring main conflicts and drives.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Anxiety Disorder; Trauma; Adolescents; Cognitive Behavioral Therapy
Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy
Condition: Colonic Polyp
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      This is a prospective randomized placebo-controlled trial to evaluate the efficacy of
      peppermint oil spraying into the colonic lumen through the scope channel during screening
      colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil
      and placebo. The secondary outcomes compare the procedural time, polyp detection rate,
      adenoma detection rate, and adverse events.
    


Intervention name(s): Intraluminal peppermint oil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal; Intraluminal flushing of placebo solution through the scope during scope withdrawal
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Peppermint oil, Adenoma detection rate, Colonic peristalsis
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients
Condition: Chronic Low Back Pain; Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the benefit of biofeedback training on the
      capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles
      activity during trunk full flexion and its relationship with changes in clinical outcomes. To
      do so, twenty patients with nonspecific mechanical low back pain will be recruited and all
      participants will take part in four sessions of supervised biofeedback training, consisting
      of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that
      participants will have improved neuromechanical parameters with the biofeedback training and
      that this improvement will be positively associated to changes in clinical outcomes. This
      study will also allow for generation of preliminary data, in order to plan for a larger
      randomized control trial.
    


Intervention name(s): Biofeedback
Intervention type(s): Other
Intervention description(s): Idem as described in the arm section (above)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; Rehabilitation; Biofeedback; Electromyography; Kinematic
Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in
      treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following
      the onset of the first symptoms is beneficial compared to placebo.
    


Intervention name(s): Rosuvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy
      subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of
      SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a
      high-fat meal on the PK of SAM-531 administered to healthy subjects.
    


Intervention name(s): SAM-531
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment