bioihbjkbjnl/mcl2 huggingface dataset:
High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to define an improvement in patients:

        -  To evaluate if patients resistant to the initial treatment for residual PET-positive
           masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early
           shift to high-dose chemotherapy supported by stem cell rescue

        -  To analyse if patients achieving early complete response (PET-2 negative), can be spared
           the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned
           six courses of ABVD. To answer this question, PET-2 negative patients will be randomized
           between radiotherapy versus no radiotherapy at the end of ABVD therapy.
    

Detailed description: 
      This study is composed by two phases:

        1. A phase II multi-centre study evaluating in patients with advanced stage Hodgkin
           lymphoma the efficacy of an early salvage treatment with high-dose chemotherapy followed
           by stem cell transplantation in patients FDG-PET positive after two courses of ABVD
           (PET-2 positive).

        2. A phase III randomised study comparing the efficacy of radiotherapy to the areas of
           initial bulky disease versus no further therapy in PET-2 negative patients in complete
           remission (PET-6 negative) at the end of six courses of ABVD.
    

Intervention name(s): ABVD; ABVD and Radiotherapy
Intervention type(s): Drug; Drug
Intervention description(s): ABVD courses are scheduled every 28 days:
Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
ABVD courses are scheduled every 28 days:
Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
Randomization to Arm A (Observation); ABVD courses are scheduled every 28 days:
Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin's lymphoma; ABVD; FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography); Radiotherapy
Laparoscopic Partial Nephrectomy for cT1 Tumors
Condition: Renal Cancer; Renal Neoplasm; Renal Cell Carcinoma; Surgery; Surgery--Complications; Renal Functional Abnormality; Oncology; Oncology Problem; Kidney Ischemia; Kidney Injury; Urologic Neoplasms; Urologic Cancer; Kidney Neoplasms
MeSH terms: Neoplasms; Carcinoma, Renal Cell; Kidney Neoplasms; Urologic Neoplasms; Ischemia
Study type: Observational

Summary: 
      The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial
      nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.
    

Detailed description: 
      From November 2009 to August 2018 a total of 292 patients who underwent LPN by global
      ischemia were included in the study. The patients were allocated into two groups according to
      the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical
      tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative
      surgical margin, warm ischemia time (WIT) < 20 min and no postoperative complications
      (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has
      defined as trifecta criteria plus >90% preservation of estimated glomerular filtration rate
      (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and
      multivariable analysis were used to identify factors predicting trifecta and pentafecta
      achievement.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Two hundred ninety-two patients who have a follow-up at least 12 months were included in
        the study. Those were allocated into two groups according to radiological tumor size; 215
        patients with tumor size ≤ 40 mm were included in group T1a and 77 patients with tumor size
        41-70 mm were included in group T1b.
      
Keywords: laparoscopic partial nephrectomy; Trifecta; Pentafecta; Outcomes
Aurinia Renal Response in Active Lupus With Voclosporin
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of voclosporin compared with placebo in
      achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
    

Detailed description: 
      The aim of the current study is to investigate whether voclosporin, added to the standard of
      care treatment in active lupus nephritis (LN), is able to reduce disease activity over a
      treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and
      initial treatment with IV methylprednisolone, followed by a reducing course of oral
      corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They
      are required to have a diagnosis of LN according to established diagnostic criteria and
      clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the
      ability of the drug combination to reduce the level of proteinuria (as measured by Urine
      Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.
    

Intervention name(s): Voclosporin; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): calcineurin inhibitor; matching placebo capsule
Other intervention name(s): ISA247
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin
The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.
Condition: Probiotic; Gut Microbiota; Helicobacter Pylori Infection; Insulin Resistance
MeSH terms: Infections; Helicobacter Infections; Insulin Resistance
Study type: Interventional

Summary: 
      Helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including
      gastric ulcer and gastric cancer. Recent epidemiological findings have also shown that it is
      also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin
      resistance.

      The aim of this study is to investigate whether the gut microbiota and insulin resistance of
      patients with H. pylori infection are abnormal. In addition, whether drinking fermented milk
      product with probiotic reduces Helicobacter pylori, improves gut microbiota, and increases
      butyrate-producing bacteria and insulin resistance.
    


Intervention name(s): Yogurt; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Drink a bottle of 200ml yogurt every morning and evening for 8 weeks; Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The addition of BioChaperone to already marketed prandial insulin analogue accelerates the
      onset and shorten the duration of action of insulin lispro due to facilitation of the
      absorption of the insulin after subcutaneous injection.

      This trial is intented to compare the post-prandial blood glucose control of BioChaperone
      insulin lispro and Humalog® when injected after a standardized meal as well as the
      pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1
      diabetes mellitus.

      This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to
      compare the blood glucose control after ingestion of a standardized meal, with BioChaperone
      Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
    


Intervention name(s): BioChaperone insulin lispro; Humalog®
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.2 U/kg body weight injected subcutaneously; Single dose of 0.2 U/kg body weight injected subcutaneously
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Stress Reduction Training for Emotion Regulation and Well-Being
Condition: Stress Reduction
Study type: Interventional

Summary: 
      This study will examine whether stress reduction training - which a growing body of research
      indicates has manifold benefits for behavior regulation, emotion regulation, and other
      salutary outcomes of relevance to this proposal - predicts lab-based and daily life-based
      neural and behavioral outcomes indicative of reduced stress, including emotions, desires, and
      reactions to adverse events such as social conflict.
    

Detailed description: 
      This research study seeks to understand how stress reduction training influences neural
      responses (brain activation) and behavior related to stress, including emotions, desires, and
      reactions to adverse events such as social conflict. The full research project will be
      conducted over approximately 4-6 weeks, and will consist of two data collection sessions on
      the Virginia Commonwealth University (VCU) campus, one before and one after a 14-day stress
      reduction training course conducted via mobile phone (SmartPhone). The two courses entail
      instructor-facilitated stress reduction exercises previously shown to reduce stress and
      improve well-being. Participants will be randomly assigned to a mindfulness course or an
      active coping course. Both of these courses - mindfulness training (MT) and coping training
      (CT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based
      techniques to reduce stress and promote well-being, whereas CT emphasizes established emotion
      regulation techniques to reduce stress and promote well-being.

      Some study details are purposely omitted at this time to preserve scientific integrity.
    

Intervention name(s): Mindfulness Training (MT); Active Coping Training (CT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 week SmartPhone-based mindfulness training; 2 week SmartPhone-based structurally equivalent coping training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: stress; mindfulness; active coping
Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial
Condition: Occlusion of Artery
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluating the effect of ulnar artery compression while pressing on radial artery to stop
      bleeding, in maintaining radial artery potency, after cardiac catheterization through the
      radial artery. We prospectively plan to compare 3000 patients referred for cardiac
      catheterization, randomized into two groups, one group receiving radial artery compression
      for stopping bleeding, in a standard fashion following best practices, and the other group
      receiving radial artery compression using standard best practices and ulnar artery
      compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure
      to evaluate its potency, using plethysmography.
    


Intervention name(s): Ulnar artery compression
Intervention type(s): Procedure
Intervention description(s): Compression of ulnar artery for 2 hours with radial artery hemostasis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Health Effects of Commuter Cycling
Condition: Prevention
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cycling to school is effective in the
      prevention of the metabolic syndrome.
    

Detailed description: 
      Physical activity plays a crucial role in relation to prevent a clustering of risk factors.
      In adults a lower all-cause mortality has been found in those cycling to work compared to
      inactive commuters. It thus seems possible that cycling to school will entail health
      beneficial effects for children.
    

Intervention name(s): Cycling to school
Intervention type(s): Behavioral
Intervention description(s): Regular cycling to school
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: commuter cycling; fitness; metabolic syndrome; children
Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy
Condition: Major Depressive Disorder; Irritability
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a
      naturalistic setting of depressed patients with irritability.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): 2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fed Bioequivalence Study of CBZ Formulations
Condition: Bio-equivalence Study; Fed Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer
      drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with
      time due to metabolism autoinduction.

      The primary objective of this study is to estimate the bioequivalence of the new brand
      generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product
      (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective
      will be evaluation of safety issues.

      The study design will be randomized two sequences, two periods and crossover. For a power of
      not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be
      administered with food (high calories/high fat breakfast) after an overnight fast.

      Time vs. concentration curves will be built for each subject and formulation and Area Under
      Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to
      infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual
      curves.

      This parameters will be statistically processed with the WinNonlin 6.3
      Pharmacokinetics/Statistic software in order to prove bioequivalence between the study
      products.
    


Intervention name(s): Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose; Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
Intervention type(s): Drug; Drug
Intervention description(s): Carbamazepine CR Tablets 400 milligrams is given orally with 250 mL of water at room temperature.; Auration CR 400 milligrams Single Dose is given orally with 250 mL of water at room temperature.
Other intervention name(s): Carbamazepine; Carbamazepine CR; Carbamazepine CR 400 millligrams; Carbamazepine; Carbamazepine CR; Carbamazepine CR 400
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Keywords: Antiepileptic; Carbamazepine; Bio-equivalence; Fed; Crossover
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
Condition: Liver Cirrhosis; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the clinical response of the efficacy and safety of the combination
      therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free
      group in CHC patients with compensated LC.

      Additionally, this study evaluated the dosage reactivity and the pharmacokinetic
      characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC
      patients with compensated LC.
    


Intervention name(s): peginterferon alfa-2a 180μg; peginterferon alfa-2a 90μg; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 180μg（s.c.）/week for 48 weeks; 90μg(s.c.)/week for 48 weeks; 600, 800, or 1,000 mg X 2(p.o.)/day
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHC with compensated LC
Effect of Danazol on Endometrial αvβ3 Integrin Expression in Patients With Unexplained Recurrent Implantation Failure
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates the presence of a possible link between treatment with danazol and
      expression of endometrial αvβ3 integrin which might allow tailoring of danazol treatment to
      the subset of repeated IVF/ET failure that might benefit most from it.

      38 eligible ovulatory women were recruited aged 20 - 38 years with unexplained recurrent
      implantation failure (RIF). Timed suction endometrial biopsy was obtained from participants
      during the implantation window of the pretreatment cycle, followed by immunohistochemical
      staining for endometrial αvβ3 integrin expression, scored using H-score.

      Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in
      daily dosage of 400 mg for 12 weeks. Post-treatment suction endometrial biopsy was obtained
      during the implantation window following the first ovulation after danazol treatment and
      endometrial αvβ3 integrin expression was compared to the pretreatment cycle.
    


Intervention name(s): Pre-treatment endometrial biopsy; Danazol; Post-treatment endometrial biopsy
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Timed suction endometrial biopsy was obtained from participants via Wallach Endocell® 908014A endometrial cell sampler timed during the implantation window of the pretreatment cycle; followed by immunohistochemical staining using immunoperoxidase staining incorporating avidin-biotin complex (ABC) method.; Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in daily dosage of 400 mg for 12 weeks.; Post-treatment suction endometrial biopsy was obtained during the implantation window following the first ovulation after danazol treatment, timed, processed and stained as described previously.
Intervention MeSH terms: Danazol
Intervention model: Single Group Assignment
Intervention model description: 38 ovulatory patients with unexplained recurrent implantation failure were recruited. Endometrial αvβ3 integrin expression (using immunohistochemically stained endometrial biopsy) was compared before and after treatment with danazol.
Masking: None (Open Label)
Primary purpose: Treatment
Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Interventional

Summary: 
      This is a prospective, randomized study designed to evaluate the effects of different initial
      postoperative follow-up modalities. Given the nature of the study, it is not possible for
      either the surgeons or the subjects to be blinded. Patients will be assigned to either group
      based on the last digit of their medical record number (MRN). Patients with an even-ending
      medical record number will be randomized to virtual visit/telemedicine, while patients with
      an odd-ending medical record number will be randomized to the office visit.
    

Detailed description: 
      This study aims to evaluate the differences between two forms of postoperative follow-up with
      respect to patient satisfaction. The primary outcome will be patient satisfaction with their
      surgeon and with their overall experience. Following their second postoperative visit, the
      subjects will complete one electronic survey. The survey is designed to assess subject's
      overall satisfaction and satisfaction with their surgery. This survey is standardized and
      will be used by both groups.
    

Intervention name(s): virtual doctor visit; Standard care doctor's visit
Intervention type(s): Other; Other
Intervention description(s): interactive live-video feed at home through EPIC; In person visit as per standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research