bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Study type: Interventional

Summary: 
      This study is a non randomized non comparative study with two Siddha formulations
      Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts
      existing for longer period. But there is no scientific data is documented about these
      formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis.
      After the preliminary drug standardization the clinical study is Started at The National
      Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones
      or Changes in the number and size of the stones with 45 days drug treatment.
    

Detailed description: 
      Objectives:

      Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu
      kudineer in Urolithiasis.

      Secondary objectives

        1. To standardize the study drugs.

        2. To observe the adverse effects if any

      Methods of proposed research:

      The consists of two segments Part - A. Non- clinical studies -standardisation of the study
      drugs. Part - B. Clinical studies.

      Study drugs

        1. Sindhu Vallathy mezhugu will be prepared as per the literature Agasthiar vaidhya
           vallathy 600.

        2. Kalldaippu Kudineer will be adapted from Athmaraktchamirtham Ennum Vaidhya
           Sarasangeeragam, 1968,page 349, 2.Siddha formulary of India part-II
    

Intervention name(s): Sindhuvallathy mezhugu ( SVM); Kalladaippu Kudineer (KK) -
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation; 130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
Other intervention name(s): Sirupeelai kudineer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urolithiasis; Kalladaippu Kudineer; Siddha; Sindhuvallathy; Kidney stones
Effects of Buprenorphine and Naloxone in Opiate Addicts - 4
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the behavioral and physiological effects of
      buprenorphine and naloxone, both alone and in combination.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: opiate dependence
A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and the immunological
      effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in
      healthy adults.
    

Detailed description: 
      2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the
      L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for
      prophylaxis against HPV infection in adolescents and adults.

      This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated
      dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male
      and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16)
      subjects will be randomized to receive the active drug and 4 subjects to receive the placebo.
      At least 1 subject of each gender will be randomized to receive the placebo.

      Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two
      boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed
      until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity
      and neutralising antibodies assessment.
    

Intervention name(s): AAVLP-HPV; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 20μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection.; 0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection.
Other intervention name(s): 2AP01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV-L2
Inpatient Versus Outpatient Rehabilitation After TKA
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of inpatient and outpatient
      rehabilitation following total knee arthroplasty. No studies exist that have evaluated these
      two rehabilitation programmes in a specific orthopaedic patient population with a focus on
      motor performance. We hypothesized that patients participating in outpatient care tend to be
      physically more active than patients in the rehabilitation clinic, leading to the assumption
      that outpatient rehabilitation has superior functional outcomes compared to the inpatient
      standard-of-care therapy.
    


Intervention name(s): inpatient rehabilitation; outpatient rehabilitation
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; total knee arthroplasty
Curcumin Biomarkers
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Colorectal cancer is a major problem in the United States and other developed countries. A
      safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia.
      Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of
      years as a traditional remedy. Curcumin blocks a number of targets involved in tumor
      initiation, promotion, and progression, and is considered a promising chemopreventive agent.
      The investigators propose to enroll 40 patients after screening colonoscopy who will have
      rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators
      will use microarray analysis to identify genes that are modified by curcumin that could be
      used as biomarkers in future chemoprevention studies. The study will also evaluate
      tolerability and toxicity.
    


Intervention name(s): Curcumin C3 tablet
Intervention type(s): Drug
Intervention description(s): 4 grams Curcumin C3 tablet daily x30 days
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Curcumin; Colorectal Cancer; GWAS
Linking Self-Management and Primary Care for Diabetes 2
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This project is primarily a behavioral study. We employed a three-arm, patient-randomized
      practical effectiveness trial to evaluate the impact of two different interactive, multimedia
      self-management programs, relative to "enhanced" usual care. The two interventions will be
      (a) the revised program from our present study, based on our social-ecological theory and the
      5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but
      extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs
      will be compared to a realistic "enhanced usual care" (UC) condition that will provide health
      risk appraisal feedback, control for computer interactions, and provide standardized advice
      on behavior change, but not the hypothesized key intervention processes of goal-setting,
      barriers identification, problem-solving, or social-environmental support. Patients will be
      randomized to conditions within clinic and will participate for 1 year.

      The proposed project will test the effectiveness of a practical, automated-based intervention
      for primary care patients to facilitate dietary and physical activity practices, and
      medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity,
      medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary
      quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the
      RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and
      maintenance of the intervention programs (Specific Aim #3), and also factors related to
      program implementation, linkage to primary care, and program success with emphasis on cost,
      cost-effectiveness, and mediators and moderators of outcomes such as social-environment
      support (Aim #4).

      Primary hypotheses:

        1. That the Automated Intervention received by Automated self-management (ASM) condition
           and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the
           primary outcomes.

        2. That the ASM+ES condition will be superior to the ASM alone condition on primary
           outcomes at the 12-month follow-up.
    


Intervention name(s): CASM +; CASM
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer Assisted Self Management plus Social Support; Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: RE AIM model; Type 2 Diabetes Mellitus; Interactive voice recognition; Computer Assisted Self Management
OCT-A and Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Observational

Summary: 
      Detect changes in retinal vessel density in the superficial and deep capillary plexuses using
      OCTA in children with anisometropic amblyopia
    


Intervention name(s): Optical Coherence tomography angiography
Intervention type(s): Diagnostic Test
Intervention description(s): Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with unilateral anisometropic amblyopia without previous treatment with glasses or
        patches
Reducing Self-stigma Using Brief Video Intervention
Condition: Stigma, Social; Mental Health Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Stigma is a profound obstacle to care. Self-stigma decreases sense of self-competency, as
      well as healthcare seeking and treatment adherence and creates barriers to pursuing
      employment, independent living, and fulfilling social life. For example, people with mental
      disorders avoid, delay, or drop out of treatment due to a fear of labeling and discrimination
      or experience treatments as ineffective or disrespectful. Therefore, reducing self stigma can
      reduce self-blame, improve self-confidence and provide support for people living with mental
      illness.

      In a prior study, the investigators developed a short video intervention to reduce
      self-stigma among people with schizophrenia. The investigators would like to test the
      efficacy of this video using Prolific (a crowdsourcing platform). Specifically, the
      investigators are interested in recruiting 1,200 Prolific participants, ages 18-35, who
      mentioned in their profile while enrolling to Prolific that they have a mental health
      condition, and randomized them into watching the newly developed video to reduce self-stigma
      or participate in the non-intervention control arm. Participants will be invited to
      participate in a follow-up survey 30 days after completing the first survey.
    

Detailed description: 
      The primary objective of this study is to test the video efficacy in reducing self stigma
      among 1,200 Prolific users who mentioned in their profile while enrolling to Prolific that
      they have a mental health condition (600 in an intervention group, and 600 in a
      non-intervention control group). The study participants will be invited to participate in a
      30-day follow up questionnaire. The investigators hypothesize finding a reduced level of
      self-stigma among those who watch the intervention video.
    

Intervention name(s): video
Intervention type(s): Behavioral
Intervention description(s): A brief (119 seconds) social contact-based video. The video presented a young Black man in his early twenties, a professional actor, sharing his scripted personal story of struggles with psychotic illness and raising themes of recovery and hope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"
Condition: Adhesion; Thyroidectomy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      One of most important complication of thyroid surgery is adhesion. There are many
      anti-adhesive materials, but none of them showed significant outcomes. The investigators
      planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to
      reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients
      (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
    


Intervention name(s): MEDICLORE
Intervention type(s): Combination Product
Intervention description(s): use MEDICLORE at the end of surgery as antiadhesive product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      To determine the effect of power walking on quality of life in Post CABG population
      undergoing phase 2 cardiac rehabilitation
    


Intervention name(s): Power Walking; Standardized Outpatient Cardiac Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): For 1- 2 Week 60% of the target heart rate with 5,000 to 7,500 steps/day Total 30 min Session The exercise intensity was set at 60% of the target heart rate during the first 2 weeks.
For 3- 4 week 70 % of the target heart rate with 7,500 to 10,000 steps/day Total 30 min Session B) Progressive increase walk according to 6MWD as improved Low intensity; For 1- 2 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 60 % of of target heart rate, resistive ex with 1- 3 kg of weight for 20 min and 10 min of cool down)
For 3 - 4 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 70 % of target heart rate, resistive ex with 2- 3 kg of weight for 20 min and 10 min of cool down)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study
Condition: Endoscopy; Moderate Sedation
Study type: Interventional

Summary: 
      The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However,
      the optimal sequence of performing a same-day BDE has not been well-established.The primary
      aims of this study are to compare the sedative doses and patient discomfort between the study
      groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed
      by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess
      colonoscopy performance, including the cecal intubation time and adenoma detection rate
      between the two endoscopic sequences.
    


Intervention name(s): EGD and colonoscopy
Intervention type(s): Procedure
Intervention description(s): Cold forceps biopsy, cold snare polypectomy, and/or hot snare polypectomy will be performed for stomach and/or colon polyps during EGD and colonoscopy examinations will be performed whenever indicated.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART
Condition: HIV
MeSH terms: Pneumonia; Pneumonia, Pneumocystis
Study type: Observational

Summary: 
      From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been
      distinguished as one of the most frequent opportunistic diseases with high morbid-mortality.
      As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the
      characteristics of such epidemic by reducing its related diseases and, as a result,
      AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference,
      376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.
    

Detailed description: 
      From the beginning of the AIDS epidemic, pneumocystis pneumonia (PCP) has been distinguished
      as one of the most frequent opportunistic diseases with high morbid-mortality. As from 1996,
      the advent of the highly active antiretroviral therapy (HAART) has changed the
      characteristics of such epidemic by reducing its related diseases and, as a result,
      AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference,
      376 HIV-infected or AIDS patients were studied from January 1992 to December 2002. Among
      them, 58 (15.5%) PCP cases were found. There was a higher occurrence of PCP in the group of
      patients in which HAART was not used, with 40 (69.0%) of the episodes. As regards the studied
      period, a tendency to a linear reduction in annual PCP incidence was observed. The mean of T
      CD4+ lymphocytes in the patients with PCP (117 cells/mm3) was significantly lower when
      compared to that of the other individuals (325 cells/mm3). Therefore, this study suggests a
      temporal reduction in PCP occurrence related to HAART use with higher T CD4+ lymphocyte
      counts. Nevertheless, this opportunistic infection still shows significant incidence in AIDS
      patients.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        376 HIV-infected or AIDS patients were studied from January 1992 to December 2002
      
Keywords: Pneumocystis Pneumonia; Acquired Immune Deficiency Syndrome; Highly Active Antiretroviral Therapy; Treatment Experienced; Treatment Naive
Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Recurrence; Hernia
Study type: Observational

Summary: 
      There are currently no standard criteria for evaluating the risk of recurrent disk herniation
      following surgical repair. This study investigated the predictive values of five presurgical
      imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified
      Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.

      Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months
      post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short
      Form 36 (SF36).
    


Intervention name(s): magnetic resonance imaging
Intervention type(s): Device
Intervention description(s): Preoperative magnetic resonance imaging
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        18-75 male and female single-level lumbar disk herniation
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
Condition: Extranodal NK-T-Cell Lymphoma, Nasal Type
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide,
      pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell
      transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell
      lymphoma, nasal type.
    

Detailed description: 
      Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of
      non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based
      chemotherapy improved overall response and prolonged the long-term survival for patients with
      stage IV. But the optimal treatment schedule has not been established. This study is designed
      with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly
      onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the
      treatment of will be measured.
    

Intervention name(s): MEDA; Auto-HSCT
Intervention type(s): Drug; Procedure
Intervention description(s): Methotrexate, 3.0g/m2/d iv, day 1
Etoposide, 100mg/m2 iv, day 2 to day 4
Dexamethasone, 40mg/d iv, day 1 to day 4
Pegaspargase, 2500IU/m2/d im, day 4
The MEDA chemotherapy will be repeated every 3 weeks.; Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
Other intervention name(s): Methotrexate, Etoposide,Dexamethasone,Pegaspargase
Intervention MeSH terms: Dexamethasone; Methotrexate; Etoposide; Pegaspargase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment