bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label
      telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of
      the study is the proportion of patients achieving undetectable HBV DNA at week 52.
    


Intervention name(s): Telbivudine
Intervention type(s): Drug
Intervention description(s): 600 mg/day, oral tablets, once daily, 52 weeks
Intervention MeSH terms: Telbivudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Adult; HBV DNA suppression; Telbivudine
D Mannose for Prevention and Treatment of RUTIs
Condition: Recurrent Urinary Tract Infections; Antibiotic Prophylaxis; Antibiotic Resistance
MeSH terms: Infections; Urinary Tract Infections; Recurrence
Study type: Observational

Summary: 
      The aim of this review is to address clinical reliability, efficacy and safety of long-term
      treatment with oral D Mannose for the prevention of recurrent urinary tract infections
      (RUTIs) in females.
    

Detailed description: 
      A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English
      language reports published before December 2018 using the term "recurrent urinary tract
      infections and d mannose." We searched Medline, Embase, and the Cochrane Register of
      Controlled Trials since January 2010 to December 2018. Eligible studies did not include
      non-oral therapy, local (vaginal) treatment in women with RUTIs.

      Study eligibility criteria- We identified eligible original articles. The heterogeneity of
      the available studies, their different rationale and aim, the assumption of d mannose for
      prophylaxis or treatment of recurrent UTIs need to be taken into account.
    

Intervention name(s): systematic review
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Search strategy and selection criteria Only publications with the text and/or the abstract
        written in the English language were considered. Additional papers cited in the references
        of the search manuscripts were further examined. Articles not addressing topics of interest
        were excluded, and the full text of the remaining articles was examined. Our literature
        search identified 15 articles pertaining to the search terms (Word variations have been
        searched). Further analysis of these articles resulted in 11 clinical trials which were
        deemed relevant to our review. The retrieved studies were assessed for their relevance
        based on the title and abstracts. Finally, studies references were screened in order to
        identify eventually unknown studies.
      
Keywords: recurrent urinary tract infections; d mannose prophylaxis; antibiotic prophylaxis
Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      The first purpose was to compare the difference between leg press exercise(LPE) and
      additional hip abductor and external rotator muscle strength training to leg press
      exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and
      function for patients diagnosed with patellofemoral pain syndrome. The second one was to
      discover the relationship between the change in muscle strength performance and the
      difference of hip joint kinematics post treatment.
    


Intervention name(s): Additional Hip Muscle Strengthening to Leg Press Exercise; Leg Press Exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objectives of the study are 1) to determine the influence of daily consumption of
      well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine
      inflammatory marker changes consistent with decreased cancer risk.
    

Detailed description: 
      Consumption of Brassica vegetables is inversely associated with incidence of several cancers,
      including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and
      ovaries. Brassica vegetables are a good source of many nutrients, but the unique
      characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates.
      Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by
      an enzyme in the plant called myrosinase, which is released when the vesicles containing
      myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the
      active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely
      inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes,
      and apoptosis.

      The aim of this study is to investigate how daily consumption of broccoli with myrosinase
      inactivated by cooking influences glucosinolate metabolism and absorption, and consequent
      regulation of inflammatory markers.
    

Intervention name(s): Control Diet; Base Diet with Broccoli
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.; Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
Other intervention name(s): Base Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This project focuses on development of new strategy for the prevention of exercise-associated
      hypoglycemia using mini-dose glucagon.
    

Detailed description: 
      The primary objective of the protocol is to determine if the administration of mini-dose
      glucagon administered subcutaneously just before exercise produces better glucose stability
      than no adjustments for moderate intensity exercise in patients with Type 1 Diabetes (T1D).
      It will also be assessed whether mini-dose glucagon before exercise produces better glucose
      stability than basal insulin reductions or extra carbohydrate consumption.

      This is a randomized, 4-way crossover trial. The trial will include 16 participants who
      complete the study.

      Each participant will undergo four aerobic exercise sessions (in random order), with
      different strategies for glucose regulation:

        -  Control Trial: Fasted exercise, no basal insulin reduction

        -  Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate
           at 60 minutes before exercise, for the duration of the exercise)

        -  Strategy 2: Fasted exercise, no basal adjustment + pre-exercise glucose tabs (buccal
           route-40 grams in total )

        -  Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc)

      In all 4 sessions, aerobic exercise will be performed in the fasted state (before a
      standardized meal) for 45 minuets at ~50-55% of the participant's per-determined aerobic
      capacity. The participant's pump will be blinded during the control trial, strategy 1, and
      strategy 3 and an injection of saline will be given during the control trial and strategy 1
      so that participant is blinded to strategy.

      The primary outcome for this study will be the glycemic response during exercise and early
      recovery.
    

Intervention name(s): G-Pen Mini™ (glucagon injection); Glucose Tabs; Basal Insulin Reduction
Intervention type(s): Drug; Other; Other
Intervention description(s): Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).; Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).; Basal insulin reduction to 50% 5 minutes before the start of exercise.
Other intervention name(s): mini-dose glucagon; over-the-counter oral glucose tablets
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: T1D; Type 1 Diabetes; Mini-dose Glucagon; Adults; Exercise; Hypoglycemia
Effectiveness of Colchicine Among Patients With COVID-19 Infection
Condition: Coronavirus Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      In November 2019, there were a lot of cases of an acute respiratory illness (then named at
      February 11th as COVID_19) which first case was reported in Wuhan, China,The SARS COV-2 had
      been spread in a fast way to involve whole world, As it's obvious that Colchicine is a drug
      that is most commonly and widely used to treat and prevent acute attacks of Gout, other
      crystal induced arthropathy,colchicine has important role in inhibiting activation of NLRP3
      inflammasome these lead to decrease cytokine production , aim of study To evaluate whether
      colchicine is effective in the treatment of COVID-19 cases. And to measure the effectiveness
      of colchicine in alleviating and controlling pulmonary and extra pulmonary complications of
      COVID-19
    

Detailed description: 
      this is an open label, randomize control clinical trial ,the participant will be randomly
      assign in to two groups ( Group A and Group B), colchicine (group A) will treat with
      colchicine tablet alone or add to their Current treatment,Colchicine 0.5 mg twice daily
      (reduce to 0.5 mg/day, in patients with low body weight or develop side effects like
      gastrointestinal symptoms ),For 14 days or until symptoms subsides, while the control group
      will treat according to usual treatment guideline in COVID-19.
    

Intervention name(s): Colchicine 0.5 MG; usual care treatment
Intervention type(s): Drug; Drug
Intervention description(s): participant will be given a Colchicine regimen in a dose of 0.5mg twice daily for 14 days or until symptoms subsides,those with low body weight and develop side effect like diarrhea and vomiting dose will be reduced and supportive treatment will be given .; control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
Other intervention name(s): colcrys; colchicum; treatment
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 100 Patients will participate for eligibility and enroll in the study, an open labell randomize control clinical trial will held among patients who will infect with COVID-19 in whom they met the inclusion criteria, either treat at home with healthcare advises and follow up or at centres of COVID-19 in ERBIL city ( Rozhawa emergency hospital, Erbil international private hospital) .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: covid-19, colchicine; Erbil,Iraq
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Condition: Obesity; Schizophrenia; Schizoaffective Disorder
MeSH terms: Obesity; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to find out how effective low dose oral naltrexone is
      on reducing body weight when compared to placebo in women with schizophrenia and
      schizoaffective disorder.
    


Intervention name(s): Naltrexone 25mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Naltrexone 25mg caplets taken orally once a day for 8 weeks; Placebo caplet (inactive substance) taken orally once a day for 8 weeks
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; schizophrenia; schizoaffective disorder; weight loss
Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study
Condition: Pelvic Fracture
MeSH terms: Hip Fractures
Study type: Observational [Patient Registry]

Summary: 
      The investigators aimed to evaluate the effect of early pelvic binder use in emergency
      management of suspected pelvic trauma, compared with the conventional stepwise approach.
    

Detailed description: 
      There is currently no universal consensus on all aspects of management of pelvic injuries.

      Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the
      pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In
      theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the
      fracture site, as reduction of pelvic volume has been shown to reduce the extent of
      hemorrhage from such injuries.The application of a pelvic binder has become part of the
      emergency care of all trauma patients with suspected pelvic fractures, in both the
      pre-hospital environment and emergency department (ED). The present study aimed to assess the
      effectiveness of the early use of pelvic binders to treat patients with a suspected high risk
      of pelvic bleeding from blunt force pelvic fractures.
    

Intervention name(s): pelvic binder
Intervention type(s): Device
Intervention description(s): The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)
Other intervention name(s): Angiography for TAE
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We enrolled trauma patients with initial stabilization using a pelvic binder for suspecting
        pelvic injury. Inclusion criteria were traumatic injury requiring a trauma team and at
        least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13;
        systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and
        suspected pelvic injury. Various parameters, including gender, age, mechanism of injury,
        GCS, mortality, hospital stay, initial vital sign, revised trauma score, injury severity
        score, and outcome, were assessed and compared with historical controls.
Evaluation of Fats on Postprandial Glucose Control
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is examine the effect of different fat types on postprandial
      glucose control in patients with type 1 diabetes.

      Subjects will have several admissions and, in random order, will receive lunches with
      identical carbohydrate content but different fat content: lunch A will minimal fat content,
      lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will
      contain added cheese. Total fat content in lunches B-D will be the same. Subjects will
      receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate
      ratio) for the meals.

      The investigators hypothesize that, despite identical carbohydrate content,the lunches higher
      in saturated fat will lead to more postprandial hyperglycemia than the lunch containing
      minimal fat and the lunch high in monounsaturated fat.

      The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B,
      C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be
      greater than that of Lunch A and C.
    

Detailed description: 
      Subjects for this study will be adults with type 1 diabetes who use insulin pump in their
      diabetes self-management. Prior to admission the the clinical research center the basal rates
      and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical
      procedures.

      Subjects will be admitted to the clinical research center in mid-morning following a light
      breakfast at home. Subjects will have several admissions and, in random order, will receive
      lunches with identical carbohydrate content but different fat content: lunch A will minimal
      fat content, lunch B will contain added butter, lunch C will contain added olive oil, and
      lunch D will contain added cheese. Total fat content in lunches B-D will be the same.
      Subjects will receive identical insulin doses (calculated using the subject's usual
      insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose
      and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial
      glucose levels 3-6 hours after start of the meal will be higher following lunches B and D,
      compared to lunches A and C.
    

Intervention name(s): Different fat types
Intervention type(s): Other
Intervention description(s): Saturated, monounsaturated fats
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
Condition: Hepatitis C and HIV Coinfection
MeSH terms: Hepatitis C; Coinfection; HIV Infections
Study type: Interventional

Summary: 
      This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the
      pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based
      antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r)
      and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate.
      The study consists of three visits: a screening visit and two abbreviated 4-hour
      pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks
      after initiating SOF/LDV).
    


Intervention name(s): Blood draws for tenofovir PK, renal function
Intervention type(s): Other
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess changes in ADHD symptoms and tolerability of
      medication in children and adolescents switching from a stimulant to atomoxetine.
    


Intervention name(s): Atomoxetine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis
Condition: Diagnostic Self Evaluation
MeSH terms: Pericarditis, Tuberculous; Pericarditis
Study type: Observational

Summary: 
      A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to
      analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.
    

Detailed description: 
      A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from
      January 2015 to February 2022 in the affiliated hospital of Jiangnan university were
      retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in
      tuberculous pericarditis.
    

Intervention name(s): 18F-FDG
Intervention type(s): Diagnostic Test
Intervention description(s): 18F-FDG intravenous injection
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study.
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who
      have had a suboptimal response to an adequate course of DMT. Participants will receive
      ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg
      total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up
      to 96 weeks). Anticipated time on study treatment is 96 weeks.
    

Detailed description: 
      Participants who complete their Week 72 ocrelizumab infusion and do not experience any
      serious infusion related reaction (IRR) throughout the main study will be eligible to enroll
      in an optional, open-label, non-randomized substudy to MN30035 and receive one additional
      shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately
      100 patients from MN30035 main study.
    

Intervention name(s): Ocrelizumab; Ocrelizumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).; Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Other intervention name(s): RO4964913; RO4964913
Intervention MeSH terms: Ocrelizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment