bioihbjkbjnl/mcl2 huggingface dataset:
Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess whether patients with recurrent hepatitis C after liver
      transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment
      for 48 weeks.
    

Detailed description: 
      The aim of the study is to assess whether patients fulfilling the criteria as defined in
      section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This
      study will be open to all patients with histologically documented hepatitis C recurring after
      LT, provided that all inclusion and exclusion criteria, as defined below, are met, and
      irrespectively of the pattern of response to a previous antiviral treatment (if any).

      The benefit will be assessed in terms of biochemical (normalization of serum transaminases
      levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of
      the histological signs of hepatitis) response. The presence of a sustained virological
      response, as defined below in section 6, will also be studied in relation to the early
      kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C
      patients, which suggest that an early rapid decrease of HCV viremia is associated with a
      durable response.
    

Intervention name(s): Ribavirin; Pegylated interferon alpha2a
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Presence of HCV RNA in serum; Absence of graft rejection; Recurrent hepatitis C after liver transplantation
Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open-label multi-center to evaluate the tolerability of treatment with
      NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an
      open-label study. No hypothesis testing will be performed.

      Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate
      for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to
      a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for
      60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on
      chronic pain medication regimens, but currently will not be using any topical pain
      medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol,
      methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or
      capsaicin.
    


Intervention name(s): capsaicin 8%; Lidocaine (2.5%)/Prilocaine (2.5%) Cream
Intervention type(s): Drug; Drug
Intervention description(s): High concentration capsaicin 8% dermal patch applied for one hour; Pre-treatment for NGX-4010
Intervention MeSH terms: Lidocaine; Prilocaine; Capsaicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability study
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral
      administered to healthy subjects.
    

Detailed description: 
      A Phase 1 Single Dose Study to investigate the safety, tolerability and Pharmacokinetic
      profile of SNP-630 in Health Subjects To evaluate the safety, tolerability and
      Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.

      This is a phase 1, open-label, single-dose study to assess its safety, tolerability and
      pharmacokinetic profile of SNP-630 in 14 health volunteers. Subjects will receive oral
      SNP-630 at a dose of 720 mg to assess its safety, tolerability and pharmacokinetic profile.

      After written informed consent has been obtained, all screening procedures and tests that
      establish study eligibility will be performed within 28 days prior to day -1 visit.

      The primary endpoint is to assess the following variable:

      Clinical safety observations will include Adverse Events (AEs), vital sign measurements,
      12-lead ECG and clinical laboratory assessments. Safety data will be tabulated and where
      appropriate, analyzed by the use of descriptive statistics. Safety data will be tabulated by
      system organ class and preferred term and will be further classified by relationship to
      treatment. The probability of safety events will be estimated and with associated 95%
      corresponding confidence intervals for each cohort using the binomial distribution.

      Participants are free to withdraw from participation in the study at any time upon request
    

Intervention name(s): SNP-630
Intervention type(s): Drug
Intervention description(s): Subjects will receive one single dose of SNP-630 at Day 1. Blood and urine samples will be obtained to determine the PK of orally administered SNP-630.
Intervention model: Single Group Assignment
Intervention model description: SNP-630
Masking: None (Open Label)
Primary purpose: Treatment
GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria
Condition: GDM Screening During COVID Pandemic; Comparison Between IADPSG vs WHO '99 Criteria
Study type: Observational

Summary: 
      All pregnant women who performed an OGTT following Italian Guidelines and then delivered at
      our University Hospital from march 2020 to march 2021 were prospectively enrolled in this
      study. Primary outcome of the study was the number of women to whom was diagnosed GDM with
      only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies
      recommendations for COVID 19 pandemic period. In the same time, we prospectively collected
      the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value
      ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From
      the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35
      years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical
      outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth
      restriction and Caesarean section in emergency.

      These data will be compared between the 2 groups consisting in those diagnosed with only
      IADPSG criteria versus those diagnosed with only WHO '99 criteria.
    


Intervention name(s): GDM screening criteria
Intervention type(s): Procedure
Intervention description(s): difference in risk factors and clinical outcomes between groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women who in a 12-month period perform GDM screening and then deliver at our
        University Hospital
Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      The purpose of this pilot study is to compare the dynamic response of microcirculation in the
      skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic
      subjects with a history of foot ulcer and 25 age-matched healthy controls to better
      understand the role of local hypoxia in neuropathic foot ulceration in subjects with
      diabetes.

      The investigators hypothesize that if they apply a gait simulating load to the plantar foot
      and measure microvascular function, diabetic individuals will demonstrate an increased delay
      in reestablishing microvascular flow compared to healthy individuals.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A community sample
      
Keywords: laser doppler anemometry; dynamic testing of tissue mechanical property; diabetic foot complications; ulcer genesis
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, non-randomized, open-label, two-part study to investigate the effect
      of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male
      and female participants with stable mild, moderate or severe renal impairment and a control
      group of participants with normal renal function. Part 2 will be conducted in adult male and
      female participants with stable end-stage renal disease undergoing hemodialysis.
    


Intervention name(s): RO7079901
Intervention type(s): Drug
Intervention description(s): Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Tapentadol in Post-Bunionectomy Pain
Condition: Bunion; Pain
MeSH terms: Bunion
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to established the safety and efficacy of multiple dose
      treatment with tapentadol IV in an adult population with moderate to severe pain following
      bunionectomy.
    


Intervention name(s): Tapentadol; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg per administration, maximum 12 administrations over 48 hours; Maximum 12 administrations over 48 hours
Other intervention name(s): Palexia, Nucynta
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bunionectomy; Postsurgical Pain; Acute Pain
Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
Condition: Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The aim of the study is to investigate the efficacy of connective tissue massage and lumbar
      stabilization exercise treatment on pain severity, functional capacity and quality of life in
      those who have experienced peripheral neuropathy
    

Detailed description: 
      The patients diagnosed with fine fiber neuropathy by the neurology department of hacettepe
      university will be included and the patients referred to physical therapy will be included.

      Patients meeting the inclusion criteria will be randomly divided into 3 groups by simple
      randomization. The first group consisted of lumbal stabilization exercises, the second group
      with connective tissue massage and the third group with only medical treatment. All patients
      will be evaluated 2 times before and after 6 weeks. The treatment will be 2 days per week for
      6 weeks. Exercise programs of the patients will be performed under the supervision of
      physiotherapist. In the first group, lumbal stabilization exercises will be applied for 6
      weeks and the second group will be given connective tissue massage.

      Statistical analysis of the study will be done using SPSS 21 statistical program.

      In the statistical analysis to be carried out within the scope of the study, p value will be
      selected as 0.05 and p <0.05 will be considered significant. Mean ± standard deviation,
      number, percentage, minimum and maximum values will be used as descriptive statistics.
      Wilcoxon test is used to compare the pre- and post-treatment values of the groups in the
      variables and the Kruskal-Wallis test will be used to compare the groups with each other.
    

Intervention name(s): Physical therapy and rehabilitation
Intervention type(s): Other
Intervention description(s): Physical therapy and rehabilitation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
Condition: Metabolic Disease; Obesity; Exercise
MeSH terms: Obesity; Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of acute beetroot juice supplementation on
      exercise performance and cardiometabolic health in obese individuals with secondary
      cardiometabolic complications. Additionally, we will determine if the ergogenic health
      benefits of beetroot juice is due to the nitric oxide compound within the product, the
      antioxidant compound within the product, or a combination of the two compounds.
    


Intervention name(s): Sodium Nitrate; Beetroot Juice no Nitrate; Beetroot Juice
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm; 70ml Concentrated Beetroot Juice with nitrate removed; 70ml Concentrated Beetroot Juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)
Condition: Alcohol Dependence; Drug Dependence
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test an HIV prevention intervention in a Russian substance
      abuse treatment facility using a randomized trial study design.
    

Detailed description: 
      A randomized controlled trial of an HIV prevention intervention in a narcology hospital using
      a stratified randomization design (by gender and substance use diagnosis) will be
      implemented.

      We will conduct a trial among 180 inpatient subjects undergoing treatment at the LRCA. This
      adapted HIV prevention intervention (adapted Enhanced-RESPECT), Project RESPECT, is a
      2-session, one-on-one HIV prevention counseling and testing activity with a trained health
      educator. By random assignment, half of the subjects will receive the Enhanced-RESPECT
      intervention, which will include 3 additional booster sessions. And half will receive CDC
      post-test counseling or standard of care depending on the results of their HIV antibody test.
      The post-test counseling will follow CDC counseling and testing guidelines. Subjects in the
      Control group who are not HIV-infected will receive the current standard of care in Russia
      for non-infected patients; receipt of negative test results by a clinician. HIV pre-test
      counseling occurs within the first 48 hours of patient arrival at LRCA. CDC post-test
      counseling guidelines represent a higher standard of care than currently exists within this
      facility for HIV-infected patients and is equivalent to the standard of care recommended for
      US HIV testing facilities.

      All study participants will be evaluated regarding substance abuse and HIV risk behaviors at
      baseline and follow-up. Follow up interviews will take place at 3 time points (just before
      discharge from the hospital and at 3 and 6 months post-randomization). All Intervention
      participants will receive the basic 2-session adapted RESPECT intervention while inpatients;
      booster sessions for adapted Enhanced-RESPECT HIV Intervention participants will take place
      after discharge. Booster sessions will be offered once a month for 3 months.
    

Intervention name(s): Adapted Enhanced-RESPECT (HIV prevention intervention)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Russia; Prevention; Behavioral intervention; Alcohol dependence
Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether the addition of a nicotine patch to varenicline
      increases smoking cessation success rate and whether the combination is safe.
    

Detailed description: 
      This is a phase-II multicenter study involving 438 smokers, to be conducted at 7 sites in
      South Africa, over 6 months. In a randomized 1:1 allocation varenicline tartrate 1 mg twice
      daily, given in an incremental dosage for the first week before target quit date (TQD), will
      be compared to varenicline tartrate in the same dose combined with a 15mg nicotine patch. The
      nicotine patch (active and placebo) will be provided by McNeil. The patch will be given 2
      weeks prior TQD. Treatment duration from TQD is 12 weeks with varenicline being tapered off
      during week 13.

      A total of 12 clinic visits and 1 telephonic contact is planned for the 6-month study
      duration. The main efficacy outcome will be the 4-week continuous abstinence rate during the
      last four weeks of treatment, i.e. weeks 9 - 12. Efficacy assessments will be based on a
      Nicotine Use Inventory and measurements of end-expiratory exhaled carbon monoxide. Safety
      assessments will be based on adverse events evaluation, with special attention being given to
      the occurrence of nausea during the pretreatment period, as well as neuro-psychiatric
      symptoms such as depression or suicidal ideation. Participants will not be subjected to any
      invasive procedures.

      This protocol is based on current evidence and two further abstracts presented at the
      European Respiratory Society Conference in Vienna, September 2009, that a combination of
      varenicline tartrate and nicotine replacement therapy indicate superior efficacy in cessation
      rate, but also an excellent good safety profile.

      This study relates to the area of pharmacotherapy of smoking cessation, and will answer a
      frequently asked question. Importantly, several leading pulmonologists with experience in
      smoking cessation in South Africa have expressed their keen interest to participate in this
      study.
    

Intervention name(s): Varenicline, Nicotine Patch; Varenicline and Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): active nicotine patches added to varenicline.; placebo nicotine patches added to varenicline.
Other intervention name(s): Champix; Nicorette
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; Smoking cessation; Pharmaceutical aids
Target Volume in Noninvasive Positive Pressure Ventilation
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive
      positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of
      automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a
      pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to
      achieve these ideal targets are different among different commercialized devices and the
      relative efficacy from an algorithm compared to another remains unknown. The main objective
      is this study is to compare two commercialized NIPPV that have this option
    

Detailed description: 
      RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
    

Intervention name(s): IVAPS; AVAPS
Intervention type(s): Device; Device
Intervention description(s): IVAPS mode (RESMED Stelar 150) during 1 night; AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Noninvasive ventilation; Obesity Hypoventilation Syndrome
BN Brachyury and Radiation in Chordoma
Condition: Chordoma
MeSH terms: Chordoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine if the combination of BN-Brachyury plus radiation
      therapy can induce objective radiographic response rate (ORR) in patients, using a Simon
      2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed
      to stage 2.
    


Intervention name(s): BN-Brachyury plus radiation
Intervention type(s): Biological
Intervention description(s): MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC With Major Portal Vein Tumor Thrombosis
Condition: HepatoCellular Carcinoma; Portal Vein Thrombosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib
      is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),
      but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not
      benefit much from sorafenib in previous studies. There is no established standard treatment
      for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to
      investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy
      (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with
      Major Portal Vein Tumor Thrombosis.
    


Intervention name(s): HAIC; Sorafenib
Intervention type(s): Procedure; Drug
Intervention description(s): Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.; 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Portal vein tumor thrombosis; Hepatic arterial infusion chemotherapy; Sorafenib