bioihbjkbjnl/mcl2 huggingface dataset:
Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)
Condition: Carcinoma, Hepatocellular
MeSH terms: Hepatitis C; Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no
      treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis
      and initial signs of portal hypertension who did not respond to previous combined therapy
      with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa
      monotherapy and with a high proliferation rate before entering the study. The duration of
      treatment will be 3 years, and the follow-up period will be 2 years.
    


Intervention name(s): Peginterferon alfa-2b; Observation (no treatment)
Intervention type(s): Biological; Other
Intervention description(s): Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years.; No treatment was given to participants enrolled in the control arm (Arm B).
Other intervention name(s): PegIntron; Pegylated Alfa-2b; SCH 054031
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the drug interaction potential and time course of the
      effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.
    


Intervention name(s): Single-Dose IV Oritavancin Diphosphate and Warfarin; Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
Intervention type(s): Drug; Drug
Intervention description(s): Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.; Oritavancin will be administered as a single IV infusion and 24 hours post dose subjects will receive 25mg of Warfarin. The infusion will last approximately 3 hours.
Other intervention name(s): Oritavancin Diphosphate; Oritavancin Diphosphate
Intervention MeSH terms: Oritavancin; Warfarin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
Condition: Primary Immunodeficiency Diseases (PID)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to acquire additional data on efficacy, safety, tolerability,
      immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to
      <16 years) participants with primary immunodeficiency disease (PIDD).
    


Intervention name(s): HYQVIA
Intervention type(s): Biological
Intervention description(s): Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)
Other intervention name(s): IGI 10% with rHuPH20
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes
Condition: At Risk of Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Open-label, randomised, placebo-controlled, crossover study with two intervention arms. The
      study was conducted in 30 respondents and the primary objective is to show an improved
      glycemic response after Melon Manis Terengganu (MMT) peel powder consumption in people at
      risk of type 2 diabetes.
    

Detailed description: 
      The main aim of the study is to investigate the acute effect of MMT peel powder on glycemic
      response in people at risk of type 2 diabetes. Besides, the acute effect of MMT peel powder
      on perceived satiety and energy intake were explored.
    

Intervention name(s): Formulation 3; Control
Intervention type(s): Other; Other
Intervention description(s): Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast; Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
Other intervention name(s): Formulated MMT peel powder; Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The respondents consumed Formulation 3 (A) and control (B) with study breakfast based on randomly assigned treatment sequences (AB, BA). Each visit was separated with three days washout period and lasted about 3 hour (starting around 8 am and finishing at approximately 11 am).
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Melon Manis Terengganu peel; Glycemic response; Perceived satiety; Food intake; At risk of type 2 diabetes
Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
Condition: Diabetes
Study type: Observational

Summary: 
      PURPOSE

      The goal of the present project is to unravel the importance of bile acid-induced GLP-1
      secretion (via the G protein-coupled receptor TGR5) in human physiology.

      In the present study the investigators examine the GLP-1 secretion in healthy subjects and in
      Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with
      T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and,
      consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1
      responses (primary endpoint).
    


Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects and type 2 diabetes patients (T2DM)
      
Biospecimen description: 
      blood samples
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
Condition: Influenza; HIV Infections
MeSH terms: Influenza, Human; HIV Infections
Study type: Observational

Summary: 
      The purpose of this research is to determine the effectiveness of the novel H1Nl influenza
      (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons.
      The administration of the H1Nl vaccination is not part of the study's procedures, but is
      being given as part of routine care.
    

Detailed description: 
      The investigators study is being conducted to evaluate and compare the seroresponses of the
      novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1
      vaccination as part of routine clinical care, with secondary objectives examining the impact
      of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination,
      determining potential reactions (local or systemic) to this new vaccine among patients, and
      assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1
      vaccination among HIV patients. Finally, the investigators will collect data on
      influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and
      influenza isolates causing ILI events will be genetically characterized.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and females of all races and all military beneficiaries including active duty
        enlisted and officers (from all branches of service), retirees, and their dependents
        presenting for H1N1 vaccination as part of routine clinical care will be eligible for
        participation. Both HIV-positive and negative persons can participate. Since most of our
        HIV patients are 18-50 years of age, and seroresponse varies by age, we will enroll persons
        between the ages of 18-50 years.
      
Biospecimen description: 
      Blood samples will be collected for immunologic studies including antibody titers and
      cellular responses. Viral isolates will be obtained and characterized among ILI cases during
      study participation. Blood for CD4/HIV RNA levels will also be obtained among HIV patients to
      determine the impact of the vaccine on these counts.
    
Keywords: HIV; H1N1; Influenza; Vaccination; Seroresponse; Immunogenicity; Vaccine
Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise
      programme improving quality of life of subjects with Fibromyalgia.
    

Detailed description: 
      Objective:

      This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong
      exercise programme for the improvement of the quality of life of subjects with Fibromyalgia.

      Design:

      A single-blind randomized clinical controlled trial.

      Setting:

      University of Extremadura, Spain

      Subjects:

      Women with Fibromyalgia

      Interventions:

      141 Participants were randomized to a Qigong exercise program group (n=47), a physiotherapy
      treatment group (n=47) and control group (n=47) for 6 weeks.

      Main Measures:

      Measures were taken at baseline (week 0), pre intervention (week 1) and post intervention
      (week 6). The primary outcome measure were quality of life (Spanish Fibromyalgia Impact
      Questionnaire (SFIQ), pain (VAS), perceive exertion (Borg scale), spirometry measures
      (Spirobank-G MIR spirometry) and balance (Wii-Fit, Nintendo ©). The secondary outcome
      measures were flexibility (Wells and Dillon test and Sit and Reach test), Range of movement
      (goniometer), muscle strength (Lowett scale).
    

Intervention name(s): Qigong group; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Traditional Chinese Medicine exercise programme; Physiotherapy exercise programme
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Physiotherapy; Qigong; Quality of life
Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant
      chemotherapy with capecitabine during the resting periods in patients with locally advanced
      rectal cancer.
    

Detailed description: 
      Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients
      with locally advanced rectal cancer (LARC) because of increased local control, enhanced
      sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced
      local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of
      distant metastasis was still reported as high as 30%.

      Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival
      benefit. We inferred that additional chemotherapy during the resting period could enhance the
      pCR rate. The aim of the present study is to evaluate the safety and efficacy of an
      additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in
      patients with LARC.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients of our hospital
      
Keywords: rectal cancer; neoadjuvant chemoradiotherapy; Capecitabine
Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)
Condition: Anemia; Transfusion
MeSH terms: Anemia
Study type: Interventional

Summary: 
      The object of this study is to evaluate whether low dose intravenous iron and erythropoietin
      (Epo) can decrease transfusion requirement after the bilateral TKRA.
    

Detailed description: 
      Total knee replacement arthroplasty (TKRA) in severe osteoarthritis usually requires
      extensive soft tissue and bone dissection associated with substantial bleeding. Because TKRA
      is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial,
      however, over 80% of the total blood loss occurs within the first 24 hour after the operation
      and the hidden blood loss is 50% of the total loss, making the true blood loss twice.
      Consequently, many patients can become anemic at early postoperative period and this anemic
      condition may lead to overall physical deterioration which include fatigue, dizziness,
      reduced exercise tolerance and delayed recovery.

      Therefore, many patients frequently received the autologous or allogenic blood transfusion.
      In order to reduce the allogenic blood transfusion (ABT), various methods have been used,
      such as preoperative autologous blood donation (PABD), use of pharmacologic agents, iron or
      erythropoietin (Epo) and postoperative blood salvage. All of the above methods have been
      proved to reduce the ABT effectively6, without increase in cost.

      Iron and Epo have been used widely in a variety of clinical situations instead of allogenic
      RBC transfusion. They also have been used for augmenting PABD or improving preoperative
      hemoglobin (Hb) level. However, there still remains a controversy about the efficacy of the
      method on the postoperative anemia. We think that these various results may be related with
      individual iron state of the patients and dose of drug or timing of drug application.

      In this trial, iron and Epo are planned to be administered to the iron deficient non anemic
      patients during the operation and once again after surgery.
    

Intervention name(s): iron sucrose, erythropoietin-β; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.; 100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
Other intervention name(s): Venoferrum; recormon; sodium chloride
Intervention MeSH terms: Epoetin Alfa; Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: iron; erythropoietin; hemoglobin; Total knee replacement arthroplasty
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain
Condition: Chronic Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This clinical pilot trial will investigate the effects of technology-supported exercise
      therapy for chronic non-specific low back pain. Patients will follow an intensive
      rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that
      is supported by technology. The technological system consists out of motion tracking sensors
      that register the movements and position of the lumbar spine.
    


Intervention name(s): intensive rehabilitation program
Intervention type(s): Other
Intervention description(s): Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. The technological system consists out of motion tracking sensors that register the movements and position of the lumbar spine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This study tests the reliability of thermodilution cardiac output measurements with pulmonary
      artery catheters in immediate connection with heart surgery. In accordance with our clinical
      practice, thermal indicator injections are synchronized with respiration. The impact on
      measurement repeatability of spontaneous vs artificial ventilation and the effect of the
      injectate temperature is tested.

      The study hypothesis is that when injections are synchronized with the respiration, only
      three injections at room temperature are needed to be within 5 % of the "true" cardiac output
      in mechanically ventilated patients.
    

Detailed description: 
      Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have
      been a mainstay of monitoring critically ill patients for more than thirty years. Recent
      studies have questioned wether the traditional practice of averaging measurements from tree
      room temperature thermal indicator injections give sufficient precision.

      This study tests the number of indicator injections necessary to be within 5 % of the "true"
      cardiac output (taken as the average of 16 injections) when the injection is synchronized
      with the respiration. The reliability of the thermodilution measurements are tested A) in
      sedated, artificially ventilated cardiac surgical patients and B) in the same patients when
      postoperatively awake and spontaneously breathing. We further compare the use of room
      temperature and iced thermal indicator injections.

      The study hypothesis is that when injections are synchronized with the respiration, only
      three injections at room temperature are needed to achieve the desired precision in
      mechanically ventilated patients.

      Only patients receiving a pulmonary artery catheter according our institution standard
      procedure of care will be included.
    

Intervention name(s): Pulmonary artery catheter
Intervention type(s): Device
Intervention description(s): Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.
Other intervention name(s): Baxter
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elective patients for cardiac surgery
      
Keywords: Cardiac output; Thermodilution
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Condition: Hypoxia-Induced Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of
      the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects
      exposed to high altitude and is correlated to pulmonary artery pressure.

      The aim of the study is to investigate whether blockade of ET1 receptors would reduce the
      acute rise in systolic pulmonary artery pressure induced by hypoxia.
    

Detailed description: 
      Patients will be examined on a variable load supine bicycle ergometer. The exercise table
      will be tilted laterally by 20 to 30 degrees to the left. PASP will be assessed using Doppler
      echocardiography at rest and during during supine bicycle exercise in NORMOXIA and hypoxia.
      Exposure to normobaric hypoxia will be performed by breathing a hypoxic gas mixture at sea
      level during 90 minutes (12,3 % O2 + 87.7 % N2) reproducing conditions at 4300 m altitude.
      Exercise will be started at an initial workload of 40 watts and increased by 10 watts every
      minute to reach a workload level defined by a heart rate (HR) corresponding to 50% of the
      estimated maximal aerobic power
    

Intervention name(s): Bosentan; Bosentam TRACLEER
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo; Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
Other intervention name(s): TRACLEER
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypoxia-induced pulmonary artery hypertension; High-altitude pulmonary oedema; ETA receptor antagonist
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes results when the body does not produce enough insulin and/or is unable to
      properly use the insulin it makes (insulin resistance). This study was undertaken to assess
      the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.
    


Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vildagliptin; Type 2 diabetes; Insulin sensitivity; Insulin action
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
Condition: Sleep Disorders; Obstructive Sleep Apnea; Major Depressive Disorder; Dysthymic Disorder
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Sleepiness; Depressive Disorder; Depression; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate whether armodafinil at a target dosage of
      200 mg/day is more effective than placebo treatment in improving excessive sleepiness in
      patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major
      depressive disorder or dysthymic disorder.
    


Intervention name(s): armodafinil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg/day; placebo
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea/Hypopnea Syndrome; Excessive Sleepiness
Bupropion Treatment for Youth Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion
      SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in
      adolescents and 2) to examine which factors, such as medication adherence, nicotine
      dependence, and motivation to quit, affect treatment outcome.
    


Intervention name(s): bupropion SR
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment