bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Septal Versus Apical Pacing- a Comparative Study Using Cardiac MRI
Condition: Ventricular Dysfunction; Ventricular Remodelling
MeSH terms: Ventricular Dysfunction; Ventricular Remodeling
Study type: Interventional

Summary: 
      Despite considerable effort the optimal site to place a pacemaker lead at the time of
      pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at
      the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated
      with an increase in heart rhythm problems and also heart failure (impaired pumping function).
      The top of the ventricle (septum) has been investigated as an alternative site and is now
      routinely used by some centres. Previous estimation of the hearts pumping function (ejection
      fraction) has been limited to the use of echo (sound waves). Echo is not sensitive enough to
      detect small changes in the ejection fraction reliably (measure of pumping function of
      heart). The gold standard for measurement of ejection fraction is MRI (using magnets).
      Previous pacemakers have not been compatible with MRI scans. The latest generation of
      pacemakers are now able to be safely scanned within an MRI scanner. This allows a much more
      accurate estimation of the effects of a pacemaker on the ejection fraction which has not yet
      been studied.

      The investigators plan to study those patients undergoing a pacemaker implant and ablation
      procedure as part of their standard care.

      Individuals will have an exercise test, blood test used to measure biomarkers and fill in a
      symptom questionnaire.

      Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will
      be inserted, one apically and one septally. Only one lead will be used at any given time.
      Individuals will then undergo their planned AV node ablation.

      Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9 and
      18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart
      muscle strain, exercise testing and echocardiograms.

      The hypothesis is that a lead placed on the septum will produce superior cardiac performance
      over the short and long term.
    


Intervention name(s): Apical pacing; Septal pacing; Pacemaker
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Pacemaker set to pace at right ventricular apex initially.; Pacemaker set to pace at right ventricular septum initially.; MR conditional Pacemaker implanted in all study patients
Other intervention name(s): MR conditional Pacemaker
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Ventricular dysfunction; MRI; Echocardiography; Pacemakers
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Condition: NASH
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to characterize the pharmacokinetics as well as safety and tolerability of a
      single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to
      matched healthy subjects.
    


Intervention name(s): EDP 305
Intervention type(s): Drug
Intervention description(s): Each subject will receive a single dose of EDP 305 on Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment
Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave
Condition: Common Mental Disorders and/or Stress Related Symptoms
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Purpose

      Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden,
      resulting in suffering for the individual and financial costs for the employer as well as for
      society at large. Studies on interventions that address stress and mental ill-health and that
      focus on sick leave and return to work (RTW) show little or no effect of commonly used
      methods such as medication or psychological approaches. Furthermore, these interventions
      often focus on the individual's symptoms without considering their work situation. The
      occupational health services (OHS) has knowledge of the employee's work environment and can
      offer treatment facilitating the employee's RTW and improving the employee's work ability
      while taking into account both the individual and the work situation. The intervention in the
      current study will be performed at the OHS.

      The study aim is two-fold: first, an intervention that addresses both individual and
      workplace related aspects among employees with work-related CMD:s and/or stress related
      symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on
      sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence
      to the intended treatment and associations with the outcome of the intervention will be
      assessed.
    


Intervention name(s): Problem-solving based intervention; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.; Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sick-leave; Return to work; Occupational health; Common mental disorder; Depression; Anxiety disorders; Adjustment disorders; Problem solving therapy; Occupational Health Services; Randomized controlled trial; Intervention studies; Occupational stress
Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and
      survival period. by performing a phase I/II study of this combination in patients with
      inoperable or with postoperative gastric cancer
    

Detailed description: 
      A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with
      histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this
      regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival
      rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
    

Intervention name(s): irinotecan; S-1
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irinotecan,; S-1,; Phase I/II,; gastric cancer
Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a
      well-controlled feeding trials. Current study have been determined the effects of daily
      walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic
      individuals.
    

Detailed description: 
      In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly
      divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All
      subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The
      walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In
      order to follow nutritional status of subjects, they were visited every 15 days (in total 4
      times). Anthropometric measurements of the subjects were taken and were monitored at each
      visit during the study. Blood samples were measured at the beginning and again at the end of
      the study.
    

Intervention name(s): Walnut-enriched Group
Intervention type(s): Dietary Supplement
Intervention description(s): All subjects supplemented with 40 g/day of walnuts for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Serum lipids; Hyperlipidemia; Walnut
Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study
Condition: Growth Hormone Deficiency
Study type: Observational

Summary: 
      The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid
      retention; this effect is dose dependent and temporary. The symptoms are swelling of soft
      tissue and joint stiffness. The objective of this study is to create bioelectric
      impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of
      healthy persons of both genders in the age 20-70 years.
    

Detailed description: 
      The treatment of Growth Hormone deficiency (GHD) patients with GH, has since 1994 been
      approved in several countries. The approval is based on studies that show positive effect on
      body composition, physiology, lipid profile, bone density and life quality. One often
      observed side effect is fluid retention; this effect is dose dependent and temporary. The
      symptoms are swelling of soft tissue and joint stiffness.

      By comparing the body bioelectric impedance (BIA) with an Arm Muscle Area (AMA) measurement,
      it is possible to determine the hydrations status of a person. This measurement is a simple
      and non invasive method to evaluate the GH dosages applied in the treatment of GHD persons.

      The objective of this study is to create BIA/AMA reference data of healthy persons of both
      genders in the age 20-70 years.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subjects are healthy persons in the age 20-70 years, both males and females will be
        recruited from the city Aarhus in Denmark.
      
Biospecimen description: 
      Blood sample to measure "Insulin like growth factor-1" (IGF-1)
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open-label, single-dose, parallel-group study which will
      enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use
      disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential
      (Inpatient) and Non-Residential (Outpatient) Period.
    


Intervention name(s): RBP-6000; SUBOXONE Sublingual Film
Intervention type(s): Drug; Drug
Intervention description(s): RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.; Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.
Other intervention name(s): buprenorphine; buprenorphine HCl and naloxone HCl dihydrate
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buprenorphine; opioid use disorder
Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
Condition: Metabolism; Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of growth hormone during fasting in
      healthy lean men.
    

Detailed description: 
      During fasting the human body is known to metabolize relatively large amounts of fat, in the
      expense of proteins and glucose. Partly this shift in metabolism is caused by increasing GH
      secretion, but exactly how growth hormone exerts these effects remains to be further
      investigated.

      10 healthy lean young men are studied at 4 different occasions in a randomized single-blinded
      cross-over study. 1: after 12 hours of fasting + GH bolus, 2: after 36 hours of fasting + GH
      bolus, 3: after 36 hours + saline, 4: after 36 hours of fasting + Somavert.

      Aim:

        -  to study the signal transduction in muscle and fat tissue

        -  to study the metabolism during fasting

        -  to study the intrahepatic fat content using magnetic resonance techniques
    

Intervention name(s): Somatropin and pegvisomant
Intervention type(s): Drug
Intervention description(s): Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Growth hormone; Fasting; Signaltransduction; fatty liver; insulin sensitivity; forearm model; protein metabolism; respiratory quotient
Acupuncture for Nausea in HIV
Condition: HIV Infections
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 2

Summary: 
      The subjects in this research study will be 159 men and women with HIV infection who have a
      history of chronic nausea for three months or greater and show evidence of two or more
      episodes of nausea and/or report a duration of two hours or more (per day) in baseline
      symptom diaries. Subjects will be randomized (by chance) to one of three conditions:
      Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects
      receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active
      treatment); Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in
      Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.
    

Detailed description: 
      The subjects in the proposed experiment will be 159 men and women with HIV infection who have
      a history of chronic nausea for three months or greater and show evidence of two or more
      episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective
      baseline symptom diaries. Subjects will be randomized to one of three experimental
      intervention conditions: Condition 1, subjects receive Standard acupuncture; Condition 2,
      subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis;
      Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2,
      & 3 will attend 16 scheduled sessions over 24 weeks. All subjects will: be assessed by a
      diagnostic acupuncturist (blinded to treatment assignments); be administered the same
      instruments; and submit their symptom diaries for data entry and analysis. After a
      screening/intake session, randomization and treatment sessions will follow. There will be
      four weeks of twice weekly treatment sessions, four weekly treatment sessions and three
      follow-up sessions. All conditions will be identical in duration and be administered by
      licensed acupuncturists trained in Traditional Chinese Medicine. This study is a prospective,
      randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed
      at reducing chronic nausea and improving quality of life in persons with HIV/AIDS.
    

Intervention name(s): Acupuncture; Individualized Acup based on TCM diagnosis; Sham Acup
Intervention type(s): Other; Other; Other
Intervention description(s): Standard Acup point protocol for treating nausea; Acup; Sham Acup - Non-Active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nausea; Vomiting; Retching; HIV/AIDS; Symptom Management; Complementary Therapies
Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
Condition: Toxoplasmosis
MeSH terms: Toxoplasmosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of
      toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body
      (Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare
      [MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following
      administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the
      study did not provide sufficient information for approval of Pyrimethamine in Japan; hence,
      PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese
      and Caucasian healthy subjects. This study will be a single centre, open-label,
      parallel-group, single oral dose study to evaluate the PK, safety and tolerability of
      Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a
      screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will
      be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium
      folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to
      receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for
      PK analysis and safety assessments will be performed prior to dosing and over 22 days after
      dosing. Each subject will participate in the study for approximately 2 months from screening
      to follow-up.
    


Intervention name(s): Pyrimethamine; Calcium folinate
Intervention type(s): Drug; Drug
Intervention description(s): Pyrimethamine will be available as 25 mg tablets. Subjects will be orally administered two pyrimethamine tablets on Day 1 in a fasted condition with 240 mL of water.; Calcium folinate will be available as 5 mg tablets. Subjects will be orally administered three calcium folinate tablets on Day 1 along with pyrimethamine followed by once daily administration of calcium folinate until Day 8. Each administration will be with 240 mL water.
Intervention MeSH terms: Leucovorin; Pyrimethamine; Calcium; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japanese; Caucasian; pharmacokinetics; pyrimethamine; toxoplasmosis
Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess if regular use of tiotropium (i.e. daily) results in loss of
      bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.
    

Detailed description: 
      A single dose of an inhaled muscarinic antagonist will protect against methacholine induced
      bronchoconstriction and increase the dose of methacholine required to cause
      bronchoconstriction about 4 doubling doses. Beta agonist bronchodilators also shift the dose
      response curve to the right but the protection against methacholine induced
      bronchoconstriction is lost (i.e. tolerance develops) with regular use. This study will
      determine if bronchoprotection is lost following regular use of tiotropium.

      This will be a randomized, double-blind placebo controlled study to assess the development of
      tolerance following regular use of tiotroium in a population of mild asthmatics.

      Tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of
      8 days. Methacholine challenges will be performed at baseline (pre-treatment), at one hour
      post first dose and on day 8, one hour after the final dose. The same will dosing schedule
      and assessments will occur with an identical placebo inhaler.
    

Intervention name(s): Tiotropium Bromide; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): respimat inhaler 2.5mcg/puff; matching placebo Respimat inhaler
Other intervention name(s): Spiriva Respimat
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tiotropium; bronchoprotection; tolerance; methacholine PD20
Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aims of this study are to determine whether neuromuscular stimulation (NMES) of the
      quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and
      staff and whether it can impact clinical and healthcare resource usage outcomes.

      .
    

Detailed description: 
      Patients with IPF who consent to participate in the study will be allocated by chance to use
      'active' or 'sham/placebo' NMES for six weeks. Patients will also complete a home exercise
      programme and receive advice on how to manage breathlessness. Clinical outcomes and trial
      flow after this six week programme and six weeks after patients have stopped using NMES will
      be assessed. After this point, healthcare resource use during the study period will be
      evaluated and interviews involving participants, their carers, and staff about their
      experiences of the study and using or delivering NMES will be conducted.
    

Intervention name(s): Active NMES; Sham NMES; Home exercise programme; Breathlessness advice
Intervention type(s): Device; Device; Other; Other
Intervention description(s): Neuromuscular electrical stimulation to the quadriceps muscle; Sham neuromuscular electrical stimulation to the quadriceps muscle; Home exercise programme. Both arms of the trial receive this intervention.; Breathlessness advice. Both arms of the trial receive this intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a study that comprises:
A parallel group, randomised placebo-controlled, assessor-blinded trial with participants randomised (1:1) to usual care (home based exercise programme) with either placebo or active NMES for six weeks, with a 12 week follow-up.
Qualitative interviews with participants and staff.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuromuscular electrical stimulation