bioihbjkbjnl/mcl2 huggingface dataset:
A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
Condition: Diabetes Mellitus; Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerance of a single intravenous
      (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.

      Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group
      throughout the study.

      Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug
      enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).

      Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on
      appetite, mood or behavior, and selective biomarkers (substances in your blood that may
      change in response to the study drug).
    


Intervention name(s): Trodusquemine (MSI-1436)
Intervention type(s): Drug
Intervention description(s): A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN Alfa-2b), and Ribavirin (RBV) Treatment in Patients With Hepatitis C and HIV Coinfection
Condition: HIV Infections; Hepatitis C
MeSH terms: Infections; Hepatitis A; Hepatitis C; HIV Infections; Coinfection; Hepatitis
Study type: Interventional

Summary: 
      This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in
      patients who also have HIV.

      The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with
      ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study
      will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved
      by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study
      also will use IL-2, which is a substance that the body naturally produces. People with HIV
      infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it
      will "boost" the immune system's response to HCV. The FDA has approved IL-2 for the treatment
      of some cancers.
    

Detailed description: 
      HCV infection is an increasingly important clinical problem in patients infected with HIV. In
      HIV-uninfected patients with acute HCV infection, the presence of vigorous T-cell
      proliferative responses to HCV proteins is associated with normalization of serum
      transaminase levels and viral clearance. Furthermore, early results suggest IL-2 may improve
      transaminase levels in HCV/HIV patients. These observations provide the rationale for an
      immune-based therapeutic approach to HCV/HIV coinfection. This study explores the use of
      initial immunostimulatory therapy with IL-2 followed by the addition of antiviral therapy
      with PEG-IFN alfa-2b and RBV, as a possible synergistic approach to treatment.

      Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the
      Week 12 visit. Patients remain on IL-2, PEG-IFN alfa-2b, and RBV for an additional 48 weeks.
      At Week 60, all study treatment is permanently discontinued and patients continue to be
      evaluated through Week 84. Toxicity or intolerance is evaluated. Data is collected on
      biochemical and virologic responses.
    

Intervention name(s): Ribavirin; Aldesleukin; Peginterferon alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ribavirin; Aldesleukin; Peginterferon alfa-2b
Primary purpose: Treatment
Keywords: Ribavirin; Polyethylene Glycols; Interferon Alfa-2b; Dose-Response Relationship, Drug; Drug Therapy, Combination; Antiviral Agents; Hepatitis C; Aldesleukin; Peginterferon
Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery
Condition: Retinal Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or
      dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal
      surgery.
    

Detailed description: 
      regarding patient registry; G power analysis was done was done to estimate the sample size.
      Assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 18 patients
      per group would be sufficient to detect a difference 20 % in hemodynamics indices among the
      groups. A drop out 10% of cases was expected therefore 20 patients were required in each
      group to detect the difference.

      - Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social
      Sciences). Program version 22. Distribution of data will be first tested by
      Kolmogorov-Smirnov test. Data is presented as mean and standard deviation (SD), median and
      range or numbers and percentages. For normally distributed data, one way ANOVA test will be
      used to compare between mean values of three groups with post hoc Bonferroni test for paired
      comparisons. Repeated measures ANOVA with post hock Bonferroni will be used for intra-groupal
      comparisons. For non-parametric data, Kruskal Wallis H test to compare between median values
      of 3 groups with Mann Whitney U test for paired comparisons. Chi Square test will be used for
      testing significance of categorical data. The P value ≤ 0.05 was considered as the level of
      statistical significance
    

Intervention name(s): Dexmedetomidine group (D); Ketorolac-Midazolam group (KM); Control group (Normal Saline) (C)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received 1ug/kg dexmedetomidine in 50 ml saline over 10 min i.v 30 min before induction then 0.4 ug/kg/h dexmedetomidine (4ug/ml) and normal saline 0.1 ml/kg till end of surgery, using two syringe pumps one for dexmedetomidine and the other for saline; Patients received 0.5mg/kg ketolac in 50 ml saline over 10 min before induction and 25ug/kg midazolam in 50 ml saline over 10 min i.v 30 min before induction then 50ug/kg/h of ketolac and 40ug/kg/h midazolam till end of surgery in two separate syringe pumps.; Patients received normal saline in two sets
Intervention MeSH terms: Ketorolac; Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Misoprostol Administration Before Operative Hysteroscopy
Condition: Endometrial Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no
      misoprostol prior to operative hysteroscopy in premenopausal women.
    

Detailed description: 
      The route of administration of misoprostol for cervical dilatation prior to operative
      hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is
      more effective and less harmful for cervical dilation prior to operative hysteroscopy in
      premenopausal women. Furthermore, there have been no studies comparing among oral,
      sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of
      this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no
      misoprostol prior to operative hysteroscopy in premenopausal women.
    

Intervention name(s): Oral misoprostol; Sublingual misoprostol; Vaginal misoprostol; Control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation; Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation; Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation; The control group was not given any cervical priming agents or placebo.
Other intervention name(s): two tablets of Cytotec (200 μg); two tablets of Cytotec (200 μg); two tablets of Cytotec (200 μg)
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hysteroscopy; misoprostol
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Condition: Renal Osteodystrophy
MeSH terms: Chronic Kidney Disease-Mineral and Bone Disorder; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional

Summary: 
      The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and
      4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control
      hyperparathyroidism in this group is unknown. The National Kidney Foundation presented
      guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients
      and active vitamin D therapy in patients with sufficient levels. These guidelines are based
      on opinion since there are no significant trials to determine if vitamin D supplementation is
      effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol,
      and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have
      not been compared with vitamin D supplementation with a calciferol (ergocalciferol or
      cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in
      vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood
      pressure and strength. In this proposed study we wish to directly compare the effectiveness
      of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with
      CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary
      endpoints will be change in blood pressure.
    

Detailed description: 
      Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either
      cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or
      doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH;
      secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were
      done at baseline and at 3 months.
    

Intervention name(s): doxercalciferol; Cholecalciferol
Intervention type(s): Drug; Drug
Intervention description(s): form of vitamin D that is already in active form.; from of vitamin D that requires cells in the body to make active
Other intervention name(s): Hectoral; vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol; 1 alpha-hydroxyergocalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: kidney, parathyroid hormone, vitamin d
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to demonstrate the effectiveness and tolerability of the
      buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal
      system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently
      treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during
      which time supplemental analgesic medication (acetaminophen) will be provided to all subjects
      in addition to study drug.
    

Detailed description: 
      Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical
      experience indicating it to be safe and effective in a variety of therapeutic situations for
      the relief of moderate to severe pain.
    

Intervention name(s): Buprenorphine transdermal patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.; Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Other intervention name(s): Butrans™
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic pain; opioid; transdermal; osteoarthritis
fMRI In Spinal Cord Injury Patient After Rehabilitation
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the potential reorganization in the sensorimotor
      cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training
      (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized
      that training with weight bearing associated with conventional motor rehabilitation will be
      able to reorganize the brain.
    


Intervention name(s): Treadmill gait training
Intervention type(s): Other
Intervention description(s): Five days a week, 40 sessions of Kinesiotherapy (passive and active mobilizations, muscle lengthening), Body Weight Supported Treadmill Training, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diabetic Shoulder Mobility
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The primary goal of this project is to determine how advanced glycation end-product (AGEs)
      accumulation and shoulder movement (humeral thoracic range of motion and "activity count")
      interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if
      an intervention consisting of a tailored dose of stretching and active shoulder movement can
      reduce these problems in people with diabetes mellitus (DM). The investigators will focus on
      the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs;
      Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and
      "activity counts" to measure shoulder movements; and the Disability of the Arm, Shoulder and
      Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators
      will test the innovative hypothesis that metabolic and movement factors interact to cause
      severe shoulder problems in people with DM and that an optimized shoulder movement
      intervention can have an important impact on reducing the development of limited joint
      mobility, pain and disability in this population.
    


Intervention name(s): Optimized Shoulder Movement Program; ADA Guideline Instructed
Intervention type(s): Other; Other
Intervention description(s): A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured "activity count" at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity.; The ADA guideline instructions are to include: blood sugar control (goal is A1c < 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is <130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver
Condition: Hepatobiliary Disorders; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver
      disease.This study is comparing the change in early stages of scar tissue in the liver and
      fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine).

      Participants will either get semaglutide or placebo; which treatment participants get is
      decided by chance. Semaglutide is a medicine under clinical investigation. That means that
      the medicine has not yet been approved by the authorities. Participants will need to
      self-inject medicine once daily for 72 weeks. The medicine should be injected under the skin
      in the stomach, thigh or upper arm.

      There are about 3 weeks before participants start the study medicine and 7 weeks after you
      stop it. The study will last for about 82 weeks in total.

      Participants will have 12 clinic visits, 6 phone calls and 4 visits to an MRI centre.

      The study includes MRI scans of the stomach. The MRI scans will take place at a different
      location. Participants will be excluded from the study if the study doctor thinks that there
      are risks for participants health. Women cannot take part if pregnant, breast-feeding or plan
      to become pregnant during the study period.
    


Intervention name(s): Semaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.; Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of Investigational Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses
      bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will
      complete a questionnaire for each study lens.
    


Intervention name(s): Etafilcon A Design 1 (Test 1); Etafilcon A Design 2 (Test 2); Etafilcon A (Control)
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the current study was the determination of the recommended standard treatment dose
      of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as
      assessed by follicle growth.
    

Detailed description: 
      This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study
      in women undergoing ICSI treatment.

      The primary objective of the study was the determination of the recommended standard
      treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37
      years of age who were undergoing intracytoplasmic sperm injection treatment.
    

Intervention name(s): Follitropin Epsilon; Follitropin Alfa
Intervention type(s): Drug; Drug
Other intervention name(s): FSH-GEX(TM); Gonal-f(R)
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: in-vitro fertilization; reproductive disorder
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of cycling at mild to moderate intensity
      during hemodialysis treatment on cardiovascular function in a crossover design.
    

Detailed description: 
      Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high
      rates, despite advances in HD techniques and pharmacological therapies. This indicates
      additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during
      HD treatment) represents a low-cost, easy to administer treatment strategy that could
      potentially improve cardiovascular function, physical function and quality of life. However,
      nephrologists rarely counsel their patients to increase their physical activity levels or to
      exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.

      Providing more robust evidence for the safety and effectiveness of IDEX, as well as
      evaluating the impact of exercising early vs late in the treatment, could help improve
      adoption of exercise training as a standard practice in HD clinics.

      Therefore, investigators plan to examine the impact of IDEX and its timing during treatment
      (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study
      also includes various cardiovascular measures to allow deeper mechanistic understanding of
      cardiovascular physiology with IDEX. Such understanding will significantly advance the field
      and lead to improved therapeutic approaches, including exercise training, which may help
      mediate the deleterious effects of renal failure.
    

Intervention name(s): exercise; Hemodialysis treatment
Intervention type(s): Behavioral; Procedure
Intervention description(s): Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment; Participants will receive a standard hemodialysis treatment during the study period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intradialytic exercise; Cardiac and arterial function