bioihbjkbjnl/mcl2 huggingface dataset:
Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a
      sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1
      Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will
      improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic
      euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20
      year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c
      7.0%-9.9%).
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in the morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography
Condition: To Assess the Presence of Internal Pudendal Artery Disease in Patients With Erectile Dysfunction Undergoing Coronary Angiography
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      Subjects in this study have recently had or are scheduled for a coronary angiography as part
      of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of
      the heart's blood vessels.

      This research study will evaluate the possible relationship between erectile dysfunction and
      vascular disease (diseases of the veins). In order to look at this possible relationship,
      subjects will complete a questionnaire which will ask questions regarding their sexual
      activity. Additionally, we will gather information from their medical records and take extra
      images during the coronary angiography procedure.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only stable patients scheduled to undergo clinically indicated coronary angiography under
        non-emergent conditions will be approached for participation in the study.
      
Keywords: pudendal artery disease; erectile dysfunction; coronary angiography; coronary disease; cardiac
An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
Condition: Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Observational

Summary: 
      The aim of this project is to use both multimodal MRI and behavioral measures to investigate
      how changes in frontostriatal neural systems contribute to the development and persistence of
      Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our
      understanding of the development and treatment of BN.
    

Detailed description: 
      Patients with Bulimia Nervosa (BN) have difficulty regulating impulsive behaviors as
      suggested by their binge-eating and purging, as well as the high incidence of drug abuse and
      shoplifting in this population. Understanding dysfunction in the frontostriatal circuitry
      that mediates self-regulatory control processes will aid development of new therapeutics for
      the impulsivity associated with BN. We are conducting a longitudinal study to better
      understand the development and persistence of BN.

      Participation in this study includes 4 sections: Neuropsychological Tests, Diagnostic
      interviews, Pregnancy Test, and MRI scan. All efforts are made to coordinate procedures into
      one day, and they require between 4 and 5 hours of the participant's time. The option of
      splitting participation into two study days is also offered for participants who find it more
      convenient. Participants are compensated with $100 in the form of a check, which is mailed to
      their home address. Participants will be invited back for follow-up visits.
    

Intervention name(s): MRI; Neuropsychological Testing
Intervention type(s): Other; Behavioral
Intervention description(s): Magnetic Resonance Imaging scans; Neuropsychological tests
Other intervention name(s): GE 3T scanner; Anatomical Images, DTI, and MRS; Wechsler Abbreviated Scale of Intelligence (WASI); Continuous Performance Task; Stroop Word-Color Interference; Weather Prediction Task
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched
        controls
      
Keywords: Eating Disorders; Bulimia Nervosa; Bulimia; fMRI; Magnetic Resonance Imaging
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Condition: Jaundice; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Jaundice
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to assess the effect of jaundice on the ability of G17DT to generate
      antibodies before and after treatment of biliary obstruction due to advances pancreatic
      cancer.
    

Detailed description: 
      Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic)
      were treated with G17DT either immediately (Group A), or following biliary stenting when
      jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter
      Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A
      booster injection was offered to patients who had measurable anit-G17Dt antibodies but had
      anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were
      evaluated until study closure ort until patient death.
    

Intervention name(s): G17DT
Intervention type(s): Drug
Other intervention name(s): Polyclonal Antibody Stimulator (PAS)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study objectives

        -  To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine
           besylate after a single oral administration in healthy male volunteers.

        -  To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral
           administration in healthy male volunteers.
    


Intervention name(s): CJ-30044; TALION TAB. 10mg
Intervention type(s): Drug; Drug
Intervention description(s): 20.51mg a day,PO,QD; 10mg a day,PO,BID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Pharmacokinetics
Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of water-based exercises on lipid
      profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.

      It was hypothesized that a water-based aerobic interval-training period would decrease plasma
      concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as
      well as maximal oxygen uptake (VO2max) values.
    


Intervention name(s): Water Aerobics Training
Intervention type(s): Other
Other intervention name(s): HA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
Condition: Pain, Nerve; Prolapsed Intervertebral Disc
MeSH terms: Intervertebral Disc Displacement; Neuralgia; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic
      pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed
      intervetebral lumbar disc.
    

Detailed description: 
      All patients were informed in detailed regarding the risk and complications and given written
      and informed consent, coming to our clinics were assessed by one of the senior team members
      of the spine, patient fulfilling the eligibility criteria were selected and included in the
      study. One week before the surgery the patients who met the eligibility criteria were
      randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into
      Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were
      recorded by VAS and Roland Morris score system on preoperative day compared to the scores on
      the 1st week postoperative follow-up.
    

Intervention name(s): Pregabalin 75mg; Placebo
Intervention type(s): Drug; Device
Intervention description(s): 75 mg capsule; 75 mg
Other intervention name(s): Lyrica (Pregabalin) 75mg; Pregabalin placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Microdiscectomy; Pregabalin
Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to evaluate the uterine artery doppler just before labour in term low
      risk pregnancies. And to investigate with this measurement if investigators could foreseen
      the amount of postpartum hemorrhage looking at decreased in the hematocrit values.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The pregnant women that is term and have no risk factors for postpartum hemorrhage
Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the
      last decade active research allowed to gain more precise insights in the pathophysiology of
      IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the
      microbiota of the gut in particularly susceptible individuals. Genetic studies and more
      recently genome-wide association studies (GWAS) have allowed to identify over 70
      susceptibility genes which confer an increased risk of developing IBD. In the last years the
      attention of researchers has shifted to the identification of the early immunological changes
      that occur already at a preclinical stage of the disease, trying also at identifying the
      disease before it shows itself. Recently, the ability of a combination of serological markers
      in predicting the development of IBD has been demonstrated in adults. However, there are no
      studies evaluating a cohort of children at high risk for the disease, in whom the first
      immunological changes underlying the development of IBD could be studied, including a
      combination of genetic, serological, fecal and clinical markers.

      The purpose of this study is to evaluate in a population genetically well-characterized, as
      siblings and twins of patients affected with IBD, early genetic, serologic, fecal and
      clinical markers of disease, which may be present even years before developing the disease.
      The identification of these markers in predisposed individuals could help to implement
      strategies for prevention or early treatment to modify the natural history of IBD.
    

Detailed description: 
      This is a multicenter, prospective, study evaluating the role of serological, genetic, fecal
      and clinical markers in predicting the development of IBD in a high risk population. The
      study will be divided in two phases. In the first phase the prevalence of genetic, serologic,
      fecal, clinical risk factors in 100 siblings of children affected with IBD compared to 100
      healthy children with no family history for IBD will be evaluated. The estimated duration of
      the first phase of the study is 12 months. In a second phase, a long-term follow-up (5 years)
      will be performed in order to evaluate the accidental cases of IBD in this population.
    

Intervention name(s): sample blood and fecal collection
Intervention type(s): Other
Intervention description(s): Blood and fecal samples will be collected at the day of enrolment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: inflammatory bowel disease; siblings
Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy
Condition: Wound Heal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study is to test the safety of the study drug (FSR peptide) after a
      punch biopsy in healthy subjects.
    


Intervention name(s): FSR Peptide 20μM; FSR Peptide 50μM; FSR Peptide 100μM; FSR Peptide 200μM; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered immediately after punch-biopsy and 24 hours after punch biopsy.; Administered immediately after punch-biopsy and 24 hours after punch biopsy.; Administered immediately after punch-biopsy and 24 hours after punch biopsy.; Administered immediately after punch-biopsy and 24 hours after punch biopsy.; Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the
      pharmacokinetics of BV100 in healthy volunteers.
    

Detailed description: 
      This is an open-label, fixed-sequence Phase I clinical study to evaluate the effect of
      multiple doses of itraconazole on the pharmacokinetics of rifabutin, 25 O deacetyl-rifabutin
      and DMI in healthy volunteers.
    

Intervention name(s): BV100 (300 mg); Itraconazole 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous solution; Oral solution
Other intervention name(s): Rifabutin for Infusion; Sporanox Oral solution
Intervention MeSH terms: Itraconazole; Rifabutin
Intervention model: Single Group Assignment
Intervention model description: Fixed sequence
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of
      SK&F-105517-D in japanese patients with chronic heart failure.
    


Intervention name(s): SK&F-105517-D 10 mg capsule; Carvedilol-immediate release (IR) 2.5 mg tablet; SK&F-105517-D 20 mg capsule; SK&F-105517-D 40 mg capsule; Carvedilol-IR 10 mg tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule once a day; 1 or 2 tablet(s) twice a day; 1 capsule once a day; 1 or 2 capsule(s) once a day; 1 tablet twice a day
Other intervention name(s): carvedilol phosphate; carvedilol phosphate; carvedilol phosphate
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carvedilol phosphate; ß-blocker; SK&F-105517-D; Chronic heart failure(CHF)
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was initiated to evaluate the potential of dietary supplementation of omega-3 for
      providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive
      lichen planus.
    


Intervention name(s): Prednisone tablet 5mg; Omega-3 soft capsules 1000 mg
Intervention type(s): Drug; Drug
Intervention description(s): This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.; This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.
Other intervention name(s): Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy; Super Omega; Technopharma, Cairo, Egypt
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oral Lichen Planus; Corticosteroid; Omega -3
Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate how quickly and to what extent the 14-Carbon
      labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body
      after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is
      radioactive, this enables the compound to be traced in blood, urine and feces.
    


Intervention name(s): SAM-531
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Testopel ® vs. Generic Testosterone Pellets.
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate changes in vascular parameters in subjects receiving
      Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one
      time) versus subjects receiving Compounded Testosterone pellets 200mg (one time) to
      participant with clinical hypogonadism.
    

Detailed description: 
      Hypogonadism, or low testosterone (Low T), is the deficiency in producing testosterone by the
      testes. Testosterone pellets is a long-acting formulation of Testosterone Replacement Therapy
      (TRT) that is delivered subcutaneously to men diagnosed with low T. Advantages to
      subcutaneous testosterone pellets include ease of delivery and decreased risk of the
      medication being transfer upon skin contact to woman or children. Long acting testosterone
      replacement Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total
      testosterone into the therapeutic range at 1 month post-implantation and sustained
      therapeutic levels (>300) for 4-6 months.

      Participants will be randomly assigned to 1 of 3 study groups. In one of the groups the
      treatment will include implantation of Testopel ® 750mg (10 pellets with 75mg pellet) one
      time, in the second group, treatment will include compounded subcutaneous testosterone 800mg
      (8 pellets with 100mg pellet) one time and in the third group, treatment will include
      compounded subcutaneous testosterone 800mg (4 pellets with 200mg pellet) one time.

      The treatment takes approximately 30 minutes and will include: Clean and numb the insertion
      site with lidocaine at 1%, followed by small incision in the skin, implantation of pellets
      into subdermal fat layer and sealing the incision with Steri-strip. This is the current
      standard of care of Testopel insertion and same procedure will be followed with both
      compounded and commercial pellets.
    

Intervention name(s): Testopel 75mg Drug Implant; Testopel 100mg Drug Implant; Testopel 200mg Drug Implant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg Testosterone pellets administered subcutaneously.; 100 mg Testosterone pellets administered subcutaneously.; 200 mg Testosterone pellets administered subcutaneously.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low T; Low Testosterone
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to research for genetic factors involved in the extreme modifications
      of the QT interval of the electrocardiogram in answer to a pharmacological stimulation
      (sotalol) and physiological stimulation in the apparently normal general population.

      The phenotypic characterization, based on the ventricular repolarisation dynamics will be
      used aiming at term of the predictive genetic factors of the acquired long QT syndrome
    

Detailed description: 
      Study of 1000 apparently healthy subjects which will receive an unique dose of Sotalol and
      will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA.
    

Intervention name(s): Sotalol 80 mg
Intervention type(s): Drug
Intervention description(s): healthy subjects will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA
Intervention MeSH terms: Sotalol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long QT syndrome; Cardiac repolarisation; Genome-wide association; Electrophysiology; Drugs/adverse effects
Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, 2-period, sequential study to determine the impact of multiple doses of
      ketoconazole on single-dose pharmacokinetics of HCV-796
    


Intervention name(s): Ketoconazole
Intervention type(s): Drug
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment