bioihbjkbjnl/mcl2 huggingface dataset:
Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes
      in plasma glucose and lipids concentrations on the endothelial function together with other
      metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.

      Hypothesis:

      Different changes in endothelial function to acute in vivo induced hyperinsulinemia and after
      the meal test will be found in patients with T2D compared to healthy subjects.

      A significant relationships between insulin sensitivity, selected adipokines intramyocellular
      fat content, hepatic fat content and high energy phosphates in soleus muscle will be
      documented in both groups.
    

Detailed description: 
      30 patients with T2D and 30 healthy control subjects will be examined on an outpatient basis.
      The following examination will be carried out in each subject after 12 hrs fasting:

        -  Hyperinsulinaemic euglycemic clamp study lasting 4 hours combined with indirect
           calorimetry and biopsy of subcutaneous adipose tissue and muscle aspiration biopsy

        -  Meal test:Plasma glucose, immunoreactive insulin, plasma lipids, oxidative stress
           markers and gastrointestinal peptides measured in response to a standard meal(at times
           0´,30´,60´,120´,180´)

        -  At the beginning and after 120 minutes during the meal test and clamp peripheral
           microvascular endothelial function will be measured using EndoPat(Itamar Medical)

        -  Proton and phosphorus magnetic resonance spectroscopy(MRS).

        -  Dual Energy X-ray Absorptiometry(DXA) scanning to measure body composition.
    

Intervention name(s): mixed meal; Acute in vivo induced hyperinsulinemia
Intervention type(s): Other; Other
Intervention description(s): Baguette Cheese Gourmet (Crocodile:
180g, energy 452.8 Kcal, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.; Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin Resistance; Hyperglycemia; Endothelial function; Oxidative stress
Improving Mental Health and Well-Being Via Awe Walks
Condition: Awe; Compassion; Anxiety
Study type: Interventional

Summary: 
      Awe is a powerful positive emotion that offsets negative emotion and fosters prosocial
      behavior. This study examined the effects of awe on health and well-being in healthy older
      adults. Half of the participants took a weekly "awe walk" while the other half took a weekly
      walk with no further instructions.
    

Detailed description: 
      Awe fosters well-being and positive emotions that promote social relationships. Awe shifts
      attention from ourselves to the outside world and is associated with diminished self-focused
      attention. We aimed to increase awe in healthy older adults to test whether greater awe
      experience would lead to gains in other types of positive emotional experience and reductions
      in negative emotional experience.
    

Intervention name(s): Awe Walk; Control Walk
Intervention type(s): Behavioral; Behavioral
Intervention description(s): To examine the effect of weekly awe walks in cognitively healthy older adults.; To examine the effect of weekly walks in cognitively healthy older adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Awe; Compassion; Anxiety; Positive emotions; Aging
Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The aim of this study is to evaluate scintigraphic methods as objective factors for
      functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The
      gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the
      functional outcome.
    


Intervention name(s): Transittime. Defecography
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Ulcerative colitis
Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of oral Foipan® (camostat mesilate) compared with the
      current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in
      patients with mild-moderate COVID-19 disease.

      Patients will attend 4 study visits over a period of up to 28 days.
    


Intervention name(s): Camostat Mesilate; Placebo; Standard of Care Treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): Camostat Mesilate administered as oral tablets; Placebo to match camostat mesilate; Standard of Care Treatment for COVID-19 Infection
Other intervention name(s): Foipan®
Intervention MeSH terms: Camostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3
      different sustained release formulations of naproxen 660 mg relative to the established
      commercial Aleve 220 mg tablet.
    


Intervention name(s): Naproxen Sodium ER (BAY117031), 20% HPMC; Naproxen Sodium ER (BAY117031), 30% HPMC; Naproxen Sodium ER (BAY117031), 40% HPMC; Aleve (Naproxen Sodium, BAY117031)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet 660 mg administered orally once daily; 1 tablet 660 mg administered orally once daily; 1 tablet 660 mg administered orally once daily; 1 tablet 220 mg administered orally three times daily
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of single
      ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and
      females
    


Intervention name(s): REGN3500; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Safety; Tolerability; Pharmacokinetics; REGN3500
Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers
Condition: Coronary Heart Disease; Periodontitis
MeSH terms: Periodontitis; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational [Patient Registry]

Summary: 
      The research question was to investigate whether non-surgical periodontal therapy could
      reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.
    

Detailed description: 
      CHD patients or non-CHD with or without periodontitis were included. They were provided with
      non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk
      markers were measured at baseline and 3 months and 6 months after NSPT.
    

Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): scaling and root planing, home care instruction
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients who came to the Hospital for Tropical Medicine, Faculty of Tropical Medicine,
        Mahidol University or Rajavithi Hospital, Thailand
      
Keywords: Coronary heart disease, peridontitis,
Effects of MDMA on Emotional and Social Memories
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of MDMA on encoding and retrieval of
      emotional and social memories in healthy young adults. The study will explore the effects on
      memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.
    

Detailed description: 
      Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of
      positive, negative, social, and neutral memories. The study will use a between subjects
      design with three groups (N = 20 per group). Two of the groups will be randomly assigned to
      receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The
      third group will receive placebo only (PLC). All three groups will receive capsules before
      viewing the study materials, and at retrieval two days later, but they will receive MDMA only
      in the capsule appropriate to their condition, and other capsules will contain placebo.

      Participants will participate in two sessions: a viewing session during which they will view
      emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which
      there will be a surprise memory test with two components (verbally cued recollection and
      picture recognition). On all sessions subjects will also complete mood questionnaires.
    

Intervention name(s): MDMA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; adult
TD-6450 SAD and MAD in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD)
      study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy
      subjects.
    


Intervention name(s): TD-6450; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C
Ventricular Arrhythmias After Pulmonary Vein Isolation
Condition: Ventricular Arrhythmias; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The investigators study aimed to observe the occurrence of new premature ventricular
      complexes and other ventricular arrhythmias after pulmonary vein isolation.
    

Detailed description: 
      Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of
      over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with
      symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably
      modulates the intracardiac autonomic nervous system. While this ablation might alter atrial
      electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Cantharone for the Treatment of Perenial Warts
Condition: Wart, Genital
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.
    

Detailed description: 
      Warts are one of the most common sexually transmitted diseases. They are caused by the human
      papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and
      spread. Patients presenting to the obgyn clinic with perenial warts were randomized to
      treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment
      with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which
      painlessly causes a small blister to form and cures the patient from the HPV infection
      causing the wart . We compared cosmesis, scar formation, pain and number of treatments
      (visits) as well as effectiveness in both groups.

      Objectives

        1. Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of
           warts

        2. Compare pain levels (pain during application) for each method

        3. Compare patient satisfaction for each method

        4. Compare scar formation and cosmesis for each method
    

Intervention name(s): Cantharidin; Trichloroacetic Acid
Intervention type(s): Drug; Drug
Intervention description(s): A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.; Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.
Intervention MeSH terms: Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: warts; trichloroacetic acid
Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections
Condition: Fungal Infection by Site
MeSH terms: Infections; Communicable Diseases; Mycoses
Study type: Observational

Summary: 
      The primary aims of this study are to identify and characterize the immediate consequences of
      patients who fail fluconazole treatment during the treatment of severe infection, and to
      determine if fluconazole failures are more frequently associated with fluconazole-resistant
      or fluconazole-susceptible strains of C. albicans.
    

Detailed description: 
      The primary aims of this study are to identify and characterize the immediate consequences of
      patients who fail fluconazole treatment during the treatment of severe infection, and to
      determine if fluconazole failures are more frequently associated with fluconazole-resistant
      or fluconazole-susceptible strains of C. albicans (i.e. does in vitro resistance matter?).
      Perhaps the breakpoints are not correct and need to be changed, as has recently happened with
      vancomycin.

      A third objective is to calculate fluconazole PK/PD parameters such as AUIC, and compare the
      calculated AUIC values of patients who fail with fluconazole-susceptible vs
      fluconazole-resistant isolates. Specifically for fluconazole, the question here is whether
      dose matters, and can aggressive dosing offset higher MICs. Thus in all cases, we will also
      determine the AUIC of fluconazole in order to fully characterize the impact of dose chosen on
      the outcomes of treated patients who fail to respond to fluconazole. The clinical,
      microbiological, and pharmacoeconomic outcomes of patients who fail fluconazole therapy and
      are subsequently hospitalized with severe infections caused by C. albicans will be documented
      and described.
    

Intervention name(s): Fluconazole
Intervention type(s): Drug
Intervention description(s): Patients hospitalized with severe infection caused by C. albicans, documented by standard clinical signs, symptoms, and radiology, and having failed at least four days of fluconazole therapy
Intervention MeSH terms: Fluconazole
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a multi-center study of adult and pediatric patients hospitalized with severe
        infection caused by C. albicans. An announcement of this case series collection study will
        be sent to our ongoing list of primary care practitioners, hospitalists, specialists in
        infectious diseases, pulmonologists, clinical pharmacists, and other investigators
        throughout the USA.
      
Keywords: C. albicans; fluconazole
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 3

Summary: 
      There are very few randomized controlled trials in open splenectomy surgery, which compare
      paravertebral block with ESP block. The purpose of this randomized controlled trial is to
      compare the efficacy of ultrasound-guided paravertebral block with ESP block for
      perioperative analgesia in open splenectomy .
    


Intervention name(s): ultrasound guided erector spinae plane block; ultrasound guided paravertebral block; conventional analgesia
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.; patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.; patients will receive combined general anesthesia and conventional analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
Condition: Healthy Subjects; Pharmacokinetics; Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the
      test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product,
      Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of
      absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure)
      after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference
      product) and 200 mg 24-hourly at 07:30 (test product), were compared.
    


Intervention name(s): Tramadol HCl; Tramadol HCl
Intervention type(s): Drug; Drug
Intervention description(s): 1x200 mg Tramadol HCl OAD tablet daily; 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects; Pharmacokinetics; Bioavailability
Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Aim:

      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological
      intervention for Bipolar disorder in Pakistan

      Design:

      Randomized Control Trial

      Setting:

      Psychiatric Departments of different Hospitals in Karachi.

      Participants:

      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and
      treatment as usual arm.

      Intervention:

      Culturally Adapted psychological intervention for bipolar disorder

      Outcome measure:

        -  Acceptance of intervention in terms of attending session and dropouts

        -  Knowledge and attitudes towards bipolar disorder
    

Detailed description: 
      The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted
      psychological intervention for Bipolar disorder in Pakistan

      Primary Objectives :

        1. To determine effectiveness of educational intervention in terms of patient Satisfaction
           with overall care, knowledge and attitudes to bipolar disorder and medication adherence.

        2. To assess feasibility in terms of

             -  Recruitment

             -  Using instruments that will be used to assess recurrence rate in the main study
                (BDI, YMRS and obtaining prospective hospitalisation and medication data)

             -  acceptability of a culturally adapted bipolar group education package

        3. To allow 'fine tuning' of culturally adapted bipolar group education package (this will
           partly be achieved by using the SEMI at study entry)

      The Participants will be recruited from psychiatric department of different hospitals.

      They will be randomly divided into two groups; intervention group and treatment-as-usual
      group. A total of thirty six participants will be recruited in the pilot study and divided
      equally into two arms. This will ensure that, even after loss to follow-up, we will have at
      least 12 subjects per group for analysis (FDA guidance
      http://www.fda.gov/cder/guidance/5356fnl.pdf) .Randomization will be carried out by the on
      offsite statistician. This will provide a reliable geographically remote service. For
      intervention group twelve sessions of psychoeducation will be provided by trained research
      clinician during the period of three months. Patients in the treatment as usual (TAU) group
      will be given details of intervention at the end of the study and interested patients will be
      offered psychoeducation.
    

Intervention name(s): Psycho education
Intervention type(s): Behavioral
Intervention description(s): Psycho-education Sessions will be offered weekly basis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psycho-education, Bipolar , cultural adaptation, Pakistan
Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS)
      and to determine the correlation between the symptom and cerebral changes.
    

Detailed description: 
      Only recruiting from:

      Department of Neurology, Aarhus University Hospital, Denmark
    

Intervention name(s): 3,4-diaminopyridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose 3,4 diaminopyridine; Single dose placebo treatment
Other intervention name(s): n/d
Intervention MeSH terms: Amifampridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Motor fatigue; Cognitive fatigue