bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Drainage on Laparoscopic Gastric Bypass Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life
      are the criteria that should be given priority in this treatment method. The purpose of this
      study is to determine the use of drain, which closely affects these criteria; And the effect
      on patient comfort.
    

Detailed description: 
      Question the necessity of routine use of drain in RYGB surgeon
    

Intervention name(s): Drainage
Intervention type(s): Other
Intervention description(s): Using drain after operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; VAS; Pain; Laparoscopy; Bypass
Comparison Between Two Ss-OCT Biometry
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Observational

Summary: 
      Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry
      device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective
      data collection of patients who were measured with both ss-OCT optical biometry devices and
      to assess the limits of agreement of the two devices.

      Retrospective comparison of two ss-OCT biometry devices concerning comparability of
      measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.
    

Detailed description: 
      This a retrospective study including data acquired from patients that attended pre-surgical
      examination as it is the standard in the investigator's hospital.

      The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg
      Engineering, Germany) are biometry devices that use swept-source optical coherence tomography
      technology in combination with a multidot-keratometer, that obtain two-dimensional images of
      ocular structures.

      The difference between the two devices resides in the wavelength of the infrared laser:
      1200-1400nm for the Anterion and 1050nm for the IOL Master 700.

      The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the
      IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.
    

Intervention name(s): Biometric measurement agreement
Intervention type(s): Other
Intervention description(s): Patients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL).
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The participants were selected by the clinical investigators at the Hanusch Hospital.
      
Keywords: biometry; ss-OCT; cataract
Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients
Condition: Obesity; Hypogonadism; Prostatic Hyperplasia; Insulin Resistance
MeSH terms: Prostatic Hyperplasia; Insulin Resistance; Hypogonadism; Hyperplasia
Study type: Observational

Summary: 
      The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible
      for bariatric surgery, the effect of testosterone replacement therapy in improving lower
      urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score)
      questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.
    

Detailed description: 
      Primary objective:

      - Evaluation in obese and hypogonadal patients candidates for bariatric surgery of the effect
      of testosterone replacement therapy in improving the symptoms of LUTS (assessed using the
      IPSS questionnaire) compared to hypogonadal untreated subjects and eugonadal subjects.

      Secondary objectives:

        -  Evaluation of the effect of testosterone in obese and hypogonadal patients candidates
           for bariatric surgery in improving metabolic parameters (glycaemia, oral glucose
           tolerance test, HbA1c, total cholesterol, HDL cholesterol, triglycerides, arterial
           pressure, BMI, waist circumference) compared to hypogonadal untreated subjects and
           eugonadal subjects

        -  Evaluation of the effect of testosterone in obese and hypogonadal patients candidates
           for bariatric surgery in improving uroflowmetric parameters compared to hypogonadal
           untreated subjects and eugonadal subjects

        -  Evaluation of the effect of testosterone in obese and hypogonadal patients candidates
           for bariatric surgery on the ultrasound characteristics of the prostate
           (macro-calcifications, intraprostatic arterial velocity, volume of the prostate gland).

        -  Evaluation of the effect of testosterone in obese and hypogonadal patients candidates
           for bariatric surgery on pre-adipocytes isolated from visceral adipose tissue samples
           collected during surgical procedures, as compared to hypogonadal untreated subjects and
           eugonadal subjects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male adults subjects suffering from severe obesity in a waiting list for bariatric surgery
        for weight loss will be considered eligible.

        The diagnosis of hypogonadism will be defined by levels of total testosterone <12nmol / l
        or free testosterone <225 pmol / L (calculated according to the formula of Vermeulen).
      
Keywords: Testosterone replacement therapy
Effect of Citalopram on Reflux Episodes in Healthy Volunteers
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however,
      there are no empirical data to support this. The investigators would like to know if
      citalopram has an effect on the lower esophageal sphincter pressure, transient lower
      esophageal sphincter relaxations and reflux episodes. The investigators will investigate this
      by performing high resolution impedance manometry in healthy volunteers before and after a
      solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind
      condition.
    


Intervention name(s): Citalopram HCl; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Citalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.; Placebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation
Condition: Fabry Disease; Cerebrovascular Accident
MeSH terms: Stroke; Fabry Disease
Study type: Observational

Summary: 
      New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause
      could have been an undiagnosed genetic disease, the so called Fabry disease. In this case
      certain fat molecules are not digested and broken down by the body - but remain in the cells.
      These fat molecules build up to dangerous levels, which start to damage the body, because
      they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood
      vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a
      stroke.

      The purpose of this study is to investigate the stroke rehabilitation of Fabry patients
      during different therapeutic standard approaches for stroke and for Fabry disease (if any).
      During this study, stroke patients with Fabry disease will be monitored in greater detail to
      determine whether the differences in treatment are significant for patient recovery and on
      what they depend.
    

Detailed description: 
      In a group of young stroke patients with diagnosed Fabry disease the stroke rehabilitation
      will be investigated during different prophylactic therapeutic approaches. In this study the
      investigator will not be given any instructions on stroke and Fabry therapy.

      All patients with any etiology of stroke and a diagnosed Fabry disease submitted to the
      stroke unit of the participating centres which commit to work with the EUSI (European Stroke
      Initiative) recommendations for stroke management and diagnosis will be included into the
      study.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Observational, epidemiological, prognosis study; no drug tested; only laboratory analysis and diagnostic interventions done.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients (18 - 55 years of age) with an acute cerebrovascular event (CVE) of any
        etiology defined as patients having an ischemic stroke or transient ischemic attack and
        genetic diagnosis (a-galactosidase defect) of Fabry disease.
      
Biospecimen description: 
      EDTA-blood and urine sample for central laboratory analysis of agalsidase antibodies and Gb3
      for safety issues.

      There will be a proteomic analysis in blood to check whether there will be the possibility to
      characterize a biomarker for Fabry disease.
    
Keywords: Cerebrovascular Accident; Cerebrovascular Accident, Acute; Fabry Disease; Fabry's Disease; Anderson-Fabry Disease; CVA (Cerebrovascular Accident); Stroke, acute; Cerebral Stroke
A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Plaque, Amyloid; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque
      burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB
      (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and
      after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and
      day 45.
    


Intervention name(s): VX-745
Intervention type(s): Drug
Intervention description(s): Orally-Active Selective P45 MAP Kinase inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome (PCOS)
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with
      6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in
      improving reproductive parameters and to evaluate the safety of DLBS3233 in women with
      polycystic ovary syndrome compared with metformin, as an active control.
    

Detailed description: 
      There will be 2 groups of treatment; each group will consist of 62 subjects with the
      treatment regimens :

        -  Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of
           Metformin XR (twice daily)

        -  Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of
           DLBS3233 (once daily) for 6 months of treatment.

      Clinical examination to evaluate the efficacy of the investigational drug will be performed
      at baseline and every interval of 1 month.

      Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography
      (USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In
      addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and
      after Month 5th (Month 5.5th).

      Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive
      hormone levels) and safety, at baseline and Month 6th (end of study).

      General counseling on lifestyle modification will be provided to the subjects by the assigned
      Nutritionist. All study subjects should follow a lifestyle modification. Evaluation on
      subjects' performance on lifestyle modification will be conducted every follow-up visit by
      Investigator, but particularly at baseline, Month 3rd, and end of study (Month 6th) by the
      Nutritionist.
    

Intervention name(s): DLBS3233; Metformin XR; Placebo caplet of Metformin XR; Placebo capsule of DLBS3233
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 DLBS3233 capsule 100 mg once daily for 6 months; 1 Metformin XR caplet 750 mg twice daily for 6 months; 1 placebo caplet of Metformin XR twice daily for 6 months; 1 placebo capsule of DLBS3233 once daily for 6 months
Other intervention name(s): Inlacin; Glumin XR; Placebo caplet of Glumin XR; Placebo capsule of Inlacin
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent
MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases
Condition: Rheumatic Diseases; Physician-Patient Relations; Contraception
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      This is a pilot trial to assess feasibility and acceptability of MyVoice vs. a patient
      pamphlet among female patients ages 18-44 (n=50) who receive rheumatology care.

      • Hypothesis: MyVoice will be feasible and acceptable to patients who receive rheumatology
      care.
    

Detailed description: 
      The pilot will demonstrate if the MyVoice decision aid can be feasibly and acceptably
      implemented into the rheumatology context and inform operational procedures for a future
      hybrid effectiveness-implementation trial. Women in the intervention arm will receive the
      MyVoice decision aid (n=38). Women in the control arm (n=12) will receive a widely-accessible
      paper-based pamphlet about pregnancy, which, similarly to MyVoice, targets women with a broad
      range of rheumatic diseases.

      Rheumatologists will have no obligatory actions; however, if one or more of their patients
      completed the study, they will be emailed an anonymous survey about their experiences with
      the study and related patient encounters. This will occur 2 weeks after the final patient
      participant completes the study. Rheumatologists will not be informed by study personnel
      which of their patients participated in the study.
    

Intervention name(s): MyVoice:Rheum; Pamphlet; Provider Experience
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).; Participants in this arm will be given a copy of an existing patient pamphlet; Rheumatologists will take a survey to assess their experiences with MyVoice and/or the pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: rheumatic diseases; shared decision-making; sexual and reproductive health; decision aids
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate of absorption and oral bioavailability of a test formulation of
      Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral
      dose of the commercially available reference product Atlace® manufactured by Monarch
      Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast
    

Detailed description: 
      Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period
      crossover study

      Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of
      Ramipril10 mg Capsules Under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Ramipril10 mg Capsules, single dose; Atlace® 10 mg capsules, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fasting conditions; B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fasting conditions
Other intervention name(s): Ramipril; Ramipril
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ramipril; Healthy subjects
Midds Ankle Fracture
Condition: Ankle Fracture Requiring Internal Fixation
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      The geko™ device is indicated for the prevention and treatment of oedema. The aim of this
      study is to show that recruiting, and performing study assessments in ankle fracture patients
      requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to
      obtain data to support the powering of a larger study to demonstrate the effectiveness of the
      geko™ device at reducing length of stay for this population of patients. This study will also
      allow us to assess the acceptability, tolerability and compliance of treatment with the geko
      device.
    


Intervention name(s): geko neuromuscular electrostimulation device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis
Condition: Childhood Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte
      Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients
      treated only with conventional treatment.
    


Intervention name(s): Conventional treatment plus DLE; Conventional treatment plus placebo
Intervention type(s): Biological; Biological
Intervention description(s): Paediatric patients with diagnosis of atopic dermatitis according to Hanifin and Rajka and evaluated with SCORAD as moderate atopic dermatitis were included. Patients were randomized and received in a double blind placebo-controlled treatment:
Group 1: Conventional treatment plus DLE Conventional Treatment: oral Cetirizine 0.25mg/kg, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; and topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; plus oral DLE (Transferon) (2mg/5mL), every day for 5 days, then every 72hrs to complete one month; Group 2: Conventional treatment plus placebo. Conventional treatment: Cetirizine 0.25mg/kg oral, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; and oral placebo, every day for 5 days, then every 72hrs to complete one month.
Other intervention name(s): Transferon; Dialyzable Leukocytes Extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dialyzable Leukocyte Extracts; Transferon; atopic dermatitis
Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load
Condition: Alcohol Drinking; Alcohol Use Norms; Alcohol Use Among ART Clients
MeSH terms: Alcohol Drinking
Study type: Observational

Summary: 
      This study is the Formative Phase of a larger study; once this phase is completed, enrollment
      into the randomized controlled trial (RCT Phase) will begin. The primary objective of the
      Formative Phase is to gain a better understanding of the context in which drinking alcohol
      among ART client in Vietnam occurs, in order to culturally tailor the intervention to be
      tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth
      interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics
      in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the
      ART clinics (whom we will refer to as general population PWID).
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol
        use