bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness
Condition: Corneal and Endothelial Cell Measurements
Study type: Observational

Summary: 
      The primary objective of this clinical study is to collect clinical data to support an FDA
      510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to
      evaluate any adverse events found during the clinical study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology Practice
CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement
Condition: Smoking
Study type: Interventional

Summary: 
      This study will examine elements of abuse liability (AL) related to potential product
      adoption of three electronic tobacco vapor products by current smokers relative to high and
      low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in
      subjective measures, speed and amount of nicotine uptake, and maximum changes in
      physiological effects during and after product use that follows a 12-hour (minimum) tobacco
      and nicotine abstinence period, will be determined. The electronic tobacco vapor products
      will not be compared to each other.
    

Detailed description: 
      This is a single-center, randomized, open-label, crossover study, designed to evaluate
      subjective effects (i.e., Product Liking [PL], Overall Intent to Use Again [OIUA], Product
      Effects [PE], Urge to Smoke [UTS], and Overall Product Liking [OPL]), plasma nicotine uptake,
      and physiological measures (blood pressure and heart rate) during and following ad libitum
      use of the following five IPs by healthy subjects. Subjects will be evaluated in five
      separate Test Sessions and the active period of each Test Session will last for approximately
      4 hours during and following IP use.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Usual Brand Cigarette; FT21039 an electronic tobacco vapor product; FT21092 an electronic tobacco vapor product; FT21018 an electronic tobacco vapor product; 4mg nicotine gum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Role of Volatile Anesthetics for Hepatic Protection
Condition: Reperfusion Injury
MeSH terms: Reperfusion Injury
Study type: Interventional

Summary: 
      This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after
      sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury
      is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory
      mediators).
    

Detailed description: 
      Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Surgery with Pringle maneuver needed for liver resection
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Condition: Diabetic Retinopathy; Retinal Detachment
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Dissociative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the amount of intraoperative intraocular bleeding
      during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD)
      with and without preoperative intravitreal bevacizumab treatment.
    


Intervention name(s): Bevacizumab; pars plana vitrectomy
Intervention type(s): Drug; Procedure
Intervention description(s): Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline; pars plana vitrectomy 3 weeks after baseline
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Retinopathy; Retinal detachment; Vitreous Hemorrhage; Bevacizumab; preoperative; pars plana vitrectomy
Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to evaluate the clinical efficacy of apatinib mesylate tablets combined with
      PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma after IMRT with
      concurrent chemotherapy,including The Overall Response Rate (ORR), Progression-free survival
      (PFS),Overall survival (OS),and Toxicities.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      To determine the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the
      treatment of recurrent and metastatic nasopharyngeal carcinoma.

      SECONDARY OBJECTIVES:

      Ⅰ.To explore the adjuvant medication regimen of recurrent and metastatic nasopharyngeal
      carcinoma.

      Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment
      strategy of nasopharyngeal carcinoma patients.

      OUTLINE:

      Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets
      at the recommended dose of 250mg,orally, QD, continuous administration, 4 weeks (28 days) as
      an observation cycle. Until the disease progressed or unbearable adverse reactions appeared.
      If missed medication occurs during the medication period, it is confirmed that the next
      medication time is less than 12 hours, then there will be no replenishment. The recommended
      dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation
      cycle, until disease progression or intolerable toxicity.
    

Intervention name(s): Apatinib mesylate tablet; PD-1
Intervention type(s): Drug; Drug
Intervention description(s): The dose of apatinib mesylate tablets is 250mg, oral, qd, continuous administration, 4 weeks (28 days) as an observation cycle.; The dose of PD - 1 is 200 mg/ time, intravenous injection, q2w, 4 weeks (28 days) for an observation period.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal Carcinoma; Apatinib; PD-1; Second-line treatment; Overall response rate
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single-dose, Randomized, two-Period, Cross over Study
    

Detailed description: 
      Randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the
      relative bioavailability of two risperidone 1 mg tablet formulations under Fed conditions.

      The test formulation was Dr. Reddy's Laboratories Limited's 1 mg Risperidone tablet, and the
      reference formulation was Risperdal® (risperidone) 1 mg tablet (Janssen Pharmaceutica
      Products, L.P.).

      The study was conducted with 26 healthy adults. In each study period, a single 1 mg dose was
      administered to the subjects following a standardized high-fat breakfast preceded by an
      overnight fast of at least 10 hours.

      The subjects received the test product in one study period and the reference product in the
      other period; the order of administration was according to the dosing randomization schedule.
      There was a 7-day interval between treatments.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention description(s): Risperidone Tablets 1 mg
Other intervention name(s): Risperdal® Tablets, 1 mg
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following
      IVF outcome
    


Intervention name(s): Combined treatment with Arimidex and Zoladex before IVF
Intervention type(s): Drug
Intervention MeSH terms: Goserelin; Anastrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      This study aims to examine the psychological well-being and QoL of Hong Kong Chinese
      adolescents with CHD by

        -  comparing the self-esteem level, depressive symptoms, and quality of life of adolescents
           suffering from CHD with healthy norms and cancer survivors.

        -  identifying possible factors affecting the quality of life of adolescents suffering from
           CHD.
    

Detailed description: 
      Congenital heart disease (CHD) is the most common type of congenital malformation in the
      world with birth prevalence as 8 per 1000 live births. Survival rate has been drastically
      improved as a result of improvement in surgical treatments and intensive care but adolescents
      with CHD still suffer from limitations on their psychological functioning and restrained
      quality of life. Number of evidences have indicated that adolescents with CHD experience more
      depressive symptoms and lower self-esteem level than their healthy counterparts. In addition,
      adolescents with CHD are more prone to develop emotional and behavioral problems than their
      healthy norms. Given the above issues, It is imperative for nurses to develop psychological
      interventions to promote psychological well-being among adolescents with CHD, with the goal
      of improving their quality of life. There have been increasing concerns worldwide on the
      quality of life of such population especially on how does the disease pose threats on their
      daily living. However, at present, there is no study examining how does CHD affect the
      psychological well-being and quality of life in Hong Kong Chinese adolescents. It is explicit
      that Hong Kong has a distinctively different cultural context from that of the West. Hence,
      the effects of CHD and its treatments are likely to differ markedly in the two regions .To
      conclude, results of previous studies from the West may not fit into Hong Kong Chinese
      cultural context.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric with congenital heart disease, aged at 12-17 years old, fluent in Cantonese and
        are attending the day centre and specialized outpatient sector of Department of Pediatric
        Cardiology in Queen Mary Hospital .
      
Keywords: adolescents; quality of life; psychological well-being
Refractive Accuracy of "2WIN" and Portable Autorefractors
Condition: Refractive Error - Myopia Axial; Astigmatism; Accomodation; Visual Impairment; Hyperopia of Both Eyes
MeSH terms: Vision Disorders; Vision, Low; Astigmatism; Refractive Errors; Hyperopia
Study type: Observational

Summary: 
      Youth and some adults have photoscreening refractions and hand-held auto refraction before
      cycloplegia refraction during new and follow up eye examinations. Vector math is applied to
      each refraction to determine how closely the hand-held "dry" devices match actual refraction.
    

Detailed description: 
      A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and
      applied to 50-years of clinical international refractive experience.

      As a part of new and follow up comprehensive eye examinations, patients and parents consented
      to confirm the cycloplegic refraction to other portable refractive tools.

      The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg,
      Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed
      utilizing the new algorithm.

      This algorithm could then be applied to batches of donated spectacles distend by charitable
      organizations worldwide if portable auto refracting devices are employed.
    

Intervention name(s): "2WIN" Photoscreener; "Plusoptix A12"; "Retinomax"
Intervention type(s): Device; Device; Device
Intervention description(s): non-cycloplegia refraction by Adaptica "2WIN"; non-cycloplegic refraction by "Plusoptix A12" photoscreener; non-cycloplegic refraction by "Retinomax K+" auto refractor
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        children and adults attending pediatric ophthalmology and adult strabismus clinic
      
Keywords: photoscreening; photo refraction; auto refraction; spectacle dispensing
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
Condition: Cancer; Cancer Cachexia; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Heart Failure; Weight Loss; Body Weight; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements
      in maintaining weight in people with disease-related weight loss and/or cachexia.
    

Detailed description: 
      The overall goal of this project is to evaluate the safety and efficacy of nutritional
      supplementation with fish oils to maintain weight in patients with disease-related weight
      loss (cachexia). Weight loss commonly results in a poorer prognosis, functional status, and
      quality of life. Despite the high morbidity and mortality associated with cachexia,
      mainstream treatment does not sustain weight and although nutritional supplements are
      commonly used, many of these have not been tested in clinical trials. Recent work in cachexia
      has revealed that this is mediated by pro-inflammatory cytokines. There are data that
      suggests that fish oils can affect the underlying pathogenic inflammatory response and have
      an affect on weight maintenance and nutritional balance

      Diseases in which cachexia is most common:

        -  Cancer

        -  Chronic Heart Failure (CHF)

        -  Chronic Obstructive Pulmonary Disease (COPD)

        -  Rheumatoid Arthritis (RA)

      Goals of the Study:

        -  To evaluate the safety and efficacy of fish oils vs. corn oil in the maintenance of
           weight and lean body mass in patients with disease-related weight loss.

        -  To understand the mechanism of fish oil effect on health maintenance by evaluating the
           anti-inflammatory, anti-catabolic, anti-oxidant and anabolic actions of these compounds

        -  To document the effect of our interventions on quality of life and functional status.

      Study Outline:

      Participants will be randomly assigned to receive either fish oil supplements or corn oil for
      the duration of this 3-month study. Participants will have five study visits and two
      telephone interviews. During each study visit, participants will undergo laboratory tests, a
      physical exam, and a dual energy X-ray absorptiometry (DEXA) bone scan. Participants will be
      asked to keep a food diary during the study. During the telephone interviews, participants
      will be asked health-related questions and discuss their current functional status.
    

Intervention name(s): Fish oil supplement
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cancer; Cancer Cachexia; Weight Loss; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure; Rheumatoid Arthritis
Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be performed in 2 parts conducted in parallel:

      Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen
      500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the
      pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the
      elimination of the drug after its administration) of nitrates (metabolite of naproxcinod)
      present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7
      days or naproxen 500 mg bid for 7 days as a reference.

      Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000
      mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the
      absorption, the distribution, the metabolism and the elimination of the drug after its
      administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the
      transformation of the naproxcinod, after oral administration of a single supratherapeutic
      dose of 3000 mg.
    


Intervention name(s): naproxcinod 750 bid; naproxcinod 3000 mg od; naproxen 500 mg bid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): naproxcinod 750 bid; naproxcinod 3000 mg od; naproxen 500 mg bid
Intervention MeSH terms: Naproxen; Naproxen-n-butyl nitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in
      terms of improvement of both skin and systemic manifestations of psoriasis.

      The investigators assume that pioglitazone (one of thiazolidinediones readily available in
      Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in
      addition to improving the insulin resistance in peripheral tissues observed in many psoriatic
      patients and causing metabolic syndrome. This will allow to give a safer therapy than the
      available ones for psoriasis and to treat the patient in a more global perspective.
    


Intervention name(s): actozone A; actozone B
Intervention type(s): Drug; Drug
Intervention description(s): pioglitazone 30 mg tablet , once daily dose for 10 weeks; one tablet of vehicle without active ingredient pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: psoriasis; insulin resistance; metabolic syndrome; pioglitazone; randomized control trial
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Condition: Skin Laxity; Wrinkles
MeSH terms: Cutis Laxa
Study type: Observational

Summary: 
      Up to 120 subjects within the study site's practice who have already had an Ultherapy™
      treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up
      visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each
      follow-up visit.
    

Detailed description: 
      This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera
      System for non-invasive treatment of skin texture and laxity six months after treatment.
      Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality
      of life questionnaires will be obtained.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of males and females from the investigator's practice
        between 25 and 85 years of age, who have received an Ultherapy™ treatment on or prior to
        October 1, 2011, who had pre-treatment baseline photographs taken, and who have chosen to
        participate in this clinical trial.
      
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently
      colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of
      S. aureus skin infections. In addition, research in the investigator's lab has shown that
      these patients have fewer protective antimicrobial Staphylococcal species such as
      Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides
      that play a role in protecting the skin from invading pathogens. In this study, the
      investigator will attempt to decrease S. aureus colonization and increase colonization of
      protective Staph species in AD patients. First the investigator will capture the bacteria on
      subjects' skin. Next the investigator will selectively grow the subject's antimicrobial
      Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus bacteria
      will be applied to one of the subject's arms for one week. Some subjects will receive
      placebo, which is the moisturizer alone (without bacteria). The investigator will then swab
      the arms at specified time points during and after the one week application in order to
      determine whether the S. aureus abundance was affected by the application of the transplanted
      bacteria.
    


Intervention name(s): Autologous Microbial Transplant
Intervention type(s): Biological
Intervention description(s): Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment