bioihbjkbjnl/mcl2 huggingface dataset:
Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser
      photocoagulation employing a pattern scanning laser system Pascal given in a single-session
      versus conventional laser multiple-session treatment of the same patient with diabetic
      retinopathy.

      Methods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic,
      Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on
      one eye using the multispot panretinal photocoagulation given in a single-session system
      Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was
      carried out by the classic conventional multiple-session method (MSM).
    


Intervention name(s): lasercoagulation by Pascal system; conventional laser
Intervention type(s): Device; Device
Intervention description(s): pattern scanning laser system Pascal given in a single-session; conventional laser multiple-session treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic retinopathy; patterns; low time of impulse; Pascal
Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      The investigators are doing a study on the bacteria that normally live in the vagina and what
      effect, if any, Depo-Provera has on the bacteria.

      Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or
      sexually transmitted disease (STD) check-up, or have a child and are planning to receive a
      Depo-Provera shot for contraception or have declined the use of hormonal contraception may
      join.
    

Detailed description: 
      The investigators are doing a study on the bacteria that normally live in the vagina and what
      effect, if any, Depo-Provera has on the bacteria.

      Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or
      STD check-up, or have a child and are planning to receive a Depo-Provera shot for
      contraception or have declined the use of hormonal contraception may join.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy 13-24 Adolescent Girls and Young Women
Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this research is to determine whether varying the energy density and portion
      size of the main course will affect meal energy intake after consumption of a first course
      that has previously been shown to enhance satiety. It is hypothesized that increasing either
      the energy density or portion size of the main course will increase meal energy intake after
      consumption of the first course. It is also hypothesized that compared to when a first course
      is consumed, not consuming a first course will increase meal energy intake.
    


Intervention name(s): Energy density and portion size feeding study
Intervention type(s): Other
Intervention description(s): In a crossover design, adults are served breakfast and lunch, 1 day a week for 6 weeks. Breakfast is not varied across weeks. At 4 of the lunch meals, a salad first course will be served that needs to be eaten in its entirety. At these 4 meals the lunch entree will vary in energy density (100% and 133%) and portion size (100% and 133%). At the 2 lunch meals for which no first course is served, the lunch entree will be vary in energy density (100% and 133%) but be the same portion size (133%).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Feeding behavior
Time to Peak Effect of Propofol in Children
Condition: Propofol; Child
Study type: Interventional
Phase: Phase 4

Summary: 
      In order to determine the speed of onset of the anaesthetic propofol in children,
      investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome
      measure is the time to peak effect of a bolus of proposal, which is measured by analysing the
      electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will
      enable investigators to quantify the difference with age in the hypnotic effect of propofol.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacodynamic; Permutation Entropy; EEG
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose
      (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and
      pharmacodynamic (PD) profiles of HTD1801 in overweight to obese adults with
      hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with
      16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.
    


Intervention name(s): HTD1801 Tablets, 500 mg; HTD1801 Tablets, 1000 mg; HTD1801 Tablets, 2000 mg; Placebo to match 500 mg HTD1801; Placebo to match 1000 mg HTD1801; Placebo to match 2000 mg HTD1801
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500 mg/day (250 mg BID); 1000 mg/day (500 mg BID); 2000 mg/day (1000 mg BID); 2 tablets/day (1 tablet BID); 4 tablets/day (2 tablet BID); 8 tablets/day (4 tablet BID)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients
Condition: Severe Stroke; Acute Stroke; Mild Stroke; Central Nervous System Diseases; Cerebrovascular Disease; Brain Diseases; Cardiovascular Diseases; Gait, Hemiplegic
MeSH terms: Stroke; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Gait Disorders, Neurologic; Cardiovascular Diseases
Study type: Interventional

Summary: 
      To date, no studies seems to compare conventional gait rehabilitation program with
      end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics
      beyond clinical multi prospective outcomes.

      The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute
      stroke patients in terms of clinical outcomes and gait kinematics, comparing them with
      conventional gait rehabilitation program.
    

Detailed description: 
      To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of
      clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation
      program, patients following first ever stroke in sub-acute phase will be recruited and
      assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end
      of training program (T1). The patients will be divided into 2 groups and will conduct two
      different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of
      Rome and will perform, in addition to conventional therapy, gait training using an
      end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited
      by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait
      rehabilitation program(Conventional Group, CG).
    

Intervention name(s): Robot-Assisted Gait Training (RAGT)
Intervention type(s): Device
Intervention description(s): The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded, non randomized, pilot study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Robot; Hemiparesis; Gait Training; Rehabilitation; Functional Recovery; Robot-Assisted Gait Training
A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to
      evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of
      MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
    

Detailed description: 
      This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to
      evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and
      multiple ascending doses to subjects with T2D.
    

Intervention name(s): MEDI-4166; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): MEDI-4166 administered subcutaneously; Placebo administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MEDI-4166, diabetes
The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
Condition: Hypertension; Mineralocorticoid Receptor Antagonist
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test if a study drug (CS-3150) will affect the heart rate in healthy males
      and females. Two doses of the study drug will be tested. Heart rate is not expected to be
      different between the study groups.
    

Detailed description: 
      This study will assess the effect of therapeutic and supratherapeutic plasma exposures of
      CS-3150 on the corrected QT (QTc) interval duration after administration of single oral 10-mg
      and 40-mg doses of CS-3150 in healthy male and female participants. This study will also
      determine the safety and tolerability of CS-3150 administration, assess the effect on
      electrocardiogram (ECG) parameters, detect QT interval (QT)/QTc prolongation with a positive
      control (moxifloxacin), characterize pharmacokinetics (PK) of CS-3150, and assess
      exposure-response relationship of CS-3150 on QTc.
    

Intervention name(s): CS-3150; Moxifloxacin; Placebo matching moxifloxacin tablet; Placebo matching CS-3150
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single, oral administration; 10-mg or 40-mg dose; Single, oral administration; 400 mg-tablet; Placebo tablets matching moxifloxacin tablets; Placebo tablets matching CS-3150 tablets
Other intervention name(s): Esaxerenone; Avelox; Placebo; Placebo
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a phase 1, single center, randomized, single-dose, double-blind, double-dummy, placebo- and positive-controlled, 4-period crossover study. Participants will be randomized to one of the following 4 treatment sequences:
CS-3150 (10-mg dose)/CS-3150 (40-mg dose)/moxifloxacin/placebo
CS-3150 (40-mg dose)/placebo/CS-3150 (10-mg dose)/moxifloxacin
Moxifloxacin/CS-3150 (10-mg dose)/placebo/CS-3150 (40-mg dose)
Placebo/moxifloxacin/CS-3150 (40-mg dose)/CS-3150 (10-mg dose)
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hypertension; Mineralocorticoid receptor antagonist
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Condition: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional

Summary: 
      The purpose of this study is to access the efficacy of MMF compared to CTX in inducing
      remission and improving renal function in subjects with ANCA associated vasculitis with renal
      involvement.
    

Detailed description: 
      The ANCA-associated vasculitides can be life threatening. Glucocorticoids and
      cyclophosphamide therapy is effective in about 80% patients. However, the side effects such
      as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further
      use of cyclophosphamide in some patients and the relapse rate is high.

      Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate
      mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition
      of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis,
      which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus
      nephritis with vasculitic lesions. This study was a feasibility study to assess the safety
      and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared
      with pulse intravenous cyclophosphamide. After enrollment, subjects were followed
      longitudinally, and formal measurements of disease activity were determined using the
      Birmingham Vasculitis Activity Score (BVAS).
    

Intervention name(s): mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): MMF,1.0g/d
Other intervention name(s): MMF,cellcept,mycophenolate mofetil
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ANCA; vasculitis; mycophenolate mofetil; cyclophosphamide; treatment
Exercise and Repetitive Diving
Condition: Decompression Sickness; Endothelial Dysfunction; Neutrophil Activation; Venous Gas Emboli
MeSH terms: Decompression Sickness
Study type: Interventional

Summary: 
      SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this
      study was to see how exercise impacts microparticles (MPs), endothelial function, and venous
      gas emboli (VGE) over a series of dives.

      16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by
      5 days rest then 3 dives preceded by exercise. The other group completed the opposite
      protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before
      and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min
      after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4
      min intervals at 90% VO2max effort.
    


Intervention name(s): Aerobic running exercise
Intervention type(s): Other
Intervention description(s): 60 min of aerobic intervals completed prior to SCUBA diving
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SCUBA diving; Exercise; Microparticles; Repetitive diving; Endothelial function
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
Condition: Lupus
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets
    


Intervention name(s): BMS-986165-01; BMS-986165 Tablet; Famotidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive BMS- 986165 -01 in prototype formulation; Participants will receive BMS-986165 in tablet form.; Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
Intervention MeSH terms: Deucravacitinib; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic
      AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic
      dermatitis using biometrological, biological and clinical parameters.
    


Intervention name(s): Lactibiane Topic AD; Placebo
Intervention type(s): Other; Other
Intervention description(s): Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area; Application of placebo twice a day (morning and evening) on the symmetrical lesional area
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus
      erythematosus.

      II. Evaluate objective disease parameters, including serum complement levels, anti-DNA
      antibody titers, sedimentation rate, and the systemic lupus activity measure in these
      patients.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a
      maximum of 3 courses; those who relapse prior to the second course are re-treated every 3
      weeks.
    

Intervention name(s): cytarabine
Intervention type(s): Drug
Intervention MeSH terms: Cytarabine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis & connective tissue diseases; immunologic disorders and infectious disorders; rare disease; systemic lupus erythematosus
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is a comparison of abstinence maintenance in subjects
      randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded
      to an intial 12-week open label course of varenicline, with post-treatment follow-up of
      smoking status to Week 52.
    


Intervention name(s): varenicline (CP-526,555)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Condition: Premature Birth; Infant, Very Low Birth Weight; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is multicentered, prospective, randomized, opened, parallel, intervention study.

      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the
      prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational
      age.

      The investigators evaluate the first effectiveness through the morbidity and mortality of
      bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness
      through the oxygen index, the usage of mechanical ventilator about taking medicine after 2
      Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial
      lavage fluid.
    


Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: montelukast; BPD; singulair; prematurity
Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness
Condition: Fertility
Study type: Interventional

Summary: 
      Fertility knowledge and awareness is considered insufficient in women of reproductive age
      from developed countries. The objective of this study is to evaluate if educational
      interventions in oocyte donors increase on their level of fertility knowledge and awareness.
    

Detailed description: 
      Fertility knowledge and awareness is considered insufficient in women of reproductive age
      from developed countries. The objective of this study is to evaluate if educational
      interventions in oocyte donors increase on their level of fertility knowledge and awareness
      through a RCT. The investigators will evaluate the effect of the interventions through a
      questionnaire filled in at first visit (pre-test) and at the end of the treatment
      (post-test); the investigators will compare the increase in the total score between groups.
    

Intervention name(s): Written information; Written and oral information
Intervention type(s): Other; Other
Intervention description(s): Brochure; Written information consists in a brochure with information about fertility, while oral information consists in a tailored oral explanation about the wrong answers to the pre-test (that is related to the brochure).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test the efficacy and safety of the combination of Calcium
      Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class)
      and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not
      adequately controlled with olmesartan medoxomil alone
    


Intervention name(s): olmesartan medoxomil and a CCB; olmesartan medoxomil and a diuretic
Intervention type(s): Drug; Drug
Intervention description(s): olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks; olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Diuretics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Essential hypertension; Combination therapy