bioihbjkbjnl/mcl2 huggingface dataset:
Immune Mechanisms of Rejection in Human Lung Allografts
Condition: Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Observational

Summary: 
      The investigators have obtained compelling evidence that the development of anti-human
      leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly
      correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA
      antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag
      period between the development of anti-HLA antibodies and the onset of BOS gives us an
      opportunity to intervene to delay and/or prevent the development of BOS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patient who is a candidate for a lung transplant.
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in
      the treatment of acne vulgaris.
    

Detailed description: 
      The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product
      to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy
      of the test and reference products over the placebo control.
    

Intervention name(s): CLPG Topical Gel 1%; Clindamycin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.); Clindamycin Phosphate topical gel 1%; Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Other intervention name(s): Topical Gel 1%; Topical Gel 1%; Vehicle
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Condition: Leprosy
MeSH terms: Leprosy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy

      Objective: A randomised double blind controlled trial comparing Ciclosporin and
      Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the
      treatment of new Type 1 Reactions as Prednisolone.
    

Detailed description: 
      We tested our hypothesis that ciclosporin would be as effective as prednisolone in the
      treatment of patients with leprosy reactions and nerve function impairment and that patients
      treated with ciclosporin would have fewer side effects than patients treated with
      prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the
      treatment of acute leprosy T1R was conducted.
    

Intervention name(s): Ciclosporin; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks); prednisolone 40mg daily then reducing regimen over 24 weeks
Other intervention name(s): Cyclosporine; Cyclosporine A; corticosteroids
Intervention MeSH terms: Cyclosporine; Prednisolone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Leprosy; Type 1 Reactions; Prednisolone; Ciclosporin
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
Condition: Rotator Cuff; Arthroscopic Surgery
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      This is an observational study that involves subjects with full-thickness rotator cuff tears
      treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The
      primary objective of this study is to observe the timing and rate of tendon retear in those
      subjects.
    

Detailed description: 
      Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to
      assure they meet all eligibility criteria prior to enrolling them into the study.
    

Intervention name(s): Observational study of the surgical outcome
Intervention type(s): Other
Intervention description(s): Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Observational; rotator cuff tear; arthroscopic; surgical; outcome study
Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Nervous System Diseases; Central Nervous System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human
      anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of
      newborns with congenital CMV infection and no central nervous system disease.

      II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic
      outcome.

      III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus
      from the urine.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are treated with human anti-cytomegalovirus monoclonal antibody
      MSL-109, administered intravenously every other week for a total of 3 doses.

      Groups of 6 patients are treated at each of 3 MSL-109 doses; there is no intrapatient
      escalation.

      No concurrent therapy with antibiotics for systemic infection, parenteral antifungal agents,
      biological response modifiers, or other antiviral agents is allowed.

      Patients are followed every 2 weeks for 6 weeks, every 4 weeks for 12 weeks, then annually
      for 5 years.
    

Intervention name(s): SDZ MSL-109
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: congenital cytomegalovirus infection; cytomegalovirus infection; herpesvirus infection; immunologic disorders and infectious disorders; neonatal disorders; rare disease; viral infection
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography
Condition: Myocardial Bridge of Coronary Artery
MeSH terms: Myocardial Bridging
Study type: Observational [Patient Registry]

Summary: 
      Although the incidence of myocardial bridge (MB) has been defined in different conventional
      coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography
      (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients
      undergoing RACA.
    


Intervention name(s): radial access coronary angiography
Intervention type(s): Procedure
Intervention description(s): The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A retrospective evaluation was made of the coronary angiographies of 2600 consecutive
        patients who underwent radial access coronary angiography between January 2018 and February
        2020
      
Keywords: myocardial bridge; radial access coronary angiography
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and
      intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was
      to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive
      (NMIBC) patients treated with BCG or gemcitabine.
    

Detailed description: 
      Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for
      non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the
      management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC,
      however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options
      since the superiority of BCG has been only established for disease recurrence but not
      progression and it needs to be balanced against higher toxicity. According to current
      evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C
      or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine
      has an excellent toxicity profile and promising efficacy in NMIBC patients, including those
      at high-risk of disease recurrence, even if its role on the management of NMIBC has not been
      well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical
      chemotherapy addressing quality of life (QoL) issues. The aim of this study was to
      prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with
      BCG or gemcitabine.
    

Intervention name(s): Gemcitabine 2 g; BCG Vaccine
Intervention type(s): Drug; Drug
Intervention description(s): six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline; six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline
Other intervention name(s): Gemzar, Eli Lilly SpA; BCG Connaught 1/3 dose
Intervention MeSH terms: Gemcitabine; BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: non muscle invasive bladder cancer
Taste Supra-thresholds Among a Sample of Depressed Egyptian Adult Under Anti-depressants Therapy
Condition: Taste Disorders
MeSH terms: Taste Disorders
Study type: Observational

Summary: 
      Determine the taste intensity at supra-threshold among a sample of depressed Egyptian adults
      (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using
      filter paper disc(FPD) method using a psychophysical method through a scoring system.
    

Detailed description: 
      PECO

        -  P Population: depressed Egyptian adults under anti-depressants therapy

        -  E1 Exposure 1: Tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)

        -  E2 Exposure 2: Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine,
           Fluvoxamine, Sertraline, Citalopram, Paroxetine)

        -  C control (non exposure) : non-pharmacological treatment ( psychotherapy)

        -  O Outcome: Determine the taste intensity at supra-threshold among these patients using a
           psychophysical method through a scoring system
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Depressed Egyptian adults under anti-depressants therapy The patients will be recalled
        using their phone numbers recorded in their follow up records in order to come to the
        Diagnosis center at the faculty of Dentistry, Cairo University to be assessed for taste
        intensity at supra-threshold level and will be given identification numbers and divided
        into three groups, to which the operator shall be blinded.
Framing Messages for Smoking Cessation With Bupropion - 6
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This is a randomized study of message framing in individuals beginning a smoking cessation
      program utilizing bupropion SR and brief counseling, videos, and pamphlets.
    


Intervention name(s): Bupropion; Smoking Abstinence Program
Intervention type(s): Drug; Behavioral
Intervention description(s): This investigation was a randomized controlled study of two framed message conditions for smoking cessation in combination with open label bupropion SR (300 mg/day). Two hundred fifty-eight cigarette smokers were randomly assigned to receive either gain- or loss-framed video and printed messages encouraging smoking abstinence. Preproduced video and printed information were chosen as the intervention media because of their reliability in delivering specific framed messages. All participants were seen at a community mental health center for 6 months and received a 7-week supply of bupropion SR.
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft
      Contact Lens could retard myopia progress in youth
    

Detailed description: 
      This study is designed as a prospective, multicenter, randomized, double blinded, controlled,
      paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D
      in the past 12 months will be recruited from 2 study sites. The experimental soft contact
      lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right
      eye or the left eye of the subject , then the fellow eye will be assigned a control lens with
      a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8
      hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief
      assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3,
      6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical
      equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The
      secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary
      outcome measure is used to corroborate any changes in SER
    

Intervention name(s): soft contact lens
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: paired-eye design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myopia control; soft contact lens; eye diseases
A First in Human Study of RT001 in Patients With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      RT001 in patients with Friedreich's ataxia.
    

Detailed description: 
      Study RT001-002 is a randomized, double-blind, controlled, ascending dose study to evaluate
      the safety, tolerability, pharmacokinetic, disease state, and exploratory endpoints in
      patients with Friedreich's ataxia after oral administration. The study includes 2 dose levels
      of RT001.
    

Intervention name(s): Low dose cohort; High dose cohort
Intervention type(s): Drug; Drug
Intervention description(s): RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.; RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
Other intervention name(s): RT001 1.8 g/d (2 capsule per day); RT001 comparator 1.8 g/d (2 capsule per day); RT001 9.0 g/d (9 capsule per day); RT001 comparator 9.0 g/d (9 capsule per day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Voice Therapy With a Semi-occluded Vocal Tract
Condition: Voice Disorders
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      1. The first objective of this research is to investigate the immediate effects of three
           semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in
           2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally
           healthy participants and patients with voice disorders (dysphonia) visualized with
           laryngovideostroboscopy.

           Participants will receive a flexible laryngovideostroboscopy, both during normal
           phonation and during the specific SOVT exercise. These videos will be randomly and
           blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal
           Imaging (VALI) rating form (Poburka et al., 2017).

           Researchers will compare the effects of these SOVT exercises on the (supra)glottic
           activity with the effects found in a control group producing /u/ phonation, using a
           randomized controlled trial.

        2. The second objective of this research is to investigate the short- and long-term effects
           of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and
           self-report of patients with voice disorders (dysphonia).

      Participants will receive a short-term intensive therapy with the specific SOVT exercise
      across four weeks.

      Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the
      participants will be re-evaluated.
    


Intervention name(s): Straw phonation in air; straw phonation in water; /u/ phonation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air; Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water; /u/ phonation without a straw, control condition
Other intervention name(s): steady SOVT exercise; water-resistance therapy, fluctuating SOVT exercise; articulatory/steady SOVT exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: voice; semi-occluded vocal tract; larynx; randomized controlled trial; efficacy study
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis
Condition: Severe Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional

Summary: 
      After successful screening, first the investigators first treat patients of severe alcoholic
      hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's
      score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to
      steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non
      responders will be randomized to receive G-CSF for 28days.
    


Intervention name(s): G-CSF; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.; Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Randomized clinical trial in patients with knee osteoarthritis. Sixty patients will be
      evaluated, divided in three groups (20 in each). One group A will be treated by dry needling
      in the vast internal, other group B will be treated with a standardized treatment protocol
      (electrotherapy and manual therapy), and group C will be treated with hialuronic acid. The
      investigators want to observe which technique is the most effective in osteoarthritis.
    


Intervention name(s): dry needling; ultrasound; hyauluronic acid
Intervention type(s): Device; Other; Device
Intervention description(s): dry needling on the trigger point of the vastus medialis of the quadriceps; aply ultrasound on the knee; aply hyaluronic acid on the knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment