bioihbjkbjnl/mcl2 huggingface dataset:
Isotretinoin for Proliferative Vitreoretinopathy
Condition: Proliferative Vitreoretinopathy
MeSH terms: Vitreoretinopathy, Proliferative
Intervention: Isotretinoin
Intervention description: Isotretinoin 20mg daily for 12 weeks
Intervention MeSH terms: Isotretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an
      important cause of retinal re-detachment. The purpose of this study is to evaluate the effect
      of oral isotretinoin, which inhibits the growth of cells responsible for proliferative
      vitreoretinopathy (PVR), on recurrent retinal detachment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-70 year-old men or 50-70 year-old, post-menopausal women.

          -  Healthy enough to participate in the study.

          -  Willing and able to consent to participation.

          -  Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or

          -  Primary RD (retinal detachment) associated with one or more high-risk features

        Exclusion Criteria:

          -  History of hypersensitivity to isotretinoin.

          -  Current use of a corticosteroid (excluding topical).

          -  Any history of depression, anorexia, liver or pancreatic disease.

          -  More than one prior surgical RD repair.

          -  Patients with closed funnel retinal detachments.

          -  Patients with chronic retinal detachment, defined as longer than 12 weeks.

          -  Any use an oral retinoid within 6 months.

          -  Systemic chemotherapy within 6 months.

          -  Patients taking supplemental vitamin A.

          -  Corneal opacity sufficient to impair surgical view.

          -  Proliferative diabetic retinopathy.
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Condition: Smoking Cessation
Intervention: Varenicline Tartrate; Placebo
Intervention description: Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration); Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1510.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking reduction; smoking cessation

Summary:

      This study will determine whether varenicline is safe and helps people to quit smoking
      through reduction when they are not willing/able to make an abrupt quit attempt.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female cigarette smokers over the age of 18 years who are not willing/able to
             quit smoking within the next month but who are willing to attempt to reduce their
             smoking to work toward a quit attempt within the next 3 months.

          -  Subjects must have smoked an average of at least 10 cigarettes per day during the past
             year and during the month prior to the screening visit, with no continuous period of
             abstinence greater than 3 months in the past year and who have an exhaled carbon
             monoxide (CO) >10 ppm at screening.

          -  Subjects with mild to moderate depression or anxiety may be included if their
             condition is stable.

        Exclusion Criteria:

          -  Subjects with a history of a suicide attempt or any suicidal behavior in the past two
             years.

          -  Subjects with severe depression or anxiety.

          -  Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress
             disorder (PTSD), or schizophrenia.

          -  Subjects with alcohol or substance abuse or dependence (except nicotine) unless in
             full remission for at least 12 months.
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Intervention: Ablation of the incompetent small saphenous vein
Intervention description: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic venous insufficiency; varicose vein; small saphenous vein

Summary:

      The aim of this study is to perform a randomized, prospective trial comparing the two current
      methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein
      (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one
      is superior to the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic chronic venous insufficiency.

          -  Patients in whom endovenous thermal ablation is clinically indicated.

          -  Have previously undergone at least 6 weeks of conservative treatment with compression
             stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).

          -  Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow
             in the saphenous vein >0.5 seconds after calf compression or while standing.

        Exclusion Criteria:

          -  Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive
             of spider vein injections or other cosmetic surface procedures).

          -  Have a history of Deep Venous Thrombosis (DVT).

          -  Have a history of hypercoaguability disorder.

          -  Are pregnant or breastfeeding.

          -  Are nonambulatory.
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Condition: Healthy Volunteers
MeSH terms: Depression
Intervention: Restylane Lidocaine; No-treatment control
Intervention description: Hyaluronic acid based filler; No-treatment control
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for
      treatment of depressed facial acne scars
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intent to undergo treatment of depressed acne scars

          -  Presence of 5-20 scars with a diameter of up to approximately 4 mm within the
             treatment area

          -  Similar type, size and number of scars on both cheeks

          -  Men or non-pregnant, non-breast feeding women

          -  Fitzpatrick skin type I-IV

          -  Signed and dated informed consent to participate in the study

        Exclusion Criteria:

          -  Presence of more than 3 scars per cheek (within the treatment area) of the following
             types: icepick scars or atrophic acne scars with a diameter of > 4 mm.

          -  Active acne with inflammatory component

          -  Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide,
             alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration
             above 2%, or antibiotic treatment for active acne within 4 months before treatment

          -  Use of isotretinoin within 6 months before treatment

          -  Post-surgical scars in the treatment area

          -  Previous tissue augmenting therapy or contouring with permanent filler or
             fat-injection in the treatment area

          -  Previous tissue augmenting therapy, contouring or revitalisation treatment with
             Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area
             within 24 months before treatment

          -  Previous tissue augmenting therapy, contouring or revitalisation treatment with
             non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area
             within 12 months before treatment

          -  Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy,
             chemical peeling or dermabrasion in the treatment area within 6 months before
             treatment

          -  Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo
             in the treatment area

          -  Any medical condition that, in the opinion of the treating Investigator, would make
             the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease
             that may interfere with the outcome of the study)
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Condition: Uterine Fibroids; Fertility Disorders
MeSH terms: Leiomyoma; Tissue Adhesions
Intervention: Ringer lactate solution; Prevadh film
Intervention description: Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.; Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 61.0
Sex: Female
Minimum age: 20 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: myomectomy; adhesion prevention; pregnancy rate

Summary:

      The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the
      prevention of adhesions in gynaecologic surgery, and to assess post-operative complications
      related to adhesions and pregnancy rate after myomectomy by open surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with
             the fertility by the patient who having an immediate or differed desire of pregnancy.

          -  Size: diameter ≥ 6 cm at echographia (for the highest diameter)

          -  Location interstitial and / or subserosa

          -  planned laparotomic surgery

          -  negative pregnancy test within 48 hours of surgery

          -  signed inform consent

        Exclusion Criteria:

          -  History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)

          -  Pre-operative embolization

          -  Endometriosis stage >1 (American Fertility Society classification ≥ 5)

          -  Pregnant patient

          -  Diabetes

          -  Chronic corticotherapy / immuno-supressor or immuno-modulator drugs

          -  Previous analog LH-RH drug therapy for the uterine myoma
Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Condition: Brain Neoplasm
MeSH terms: Brain Neoplasms
Intervention: Injection Tramadol; placebo
Intervention description: 0.9% Normal saline in 10 ml syringe
Intervention MeSH terms: Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: supratentorial craniotomy; extubation response; emergence; tramadol

Summary:

      Several modalities have been studied to prevent coughing during emergence, including
      extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no
      reliable method is recommended as standard of care. The advantages of administering tramadol
      includes a long duration of action, rapid recovery, limited depression of respiratory
      function and no effect on platelet makes it a safe medication to use for neurosurgical
      patients after craniotomy. The primary objective of the study is to observe the effect of
      single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic
      response (measurement of B.P and H.R) during extubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with craniotomy for supratentorial tumors under general anesthesia

          -  American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients

          -  Elective surgery

          -  Patients with Glasgow Coma Scale (GCS) 15/15

        Exclusion Criteria:

          -  Patients with a history of allergy or hypersensitivity to tramadol.

          -  History of epilepsy or convulsions due to any reason.

          -  Chronic usage of analgesic drugs.

          -  Patients using monoamine oxidase inhibitors.

          -  Patients with clinical signs of raised ICP.

          -  Obesity (women with a body mass index >35 kg/m2 or men with a body mass index >42
             kg/m2)

          -  Language barrier.

          -  Patients taking B-blockers or Ca channel blockers.

          -  Patients above 65 years of age ( Physiology difference)
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; ribavirin
Intervention description: 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1); 1000/1200mg (< or >= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous
      intravenous (iv) drug users who have CHC and are currently enrolled in a methadone
      maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the
      target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients at least 18 years of age

          -  CHC infection, genotype 1, 2, or 3

          -  naive to treatment for CHC infection

          -  enrolled in a methadone maintenance program with documented attendance for at least 3
             months

          -  use of 2 forms of contraception during the study on both men and women

        Exclusion Criteria:

          -  previous treatment for CHC infection

          -  co-infection with human immunodeficiency virus (HIV)

          -  current use of IV or other illicit drugs

          -  decompensated cirrhosis

          -  women who are pregnant or breastfeeding
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sildenafil citrate; Sildenafil citrate; Sildenafil citrate; Sildenafil citrate
Intervention description: oral, 20 mg, tid; oral 1 mg, tid; oral 5 mg, tid; oral 20 mg, tid
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment
      of subjects with PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with
             surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute
             walk test distance is >/= 100 m and </= 450 m.

          -  Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery
             wedge pressure of </= 15 mmHg at rest via right heart catheterization performed within
             12 weeks prior to randomization.

        Exclusion Criteria:

          -  Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH
             related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or
             significant arthritis.

          -  Subjects who are currently receiving any forms of chronic treatment for PAH such as
             prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric
             oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors
             such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers.
             Subjects previously receiving any of these drugs must have stopped use for a period of
             at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3
             months).
Embryo Selection by Time Lapse Monitoring for Single Embryo Transfer ("SET")
Condition: Clinical Pregnancy After Single Embryo Transfer
Intervention: time-lapse morphokinetic evaluation
Intervention description: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 161.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: time lapse monitoring; blastocyst; single embryo transfer; clinical pregnancy; implantation rate

Summary:

      A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo
      selection technologies are inefficient in identifying the embryo with the highest
      implantation potential. Time lapse (TL) embryo monitoring provides additional information
      about embryo development and therefore may aid embryo selection. The investigators aim is to
      study whether TL monitoring is superior to traditional embryo observation when a single
      blastocyst is selected for transfer (ET).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 36 yrs

          -  baseline FSH <10 IU/l

          -  regular 25-35 day cycles

          -  less than 2 previous failed IVF cycles

          -  intact uterus

          -  an indication for IVF

          -  BMI <18- <30 kg/m2

          -  acceptance of single embryo transfer

        Exclusion Criteria:

          -  PCOS

          -  Sperm obtained by surgical extraction

          -  chromosome abnormality

          -  Presence of hydrosalpinx

          -  stage III/IV endometriosis

          -  Less than 3 good quality day 3 embryos

          -  only one good quality day 5 embryos

          -  lack of consent
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Pentosan polysulfate sodium 100 mg; Placebo; Pentosan polysulfate sodium 100 mg
Intervention description: One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks; One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks; One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Intervention MeSH terms: Pentosan Sulfuric Polyester
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interstitial Cystitis; Urinary Bladder Pain

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate
      sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo
      for 24 weeks for the relief of bladder pain or discomfort associated with interstitial
      cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis
             Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI

          -  must have experienced bladder pain, urinary urgency and urinary frequency, each not
             related to a urinary tract infection, for at least 6 months prior to entry into the
             study

          -  must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and
             averaged >= 1 void at night

          -  urine culture showing no evidence of urinary tract infection

          -  urine cytology showing no evidence of neoplastic cells

        Exclusion Criteria:

          -  Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl
             sulfoxide) during or within 4 weeks prior to the study

          -  patients who have had cytoscopic evaluation within 4 weeks prior to the study

          -  patients who are currently (within last month) receiving other medications that may
             affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines,
             antispasmodics, anticholinergics)

          -  patients who are chronic users of Schedule II narcotics or who are using any scheduled
             narcotics at the time of study entry

          -  patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as
             tissue plasminogen activator and streptokinase