bioihbjkbjnl/mcl2 huggingface dataset:
ATHENA: Natural History of Disease Study in Alport Syndrome Patients
Condition: Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2
MeSH terms: Nephritis, Hereditary; Syndrome
Study type: Observational

Summary: 
      There is limited published clinical data about the natural history of renal disease in Alport
      syndrome. The RG012-01 study will collect data to characterize the progression of renal
      dysfunction in Alport syndrome patients.

      Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be
      considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow
      an assessment of the rate of change of established clinical endpoints, such as GFR and/or the
      rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects
      whose renal function is steadily declining. The identification of surrogate markers that
      track the decline of renal function and could correlate with time to end-stage renal disease
      (ESRD) is a key goal of the natural history study.
    

Detailed description: 
      This is a natural history study, designed to collect data from patients with Alport syndrome
      with qualifying GFR. Assessments and blood and urine sample collection will be performed at
      Baseline and every 12 weeks thereafter, for up to 120 weeks. Scheduling of clinic visits will
      take in to consideration the timing of Standard of Care (SOC) visits. Alternative
      arrangements may be made to enable subjects to schedule a home nurse visit for study
      procedures instead of certain clinic visits. Remaining blood and urine aliquots will be
      stored and may be used in the future for the discovery, analysis, verification and/or
      validation of other biomarkers or test for renal disease. The samples will be kept for up to
      five years. Each sample will be identified only by it's barcode number and will not be
      individually identifiable.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Alport syndrome patients with eGFR between 45-90 ml/min/1.73 m2
      
Keywords: Alport syndrome; kidney disease
Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of ziprasidone 20
      mg capsules versus Geodon 20 mg capsules under fed conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Ziprasidone 20 mg capsules and Geodon 20
      mg capsules in healthy subjects under fed conditions.
    

Intervention name(s): Ziprasidone Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ziprasidone HCL Capsules, 20 mg
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ziprasidone hydrochloride; crossover
Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when
      surgically implanted into a leg to improve blood flow in patients with peripheral arterial
      disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.
    

Detailed description: 
      This is a prospective, open label, single treatment arm, multicenter phase 2 study to
      evaluate the safety and efficacy of the HAV in patients with PAD undergoing femoro-popliteal
      bypass surgery. The primary objective of this study is to evaluate the safety and
      tolerability of the HAV in these patients and to determine the patency of the Humacyte HAV at
      12 months post-implantation. The secondary objectives of this study are to further assess
      safety in terms of PRA response, and to determine the rates of HAV interventions required to
      keep the HAV patent. There is no formal hypothesis testing planned; the study involves only a
      single, open-label treatment group.
    

Intervention name(s): Human Acellular Vessel (HAV)
Intervention type(s): Biological
Intervention description(s): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial (RILI Trial)
Condition: Recurred Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical outcomes depending on catheter ablation
      strategy for repeat ablation procedure among the patients with recurred atrial fibrillation
      after de novo catheter ablation. After randomization, we will conduct circumferential
      pulmonary vein isolation alone in a group, and additional posterior box isolation in the
      other group. Non-pulmonary vein foci ablation will be done in all patients. We will compare
      clinical recurrence rate, complication rate, and procedure time, etc.
    


Intervention name(s): Procedure with circumferential pulmonary vein isolation; Procedure with linear ablation in addiction to pulmonary vein isolation
Intervention type(s): Procedure; Procedure
Intervention description(s): We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.; We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurred atrial fibullation; CPVI; posterior wall isolation
A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
Condition: Health
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, sequential 2 cohort, intramuscular injection study in healthy
      volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety,
      pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection
      and nalbuphine injection.
    

Detailed description: 
      Each subject in a cohort will be evaluated for study eligibility during the screening period,
      which is within 28 days prior to receiving the study drug (Day 1). Eligible subjects will be
      admitted into the study site on Day -1 and will be required to stay in clinical site for 5
      (Cohort 1) or 2 nights (Cohort 2) for study procedures in each cohort. Eligible subjects will
      undergo additional eligibility assessments on Day -1 and those reconfirmed eligible will
      intramuscularly receive NALDEBAIN ER Injection (Cohort 1) or nalbuphine (Cohort 2) on Day 1.

      The blood sampling timepoints for Cohort 1 will be at predose, 6, 12, 24, 48, 56, 64, 72, 80,
      88, and 96 hours after dosing. Subjects will be discharged after the 96-hour blood sample and
      return to the clinical site for the sample collection at 120, 168, 216, 288 and 360 hours
      post dosing. The blood sampling timepoints for Cohort 2 will be predose, 5, 15, and 30
      minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose.

      Subjects will return for a follow-up visit to complete safety evaluations for approximately
      15 days after study drug administration in cohort 1; and 1 days after study drug
      administration in Cohort 2.
    

Intervention name(s): Dinalbuphine sebacate; Nalbuphine HCl
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg Dinalbuphine sebacate; 20 mg Nalbuphine
Other intervention name(s): NALDEBAIN ER Injection; Sebacoyl Dinalbuphine Ester Injection; LT1001; Nalbuphine HCl Injection
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Different Doses of Letrozole in Ectopic Pregnancy
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic
      pregnancy considerably has a high success rate without imposing any serious side effects
      compared to daily 5mg letrozole.
    

Detailed description: 
      Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical
      treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of
      letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were
      classified into three equal groups. Group I: The control group that contained women who were
      undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1)
      for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d. After that,
      the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after
      11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and
      progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked
      apoptosis in the placenta tissue. The utilization of letrozole at a dose of 10 mg d-1 for
      inducement of abortion typically results in a substantial high-successful rate without any
      severe side effects.
    

Intervention name(s): Letrozole tablets; laparoscopic salpingectomy
Intervention type(s): Drug; Procedure
Intervention description(s): GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III); laparoscopic salpingectomy
Other intervention name(s): Femara
Intervention MeSH terms: Letrozole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LETREZOLE; Ectopic pregnancy; Induced abortion
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Condition: Neurofibromatoses
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional

Summary: 
      The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use
      with adolescents, and to test its feasibility, acceptability, and preliminary effect in
      improving quality of life, and in decreasing stress and psychological distress.
    


Intervention name(s): Stress Management Group 1; Stress Management Group 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.; Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of AD128 Versus Placebo in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders.
      Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse
      cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are
      currently approved for OSA treatment.

      This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2
      clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in
      patients with OSA.
    


Intervention name(s): AD128; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of two capsules before sleep for 7 days.; Oral administration of two capsules before sleep for 7 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients who meet the eligibility criteria will be assigned alternatively to the the treatment with a AD128 or matching placebo. After 7 days of treatment and a washout period, the patients will crossover to the other arm for 7 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Apnea Hypopnea Index
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
Condition: Post COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      As of September 2020, the COVID-19 pandemic has affected millions of people in 196 countries
      and left hundreds of thousands dead. After recovery it was found that up to 32% of cases had
      1 or 2 symptoms, 55% had 3 or more Post-COVID-19 symptoms, and persistent Post COVID-19 cough
      was recorded in 29.3% of cases in one study.

      A recent study identified Montelukast, among the top-scoring clinically-oriented drugs likely
      to inhibit SARS-CoV-2 main protease. Besides its known effect that is reported to improve
      cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed
      Montelukast in the treatment of post-infectious cough and found variable effects.

      Despite that the exact mechanism is not yet identified, Barré and colleagues proposed several
      properties of Cyst LT1 receptor antagonists that are potentially beneficial in COVID-19.
    


Intervention name(s): Montelukast Sodium Tablets
Intervention type(s): Drug
Intervention description(s): intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days
Other intervention name(s): Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Montelukast; cough; cough severity
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults
Condition: Aging; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of this study is to gain a better understanding of the effects of exercise and
      cognitive training on improving brain function in healthy older adults who may be at risk for
      developing Alzheimer's Disease.
    


Intervention name(s): Exercise Training; Cognitive Training; Flexibility Training; Educational Sessions
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Aerobic exercise training program designed by the Cardiac Rehabilitation department; Based on cognitive training program Brain Fitness®; Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department; DVD-based educational programs on history, art, and literature
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy Aging
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
Condition: Sloughing Skin; Mucosal Inflammation
MeSH terms: Mucositis; Inflammation
Study type: Interventional

Summary: 
      This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and
      an SLS-containing toothpaste..
    

Detailed description: 
      Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the
      crossover design. Clinical assessment of oral mucosa status will be performed by a trained
      examiner before supervised product application, 30 minutes after product application and
      again after 4 days of twice daily brushing with product. Supervised product application
      consists of cap splint application of allocated toothpaste to maxillary arch followed by
      brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.

      For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and
      each area evaluated for severity of sloughing on a 0 to 5 scale.

      The following outcomes will be generated from the sloughing data:

        1. Whole mouth data per subject: each non-zero severity score will be treated as one lesion
           count, giving a maximum score of 12;

        2. Subject level mucosal severity sloughing score: severity score averaged over the 12
           areas assessed.
    

Intervention name(s): Treatment
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      : The objective of this study is to determine if bromfenac reduces diabetic macular edema
      (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the
      working-aged population in the United States. 60% of patients with Type-II DM, and nearly all
      with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema
      is the principal cause of vision loss in DR. Approximately 50% of patients with DME will
      experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of
      follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem
      have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms
      and a "grid" of laser has been the mainstays of treatment since the publication of the Early
      Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH
      sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic
      macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to
      improve the results are focusing on pharmaceutical interventions injected into the vitreous
      cavity. The route of administration and lack of substantiated efficacy are problematic.
    


Intervention name(s): Bromefenac; Blink
Intervention type(s): Drug; Drug
Intervention description(s): Bromfenac BID 3 months; Blink BID for 3 months
Other intervention name(s): Xibrom; Blink tears
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment