bioihbjkbjnl/mcl2 huggingface dataset:
Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
Condition: Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Postpartum depressed women suffer from functional impairment in their mood, thoughts,
      cognition and physical well being leading to poor motivation, bonding difficulties, decreased
      productivity, conflict and neglect. Moderate/ severe depression responds best to a
      combination of antidepressants and counseling. This study will estimate the proportion of
      women who return to functionality after treatment with Desvenlafaxine and examine the
      differential impact of change in depression and anxiety symptoms on functionality over twelve
      weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires;
      functional recovery will be monitored through a simple self-report questionnaire at each
      visit.
    

Detailed description: 
      Women will be recruited through a tertiary level care program and advertisements in BC
      Children's & Women's Hospital as well as St.Paul's Hospital, Vancouver, B.C., Canada. If
      deemed eligible for the study (meeting a diagnosis of postpartum depression with or without
      comorbid anxiety disorder) and the potential participant agrees to participate, consent will
      be signed. The participant will return on a bi-weekly basis for study visits, where mood and
      anxiety will be monitored, in addition to blood pressure and weight. Starting dose of
      Desvenlafaxine is 50mg, and this can be titrated to 100mg/per day if needed. Questionnaires
      will assess depression symptoms, anxiety symptoms, quality of life, panic disorder,
      obsessive-compulsive disorder and generalized anxiety disorder.
    

Intervention name(s): Desvenlafaxine
Intervention type(s): Drug
Intervention description(s): 50mg-100mg everyday for 12 weeks over 7 study visits
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder, Postpartum Onset
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, double blind, randomized, single dose, active-controlled study to investigate
      the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine
      surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory
      distress syndrome. Main objectives of this study are to investigate the short term efficacy
      profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced
      oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in
      terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36
      weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated
      mortality through 14 days of age and other major co-morbidities of prematurity.

      Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either
      sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with
      RDS, requirement of endotracheal surfactant administration within 24 hours from birth,
      fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for
      babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2)
      between 88-95%.
    


Intervention name(s): CHF5633; Poractant alfa
Intervention type(s): Drug; Drug
Intervention description(s): Rescue treatment (if needed); Rescue treatment (if needed)
Intervention MeSH terms: Poractant alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: neonates, pulmonary surfactant
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Condition: Tobacco Use Disorder; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Regular aspirin use has been associated with a reduction in the development of a number of
      different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is
      not known. This study will evaluate whether once daily aspirin use can reduce the production
      of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically,
      this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme
      named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either
      aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various
      days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4
      timepoints in this 16-day study.
    


Intervention name(s): Aspirin 325 mg daily; Celecoxib 200 mg BID
Intervention type(s): Drug; Drug
Intervention description(s): In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.; In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.
Intervention MeSH terms: Aspirin; Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in
      diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an
      oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the
      effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12
      months of treatment. Subjects will be assessed at screening and baseline, with office visits
      every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion,
      the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve
      conduction velocity that is expected to be demonstrated in the group randomized to placebo
      treatment for up to 12 months.
    

Detailed description: 
      This 12 month double-blind, randomized, placebo-controlled, parallel group efficacy and
      safety study will enroll 400 adult diabetic subjects with diabetic peripheral neuropathy
      (DPN) to investigate the effect of diepalrestat (BNV-222) 150 mg, 300 mg, or placebo on MNCV
      and patients' perception of nerve function over 12 months as measured by VAS scales and
      composite clinical outcome patient reported scales that evaluate numbness, tingling,
      cramping, paresthesiae, hyperesthesia, coldness, weakness and spontaneous pain perception of
      upper and lower extremities, and the effects on other measures of nerve motor and sensory
      conduction. Subjects will be assessed at screening and baseline, with office visits every 12
      weeks, for a total of 6 visits. Subjects will be assessed by testing motor nerve conduction
      velocity and other assessments at each office visit. A subgroup of 24 patients will be
      selected for pharmacokinetic (PK) testing for up to 48 hours with additional blood draws on
      Day 7 and 14. This study will investigate the ability of diepalrestat to reduce the ongoing
      deterioration of nerve function which is a hallmark of the DPN process.
    

Intervention name(s): diepalrestat choline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): aldose reductase inhibitor; Placebo
Other intervention name(s): BNV-222
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Group and Mobile Care for Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      A critical variation in the provision of prenatal care to women with GDM is the need to keep
      patients engaged with their care between visits by tracking glucose levels using finger
      sticks and making dietary and other lifestyle modifications to keep these levels at or close
      to normal. Multiple studies have demonstrated that the use of mobile devices can improve
      medical outcomes. In order to keep patients engaged between appointments and improve
      self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition
      therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with
      GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give
      the user positive feedback and rewards for using the system. This model of group care with
      mobile phone monitoring and reminders for women with GDM has not been previously studied. A
      randomized control trial is purposed to determine if this approach improves patient care. The
      investigators hypothesize that group prenatal care along with inter-session mobile therapy
      will increase dietary compliance and therefore reduce the number of individuals requiring
      pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care
      (GPC) will provide a community foundation to improve learning and increase the motivation of
      patients to learn and change. This motivation will be further strengthened by the use of the
      GlucoseMama monitoring system which will provide each patient with glucose tracking and
      individualized nutritional support.
    


Intervention name(s): GlucoseMama application with blood sugar monitoring and carb monitoring.; Group prenatal care for GDM.
Intervention type(s): Other; Other
Intervention description(s): We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.; group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
RNF213 Variants and Collateral Vessels in Moyamoya Disease
Condition: Moyamoya Disease
MeSH terms: Moyamoya Disease
Study type: Observational

Summary: 
      The purpose of this study is to detect the association between RNF213 variants and collateral
      vessels in patients with moyamoya disease.
    

Detailed description: 
      Moyamoya disease (MMD) is a chronic cerebrovascular disorder characterized by the presence of
      occlusion which occurs at the internal carotid arteries and their main branches during the
      development of a basal collateral network. The ring finger 213 (RNF213) was identified as a
      strong susceptibility gene in patients with MMD in East Asia. The role of RNF213 variants in
      pathogenesis of MMD is still unclear. Specific "moyamoya vessels" correlate with the onset of
      stroke. The purpose of this study is to investigate the relationship between RNF213 variants
      and collateral vessels in patients with moyamoya disease, and provide potential pathogenesis
      of moyamoya disease.
    

Intervention name(s): Identification of genetic variants
Intervention type(s): Other
Intervention description(s): Identification of genetic variants
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Moyamoya disease patients
      
Biospecimen description: 
      Whole blood
    
Keywords: Moyamoya Disease; RNF213 Variants; Collateral Vessels
Hallux Valgus Conservative Treatment
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.
    

Detailed description: 
      30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2
      groups

        1. st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was
           measured using Xray and pain was measured using VAS before applying tape and after 8
           weeks of tape application.

        2. nd group receive placebo tape bilaterally and had the same measurements.

      2 groups were on a group of exercises
    

Intervention name(s): Kinesiotape
Intervention type(s): Other
Intervention description(s): Elastic tape used for mechanical correction of the deformity in study group and placebo in control group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pretest and posttest Control group randomized control trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in
      patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine
      the safety and tolerability of ascending single and repeated doses of HepaStem administered
      to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)
    


Intervention name(s): HepaStem
Intervention type(s): Drug
Intervention description(s): Heterologous human adult liver-derived progenitor cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NASH
Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to
      random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform
      and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene
      mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane
      (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of
      nullipara patients. Investigators will investigate which technique keep the vaginal axis is
      closer to the original anatomic position.
    

Detailed description: 
      Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described.
      Before, correcting only prolapsed part, now, we can measure anatomical and functional results
      more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12,
      IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important
      in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put
      vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral
      sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of
      anatomic results.
    

Intervention name(s): Bilateral Abdominal Sacral Hysteropexy; Conventional abdominal Sacral Hysteropexy; Nulliparous women with no uterovaginal prolapsed
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): The mesh will be fixed right and left side of sacrum.; The mesh will be fixed only right side of sacrum; This will be control group which consistent patients with no uterovaginal prolapse.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tobacco Cessation in Postmenopausal Women
Condition: HRT; Non-HRT; Continued Smoking; Smoking Abstinence
Study type: Interventional

Summary: 
      This study investigated whether being on transdermal hormone replacement therapy (HRT)
      influenced smoking cessation variables in postmenopausal women undergoing short-term
      abstinence from cigarettes. Women were recruited into two groups according to their
      pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT
      group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system
      and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants
      continued smoking as usual for one week, at which time baseline measurements were taken. For
      the remaining two weeks, participants were instructed to quit smoking. They were provided
      with smoking cessation counseling and monitored for abstinence. Data were collected during
      five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck
      Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction
      Time Test.

      Part II is identical to Part I, except it randomizes participants to use nicotine patch or
      not.
    


Intervention name(s): Part 2
Intervention type(s): Behavioral
Intervention description(s): Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gestational Diabetes Mellitus, Obesity and Periodontal Disease
Condition: Diabetes Mellitus, Gestational; Periodontal Diseases; Obesity
MeSH terms: Periodontal Diseases; Diabetes, Gestational; Diabetes Mellitus; Obesity
Study type: Observational

Summary: 
      This study evaluated the periodontal condition of gestational diabetes mellitus (GDM)
      patients and a healthy non-pregnant control group. For the GDM group all medical data were
      recorded, including obesity/insulin resistance indicators.
    

Detailed description: 
      Gestational diabetes mellitus is associated to a worse periodontal condition. Many patients
      with these two diseases are also obese. After delivery, some patients maintain the
      pre-pregnancy obesity status and this condition is also associated to periodontal disease.
      The mechanisms involved in the relationship of all these medical and periodontal conditions
      are not clear.
    

Intervention name(s): Gestational diabetes mellitus
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Only female participants
      
Keywords: Gestational Diabetes Mellitus; Obesity; Periodontal Disease
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
    

Detailed description: 
      Favipiravir is a drug with a mechanism of action different from that of the existing
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to
      antiviral activity.
    

Intervention name(s): Test: Favipiravir 200 mg (LOQULAR); Reference: Favipiravir 200 mg (Avigan)
Intervention type(s): Drug; Drug
Intervention description(s): Test Drug; Reference Drug
Other intervention name(s): LOQULAR 200 MG FT; Avigan 200 mg Film Tablet
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19 drug treatment; Antiviral Agents; Favipiravir; Novagenix; Farmagen; World Medicine