bioihbjkbjnl/mcl2 huggingface dataset:
The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
Condition: PHN - Post-Herpetic Neuritis
MeSH terms: Neuritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, crossover study, conducted in healthy Chinese
      populations, and plans to enroll 48 healthy adult subjects (male and female).
    


Intervention name(s): HSK16149，probenecid, cimetidine
Intervention type(s): Drug
Intervention description(s): 40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1~D4 200mg cimetidine QID from D1~D4
Intervention MeSH terms: Probenecid; Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU
Condition: Mechanical Ventilation
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      The objective of the study is to evaluate the effects of halogenated gases on sedation and
      analgesia, to describe the tolerance and to determine the risk factors for failure, in
      pediatric intensive care patients during prolonged sedation.

      This study will be based on the medical records of patients hospitalized between 2015 and
      2020.
    

Detailed description: 
      Sedation is a major therapeutic element in patients in intensive care under artificial
      ventilation, in order to allow their comfort and patient-ventilator synchronization. The use
      of benzodiazepines in combination with opioids is common practice. However, during prolonged
      sedation, the effects wane, then the doses must be increased, responsible for an increase in
      the incidence of a significant withdrawal syndrome in the recovery phase, a source of delay
      in extubation or early reintubation.

      The use of halogenated anesthetic gases is now possible in pediatric intensive care in these
      patients on artificial ventilation.

      Their efficacy and tolerance in prolonged use must be evaluated. Their use could improve the
      sedative effects, reduce the doses of benzodiazepines and opioids used, and reduce unwanted
      effects in terms of withdrawal syndrome.

      The objective of the study is to evaluate the effects of halogenated gases on sedation and
      analgesia, to describe the tolerance and to determine the risk factors for failure, in
      pediatric intensive care patients during prolonged sedation.

      This study will be based on the medical records of patients hospitalized between 2015 and
      2020.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation
        and prolonged invasive mechanical ventilation (> 72h).
      
Keywords: Artificial ventilation; Pediatric intensive care unit; Prolonged sedation effects; Halogenated anesthetic gases; Inhaled agents; Benzodiazepines in combination with opioids; Halogenated anesthetic gases efficacity and tolerance
Effects of Micro-osteoperforation on the Maxillary First Molar Distalization
Condition: Accretions; Teeth
MeSH terms: Dental Deposits
Study type: Interventional

Summary: 
      the study aimed to evaluate the effect of different types of Micro-osteoperforation on the
      rate of distal movement of maxillary first molars as a primary out come. Besides, it was
      aimed to study secondary effect on the first molars by evaluating root resorption, bone
      density, and level of the pain during performing the procedures.
    

Detailed description: 
      in the study, investigators tried to evaluate two methods to accelerate tooth movement by
      comparing them with control group. the first method was to apply one-time
      micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly
      till reaching the end of the phase one treatment.
    

Intervention name(s): Micro-osteoperforation
Intervention type(s): Procedure
Intervention description(s): flapless small punctures in the bone at direction of tooth movement to accelerate the movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation
      programs, improvement of exercise tolerance, with consequent reflection in functional
      capacity and quality of life of this population.
    

Detailed description: 
      BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public
      health by high morbidity and mortality rates that are associated. Studies show that changes
      in striated skeletal muscle of those individuals, possibly caused by progressive physical
      inactivity, contribute to the construction of the pathophysiology of this disease,
      emphasizing the importance of exercise for these patients. Exercise programs can be traced
      safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a
      set of activities that aims to ensure that patients with heart disease the best conditions,
      especially physical. In this context, non-invasive ventilation (NIV) is an alternative to
      provide an improved tolerance during exercise in patients with HF.

      GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in
      exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of
      life in patients with heart failure when compared to performing these exercises without
      ventilatory support.

      METHODS: This is a clinical trial, controlled, randomized and blind to be developed with
      patients arising out of the main Recife reference centers in the care of patients with heart
      failure. It will be conducted assessments of functional capacity made by cardiopulmonary
      exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity
      Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living
      with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be
      used to Patient Global Impression of Change Scale (PGIS).

      EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac
      rehabilitation programs, improvement of exercise tolerance, with consequent reflection in
      functional capacity and quality of life of this population.
    

Intervention name(s): Bilevel Positive Pressure Airway; Heart rehabilitation
Intervention type(s): Device; Other
Intervention description(s): Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week; Heart rehabilitation, for 12 weeks, 3 times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Noninvasive Ventilation; Positive- Pressure Respiration
Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome
Condition: Anovulation; Polycystic Ovary Syndrome; Hyperandrogenism
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Anovulation; Syndrome
Study type: Interventional

Summary: 
      Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS)
      involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP),
      which are generally used to establish the presence of hyperandrogenemia. In general, these
      levels are obtained during the follicular phase to maintain sampling uniformity and avoid
      spurious increases due to corpus luteum function. However, because most hyperandrogenic
      patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to
      induce withdrawal bleeding and properly time the blood sampling.

      Several medications have been described to properly induce withdrawal bleeding , with
      medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as
      MPA do not replicate precisely the constellation of biologic activities of the parent hormone
      and results in a temporary, albeit clinically relevant, suppression in ovarian function and
      circulating androgen levels , in addition of several adverse side effects .

      In this study, it is hypothesized that the administration of natural progesterone vaginally,
      which will avoid hepatic first pass, may result in significantly less hormonal suppression.

      The authors test this hypothesis by prospectively determining the effect of vaginal
      micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the
      circulating androgen and 17-OHP levels in women with PCOS.
    


Intervention name(s): Micronized Progesterone
Intervention type(s): Drug
Intervention description(s): Anovulatory women with Polycystic ovary syndrome and clinical hyperandrogenism attended in our Hospital will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.
Blood samples will be collected at baseline (Sample #1) and between the 3rd and the 5th day of withdrawal after 7 days of 100mg vaginal MP every 12 hours of administration(Sample#2).
Intervention MeSH terms: Progesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED
      patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to
      affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor
      therapy.
    

Detailed description: 
      We included severe ED patients that underwent radical prostatectomy at least one year
      previously and failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS)
      during PDE5i therapy. Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week
      no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3
      minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site).
      One-month after end of treatment the same baseline assessment was repeated. An active PDE5i
      medication regime was then provided and final erectile function was reassessed. Main
      endpoints for success were changes in RS and in the International Index of Erectile Function
      (IIEF-ED) Domain score. This study further emphasises the need to study specific populations
      with unique etiologies causing ED.
    

Intervention name(s): LI-ESWT
Intervention type(s): Device
Intervention description(s): Low intensity shock wave treatment - 12 sessions
Other intervention name(s): Omnispec model ED1000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LI-ESWT; Erectile Dysfunction; Radical Prostatectomy; Non PDE5 inhibitor responders; Shock wave
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,
      parallel group, placebo-controlled study to compare the efficacy and safety of treatment with
      SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable
      doses of donepezil HCl and memantine HCl.
    

Detailed description: 
      This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,
      parallel group, placebo-controlled study to compare the efficacy and safety of treatment with
      SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving
      donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily [bid]) or Namenda XR®
      (Extended Release, 28 mg qd) or the combination therapy, Namzaric™

      The primary objective of the study is to evaluate the efficacy of a serotonin receptor
      subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects
      with moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score of 12 to 20)
      currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and
      the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by
      the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26
      weeks of treatment.
    

Intervention name(s): SUVN-502; Placebo; Donepezil; Memantine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once-daily, tablets, orally; Once-daily, tablets, orally; Donepezil HCl (10 mg, once a day); Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
Other intervention name(s): Masupirdine; Namzaric; Namenda XR®
Intervention MeSH terms: Memantine; Donepezil; 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SUVN-502; 5-HT6; Phase 2; Cognition; Donepezil; Memantine; Alzheimer's Disease; Triple Combination; Proof of Concept (POC)
Personalized Feedback Intervention to Reduce Risky Cannabis Use.
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this project is to determine whether participants who receive a personalized
      feedback report and educational materials about risky cannabis use will be less likely to
      report risky cannabis use at follow-up compared to participants who only received educational
      materials.
    

Detailed description: 
      This project aims to reduce risky cannabis use among those with less severe cannabis use,
      most of whom will never seek formal treatment. All of the participants will receive
      educational material regarding risky cannabis use and its prevention. Half of the
      participants will also be assigned by chance to receive a personalized feedback report.

      The investigators hypothesize that:

        1. Participants who receive the full personalized feedback intervention will be less likely
           to report risky cannabis use at 3- and 6-month follow-ups compared to participants who
           receive educational materials only (Primary Hypothesis).

        2. Participants who receive the full personalized feedback intervention will report greater
           reductions in their perceptions of how much others use cannabis at a 3-month follow-up
           compared to participants who receive educational materials only.

        3. Reductions in perceptions of how much others use cannabis at 3-month follow-up will be
           positively associated with reduction in the participant's risky cannabis use at 6-month
           follow-up.

      A 2-arm parallel group randomized controlled trial will be conducted to test these hypotheses
      with follow-ups occurring at 3 and 6 months after randomization. Online media advertisements
      will be used to recruit people currently using cannabis. The advertisements will be placed
      across Canada using locations found successful in previous trials to rapidly recruit
      participants (e.g. Google AdWords).
    

Intervention name(s): Personalized Feedback; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.; Canada's Lower-Risk Cannabis Use Guidelines prepared by the Centre for Addiction and Mental Health which outlines methods to help reduce health risks associated with cannabis use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Condition: Dysgerminoma
MeSH terms: Neoplasms, Germ Cell and Embryonal; Dysgerminoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor
      prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without
      Darbepoetin alfa
    


Intervention name(s): Darbepoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity for Adolescent and Young Adult Cancer Survivors
Condition: Adolescent and Young Adult Cancer Survivors
Study type: Interventional

Summary: 
      More adolescents and young adults are surviving cancer than ever before. Many endure negative
      effects related to their cancer and its treatment, which reduces their quality of life and
      functioning. Physical activity is one strategy that has been shown to promote quality of life
      amongst cancer survivors. However, very little research has focused on adolescent and young
      adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is
      to explore the feasibility, safety, and potential benefits of a 12-week home-based physical
      activity intervention in adolescent and young adult cancer survivors.
    


Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; physical activity; pilot study; randomized controlled trial; cancer; adolescent and young adult; AYA
Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded
      molecules of Remifentanil have been marketed in Colombia, and several reports by
      anesthesiologist indicate that there are differences in the physiologic response of patients
      to these molecules. The investigators hypothesized that unbranded molecules of remifentanil
      require higher doses to obtain desired physiological responses as compared to the branded
      molecule.
    

Detailed description: 
      Introduction. Several remifentanil products are commercialized in Colombia while these have
      never been compared in a clinical setting.

      Objective. The aim of this study was to investigate the pharmacodynamic profile of the
      innovative molecule of remifentanil (group O = Ultiva®) and two unbranded molecules (group A
      = Remifentanil Laboratorios Chalver de Colombia S.A. and group B = Fada Remifentanilo)
      registered in Colombia.

      Methods. The investigators carried out a double-blind, randomized, controlled trial. The
      branded molecule of remifentanil (group O, n=29) was compared against the two unbranded
      molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation
      in adult patients American Society of Anesthesiology Physical Status Classification = I
      without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated
      were 6, 8 and 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mg/ml
      (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as
      the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and
      post-intubation (maximum measurement within 5 minutes).
    

Intervention name(s): Remifentanyl, Ultiva®; Remifentanil Laboratorios Chalver de Colombia S.A.; Fada Remifentanilo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anesthetic induction for orotracheal intubation. Group O; Anesthetic induction for orotracheal intubation. Group A; Anesthetic induction for orotracheal intubation. Group B
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remifentanil; propofol; pharmacodynamic; total intravenous anesthesia; orotracheal intubation; heart rate; mean arterial pressure; Cooper intubation condition score
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an extension to the study AC-058B201 and will investigate the long-term safety,
      tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple
      sclerosis.
    


Intervention name(s): Ponesimod 10 mg; Ponesimod 20 mg; Ponesimod 40 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ponesimod 10 mg oral use; Ponesimod 20 mg oral use; Ponesimod 40 mg oral use
Intervention MeSH terms: Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment