bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot study is to determine the feasibility of conducting a trial of
      N-Acetylcysteine in cannabis dependent adolescents.
    

Detailed description: 
      This project involves investigation of oral N-acetylcysteine (NAC) as a potential
      pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence
      continues to be a major problem among adolescents in the United States. To date, psychosocial
      interventions have produced only small to modest effect sizes in controlled trials, and
      minimal work has been done to investigate the potential role for pharmacotherapy for cannabis
      dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent
      individuals, our research group has developed preliminary evidence of decreased cocaine use
      and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated
      significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed
      target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive,
      long-available agent with a favorable tolerability profile in adults and children. However,
      it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an
      open-label pilot trial of NAC in adolescents with cannabis dependence.

      The primary specific aims of the proposed project are:

        1. To assess the feasibility of conducting a trial of NAC in cannabis dependent
           adolescents.

        2. To assess the safety and tolerability of NAC in cannabis dependent adolescents

           The secondary specific aim of the proposed project is:

        3. To gather variability information to assist in design of a larger-scale, adequately
           powered clinical trial of NAC in cannabis dependent adolescents.

      Primary hypotheses

        1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of
           NAC.

        2. NAC will be well tolerated among cannabis dependent adolescents.

           Secondary hypothesis

        3. Adequate variability information will be gathered to design a larger-scale, adequately
           powered clinical trial of NAC in cannabis dependent adolescents.

      Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results
      from this project will be used to design further studies.
    

Intervention name(s): N-Acetylcysteine
Intervention type(s): Drug
Intervention description(s): N-Acetylcysteine 1200 mg twice daily for four weeks
Other intervention name(s): GNC brand USP-grade NAC (600 mg capsules)
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cannabis; Marijuana; Pharmacotherapy; Adolescent
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
Condition: Clinical Pharmacology; Pharmacokinetics; Cardiovascular Diseases; Heart Failure
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the
      effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male
      and female subjects. Subjects will be admitted into the study site on Day -1 and will be
      confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on
      Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.
    


Intervention name(s): CRD-740; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): CRD-740; Itraconazole
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry
Condition: Critical Care; Pediatrics
Study type: Observational

Summary: 
      Computerized physician order entry with clinical decision support system CPOE+CDSS)completely
      eliminated errors in filling in the resuscitation medications order forms and significantly
      reduced time to completing the forms in a pediatric critical care department (PCCD).
    

Detailed description: 
      Introduction: Computerized physician order entry with clinical decision support system
      (CPOE+CDSS) is an important tool in attempting to reduce medication errors. The objective of
      this study was to evaluate the impact of a CPOE+CDSS on (1) the frequency of errors in
      ordering resuscitation (CPR) medications and (2) the time for printing out the order form, in
      a pediatric critical care department (PCCD).

      Methods: Setting: An 18-bed PCCD in a tertiary-care children's hospital. Design: Prospective
      cohort study. Measures: Compilation and comparison of number of errors and time to fill in
      forms before and after implementation of CPOE+CDSS. Errors were identified by reviewing
      orders and classified as potential adverse drug events (ADEs), medication prescribing errors
      (MPEs), and rule violations (RVs). They were compared during the year preceding and following
      implementation of CPOE CDSS. Simulated forms were also used to further test error occurrence.
      Time to fill in conventional, simulated and CPOE forms was measured and compared.

      Results: There were 3 reported incidents of errors among 13,124 CPR medications orders during
      the year preceding implementation of CPOE+CDSS. These represent errors that escaped the
      triple check by three independent staff members (two nurses and one physician). There was an
      average of 11.6 errors/100 orders in the simulated CPR form and potential ADEs occurred at a
      rate of 11.3/100 orders and MPEs at a rate of 0.3/100 orders. There were no errors after
      CPOE+CDSS was implemented (100% error reduction). Time to completion of drug forms dropped
      from 14 min 42 sec to 2 min 14 sec (p<0.001).

      Conclusions: CPOE+CDSS completely eliminated errors in filling in the forms and significantly
      reduced time to completing the form.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Resuscitation medication errors; critical care; pediatrics; clinical decision support systems; computerized physician order entry
Indoor Air Filtration and Young Adults Health Study
Condition: Cardiopulmonary Diseases
MeSH terms: Pulmonary Heart Disease
Study type: Interventional

Summary: 
      This study aims to explore the cardiopulmonary health effects of indoor air purification and
      other indoor environmental conditions among young healthy college students in Beijing, China.
    

Detailed description: 
      The present randomized, double-blind crossover study was conducted to investigate the
      cardiopulmonary health effects of air purification among 81 young healthy college students in
      Beijing, China. Real or sham purification was performed in the dormitories for 4 days,
      following a 15-day wash-out period in the intervals. During the study periods, the
      investigators collected indoor exposure levels of size-fractionated particulate matter (PM),
      black carbon (BC), noise, ozone, nitrogen dioxide, carbon dioxide, volatile organic
      compounds, temperature, relative humidity, illumination, and microorganism. Biological
      specimens (i.e., morning urine, fasting venous blood, exhaled breath condensate, and nasal
      mucus) were also collected and examined. Some important individual factors including
      demographical information (age, sex, height, weight, etc.), physical activity, sleep
      condition, mood and cognition, and food intake were also gathered using questionaire or
      anthropometric measurements, in order to control for the potential confounding effects. For
      further data analyses, air pollutants, noise, and other exposures would be controlled as
      confounders when addressing the health effects associated with air purification, and would
      also be used to explore their effects on cardiopulmonary health. The interaction effects of
      air pollutants, noise, and other exposures on cardiopulmonary health would also be explored.
    

Intervention name(s): Air purifier
Intervention type(s): Other
Intervention description(s): Real purification and sham purification would be conducted in the dormintory rooms (about 25 in total) of the study subjects for 4 days, following a randomized crossover design, which means a real air purifier and a sham purifier would be placed in the same dormintory room with a wash-out interval (15 days).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Exercise and RP (AVAMC and Emory)
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The purpose of this study is to look in humans at the relationship between moderate or little
      exercise and their potential effects on the retina in patients with Retinitis Pigmentosa
      (RP).
    

Detailed description: 
      Human studies have shown that regular exercise may have positive effects on common
      degenerative diseases such as Alzheimer's disease. Exercise has also shown to improve
      conditions the eye such as macular degenerations, glaucoma, and cataracts. Mice with retinal
      degeneration which were exposed to exercise showed that it helped to slow the rate of
      degeneration. The purpose of this study is to look in humans at the relationship between
      moderate or little exercise and their potential effects on the retina in patients with
      Retinitis Pigmentosa (RP).
    

Intervention name(s): Spin exercise
Intervention type(s): Other
Intervention description(s): Each exercise class will consist of 20 minutes of progressive, interval based Spin exercise 2 times a week for 6 months on stationary exercise cycles and will be led by a qualified instructor. The Duration of each session is lengthened based on the progression of the participant and the recommendation of the instructor by 1-2 minutes as needed to a maximum time of 60 minutes per session. Exercise intensity will begin at low levels (50% of maximal heart rate reserve (HRR) and increase by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Quality of life; Progression of disease; Retinitis
A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      This study assessed the efficacy of three dry mouth products (including an experimental
      Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth
      compared to water, in dry mouth population over a period of 28 days.
    

Detailed description: 
      This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by
      Modified Dry Mouth Inventory [DMI] score), randomized, parallel group study in participants
      with self-reported dry mouth symptoms as determined by participant responses to the DMI.
      Participants used their assigned dry mouth treatment at home for 28 days.
    

Intervention name(s): Experimental Oralbalance Moisturizing Gel; Biotene Original Oral Rinse; Biotene Moisturizing Mouth Spray; Water
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.; Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.; Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.; Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.
Intervention MeSH terms: Muramidase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome
Condition: Constipation-predominant Irritable Bowel Syndrome; Abdominal Pain
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation; Abdominal Pain
Study type: Interventional

Summary: 
      This study aims to investigate the effects and possible mechanisms of transcutaneous
      auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients
      with IBS-C.
    

Detailed description: 
      This study is designed as an early-feasibility, single-center, single-blinded, randomized
      controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and
      receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each
      time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the
      commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo
      MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular
      concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS,
      IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or
      sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when
      the patient cannot tolerate symptoms of constipation and abdominal pain.
    

Intervention name(s): taVNS; sham-taVNS
Intervention type(s): Device; Device
Intervention description(s): transcutaneous auricular vagal nerve stimulation; transcutaneous stimulation at the elbow area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
Condition: Cystitis, Radio Induced
MeSH terms: Cystitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to assess the relief of symptoms after Hyperbaric
      Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate
      cancer Index Composite (EPIC)symptom estimation scale as primary variable.

      Study hypothesis:

        -  HBOT can reduce or reverse the change or otherwise limit the damage of the bladder
           function and/or structure, which arose as a result of radiation therapy of cancer in the
           pelvic region organs.

        -  The effects of HBOT are associated with relief of symptoms that, at least in part, is
           related to the reduction of the extent of the radiation damage.

        -  Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as
           a sign of an improved function of the mucosa.

        -  Treatment results of HBOT remains, in whole or in part, during the follow-up (residual
           effect)
    

Detailed description: 
      Radiotherapy is commonly used in the management of malignant diseases. Despite a continuous
      improvement of the technique, with improved efficacy and tolerance, adverse effects are still
      rather common. The urinary bladder and rectum are the major organs most commonly affected by
      radiotherapy to the pelvis area.

      One of the most significant causes of the symptoms of radio therapy is inflammation and
      degeneration of blood vessels in the radiated tissue. Hyperbaric oxygen therapy involves
      administration of oxygen at greater than normal atmospheric pressures. A well-documented
      effect of HBOT is the stimulation of angiogenesis. HBOT is an established treatment for
      degeneration of blood vessels in the jaw bone as a result of radiotherapy and several
      publications have shown good efficacy also when soft tissue is affected.

      If the method of treatment with HBOT means a reduction of the radiotherapy side effect it is
      thus an obvious importance for the individual patient. There is also significant potential
      savings for the healthcare and society.
    

Intervention name(s): Hyperbaric Oxygen
Intervention type(s): Drug
Intervention description(s): 100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radio therapy; STRI; Urinary bladder; Hyperbaric Oxygen
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
Condition: Negative Pressure Wound Therapy; Vacuum Therapy; Closed Incisions
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower
      extremity orthopedic trauma to prevent infectious complications.
    


Intervention name(s): PICO, Smith & Nephew
Intervention type(s): Device
Intervention description(s): Direct application of negative pressure wound therapy following Foot and Ankle surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: NPWT
Intervention Module AGES
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The AGES-CM consortium aims to study the interaction between the polymorphisms of the
      candidate genes related with neurodevelopment, neurotransmission, brain progressive changes,
      cognitive functioning and stressful life events (prospective- and retrospectively assessed)
      and the association of the interactions with structural and functional brain measures,
      neuropsychological performance, biochemical and oxidative status in both in patients and
      controls. The investigators study aimed to examine the effectiveness of a parallel,
      structured, and specific psychoeducational group intervention (PE) for adolescent patients
      and their families by comparing it with treatment as usual).
    

Detailed description: 
      Objective: To assess the effectiveness of a structured psychoeducational group intervention
      for adolescents with early onset psychosis and their families. The intervention was
      implemented in parallel in 2 separate groups, by focusing specifically on problem solving
      strategies and structured psychosis-related information to manage daily life hassles
      associated with the disease in order to manage crises and prevent relapses.

      Method: The investigators performed a 9-month, randomized, rater-blind clinical trial
      involving adolescent patients with early onset psychosis and 1 or both of their parents. The
      primary outcomes were number of hospitalizations, days of hospitalization, and visits to the
      emergency department. The secondary outcome measures were clinical variables and family
      environment and well being.
    

Intervention name(s): treatment as usual; Psychoeducation group treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): case management; Psychoeducation therapy problem solving focus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: first episode psychosis; psychoeducation; group therapy
Muscle Dysfunction in Patients With Chronic Obstructive Lung Disease (COPD): the Role of Sympathetic Activation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The objective of the project is to better understand the causes of exercise limitation,
      dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators
      aim to explore the mutual interaction of neurohumoral activation and exercise limitation
      thereby focussing on differential effects of the peripheral muscle and the diaphragm.

      Eventually the findings might influence treatment modalities. If sympathetic activation
      contributes to exercise limitation then drugs influencing the autonomic nervous system would
      be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an
      alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to
      improve dyspnea and exercise capacity.
    

Detailed description: 
      Our aim is to investigate whether reduced exercise capacity, increased respiratory drive and
      dyspnoea are linked to heightened sympathetic activation at rest and during exercise in
      patients with COPD. Furthermore, the effect of unloading the respiratory muscles by using
      non-invasive ventilation (NIV) will be assessed. Fifteen stable COPD patients without NIV
      will be matched to 15 healthy control subjects (with sufficient microneurography recording).
      Furthermore COPD patients on regular NIV will be studied. Each participant will undergo
      symptom limited bicycle exercise and a handgrip protocol. Microneurography will be used to
      quantify sympathetic activity by the transcutaneous registration of postganglionic
      sympathetic efferents.
    

Intervention name(s): non-invasive ventilation (NIV)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose
      study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one
      clinical study center in the United States.
    


Intervention name(s): GSK2376497; 0.9% sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): GSK2376497 Active Comparator; 0.9% sodium chloride Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment