bioihbjkbjnl/mcl2 huggingface dataset:
CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
Condition: Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort
      study to evaluate the puffing patterns of individuals switching from a similar usual brand
      (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level
      ENDS product in healthy adult ENDS users. This study will be conducted for potential
      submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as
      part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery
      System (ENDS), comprised of an electrical power unit and four flavor variants each with two
      different levels of nicotine (2.4% and 5.0%).
    

Detailed description: 
      Potential subjects will complete a pre-screening interview and a Screening Visit to assess
      their eligibility and, based on meeting eligibility requirements, will be enrolled into the
      study on the same day of the Screening Visit.

      Once enrolled, the subjects will be randomized to either the 5.0% nicotine ENDS products or
      the 2.4% nicotine ENDS products. Once randomized to the nicotine level, subjects will be
      assigned to one of the four flavor variants based on alignment with their preferred UB
      flavor.

      Subjects will be provided an orientation to the product and the Product Use and Behavior
      (PUB) instrument and provided with enough cartridges (sufficient for three weeks of product
      use [125% their reported weekly use of their UB]) to last the 3-week period of the study.

      The subjects will take the products home and use them ad libitum for a 1-week acclimation
      period followed by a 2-week product use period. During this time product use will be captured
      by the PUB instrument and their data uploaded to the cloud regularly.

      At the conclusion of the 3-week ambulatory period, the subject will return to the clinic,
      return the ENDS power unit, used and unused ENDS cartridges, and the PUB instrument (and all
      cables/charger), have his/her health status reevaluated, complete the Product Evaluation
      Scale (PES) questionnaire and will then be discharged from the study.
    

Intervention name(s): CSD1902-11; CSD1902-12; CSD1902-13; CSD1902-14; CSD1902-21; CSD1902-22; CSD1902-23; CSD1902-24
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): A 2.4% nicotine ENDS product; A 2.4% nicotine ENDS product; A 2.4% nicotine ENDS product; A 2.4% nicotine ENDS product; A 5.0% nicotine ENDS product; A 5.0% nicotine ENDS product; A 5.0% nicotine ENDS product; A 5.0% nicotine ENDS product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in healthy post-menopausal female subjects to assess the
      pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination
      with Itraconazole.
    

Detailed description: 
      This open-label, fixed sequence study will comprise of:

        -  A screening period of 28 days;

        -  A fixed sequence of three treatment period:

      Treatment Period 1: Camizestrant only, Treatment Period 2: Itraconazole only, Treatment
      Period 3: Camizestrant and Itraconazole in combination.

      • A Follow-up Visit at 7 to 14 days after the last Camizestrant PK sample in Period 3.

      There will be a washout period of 7 to 10 days between Period 1 and Period 2. Each subject
      will be involved in the study for approximately 8 or 9 weeks.
    

Intervention name(s): Camizestrant; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.; Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.
Other intervention name(s): AZD9833
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Breast Cancer; Selective Estrogen Receptor Degrader (SERD); ER-Positive, HER2- Negative Breast Cancer
Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women
Condition: Skin Aging
Study type: Interventional

Summary: 
      As the body ages, the skin experiences natural changes in structure and composition. These
      changes may manifest visibly as increased skin dryness, wrinkling, and a loss of
      firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the
      investigators will recruit healthy men and women with mild to moderate signs of skin aging
      and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The
      investigators will perform a series of objective and subjective measurements to assess
      changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads
      to improvements in the general condition of the skin including skin hydration, crow's feet
      wrinkling, and other skin aging parameters.
    


Intervention name(s): HyaCera™; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 Ritual HyaCera capsule once daily; 1 placebo capsule once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy men and women with mild to moderate signs of skin aging will be randomly assigned to either receive a Ritual HyaCera or placebo for 12 weeks
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: skin aging; skin wrinkles; skin hydration; skin elasticity; skin firmness; skin smoothness; crow's feet wrinkles; dietary supplement; skin barrier function
Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS
Condition: Phelan-McDermid Syndrome; Growth Hormone Treatment
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In summary, this piot study with 6 participants shown that recombinant human growth hormone
      (rhGH) has a positive effect on the treatment with PMS. In addition, This study indicated
      that rhGH can improve PMS symptoms via increase the level of serum insulin-like growth
      factor-1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3). RhGH may be low
      cost, more accessible, alternative treatment for PMS.
    

Detailed description: 
      Compared with the placebo, rhGH treatment significantly decreased the total scores and
      subscale scores of GDS (P <0.05), while the total scores and subscale scores of SC-ABC
      significantly decreased (P < 0.05) following three-months rhGH treatment. The similar results
      were also observed in comparison with baseline. Compared with the baseline, the level of
      serum IGF-1 and IGFBP-3 increased significantly (P < 0.05) following three-months rhGH
      treatment, while the placebo group had no significant impact on serum IGF-1 and IGFBP-3 (P >
      0.05). One participant developed skin allergy the day after the first rhGH treatment, which
      were resolved later.
    

Intervention name(s): recombinant human growth hormone; Saline
Intervention type(s): Drug; Drug
Intervention description(s): RhGH treatment was started at 0.1 IU/kg once daily; Saline was started at 0.1 IU/kg once daily as the placebo
Other intervention name(s): rhGH (Changchun Jinsai Pharmaceutical Co., Ltd, S20080011)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phelan-McDermid Syndrome; Growth Hormone Treatment; cross-over; Placebo-controlled
Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
Condition: Mental Health
Study type: Interventional

Summary: 
      The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit
      to support innovative child mental health preventive interventions in FBO settings. This
      project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in
      real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare
      Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith
      Based Organizations (FBOs) in Uganda.
    

Detailed description: 
      The specific aims of this proposed study include:

      Aim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered
      design to enhance usability).

      Aim 2. To train mental health professionals and community health workers (CHWs) for the
      P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of
      training on CHWs' program implementation competency).

      Aim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e.,
      caregivers' mental health literacy, practices, and children's mental health) when implemented
      in the real world FBO settings.
    

Intervention name(s): Faith Based Outreach (FBO); community-health-workers (CHW)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Faith base outreach groups will be trained in P-MHDT; COmmon health workers will be trained in P-MHDT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated
      with inducing and enhancing allergies in children and adults. To investigate the basis for
      this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed
      at a dose known to be pro-inflammatory in healthy individuals.

      The hypothesis was that airway inflammation would be augmented in allergic rhinitics
      following exposure to diesel exhaust at an environmentally pertinent particulate matter
      concentration.

      Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel
      exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion
      particles, mean diameter 80 nm) and filtered air for two hours on separate occasions.
      Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours
      post-exposure, and samples were analysed for markers of inflammation.
    


Intervention name(s): Bronchoscopy
Intervention type(s): Procedure
Intervention description(s): Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed.
Other intervention name(s): Particulate matter; Air pollution; BAL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Particulate matter; Air pollution; Diesel exhaust; Allergic rhinitis
Effect of Deep Breathing Exercises on Post Operative Sleep Duration
Condition: Coronary Artery Bypass Graft
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study will provide the evidence that during the postoperative period deep breathing
      exercise combined with physical training can positively influence the sleep duration and
      quality. This study will provide the evidence that during the postoperative period deep
      breathing exercise combined with physical training can positively influence the sleep
      duration and quality.
    

Detailed description: 
      Subjects will be randomly placed into Control group and Interventional group. The control
      program will consist of Deep Breathing Exercises (from Morning to night every three hours;
      each session consisting of 10 deep breaths with a few seconds pause between each set, for 3
      days) in addition with progressive Exercises. Two daily sessions with an average duration of
      25 min will be performed. In addition to the physiotherapeutic program standardized by the
      hospital's team of physical therapists, the intervention group will perform additional Deep
      breathing Exercises (from Morning to night every three hours; each session consisting of 30
      deep breaths with a few seconds pause between each set, for 3 days). Deep breathing exercises
      will start 48 hours after extubation and full education along with the routine care (i.e.:
      from the fourth to sixth postoperative day).
    

Intervention name(s): Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise; Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise
Intervention type(s): Other; Other
Intervention description(s): • The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.; • The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breathing exercises; Coronary artery bypass; Sleep
Suprapatellar Nailing of Tibial Shaft Fractures
Condition: Broken Leg
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      To investigate the functional outcomes and prevalence and severity of knee pain for patients
      undergoing suprapatellar nailing of tibial shaft fractures.
    

Detailed description: 
      Suprapatellar nailing...

      Participants will be followed for 10 years prospectively. Follow up visits will occur at 2
      weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.

      Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10
      years.

      Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft
      fractures are:

        1. To evaluate the long term presence of knee pain

        2. To evaluate the long term functional outcomes
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting with tibial shaft fractures.
      
Keywords: tibial shaft fractures
Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium
      Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.
    


Intervention name(s): Tiotropium Bromide Monohydrate
Intervention type(s): Drug
Intervention description(s): In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler
Other intervention name(s): Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant J; Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant K; SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of
      intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type
      1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be
      investigated with a view to identifying trends and early immunological biomarkers which could
      predict response in halting/slowing Beta-cell destruction in this patient population.

      This exploratory study will explore the safety and tolerability between the well tolerated
      but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which
      efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr
      Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability
      dose response is considered a necessary first step to determining the therapeutic index of
      otelixizumab.
    


Intervention name(s): Otelixizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Otelixizumab is available at unit dose strength of 5 milligram/mL provided as 1 mL solution per vial to be diluted to 0.1 mg/mL in 0.9% sodium chloride. The 0.1 mg/mL solution is to be administered by intravenous infusion using a syringe pump and an in-line 0.2 micron filter by study personnel following specified regimens; Placebo is available 0.9% w/v sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Beta Cell; Monoclonal Antibody; Otelixizumab; Cytokine Release Syndrome; Epstein-Barr Virus; Diabetes Mellitus
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as
      nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from
      producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from
      dividing so they stop growing or die. It is not yet known whether hormone therapy is more
      effective with or without chemotherapy in treating prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or
      without docetaxel and estramustine in treating patients who have prostate cancer that is
      locally advanced or at high risk of relapse.
    


Intervention name(s): bicalutamide; Goserelin Acetate; docetaxel; Estramustine phosphate sodium; acetylsalicylic acid; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Other intervention name(s): CASODEX®; ZOLADEX®; Aspirin
Intervention MeSH terms: Aspirin; Docetaxel; Goserelin; Bicalutamide; Estramustine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients
Condition: Mechanical Ventilation With Oral Intubation
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The endotracheal tube secures free airway in patients undergoing surgical procedures or
      mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs
      to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A
      cuff pressure in excess of the target range is associated with a risk of tracheal injury,
      whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of
      subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown
      whether the cuff pressure changes following changes in body position of the patient. The
      objective of this study is to investigate to which extent - if any - cuff pressures change
      after body position changes of the patient.
    


Intervention name(s): cuff pressure
Intervention type(s): Procedure
Intervention description(s): The patient will be positioned in 16 distinct body positions, immediately after correct positioning, the cuff pressure is measured during an end-expiratory ventilator hold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: mechanical ventilation
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Condition: Obesity; Overweight; Craniopharyngioma
MeSH terms: Craniopharyngioma; Adamantinoma; Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether exenatide can cause weight loss in patients
      with a history of craniopharyngioma or other brain lesion.
    

Detailed description: 
      Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region,
      most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration
      and as a consequence of surgery or radiation therapy. Survivors who develop obesity have
      greater morbidity and mortality than normal weight survivors. Prevention and treatment of
      obesity in this population is vital in order to decrease the morbidity and mortality from
      diabetes, stroke and myocardial infarction.

      Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2
      diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and
      has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity
      and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery.
      The investigators hypothesize that treatment with exenatide will lead to weight loss in
      patients with hypothalamic obesity.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exenatide; Byetta; Hypothalamic Obesity; Obesity; Craniopharyngioma