bioihbjkbjnl/mcl2 huggingface dataset:
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Condition: Diabetes; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Prediabetic State
Study type: Interventional

Summary: 
      Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and
      diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure
      (CPAP) has metabolic benefits. The objective of this study is to determine the effect of
      8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.
    

Detailed description: 
      Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and
      diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure
      (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on
      glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled
      parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly
      CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory
      on each night. CPAP adherence was ensured by continuous supervision. Participants continued
      their daily daytime routine activities outside the laboratory. Glucose metabolism was
      assessed at baseline and after 2-weeks of assigned treatment using both the oral and
      intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was
      the overall glucose response as quantified by the area under the curve for glucose during
      2-hour oral glucose tolerance testing.
    

Intervention name(s): CPAP mask; Placebo
Intervention type(s): Device; Drug
Intervention description(s): The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity.
________________________________________; oral placebo tablet
Other intervention name(s): continuous positive airway pressure therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; diabetes; sleep apnea
Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
Condition: Glucose; Circadian Rhythm; Melatonin; Genes
Study type: Interventional

Summary: 
      This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose
      regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.
    

Detailed description: 
      The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has
      sparked great interest into the role of melatonin in glycemic control, for which the
      mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B
      on glycemic control under highly-controlled, in-laboratory protocols while manipulating
      circulating melatonin concentrations (both up and down) and assessing glycemic control by
      frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human
      pancreatic islets. This research will provide mechanistic insights into the metabolic effects
      of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and
      personalized recommendations to improve glycemic control in night shift workers and
      late-night eaters.
    

Intervention name(s): melatonin; placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 5 mg of melatonin per os.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to measure the impact of early bimanual stimulation in babies with
      clinical signs of underuse of one hand. The observation focuses on the developmental curve of
      hands use. The intervention is provided by the family environment and takes place in the
      child's familiar surroundings.
    

Detailed description: 
      Congenital hemiplegia, often referred to as Unilateral Cerebral Palsy (UCP), is characterized
      by a unilateral or asymmetrical brain injury that occurs around birth and impacts the
      development of manual skills and motor abilities of one side of the body.

      Affected children frequently develop hemiplegia with major limitations in the use of their
      impaired hand, resulting in poor bimanual coordination, thus impacting the performance of
      daily activities at home, school and in the community.

      Several intensive therapy approaches currently exist, including the bimanual approach (BIM)
      which aims to improve the use of the affected hand as an assisting hand in daily functional
      activities. These approaches have long been established as effective, however, with these
      children reaching 90% of their potential gross motor skills around the age of 5, or even
      earlier in some cases, there is a growing interest in earlier approaches, well before school
      age. It has also long been established that during the first year of life, there is a
      critical time frame for hand motor development.

      The investigators have thus set up an intensive bimanual stimulation program for infants
      showing early signs of UCP, delivered by the family environment, in the child's familiar
      surroundings, under the guidance of a therapist, over a period of 2 months.
    

Intervention name(s): Early Intensive Bimanual Stimulation
Intervention type(s): Other
Intervention description(s): Early intensive bimanual stimulation program for infants showing early signs of UCP, delivered by the family environment, in the child's familiar surroundings, under the guidance of a therapist, over a period of 2 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unilateral cerebral palsy; Unilateral brain lesion; Infantile cerebral palsy
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
Condition: Headache
MeSH terms: Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the efficacy of low dose Ketamine versus Compazine for the control of
      headache in patients presenting to the Emergency Department.
    

Detailed description: 
      After enrollment, each patient will randomized either to the standard treatment arm to
      receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to
      receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron
      will be administered first, and immediately afterward the prochlorperazine or Ketamine will
      be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total
      volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted
      in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also
      receive a 500 mL normal saline bolus after the study medications are administered. The ED
      pharmacist will be responsible for preparing the medications, using a double-blind protocol.
      He or she will record which arm the patient was randomized to. Only the pharmacist will have
      access to the randomization records and will not reveal the randomization until the end of
      the study. Emergency providers will be instructed not to administer any rescue medications
      for at least 30 minutes. The electronic medical record order will read "randomized study
      medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for
      the ondansetron or diphenhydramine).
    

Intervention name(s): Prochlorperazine; Ketamine; Diphenhydramine; Ondansetron; Normal Saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): prochlorperazine 10 mg IV; Ketamine 0.3 mg/kg IV; Diphenhydromine 25 mg IV; Ondansetron 4 mg IV; Normal Saline 500 cc IV Bolus
Other intervention name(s): Compazine; Ketalar; Benadryl; Zofran; NS
Intervention MeSH terms: Diphenhydramine; Promethazine; Ketamine; Ondansetron; Prochlorperazine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind Randomized Clinical Control Trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Headache, Migraine
Phase 2a EBA Trial of AZD5847
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day
      14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily,
      500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with
      newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled,
      with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of
      drug treatment is 14 days.
    

Detailed description: 
      This is a study of early bactericidal activity (EBA) in treatment-naïve patients with active
      pulmonary tuberculosis. This prospective, randomized, open-label study that will compare the
      effect of monotherapy with each of four dose levels of AZD5847 to that of an active control
      (Rifafour administered orally once daily) on the concentration of Mycobacterium tuberculosis
      (M. tb) in expectorated sputum (colony-forming units per mL of sputum). Daily quantitative
      sputum cultures will be performed during treatment and analyzed by investigators who will be
      blinded to the assigned treatment. The duration of therapy will be 14 days in order to
      support an assessment of early bactericidal activity (days 0-2) and sterilizing activity
      (days 3-14). Because of the risk of emergence of drug resistance in TB patients treated with
      a single active drug, regulatory and ethical requirements restrict monotherapy to a maximum
      duration of 14 days (EMEA Draft TB Guidance 2008). The study will utilize a standard design
      and will thus support comparison with other marketed and investigational antimycobacterial
      agents (Donald and Diacon 2008). The primary aim of the study is to assess the EBA 0-14 of
      AZD5847 at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg
      once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive
      pulmonary TB. The secondary aim is to assess the EBA 0-2 and EBA 2-14 of AZD5847 at the above
      doses.
    

Intervention name(s): AZD5847; Ethambutol, isoniazid, pyrazinamide, rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Eligible subjects will be randomly assigned to receive monotherapy with one of four doses of oral AZD5847 for 14 days: 500 mg orally once daily, 500 mg orally twice daily, 1200 mg orally once daily, or 800 mg orally twice daily.; Eligible subjects will be randomly assigned to receive treatment with standard 4 drug anti-tuberculosis regimen: Rifafour e-275 mg tablets (75 mg isoniazid/150 mg Rifampin/275 mg Ethambutol/400 mg Pyrazinamide) orally, dosed by body weight for 14 days.
Intervention MeSH terms: Rifampin; Isoniazid; Pyrazinamide; Ethambutol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD5847; dose-ranging; Mycobacterium tuberculosis; Rifafour; tuberculosis
Best Therapy for Patients With Neuroendocrine Tumors
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Observational

Summary: 
      A prospective observational study containing three arms comprising different therapeutic
      measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms
      include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor
      radiotherapy.
    

Detailed description: 
      Study design:

      Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA
      and with peptide receptor radio-therapy in patients with advanced well-differentiated
      neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation
      Primary end points: time to progression Secondary end points: survival, quality of life
      (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study
      Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to
      therapy every 3-6 months by imaging, clinical status, weight, quality of life,
      Karnofsky-index Cross-over allowed if therapy changes
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with neuroendocrine tumors in a tertiary referal center
      
Keywords: neuroendocrine tumors; transcatheter arterial chemoembolization; selective internal radiotherapy; surgery; radio-frequency ablation; peptide-receptor radiotherapy; progression-free survival; quality of life; overall survival; weight; time of hospitalization
Duodenal Exclusion for the Treatment of T2DM
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of duodenal exclusion procedure for the treatment of T2DM
    


Intervention name(s): duodenal exclusion
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos
Condition: Unwanted Tattoos
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of
      unwanted tattoos
    


Intervention name(s): Picosure Laser System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the
      currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with
      moderate to severe Alzheimer's disease.
    

Detailed description: 
      This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg
      donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in
      patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR
      (or a bioequivalent generic) for at least 3 months prior to Screening. The study will consist
      of 24 weeks of daily administration of study medication, with clinic visits at Screening,
      Baseline, 3 weeks (safety only), 6 weeks, 12 weeks, 18 weeks and 24 weeks or early
      termination. Patients will receive either 10 mg donepezil IR in combination with the placebo
      corresponding to 23 mg donepezil SR, or 23 mg donepezil SR in combination with the placebo
      corresponding to 10 mg donepezil IR.

      A total of approximately 1600 patients will be enrolled to obtain complete data from
      approximately 1200 completed patients (Revised per Amendment 02). During the Baseline visit,
      patients will be randomized in a 2:1 ratio (23 mg donepezil SR to 10 mg donepezil IR). The
      study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India,
      Israel, North America, South Africa, and South America) (Revised per Amendments 01 and 02).
      An Independent Data Monitoring Committee (IDMC) will be established to review safety aspects
      of the study and to evaluate the results of a planned interim analysis.

      Patients who complete the study may be eligible to undergo evaluation for enrollment into the
      open-label extension study, E2020-G000-328.
    

Intervention name(s): Aricept (donepezil SR 23 mg); Aricept (donepezil IR 10 mg)
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation.; Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.
Other intervention name(s): Donepezil hydrochloride; Donepezil hydrochloride
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to Severe Alzheimer's Disease
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute
Condition: PKU; Phenylketonurias; Inborn Errors of Metabolism; Metabolic Disease
MeSH terms: Phenylketonurias; Metabolism, Inborn Errors; Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate that a new protein substitute is acceptable and well
      tolerated in children with PKU.
    


Intervention name(s): Motion
Intervention type(s): Dietary Supplement
Intervention description(s): Amino acid based protein substitute
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Underlying Causes and Related Factors, and Rehabilitation Approaches
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study will be a cross-sectional observational study, followed by a pilot intervention.
      The aim of the study is to examine the underlying causes of walking-related performance
      fatigability, together with other related and influencing factors, to make up a clinical
      profile of patients with MS showing walking-related performance fatigability. In the second
      part of the study a pilot intervention will be executed to see if the investigators can
      improve the clinical status of the MS patients with walking-related performance fatigability.
    


Intervention name(s): Training intervention + Dance intervention
Intervention type(s): Other
Intervention description(s): Training intervention + Dance intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Not Invasive Monitoring at Cardiac Recompensation
Condition: Cardiac Recompensation
Study type: Observational

Summary: 
      The aim of this study is to find out if data can be provided by external sensor technology
      which is suitable for controlling the therapy of patients with cardiac recompensation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cardiac recompensation
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of bortezomib in
      combination with a standard regimen of cyclophosphamide and dexamethasone.
    

Detailed description: 
      This is open-label (both the participant and the investigator know what treatment
      participants will receive), prospective (participants are identified and then followed
      forward in time for the outcome of the study), multi-centre, and non-randomized (participants
      are assigned to different treatment groups by the investigator) study. The study will be
      conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled
      (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be
      evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be
      administered. Part 2 will include a screening period of a maximum of 14 days followed by
      chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day
      cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical
      examination, electrocardiogram, and clinical laboratory tests which will be monitored
      throughout the study.
    

Intervention name(s): Cyclophosphamide; Bortezomib; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.; Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).; Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).
Other intervention name(s): VELCADE
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Untreated multiple myeloma; Bortezomib; VELCADE; Cyclophosphamide; Dexamethasone; Chemotherapy; Remission therapy; Induction therapy; Stem Cell Transplantation