bioihbjkbjnl/mcl2 huggingface dataset:
Effect of CPAP Treatment in Women With Moderate-to-severe OSA.
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP)
      improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and
      lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).
    

Detailed description: 
      Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a
      final blind evaluation.

      Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe
      (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara
      (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las
      Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del
      Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto
      (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe
      (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real),
      and Fundación Jiménez Díaz (Madrid). All centers from Spain.

      Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for
      suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy,
      and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and
      randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will
      fulfill a standardized protocol and different quality of life questionnaires. Office blood
      pressure will be measured. Fasting blood samples will be collected to assess glucose and
      lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of
      follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at
      the end of follow-up (12 weeks).

      149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the
      sample size calculated to achieve a clinically significant improvement in the Quebec Sleep
      Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a
      per-protocol basis (data only from patients who finish the study and show good adherence to
      CPAP, defined as an average objective use of at least 4 hours/day).
    

Intervention name(s): Continuous positive airways pressure
Intervention type(s): Device
Intervention description(s): Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Female gender; Continuous Positive Airway Pressure
Macrophage Phagocytosis in COPD
Condition: Chronic Obstructive Pulmonary Disease; Emphysema; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Observational

Summary: 
      Patients with chronic obstructive pulmonary disease (COPD) that have frequent chest
      infections are the patients most likely to become worse over time. Why these people are more
      susceptible to chest infections is not known. One reason might be that the white cells in
      their lungs called macrophages do not work properly. Normally, these cells remove all the
      debris inhaled into the lung. This can also include bacteria. In patients with COPD, these
      macrophages are not able to remove these particles. The research question addresses why this
      happens
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) comprises chronic bronchitis, small airways
      disease and emphysema. The major risk factor for the development of COPD is cigarette smoking
      therefore, the prevalence of this disease is increasing. COPD accounts for increasing numbers
      of hospital admissions due to increased numbers of chest infections and exacerbations. This
      may be related to the reduced capacity of macrophages from COPD patients to phagocytose
      bacteria and apoptotic cells. The reasons for this defect in the innate immune response in
      these subjects is unclear but there are suggestions that scavenger receptors may be altered
      by oxidative stress and reduce the phagocytotic pathway. This would be relevant in COPD, as
      increased oxidative stress is associated with cigarette smoking. We have preliminary data
      that shows a similar reduce phagocytotic response in monocyte-derived macrophages (MDM) from
      COPD patients compared with smokers and non-smokers. As these cells have not been exposed to
      oxidative stress other mechanisms may play a role in reducing phagocytosis. Using this MDM
      model, by taking blood from patients with COPD, we aim to investigate the mechanism of
      defective phagocytosis in COPD. We will measure the expression and regulation of cell surface
      scavenger receptors in cells of disease patients and control subjects and examine the
      signalling pathways leading to actin polymerization and phagosome formation. Finally, we aim
      to identify novel therapeutic strategies to reverse this effect and augment phagocytosis of
      macrophages in patients with COPD. Such a strategy would reduce chest infections and
      exacerbations and hence improve quality of life.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects, smokers without COPD and COPD patients
      
Biospecimen description: 
      Blood
    
Keywords: macrophage; phagocytosis; exacerbation
Sleep Disturbances as a Risk Factor in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Dyssomnias; Parasomnias; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      This study is designed to determine if either short night time sleep or poor night time sleep
      could be a risk factor for increasing the rate at which kidney function deteriorates in
      persons with mild to moderate kidney disease.
    


Intervention name(s): Controls Short sleep; CKD- sleep extension
Intervention type(s): Other; Other
Intervention description(s): Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption; Sleep will be increased by 2 hours each night for 3 nights
Other intervention name(s): Sleep intervention; Sleep intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Chronic Kidney Disease; Poor sleep; CKD; Kidney Failure
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values
Condition: Sepsis; Coagulopathy
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial.
      After signing an informed consent a blood sample will be obtained from each participant. The
      investigators will measure the thrombin generation in plasma assessed by the calibrated
      automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be
      calculated. The relation between SOFA score and thrombin measurements will be determined.
    


Intervention name(s): Calibrated Automated Thrombogram (CAT)
Intervention type(s): Device
Intervention description(s): The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 men and womens diagnosed with sepsis.
Projected Peripheral Defocus Using a Wearable Device
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic
      progression, which is a significant public health concern across the world, especially in
      Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will
      have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in
      order to alter retinal physiology leading to myopia regulation. This study will establish the
      changes seen during a proof-of-concept that projected defocus in the periphery utilizing a
      wearable device will stimulate physiological changes similar to those in the literature.
    


Intervention name(s): Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.); No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
Intervention type(s): Device; Device
Intervention description(s): For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image; For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
Condition: Prevention of Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 3

Summary: 
      Giving women one day before and immediately after cesarean section a mouthly dissolving
      mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered
      gastrointestinal functions And assess preoperative gastrointestinal functions
    

Detailed description: 
      Uncomplicated post cesarean women one day before and immediately after elective cesarean
      receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical
      care giver follow the woman's gastrointestinal functions, including intraoperative and
      postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools,
      occurring of paralytic ileus, length of the hospital stay
    

Intervention name(s): Mosapride; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Intake mouthly dissolving mosapride tablets in immediate post cesarean section; Dummy identical tablets to mouthly dissolving mosapride tablets
Other intervention name(s): Fluxopride; Placebo
Intervention MeSH terms: Mosapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative ileus; mosapride; mouth dissolving tablets; Intraoperative vomiting
A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery
Condition: Pain
Study type: Interventional

Summary: 
      Interscalene block has been the traditional regional anesthesia for shoulder surgery and
      postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury
      have encouraged search for alternative methods.
    

Detailed description: 
      Analyzing block effects of the lateral sagittal infraclavicular brachial plexus
      block(posterior and lateral chord), the investigators found it affecting all shoulder
      relevant nerves , except for the suprascapular and the supraclavicular nerves.

      Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and
      block of the posterior and lateral chords infraclavicularly, the investigators believe this
      novel combination would provide anesthesia for patients scheduled for shoulder surgery.
    

Intervention name(s): Nerve block
Intervention type(s): Procedure
Intervention description(s): Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Mechanisms in Young Adults
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to use [C-11]NPA and amphetamine (oral, 0.5 mg/kg) to measure
      striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison
      subjects (COMP)
    

Detailed description: 
      Prenatal cocaine exposure (PCE) has consistently been associated with behavioral deficits
      through childhood, adolescence, and young adulthood in our ongoing study (PRO15080516 -
      Effects of Prenatal Cocaine Use: 25-Year Follow-Up). Further, 21-year-olds with PCE in our
      study were twice as likely to have been arrested as non-exposed offspring, were more likely
      to be diagnosed with Conduct Disorder, had higher disinhibition scores, were significantly
      more likely to use alcohol and marijuana earlier, and to have earlier sexual intercourse. The
      effects of PCE on the developing nervous system may cause changes in brain function that
      underlie these behavioral outcomes.

      This study seeks to examine dopamine (DA) transmission in vivo, using positron emission
      tomography (PET) with [C-11]NPA, in striatal regions of interest in subjects who have a
      history of exposure to prenatal cocaine (PCE). We hypothesize that PCE is associated with
      increases in dopamine in the striatum relative to COMP. This may explain the impulsivity and
      high risk behaviors in PCE subjects
    

Intervention name(s): d-amphetamine; [C-11]NPA
Intervention type(s): Drug; Radiation
Intervention description(s): is used to stimulate dopamine release in the brain; PET radiotracer
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: [C-11]NPA d-amphetamine
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: prenatal exposure
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide information about the bone anabolic properties and
      absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of
      24 weeks to postmenopausal women with osteoporosis.
    

Detailed description: 
      The choice of a 24-week treatment period was based on published studies of PTH which
      demonstrate its potential to produce a statistically significant increase in BMD in patients
      with postmenopausal osteoporosis within that observation period.
    

Intervention name(s): PTH analog; Placebo; Forsteo (Teriparatide)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A recombinant 1-31 amino acid fragment of PTH.; A recombinant 1-34 amino acid fragment of PTH.
Other intervention name(s): PTH(1-31); Forteo (US)
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Bone Density Conservation Agents
Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors
Condition: Cancer Survivors; Exercise; Sedentary Behavior
Study type: Interventional

Summary: 
      As the number of cancer survivors grows and expected survival time increases, the health
      behaviors of this population are gaining significant attention from the research and public
      health community. Adoption or maintenance of healthy lifestyles after cancer has the
      potential to reduce both cancer- and non-cancer-related morbidity and mortality. Exercise
      adoption and maintenance remains a significant challenge for adults, especially clinical
      populations such as cancer survivors who may struggle with comorbidities, symptoms and
      side-effects of the disease or medications, and overall compromised health and functioning. A
      number of site-based exercise interventions have been conducted to promote physical activity,
      often using a theoretical basis to design and execute the intervention. Although these
      programs are successful in exposing cancer survivors to regular physical activity, they often
      struggle with exercise maintenance after the conclusion of the structured site-based group
      exercise sessions. The goal of the proposed project is to enhance physical activity
      engagement among adult cancer survivors by designing a home-based program using the
      socio-ecological framework and employing constructs from social cognitive theory to guide
      participants through the project.
    


Intervention name(s): 12-Week Home Exercise Group; Education Comparison Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page; 12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children
Condition: P. Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      Following the rapid development of significant drug resistance to both chloroquine and
      sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether-
      lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that
      this drug has been widely used for some time, the investigators propose to conduct an
      antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if
      this drug remains efficacious, or if significant resistance has emerged, in which case a new
      antimalarial strategy will need to be contemplated. The investigators hypothesize that the
      efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination
      therapies will be equally efficacious.

      Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated
      with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine
      (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be
      monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.
    


Intervention name(s): artemether-lumefantrine; Dihydroartemisinin-piperaquine
Intervention type(s): Drug; Drug
Intervention description(s): administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of: 1 tablet for patients weighing 5-14 kg, 2 tablets for patients weighing 15-24 kg, 3 tablets for patients weighing 25-34 kg, 4 tablets for patients weighing 35 kg or more; once daily for 3 days as tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine at a total dosage of 6.4 mg/kg of dihydroartemisinin and 51.2 mg/kg of piperaquine divided equally between the three days
Other intervention name(s): Coartem Novartis
Intervention MeSH terms: Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; treatment; artemisinin combination therapy; Tanzania; P. falciparum malaria in children age 6-59 months
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in
      patients with CD20-positive B-cell lymphoma
    

Detailed description: 
      1. The primary objective of the study is to evaluate the safety and tolerability of
           BAT4306F in patients with CD20-positive B-cell lymphoma, when the injection dosage
           escalates, to ultimately determine the maximum tolerated dose (MTD), dose-limiting
           toxicity (DLT), and recommended dosage for phase II clinical studies ( RP2D);

        2. To evaluate the pharmacokinetics (PK) of BAT4306F(for injection);

        3. To evaluate the immunogenicity profile of BAT4306F(for injection);

        4. To evaluate the efficacy profile of BAT4306F (for injection);Using the Lugano criteria
           (2014), the 2008 IWCLL efficacy evaluation criteria, and the 2014 IWWM-7 efficacy
           evaluation criteria were used to evaluate the efficacy of related diseases at week 7,
           week 13, and week 19. The index of evaluation was ORR (including CR, PR, SD and PD, ORR
           is the proportion of patients with CR and PR).
    

Intervention name(s): 500mg BAT4306F; 750mg BAT4306F; 900mg BAT4306F; 1000mg BAT4306F
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result; Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result; Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result; Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment