bioihbjkbjnl/mcl2 huggingface dataset:
Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is
      likely significantly higher than the general population as hospitalized patients carry a high
      prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that are
      commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not
      known, though there is limited data suggesting that the rate of OSA in hospitalized patients
      is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of
      OSA in patients referred for OSA evaluation while in-hospital. These studies reported
      frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an
      observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep
      disordered breathing in patients admitted with acutely decompensated heart failure, finding
      frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and 75%
      (prospective study of 395 consecutive patients studied with portable monitors). However, all
      of these studies are limited by either study design (retrospective), small numbers, limited
      channel portable monitoring, or evaluations of highly select patient populations.
      Furthermore, none of these studies examined screening tools that may help to identify which
      patients are at risk for OSA and thus might require the more extensive and expensive
      objective testing.

      This study will test the following hypotheses:

        1. The prevalence of OSA in unselected hospitalized medical patients will be more than 50%
           of the study population.

           Specific Aim 1: To determine the prevalence of OSA in a group of unselected hospitalized
           medical patients by a combination of sleep symptoms and PSG performed while in-hospital.

        2. Screening tools will be able to accurately identify OSA in hospitalized medical
           patients.

      Specific Aim 2: To determine the accuracy of different screening questionnaires for the
      diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to
      that of a PSG performed while in-hospital.
    


Intervention name(s): Polysomnogram
Intervention type(s): Procedure
Intervention description(s): An attended polysomnogram will be conducted in the subjects room during an in patient hospital stay
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized medical patients
      
Keywords: inpatients; medical; polysomnogram; questionnaires
Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20
Condition: Hematopoietic/Lymphoid Cancer; Adult Acute Lymphoblastic Leukemia in Remission; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Refractory Chronic Lymphocytic Leukemia; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Follicular; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia, Prolymphocytic; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
      into patient autologous or donor-derived T cells may make the body build immune response to
      kill cancer cells.

      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
      treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell
      transplantation or intensive chemotherapy) or refractory to chemotherapy.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as
      overall response rate (ORR).

      SECONDARY OBJECTIVES:

      I. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to
      response (TTR), duration of overall response (DOR), progression free survival (PFS) and
      overall survival (OS).

      III. To determine in vivo expansion and persistence of TanCAR19/20 T cells.

      OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive
      anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced
      autologous T cells on day1 in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed intensively for 6 months, every 3
      months for 2 years, and annually thereafter for 3 years.
    

Intervention name(s): anti-CD19/20-CAR vector-transduced T cells
Intervention type(s): Biological
Intervention description(s): genetically engineered lymphocyte therapy
Other intervention name(s): genetically engineered lymphocyte therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      Investigate the clinical features of orbital complications of sinusitis in the Egyptian
      population, and observed that certain ophthalmological manifestations and outcomes were
      significantly associated with disease stage
    

Detailed description: 
      Retrospectively review of the medical records of all patients with orbital complications of
      paranasal sinusitis hospitalized at the ORL-HNS department at the University of Tanta between
      2010 and 2020. Sex, age, symptoms, history, ophthalmological findings, laboratory and imaging
      findings, treatments, and outcomes were analyzed by staging.

      The data that will be retrieved from the medical records including:

        1. History taking including personal present and previous medical history.

        2. General examination

        3. Oto-rhinolaryngological clinical examination

        4. Routine preoperative laboratory investigations (e.g. complete total and differential
           blood count, blood sugar, coagulation profile, and renal and liver function)

        5. Diagnostic nasal Endoscopy with zero and/or a 30-degree telescope.

        6. CT paranasal sinuses with contrast, fine cuts in coronal axial, and sagittal planes.

        7. The type of intervention whether medical or surgical. 8- Culture results, treatments,
           hospital stay durations, and outcomes.

      Ophthalmology data collection:

        1. Visual acuity (onset of decrease) (unilateral or bilateral) ant its improvement after
           sinus surgery

        2. Presence or absence of double vision (Diplopia)

        3. Ocular motility and if its associated with pain

        4. Proptosis (present or absent) and calculate the degree and direction

        5. Ptosis (present or absent)

        6. Pupil reactivity

        7. Fundus examination to exclude optic nerve neuropathy

        8. Association between ocular pain and headache and its improvement after surgery

        9. CT data collection (CT orbit, MRI of sinus and head)

       10. Fundus photography after surgery to see improvement of optic nerve neuropathy if present
    

Intervention name(s): Endoscopic sinus evacuation
Intervention type(s): Procedure
Intervention description(s): Evacuation of the sinus by using endoscope
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Condition: Treatment Resistant Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with
      treatment resistant major depressive disorder (MDD).

      This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting
      of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is
      being conducted in subjects with treatment resistant MDD.

      Subjects will be considered to have treatment resistant MDD if they have had a historical
      inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response
      to treatment with bupropion during the open-label, lead-in period.
    


Intervention name(s): AXS-05; Bupropion
Intervention type(s): Drug; Drug
Intervention description(s): AXS-05 taken daily for 6 weeks.; Buproprion taken daily for 6 weeks.
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AXS-05; Major Depressive Disorder; Treatment Resistant Depression; TRD; MDD; Axsome; NMDA receptor; Refractory depression; Resistant depression; Depression
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the safety, tolerability and plasma pharmacokinetics of multiple
      doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus
      (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by
      viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice
      daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days
      in HCV-infected male participants is sufficiently safe and well tolerated, based on
      assessment of clinical and laboratory adverse experiences, to permit continued clinical
      investigation.

      The results of this study will guide dose selection for future studies in both healthy
      participants and HCV-infected participants.
    


Intervention name(s): MK-3281; Placebo to MK-3281
Intervention type(s): Drug; Drug
Intervention description(s): MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males); Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be conducted in infants and children with acute otitis media, 6 months to less
      than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to
      describe bacteriologic efficacy in those with initial culture positive specimens with
      different dosages of faropenem
    

Detailed description: 
      The study will be conducted in infants and children with acute otitis media, 6 months to <7
      years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and
      complicated AOM.
    

Intervention name(s): Faropenem Medoxomil
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: AOM
Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The aim of the present study is to determine the extend to which OMT is effective on a sample
      of subjects affected by migraine evaluated using the headache impact test (HIT-6)
      questionnaire.
    


Intervention name(s): osteopathic manipulative treatment; sham treatment; triptans
Intervention type(s): Other; Other; Drug
Intervention description(s): It consists of 8 sessions in 6 months. Each osteopathic session is based on a structural evaluation and an indirect technique treatment.; Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. The practitioner's attention was distracted by subtracting serial seven calculation in silence; administration of triptans drug treatment according to international guidelines
Other intervention name(s): OMT; sham
Intervention MeSH terms: Serotonin 5-HT1 Receptor Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteopathic manipulative treatment; migraine
Osteolysis Development Around Uncemented Cups With or Without Screw Holes
Condition: Arthroplasty Complications
MeSH terms: Osteolysis
Study type: Interventional

Summary: 
      In order to investigate the role of acetabular cup screw holes for the transport of
      osteolysis-inducing particles in a total hip arthroplasty articulation, the investigators
      compare the amount of bone loss around acetabular cups with and without holes. Bone loss is
      measured with computed tomography at 7 years and 15 - 18 years of follow-up.
    

Detailed description: 
      Particles generated by wear and corrosion within an artificial hip articulation can cause
      biologically mediated bone loss in the surrounding pelvis. Particles can be found within
      immunologically active cells inside bone lesions. Holes intended for screw fixation in
      uncemented acetabular cups are believed to be a main route for these particles from the
      articulation into the pelvic bone. Using pressfit, screws are not always necessary for a
      successful fixation of an uncemented cup. The investigator's hypothesis is that a pressfit
      fixated cup without screw holes will display a decreased amount of periacetabular osteolysis
      compared to a cup with screw holes. Therefore, 95 hips (90 patients) were randomized to
      receive either pressfit cups without screw holes or the same type of cup with screw holes.
      The occurence and size of periacetabular osteolysis will be compared between the two groups.
      In addition, since the patients will have a computed tomography examination at 7 years and
      between 15 and 18 years the investigator will also analyze development of periacetabular
      osteolysis over time. The different cups were paired with three different types of femoral
      stems. Also, articulation wear and cup and stem fixation will be analyzed using
      radiostereometry.
    

Intervention name(s): Uncemented acetabular cup with screw holes; Uncemented acetabular cup without screw holes
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uncemented hip arthroplasty; osteolysis; polyethylene wear; implant design
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
Condition: Liver Transplantation; Transplantation Immunology; Host vs Graft Reaction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of Prograf extended
      release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant
      recipients
    


Intervention name(s): Prograf-XL; Prograf; MMF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): tacrolimus extended release; FK506E; MR4; tacrolimus; FK506; Mycophenolate Mofetil
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunosuppressant; Graft loss; Combination drug therapy; Randomized controlled trial; Open level method
Blood Levels and Effects of GSK1325756 in Healthy Adult Volunteers Aged 40 to 80 Years Old
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will invite two groups of volunteers to participate.

      The data from one group of volunteers will be used to find out how much study drug, known as
      GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected
      to find out if the level of cetain blood cells, known as neutrophils, change significantly
      after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64
      years of age.

      The data from the other group of volunteers will be used to find out if taking the study
      drug, GSK1325756, twice in one day with or without food, makes a difference to the level of
      study drug in the blood. This group of volunteers will also provide data to find out if any
      study drug metabolites are present in the bile, a fluid secreted by the liver. This group of
      volunteers will be aged 65 to 80 years of age.
    

Detailed description: 
      The current study will be conducted in two parts. In Part A - Cohort 1, healthy fed subjects
      aged 40 to 64 years (inclusive) will be enrolled to evaluate both the pharmacokinetics and
      pharmacodynamics of twice daily oral administration of GSK1325756 compared to matching
      placebo. In Part B - Cohort 2, healthy elderly subjects aged 65 to 80 years (inclusive) will
      be enrolled to evaluate the pharmacokinetic profile of twice daily oral administration of
      GSK1325756 for administered under fed and fasted conditions. Parts A and B may be performed
      in parallel.

      The approximate duration of the current study is expected to be between 64 and 74 days. The
      study will require subjects to complete a screening visit within 30 days, followed by Part A
      - Cohort 1 enrolment requiring 3 x (3 day treatment period + 7 day washout period) or Part B
      Cohort 2 enrolment requiring 2 x (3 day treatment period + 7 day washout period). All
      subjects will complete a follow up visit within seven to 14 days of last dose.
    

Intervention name(s): GSK1325756; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): GSK1325756 will be available as white, film coated immediate release tablets with dose strengths of 50 mg, 100 mg and 200 mg. The tablets will be administered twice daily by oral route with 240 milliliters of water.; Placebo will be available as white film coated GSK1325756 matching tablet which will be administered twice daily by oral route with 240 milliliters of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans
Condition: Food-drug Interaction
Study type: Interventional
Phase: Phase 2

Summary: 
      Pineapple (Ananas comosus) is a tropical fruit that is rich in antioxidents, enzymes and
      vitamins. It is used worldwide due to their anti-inflammatory and analgesic properties. The
      effect of pineapple Juice on the Pharmacokinetics of celecoxib and montelukast in Humans was
      studied.
    


Intervention name(s): Celecoxib 100mg; Montelukast 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Intervention MeSH terms: Celecoxib; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip
Condition: Osteoarthritis; Total Hip Arthroplasty
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Several studies exist on patient performance in drive simulators especially around and after
      surgery. Recommendations concerning the ability to drive preoperatively are based on these
      studies, which generated their data using drive simulators. However, in all the datasets
      driving performance remains highly individual. Since a drive simulator is not readily
      available in normal general practitioner surgeries it would be helpful to have convenient
      clinical tests to evaluate a patients individual ability to perform an emergency stop. This
      study aims at evaluating different possibilities how such performance might be predicted.
      Patients with hip osteoarthritis and patients who have received total hip arthroplasty are
      tested clinically and their results are compared with the gold standard experiment - a drive
      simulator.
    


Intervention name(s): Braking and functionality
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Quality of Life in Children With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to characterize the quality of life (QOL) and longitudinal
      patterns of change in QOL outcomes in children and youth with HIV infection; to identify
      demographic, social, disease status, treatment, and health care utilization factors that
      predict longitudinal changes in outcomes; to develop a conceptual model that characterizes
      the effects of specific factors that predict longitudinal changes in QOL; and to characterize
      the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical,
      psychological, and social role functioning.
    

Detailed description: 
      This is a Phase III study. This study will use national data available through a prospective,
      observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV
      infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about
      the quality of life (QOL) and the factors that affect it in order to be able to implement
      effective nursing interventions and clinical programs to support and improve QOL in this
      vulnerable population of children.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and youth, from birth to 25 years, with perinatally acquired HIV infection
        enrolled in PACTG 219/219C
      
Keywords: ADOLESCENCE; HIV INFECTION; PEDIATRIC AIDS; QUALITY OF LIFE; HIV