bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes
Condition: Charcot Arthropathy; Type 2 Diabetes
MeSH terms: Arthropathy, Neurogenic; Diabetes Mellitus
Study type: Observational

Summary: 
      To assess the hypothesis that Charcot foot is associated with more vascular complications
      compared to matched diabetic patients without Charcot foot and to classify patients with
      Charcot foot according to the human genetic classification of the Qatari population.
    

Detailed description: 
      Diabetes is a serious health issue for the Qatari population since approximately 1/5 of the
      population has Type 2 Diabetes, which is 2-3 times higher than the world average. Although
      much of the clinical studies of diabetes often focused on microvascular phenotypes such as
      retinopathy and nephropathy, and macrovascular diseases presenting clinically as myocardial
      infarction, stroke, and peripheral vascular disease, other rare complications such as Charcot
      foot disease confer a significant burden in Qatar diabetic population, leading to decreased
      life quality.

      Charcot foot is estimated to affect 0.8% to 8% of diabetic populations. It occurs most
      commonly in patients with diabetes complicated by severe peripheral neuropathy, often with
      coexisting sympathetic denervation, causing increased blood flow to the foot and increased
      bone resorption.

      Uncontrolled and inappropriate inflammation leading to bone resorption and deformation has
      been the hallmark of diabetic Charcot foot pathophysiology. There are two major theories that
      provide the likely mechanism of the disease. The "neurovascular (French) theory" suggests
      that increased blood flow, as a result of autonomic neuropathy, can lead to bone destruction
      and mechanical debilitation. On the other hand, the "neurotraumatic (German) theory" argues
      that the loss of protective sensation leads to unperceived injury and trauma in the insensate
      foot. One can argue that the pathogenesis of Charcot neuro-arthropathy is most likely a
      combination of these processes. For unknown reasons, Charcot foot is trigged only in some
      susceptible individuals with diabetes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited for the study at Hamad Medical Corporation. Most of the subjects
        will belong to the oupatient clinics.
      
Biospecimen description: 
      Blood Urine
Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the potency between prophylactic norepinephrine
      and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing
      caesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended
      for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential
      substitute drug for phenylephrine, norepinephrine has gradually been used in parturients
      undergoing cesarean section. There's some evidence that prophylactic infusion of
      norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension
      in parturients undergoing cesarean section. However, few studies had been indicated the ED50
      (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine
      bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in
      patients undergoing caesarean section. The purpose of this study is to investigate the
      potency between prophylactic norepinephrine and phenylephrine boluses for postspinal
      anesthesia hypotension in patients undergoing caesarean section.
    

Intervention name(s): Phenylephrine; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.; An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.
Other intervention name(s): Vasopressors; Vasopressors
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Norepinephrine; Phenylephrine; Postspinal anesthesia hypotension; Cesarean section
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of
      immune cells found in bone marrow or peripheral blood and may bring about complete remission
      in patients who have chronic phase chronic myelogenous leukemia.

      PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating
      patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic
      remission after initial treatment.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of
           the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not
           in complete cytogenetic remission after initial therapy.

      OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the
      absence of disease progression or unacceptable toxicity. Patients achieving no response
      receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or
      better after the second course of GM-CSF are removed from the study. Patients achieving a
      partial response after the first or second course of GM-CSF continue to receive GM-CSF for an
      additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic
      response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression
      or unacceptable toxicity.

      Patients are followed every 2 weeks.

      PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.
    

Intervention name(s): sargramostim
Intervention type(s): Biological
Intervention MeSH terms: Sargramostim
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive
A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately
      controlled on chronic therapy with high dose inhaled corticosteroids and a second controller
      medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of
      either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual
      asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with
      a 48-week follow-up.
    


Intervention name(s): MEMP1972A; MEMP1972A; MEMP1972A; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous repeating dose; Subcutaneous repeating dose; Subcutaneous repeating dose; Subcutaneous repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Therapeutic Recreation Activities on Emotional Adjustment of Individuals With Intellectual Disabilities
Condition: Emotional Adjustment; Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of Therapeutic Recreation Activities on
      Emotional Adjustment of Adolescents With Intellactual Disabilities. The research was carried
      out at Meram Melike Hatun Special Education Vocational School in Konya. The study took place
      between March 2019 and May 2019. The parents of the participants who participated in the
      study consisted of the experimental group (n = 17) and the remaining parents (n = 17) formed
      the control group and the sample group (n = 34). The personal information form which measures
      demographic characteristics developed by the researchers according to the literature, and
      Hacettepe Emotional Adjustment Scale were used. Data were analyzed in SPSS 22 program.
      According to Kolmogorov-Smirnov Z test, sample group was not normal. For this reason,
      non-parametric tests were performed. In descriptive data, the mean, number, percentage will
      be used; Comparative statistics were made according to the assumptions of non-parametric test
      (Wilcoxon test, Mann Whitney U test). Therapeutic Recreation Activities was applied as total
      of 16 sessions, consisting of two sessions per week and each session lasting about 1 hour.
      The program was implemented by researcher.
    


Intervention name(s): Therapeutic recreation activity program
Intervention type(s): Behavioral
Intervention description(s): The experimental recreation program, which consisted of two sessions per week and lasted approximately 1 hour each session, lasted for 8 weeks between March 2019 and May 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Game; Therapeutic Recreation; Intellectual Disability
Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa
Condition: Patient Non-compliance
Study type: Observational

Summary: 
      The goals of this research are to understand adherence and retention in care for multi-and
      extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.
    

Detailed description: 
      Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people
      living with HIV. Globally, incidence of multidrug-resistant tuberculosis (MDR-TB) and
      extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has
      approximately doubled over the past fifteen years. Nowhere has this increased incidence
      generated more concern than in South Africa where interactions between TB and generalized HIV
      epidemics are causing 'explosive' TB incidence and case-fatality threatening to undermine the
      progress reached with antiretroviral therapy (ART).

      Medication adherence, a key predictor of outcomes in multi-and extensively drug-resistant
      tuberculosis (M/XDR-TB) and HIV treatment, is understudied in high burden TB/HIV settings.
      Patient losses during transitions in the care continuum are frequent, increase mortality and
      limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including
      extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma
      with few parallels in modern medicine.

      This is a prospective observational cohort study for patients newly diagnosed with M/XDR-TB
      initiating treatment. A mixed method approach will be employed to address the complex
      research questions of distilling determinants of barriers and facilitators to both TB
      medications and ART; this study will employ complementary qualitative and quantitative
      methodologies for assessing differential adherence to TB medications and ART.

      A sub-set of patients and health care workers will be approached for participation in focus
      group discussions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with newly diagnosed active pulmonary multi- and extremely-drug resistance
        tuberculosis (M/XDR-TB) (≥ 18 years old), admitted for routine care at King DinuZulu
        Hospital in Durban, South Africa will be approached for enrollment. Only patients with
        capacity for consent will be included in the study. Healthcare workers will be approached
        for participation in focus group discussions.
      
Biospecimen description: 
      Hair samples PBMCs TB Isolates
    
Keywords: adherence; HIV; MDR/XDR TB; Health Care Worker
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy
      and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate
      to very severe COPD.
    

Detailed description: 
      A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and
      safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment
      period in subjects with moderate to very severe COPD.
    

Intervention name(s): BGF MDI 320/14.4/9.6 μg; GFF MDI 14.4/9.6 μg; BGF MDI 160/14.4/9.6 μg; BFF MDI 320/9.6 μg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Budensonide, Glycopyrronium, and Formoterol Fumarate; Glycopyrronium, and Formoterol Fumarate; Budensonide, Glycopyrronium, and Formoterol Fumarate; Budensonide, and Formoterol Fumarate
Other intervention name(s): BGF; GFF; BGF; BFF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers
Condition: Pregnancy Related; Nausea
MeSH terms: Nausea
Study type: Interventional

Summary: 
      The study aimed for:

        1. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug
           Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta
           Pharm JSC, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant:
           Tzamal Bio-Pharma, Israel, manufacturer: Duchesnay Inc, Canada), in healthy volunteers
           in fasted conditions.

        2. Comparative evaluation of the safety of the drug Doxylamine + Pyridoxine,
           enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSK, Russia), and
           Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma,
           Israel, manufacturer: Duchesnay Inc, Canada), based on the analysis of adverse events
           (AEs).
    


Intervention name(s): Doxylamine + Pyridoxine
Intervention type(s): Drug
Intervention description(s): A single dose of R or T drug in each of 2 periods of the study in fasted conditions
Intervention MeSH terms: Pyridoxine; Doxylamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG
      3350 solution concentrate to oral ingestion of a placebo solution concentrate, in
      participants with constipation.
    

Detailed description: 
      This was a randomized, single-blind, placebo-controlled study to evaluate the proportion of
      participants with abnormalities of the oral mucosa detected by visual examination of the oral
      cavity in the polyethylene glycol (PEG) 3350 group compared with the placebo group. The study
      was also to evaluate the proportion of participants with abnormalities of the esophageal
      mucosa detected by endoscopic examination of the esophagus in the PEG 3350 group compared
      with the placebo group, and to compare the safety and tolerability by evaluation of the
      proportion of participants with the occurrence of adverse events (AEs) or adverse drug
      reactions.
    

Intervention name(s): Polyethylene Glycol (PEG 3350); Placebo; Bisacodyl laxative tablets (rescue medication)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.; Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.; 5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.
Other intervention name(s): MiraLAX Solution Concentrate
Intervention MeSH terms: Bisacodyl; Polyethylene glycol 3350; Laxatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft
Condition: Gingival Recession; Atrophy
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study is to compare the effect of mesial and distal adjacent gingival
      biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of
      graft at 6 months postoperatively.
    

Detailed description: 
      The concept of gingival and periodontal phenotype was established as a result of clinical
      observation of changes in facial keratinized tissue width and thickness .It has been reported
      that gingival or periodontal diseases may develop more frequently in patients with thin
      gingival biotypes and that thick-flat biotype in implant restorations is important in
      achieving a successful aesthetic treatment outcome.

      Free gingival graft (FGG) is a mucogingival surgical procedure that is successfully used in
      the presence of inadequate keratinized gingival width and gingival recession. It is thought
      that factors that may adversely affect the continuity of graft nutrition may be effective in
      graft shrinkage. These reasons can be listed as follows; graft thickness, traumatic surgical
      procedure, graft dehydration, and suturing procedure.

      There was no study investigating the effect of periodontal biotypes on graft contraction in
      the region adjacent to the FGG operation.
    

Intervention name(s): free gingival graft
Intervention type(s): Procedure
Intervention description(s): A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival biotype of adjacent teeth; free gingival graft; shrinkage of graft
Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
Condition: Early Infant HIV Diagnosis
MeSH terms: Disease
Study type: Interventional

Summary: 
      This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the
      Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
    

Detailed description: 
      At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4
      and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to
      improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or
      control arm and an intervention arm known as the Alere arm. In both study arms, early infant
      diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will
      receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program,
      with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the
      intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried
      blood spot (DBS) drawn for confirmatory DNA PCR).

      HIV-infected infants will be followed for 12 months. The acceptability of point-of-care
      testing for EID will also be determined through the use of cross-sectional surveys of
      clinicians, laboratory personnel, and parents/guardians.

      The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM)
      analyses will also be conducted to compare the Alere Q to two additional testing
      technologies.
    

Intervention name(s): DNA PCR HIV diagnostic test; Alere Q
Intervention type(s): Device; Device
Intervention description(s): standard of care; POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV; point-of-care HIV diagnosis; Alere Q; diagnostic; children