bioihbjkbjnl/mcl2 huggingface dataset:
Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV
Condition: Efavirenz; Child Behavior; Cognitive Symptom; Medication Adherence; Drug-Related Side Effects and Adverse Reactions
MeSH terms: Neurobehavioral Manifestations; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing
      evidence shows that central nervous system side-effects in adults are more common than
      previously thought. Still, reliable data in children are lacking. As HIV-infected children
      nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential
      long-term central nervous system side-effects, interfering with neurodevelopment and
      psychosocial maturation. Using validated tools, we assessed (1) competence
      (social/activities/school) and psychopathology (internalizing/externalizing problems), (2)
      cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian
      children on an efavirenz or non-efavirenz based regimen

      In this cross-sectional observational study the investigators will examine neuropsychiatric
      and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination
      antiretroviral therapy (cART) with or without efavirenz.
    

Detailed description: 
      In this cross-sectional observational study, we include HIV-infected children (6-12 years) on
      cART for ≥ 6 months, with viral loads ≤ 1000 copies/ml in Kilimanjaro Region, Tanzania.
      Psychopathology and competence will be assessed using the Child Behaviour Checklist.
      Cognitive performance will be assessed using the Raven's Coloured Progressive Matrices and
      the digit span test. Non-adherence is defined as any reported missed doses over the previous
      3 days or <100% adherence since the last clinical visit. Analysis of covariance and logistic
      regression models will be used to assess differences between groups. .
    

Intervention name(s): Efavirenz; Nevirapine; Lopinavir-Ritonavir Drug Combination
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS; Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS; Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
Other intervention name(s): Efavirenz-group; Non-efavirenz group; Non-efavirenz group
Intervention MeSH terms: Ritonavir; Lopinavir; Nevirapine; Efavirenz
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Tanzanian children (6-12 years) living with HIV and receiving cART
      
Keywords: Efavirenz; Child Behavior; Cognition; Medication Adherence; Drug-Related Side Effects
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Primary objective of the study is the assessment of the patients' discomfort and ocular
      redness following cataract extraction surgery by means of phacoemulsification and intraocular
      lens implantation.
    

Detailed description: 
      Participants will be recruited from the Cataract Service of the University Hospital of
      Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer
      randomization program all participants will randomly populate either study group (who will
      receive Systane Ultra as additional postoperative treatment) and control group (who will
      receive standard postoperative treatment).
    

Intervention name(s): Systane Ultra; tobradex quid (Standard)
Intervention type(s): Drug; Drug
Intervention description(s): Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months; Standard medication (tobradex quid for 20 days)
Other intervention name(s): Administration of Systane Ultra (Alcon); Standard Medication
Intervention MeSH terms: Tobramycin, Dexamethasone Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The investigators will examine the beneficial impacts of applying of dHACM on the preserved
      neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted
      laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing
      and reduction of inflammation at the operative site and thus an acceleration of return of
      potency regulating cavernosal nerves.
    

Detailed description: 
      The overall objective of this study is to evaluate the effectiveness of dehydrated human
      amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate
      cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical
      prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had
      full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to
      that of full nerve sparing RALP without dHACM application to neurovascular bundles.

      Patients will be randomized to one of two possible treatment groups:

        -  Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®)

        -  Group 2 - Control Group ( Full Nerve Sparing RALP alone)
    

Intervention name(s): RALP using full nerve sparing technique; dHACM Application
Intervention type(s): Procedure; Other
Intervention description(s): RALP using full nerve sparing technique; 2x12 sheet of dHACM applied to the neurovascular bundle
Other intervention name(s): HCT/P Part 361
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies
Condition: Hematological Malignancy; Acute Leukemia in Remission; Acute Lymphoblastic Leukemia in Remission; Myelodysplastic Syndromes; Non-Hodgkin Lymphoma; Hodgkin Lymphoma
MeSH terms: Lymphoma; Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA)
      expanded cord blood stem cells defined by the lack of serious infusion reactions or graft
      failure in patients with hematological malignancies undergoing umbilical cord blood
      transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet
      engraftment as well as transplant related outcomes such as graft versus host disease (GVHD),
      treatment related mortality (TRM), and overall survival (OS).
    

Detailed description: 
      This is a phase I trial for safety of VPA expanded cord blood stem cells in patients with
      hematological malignancies undergoing allogeneic stem cell transplantation. The primary
      endpoint of the study is safety as defined by the incidence of infusion reactions and graft
      failure, lack of neutrophil engraftment by day +42. The trial will consist of two cohorts.
      First cohort of 5-7 patients, will undergo double umbilical cord blood (UCB) transplantation.
      One UCB unit will undergo CD34 selection followed VPA based expansion. CD34 negative portion
      of that unit will be cryopreserved to be infused later following infusion of the expanded
      portion. Infusion of the second unmanipulated UCB will follow it. Preparative regimen is
      Fludarabine 150 mg/m2/Cytoxan 50 mg/m2/Thiotepa 10 mg/m2/TBI 400cGy.

      Following successful engraftment in the first cohort, second cohort (10 patients) will only
      receive single manipulated unit.

      Otherwise, patients will receive standard allogeneic stem cell transplantation care.
    

Intervention name(s): Cord blood stem cells; Valproic Acid; Fludarabine; cytoxan; Thiotepa; TBI
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Biological
Intervention description(s): CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood .; Valproic Acid (VPA) expanded cord blood stem cells; Fludarabine 150 mg/m2; Cytoxan 50 mg/m2; Thiotepa 10 mg/m2; TBI 400cGy
Other intervention name(s): VPA
Intervention MeSH terms: Fludarabine; Cyclophosphamide; Thiotepa; Valproic Acid
Intervention model: Sequential Assignment
Intervention model description: Open label single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematological Malignancies; Expanded Umbilical Cord; Allogeneic Stem Cell Transplant; Leukemia; Lymphoma
Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to
      evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with
      relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up
      to 10 weeks (including screening and treatment periods). The treatment period will last 8
      weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections
      using the Rebiject II® device.
    


Intervention name(s): Rebif Rebidose; Rebiject II
Intervention type(s): Device; Device
Intervention description(s): Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.; Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis, Relapsing-Remitting; Rebif®Rebidose®; Rebiject II®
Aesthetic Evaluation of Different Abutment Materials for OsseoSpeed Implants
Condition: Aesthetic Evaluation; Implant Survival Rate
Study type: Interventional

Summary: 
      The objective of the study was to assess the aesthetic outcome of different abutments
      materials and shapes on dental implants .

      A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue
      , radiographic evaluations and clinical photographs, was used to obtain a measure of the
      aesthetic of implant-prosthesis rehabilitations.
    


Intervention name(s): aesthetic outcome
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: dental implant, aesthetic, implant abutment
PRV-based Detection of CAD in Comparison to Standard Methods
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      This is a validation study comparing a pulse wave based algorithm for the detection of
      coronary artery disease with parameters from coronary angiography, echocardiography and
      cardiogoniometry.
    

Detailed description: 
      The study will validate a pulse wave based algorithm for the detection of coronary artery
      disease (CAD) with parameters from standard methods. Subjects will be patients admitted to
      coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to
      novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These
      results be compared to the diagnoses made by coronary angiography (primary endpoint):
      presence of minimum one coronary artery stenose >=50%. For secondary analyses, results will
      be compared to parameters form echocardiography and cardiogoniometry.
    

Intervention name(s): Diagnostic algorithm
Intervention type(s): Other
Intervention description(s): Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects referred to first coronary angiography due to suspected CAD
      
Keywords: coronary artery disease; diagnosis; non-invasive
Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis
Condition: Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Acute Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the mucolytic activity of Tacholiquine® compared to
      saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles in
      sputum and serum, and clinical symptoms by standardized questionnaires [COPD activity index
      (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)and the St. George's
      Respiratory Questionnaire (SGRQ)] will be evaluated in response to Tacholiquine® vs. saline
      in chronic bronchitis patients.
    

Detailed description: 
      The aim of the study is to compare Tacholiquine ® and saline (0.9%) regarding their ability
      to promote the discharge of mucus from the respiratory passages in patients with chronic
      bronchitis (COPD). Alleviated discharge of mucus should ease breathing, improve subjective
      wellbeing, reduce inflammation in the air passages and improve lung function.

      Determine the magnitude of the effect of Tacholiquine ® compared to saline (0.9%) in chronic
      bronchitis patients. Lung function parameters, biomarker profiles in sputum and serum, and
      clinical symptoms and quality of life by standardized questionnaires [COPD activity index
      (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI), St George's respiratory
      Quality of Life Questionnaire] will be evaluated in response to Tacholiquine ® vs. saline at
      day one and at end of treatment.
    

Intervention name(s): Tacholiquine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Inhaled Tacholiquine ®1% - 5ml; Inhaled Placebo
Other intervention name(s): isotonic saline solution (0.9%)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Integrated PTSD and Smoking Treatment
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Research shows that people with PTSD are more likely to smoke than people without PTSD. It
      also shows that people with PTSD have more difficulty at attempts to quit smoking. This study
      is part of a program aimed at finding out how best to help smokers quit who also have PTSD.
      One option is to give patients standard smoking cessation treatment including nicotine
      replacement and cognitive behavioral therapy. Another option is to give patients the standard
      smoking cessation treatment in addition to treatment for their PTSD symptoms (called
      prolonged exposure). However, it is not known which method works better. In order to answer
      this question, patients will be assigned by chance to one of two groups. One group will be
      given standard smoking cessation treatment to help quit smoking. A second group will be given
      the standard smoking cessation intervention to help quit smoking in addition to a form of
      psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be
      randomly assigned (by chance) to one of these groups. If the patient is assigned to the
      smoking cessation only condition and the patient still has PTSD symptoms after the last study
      visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged
      Exposure) at no cost. The patient's participation will help the investigators determine if
      treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit
      smoking.
    


Intervention name(s): Prolonged Exposure; Smoking Cessation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.; Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Level of Knowledge and Habitual Concepts of Turkish Parents on Child Passenger Safety
Condition: Equipment Safety; Accidents, Traffic
Study type: Observational

Summary: 
      It is well known that traffic accidents are one of the major reasons for death in childhood.
      Unfortunately scientific and statistical data usually comes from developed countries. In this
      study, the investigators will try to evaluate Turkish families' knowledge on Child Passenger
      Safety, observe how they carry their babies in the car and investigated the reasons behind
      the undesired behaviors.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will be done on mothers and fathers of babies brought to the first. control.
      
Keywords: Child Passenger Safety; Parental perception of vulnerability; Neonatology; Newborn
Exercise and Nerve Function in Diabetes
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      The purpose of this study is to describe the effect of a 10-week exercise program on nerve
      function and number of nerve fibers in the skin in the lower leg in people with diabetic
      neuropathy.
    

Detailed description: 
      The objective for this application is to quantify the benefits of exercise on nerve function
      including proprioception, and investigate the relationship of these findings with
      improvements in epidermal and dermal innervation. In this pilot project, we will pursue 2
      specific aims: 1) determine the effect of an exercise intervention on nerve function in
      people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following
      participation in an exercise program.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: neuropathy; diabetes
Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving
      cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or
      general anesthesia. The investigators primary outcome was to evaluate the effects of the
      depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation
      during the ERCP procedure by analyzing the biochemical parameters. And their secondary
      outcome was the effects of anesthesia depth on propofol consumption and postoperative
      sedation status.
    

Detailed description: 
      50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was
      given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients
      whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The
      levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres
      index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery
      time were recorded.
    

Intervention name(s): Bispectral Index Monitorisation (BIS); Ramsey Sedation Scale
Intervention type(s): Device; Other
Intervention description(s): Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients; Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Depth of anesthesia; BIS; ERCP; Positive Regulation
Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron
Condition: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      -  The primary aim of this study is to evaluate the impact of titration, analgesics, and 12
           month telephone follow-up period from the B.E.T.A nurse program upon adherence to
           treatment with Betaseron in patients with a first clinical demyelinating event
           suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12
           months

        -  Secondary outcomes include analysis of the following parameters: progression of clinical
           severity by the expanded disability status scale (EDSS score), health related quality of
           life (HrQoL), and safety.

        -  Exploratory outcomes include changes over time in cytokine and neurotrophic factor
           production by immune cells and visual function as assessed by visual examination, OCT
           measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire
           (NEI-VFQ-25) with 10-item supplement.
    


Intervention name(s): Interferon-1beta (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months
Intervention MeSH terms: Interferons; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: Relapsing-Remitting Multiple Sclerosis; First demyelinating event; MRI features consistent with MS