bioihbjkbjnl/mcl2 huggingface dataset:
The Relationship of Neuropathic Pain With Incontinence, Disability and Life Quality in Multiple Sclerosis Patients
Condition: Multiple Sclerosis; Disabilities Multiple; Quality of Life; Incontinence, Urinary; Incontinence Bowel; Neuropathic Pain
MeSH terms: Fecal Incontinence; Multiple Sclerosis; Neuralgia; Urinary Incontinence; Enuresis; Sclerosis
Study type: Observational

Summary: 
      The aim of this study to evaluate the relationship of neuropathic pain with urinary and bowel
      incontinence, functional disability and quality of life in patients with multiple sclerosis.
    

Detailed description: 
      The patient's date of birth, gender, education level, body mass index, occupation, marital
      status, socioeconomic status, who they live with, the onset of their complaints about the
      disease, the time of diagnosis of multiple sclerosis (MS), the type of MS, the presence of
      any pain and the type of pain will be recorded.

      Then, while the patients will be evaluated by researcher Dr Alper Mengi in terms of
      neuropathic pain, incotinance, disability and independence in activities of daily living. The
      forms to be used in terms of health perceptions and quality of life, anxiety and depression,
      and sleep quality will be filled by the patients.
    

Intervention name(s): Neuropathic Pain
Intervention type(s): Other
Intervention description(s): Neuropathic pain degrees of the patients will be evaluated with the Douleur Neuropathic-4 (DN4) questionnaire.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        It will consist of patients who applied to the Istanbul University Cerrahpaşa Neurology
        Multiple sclerosis outpatient clinic between the dates of the study.
Vitamin A in Brown Fat Activity
Condition: Brown Adipose Tissue
Study type: Interventional

Summary: 
      Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical
      studies, however the role of retinoids in human brown fat physiology and energy metabolism
      remains elusive. This study aims to identify a possible association between retinoid
      metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using
      FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic
      profile of white and brown neck fat biopsies at room temperature and cold conditions in a
      subset of the study participants. More detailed molecular studies (involving other potential
      browning markers) will also be performed in adipocytes derived from human SVC.

      The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects
      will be repeatedly exposed to cold and circulating retinoid levels and other plasma
      parameters will be measured at various time points.
    


Intervention name(s): Cold exposure
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)
Condition: Rhinosinusitis; Acute Bronchitis; Acute Otitis Media; Pharyngotonsillitis
MeSH terms: Bronchitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      The general hypothesis is that delayed antibiotic treatment strategy present similar
      effectiveness, when compared with non-prescription of antibiotics or the prescription of
      antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.
    

Detailed description: 
      The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic
      prescribing in our country by evaluating the delayed prescription of antibiotics. The
      proposed trial will take place in the context of a prior similar study we conducted in
      adults. The study currently underway is the DAP-Adults study (a randomised controlled trial
      that evaluates several antibiotic prescribing strategies, including de delayed prescription
      in uncomplicated acute respiratory infections in adults in primary care).

      The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the
      efficacy and safety of delayed prescription of antibiotics compared to direct prescription
      and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric
      patients. This 3 arms clinical trial will include 450 children and will evaluate the duration
      and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived
      efficacy of antibiotics and the number of visits generated. The project also includes a
      qualitative study, by means of structured interviews, to assess the perception and attitudes
      of parents towards the different treatment strategies and carry out a full analysis of
      economic evaluation.
    

Intervention name(s): Antibiotic prescription strategies
Intervention type(s): Other
Intervention description(s): The patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Antibiotic treatment versus delayed antibiotic treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Delayed antibiotic treatment; Acute respiratory infections; Pediatrics; Satisfaction
The Study of Different Dose Rituximab in the Treatment of ITP
Condition: Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional
Phase: Phase 4

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University in China. In order to
      compare the efficacy, safety and response duration of different dose of rituximab in patients
      primary immune thrombocytopenia(pITP).
    

Detailed description: 
      62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided
      into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a
      fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
      In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset
      time, duration of efficacy and adverse reactions were observed to compare the efficacy and
      safety of two different plans.
    

Intervention name(s): Rituximab; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22); given with a single dose of 375mg/m2
Other intervention name(s): Mabthera; Mabthera
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thrombocytopenia; Immune Thrombocytopenia; purpura
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and
      therefore the levodopa area-under-the-concentration-curve values, half-life, and trough
      concentrations The study will help determining the safety and tolerability of ND0611 and
      determine the pharmacokinetic profile of levodopa following multiple oral dosing of
      levodopa/carbidopa (LD/CD) and continuous delivery of ND0611
    


Intervention name(s): ND0611; ND0611
Intervention type(s): Drug; Drug
Intervention description(s): Continuous delivery of ND0611; Solution of ND0611 delivered continuously
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia
Condition: Leukemia, Acute Myeloid; Leukemia, Acute Lymphoblastic
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Acute Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the safety of ex vivo expanded haploidentical
      natural killer (NK) cells for patients with leukemia.
    

Detailed description: 
      Immunotherapy with natural killer (NK) cells may improve the results of treatment for
      patients with cancer. However, for better efficiency high doses of NK cells are required. For
      this purpose, NK cells were expanded in the presence of feeder K562 cells gene-modified for
      expression 4-1BBL and membrane bound IL-21. In the result of expansion, large number of
      activated NK cells are obtained.

      Protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other
      protocol of chemotherapy) followed by expanded NK cells intravenous infusion. To sustain
      proliferation of donor NK cells in vivo patients receive 6 doses of Il-2 every second day. 10
      patients will be enrolled in phase I to test different doses of NK cells: 20, 50, 70, 100 and
      >100 x 10^6/kg.
    

Intervention name(s): Expanded Haploidentical Natural Killer cells; IL-2
Intervention type(s): Biological; Drug
Intervention description(s): One dose (from 20x to >100x 10^6 /kg) of expanded haploidentical NK cells; 6 doses of IL-2 (1 × 10^6 units/m2) from -1 day every other day.
Other intervention name(s): Ronkoleukinum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunotherapy; Natural killer cells
The Effect of Fish Oil in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized
      controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to
      moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel
      omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in
      recovery status.

      The goals of this study were to examine the therapeutic and recurrence prevention effects of
      omega-3 fatty acids on major depressive disorder.
    


Intervention name(s): Omega-3 fatty acids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EPA 2.1 g/d+DHA 1.1 g/d; high oleic oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20
      male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's
      disease on stable doses of acetylcholinesterase inhibitors.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. Up
      to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking
      stable doses of acetylcholinesterase inhibitors will be enrolled in this study. Within 28
      days prior to study drug administration, subjects will be screened based on National
      Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and
      Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State
      Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history,
      physical examination, neurological examination, vital signs, ECG, laboratory tests and
      response to Columbia-Suicide Severity Rating Scale (C-SSRS).

      The study will be performed in two groups of 10 subjects each. In each group of 10 subjects,
      7 subjects will be randomly assigned to receive ABT-354 and 3 subjects to receive matching
      placebo.
    

Intervention name(s): ABT-354; ABT-354; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-354 Low Dose; ABT-354 High Dose; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease
Fish Oil vs. Placebo on Subjective Effects of Alcohol
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      This project represents a first step in examining the potential use of fish oil for the
      treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of
      alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar
      effects in healthy social drinkers.
    

Detailed description: 
      There have been no studies to date that have examined the relationship between fish oil and
      alcohol response in humans. The current study was designed to examine the relationship
      between fish oil and subjective alcohol effects in healthy social drinkers.

      This project represents a first step in examining the potential use of fish oil for the
      treatment of alcohol use disorder (AUD). The investigators will evaluate responses to alcohol
      through administration of a steady state blood alcohol level (BAL) with an IV infusion using
      a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a
      steady state. This approach allows direct comparisons of the acute effects of a specific dose
      of ethanol between groups, without the confounding factors of variable alcohol absorption and
      peak BAL's. This approach will allow the examiners to carefully examine if fish oil changes
      the acute effects of alcohol on a number of outcome domains including subjective drug
      effects, cognitive performance, and cerebellar effects.

      As this study is a pilot study, it is not clear whether fish oil will attenuate alcohol
      induced subjective stimulation or sedation. Since this is the first study to evaluate fish
      oil's effects on alcohol-effects in the laboratory, the investigators will be testing for
      attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects
      and cerebellar effects.

      In this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice
      a day). The investigators will use 3 grams/day for two reasons: 1) it is within the range of
      doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions
      (depression, anxiety, borderline personality disorder), and 2) is a dose that has shown
      efficacy in various clinical trials for psychiatric conditions.
    

Intervention name(s): Fish Oil with ethanol and placebo ethanol infusions; Placebo with ethanol and placebo ethanol infusions
Intervention type(s): Drug; Drug
Intervention description(s): Fish Oil with ethanol and placebo ethanol infusions; Placebo with ethanol and placebo ethanol infusions
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Fish Oil
Evaluation of Postoperative Pain in Children
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain is a common symptom of a flare up after root canal treatments (RCTs).
      Insufficient instrumentation, extrusion of irrigation solutions and debris and existence of a
      periapical lesion are the factors affecting postoperative pain after root canal treatments.
      Aim of this study is to evaluate the postoperative pain and instrumentation time of
      single-file reciprocating system and multiple-file Ni-Ti rotary system in children ages
      between 9-12. Study was conducted on fifty first permanent mandibular molars with the
      diagnosis of irreversible pulpitis. Patients were randomly separated into two groups and RCTs
      were completed with either Reciproc Blue or Protaper Next file systems. Instrumentation time
      for each system was noted and patients were given a pain scale which included visual analog
      scale for 6, 24, 48 and 72 hours after treatment. Postoperative pain scores and
      instrumentation times were analyzed statistically with chi square test and student t test.
      There was no statistically significant difference in postoperative pain between Reciproc Blue
      and Protaper Next systems at all time intervals. Instrumentation time was significantly
      shorter in the Reciproc Blue group in comparison with the Protaper Next group. In conclusion,
      shorter treatment time of single-file reciprocating systems may be more patient friendly and
      comfortable than multiple-file rotary systems in RCTs among children.
    


Intervention name(s): Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next; Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files
Intervention type(s): Other; Other
Intervention description(s): Patients were randomly separated into two groups and root canal treatments were completed with Protaper Next file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment.Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test.; Patients were randomly separated into two groups and root canal treatments were completed with Reciproc Blue file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment.Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test.
Other intervention name(s): Root Canal Instrumentation; Root Canal Treatment; Assessing Postoperative Pain; Instrumentation Time; Root Canal Instrumentation; Root Canal Treatment; Assessing Postoperative Pain; Instrumentation Time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: postoperative pain; root canal treatment; reciprocal motion; rotary motion
Depot Naltrexone Treatment of Opioid Dependent Parolees
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      This is an investigation involving the use of a long-acting, injectable form (depot) of
      naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40
      on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects
      treated with 6 months of depot naltrexone plus Psychosocial Treatment .
    

Detailed description: 
      This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.
    

Intervention name(s): Depot Naltrexone
Intervention type(s): Drug
Intervention description(s): 228mg of injectable naltrexone
Other intervention name(s): Depotrex
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Pulmonary arterial hypertension (PAH) involves the narrowing of blood vessels connected to
      and within the lungs. Focal adhesion kinase (FAK) is a focal adhesion-associated protein
      kinase involved in cellular adhesion and spreading processes which leads to stiffening and
      thickening of blood vessels in lungs. This further increases the blood pressure within the
      lungs and impairs their blood flow. This study aims to demonstrate biodistribution of FAK
      inhibitor, GSK2256098, in cardiopulmonary sites i.e. heart and lung tissues. The uptake of
      11C-radiolabelled GSK2256098 within the lung and / or heart of healthy subjects and
      idiopathic pulmonary arterial hypertension (iPAH) patients will be assessed using Positron
      Emission Tomography (PET). Based on study results the decision as to whether a follow-on
      phase 2 trial should be initiated to investigate the therapeutic utility of GSK2256098 in
      iPAH will be decided. Sufficient number of subjects will be screened (up to 30 days prior to
      scan) to enrol 12 healthy subjects and 12 PAH patients in the study. Enrolled subjects will
      receive a microdose of [11C]-GSK2256098 on a scanning day which will be followed by the
      follow-up visit (2-4 weeks post-last dose).
    


Intervention name(s): [11C]-GSK2256098 500 MBq
Intervention type(s): Drug
Intervention description(s): [11C]-GSK2256098 injection will be provided as IV infusion, 20 mL, containing up to 5% ethanol in saline.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Idiopathic Pulmonary Arterial Hypertension; Biodistribution; Positron Emission Tomography; [11C]-GSK2256098; Healthy subjects