bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is
      effective in the treatment of attention deficit and emotional, executive function and social
      function dysregulation due to attention deficit disorder (ADHD).
    

Detailed description: 
      Participations will be randomly assigned to 3 groups which are CBT with booster sessions
      group, CBT only group and waiting group.With the comparison of first tow groups we will
      explore the effect of booster sessions, and the last two groups the effect of CBT programme.
    

Intervention name(s): CBT only; CBT with booster sessions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.; Participants are provided with the same CBT programme and additional 3 booster sessions which summarize and extend the 3 main topics of the CBT programme in order to improve the skills practice ability.
Other intervention name(s): Mastering Your Adult ADHD manual (Safren, et al., 2005)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention deficit disorder (ADHD); cognitive behavioral therapy (CBT); adult
Clinical Outcomes, Viscoelastic Properties and Central Pain Mechanisms After Eccentric Training in Neck/Shoulder Pain
Condition: Neck Pain; Work-related Injury; Shoulder Pain
MeSH terms: Shoulder Pain; Neck Pain
Study type: Interventional

Summary: 
      Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female
      computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain
      (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP,
      and 3) assess changes in central pain responses after training.

      Methods: In part A, twenty office workers with NSP will be compared with 20 healthy controls.
      In part B, the NSP group will undergo a 5-week eccentric training program. Participants will
      report their pain intensity, and complete the Neck Disability Index, and the Disabilities of
      the Arm, Shoulder and Hand questionnaire. Pressure pain thresholds (PPTs) will be assessed
      over the neck and forearm. Cuff algometry will identify pain detection (PDT) and tolerance
      thresholds (PTT). TSP will be evaluated by visual analogue scale pain scores during 10
      repetitive cuff stimulations. CPM will be calculated as the difference in PDT with and
      without a conditioning painful stimulus. Outcomes will be measured at baseline and
      post-intervention.
    


Intervention name(s): Eccentric Training Protocol
Intervention type(s): Device
Intervention description(s): A custom-built dynamic shoulder dynamometer (Aalborg University, Aalborg, Denmark) will be used. Participants will be seated with back support and no feet support. The maximal voluntary contraction (MVC) of the painful side will be assessed. Sessions will start with a 5-min warm-up. After that, participants will sit in the dynamometer, and the range of shoulder elevation (highest and lowest vertical position) will be measured for the affected side. During training, subjects will have to counteract a dynamometer vertical force from the highest to the lowest shoulder position at a force equal to 60% (training sessions 1-3), 70% (training sessions 4-6), and 80% (training sessions 7-10) of the MVC recorded during baseline. Three bouts of 10 repetitions (sessions 1-3), 8 repetitions (sessions 4-6) and 6 repetitions (sessions 7-10) will be performed, with a 3-second rest between contractions and a 2-minute break between bouts.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical Pain; Hyperalgesia; Intervention; Musculoskeletal disorders; Computer Work; Strength Training
PDE5-Inhibition With Sildenafil in Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide
      pathway is beneficial in chronic heart failure patients.

      Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise
      performance
    

Detailed description: 
      In chronic heart failure (CHF), endothelial function (EF) deterioration and muscle
      underperfusion elicit ergoreflex exercise oversignaling, hyperventilation and breathlessness.
      PDE5 inhibition, by improving EF, might be beneficial. We tested this hypothesis in a
      long-term therapeutic trial. CHF patients were randomly assigned to placebo (23 cases, group
      1) or sildenafil (23 cases, group 2) in addition to their current antifailure therapy, for 6
      months. In group 2 and not in group 1, assessments at 3 and 6 months showed the following
      changes: reduction of systolic pulmonary artery pressure (-25.2 and -29.0 %), ergoreflex
      effect on ventilation (-66.6 and -72.5%), ventilation to CO2 production slope (VE/VCO2, -14.0
      and -16.0%) and breathlessness (-29.6 and -27.1%); increase of brachial artery flow-mediated
      dilatation (FMD, +57.6 and +67.0%), peak exercise O2 uptake (peak VO2, +25.0 and +26.3%) and
      ratio of VO2 to work rate changes (VO2WR, +20.7 and +22.0%). These changes were
      significant at p<0.01. In group 2 and not in group 1, a significant correlation was found, at
      3 and 6 months, between changes in FMD and those in ergoreflex VE. Changes in ergoreflex
      correlated with those in peak VO2 and VE/VCO2 slope. No remarkable side effects were noted,
      but flushing in 3 patients.

      In CHF, benefits of sildenafil are sustained and consist of improvement in EF, modulation in
      ergoreflex signaling, attenuation in exercise hyperventilation and breathlessness, increase
      in aerobic efficiency and exercise performance. Thus, sildenafil can affect peripheral
      mechanisms of breathlessness and may be viewed as an effective and safe adjunct to the
      therapeutic armamentarium of CHF.
    

Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PDE5 inhibition; chronic heart failure; endothelial function; exercise ventilation
Comparison of Two Phacoemulsification-methods: HF EasyTip 2.2mm vs. HF EasyTip 2.8mm
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The aim of this study was to compare the intraoperative efficiency, safety and postoperative
      outcomes of cataract surgery with two different "high-fluidic" settings.
    


Intervention name(s): cataract surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Efficacy and Safety
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Fibrosis; Constriction, Pathologic
Study type: Observational

Summary: 
      Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the
      obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography
      Doppler, which assesses two key markers that are aortic valve pressure gradient and the
      aortic valve area. however these marker are a poor reflect of the clinical severity of AVS.
      The aim of the study is to validate new markers assessing cardiac fibrosis that might best or
      complementary markers.
    

Detailed description: 
      To validate new markers assessing cardiac fibrosis three groups of subjects were studied in
      controls subjects and patients with AVS in order to :

        1. Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and
           wall shear stress in a control population and in three groups of subjects to RA
           progressively increasing risk: asymptomatic subjects without symptomatic subjects LV
           dysfunction, symptomatic patients with LV dysfunction. The factors favoring the
           appearance of fibrosis observed in MRI will be analyzed on all subjects.

        2. To validate these fibrosis markers estimated by MRI by histological analysis of biopsies
           performed in patients undergoing aortic valve replacement.

        3. Monitoring compliance with the distribution of markers of fibrosis and wall stress
           estimated on Initial MRI are factors of aggravation or not improved function and / or
           remodeling remote myocardial. Public hospitals in Paris
    

Intervention name(s): Valvular aortic stenosis surgery
Intervention type(s): Procedure
Intervention description(s): Dilatation of Valvular aortic stenosis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Valvular Aortic Stenosis with or without surgery (symptomatic patients) or controls
      
Biospecimen description: 
      Plasma and serum
    
Keywords: fibrosis; Magnetic resonance imaging
Alpha-Blockers in Allergic Rhinitis (MAN 01)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is
      known to seriously decrease quality of life, aggravate preexisting conditions particularly
      asthma, carry significant medical treatment costs and be responsible for reduced work
      productivity and lost school days. A significant symptom of the condition, nasal blockage,
      remains difficult to treat even when using nasal corticosteroids. Decongestant medications
      act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose
      but if used for more than seven days a more severe rebound congestion of the nose develops.

      In this study, the investigators aim to assess the effects of doxazosin, a drug which is
      currently used to treat high blood pressure and symptoms of prostate enlargement, to find out
      if it has an effect on nasal blockage.
    


Intervention name(s): Doxazosin XL; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Cardozin XL 4mg Prolonged-release Tablets
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
State Of The Art Functional Imaging In Sickle Cell Disease
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      Sickle cell anemia (SCA) is a serious blood disease with blood vessel changes leading to
      brain injury and stroke. Studies show about 11% of patients with SCA will develop obvious
      stroke before age 20 years, with children less than 10 years of age especially vulnerable.
      The main objective of the SCDMR4[State Of The Art Functional Imaging In Sickle Cell Disease]
      trial is to compare the gray matter cerebral blood flow, measured by MRI,[magnetic resonance
      imaging] ASL [Arterial Spin Labeling] perfusion before treatment begins and after the
      appropriate hydroxyurea dosage is reached (~ one year). Other important objectives of the
      SCDMR4 trial include describing the effect of hydroxyurea therapy and transfusion therapy on
      the functional MRI response, diffusion tensor imaging of white matter, brain function, and
      transcranial Doppler blood velocities.
    

Detailed description: 
      The Primary Objective of the study is to compare the research participant's GM [Gray Matter]
      CBF [Cerebral Blood Flow] by ASL [Arterial Spin Labeling] techniques before and after
      reaching a stable hydroxyurea MTD [Maximum Tolerated Dose] (12±3 months after starting
      hydroxyurea).

      This is an observational study. Participants receive hydroxyurea as part of their standard of
      care treatment. This study will observe the above measures prior to beginning hydroxyurea and
      after participants reach the maximum tolerated dose in order to describe the effect of
      therapy on the participants' functional response.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The potential research participants will be recruited, screened and consented from the
        School-Age and Teen Sickle Cell Clinics by the referring St. Jude hematology
        co-investigators. There will be no advertisement per se. Affiliate hematology
        co-investigators will contact St. Jude hematology co-investigators about potentially
        eligible research participants. Affiliate potential research participants will be screened,
        and if appropriate, consented and tested at St. Jude institution.
      
Keywords: magnetic resonance imaging; sickle cell disease; hydroxyurea therapy
Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The EndoStim Stimulation System is an investigational device intended to improve the lower
      esophageal sphincter (LES) resting tone and restore LES function in individuals suffering
      with gastroesophageal reflux disease (GERD).
    

Detailed description: 
      EndoStim is developing an investigational medical device specifically designed to deliver
      electrical stimulation to the LES and has completed two clinical feasibility studies using
      the EndoStim stimulation system in fifteen subjects.

      Acute electrical stimulation resulted in significant LES pressure with no adverse effects
      reported.

      Results of these studies are promising and warrant additional clinical study to evaluate the
      effectiveness of EndoStim stimulation system to treat GERD over time.

      In this study, EndoStim proposes using a fully implantable system. Results of this study are
      expected to provide confirmation of safety of long-term LES stimulation and may provide long
      term clinical benefit for GERD patients.
    

Intervention name(s): EndoStim LES Stimulation System
Intervention type(s): Device
Intervention description(s): The EndoStim LES Stimulation System comprises three components:
an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; LES Pressure; Electrical Stimulation
TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Condition: Healthy; Sedentary
Study type: Interventional

Summary: 
      Physical inactivity is a major public health issue. Prescription of physical activity appears
      necessary in some situation with cardiovascular risk. It is important to both qualify and
      quantify daily physical activity.

      The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt)
      performance in 12 healthy subjects, wearing this system over the daytime during one week.
    

Detailed description: 
      Healthy subjects have to make different physical activities, wearing the TEMIS system like
      slow and fast walking, biking, running.
    

Intervention name(s): TEMIS system
Intervention type(s): Device
Intervention description(s): Wearing TEMIS system over the day during one week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Impact of COVID-19 Pandemic on Depression and Quality of Life
Condition: Depression; Quality of Life; Covid 19; Social Isolation
MeSH terms: COVID-19; Depression; Depressive Disorder
Study type: Observational

Summary: 
      It is aimed to investigate the depression and quality of life of Turkish society caused by
      Covid-19 pandemic and reveal the relationship between them
    

Detailed description: 
      Study hypothesis that people are tend to be depressed and the quality of life is affected
      negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate
      change on depression and quality of life observable and measurable. It is aimed to
      investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic
      and reveal the relationship between them. According to existing data and perspective of
      psychology and physiotherapy, potential solutions will be aligned.
    

Intervention name(s): Online survey
Intervention type(s): Other
Intervention description(s): Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess depression (Zung depression Scale) and quality of life (WHO Qualiy of Life - Bref version).
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It
        is calculated that there are 42.463.119 individuals cover the criterion as universe of the
        study.
      
Keywords: Covid 19; Depression; Quality of Life; Turkish Society; Social Isolation
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
Condition: Breast Cancer Female; Peripheral Neuropathy
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily
      administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer
      patients.
    

Detailed description: 
      Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen
      even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include
      pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove
      distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root
      ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of
      calcium subunits which in turn increases pain. It also causes oxidative stress in sensory
      axons leading to axon demyelination, increased sensitization to signal transduction, release
      of pro-inflammatory mediators and activation of apoptosis.

      Many animal studies and clinical trials have shown pentoxifylline to have a significant
      anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and
      ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in
      neuropathic pain in diabetic patients. These effects were mainly due to the ability of
      pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due
      to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical
      role in PIPN pathogenesis.
    

Intervention name(s): Pentoxifylline; Paclitaxel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.; Paclitaxel I.V 80 mg/m2 weekly; placebo
Other intervention name(s): Trental; Taxol
Intervention MeSH terms: Paclitaxel; Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, placebo controlled
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast cancer; pentoxifylline; paclitaxel; Taxol; peripheral neuropathy; Trental
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Stem cell transplantation has emerged as a relatively popular treatment that can help to
      regulate immunity, repair injury, and control inflammation. Several studies have used
      autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its
      associated complications, and have achieved good efficacy. Thus far, the use of umbilical
      cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In
      this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We
      observed the disease control conditions, corticosteroid dosage changes, and treatment-related
      adverse reactions.
    


Intervention name(s): UC-MSCs by peripheral intravenous infusion; received hormone maintenance therapy
Intervention type(s): Other; Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment