bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Physical activity has been used for a number of years in the treatment of fibromyalgia (FM).
      The main objective of this study is to compare the effects of physical activity on two groups
      of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of
      the condition on their daily lives. Methods: this was a randomized clinical trial to assess
      the effects of physical activity performed by subjects assigned to one of two groups on the
      scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the
      SF-36 health questionnaire) administered before and after the intervention.
    


Intervention name(s): Physical activity
Intervention type(s): Other
Intervention description(s): The intervention group: engaged in a therapeutic physical activity program involving low-intensity exercise, strength and balance work for 2 days a week over a 12-week period, with each session lasting 90 minutes. Both the intervention group and the control group separately completed the various baseline surveys which were part of the study. Once the intervention was over, they answered them again, also separately.
The classes were led by an experienced physiotherapist who followed the physical exercise guidelines established by the American College of Sports Medicine (ACSM), although the intensity of the exercises was adapted to the participants' tolerance levels
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, multi-center, clinical trial composed of two groups response variables and a twelve weeks follow up.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; fibromyalgia; pain; exercice; quality of live
Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      This is a randomized pilot study of an intervention based on principles of Cognitive
      Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and
      will be compared to a traditional medical model of psychoeducation known as Team Solutions
      (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS,
      compare adherence attitudes at the end of the treatment intervention, and to compare the time
      until the first episode of nonadherence.
    

Detailed description: 
      Overview: Many people recovering from first-episode schizophrenia typically respond very well
      to their initial course of antipsychotic medications; however, studies indicate that
      nonadherence rates soar as high as 90% in the first year and do not improve over time. To
      date, there is no effective psychosocial intervention that improves adherence or reduces the
      adverse consequences of nonadherence after it occurs. Thus, it is imperative to develop a new
      intervention to improve medication adherence and improve clinical outcomes in patients
      recovering from first-episode schizophrenia.

      This study is to pilot an intervention specifically suited for patients with first-episode
      schizophrenia based on the principles of Cognitive Behavioral Therapy (CBT). This is to focus
      on adherence from the perspective of the patient.

      Methods: This study compares the effectiveness of a standard psychoeducation program [Team
      Solutions (TS)] to a CBT approach known as the Health Dialogue Intervention (HDI). Consenting
      patients will receive a 4 week stabilization assessment period and then be randomized to a
      prospective, random-assignment study comparing the effectiveness of TS to HDI to improve
      medication adherence of patients recovering from first-episode schizophrenia.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Schizophrenia; Cognitive Behavioral Therapy; Compliance; Medication Adherence; Psychotic Disorders; Mental Disorders; Outcomes; Psychoeducation; Adherence Attitudes; Intervention; Nonadherence; Schizophrenia and Disorders with Psychotic Features
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Condition: Sleep; Circadian Dysregulation; Mood
MeSH terms: Chronobiology Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine, in healthy controls, whether LED lighting that has a
      color spectrum similar to that of sunlight is able to differentially impact mood, circadian
      rhythms, sleep, and behavior, as compared to standard fluorescent lighting.
    


Intervention name(s): Light
Intervention type(s): Device
Intervention description(s): 15 hours of light exposure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Schizophrenia Sensory Gating Deficit With Quetiapine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is the use of magnetoencephalography or MEG (a machine that
      measures magnetic activity in your brain) and electroencephalography or EEG (a technique that
      measures electrical activity in your brain) to study how sounds are processed in individuals
      with schizophrenia after three months of taking the antipsychotic medication quetiapine.
    

Detailed description: 
      .Problems with attention and perception are core features of schizophrenia and are
      hypothesized to result from defects in the filtering or gating of sensory input. Examination
      of this requires neuoimaging techniques with high temporal resolution. High-density EEG and
      MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory
      gating. In a number of recent studies patient treated with novel antipsychotics have been
      shown to have P50 gating ratios resembling those of normal controls rather than that of
      schizophrenia subjects treatment with conventional antipsychotics. To date, there is no
      literature on the effects of quetiapine on sensory gating. Subjects who meet all inclusion
      criteria and have been on a stable dose of quetiapine for three months will receive a
      clinical interview, an MRI, MEG, and neuropsychological testing to determine if patients with
      schizophrenia who are treated with quetiapine will demonstrate a sensory gating ratio similar
      to normal controls, indicating no deficit in sensory gating.
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Time perspective: Prospective
Keywords: Psychiatry; Antipsychotic; Psychopharmacology; Clinical Trial; Open Label; Schizophrenia; Sensory Gating; Attention; Memory
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Biological therapies, such as
      poly ICLC, may stimulate the immune system in different ways and stop tumor cells from
      growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining
      tumor cells from growing.

      PURPOSE: This phase II trial is studying how well giving radiation therapy together with
      temozolomide followed by temozolomide and poly ICLC works in treating patients with newly
      diagnosed glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by
           adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly
           diagnosed glioblastoma multiforme.

      Secondary

        -  Estimate the frequency of toxicity associated with this treatment regimen.

      OUTLINE: This is an open-label, multicenter study.

        -  Induction chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week,
           for 6 weeks. During the same 6 weeks, patients also receive oral temozolomide once
           daily. Four weeks later, patients are evaluated for disease progression. Patients with
           progressive disease are removed from the study. Patients with no progressive disease
           proceed to maintenance therapy.

        -  Maintenance therapy: Patients receive oral temozolomide once daily on days 1-5 (week 1).
           Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8. Courses
           repeat every 9 weeks in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 2 months for survival.

      PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
    

Intervention name(s): poly ICLC; temozolomide; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 20 mcg/kg 3x each week (Maintenance cycles); daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant); RT: 60 Gy (6 weeks) concomitant therapy
Other intervention name(s): Holtonol; Temodar; RT
Intervention MeSH terms: Temozolomide; Poly ICLC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of cilofexor
      in adults with primary sclerosing cholangitis (PSC).
    


Intervention name(s): Cilofexor; Placebo to match cilofexor
Intervention type(s): Drug; Drug
Intervention description(s): Tablet(s) administered orally once daily with food; Tablet(s) administered orally once daily with food
Other intervention name(s): GS-9674
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Condition: Emphysema; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional

Summary: 
      To establish and confirm the safety and clinical utility of BTVA applied unilaterally for
      lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.
    

Detailed description: 
      All subjects meeting the eligibility criteria and who provide written informed consent will
      be enrolled. Up to 3 segments in either the right or left upper lobe will be treated with a
      vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment
      will be based on lobar disease severity.
    

Intervention name(s): BTVA System
Intervention type(s): Device
Intervention description(s): Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emphysema; COPD; Lung Volume Reduction; BTVA
Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Fatigue
Study type: Interventional

Summary: 
      Background: Stroke puts important economic and social loads on the society and was reported
      to be the most important reason for disability throughout the world.

      Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot
      massage on happiness, sleep quality, and fatigue levels of patients with stroke.

      Material and method: The present study is a randomized clinical study with a control group.
      Participants were randomly divided into three groups (foot massage + aromatherapy,
      aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke.
      The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire,
      Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were
      performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted
      using frequency tables and descriptive statistics. Foot massage group was given 30min foot
      massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was
      given lavender oil inhaler during the foot massage.
    


Intervention name(s): foot massage; Foot massage +Aromatherapy group
Intervention type(s): Other; Other
Intervention description(s): foot massage; foot massage and lavender oil inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Foot massage; Aromatherapy massage; Happiness; Sleep quality; Fatigue
Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is comparing the effect on cerebral oxygenation by
      sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid
      endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane
      and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol
      decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the
      cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in
      general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are
      acceptable. There is little data about the effect of general anethetics on cerebral
      oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral
      circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than
      propofol in patient have impaired cerebral circulation.
    

Detailed description: 
      This study is performed by monitoring the cerebral oxygenation using near-infrared
      spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery
      clipping.

      Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil
      anesthesia group (R)

      Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2,
      body temperature

      Patient seletion

        -  inclusion criteria

             -  American Society of Anesthesiologist (ASA) physical status 1-3

             -  18 ~ 70 years

             -  patient who agree with informed concent

        -  exclusion criteria

             -  ASA physical status > 4

             -  preoperative SpO2 < 97%

             -  patient who has other neurologic disease not related to carotid endarterectomy
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Ventilation Distribution
Condition: Mechanical Ventilation
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      In mechanically ventilated patients during supine position, alveolar collapse usually
      distributes in dependent lung region.Decrease of flow trigger sensitivity might improve
      homogeneous of tidal volume distribution.
    

Detailed description: 
      In mechanically ventilated patients during supine position, alveolar collapse usually
      distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been
      applied to improve the homogeneous distribution of ventilation by increasing the end
      expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who
      increasing PEEP in some extent still existed poor aeration in the dependent region, further
      elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing
      trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for
      this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the
      regional ventilation distribution at the bedside.
    

Intervention name(s): flow trigger
Intervention type(s): Procedure
Intervention description(s): The flow trigger will be adjust during the pressure assist ventilation.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The postoperative patients receiving pressure support ventilation and existing heterogenous
        ventilation.
An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major
      Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression
      Rating Scale.

      To evaluate the tolerability, safety and efficacy on disability and quality of life in
      patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.
    


Intervention name(s): SSR149415
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; antidepressive disorders; controlled clinical trial
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an open-label study to provide an opportunity for participants with Ulcerative
      Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve
      participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to
      determine the long term safety of vedolizumab in patients afflicted with these diseases.
    

Detailed description: 
      This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously
      (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or
      Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated
      vedolizumab well during Study C13002 (NCT01177228).

      In the original study protocol, all participants were randomized to receive vedolizumab at
      doses of either 6 mg/kg or 10 mg/kg. With the implementation of Amendment 1, the assigned
      doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. To implement the dose
      changes, instead of randomizing all participants across both doses, those who rolled over
      from Study C13002 were reassigned to receive the 2.0 mg/kg dose and all participants who
      entered C13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next
      scheduled dosing day. Also, if participants assigned to the 2 mg/kg dose experienced flare,
      they were to receive the higher 6 mg/kg dose.

      In the results analyses for this study, participants are grouped according to the lowest dose
      received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.
    

Intervention name(s): vedolizumab
Intervention type(s): Drug
Intervention description(s): Vedolizumab for intravenous (IV) infusion
Other intervention name(s): Entyvio; MLN0002; MLN02; LDP-02
Intervention MeSH terms: Vedolizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analgesia in Inguinal Hernia Repair Using a Cyclooxygenase-2-specific Inhibitor
Condition: Adverse Anesthesia Outcome
MeSH terms: Hernia, Inguinal
Study type: Interventional

Summary: 
      Acute pain is the result of activating nociceptive pathways in both the peripheral and
      central nervous system. The origin of most acute pain from surgical stimulation is the
      mechanical trauma of the local tissue and the subsequent acute inflammatory response.

      No studies have investigated the combined use of anti-inflammatory analgesics with spinal
      anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients
      undergoing day-case IHR. The aim of the investigators study is therefore to assess the
      efficacy of preoperative combined administration of etoricoxib and standard spinal
      anaesthesia in the reduction of postoperative pain following IHR.
    

Detailed description: 
      Acute pain is the result of activating nociceptive pathways in both the peripheral and
      central nervous system. The origin of most acute pain from surgical stimulation is the
      mechanical trauma of the local tissue and the subsequent acute inflammatory response. Open
      inguinal hernia repair is one of the commonest surgical procedures which may provoke pain of
      variable intensity and duration.

      Etoricoxib (Arcoxia®) is a NSAID with anti-inflammatory and analgesic properties mainly
      achieved via selective peripheral COX-2 inhibition. Spinal anaesthesia using local
      anaesthetics combined with opioids affects the transmission, modulation and modification
      stages of nociceptive afferent impulses and its analgesic qualities are superior to local
      anaesthesia alone.

      No studies have investigated the combined use of anti-inflammatory analgesics with spinal
      anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients
      undergoing day-case IHR. The aim of the investigators study is therefore to assess the
      efficacy of preoperative combined administration of etoricoxib and standard spinal
      anaesthesia in the reduction of postoperative pain following IHR.
    

Intervention name(s): Etoricoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction; 120mg of placebo
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Etoricoxib; Spinal anaesthesia; Postoperative pain