bioihbjkbjnl/mcl2 huggingface dataset:
Combined Interventions for Treating Depression and Chronic Back Pain
Condition: Back Pain; Depression
MeSH terms: Back Pain; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will determine the effectiveness of an intervention consisting of combined
      strategies in reducing the symptoms of both depression and chronic back pain.
    

Detailed description: 
      The relationship between depression and back pain is complex. Depression is the most common
      mental condition associated with chronic back pain. Despite this relationship, many patients
      with depression and back pain seek treatment only for one of the two conditions, which can
      worsen the untreated condition. An intervention that reduces the symptoms of both depression
      and back pain is needed. This study will determine the effectiveness of an integrated
      intervention in reducing both back pain and depression symptoms.

      Participants will be randomly assigned to receive either an integrated intervention or
      standard of care for 6 months. Participants in the integrated intervention group will receive
      cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy
      for depression. Study visits will initially occur once a week and then taper to once every 2
      weeks for the 6-month duration; the time of tapering will depend on participant response to
      treatment and will be at the investigator's discretion. Depression and back pain symptoms
      will be assessed in all participants at study entry, at the end of treatment, and 6 months
      after the end of treatment. The study entry and study completion assessments will occur
      during study visits. The last assessment will be a telephone interview.
    

Intervention name(s): Cognitive behavioral therapy; Antidepressants; Problem solving therapy
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.; Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.; Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive behavioral therapy; Problem solving therapy; CBT
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly
      migraine days, in adults with episodic migraine.
    

Detailed description: 
      Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4
      to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to
      placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week
      double-blind treatment phase and open-label erenumab will be administered during the 28-week
      open-label treatment phase.
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered once a month by subcutaneous injection; Administered once a month by subcutaneous injection
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache; Episodic; Prevention; Prophylaxis
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Condition: Thyroid Carcinoma; Thyroidectomy
MeSH terms: Thyroid Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well.
      However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel
      is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus
      reducing op time and postoperative drain, which is important to minimize hospital stay. The
      investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted
      procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior
      compartment neck dissection.
    


Intervention name(s): Usage of Fibrin sealant; Thyroidectomy
Intervention type(s): Drug; Procedure
Intervention description(s): Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection; surgical removal of bilateral thyroid glands
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck dissection
Riluzole Effects on Hippocampus Biomarkers
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine the clinical efficacy of the anti-glutamatergic medication riluzole in
      posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our
      laboratory previously has identified using MRS.
    


Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention description(s): 30 PTSD patients with riluzole 100 mg daily (50 mg bid).
Intervention MeSH terms: Riluzole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT
      neoadjuvant regimen in patients with stage III breast cancer.
    

Detailed description: 
      2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient
      before breast surgery.

      The required number of patients has been calculated following Simon's method. 43 patients
      will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2
      pathological complete responses obtained. Patients recruitment will continue until 43
      patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate
      of pathological complete responses of at least 10%.
    

Intervention name(s): Gemcitabine; Adriamycine; Paclitaxel
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Gemzar; doxorubicin; Taxol
Intervention MeSH terms: Paclitaxel; Gemcitabine; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant chemotherapy.; Stage III disease.
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional

Summary: 
      The study is designed to identify and validate new protein biomarkers in blood related to
      testosterone activity. Thirty healthy young males underwent pharmaceutical castration to
      lower testosterone levels. After three weeks the subjects received an intramuscular injection
      of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three
      weeks after castration, and one week after injection of testosterone undecanoate were
      collected representing normal testosterone levels, low testosterone levels, and testosterone
      at eugonadal levels.
    


Intervention name(s): GnRH antagonist
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CLARITY Extension Study
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this extension trial was to further evaluate the safety and tolerability of
      oral cladribine in subjects who have previously completed treatment within Trial 25643
      (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week
      treatment.
    


Intervention name(s): Cladribine; Placebo; Cladribine; Cladribine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.; Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.; Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.; Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.; Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Intervention MeSH terms: Cladribine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug
      interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.
      Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,
      danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days
      18-21.
    


Intervention name(s): danoprevir; raltegravir; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg q12h Days 8-21; 400 mg q12h Days 1-4 and 18-21; 100 mg q12h Days 8-21
Intervention MeSH terms: Ritonavir; Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
Condition: Ischemic Heart Disease; Congestive Heart Failure
MeSH terms: Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      The hypothesis of the study is that aerobic conditioning following acute heart attack will
      improve autonomic function and electrical stability of the heart.
    


Intervention name(s): aerobic training; aerobic and strength training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a pilot randomized controlled trial examining post-operative pain scores and outcomes
      after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine
      post-operative multi-modal analgesia, compared to those patients prescribed routine
      multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic
      hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If
      eligible, patients will be invited to participate in the study and standardized informed
      consent process will ensue. After surgery is completed participants will be randomized to
      either the control group or the study group. The study group will be prescribed the use of
      cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy
      is to be applied to participants' incisions for the first three postoperative days, in
      addition to routine post-operative analgesia regimen. Investigators will then collect
      information on pain scores, narcotic use, quality of life and surgical recovery scores.

      This study aims to examine if there is a difference in post-operative pain scores with the
      application of cold therapy to laparoscopic abdominal incisions following laparoscopic
      hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine
      post-operative quality of life scores, postoperative surgical recovery scores, as well as
      narcotic use among the two groups. Investigators also aim to ascertain additional information
      regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.
    


Intervention name(s): Cold therapy via reusable cold gel pack
Intervention type(s): Device
Intervention description(s): Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Condition: Sickle Cell Anemia Crisis
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether IV acetaminophen can decrease the need for
      subsequent opioid administration in the acute management of sickle cell crisis pain in the
      pediatric emergency room.
    

Detailed description: 
      This is a single-center, prospective, randomized, double-blinded, controlled study in an
      academic urban pediatric emergency department of children with sickle cell disease presenting
      with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10
      or higher on the Wong-Baker modified FACES pain scale. In order to detect a difference of 0.2
      mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an
      inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we
      calculated a sample size of 33 patients in each group. All patients will receive IV ketorolac
      and IV morphine. Patients will be randomized to receive IV acetaminophen or IV saline
      (volume-equivalent). Pain scores will be obtained at baseline, and again at 30 minutes, 60
      minutes, 90 minutes, and 120 minutes after medication administration. Cumulative morphine
      dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed.
      Our primary objective is to decrease the need for subsequent opioid administration. Our
      secondary objectives are to determine if IV Acetaminophen decreases pain score at 30 minutes,
      60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the
      rate of adverse effects from opioids.
    

Intervention name(s): Acetaminophen; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen; Normal saline volume equivalent
Other intervention name(s): Ofirmev; Tylenol; Sodium chloride solution
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sickle cell; acetaminophen in pain crises; opioid-sparing
To Advance the New Disability Evaluation System in Taiwan
Condition: Motor Dysfunction
Study type: Observational

Summary: 
      Before 2007, the disability evaluation was based on the medical model in Taiwan. According to
      the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment
      of a person's eligibility for disability benefits has to be determined as suffering one of
      eight malfunction categories based on the International Classification of Functioning,
      Disability, and Health (ICF) framework. People with disabilities want to issue a disability
      identification and other welfare & services need processes of evaluation & assessment based
      on the ICF framework for the evaluation report and result of living need by the committee
      composed of professionals from medicine, social work, special education and employment
      counseling and evaluation.

      In this year, investigators planed the project with the Taiwan Society of ICF to develop the
      evaluation form. The experts from various disciplines of the ICF Office convened internal
      integration meetings to reach a consensus for developed the ICF evaluation form, add the code
      of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire.
      The results were used to analysis other relevant factors affecting the disability evaluation.
      And then add the core set from World Health Organization to both physical and mental
      disorders linked coding group, compared the new disability evaluation system and evaluate the
      living need of people with disability to provide suggestion for core set.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People with disabilities want to issue a disability identification
      
Keywords: Disability Evaluation System; SF-12; ICF model
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia; Schizophrenia
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the efficacy, safety, and cognitive function of
      transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive
      dyskinesia (TD).
    

Detailed description: 
      This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD
      were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received
      2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions:
      Monday to Friday once daily, every other week to do a group of treatment). Abnormal
      Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of
      Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge
      Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations
      were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS
      were assessed with an experimenter-administered open-ended questionnaire during the whole
      experiment.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment).; For sham stimulation, the device was set to turn off after 30 seconds(study model).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial Direct Current Stimulation; Randomized Controlled Trial; Schizophrenia; Tardive Dyskinesia; Abnormal Involuntary Movements Scale; Tardive Dyskinesia Rating Scale; Cognition