bioihbjkbjnl/mcl2 huggingface dataset:
The Neurobiology of Approach Avoidance Training in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a computerized approach/avoidance
      training (AAT) procedure on behavioral, affective, and brain mechanisms that are important
      for reward sensitivity and well-being in individuals diagnosed with major depression. The
      training procedure is designed to modify automatic approach responses for positive social
      stimuli. The primary aim is to determine the effects of approach/avoidance training on the
      functioning of brain systems during reward processing in individuals diagnosed with major
      depression. A secondary aim will determine whether brain activation patterns following
      approach/avoidance training predict subsequent affective and behavioral responses during
      reward processing. An exploratory aim will test whether completing the approach/avoidance
      training procedure in combination with a brief computer-delivered behavioral activation
      program for depression will produce larger changes in depression symptoms, positive emotions,
      and social relationship functioning from pre- to post-intervention compared to the control
      training procedure.
    


Intervention name(s): Approach-positive AAT; Control AAT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One session of approach-positive AAT (Aim 1 and 2) followed by 4 sessions of approach-positive AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).; One session of control-AAT (Aim 1 and 2) followed by 4 sessions of control-AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Economic Analyses of the REDUCE Trial
Condition: Neoplasms, Prostate; Benign Prostatic Hyperplasia; Cancer
MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      The objective of this project is to conduct a retrospective economic analysis of the use of
      dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical
      trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical
      trial of the use of dutasteride compared with no chemopreventive treatment.

      The REDUCE trial was a four-year, international, multicenter, randomized, double-blind,
      placebo-controlled, parallel group study. There were 790 investigators in 42 countries.
    


Intervention name(s): Dutasteride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dutasteride 0.5mg daily.; Men taking placebo daily
Other intervention name(s): Placebo
Intervention MeSH terms: Dutasteride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study
      
Keywords: cost effectiveness; dutasteride; elevated risk population; Prostate cancer; prevention
Confocal Laser Endomicrospy in Colonic Diverticular Disease
Condition: Diverticular Disease; Diverticulitis; Diverticula
MeSH terms: Diverticulitis; Diverticular Diseases; Diverticulum
Study type: Observational

Summary: 
      Confocal laser endomicroscopy detects inflammatory markers undetectable during high
      definition endoscopy. The investigators aimed to evaluate the role of peridiverticular and
      colonic mucosa inflammation in the prediction of the complicated diverticular disease using
      confocal laser endomicroscopy evaluation in the peridiverticular area in consecutive
      patients.
    

Detailed description: 
      Diverticular disease of the colon is a prevalent condition in the western hemisphere.
      Currently there is an endoscopic classification system for classifying diverticular disease;
      however, white light endoscopic fails to accurately detect inflammation.

      Confocal laser endomicroscopy offers a real-time, in-vivo evaluation of the colonic mucosa,
      with an adequate correlation to histological findings. The investigators aimed to evaluate
      the role of peridiverticular and colonic mucosa inflammation in the prediction of complicated
      diverticular disease.
    

Intervention name(s): Probe-based confocal laser endomicroscopy evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with uncomplicated diverticular disease detected on colonoscopy and evaluation of
        peridiverticular and colonic mucosa assed via pCLE.
      
Keywords: colonoscopy; diverticular disease
A Food Effect Study of FMTN on Healthy Chinese Adult Subjects
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the effect of high-fat and low-fat meal on
      the pharmacokinetics of FMTN in Chinese adult healthy subjects.

      The secondary objective of the study was to assess the safety of FMTN administered in adult
      healthy subjects.
    


Intervention name(s): FMTN
Intervention type(s): Drug
Intervention description(s): Single dose of FMTN after high-fat meal,low-fat meal and fast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to use the proteomic analysis of synovial fluid to perform the
      comprehensive investigation of the biomarker that will be useful to assign the tratment
      effectiveness of five weekly intra-articular HA injection.
    

Detailed description: 
      The intra-articular injection with HA is an accepted therapy for OA. However, the exact
      regulation of HA treatment is unclear. Compared the expression SF proteome from OA patients
      who received HA/800 treatment or not (post and pre-HA treatment) may be possible to identify
      the protein that response to the HA treatment and apply this to prognosis of OA. We used
      two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser
      desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the
      differentially displayed proteins in human SF. Finally, we used Western blotting and ELISA
      analysis to validate the potential biomarkers.
    

Intervention name(s): proteomic analysis
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Osteoarthritis; synovial fluid; hyaluronic acid
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the
      tumor. Prednisone may be effective in preventing relapse of multiple myeloma.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide
      combined with prednisone following peripheral stem cell transplantation in treating patients
      who have multiple myeloma.
    

Detailed description: 
      OBJECTIVES: I. Determine which dose of thalidomide (200 mg vs 400 mg) combined with
      prednisone is the optimally tolerated dose when used as maintenance therapy following
      autologous stem cell transplantation in patients with multiple myeloma. II. Compare the
      response rate in patients treated with these regimens. III. Compare the progression-free and
      overall survival in patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to age (60 and over vs under 60). Within 60-100 days after autologous stem cell
      transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive
      lower dose oral thalidomide daily and oral prednisone every other day. Arm II: Patients
      receive higher dose thalidomide daily and oral prednisone every other day. Treatment
      continues for 2 years in the absence of disease progression or unacceptable toxicity.
      Patients are followed monthly for 6 months, every 3 months, and then at time of disease
      progression.

      PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study
      within 17-21 months.
    

Intervention name(s): prednisone; thalidomide
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone 50mg on alternate days; THALIDOMIDE 200 mg qhs
Intervention MeSH terms: Thalidomide; Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      The Purpose of this study is to evaluate the effect of gum chewing on recovery of
      gastrointestinal function in patient undergoing major colorectal surgery. The investigators
      hypothesize that patients who chew gum after major colorectal surgery will have faster
      recovery of gastrointestinal function.
    


Intervention name(s): Sugared Chewing Gum (Juicy Fruit)
Intervention type(s): Dietary Supplement
Intervention description(s): One stick of gum, 3 times daily from Postoperative day 1 to 7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chewing gum; ileus; gastrointestinal function; colorectal surgery; abdominal surgery
Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
Condition: Chronic Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is designed to assess the safety and efficacy of allogeneic human umbilical
      cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted
      into patients with chronic ischemic cardiomyopathy.
    


Intervention name(s): hUC-MSCs+Injectable collagen scaffold+CABG; hUC-MSCs+CABG; CABG
Intervention type(s): Biological; Biological; Procedure
Intervention description(s): Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.; Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.; Patients underwent CABG alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Chewing Function in Pediatric Neuromuscular Disorders
Condition: Mastication Disorder
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and
      investigate reliability of the Karaduman Chewing Performance Scale (KCPS).
    

Detailed description: 
      Chewing disorders (CD) can be seen due to muscle weakness in children with neuromuscular
      disorders neuromuscular disorders (NMD). Normal diet consists of all food consistencies
      including liquid, pudding and solid foods, and CD causes inability to intake solid food. This
      condition can affect development, nutritional behavior and child-parent interaction in
      children. Thus, it is important to determine CD in an early period with appropriate
      assessment methods and plan appropriate therapies in NMD. We aimed to evaluate chewing
      function (CF) in children with NMD, and investigate reliability of the Karaduman Chewing
      Performance Scale (KCPS).
    

Intervention name(s): Chewing evaluation
Intervention type(s): Other
Intervention description(s): Children with neuromuscular disorders (NMD) will be participated. Children will be asked to chew a standardized biscuit while video recording. Two physical therapists will assess all video recordings independently and score each video according to the KCPS. The correlation between the KCPS scores of two therapists will be used for interobserver reliability. One therapist will rescore the recordings after an interval of 2 weeks for intraobserver reliability.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: mastication; children with neuromuscular disorders
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
Condition: Pain, Postoperative; Bunion
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to show the effectiveness of repeated doses of COV795
      versus placebo, using the summed pain intensity difference over the first 48 hours in
      subjects with acute moderate to severe pain following bunionectomy.
    


Intervention name(s): COV795; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets taken every 12 hours; 2 tablets taken every 12 hours
Other intervention name(s): MNK795
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate Post-Operative Pain; Severe Post-Operative Pain; Bunionectomy
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and
      the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and
      patients with mild, moderate or severe hepatic impairment. Participants will be administered
      repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is
      10 days.
    


Intervention name(s): danoprevir; ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Repeated oral doses; Repeated oral doses
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations
Condition: Auditory Hallucination; Schizophrenia
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients
      with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each
      eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current
      stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4
      week follow-up period.
    

Detailed description: 
      The aim in this study is to conduct a pilot study on the efficacy of tDCS by assessing its
      efficacy in treatment refractory auditory verbal hallucinations in inpatients with chronic
      schizophrenia. Based on and expanding the findings by Brunelin et al. the hypothesis is that
      tDCS treatment with the cathode on the left temporal-parietal junction and the anode on the
      left dorsolateral prefrontal cortex can reduce the severity of auditory verbal hallucinations
      in patients with treatment refractory schizophrenia. The impact of tDCS on other
      schizophrenia symptoms in secondary exploratory outcome analyses together with the
      examination of the durability of an ameliorating effect will also be investigated.
    

Intervention name(s): Transcranial direct-current stimulation (tDCS); Placebo
Intervention type(s): Device; Device
Intervention description(s): Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks; Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period
Other intervention name(s): Active Transcranial direct-current stimulation (tDCS)'; Sham Transcranial direct-current stimulation (tDCS)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group randomized, parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for
      the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).
    

Detailed description: 
      This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to
      see the inducement of Cytotoxic T Lymphocyte.

      The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed
      by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c
      1000mg for 8 weeks followed by 1 week observation The Third treatment group will be
      administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth
      treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by
      8 weeks observation
    

Intervention name(s): BLS_ILS_E710c 500mg; BLS_ILB_710c 1000mg; BLS_ILS_E710c 1500mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): - 2 capsules per day for 20 days (week 1,2,4 & 8); - 4 capsules per day for 20 days (week 1,2,4 & 8); - 6 capsules per day for 8 weeks (week 1,2,4 & 8)
Other intervention name(s): CIN3 Theraputic Vaccine; CIN3 Theraputic Vaccine; CIN3 Theraputic Vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of Cervical Intraepithelial Neoplasia(CIN3)
Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional

Summary: 
      Comparison the result of skin prick tests and atopy patch test of lyophilized food extracts
      at different storage time (0, 3 and 6 months) after preparation
    

Detailed description: 
      Skin prick test were performed with lyophilized food extracts (cow milk, egg white, egg yolk,
      wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation.

      Atopy patch test were performed with lyophilized food extracts (cow milk, egg white, egg
      yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation
    

Intervention name(s): skin test with food at different storage times
Intervention type(s): Diagnostic Test
Intervention description(s): Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Perform skin prick test and atopy patch test of lyophilized foods (cow milk, egg white, egg yolk, wheat, soy and shrimp) stored at different time; 0, 3 and 6 months after preparation.
Then compare the results.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of
      stress urinary incontinence.
    


Intervention name(s): SS-RBX
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether donepezil HCl is effective and safe in
      improving cognitive dysfunction exhibited by children and adolescents with Down syndrome
      (DS). Effectiveness will be measured by rating communication, daily living skills, and social
      skills and relationships in subjects aged 10 to 17.
    


Intervention name(s): Donepezil HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for participants with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).; Liquid formulation matched to active treatment for oral administration.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Down Syndrome; trisomy 21
Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer
Condition: Inflammatory Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after
      pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory
      breast cancer (IBC).
    


Intervention name(s): Docetaxel; Cyclophosphamide; Epirubicin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment