bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the Chinese Version of Oxford Depression Questionnaire
Condition: Mood Disorders; Emotional Blunting
MeSH terms: Mood Disorders
Study type: Observational

Summary: 
      Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy,
      and motivation. Emotional blunting has been observed in clinical practice in patients with
      mood disorders. Emotional blunting has a negative impact on patients' overall treatment and
      leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring
      instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for
      detecting emotional blunting. The ODQ has high construct validity and internal reliability.
      However, no scientific validity studies have been conducted on ODQ in Chinese population.
      Therefore, this study is intended to investigate the reliability and validity of the ODQ in
      Chinese patients with mood disorders.
    


Intervention name(s): Oxford Depression Questionnaire (ODQ)
Intervention type(s): Diagnostic Test
Intervention description(s): The Oxford Depression Questionnaire (ODQ)is a patient-centered questionnaire. The scale contains three sections: i) the patient's experience in the past week; ii) the patient's experience before the illness worsened, and iii) the patient's emotional feelings about receiving antidepressant treatment. The 26-item questionnaire contains four dimensions of "emotional blunting": not caring (NC), emotional detachment from others (ED), reduction in positive emotions (RP), and general reduction in emotions (GR). Patients not taking antidepressants were only required to rate the first two sections .
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with mood disorders are recruited as outpatients or inpatients with the First
        Affiliated Hospital of Zhejiang University, School of Medicine.
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to evaluate the effect of GLPG3970 compared to
      placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with
      moderately to severely active RA and an inadequate response to methotrexate (MTX).
    


Intervention name(s): GLPG3970; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3970 powder and solvent for oral solution to be reconstituted prior to use.; Placebo powder and solvent for oral solution to be reconstituted prior to use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Rheumatic Diseases; Moderately active rheumatoid arthritis; Severely active rheumatoid arthritis; Joint Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Musculoskeletal and connective tissue disorders
Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in
      Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy
      Participants
    


Intervention name(s): Ravidasvir; Danoprevir; Ritonavir; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23; Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Placebo
Other intervention name(s): ASC16(RDV); ASC08 (DNV); RTV
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; Danoprevir/r; Ravidasvir
Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of
      this study is the long-term prognostic values of carotid intima-media thickness and coronary
      flow reserve in cardiovascular mortality of peritoneal dialysis patients.
    

Detailed description: 
      Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of
      endothelial thickness and coronary microvascular function could be useful for detecting ED.
      Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima
      media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of
      cardiovascular events and mortality in peritoneal dialysis patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients were treated by peritoneal dialysis or followed up as kidney transplant
        recipient at the Istanbul Medical Faculty from October 1994 to October 2011. Two groups
        were established for trial as peritoneal dialysis patients and renal transplant recipients.
        Patients had follow up shorter than six months and missing data not included in the trial
      
Biospecimen description: 
      hemogram, serum creatinine, uric asid, calcium, phosphorus and albumin
    
Keywords: peritoneal dialysis; carotid intima-media thickness; coronary flow reserve; cardiovascular mortality
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
Condition: Critical Lower Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with
      critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of
      the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular
      procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard
      (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with
      pre-study, post-study, and follow-up evaluations.
    


Intervention name(s): IN.PACT Amphirion; Standard PTA
Intervention type(s): Device; Device
Intervention description(s): Balloon Angioplasty; Balloon Angioplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BTK; CLI; PTA
Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study considers whether treatment effects in response to spinal manipulative therapy for
      individuals experiencing low back pain are dependent upon the context in which the
      intervention is provided. Half of the participants will receive spinal manipulative therapy
      with encouragement to interact with the provider and information to enhance expectations for
      the effectiveness of the intervention. The other half will receive spinal manipulative
      therapy with minimal interaction with the provider.
    


Intervention name(s): spinal manipulative therapy
Intervention type(s): Procedure
Intervention description(s): refer to arm descriptions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease
Condition: Parkinson's Disease With Cognitive Impairments
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research trial is to determine if safinamide (experimental drug) can
      improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The
      word "experimental" means the trial drug is not approved by Health Authorities (government
      authorities) and is still being tested for safety and effectiveness.

      Approximately one hundred (100) patients will participate in this research trial. The
      research trial will be conducted in approximately thirty (30) medical centers in the
      following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The
      research trial will last until June 2012.
    


Intervention name(s): safinamide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Safinamide will be provided in tablets equivalent to 50 mg in blisters. After randomization, patients receiving safinamide will take two 50 mg tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).; Identical placebo tablets will be provided in blisters. After randomization, patients receiving placebo will take two tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Cognition; Safinamide; Phase 2; Non-demented patients; Levodopa; Dopamine agonist
Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic
Condition: Anemia in Pregnancy
Study type: Observational

Summary: 
      Pregnant patients in the UT Medical Branch outpatient obstetric clinic are screened for
      anemia via blood draw at first prenatal visit. Those who meet Center for Disease Control
      (CDC) criteria for anemia during pregnancy (hemoglobin less than 11g/dL in first and third
      trimesters and hemoglobin less than 10.5g/dL during the second trimester), will be approached
      for participation in this study. It is the protocol of the UT Medical Branch outpatient
      obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. At the time of
      their blood draw, patients who participate in our study will have the Masimo Spot
      Non-invasive Hemoglobin monitor placed on our finger. The primary aim of the study is to see
      how accurate the non-invasive monitor is compared with blood draw. With the potential benefit
      being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.
    

Detailed description: 
      Pregnant women who are patients in the UT Medical Branch outpatient obstetric clinic will be
      screened for anemia using blood draw for CBC during the first prenatal visit. Those who are
      found to have anemia will be prospectively enrolled in this proof-of-concept study. Anemia
      will be defined according to the CDC guidelines (first and third trimesters hemoglobin level
      less than 11g/dL, and less than 10.5g/dL in the second trimester). Patients meeting these
      criteria will be approached for inclusion. If patients consent to participate, they will have
      their hemoglobin checked via the non-invasive monitor at the same time as their clinically
      indicated CBC testing. At the UT Medical Branch outpatient obstetric clinic, this is usually
      every 3-4 weeks and determined by the health care provider. The hemoglobin measured by the
      non-invasive monitor will be compared with the hemoglobin obtained via the complete blood
      count. Other data collected from the patient's medical record will include general
      characteristics such as demographics, medical history and hemoglobin levels obtained from
      blood draw.
    

Intervention name(s): Masimo spot hemoglobin non-invasive monitor
Intervention type(s): Device
Intervention description(s): This non-invasive monitor measures hemoglobin using LED light technology. We will be using it to determine if it is as accurate as routine CBC in anemic obstetric patients.
Intervention MeSH terms: Chrysarobin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant patients, aged 18-50, in the UTMB Outpatient Obstetric Clinic with anemia (defined
        as hemoglobin less than 11g/dL during first and third trimester and less than 10.5g/dL
        during second trimester)
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether transcranial direct current stimulation
      (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to
      identify the cerebral mechanisms involved in these potential effects.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: essential tremor; primary motor cortex; cerebellum; transcranial direct current stimulation; electrophysiology
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A premarket, international multicenter, prospective, open label, adaptive, randomized
      controlled study.

      The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and
      SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous
      insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia.
      The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events
      when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at
      evaluating the difference in glycemic parameters and HbA1c.
    


Intervention name(s): MiniMed™640G and Suspend before low; MiniMed™640G
Intervention type(s): Device; Device
Intervention description(s): All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON.
Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.; Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
Other intervention name(s): MiniMed™640G and SmartGuard™; MiniMed™640G and Predictive Low Glucose Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Condition: Pain, Postoperative
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual
      treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia
      Repair Mesh
    

Detailed description: 
      This study will be: controlled, prospective, randomized and double blind.

      Randomized experimental study in which all patients scheduled to undergo unilateral inguinal
      hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be
      invited to participate. At the time of admission to the study, they were assigned randomly to
      one of the two branches of intervention:

      (Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in
      physiological solution to a final volume of 30 ml.

      (Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight +
      dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.

      Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st
      postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24
      hours, 48 hours and at 8 days .

      It will also evaluate analgesic consumption, complications and labor return
    

Intervention name(s): Bupivacaine-Dexamethasone; Bupivacaine- physiological solution
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg; Bupivacaine 1,5 mg/kg- physiological solution
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pain; hernia repair; Dexamethasone
A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are
      infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
    

Detailed description: 
      This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who
      are infected with HIV. In phase I studies, a single vaccination with MVA85A, when
      administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both
      mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected
      individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG
      vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly
      higher immune response but did not have a higher AE profile. In addition, because of a
      variable immune response, the trial in HIV positive subjects in the UK is split into two
      groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has,
      therefore, been decided to use the higher dose in order to maximise the immune response
      whilst maintaining a good safety profile.
    

Intervention name(s): MVA85A
Intervention type(s): Biological
Intervention description(s): Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
fMRI Study of Expectancy on Acupuncture Treatment Outcomes in Knee OA
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The results of the proposed experiments will directly inform clinicians who treat patients
      with osteoarthritis of the knee about how to maximize the benefits of acupuncture treatments.
      And because the experiments specifically asks the question of what is the relation between a
      patient's expectation of how a treatment will relieve their pain and the outcome of the
      treatment, the results will potentially inform care givers about all treatments for
      osteoarthritis and other chronic pain disorders. We hypothesize that acupuncture treatment
      will produce clinically significant analgesia as indicated by lowered sensory ratings of
      noxious stimuli and endogenous knee pain.
    


Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): This study follows a standardized acupuncture protocol for OA knee pain. Approximately 6 acupuncture needles are placed in the skin of the leg for 25 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Condition: Hepatitis C; Depression; PTSD; Substance Use Disorder; Fibrosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Substance-Related Disorders; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      To determine the effect of an integrated care protocol on antiviral treatment and sustained
      virologic response (SVR) rates following initiation of direct acting antiviral therapies
      (DAA) treatments in 2011.
    

Detailed description: 
      Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a
      new era of more effective treatments for hepatitis C (HCV). The impact of more effective
      therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient
      case management may overcome barriers to treatment access imposed by psychiatric and
      substance use disorders (SUD).

      Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk
      for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to
      IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and
      provided brief mental health care and case management.
    

Intervention name(s): Brief mental health interventions and case management
Intervention type(s): Behavioral
Intervention description(s): The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Care Integration; Hepatitis C; Substance Use Disorder; PTSD