bioihbjkbjnl/mcl2 huggingface dataset:
To Investigate the Correlation of Stroke Patients and Demoralized
Condition: Post-stroke Depression
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study aim to clarify the participants's mental state with Demoralization Scale- Mandarin
      Version(DS-MV). Based on clinical observations and literature review, investigators assume
      participants's DS-MV score high correlation with PHQ-9 score.
    

Detailed description: 
      The Chinese version of Demoralization Scale-Mandarin Version (DS-MV) was used to assess the
      mental state of patients with stroke after debridement. The statistical analysis test of
      correlation is carried out, and the reliability and validity test and the norm establishment
      of the Chinese version are further tested. Convenient sampling will be performed at a single
      medical facility. The planned implementation period is 2019/01/01 ~ 2019/12/31, and the
      location of the case is the rehabilitation ward and outpatient clinic of Taoyuan Hospital.
      The diagnosis must be: intensive stroke or hemorrhagic brain within three years. In the case
      of a 20- to 100-year-old clinical patient with stroke, the subject should explain the content
      of the case, and the subject will complete the test consent form after informed consent, and
      then begin the evaluation process of the self-assessment questionnaire. The assessment
      procedure is preceded by a clinical psychologist conducting with MMSE test to determine the
      cognitive function. When the patient's consciousness is blurred, the simple intelligent state
      test (MMSE) score less than 24 points, aphasia can not be effectively communicated, the
      diagnosis of mental illness or mental disorder has been recorded on the medical record, or
      the patient or family member is unwilling to sign the informed consent form. If the above
      situation is met, subjects will be excluded. The self-assessment questionnaire will obtain
      the scores of the subjects in the Chinese version of the Demoralization Scale-Mandarin
      Version (DS-MV) and the Patient Health Questionnaire (PHQ-9). Statistical analysis, as well
      as the Chinese version of the loss of the scale of the reliability and validity of the test
      and the establishment of clinical norm scores.
    

Intervention name(s): Questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): Questionnaire
Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        infarct stroke or hemorrhagic stroke within three years
      
Keywords: Demoralization Scale-Mandarin Version; Demoralization syndrome
Neurostructural Integration Technique for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have
      found that our patients seem to benefit from a soft tissue physical therapy called
      neurostructural integration therapy (NST). The purpose of this study was to compare NST to
      hydrotherapy which is already used to manage fibromyalgia symptoms.
    

Detailed description: 
      Twenty female patients who met the American College of Rheumatology diagnostic criteria for
      the classification of FM were enrolled in the study. Patients were randomly allocated to
      receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six
      weeks, three months, and six months. Primary outcome measures included the SF-36 quality of
      life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score.
      Duration of morning stiffness and duration of weekly aerobic exercise as reported by the
      participants were secondary outcome measures. Statistics analysis was performed by standard
      parametric and non parametric methods.
    

Intervention name(s): NST; Hydrotherapy
Intervention type(s): Other; Other
Intervention description(s): A form of physical therapy
Other intervention name(s): A form of physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: fibromyalgia treatment; physical therapy; hydrotherapy
Neuropharmacological Basis of Social Connection: The Role of Opioids
Condition: Psychology, Social
Study type: Interventional

Summary: 
      From birth we rely on others for comfort and care and derive pleasure from being together.
      Research from the fields of health psychology, social psychology, and public health converge
      to highlight the importance of having and maintaining good relationships for overall health.
      Indeed, having close friends and family and feeling connected to them has been called a basic
      need, similar to our need for food and water. It may not be a coincidence then that feelings
      of connection rely on similar systems in the body as other needs that are both basic and
      highly pleasing and rewarding. For instance, its possible that opioids, a substance in the
      body associated with pleasant, euphoric feelings, may also be important for connecting with
      others. This study will examine the role of opioids in feeling connected to others by
      administering a drug called naltrexone, that effects opioid processing in the body, on
      perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the
      effects of naltrexone outside of the lab, participants will complete daily diary responses
      via text and online surveys.

      40 participants will take both placebo and naltrexone. Participants will complete two
      sessions, one in each drug condition, in which they complete a number of tasks including
      reading messages on a computer screen, holding a number of objects, and viewing images while
      undergoing electric shocks. Participants will also complete a daily diary for 14 days while
      on naltrexone and placebo. Prior to these lab sessions participants will be screened at
      UCLA's Clinical & Translational Research Center (CTRC) to ensure that they are healthy and
      that it is safe for them to take the study drug.

      We hypothesize that people will report feeling less socially connected when on naltrexone
      compared to placebo and will show subsequent changes in social behavior outside of the lab.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Other intervention name(s): Depade; ReVia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: opioids; social connection
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that AndroGel may offer some relief to subjects with low or borderline
      testosterone levels who suffer from depression and have failed to respond to a trial of a
      standard antidepressant.

      During this nine week, outpatient, double-blind study, male subjects between the ages of 30
      and 65 years with treatment-refractory depression and low or borderline low testosterone
      levels will be treated with either AndroGel or placebo. Following this nine week,
      double-blind phase, eligible subjects will have the option to continue into a six month,
      open-label phase during which time all subjects will receive the AndroGel patch.
    

Detailed description: 
      We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory
      depression and low or borderline low testosterone levels for participation in this study. For
      a period of nine weeks subjects will receive double-blind treatment with either AndroGel
      (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to
      McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of
      your levels of depression and anxiety, quality of life, and visuospatial memory)and
      laboratory tests will be performed at these visits. Following the nine week, double-blind
      phase, eligible subjects may enter into a six month, open-label treatment phase in which all
      subject receive AndroGel. If you participate in the open-label phase, you will be asked to
      return to the site for 8 visits during the six month period.
    

Intervention name(s): Testosterone gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.; Placebo
Other intervention name(s): AndroGel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
Condition: Non-hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE)
      and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT)
      in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
    

Detailed description: 
      Intravenous busulfan containing regimens as conditioning regimen have been used for both
      allogeneic and autologous stem cell transplantation in patients with hematologic and
      non-hematologic malignancies.

      The investigators have previously studied that conditioning regimen of i.v.
      busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with
      relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning
      regimen has been extensively utilized in ASCT for NHL.

      Therefore, based on the encouraging results, the investigators will conduct a randomized
      phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients
      with NHL.
    

Intervention name(s): Busulfan; Cyclophosphamide; Etoposide; Melphalan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6; cyclophosphamide 50mg/kg/day i.v. on days -3 and -2; etoposide 400mg/m2 day i.v. on days -5 and -4; melphalan 50mg/m2/day i.v. on days -3 and -2
Other intervention name(s): Busulfex; Alkeran
Intervention MeSH terms: Cyclophosphamide; Melphalan; Busulfan; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons
      with impairments in neuropsychological functioning. To assess the safety, virologic, and
      immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological
      impairment but minimal other symptomatology.
    


Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Neuropsychological Tests; AIDS-Related Complex; Zidovudine
Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
Condition: Surgery
Study type: Interventional

Summary: 
      The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal
      resection of the stomach. This is the first experience using this stapler in humans. The
      purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal
      gastric resection. Safety is defined by the absence of device related adverse events in the
      study period. Usability is evaluated based on surgeon evaluation of the device following each
      use.

      This is a open label clinical trial to be conducted at three US sites. Up to 60 participants
      will be enrolled and will be followed for 6 weeks after surgery.
    


Intervention name(s): Titan SGS stapler
Intervention type(s): Device
Intervention description(s): Stapler for the longitudinal resection of the stomach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release
      vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive
      Disorder (MDD).
    


Intervention name(s): desvenlafaxine succinate sustained release; fluoxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.; Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules; Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Intervention MeSH terms: Fluoxetine; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: major depressive disorder; MDD; depression
The Effect of Partial Bladder Filling on Post-operative Time to Void in Minimally Invasive Gynecologic Procedures
Condition: Hysterectomy; Myomectomy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if partially filling the bladder after
      laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to
      spontaneously void for patients to determine if this subsequently shortens patient stay times
      in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be
      compared to the current standard of care, which involves removing the patient's Foley
      catheter with an empty bladder and then giving the patient up to 6 hours to void in the PACU.
    

Detailed description: 
      Patients undergoing laparoscopic/robotic hysterectomy or myomectomy who meet the study
      criteria will be contacted by the research assistant at a pre-operative visit. The risks and
      benefits of participation will be explained to them. If they choose to participate they will
      sign the consent form at that time.

      At the time of the surgery, the research coordinator will open a sealed envelope containing
      the patient's assignment to partial bladder filling or no bladder filling. The research
      coordinator will then notify the surgeon via secure phone call or secure messaging service
      and the patient/subject will have their bladder partially filled or completely emptied as
      relayed to the surgeon at the end of the procedure in the Operating Room, unless there are
      issues of patient safety or operative complications. In the patients who are chosen for
      partial bladder filling, the bladder will be back-filled with 150 cc of normal saline and
      then the Foley catheter will be removed at the end of the procedure. In patients who have no
      bladder filling, the bladder will be completely emptied and then the Foley catheter will be
      removed. One of the providers who perform the gynecological surgical procedures will be
      responsible for back-filling or completely emptying the bladder with the Foley catheter.

      The patients will be followed in the PACU to determine the time it takes for them to void.
      The will also be followed for any complications until they are four weeks post surgery. The
      electronic medical record will be examined to see if they have any complications reported at
      their post-operative visits or any readmissions to the hospital.
    

Intervention name(s): Bladder filled with saline solution; saline solution
Intervention type(s): Other; Other
Intervention description(s): Patients in this arm will have their bladders filled with 150 cc of saline solution.; Saline solution will be used to partially fill patients' bladders
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis
Condition: Langerhans Cell Histiocytosis
MeSH terms: Histiocytosis, Langerhans-Cell; Histiocytosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Type: Interventional

      Study Design:

      Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking:
      Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying
      efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside
      in newly diagnosed adult with Langerhans cell histiocytosis.
    

Detailed description: 
      This single arm clinical trial is studying efficacy and tolerance of combination chemotherapy
      with methotrexate and cytosine arabinoside in newly diagnosed adult with Langerhans cell
      histiocytosis.
    

Intervention name(s): methotrexate
Intervention type(s): Drug
Intervention description(s): Single Group Assignment
Other intervention name(s): cytosine arabinoside
Intervention MeSH terms: Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult with Langerhans cell histiocytosis; newly diagnosed; methotrexate; cytosine arabinoside
Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC (Phase III)
Condition: Signs and Symptoms
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is conducted to evaluate the safety and Immunogenicity of Measles-Rubella combined
      vaccine MRVAC produced by POLYVAC (phase 3) on Vietnamese volunteers and to demonstrate
      non-inferiority on the immunogenicity of MRVAC in comparison to MR vaccine produced by Serum
      Institute, India.
    

Detailed description: 
      A phase III, Randomized, control study to compare the immunogenicity and safety of MRVAC
      vaccine produced by POLYVAC with MR vaccine licensed in Vietnam produced by Serum Institute,
      India.

        1. Evaluate the safety of MRVAC produced by POLYVAC on Healthy Vietnamese volunteers from 1
           - 45 years old.

           Evaluate the safety by the ratio of participants having following symptom/signs:

             -  The ratio of immediate adverse events (local adverse events and systemic adverse
                events), within 30 minutes after vaccination.

             -  The ratio of participants having local and systemic adverse events (including
                unexpected adverse events) occur within 28 days after vaccination.

             -  The ratio of serious adverse events (SAEs) occur from day 0 to day 28 after
                vaccination. (SAEs).

        2. Evaluate the immunogenicity of MRVAC produced by POLYVAC on the healthy volunteers from
           1 - 45 years.

             -  The rate of sero-conversion;

             -  GMT (Geomatric mean Antibody titer) after vaccination.

        3. Comparison the safety and immunogenicity between MRVAC and control vaccine.
    

Intervention name(s): Trial arm (MRVAC); Control arm
Intervention type(s): Biological; Biological
Intervention description(s): Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine; Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomized receiving either MRVAC or MR vaccine produced by Serum Institute, India, which was using in Vietnam National Expanded program on Immunization in the ratio of 2:1. The Participants will be received only 1 dose of vaccine at the age from 1 year to 45 years.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: MRVAC vaccine, fever, rash
Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this research is to look at the effects of computerized cognitive training on
      anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such
      as arousal.
    


Intervention name(s): Cognitive Training; Trivia Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.; Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and self-reported arousal at baseline, and post-intervention
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Middle-Aged; Sleep; Cognition; Older Adults