bioihbjkbjnl/mcl2 huggingface dataset:
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Study will look at the effect of a game-based, task-oriented home exercise program on
      adherence in persons with chronic (> 6 months post) stroke as compared to a standard home
      exercise program. The study will also look at the effect of a game-based, task-oriented home
      exercise program on upper extremity motor function and occupational performance in persons
      with chronic (> 6 months post) stroke as compared to a standard home exercise program.
      Finally, the study will look at barriers and facilitators to successful use of the
      game-based, task-oriented home exercise program in the home setting.
    

Detailed description: 
      Approximately 26% of stroke survivors are still fully dependent in activities of daily living
      (ADLs) when they enter the chronic phase at 6-months post stroke, and over half have
      hemiparesis that impacts upper extremity motor function. Exercise and activity in the chronic
      phase of stroke are essential in reducing disability, improving balance, increasing mobility,
      and improving overall quality of life. Without regular activity and exercise in the chronic
      phase, survivors are at risk for a developing comorbid conditions (e.g., diabetes) and
      experiencing a recurrent stroke. Unfortunately, people with stroke report many barriers to
      exercise, such as fatigue or pain, and lack of motivation and engagement. A promising
      solution may lie in interactive video games and virtual reality (VR), which have been used as
      intervention tools to potentially increase patient engagement and adherence, over the past 15
      years. The investigators have developed an interactive, customized VR system called Mystic
      Isle that has shown to be feasible for general home-based rehabilitation. Mystic Isle
      utilizes portable, low-cost technology (the Microsoft Kinect® sensor, Microsoft) and can
      provide a customized program with remote monitoring by an occupational therapist (OT). This
      study will explore the preliminary effect of the game-based home program on adherence to a
      home program in comparison to a control. It will also explore the barriers and facilitators
      to home use of a virtual reality-based intervention.
    

Intervention name(s): Virtual Reality Mystic Isle Game; Standard Home Exercise Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 week virtual reality based exercise program; 8 week standard occupational therapy home exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Upper Extremity Hemiparesis; Virtual Reality (VR)
Evaluation of the School Kids Influenza Prevention Project
Condition: Childhood Influenza Vaccination; School-located Influenza Vaccination
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Children whose parents receive text reminders are more likely to be consented to participate
      in the school located influenza vaccination clinic than children whose parents do not receive
      text reminders.
    


Intervention name(s): Text message notification
Intervention type(s): Other
Intervention description(s): Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Influenza vaccination rates; Respiratory Tract Diseases
Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder
Condition: Pilot Study
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This project apply curriculum of online programme materials and structure for mindful
      parenting and caregiving. It will include four modules (introductory mindfulness, mindful
      parenting, applying mindfulness in challenging moments, and advanced exercises for parents of
      children with special needs). Each module will include short psychoeducation videos and audio
      mindfulness exercises that can be used in various web-based or application-based platforms. A
      set of videos and audio exercises will be produced for the core program materials. One study
      of online mindful parenting program reported a low completion rate below 30%, showing the
      significance of weekly video or phone contact by professionals in program engagement.
      Although web-based or application-based mindfulness intervention have become popular, very
      limited effort has been developed for applying mindfulness in parenting and caregiving using
      technology. Only two published studies on online mindfulness-based intervention for parents
      are identified. Objectives of the study are: 1. Investigate the effects of online
      mindfulness-based intervention for parents of children with Attention Deficit/Hyperactivity
      Disorder. 2. Validate the protocol of the programme and explore the needs to make refinements
      of the programme based on the quantitative outcome and qualitative interview analyses
    


Intervention name(s): Mindfulness-based intervention
Intervention type(s): Behavioral
Intervention description(s): 1. Psychoeducation video on mindfulness and mindful parenting. 2. Audio files of mindfulness exercises including mindfulness of breath, body scan, mindful stretching, mindfulness of soles of the feet, befriending exercises. 3. Informal mindfulness exercises by applying mindfulness in daily lives
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ADHD; parent; Mindfulness-based intervention; Online
Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites
Condition: Ascites; Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with
      cirrhosis ascites who fail to response adequately to treatment with common diuretics.
    

Detailed description: 
      For symptoms of fluid retention due to liver diseases (ascites and/or lower extremity edema,
      i.e. hepatic edema), treatment generally starts with bed rest and a low-salt diet.
      Aldosterone antagonists and loop diuretics are commonly used diuretics in the treatment of
      fluid retention due to liver diseases. In aldosterone antagonists' therapy, nevertheless,
      hyperkalemia is frequently reported, slow onset of action and dose escalation needed also
      impair its effect. If aldosterone antagonists' therapy is ineffective, loop diuretics as
      strong diuretics are usually added up. However, Dose escalation of loop diuretics also boost
      the occurrence of hyponatremia and hypokalemia, and combination of the two drugs provided
      fastest onset of effectiveness with less adverse events. While, because both diuretics can
      cause sodium lose which is difficult to prevent and treat, hyponatremia is easy to occur. The
      combination of aldosterone antagonists and K-sparing diuretics reduces the occurrence of
      hypokalemia but have little effect on the prevention and treatment of hyponatremia. In
      addition, there are still some patients who are resistent to loop diuretics or intolerant of
      an effective diuretic dosage due to adverse events.

      Tolvaptan increases the excretion of electrolyte-free water (aquaretic) without changing
      electrolytes excretion by inhibiting the water reabsorption of collecting duct in kidney. It
      is demonstrated that Tolvaptan increased urine volume without impairing renal function.
    

Intervention name(s): Tolvaptan; Tolvaptan; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, 15 mg, Qd, for 7 days; tablet, 7.5 mg, Qd, for 7 days; tablet, 7.5/15mg , Qd, 7days.
Other intervention name(s): SAMSCA; SAMSCA; Blank tablet
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tolvaptan treatment to ascites and hepatic cirrhosis
Assessment of Cardiac Sparing in Fetal Hypoxia
Condition: Fetal Hypoxia
MeSH terms: Fetal Hypoxia; Hypoxia
Study type: Interventional

Summary: 
      The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental
      insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal
      growth restriction show that the umbilical artery and middle cerebral artery are the first
      variables to become abnormal . These arterial Doppler abnormalities are followed by
      abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic
      indices, and finally by both left diastolic and systolic cardiac indices .

      Preserving the left systolic function as the last variable to become abnormal ensures an
      adequate left ventricular output , which supplies the cerebral and coronary circulations.This
      defence is contingent on the fetal cardiovascular system, which in late gestation adopts
      strategies to decrease oxygen consumption and redistribute the cardiac output away from
      peripheral vascular beds and towards essential circulations, such as those perfusing the
      brain.

      Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth
      retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular
      compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the
      degree of fetal adaptation and provides information on how long the pregnancy can be
      continued safely.

      The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by
      estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).
    


Intervention name(s): Ultrasound; Doppler ultrasound; Fetal echocardiography
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): ultrasound assessment of gestational age, amniotic fluid index, and fetal weight; Umbilical artery and Middle cerebral artery Doppler blood flow assesment; The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Neural Correlates of Cognition in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor
      outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now
      an evidence-based treatment for certain cases of PD, has the risk of causing deficits in
      multiple areas of cognition.

      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic
      basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by
      measuring brain signal activity while PD patients are engaged in cognition on a computer.
    

Detailed description: 
      Study Participants: For this study, the investigators will recruit 75 Parkinson's disease
      (PD) patients that are undergoing deep brain stimulation (DBS) as routine standard of care.

      Screening: For healthy control participants, investigators will approach adults, aged 18-90,
      for possible involvement in our study. Potential participants will be asked if they have ever
      been diagnosed with a movement disorder, psychiatric disorder, or dementia. For PD patients
      undergoing evaluation for DBS, investigators will first consult with their neurologist and
      neurosurgeon. Next, investigators will approach the participant and explain the study.

      PD Participants: As part of the usual DBS process at University of Florida (UF), PD
      participants will be asked to participate in this trial. There are three evaluation time
      points: before surgery, during surgery, and possibly after surgery. Before surgery, the PD
      patients will complete standardized questionnaires and be trained on a computer game to
      assess cognition. During surgery, the participants will play the same computer game while
      brain signals are recorded. When the patients return to University of Florida for DBS
      programming visits within 48 months after surgery, they will repeat the standardized
      questionnaires and computer game once again.
    

Intervention name(s): Computer task assessing cognition; Impulsive-Compulsive Disorders in Parkinson's Disease; Deep Brain Stimulation Surgery
Intervention type(s): Behavioral; Behavioral; Procedure
Intervention description(s): Participants will complete a short computer game to assess cognition.; Standard clinical questionnaire; DBS surgery for the implantation of electrodes for the treatment of motor disorders.
Other intervention name(s): QUIP-RS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinsons Disease; Cognition
Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
Condition: Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer
      vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent
      and in combination with lenalidomide.
    

Detailed description: 
      This is a dose escalation, phase 1/2a study to assess the safety and tolerability of PVX-410,
      (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple
      myeloma as a single agent and in combination with lenalidomide.. Approximately 22 patients
      will receive six (6) bi-weekly, subcutaneous injections of PVX-410 for a total of twelve (12)
      weeks of treatment. Safety will be monitored throughout the study. Tolerability,
      immunogenicity and clinical response will also be measured as described in the protocol.
    

Intervention name(s): PVX-410
Intervention type(s): Biological
Intervention description(s): Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Other intervention name(s): Revlimid
Intervention MeSH terms: Lenalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Shoulder Proprioceptive Rehabilitative Tool (SRPT) for the Evaluation of the Role of the Shoulder During Reaching
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Observational

Summary: 
      The aim of the study focused on the creation of a rehabilitative measuring device
      (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination
      methodology for assessing the proprioception of the glenohumeral joint respect to scapula
      abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects
      and in patients with shoulder impingement syndrome.
    


Intervention name(s): shoulder proprioceptive rehabilitation tool
Intervention type(s): Other
Intervention description(s): Using of this tool to measure which is the average error in reaching back in both healthy subjects and subjects with shoulder impingement syndrome starting from the assumption that the shoulder, through the articulation scapulothoracic, helps to determine direction and distance during the "reaching" of an object.
Other intervention name(s): SRPT
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects affected by shoulder impingement syndrome and healthy subjects.
      
Keywords: shoulder; proprioception; movement; reaching
The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Observational

Summary: 
      The primary objective of this study is to apply best-practice stated-preference methods to
      quantify the extent to which women with ovarian cancer accept the risks, side effects, and
      out-of-pocket costs associated with treatment in return for progression-free survival benefit
      afforded by a treatment, regardless of whether there is an overall survival benefit.
    

Detailed description: 
      The investigators propose to perform a preferences survey to be administered to women with
      ovarian cancer.The investigators anticipate that about 1/3 of the study cohort will include
      patients who are receiving treatment with an oral ADP-ribose polymerase inhibitors (PARPi).
      The investigators will begin by conducting interviews with 5 pilot subjects as they test the
      preferences survey. Based on their feedback the survey may be updated for clarity. During the
      final survey phase, subjects will be recruited and invited to participate in the choice
      experiment by Biologics, Inc., a specialty pharmacy company that dispenses oral PARPis.
      Subjects may also be recruited through ResearchMatch.org and at the Gynecologic Oncology
      division at Duke. Up to 300 women may be included in this study, at least 100 women will have
      received treatment with a PARPi.

      Discrete choice experiment (DCE) questions generate limited dependent-variable,
      cross-section/time-series data. The study team will use random-parameters logit (RPL) to
      analyze the choice-format conjoint data collected in the DCE survey. Unobserved variation in
      preferences across the sample can bias estimates in conventional conditional-logit choice
      models. RPL avoids this potential bias by estimating a distribution of preferences around
      each model parameter that accounts for variations among individual preferences not accounted
      for by the variables in the model. The flexible correlation structure of RPL also accounts
      for within-sample correlation in the question sequence for each respondent.

      There are no physical risks to subject participation in this survey protocol.
    

Intervention name(s): Preference Elicitation
Intervention type(s): Other
Intervention description(s): Survey of patient preferences for treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A maximum on 300 subjects will be enrolled on this study. All subjects will have been
        diagnosed with ovarian, fallopian tube, or primary peritoneal cancer and at least 100 of
        them will have been treated with a PARPi.
      
Keywords: patient preferences
A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the pharmacokinetic profiles of the test product,
      300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when
      administered as a single dose, and the reference product, 100 mg trazodone HCl
      immediate-release tablets (Apotex Corp), when administered three times daily. For this
      purpose the rate and extent of absorption of trazodone and formation of
      m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared
      under fasting conditions.
    


Intervention name(s): Trazodone HCl; Trazodone HCl
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form: Extended-release caplets containing 300 mg trazodone HCl
Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours.; Dosage form: Immediate-release tablets containing 100 mg trazodone HCl
Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.
Other intervention name(s): Oleptro
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects
Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
Condition: Malignant Solid Tumor
MeSH terms: Tuberculosis; Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express
      homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The
      hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may
      resist inflection and decrease the tumor burden and improve overall survival. The purpose of
      this study is to assess the safety and efficacy of treatment of tuberculosis with malignant
      solid tumor by infusing of iNKT cells.
    

Detailed description: 
      Treatment of tuberculosis with malignant solid tumor is great unsolved challenge to the
      physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and
      chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects.

      Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and
      intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing
      CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role
      in immune regulation by secreting various cytokines. Expansion method of iNKT cells in vitro
      is developed as published in the patent of the investigators. Infusion of iNKT cells has been
      proved safe in mice.

      In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT
      cells are assessed.
    

Intervention name(s): Infusion of iNKT cells
Intervention type(s): Biological
Intervention description(s): The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment