bioihbjkbjnl/mcl2 huggingface dataset:
Turning Dysfunction After Stroke: Assessment and Intervention
Condition: Stroke; Walking, Difficulty; Balancing Interference
MeSH terms: Stroke; Mobility Limitation
Study type: Interventional

Summary: 
      The study aims to investigate the 1) differences between stroke patients and healthy controls
      in time, steps, angular velocity, stepping patterns, electromyographic responses during
      turning, and the association of turning to trunk control and motor function after stroke; 2)
      the effectiveness of trunk training on turning performance, trunk control and motor function
      in stroke patients.
    

Detailed description: 
      This study has two parts. The first part is a cross-sectional observatory study.Eligible
      stroke and healthy subjects are asked their demographic data and assessed for turning
      performance (stepping patterns and electromyography data of trunk muscles), trunk control
      (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor
      function (recovery of extremities and balance function). The second part is a randomized
      controlled trial. Stroke participants are randomly allocated into trunk exercise and control
      groups. Trunk exercise group receives trunk exercise including trunk muscles stretching,
      trunk muscles strengthening, and task-related trunk control training for 30 minutes per
      session, twice a week for 12 weeks while control group remains their regular activities.
      Turning performance, trunk control and motor function are evaluated before and after training
      session.
    

Intervention name(s): Trunk exercise
Intervention type(s): Other
Intervention description(s): Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Melatonin for Cerebral Palsy Children's Sleep and Health
Condition: Cerebral Palsy; Melatonin; Growth; Children, Only
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The present study was prospective uncontrolled, single-armed and un-blinded study. Held in
      the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams
      University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP)
      patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin
      given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep
      habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity
      score, and EEG were done at enrollment and after the 3-months.
    

Detailed description: 
      A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital,
      Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure
      problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets
      daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ)
      Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at
      enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).
    

Intervention name(s): Melatonin 3 mg
Intervention type(s): Drug
Intervention description(s): The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.
Other intervention name(s): Melatonin CP
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Intervention model description: A prospective, cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children's sleep habits questionnaire (CSHQ) Arabic version; Anthropometry; GERD; Constipation; Polysomnography
Motivation and Executive Control in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      In order to control a behaviour, investigators need to realise goal directed actions and to
      priories some actions. This control is required in unusual situation. Appropriate actions are
      selected and coordinated according to context and aim.

      Several studies try to draw a model of executive function. Recently, Koechlin has suggested a
      three levelled organisation to explain how the prefrontal cortex controls actions.

      Contextual control is useful to answer appropriately with the immediate context. Episodic
      control allows selecting the action according to specific information given before. Sensorial
      control is the automatic response when a stimulus is presented.

      Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal
      cortex. Chambon and al (2008) have identified a dysfunction of contextual control in
      schizophrenia.

      As the prefrontal cortex is involved in motivational process, it seems interesting to study
      potential links between executive function and motivation. A study from Kouneiher shows
      contextual and episodic activation of motivation in healthy population.

      Investigators aim to study the way motivational process are recruited in schizophrenia.
    

Detailed description: 
      behavioral protocol. Letters (vowel and consonant; upper- or lower- case) are presented in
      several colours into successive blocks. Each block included a series of eight letters. Each
      colour required a specific task given by a fixed rule (contextual control) but for some
      colour, the rule changes sometimes (episodic control). Participants are informed that payoffs
      vary according to their own performance. A frame indicates essay with bonus reward. Moreover
      a dashed frame indicates a low-bonus reward and a solid frame means a high-bonus reward. Thus
      different blocks are designed: low-incentive block and high incentive block.

      This reward increased from standard to bonus motivation in high-incentive block (contextual
      motivation) and from low to high according to the type of blocks (episodic motivation)
      Reaction time may be higher in bonus reward Patients with schizophrenia are not sensitive to
      contextual motivation, and therefore patients should behave differently than control in
      contextual motivation.
    

Intervention name(s): realization of computerized exercises
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: schizophrenia; motivation; executive control
Comparison of Eprosartan/HCT Versus Enalapril/HCT in Hypertensives With Type II Diabetes
Condition: Hypertension; Type 2 Diabetes
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus
      ramipril/HCTZ.
    


Intervention name(s): eprosartan/HCTZ
Intervention type(s): Drug
Intervention MeSH terms: Eprosartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: comparator trial; hypertension; diabetes; blood pressure
The Intrepid Clinical Engineering Study
Condition: Sudden Cardiac Arrest
MeSH terms: Death, Sudden, Cardiac
Study type: Interventional

Summary: 
      The purpose of this research study is to collect clinical data to validate a software update
      for 12-lead electrocardiogram monitoring.
    

Detailed description: 
      The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as
      intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was
      completed to address instances of high impedance. This study will also determine the
      diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid
      Monitor/Defibrillator.
    

Intervention name(s): 12 lead Electrocardiogram
Intervention type(s): Diagnostic Test
Intervention description(s): 12 lead Electrocardiogram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Monitor
Efficacy and Safety of LH-8 in Paediatric Alopecia Areata
Condition: Alopecia Areata; Pediatric Disorder
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8
      cutaneous solution versus placebo in children and adolescents with moderate to severe scalp
      alopecia areata.

      Phase 2/3 study performed in France, Germany, Bulgaria and India in 100 patients.
    

Detailed description: 
      Methods / trial design:

      Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.

      At screening (Visit 0), subjects will discontinue their previous treatment for alopecia
      areata, if any. Screening period will last up to 28 days. The 24-week treatment phase will
      include assessment Visits 1 to 3, which will take place at 12-week intervals. At assessment
      Visit 1, eligible subjects will be randomly assigned in a 2:1 ratio to receive LH-8 cutaneous
      solution or vehicle (placebo) twice daily for a 24 week treatment period. During the
      treatment phase the subjects will complete daily their drug diaries. The post-treatment
      safety and efficacy follow-up phase will include Visit 4 and Visit 5, 12 and 24 weeks after
      end of treatment, respectively.

      Subjects (as applicable) and parents will be instructed to contact the investigator, if an
      event on scalp (intolerance) occurs during the treatment or post-treatment period. They may
      be asked to come to the site for an unscheduled visit, in order to perform additional
      examinations.
    

Intervention name(s): LH-8; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LH-8 cutaneous solution; Placebo cutaneous solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is examining the safety and effectiveness of two medications, ketamine and
      riluzole, in treating patients with treatment resistant major depressive disorder. This study
      will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing
      the potential side effects associated with ketamine.
    

Detailed description: 
      This research proposal will investigate a glutamate-modulating agent, riluzole, in
      treatment-resistant patients who exhibit an acute, sustained response to a single dose of
      intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole
      or placebo in a 4-week, randomized, double-blind, continuation-phase study.
    

Intervention name(s): Lamotrigine; Ketamine; Riluzole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): anticonvulsant medication; subanesthetic dose of NMDAR antagonist; glutamate release inhibitor
Other intervention name(s): lamictal; ketalar; rilutek
Intervention MeSH terms: Lamotrigine; Ketamine; Riluzole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo
Condition: Placebo Effect; Pain; Expectancy
Study type: Interventional

Summary: 
      To date, very little is known about the mechanisms of open-label placebo treatment and there
      is a lack in highly controlled experimental designs. Therefore, the planned project will test
      well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning
      response, in an open-label placebo design, investigating their influence on placebo
      analgesia.
    

Detailed description: 
      The current project will consist of one experimental study and one qualitative study:

        1. the effects of open-label, and deceptive placebo administration on placebo analgesia
           will be directly compared when both groups have a comparable expectancy-inducing
           scientific rationale;

        2. subjective meaning models will be assessed by comparing subjective narratives of the
           placebo effect in open-label and deceptive placebo groups in a nested qualitative study.

      The experimental study will be a randomized experiment with healthy subjects (N=120), and
      pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel;
      thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed
      both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective
      pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly
      select 30 participants to take part in a nested qualitative study in order to qualitatively
      assess the meaning response by comparing subjective narratives of the placebo effect in the
      open-label and deceptive placebo groups, as well as in the control group.
    

Intervention name(s): open-label placebo; deceptive placebo
Intervention type(s): Other; Other
Intervention description(s): Placebo Cream, openly described as "Placebo"; Placebo Cream, described as "Voltaren, containing Diclofenac"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation
      study of TT-00920 in healthy subjects.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation
      study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized
      subjects dosed three times daily for 13 days and one time for 1 day. The study will consist
      of a Screening Period, an In-house Period and a Follow-up.
    

Intervention name(s): TT-00920; TT-00920 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TT-00920 Tablets; TT-00920 Placebo Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Psychologists' Lived Experience of Client Violence
Condition: Life Experiences
Study type: Interventional

Summary: 
      The objective of the proposed research is to gain a detailed understanding and account of
      psychologists' experience of client violence in clinical practice. The emphasis is upon a
      detailed understanding of how psychologists perceive and understand their experience of
      client violence and its impact upon their identity as clinicians and as individuals.
    

Detailed description: 
      This research is interested in Counselling and Clinical Psychologists who have experienced
      client violence at their work place. The main research question being asked is how do
      psychologists' understand their personal experiences of client violence. This is an important
      and interesting subject for Counselling and Clinical Psychologists as it provides a detailed
      personal account of the implications of violence upon their personal and professional
      identity, psychological well being and how they define violence. Furthermore, this research
      may help facilitate in designing a specific policy and help future research to issue
      guidelines for counselling and clinical psychologists in order to keep themselves safe within
      their professional practice. Psychologists working for the National Health Service will be
      recruited and provided with information regarding the research aims and objectives. There
      will be interviews held at their place of work for approximately one hour.
    

Intervention name(s): Information Sheet; Consent; interview; Debrief
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Providing the Participant with information regarding the aim of the experiment; Providing a consent form for participants. The participant is aware of his or her rights; participants will interviewed by fardin jussab for approximately one hour regarding their experience of client violence; at the end of each interview the researcher will ask participants whether the emotions aroused in the interview require further discussions. Interviewees will be also advised that should they wish to talk further about any topics covered the in the interview, they could telephone the researcher at a later time. There will also be leaflets of supporting agencies.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: violence
Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      This study will examine patient satisfaction and spectacle independence using a survey in
      patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens
      at least 2 years prior to administration of the survey.
    

Detailed description: 
      Purpose: To compare patient-reported satisfaction with a multifocal vs an accommodating
      presbyopia-correcting at least two years following implantation of either type of implant.

      Number of study subjects: 200 (half with multifocal and half with accommodating lens
      implants)

      In this study, we will send a secure, online questionnaire to patients who have previously
      undergone cataract surgery at least two years previously. Patients will receive an email
      invitation, and by clicking the embedded link and verifying their identity with date of birth
      and phone number, they will be directed to a survey. The survey will ask the following types
      of questions:

        -  overall satisfaction with the surgery

        -  would they do the same surgery again?

        -  would they choose the same (elective) lens implant again?

        -  for what types of activities (reading newspaper, driving, driving at night, fine print)
           do they require glasses to see clearly?

        -  do they experience glare and halo symptoms?

        -  how bothered is the patient by these symptoms?

      These data will be stored on a secure server. Statistical analysis will be done by a
      statistician, using a student's t-test to determine statistical significance of any
      difference between patients with different types of lens implants.

      No intervention will be planned with patients, other than analyzing the survey results. All
      patient identifying (demographic) information will be carefully protected according to HIPAA
      and HITECH standards.
    

Intervention name(s): Survey
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent cataract surgery with a multifocal or accommodating lens implant at
        least two years prior to the survey.
      
Keywords: cataract satisfaction
Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Neoplasm Metastasis; Stomach Neoplasms
Study type: Observational

Summary: 
      Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells
      in patients with gastric cancer.
    

Detailed description: 
      Gastric cancer (GC) remains one of the most common causes of cancer-related mortality
      worldwide. Surgery has always been considered as the most effective treatment for GC.
      Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients
      with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a
      poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early
      stage. As we know, the implantation of peritoneal free cancer cells exfoliating from
      serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of
      peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However,
      more than half of patients with negative cytological results develop peritoneal recurrence.
      Low sensitivity and poor negative predictive value of this method have heralded the
      development of advanced techniques in detecting peritoneal free cancer cells.

      In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer
      cells in abdominal cavity. The present clinical trial aims to find a better tool to detect
      abdominal micrometastasis in GC patients, which may become a valid clinical index to predict
      postoperative relapse and direct treatment.
    

Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): Lavage of the Peritoneal Cavity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
      
Biospecimen description: 
      tumor biopsy, peritoneal lavage
    
Keywords: Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer
The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans
Condition: Chronic Myeloid Leukemia (CML)
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the mass balance and routes of excretion of total
      radioactivity after a single oral 30mg (100µCi) dose of [14C] HQP1351 given as a suspension.
      For further clinical development, human mass balance data are required to elucidate the
      absorption, metabolism, and excretion of HQP1351.
    


Intervention name(s): [14C] HQP1351
Intervention type(s): Drug
Intervention description(s): Orally, single dose of 30mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myeloid Leukemia; HQP1351
Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the
      treatment of generalized anxiety disorder.
    


Intervention name(s): Pregabalin; Venlafaxine XR
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pregabalin; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment