bioihbjkbjnl/mcl2 huggingface dataset:
To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of TC-5214 following oral administration of single
      and multiple ascending doses compared to placebo.
    


Intervention name(s): TC-5214; TC-5214; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 mg tablet, oral, BID, group 1; TBD tablet, oral, BID, groups 2-6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Double-blind; randomized; placebo-controlled; parallel-group study; Safety; pharmacokinetics
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this proposed study is to assess the use of a new feature of the Control-IQ
      system, MyTDI.
    

Detailed description: 
      This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin
      parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with
      Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1
      diabetes.

      Once deemed eligible, participants and their parent(s) will be trained on the use of the
      Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system.
      Participants will then use the this study equipment with their home insulin parameters at
      home for at home for 5 days. Participants will then come to the ski resort to participate in
      a 72-hour ski admission. Upon arrival, each participant will be randomized to either the
      using the Control-IQ system with their usual insulin parameters during the ski study and the
      at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and
      the at-home 5 days at home study. Study duration for each participant will require 5 study
      visits over about 2 weeks.
    

Intervention name(s): Hybrid Closed Loop (HCL); Control-IQ with MyTDI
Intervention type(s): Device; Device
Intervention description(s): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.; Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Insulin Pump; Continuous Glucose Monitor (CGM); MyTDI; Hybrid Closed Loop (HCL); Total Daily Insulin (TDI)
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Prospective, Open label, single arm, non-randomized, non-comparative registry study of
      Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients
      with Spinal cord or other injury preventing unsupported patient ambulation.
    

Detailed description: 
      The objective of this feasibility study is to evaluate the overall device safety when used in
      Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician
      and/or qualified rehabilitation specialists.
    

Intervention name(s): Rehabilitation using REX
Intervention type(s): Device
Intervention description(s): Exercises of wheelchair dependent subjects using REX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects (0431-108)(COMPLETED)
Condition: Diabetes Mellitus Non-insulin-dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To support the registration of sitagliptin 100mg in china.
    


Intervention name(s): sitagliptin phosphate
Intervention type(s): Drug
Intervention description(s): Sitagliptin 100mg once daily on Day 1 for single dose, and once daily on Day4-9 for multiple dose.
Other intervention name(s): Januvia™; MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and
      immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for
      injection.
    

Detailed description: 
      Approximately 350 adult subjects will be recruited from approximately 80 study centers in the
      United States, Canada, and Europe who were enrolled in the ASPEN-1 Study Protocol 1720302 and
      de novo subjects (not previously enrolled in ASPEN-1 Study Protocol 1720302) will be treated
      with up to 4 different doses of daxibotulinumtoxinA for injection.
    

Intervention name(s): daxibotulinumtoxinA for injection
Intervention type(s): Biological
Intervention description(s): DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Intervention model description: This is a Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection with up to four different doses in adults with isolated cervical dystonia (CD).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DAXI; Cervical Dystonia; TWSTRS; Toxin; multiple treatment
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
Condition: Infant, Premature; Anemia; Intracranial Hemorrhages; Leukomalacia, Periventricular; Apnea
MeSH terms: Intracranial Hemorrhages; Leukomalacia, Periventricular; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether restrictive guidelines for red blood cell
      (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse
      consequences.
    

Detailed description: 
      Design, Setting, and Patients. We enrolled 100 hospitalized preterm infants with birth
      weights 500 to 1300 g into a randomized clinical trial comparing two levels of hematocrit
      threshold for RBC transfusion.

      Intervention. The infants were randomly assigned to either the liberal or the restrictive
      transfusion group. For each group, transfusions were given only when the hematocrit fell
      below the assigned value. In each group, the transfusion thresholds decreased with improving
      clinical status.

      Main Outcome Measures. We recorded the number of transfusions, the number of donor exposures,
      and various clinical and physiological outcomes.

      Results. Infants in the liberally transfused group received more RBC transfusions, mean 5.2
      (SD 4.5) vs 3.3 (SD 2.9) in the restrictive transfusion group (P=0.025). However, the number
      of donors to whom the infants were exposed was not significantly different, mean 2.8 (SD 2.5)
      vs 2.2 (SD 2.0). There was no difference between the groups in the percentage of infants who
      avoided transfusions altogether, 12% in the liberal transfusion group vs 10% in the
      restrictive group. Infants in the restrictive group were more likely to have intraparenchymal
      brain hemorrhage or periventricular leukomalacia (P=0.012), and they had more frequent
      episodes of apnea (P=0.004), including both mild and severe episodes.
    

Intervention name(s): Red blood cell transfusion guidelines
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transfusions; Erythrocyte; Anemia; Brain; Infant, Premature
Self-Management for Amputee Rehabilitation Using Technology
Condition: Unilateral Trans Tibial/Femoral Lower Limb Amputation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the
      walking capacity and confidence of individuals with unilateral lower limb amputation (LLA).
      Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA.
      Our secondary hypothesis is that SMART can improve ambulation confidence, body function,
      depression, body image, pain, balance confidence, activities of daily living, satisfaction
      with life and habit formation for skin monitoring and prosthetic cleaning in individuals with
      LLA. A post-intervention one on one interview will be conducted to understand SMART
      acceptability. The entirety of the study, including intervention administration, assessment,
      and interviews will be conducted online.
    

Detailed description: 
      Participants will receive an online link to access the SMART platform. Online training on
      using the SMART platform will be provided for participants. Participants will be asked to
      complete one education module per week at their own convenience and weekly online meetings
      with a peer over the 6-week intervention period. The educational modules include
      psychological adaptation, residual limb management, nutrition/weight control, managing a
      prosthetic limb, managing chronic conditions and enhancing mobility. The modules include
      instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound"
      at any point, and the participant's place and work-to-date is automatically saved. The SMART
      platform will be asynchronously monitored through a web portal by the trainer, who will be a
      PhD candidate in Rehabilitation Sciences and observe participant progress and provide
      feedback if required. If there is no online activity within a 7-day (consecutive) period, the
      trainer will contact the participant to inquire the reasons for inactivity and troubleshoot
      any problems including technical issues. Clinical outcomes measures will be collected at two
      timepoints (T1 & T2). A post-intervention one on one interview will be conducted to explore
      SMART acceptability.
    

Intervention name(s): Self-Management for Amputee Rehabilitation using Technology [SMART]
Intervention type(s): Device
Intervention description(s): Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Occupational Therapy; Rehabilitation; Lower-Limb Amputations; Amputees; Telehealth; Remote Rehabilitation; Telerehabilitation; E-learning; Education; Self-Management; Ambulation; Coping Strategies; Outcomes; Prevalence
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to help determine if 10 injections of Botox ® 100 units
      is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing
      urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse
      outcomes of 20 injections versus 10 injections.
    

Detailed description: 
      This study is a randomized clinical trial to assess whether or not 10 injections of 100 units
      of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100
      units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.
    

Intervention name(s): OnabotulinumtoxinA 100 Units
Intervention type(s): Drug
Intervention description(s): BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Other intervention name(s): BOTOX
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Overactive Bladder; Botox/OnabotulinumtoxinA; Pain; OAB; Non-neurogenic Overactive bladder
Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with
      T-cell acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To confirm an association between induction failure (IF) status predicted by a
           previously identified 116-member genomic classifier and actual induction therapy outcome
           observed on COG study AALL0434.

        -  To explore whether there is an association between early relapse (as defined by bone
           marrow or extramedullary relapse within 18 months of diagnosis) predicted by previously
           identified 5-member (primary) and 57-member (secondary) genomic classifiers, and actual
           relapse status at 18 months on COG study AALL0434. (Exploratory)

      OUTLINE: RNA from cryopreserved bone marrow samples are analyzed for gene expression by
      microarray methods. Samples are then compared with the 116-member genomic classifier.
    

Intervention name(s): gene expression analysis; microarray analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newly diagnosed T-cell acute lymphoblastic leukemia
      
Biospecimen description: 
      Bone Marrow
    
Keywords: adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This study will employ a double-blind, placebo-controlled approach to assess the effect of
      1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with
      early and mid-stage dementia.
    

Detailed description: 
      What hypotheses are you testing?

      We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared
      stimulation of the cortex surface improves cognitive and behavioral functioning as indicated
      by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement
      on standardized neuropsychological measures.

      Intensive near infrared stimulation has been shown to be effective in accelerating healing of
      injuries and functional modification including increasing blood flow and perfusion. Dementia
      research has suggested that hypoperfusion is a significant underlying mechanism in the
      progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive
      measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to
      explore whether the increasing of regional cerebral perfusion and oxygenation using infrared
      light stimulation will result in improved cognitive and behavioral functioning.
    

Intervention name(s): 1072nm infrared Photobiomodulation; Photobiomodulation SIMULATED
Intervention type(s): Device; Device
Intervention description(s): 1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.; Device mounted and procedure followed but with no stimulation.
Other intervention name(s): Photobiomodulation, Low-level LED Light Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Small placebo controlled randomized trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dementia alzheimers frontotemporal lyme,; lewy body cognitive impairment
Physical Exercise Therapy in Pediatric Stem Cell Transplantation
Condition: Hematopoetic Stem Cell Transplantation
Study type: Interventional

Summary: 
      The purpose of this randomized controlled two-part study examines the effects of a structured
      sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in
      children and adolescents.

      The main aspects in the sports groups are resistance, endurance and flexibility training. The
      control group performs a mental training as well as relaxation exercises.
    


Intervention name(s): Exercise; Mental Training
Intervention type(s): Other; Other
Intervention description(s): Supervised exercise training (aerobic, resistance, flexibility), 5 times per week; Memorial/ mental training and relaxation, 5 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; Hematopoetic cell transplantation; Children
The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
Condition: Stellate Ganglion Block
MeSH terms: Ganglion Cysts; Synovial Cyst; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Postoperative delirium is an acute state of confusion, which is characterized by changes in
      attention and cognitive functions and fluctuations in consciousness; postoperative cognitive
      dysfunction is a common central nervous system complication in elderly patients after
      surgery, often manifested as memory, Obstacles in abstract thinking and orientation are
      accompanied by a decline in social activity ability. Postoperative delirium and cognitive
      dysfunction can prolong hospital stay, increase medical expenses, affect postoperative
      functional recovery, and even increase postoperative mortality. Sleep disorders are a group
      of diseases that affect the ability to sleep well regularly and cause severe impairment of
      social and occupational functions. Stellate ganglion block is a selective sympathetic
      ganglion block, in which a local anesthetic is injected into the loose connective tissue of
      the neck including the stellate ganglion. There are complex connections between stellate
      ganglia and multiple brain regions in the brain, which can improve postoperative delirium,
      cognitive function and sleep disturbance to a certain extent, and have certain guiding
      significance for postoperative rehabilitation of elderly patients.
    


Intervention name(s): Stellate ganglion block
Intervention type(s): Procedure
Intervention description(s): Find the position of the stellate ganglion under ultrasound guidance, and inject 0.375% ropivacaine near the stellate ganglion to block the sympathetic nerves in the upper chest and head and neck
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Delirium; Cognitive Dysfunction; Sleep Disorders
Brain Biomarkers of Response to Treatment for Apraxia of Speech
Condition: Aphasia; Stroke
MeSH terms: Aphasia; Apraxias
Study type: Interventional

Summary: 
      The study will use MRI brain imaging to identify brain changes associated in stroke patients
      after they receive speech-language treatment for their speech difficulties.
    

Detailed description: 
      The goals of the current study are to identify grey and white matter regions that are
      predictive of speech treatment response and measure neural plasticity in response to speech
      treatment, using state-of-the-art neuroimaging and statistical processing techniques in a
      group of well-characterized left hemisphere patients meeting strict inclusionary criteria.
      Specifically, the investigators will use voxel-based lesion symptom mapping to identify
      lesion sites most predictive of a positive response to speech treatment and advanced
      diffusion imaging techniques to map changes in the integrity of white matter tracts from pre-
      to post-treatment.
    

Intervention name(s): Speech Production Treatment
Intervention type(s): Behavioral
Intervention description(s): This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: aphasia; stroke; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic
      confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028
      cream 0.1%, 0.3% and 1.0% in patients with rosacea.
    


Intervention name(s): PAC-14028 cream 0.1%; PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; PAC-14028 cream vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application; Topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment