bioihbjkbjnl/mcl2 huggingface dataset:
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
Condition: Fetal Alcohol Syndrome; Alcohol-related Neurodevelopmental Disorder
MeSH terms: Fetal Alcohol Spectrum Disorders; Syndrome; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Children will receive comprehensive evaluations through the Children's Research Triangle
      (CRT) clinical program. The assessment for the child will be in accordance with the protocol
      developed by Astley and Clarren as performed by one of the clinic pediatricians and final
      diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be
      randomized into either a Treatment or Control group. The Treatment group will receive (in
      addition to standard referrals) neurocognitive habilitation and psychotherapy services as
      well as parent psychoeducation. The Control group will be referred for intervention through
      existing community and school-based agencies.
    

Detailed description: 
      Neurocognitive habilitation, based on the traumatic brain injury literature for teaching
      compensatory skills, will be the primary intervention. Interventions will be individually
      designed and delivered through individual therapy sessions. Audiotapes will augment the
      sessions to facilitate implementation of strategies in the home environment. Didactic therapy
      will be used to foster appropriate interactions and relationships between parent and child.
      Children will participate in 8-week group sessions that will include neurocognitive
      exercises, homework sessions, and possibly group psychotherapy. An educational specialist
      will provide school and legal advocacy services as well as observations of the child in the
      classroom that could lead to educational modifications.

      Parent Component: Family education programs and parent support groups using psychoeducational
      approaches will be the means of intervening with parent behaviors. Parents will be instructed
      on becoming advocates for their child. Groups of 8 to 12 parents will meet for one 2-hour
      session per week for 8 weeks. Each session will include:

        1. neurocognitive exercises (relaxation);

        2. specific topic discussions; and

        3. general support.

      During the last hour of the final two weeks of the program, parent and children will be
      combined to practice learned techniques. Children and parents will participate in monthly
      "booster" sessions.

      Evaluation Plan: Treatment and control groups will be compared using pre- and post-test
      measures. Post-tests will be at the conclusion of the intervention, as well as at 12, and
      24-month follow-ups. Process and outcome measures will be evaluated.
    

Intervention name(s): neurocognitive habilitation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: fetal alcohol syndrome (FAS); alcohol-related neurodevelopmental disorder (ARND)
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Condition: Oral Cancer
MeSH terms: Mouth Neoplasms; Lip Neoplasms
Study type: Interventional

Summary: 
      Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location.
      Advanced treatment of oral cancer increases survival rates; however, it also increases the
      risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity
      and psychological issues. The probability of shoulder dysfunction after neck dissection is as
      high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are
      needed for further studied.The purpose of this randomized clinical trial is to explore the
      effects of rehabilitation for shoulder function in oral cancer survivors.
    

Detailed description: 
      Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location.
      Advanced treatment of oral cancer increases survival rates; however, it also increases the
      risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity
      and psychological issues. The probability of shoulder dysfunction after neck dissection is as
      high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are
      needed for further studied.

      The purpose of this randomized clinical trial is to explore the effects of rehabilitation for
      shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer
      subjects through the plastic surgeon's referral from April 2018 to March 2020. The
      participants will be randomized separated into experimental or control group. Each group
      would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical
      stimulation, shoulder joint range of motion exercise, scapular muscle strengthening
      training). Experimental group would be supplemented by motor control therapy targeting the
      scapular muscle progressive resistance exercise (exercise plus manual therapy).
    

Intervention name(s): motor control therapy; regular physical therapy
Intervention type(s): Other; Other
Intervention description(s): scapular muscle progressive resistive exercise(PRE); transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: oral cancer; shoulder dysfunction; quality of life; motor control; strengthening exercise
A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on the
      heart rate-corrected QT (QTc) interval and to conduct blood tests to measure how much
      pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates
      pirtobrutinib. The study will also evaluate the safety and tolerability of pirtobrutinib. The
      study will last up to 71 days, including screening.
    


Intervention name(s): Pirtobrutinib; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Moxifloxacin; Pirtobrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Acupuncture and Skin Temperature Behavior
Condition: Thermography; Acupuncture Therapy; Electroacupuncture
Study type: Interventional

Summary: 
      Objective: Evaluating the behavior of skin temperature through infrared thermography after
      application of acupuncture and electroacupuncture in Weizhong (B40) and Kunlun (B60)
      acupunctures points. Methods: A single-blind randomized clinical trial was performed with 54
      participants of both sexes, mean of 21.88±2.53 years, randomized into three groups (n=18):
      electroacupuncture (EAG), acupuncture (AG) and control (CG). The application was bilateral in
      the acupoints (B60 and B40), for 20 minutes. The skin temperature of the lower limbs was
      measured at the following times: before application, 10 minutes of application, 20 minutes of
      application and 10 minutes after needle removal.
    


Intervention name(s): Acupuncture therapy and Electroacupuncture
Intervention type(s): Device
Intervention description(s): We used the following Bladder acupuncture points, Weizong (B40) in the middle of the popliteal fossa and Kunlun (B60) located in a depression between the lateral malleolus and the Achilles tendon. The subjects were instructed to report the "De Qi" perception (paresthesia or numbness) that was the advice to the researchers that the point was right punctured. After the De qi was reported, the needle remained in the acupuncture point for 20 minutes and was rotated three times more for the preservation of the effect. During this time, all subjects remained in the supine laying down position on the stretcher.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy
Condition: Segmentectomy; Video- Assisted Thoracoscopic Surgery; Three-dimensional-computed Tomography (3D-CT); Thin Cross- Section of CT
Study type: Interventional

Summary: 
      Three-dimensional (3D) simulation of pulmonary vessels and the space between the lesion and
      adjacent tissues is regarded improving the safety and accuracy of video-assisted
      thoracoscopic surgery (VATS) for segmentectomy for ground glass opacity (GGO) in lung.
      However, not every thoracic surgeon can handle the technique, in addition, the 3D
      reconstruction originate from the thin CT scan. Actually, the investigators found that, the
      reading and comprehension of the thin cross- section of CT can guide the accurate anatomic
      segmentectomy in most situations. The investigators designed a retrospective study to compare
      the reading of thin cross- section of CT with 3D reconstruction or without 3D reconstruction
      during the guidance of anatomic segmentectomy.
    


Intervention name(s): Cross- Section of CT Guided Anatomic Segmentectomy; 3D simulation Guided Anatomic Segmentectomy
Intervention type(s): Other; Other
Intervention description(s): The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.; The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Study of LY2140023 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the extent and rate of absorption of LY2140023 in
      healthy participants. The study has two periods. In Treatment Period 1, participants will
      receive a single oral dose of 80 milligrams (mg) LY2140023 followed by a 2-hour intravenous
      (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100
      nanocuries (nCi) [14C]-LY2140023. In Treatment Period 2, participants will receive an oral
      dose of 80 mg LY2140023 followed by a 2-hour IV infusion of approximately 100 µg LY404039
      containing approximately 100 nCi [14C]-LY404039. There will be at least a 3-day washout
      between doses.
    


Intervention name(s): LY2140023; 14C-LY2140023; 14C-LY404039
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered IV.; Administered IV.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Mobile Phone Telemedicine on Diabetes Care
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Adult patients with diabetes on insulin are eligible for the study. They will be randomized
      to a group using standard of care communication and a group using an I phone intervention.
    

Detailed description: 
      Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are
      between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the
      study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in
      our clinic at an initial/baseline and three month clinical visit. The control group will
      e-mail, fax, or call their blood glucose log results once a month for an insulin regimen
      adjustment through verbal communication with a certified diabetic educator once a month as is
      already implemented at the Diabetes Center. This group will be compared to the intervention
      group who will submit their blood glucose log results through an iPhone mobile application,
      called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a
      text message response. The two groups will have their HbA1c, hypoglycemic events, blood
      glucose dispersion compliance, quality of life, usability and satisfaction with the use of a
      mobile application will be assessed at each visit with surveys.
    

Intervention name(s): Diabetes Doctor Mobile app
Intervention type(s): Other
Intervention description(s): Diabetes Doctor is a mobile application software. The mobile phone application allows a subject to register blood glucose values obtained from their fingerstick glucose meter readings, the type and amount of insulin they are administering, any notes they would like to document, and the date and time of each entry. All data will be entered by the subject manually. The data will be submitted through encryption coded private servers and can be retrievable by a physician on a password protected website for privacy. A physician will evaluate this information to recommend a change of the subject's insulin regimen. The recommended insulin regimen will be delivered to the patient using the same website and received by the subject on the same mobile application software.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consists of 2 periods: [1] Study Period A - evaluating the efficacy and safety of
      Crenezumab versus Placebo in participants who carry the PSEN1 E280A autosomal-dominant
      mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due
      to AD and are thus, in a preclinical phase of AD. Participants will be randomised in a 1:1
      ratio to receive either Crenezumab or Placebo subcutaneously (every 2 weeks) or intravenously
      (every 4 weeks) for at least 260 weeks. A cohort of participants (non-mutation carriers) will
      also be enrolled and will be dosed solely on Placebo and [2] Study Period B - Participants
      will be offered the opportunity to continue to receive study drug until the results of the
      study are known and post trial access to Crenezumab is started or development of Crenezumab
      is discontinued.
    


Intervention name(s): Crenezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Crenezumab will be administered as per the schedule specified in the treatment arm.; Placebo will be administered as per the schedule specified in the treatment arm.
Other intervention name(s): MABT5102A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with
      Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM
      injections in healthy adults 18 to 49 years. The investigators will measure the
      immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given
      with VAX102 compared to TIV alone.
    


Intervention name(s): VAX102; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo; All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
Other intervention name(s): Universal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; universal influenza vaccine
Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given
      to Japanese patients with acute ischemic stroke
    

Detailed description: 
      The study is a safety and tolerability study of desmoteplase in Japanese patients with acute
      ischemic stroke. The study will test two doses
    

Intervention name(s): Desmoteplase; Desmoteplase; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 1 bolus injection of desmoteplase 70 µg/kg intravenous (IV); 1 bolus injection of desmoteplase 90 µg/kg (IV); 1 bolus injection of placebo IV
Intervention MeSH terms: Salivary plasminogen activator alpha 1, Desmodus rotundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Ischemic Stroke; Desmoteplase; Japan; Safety; Stroke; Tolerability
Effects of Glucose-fructose Drinks During Training on Lactate Transport
Condition: Normal Physiology on Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether glucose-fructose intake during training
      increases lactate transport and oxidation and improve endurance performance.
    

Detailed description: 
      The study will enroll 24 healthy male volunteers. After baseline assessment of lactate
      transport and endurance performance, subjects will be randomized to either a 3-week
      intervention arm in which they will train with glucose-fructose intake during training, or to
      a control arm (water during training). After this 3-week intervention, lactate transport and
      endurance performance will be assessed again.
    

Intervention name(s): Glucose-fructose; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 0.8 g/h glucose and 0.5 g/h fructose during training; Only water intake during training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fructose; Exercise; Lactic acid; Monocarboxylic Acid Transporters
Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of the intravenous drip
      infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis
      (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group
      comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as
      the primary endpoint.
    


Intervention name(s): ART-123; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy; Placebo by intravenous drip infusion in addition to standard of care steroid therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute exacerbations; Idiopathic pulmonary fibrosis; Recombinant human soluble thrombomodulin; ART-123
Mechanisms of Exercise Intolerance in Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are
      associated with endothelial dysfunction, and the endothelium plays an important role in
      regulating vascular tone, tissue blood flow, coagulation and the inflammation process.
      Although the specific causes of endothelial dysfunction remain unclear, physical inactivity,
      chronic systemic inflammation and smoking are all known to be associated with endothelial
      abnormality.

      2. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of
      blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore
      contribute to the exercise intolerance and skeletal muscle depletion seen in patients with
      COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is
      thus adapted to meet energy requirements. During physical activity, the sympathetic nervous
      system is activated ("exercise pressor reflex"), resulting in increased ventilation, heart
      rate and a redistribution of cardiac output from inactive to active tissues. The
      redistribution of cardiac output to the body organs is heterogeneous. Blood flow to skeletal,
      respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow
      to gastrointestinal, renal and reproductive tissues decreases. As blood pressure during
      exercise remains largely unchanged, the redistribution of blood flow is caused by changes in
      vascular conductance. These conductance changes are caused by an overall vasoconstriction
      induced by the increased sympathetic outflow of noradrenaline (NA), and a vasodilation of
      vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.
    


Intervention name(s): Exercise
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science