bioihbjkbjnl/mcl2 huggingface dataset:
Strength and Dexterity of Less Affected Hand of Hemiparetic Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The contralateral hand deficits are often masked by the complex clinical presentation of the
      more affected hand in children with spastic hemiparesis. Thus, intervention targeting the
      contralateral hand is not often a component of the child's rehabilitation plan of care. The
      presence of bilateral hand deficits, even if subtle in the contralateral hand, may limit the
      transfer of unimanual gains following rehabilitation to bimanual activities of daily living
      tasks. However, conservation of upper-limb function of the less-affected side is highly
      important for individuals with hemiparesis, because this side is often employed as a
      compensatory 'tool' in performing activities of daily living . Therefore, the current study
      will be conducted to determine and compare the motor abilities of the less affected hand of
      children with hemiparesis.
    

Detailed description: 
      An impairment of the less affected hand of hemiparetic cerebral palsy children can be
      detrimental to the development of bimanual skills. It would be beneficial to identify and
      quantify the severity of any impairment of the less affected hand of hemiparetic cerebral
      palsy children. Hemiparetic cerebral palsy may present with substantial deficits in hand
      function, because bimanual activities involve the ability to use the affected and
      contralateral hands together for grasp and stabilization. Several authors have evaluated
      bimanual involvement in cerebral palsy but these studies have not compared the contralateral
      hand with norms. The less affected hand is widely regarded as "normal" or "unaffected" and is
      consequently rarely evaluated.

      Several authors have reported incidental findings of subtle deficits in the less affected
      extremity, noted that hemiparetic children "also presented motor impairments in their
      non-paretic hand, especially in dexterity.

      The purpose of this study is to assess the grip ,pinch strength and dexterity of less
      affected hand of hemiparetic cerebral palsy children and compare with dominant hand of normal
      peers
    

Intervention name(s): Assessment of hand grip strength; Assessment of pinch strength; Assessment of upper limb dexterity
Intervention type(s): Other; Other; Other
Intervention description(s): Assessment of hand grip strength; Assessment of pinch strength; Assessment of upper limb dexterity
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include 120 children of both gender with age from 6 years to 10 years
      
Keywords: Cerebral Palsy; Unilateral cerebral palsy; grip strength; pinch strength; upper limb dexterity
A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d
      supplementation in schizophrenia patients with mild or greater negative symptoms.
      L-methylfolate, a prescription medical food, is the activated form of folate required for
      conversion of homocysteine to methionine and hence is the optimal form of folate for
      supplementation, since it eliminates the need for activation by MTHFR. The purpose of this
      study is to examine the change in plasma L-methylfolate concentrations following a
      three-month trial of L-methylfolate 15 mg/d compared to placebo.
    

Detailed description: 
      Blood levels of L-methylfolate and biological activity will be evaluated by examining changes
      in plasma homocysteine concentrations, serum methionine concentrations and changes in brain
      activation as measured by fMRI.
    

Intervention name(s): Placebo; L-methylfolate
Intervention type(s): Other; Other
Intervention description(s): Placebo once a day for 12 weeks; L-methylfolate 15mg once a day for 12 weeks
Other intervention name(s): Deplin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: L-methylfolate; Deplin; schizophrenia; folate; folic acid; homocysteine; methionine; MTHFR genotype; C677T mutation; vitamin B6; vitamin B12; psychotic symptoms; MTHFR C677T Polymorphism
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Condition: Hypovolemic Hyponatremia
MeSH terms: Hyponatremia; Hypovolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy +
      placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients
      with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in
      each group) patients are to be enrolled randomly into Tolvaptan group or placebo group.
      Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while
      those in control group receiving standard therapy + placebo. The starting dose of tolvaptan
      is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg
      according to a certain titration scheme based on patients' response of serum sodium level.
      The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study
      treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety
      events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from
      baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of
      body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed
      as secondary efficacy variables.
    


Intervention name(s): Tolvaptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet;15mg/tab;15/30/60mg/day for 7days Plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.; placebo plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyponatremia; Non-acute and non hypovolemic hyponatremia
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop
      versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type
      1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
    

Detailed description: 
      The purpose of this study is to evaluate the effectiveness of the control system in reducing
      hypoglycemia by comparing, in a randomized study, 24 hour control with USS Virginia versus
      sensor augmented pump (SAP) therapy in subjects with type 1 diabetes and hypoglycemia
      unawareness and/or risk for hypoglycemia. We will also evaluate the effectiveness of the
      control system to improve hypoglycemia counterregulation, hypoglycemia awareness, and overall
      glycemic control. To achieve this goal, we will conduct pre- and post-intervention inpatient
      assessments of hypoglycemia counterregulation and symptom awareness. Subjects randomized to
      USS Virginia will participate in two training visits at a monitored outpatient setting for
      the step-wise deployment of the cell phone based Artificial Pancreas (AP) System at home. The
      first training visit includes training on the study pump and AP System followed by 1 week use
      of AP System at home in Pump mode. The second training visit includes additional training on
      USS Virginia+AP System and confirmation of independent use by the subject followed by 4 week
      use of the AP System at home in Closed Loop mode. Subjects randomized to sensor-augmented
      pump therapy will complete 5 weeks of CGM with the home pump.
    

Intervention name(s): AP System (DiAs or inControl) with USS Virginia; Sensor-Augmented Pump Therapy (placebo)
Intervention type(s): Device; Device
Intervention description(s): Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.; Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1 (T1DM); Diabetes Assistant (DiAs); Artificial Pancreas (AP) System; Closed-Loop Control (CLC); Unified Safety System (USS) Virginia; Sensor Augmented Pump (SAP); Low Blood Glucose Index (LBGI); Continuous Glucose Monitor (CGM); inControl Diabetes Management Platform
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of
      LY2963016 compared to those of basal insulin. The study will also gather information on the
      safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12
      weeks.
    


Intervention name(s): LY2963016; Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Other intervention name(s): Insulin Glargine
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause
      of death in Europe and North America. A key limitation of contemporary treatment strategies
      of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an
      effective treatment for large AAA, it is associated with significant mortality and morbidity
      as well as substantial cost. The rationale for this randomized controlled study is to
      investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic
      aneurysms.
    


Intervention name(s): Ticagrelor; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aorta; Aneurysm; Antiplatelet
Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
Condition: Colorectal Neoplasm
MeSH terms: Neoplasms; Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators plan to conduct a multi-center, randomized controlled trial to investigate
      the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal
      polyp. This study will be performed using web-based research network, e-VELOS in Korea.
    

Detailed description: 
      Various endoscopic tools have been tried to reduce polyp missing rate which has been reported
      to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve
      visualization of the lesion that are difficult to access, such as tangentially located
      lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine
      spraying was reported to increases the detection rates of polyp, especially in right colon
      and rectum. However, there also have been mixed results regarding polyp detection rates of
      the endoscopic methods. Moreover, there is no data regarding the impact of the screening
      tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to
      perform a multi-center, randomized controlled trial to investigate the efficacy of
      cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This
      study will be performed using web-based research network, e-VELOS in Korea.
    

Intervention name(s): cap-assisted chromoendoscopy
Intervention type(s): Device
Intervention description(s): A cap (irrigation cap) is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. For chromoendoscopy, 0.09% indigocarmine was administered via irrigation cap .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colorectal neoplasm; Colonoscopy; chromoendoscopy; cap-assisted colonoscopy
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid
      ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and
      secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles,
      in subjects with hypertriglyceridemia.
    

Detailed description: 
      This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2
      (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment
      sequences: placebo or POM3 for the first 6 week phase followed by the study product they did
      not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a
      2-week washout period between treatment phases.
    

Intervention name(s): POM3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 g/day; matching placebo capsule, 4 g/day
Other intervention name(s): Lovaza; prescription omega-3 acid ethyl esters
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effects of strong CYP1A2 (Cytochrome P450 1A2) inhibitor
      (fluvoxamine) on savolitinib exposure in healthy male subjects, performed at a single
      clinical unit.
    

Detailed description: 
      This study will be a Phase I, open-label, fixed-sequence, 2-treatment period study.

      The study will consist of 2 periods. During period 1 of the study, each subject will receive
      a single oral dose of savolitinib following an overnight fast. A low-fat breakfast will be
      provided prior to dosing. There will be a minimum washout period of 10 days (14 days between
      two successive savolitinib doses) between period 1 and period 2.

      During period 2 of the study, subject will take oral doses of fluvoxamine alone from Days 1
      to 4. There would be no dietary restrictions for fluvoxamine dosing. On Day 5, subjects will
      take a single oral dose of savolitinib and oral dose of fluvoxamine. On Day 6, subject will
      receive an oral dose of fluvoxamine alone. Each subject would be involved in the study for 9
      weeks (including screening window).
    

Intervention name(s): Savolitinib; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): Savolitinib will be administered as a single oral dose on Day 1 of Period 1 and on Day 5 of Period 2.; Only fluvoxamine will be administered as a twice daily oral dose from Days 1 to 4 of Period 2. On Day 5 of Period 2, subject will receive a twice daily oral dose of fluvoxamine along with savolitinib. On Day 6 of Period 2, subject will receive a twice daily oral dose of fluvoxamine alone.
Intervention MeSH terms: Fluvoxamine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fixed-sequence; CYP1A2 inhibitor; Drug-drug interaction
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults
Condition: Nasal Congestion
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day,
      versus placebo on nasal congestion in subject with common cold.
    

Detailed description: 
      This study is designed as a multicentric, randomized, double-blind, placebo-controlled with
      two-arm parallel groups clinical trial. 144 subjects presenting with early symptoms of common
      cold will be recruited for this study, according to the defined inclusion and exclusion
      criteria. The main objective is to evaluate the efficacy of Azéol Spray Nasal
      (Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of
      Leguminosae Glycyrrhiza glabra L., glycerin and mannitol), taken two times a day, versus
      placebo on nasal congestion in subject with common cold.
    

Intervention name(s): Azeol spray nasal; Placebo nasal spray
Intervention type(s): Device; Device
Intervention description(s): Azeol Spray Nasal is a nasal spray intended to reduce the nasal congestion due to rhinitis, rhinosinusitis and colds which is marketed. The ID is conforming to the European Union (EU) legislation and is bearing the CE-mark. The ID is manufactured by PILEJE S.A.S (France).; with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis
Condition: Motor Neuron Disease, Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that targets
      motor neurons. Prognosis is invariably fatal within 3-5 years since manifestation of the
      disease. Despite improved understanding of the mechanisms underlying ALS, the treatment
      remains essentially only supportive and focused on symptoms relief. Over the past few years,
      stem cell research has expanded greatly as a tool for developing new therapies to treat
      incurable diseases. Stem cell therapy has been shown as promising in several animal ALS
      models and human clinical trials.
    

Detailed description: 
      Subjects will be assigned to autologous mesenchymal stromal cell (AMSC) treatment according
      to inclusion and exclusion criteria (see below) screened four times prior to administration.
      Then the subjects will be observed for three consecutive yearsAfter a half year of screening
      period, the autologous multipotent mesenchymal stromal cells from bone marrow will be
      isolated. The cells will be cultivated for 3 passages (3 - 4 weeks) in order to get
      sufficient amount for therapy, cell suspension for intrathecal application will be prepared
      and introduced intrathecally through lumbar puncture. Subsequently, all the subjects will be
      observed at the range of standard medical care used at these types of interventions.
    

Intervention name(s): Suspension of human autologous MSC 3P in 1.5 ml
Intervention type(s): Biological
Intervention description(s): Intrathecal application of Autologous Multipotent Mesenchymal Stromal Cells 3P suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
Condition: Non Alcoholic Fatty Liver Disease; Lifestyle; Diet Modification
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The study is an open-label intervention non pharmacological Cohort Study without control arm
      in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.

      The intervention in patients with NAFLD is educational, providing personalized suggestions to
      improve diet and physical activity; the intervention in healthy subjects is educational,
      providing general suggestions to improve diet and physical activity.
    


Intervention name(s): Mediterranean Style
Intervention type(s): Behavioral
Intervention description(s): After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.
Intervention model: Single Group Assignment
Intervention model description: A single cohort of patients with NAFLD, without control group.
Masking: None (Open Label)
Primary purpose: Treatment
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
Condition: Arthroscopic Surgery
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of Ostenil
      application (1% hyaluronan) after arthroscopy of the wrist.
    


Intervention name(s): Ostenil; Standard arthroscopic procedure
Intervention type(s): Device; Procedure
Intervention description(s): Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic.; Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrist; joint; arthroscopy; hyaluronan; hyaluronic acid; Necessity of Arthroscopic surgery