bioihbjkbjnl/mcl2 huggingface dataset:
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Condition: Upper Extremity Hemiplegia; Stroke
MeSH terms: Stroke; Hemiplegia
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine if adding a video game component to an electrical stimulation therapy improves hand
      function in stroke patients
    

Detailed description: 
      A single-blinded randomized controlled trial will be carried out to assess the effects of 12
      weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy
      Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0
      (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment
      dose will be the same for both groups: 10 sessions per week of self-administered treatment at
      home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.
    

Intervention name(s): Contralaterally Controlled Functional Electrical Stimulation (CCFES); Hand Therapy Video Games
Intervention type(s): Device; Device
Intervention description(s): The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. uses surface electrodes over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove.; The use of video games with CCFES to encourage therapeutic hand movement at home
Other intervention name(s): CCFES; HTVG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; rehabilitation; Hemiplegia
Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging
Condition: Pulmonary Hypertension; Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Observational

Summary: 
      Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early
      detection of Pulmonary Arterial Hypertension. A number of reports have provided some
      preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by
      imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI
      could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will consist of a total of 90 subjects separated evenly into the following
        subgroups: 1) Mild PAH, 2) Moderate or Severe PAH, and 3) Normal Controls.
      
Keywords: pulsatility; normal subjects; mild pulmonary hypertension; exercise-associated pulmonary hypertension
Behavior of Children Related to Numbness After Dental Local Anesthesia
Condition: Anesthesia, Local; Anesthesia, Dental
MeSH terms: Hypesthesia
Study type: Observational

Summary: 
      In children, behavior management is critical to the success of pediatric dental procedures.
      Most of the studies on local anesthesia performed in children deal with the question how to
      avoid or minimize pain during injection. Due to the sensation of numbness children scratch
      the soft tissues and bite lips and tongue. In many cases, this may be kept in children's
      memory as a "painful experience" and may affect their behavior in the following visit. The
      purpose of this study is to evaluate children's reactions to the administration of local
      anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal
      infiltration), and to assess their behavior in the following visit related to each type of
      injection.
    

Detailed description: 
      Children between the ages of 4 to 7, undergoing dental treatment at the Department of
      Pediatric dentistry of the Hadassah School of Dental Medicine will participate in the study.
      All patients should be ASA Class I with no prior dental treatment who need at least two
      clinical sessions of similar operative procedures preceded by local anesthetic injection, one
      in each jaw, none of which due to emergency. Subjective and objective evaluation will be
      performed according to previously validated scales.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children receiving routine dental treatment at the hadassah school of dental medicine
      
Keywords: behavior; local anesthesia; behavior after dental local anesthesia
Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
Condition: Anemia; Inflammation; Malaria Morbidity; Cognitive Development
MeSH terms: Anemia; Inflammation
Study type: Interventional

Summary: 
      The research questions to be answered by this study are:

        1. Is treatment with iron more effective at improving anemia if given at the time of a
           malaria episode or 1 month after the episode?

        2. Which treatment timing is associated with more malaria episodes - 1 month delayed
           treatment or immediate treatment at the time of malaria?

        3. Does timing of iron treatment affect later thinking processes and behavior?
    

Detailed description: 
      The study population in this study will be children who are enrolled in our ongoing study of
      cerebral malaria and severe malarial anemia, "Pathogenesis of cognitive/neurologic deficits
      in central nervous system malaria", underway in Kampala, Uganda. The pathogenesis study seeks
      to address the question of why children with severe malaria have later problems in thinking.
      The study we are now proposing will build on this study by assessing whether children with
      severe malaria have iron deficiency, and if they do, whether treatment with iron at the time
      of malaria is less effective than treatment one month later. We believe that treatment one
      month later may be more effective because there is data that shows that the inflammation that
      occurs with a malaria episode may decrease the body's ability to absorb iron in the gut and
      to send iron to the places it is needed, like the bone marrow and the brain. We are doing
      this study to see if our hypothesis about more effective iron treatment if it is delayed is
      correct and assessing anemia prevalence, iron status, and long-term neurobehavioral
      development as outcomes.

      We have three study groups: children with cerebral malaria, children with severe malarial
      anemia, and healthy community control children. Children found to be iron deficient will be
      randomized to receive iron (as ferrous sulphate syrup) either immediately or at their
      one-month follow-up visit. At 1-, 6, and 12-month follow-up visits changes in iron and
      inflammation indicators will be assessed. At the 6- and 12-month visits, neurocognitive
      behavior will also be evaluated and compared between the immediate vs. delayed iron groups.
      Malaria morbidity will be assessed via home visits during the period of iron supplementation
      and via clinic monitoring for the duration of the study.
    

Intervention name(s): Ferrous Sulphate Syrup
Intervention type(s): Dietary Supplement
Intervention description(s): Iron therapy will consist of a three-month course of ferrous sulphate syrup. For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an
      additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy
      White subjects will be investigated.
    


Intervention name(s): Gemigliptin
Intervention type(s): Drug
Intervention description(s): Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.
Other intervention name(s): Zemiglo
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment; Pharmacokinetics; Pharmacodynamics; Gemigliptin
OTR Tablet 40 mg Fasted-state Bioequivalence Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single dose, randomised, cross-over study to confirm the
      bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in
      Chinese subjects with chronic pain
    

Detailed description: 
      In this BE study, subjects with histories of chronic pain are chosen as the target
      population.

      Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK
      data.

      Single dose design is chosen per Food and Drug Administration (FDA)/WHO guideline on
      bioavailability (BA)/BE studies for modified-release products.

      As a general rule, cross-over design is applied in the study to decrease the inter-individual
      variations between the two cohorts. A washout period lasting for at least 7 half-lives of the
      investigational medicine is needed to eliminate the drug residual from the previous period7.
      The elimination half-life of oxycodone from OTR is 4.5 hours, and a 6-day washout period is
      sufficient to achieve the aim.
    

Intervention name(s): Oxycodone Tamper Resistant; OXYCONTIN®
Intervention type(s): Drug; Drug
Intervention description(s): Orally taking Oxycodone Tamper Resistant 40mg in fast state; Orally taking OXYCONTIN® 40mg in fast state
Other intervention name(s): Oxycodone Tamper Resistant (OTR) Tablet 40 mg; OXYCONTIN® Tablet 40 mg
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective

      To assess both the short-term and the long term effectiveness of spa therapy in patients with
      primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.
    

Detailed description: 
      Osteoarthritis is the most common form of joint disease and a major contributor of disability
      in older people. Current treatment of OA include pharmacological and non-pharmacological
      modalities. Spa therapy has a long history in the treatment of OA, but few articles have
      evaluated the effectiveness of thermal treatment in patients with primary OA of the hands.

      The aim of this study is to assess the duration of the clinical effectiveness of mud-packs
      application and mineral bath in patients with primary OA of the hands in a single blind,
      controlled, randomized trial.

      Our study will follow the patients for a longer period of time (12 months) than was done in
      previous studies.

      60 outpatients will be enrolled; 30 patients will be treated with a combination of daily
      local mud packs and mineral bath water from the spa centre of Fonteverde Natural Spa Resort
      (San Casciano Terme, Siena, Italy) for two weeks; 30 patients will continue regular, routine
      ambulatory care. Patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and
      12 months following the beginning of the study and will be evaluated by VAS for spontaneous
      pain, Dreiser Algofunctional index, HAQ, AIMS1 and symptomatic drugs consumption.
    

Intervention name(s): local mud-pack therapy and balneotherapy
Intervention type(s): Other
Intervention description(s): Patients will be treated with local mud-pack application on the hands for 20 minutes and thermal-mineral bath once a day for 15 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; hands; mud-packs therapy; balneotherapy; Osteoarthritis of the hands
Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF),
      however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA)
      reconnection, the cause of recurrence has been not yet fully clarified.

      The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It
      was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore
      the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have
      been conducted. Some study showed the efficacy of GP ablation for AF patients.

      According to the previous reports, heart rate (HR) increased, and heart rate variability
      (HRV) reduced after PVI. These are considered to be due to "autonomic denervation" caused by
      catheter ablation of GP.

      For the best of investigators knowledge, there have been no data on heart rate turbulence
      (HRT) of baroreflex sensitivity (BRS) concerning PVI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who undergo PVI for paroxysmal AF
      
Keywords: atrial fibrillation; pulmonary vein isolation; heart rate turbulence; baroreflex sensitivity
Acne Treatment With Active Oplon's Patches
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to demonstrate the effect of short treatment with active OPLON
      patches on Acne.
    

Detailed description: 
      Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at
      the end of the treatment and 24 hours later.
    

Intervention name(s): Oplon Active Patch; Placebo Patch
Intervention type(s): Device; Device
Intervention description(s): Patches are placed over acne lesion overnight. Treatment is a single treatment.; same as active patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")
Condition: Tooth Loss; Periodontal Disease; Tooth Decay
MeSH terms: Periodontal Diseases; Tooth Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if regular rinsing with chlorhexidine is effective
      as a long-term preventive method for reducing the incidence of tooth loss in low income older
      adults. The true end-point of the study is tooth loss after five years of regular rinsing
      with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and
      coronal decay.
    

Detailed description: 
      "TEETH" is a double-blinded, randomized clinical trial, supervised by a Data & Safety
      Monitoring Board, designed to provide unequivocal evidence regarding the impact of regular
      rinsing 0.12% chlorhexidine solution on tooth loss in low income, community-dwelling older
      adults who are irregular users of dental services. Of the 1101 subjects enrolled in the study
      in Seattle, WA and Vancouver, B.C., one/half have been assigned to the active rinse
      condition; the other half to the placebo rinse which looks and tastes like the chlorhexidine
      rinse but does not have the active ingredient. Subjects receive two bottles of rinse every
      six months; the first to be used daily for one month, the second weekly for five months.
      Reminder calls are designed to help subjects maintain this rinse regimen. Subjects return
      yearly to research clinics at each participating university, where they are examined by a
      dentist who is trained in clinical research methodology and calibrated annually. The purpose
      of these visits is to examine subjects for tooth loss (followed by contacts with extracting
      dentists to determine the dentist's reasons for extracting the tooth), pocket depth,
      recession, caries and restorations on root and coronal surfaces. Interviews are also
      conducted annually with participants to assess health status, health behaviors, and oral
      health quality of life. A panoramic radiograph was taken at baseline of each subject and is
      to be done again at the five-year (final) yearly exam. These radiographs are used to confirm
      tooth loss and possible reasons for extractions
    

Intervention name(s): Chlorhexidine rinse
Intervention type(s): Drug
Intervention description(s): chlorhexidine solution on tooth loss in low income
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aging; Elderly; Periodontal Disease; Dental Caries; Fluoride; Antibacterial rinse; Chlorhexidine; Tooth Mortality
Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or
      0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in
      healthy children aged 6 to <60 months.
    


Intervention name(s): Influenza Trivalent Inactivated vaccines Novartis; Influenza Trivalent Inactivated vaccines
Intervention type(s): Biological; Biological
Intervention description(s): Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.; Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; vaccine; children
Insulin in Treatment of Diabetes Mellitus With Pregnancy
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The prevalence of diabetes melilites is rapidly increasing over years and consequently during
      pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of
      which 86.4% of them were diagnosed with gestational diabetes melilites.

      Pregnancy in women with diabetes is associated with an intensification in adverse maternal,
      fetal and perinatal outcomes including spontaneous abortions, congenital malformations,
      preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in
      women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with
      poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through
      all pregnancy markedly improves both maternal and fetal outcomes.

      Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary
      control and exercise fail. However, insulin therapy has its difficulties like approaches to
      mimicking postprandial insulin release, providing adequate background insulin, balancing
      insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a
      struggle for doctors and patients and much affecting their lifestyle
    


Intervention name(s): Basal insulin analogue; rapid acting insulin; Neutral Protamine Hagedorn; regular insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Analogue insulin is a sub-group of human insulin; Rapid acting insulins are usually taken just before or with a meal. They act very quickly to minimise the rise in blood sugar which follows eating.; is an intermediate-acting insulin; is a type of short-acting insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Protamines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study attempts to deepen our understanding of repetitive behaviors in autism
      spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits
      associated with risperidone treatment using functional MRI. This study is a substudy of a
      larger center grant (IRB#07-03-066). Other studies also under this center grant, include:
      IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another
      sub-study, should they meet criteria. The proposed study will address this aim by mounting a
      controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,
      children will enter a three-part study. Phase 1 will be an 8-week, double-blind,
      placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week
      open-label maintenance phase for responders to risperidone or placebo. Non-responders to
      placebo will be invited to enroll in the eight-week open-label study. 48 of the participants
      will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The
      medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to
      4.0mg.
    


Intervention name(s): Risperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): children get randomized to either placebo or active risperidone; Children get randomized to either placebo or risperidone
Other intervention name(s): Risperdal; Inactive medicine
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ages 8-16; Repetitive Behaviors