bioihbjkbjnl/mcl2 huggingface dataset:
Brain Change After Fun, Athletic, Sports-skill Training (BeFAST)
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the associations between changes in neural activity
      and structure, advanced gross motor skills, gait characteristics, and physical activity
      participation following a gait-related intervention that is based on motor learning
      principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The
      investigators' hypothesis is that in conjunction with a program of motor learning based
      training, functional neuroplastic changes in the involved motor areas will be strongly
      associated with changes in gait and advanced gross motor skills, moderately associated with
      physical activity based participation changes, and will have a fair association with
      structural neuroplastic change.
    


Intervention name(s): Functional gait-related training
Intervention type(s): Behavioral
Intervention description(s): The motor learning (ML)-based functional gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Scheduling flexibility will promote adherence, with a minimum one day between sessions to provide opportunity for rest. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined active/imagery) will be five per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Condition: Hypogonadism; Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 2

Summary: 
      The combination of testosterone and dutasteride is intended for use in hypogonadal men. This
      study will evaluate the effect of 28-day repeat dosing of this combination with varying BID
      doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well
      as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the
      effects of each compound on the other, and to look for any safety problems that may result
      when the 2 drugs are given together.
    


Intervention name(s): Nanomilled testosterone; Nanomilled dutasteride; commercially available dutasteride
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Nanomilled testosterone; Nanomilled dutasteride
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DHT; Testosterone; Hypogonadism; Dutasteride; Androgen deficiency
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
Condition: Influenza Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus
      Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months
      of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere
      influenza season.
    


Intervention name(s): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Intervention type(s): Biological; Biological
Intervention description(s): 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; children
Pharmacokinetic Comparisons of Two Donepezil Formulations
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability and pharmacokinetic characteristics of a newly
      developed donepezil formulation with a conventional formulation in healthy subjects with a
      single dose, randomized, open-label, 2-sequence -2period crossover study.
    

Detailed description: 
      This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence,
      crossover study was conducted to compare the relative bioavailability and pharmacokinetic
      characteristics of a newly developed formulation with a conventional formulation in healthy
      subjects.

      For this, a single-center, randomized, single-dose, open-label, 2-way crossover study with a
      21-day washout period was conducted in 22 healthy volunteers. Plasma samples for the analysis
      of donepezil were collected up to 240 h after drug administration. Participants received
      either reference or test drug formulation of 10 mg donepezil in the first period and the
      alternative formulation in the second period. Plasma concentrations of donepezil were
      determined by validated high-performance liquid chromatography coupled to tandem mass
      spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined
      by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using
      log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI)
      were calculated. According to regulatory requirements set forth by Korea and the US Food and
      Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean
      ratios for Cmax and AUC are within the range of 0.80 to 1.25.
    

Intervention name(s): Donepezil, ODT 10 mg; Donepezil, 10 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Test- Donepezil Hydrochloride 10 mg Tablet single dose; Reference: Donepezil Hydrochloride 10 mg Tablet
Other intervention name(s): Neuropezil ODS; developed by Chong Kun Dang Co, Ltd.; Aricept:; Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Bioequivalence; Donepezil
A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal
      injections of individual doses of the study insulins.
    


Intervention name(s): Regular Human Insulin; Lispro; VIAject; VIAject 50%; VIAject/Insulin Glargine; Insulin Glargine/VIAject
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Individual dose of RHI administered subcutaneously; Individual dose of lispro administered subcutaneously; Individual dose of VIAject administered subcutaneously; Individual dose of VIAject 50% administered subcutaneously; VIAject mixed wiht insulin glargine and administered subcutaneously; Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mealtime Insulin; Rapid acting insulin; Ultra fast VIAject; prandial insulin
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind,
      placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an
      adjunctive treatment of Major Depressive Disorder. Study participants will continue to take
      their current antidepressant therapy in addition to the study drug or placebo for the
      duration of the treatment period.
    


Intervention name(s): REL-1017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): REL-1017 tablet; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: REL-1017
Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
Condition: Melasma; Hyperthyroidism
MeSH terms: Melanosis; Hyperthyroidism
Study type: Interventional
Phase: Phase 1

Summary: 
      Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and
      to compare severity of melasma before and after medications of three months hyperthyroid
      therapy using modified melasma area and severity index (mMASI) score. A quasi experimental
      (pre-post intervention) study was conducted in Jakarta in August 2019-February 2020.
    

Detailed description: 
      Melasma is an acquired and chronic disorder of hyperpigmentation characterized by symmetrical
      hypermelanoses of the face. The exact pathogenesis of melasma is still unknown. Several
      hormones are thought to play a role, including thyroid hormone. Although melasma is not
      life-threatening, it affects greatly on the quality of life of patients. Study's objectives
      are to determine proportion of melasma cases in hyperthyroid patients and to compare severity
      of melasma before and after medications of three months hyperthyroid therapy using mMASI
      score. An experimental (before and after) study was conducted in Jakarta in August
      2019-February 2020. Twenty three newly-diagnosed hyperthyroid patients or had taken
      hyperthyroid medications of maximum 3 months with melasma were recruited. The severity of
      melasma were scored with mMASI and dermoscopy of the lesions were collected. The same
      procedures were done after 3 months of hyperthyroid therapy. The data collected was
      statistically analyzed using Stata version 15.0
    

Intervention name(s): Thiamazol
Intervention type(s): Drug
Intervention description(s): All new hyperthyroid with melasma patients were recruited and their mMASI were calculated All subjects were given thiamazole by Internist based on their clinical hyperthyroidism After 3 months of taking hyperthyroid drugs (thiamazole), mMASI were recalculated and compared
Intervention MeSH terms: Methimazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Melasma; modified melasma area and severity index; Thyroid stimulating hormone; Free thyroxine
Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
Condition: Ovarian Stimulation
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To compare the efficacy of using mild ovarian stimulation protocol and
      conventional stimulation protocol in IVF outcome.

      Design: Prospective randomized trial

      Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile
      couple that women had regulary menstruation.

      Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and
      GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).

      Main outcome measure: Clinical pregnancy rate.

      Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization,
      pregnancy rate.
    


Intervention name(s): clomiphene citrate; Ultrasound; GnRH antagonist; gonadotopin (HMG); buserelin; rFSH
Intervention type(s): Drug; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg from cycle day 3 through 7; cycle day 8; Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).; 75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany); Buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg.; 150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene; Buserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: clomiphene citrate; GnRH agonist; GnRH antagonist; in vitro fertilization; clinical pregnancy; pregnancy
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Atherosclerosis; Mucocutaneous Lymph Node Syndrome
Study type: Interventional

Summary: 
      Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.

      It has been reported worldwide, but it is ten times more common in Asian population. The
      annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the
      second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of
      cases between 1 and 5 years, with a maximal incidence around the age of 12 months.

      It may results in acquired heart disease in children in developed countries, and may be the
      cause of premature coronary artery disease in adulthood.

      A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S
      population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are
      conflicting on this issue and the prevalence of this allel is unknown in North America and
      Europe populations.

      The clinical picture of KD associate a persistent fever and an antipyretics resistance with
      mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is
      confirmed by the presence of five clinical signs (major criteria). The presence of
      inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.

      KD can resolve spontaneously with no treatment. The severity of the disease is primarily
      related to complications of coronary aneurysms in acute or chronic stages.

      Several arguments support the fact that adult patients have diffuse vascular lesions
      different from aneurysmal lesions initially described in childhood.

      Despite abundance of publications on KD, there is no prospective or retrospective study which
      explored anomalies resulting from KD in adult subjects.

      Therefore, this project will describe the patient's vascular evolution, the prevalence of
      atherosclerotic lesions and to determine the biological and functional abnormalities, markers
      of accelerated atherosclerosis.

      Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in
      adulthood.

      The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and
      their severity in adults with a history of KD in childhood compared to a control population.
    


Intervention name(s): Cardiac evaluation
Intervention type(s): Other
Intervention description(s): complete cardiac evaluation with :
Electrocardiogram Echodoppler Echodoppler with dobutamine stress Carotid Echodoppler Coronary scan Positron emission tomography with adenosine stress Blood test (search for early atherosclerosis marker Genotyping
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Kawasaki disease
A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study will assess the nutritional effect of cashews on LDL-C concentrations and
      secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and
      women with moderately elevated cholesterol.
    

Detailed description: 
      This trial will utilize a randomized, two-period crossover design to examine the effects of
      cashew consumption on LDL-C and other aspects of the fasting lipoprotein lipid profile in
      healthy, moderately hyper-cholesterolemic individuals consuming a typical "American diet."
      Two arms consisting of two 28-day controlled-feeding treatment periods will allow for an
      isocaloric comparison of a diet with or without cashews.
    

Intervention name(s): Cashews followed by Control; Control followed by Cashews
Intervention type(s): Other; Other
Intervention description(s): Participants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II.; Participants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cashew; Lipoprotein
Effect of Sesame Oil in Preventing Phlebitis
Condition: Phlebitis After Infusion
MeSH terms: Phlebitis
Study type: Interventional

Summary: 
      Background: To determine the effect of sesame oil in preventing phlebitis that may occur
      during intravenous therapy in patients undergoing cardiac surgery.

      Material and Method: A randomized controlled interventional study will be conducted with
      patients treated in the coronary intensive care unit of a university hospital. The population
      of the study will be the patients hospitalized in the intensive care unit after cardiac
      surgery and administered parenteral amiodarone infusion. The power analysis was carried out
      by taking the study by. The sample size was determined as 44 patients. Personal Information
      Form and Visual Infusion Phlebitis Scale will be used to collect data. Sesame oil will be
      applied to the patients in the intervention group as 10 drops, 10 cm around the cannula, for
      10 minutes. This administration will be repeated every eight hours during the 24-hour
      amiodarone infusion. No application will be made by the researcher to the patients in the
      control group. At the end of each 24 hours, patients in both groups will be evaluated by the
      investigator on the Visual Infusion Phlebitis Scale. Descriptive statistics, chi square,
      independent t test and Fisher's exact test will be used to evaluate the data.
    

Detailed description: 
      No application was made to the patients assigned to the control group. Sesame oil was applied
      by the researcher to the patients assigned to the intervention group. Sesame oil was applied
      to the 10 cm circumference of the cannula by applying 10 drops and 10 minutes. This
      application was repeated every eight hours during the 24-hour amiodarone infusion. The area
      where the intravenous line is located is covered with a standard transparent dressing
      (Tegaderm) so that it can be observed. Patients in the intervention and control groups were
      evaluated for phlebitis at the end of every 24 hours (1st day, 2nd day, 3rd day) according to
      the VIP scale. The highest of the phlebitis stages obtained as a result of the evaluation was
      accepted as the final evaluation.
    

Intervention name(s): Complementary treatment practice
Intervention type(s): Other
Intervention description(s): Applying sesame oil to the patients assigned to the intervention group by applying 10 drops to the 10 cm circumference of the cannula for 10 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: aromatherapy; amiodarone infusion; phlebitis; cardiac surgery; Sesame oil
Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap
Condition: Soft Tissue Loss With Nerve Defect
Study type: Interventional

Summary: 
      Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss
      of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a
      challenge problem. To resolve this problem, we combined the nerve branch with the boomerang
      flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For
      comparison, we also collected a consecutive series of 32 patients with similar injury in the
      finger treated using a cross finger flap and a secondary free nerve graft.
    

Detailed description: 
      The patients in this study group were required to meet all of the following criteria: soft
      tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1
      to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss
      and PDN defect. Patients were excluded when they had the following: injury to the course of
      the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or
      larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.
    

Intervention name(s): the Boomerang Nerve Flap
Intervention type(s): Procedure
Intervention description(s): The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: defect;; dorsal branch of the proper digital nerve;; proper digital nerve;; vascularized nerve graft