bioihbjkbjnl/mcl2 huggingface dataset:
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Condition: Preterm
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm birth and perinatal events related can interrupt microscopic maturation of the
      developing white matter leading to diffuse injury and subsequent neurocognitive impairments.
      Brain maturation can be studied using diffusion tensor imaging but is difficult to assess
      early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could
      be of interest in this clinical setting. This technique, already investigated in adults
      (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

      Objective:

      To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm
      infants and to correlate to gestational age.

      Methods:

      SSI is a quantitative stiffness imaging technique based on the combination of a remote
      palpation induced into tissues by the radiation force a focused ultrasonic beam and an
      ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real
      time the displacements induced by the propagation of the resulting shear waves. For each
      pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the
      local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a
      new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en
      Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25
      and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area
      of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5
      cm².
    

Detailed description: 
      White matter damage occurs in 20% of preterm infants in industrialized countries. These
      lesions are difficult to evaluate by standard ultrasound. The quantitative elastography is a
      new medical imaging technique and potentially a diagnostic tool in brain lesions in preterm
      infants. Shear wave Imaging (SSI) could be of interest in this clinical setting. This
      technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has
      not been yet evaluated in neonates.
    

Intervention name(s): diagnosis of white matter damage in preterm infants
Intervention type(s): Other
Intervention description(s): Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm and term newborns; diagnosis of cerebral white matter damage; quantitative brain elasticity; Transfontanel ultrafast doppler
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)
      program for treating core autism symptoms, social and emotional problems, and adaptive
      behavior deficits in children with autism spectrum disorders.
    


Intervention name(s): cognitive behavioral therapy; Usual community care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 32 weeks of CBT, 1.5 hours weekly.; 16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tonsillotomy or Follow-up in PFAPA Syndrome
Condition: PFAPA Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome
      diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months
      follow up. At follow up visit 3 months after randomisation the children from either groups
      with ongoing symptoms will be sent to tonsillectomy.
    

Detailed description: 
      Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome
      diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months
      follow up.

      In both groups the symptoms are monitored with symptom diaries. At follow up visit 3 months
      after randomisation the children from either groups with ongoing symptoms will be sent to
      tonsillectomy (total remove of palatine tonsil).

      The design is sequential trial. From the previous trials we know that the effect of
      tonsillectomy is about 90% and that during follow up for six months as much as 50% of the
      patients will recover. Because the syndrome is rare and because the rescue operations of the
      tonsils (tonsillectomy in a person who has gone through tonsillotomy), the sample size has to
      be as low as possible. That is the reason why we chose sequential design, with assessments
      after every 8 patient.

      Randomization is made in blocks of four. In sequential design we use the following
      assumptions:

        -  We are looking for a 40% absolute difference in cure rate between tonsillotomy (90%) and
           follow up (50%) groups.

        -  Two sided Whitehead design

        -  Maximum likelihood estimation (MLE)

        -  Five assessments (sample size 4+4, 8+8. 12+12, 16+16 and 19+19)

        -  type 1 error 5 % and power 80%

        -  The sample size will be from 8 to 38 patients depending on when the trial can be stopped
           along assessments.
    

Intervention name(s): Tonsillotomy
Intervention type(s): Procedure
Intervention description(s): About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      This research project will determine the safety and tolerability of ginseng in subjects with
      MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment
      of MS fatigue.
    

Detailed description: 
      Fatigue is a major cause of disability in MS and is associated with a reduced quality of
      life. Treatment options for MS fatigue include central nervous system stimulants and
      amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be
      expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has been
      tested in clinical trials for its ability to improve mental alertness and fatigue. However,
      there have been no published clinical trials addressing the effects of ginseng in subjects
      with MS, even though many people with MS use ginseng and report deriving benefit from it.

      This double-blinded, placebo controlled crossover pilot study will determine the safety and
      tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy
      of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will
      collect information on the impact of ginseng on cognition, stress, actigraphy, salivary
      cortisol, differential cytokine response, and quality of life.
    

Intervention name(s): American ginseng extract HT-1001; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.; Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.
Other intervention name(s): placebo (matched capsules to ginseng drug)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; fatigue; ginseng
Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)
Condition: Muscular Dystrophy, Duchenne; Ambulatory Care
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary
      function, motor function, muscle strength and quality of life in patients with DMD.
      Furthermore, the safety and tolerability of idebenone was assessed.
    

Detailed description: 
      This study was a Phase III, multicenter, randomized, double-blind, placebo-controlled
      efficacy and safety study. DMD patients (ambulatory and non-ambulatory) at age 10-18 years
      were enrolled at sites in Europe and North America. Study subjects were randomized in a 1:1
      ratio to receive either idebenone (900 mg/day) or placebo 3 times a day with meals for 52
      weeks. The primary endpoint was the difference between Catena®/Raxone® and placebo in the
      change from Baseline to week 52 in Peak Expiratory Flow (PEF as percent predicted, PEF%p, a
      measure of respiratory muscle strength) as measured by hospital-based spirometry. PEF was
      also measured by the patient at home using the hand-held ASMA-1 device (secondary endpoint).
      Other respiratory endpoints included Forced Expiratory Volume in 1 second (as percent
      predicted, FEV1%p, an additional measure of respiratory muscle strength) and Forced Vital
      Capacity (as percent predicted, FVC%p, a measure of restrictive lung disease predictive of
      morbidity and mortality in DMD).
    

Intervention name(s): Placebo; Idebenone
Intervention type(s): Drug; Drug
Intervention description(s): Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals; Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
Other intervention name(s): CATENA®; RAXONE®
Intervention MeSH terms: Idebenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idebenone; Duchenne Muscular Dystrophy (DMD); Respiratory function; Ambulatory and non-ambulatory patients; Subjects not using glucocorticoids
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
Condition: CKD5 Stage Dialysis; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into
      Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival
      rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate
      whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD
      dialysis combined with heart failure is superior to that of irbesartan.
    


Intervention name(s): Sacubitril/Valsartan; Irbesartan
Intervention type(s): Drug; Drug
Intervention description(s): The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).; The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.
Other intervention name(s): ARNI; ARB
Intervention MeSH terms: Valsartan; Irbesartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CAP Pilot Study for Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      This is a pilot to review the feasibility of a program that assists patients towards therapy
      compliance by scheduled intervention through the first month of therapy. The hypothesis of
      this study is that the trial program will function as intended and average patient adherence
      will be over 4 hours per night.
    


Intervention name(s): CAP
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sleep laboratory, DME supplier
Regulation of Metabolism and Ion Handling
Condition: Healthy
Study type: Interventional

Summary: 
      This study investigates the relation between ion-handling (K+) and fatigue development during
      exercise. Before and after a 6-week period of high intensity interval training, performance
      and ion-handling is assessed in young adults. In addition, mitochondrial function is
      examined.
    


Intervention name(s): Speed endurance training
Intervention type(s): Behavioral
Intervention description(s): Speed endurance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males
    


Intervention name(s): BMS-986165
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how
      the body reacts to Racivir will be studied.
    

Detailed description: 
      The study is a 14-day study with a 21-day follow-up period. During the 14-days of active
      study period, participants will receive Racivir once daily in combination with efavirenz and
      stavudine. Following the administration of the first and last dose of study medication,
      patients will remain in the clinic overnight. During the study there will be medical and
      medication histories taken, physical examinations, vital sign measurements, EKGs, and routine
      clinical laboratory tests.
    

Intervention name(s): Racivir
Intervention type(s): Drug
Intervention MeSH terms: Racivir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: treatment experienced; HIV; Phase I; Combination Therapy
Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment
Condition: Hepatitis C; HIV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done to find out whether abacavir (Ziagen®) lowers the levels of
      ribavirin (Ribapak®) in the body of persons taking these two drugs.
    

Detailed description: 
      Abacavir is an anti-HIV drug that belongs to the class of nucleoside reverse transcriptase
      inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and
      ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and
      ribavirin used in this study are also FDA approved.Some individuals who have HIV infection
      also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV
      and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level
      of ribavirin in the body, in the blood and in cells named peripheral blood mononuclear cells
      (PBMC's). Thus, taking ribavirin and abacavir together could lead to treatment failure for
      hepatitis C. Therefore, it is important to understand whether ribavirin levels are affected
      when the two medications are taken together.
    

Intervention name(s): Ribavirin; Ribavirin plus Abacavir (ABC)
Intervention type(s): Drug; Drug
Intervention description(s): Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg); Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
Plus
Daily Abacavir 300 mg orally every 12 hours
Other intervention name(s): Ribavirin (RBV); RBV + ABC
Intervention MeSH terms: Ribavirin; Abacavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
THE ENLIGHTEN STUDY
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The primary objective of this study is to demonstrate the safety and efficacy of the Elipse
      Gastric Balloon System for the treatment of obese adults.
    

Detailed description: 
      This is a prospective, double-blinded, randomized, two-phase study to be conducted in a
      planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study
      is 48 weeks.
    

Intervention name(s): Active Elipse Device; Elipse Sham Device
Intervention type(s): Device; Device
Intervention description(s): Intervention Device; Control Device
Other intervention name(s): Elipse Gastric Balloon System (active); Elipse Gastric Balloon System (control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Non Obstructive Versus Obstructive Coronary Artery Disease
Condition: Non-Obstructive Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational [Patient Registry]

Summary: 
      The goal of this observational study is to study the non obstructive type of ischemic heart
      disease by identifying unique clinical features , frequency and age group .in patient
      admitted in coronary care unit , suffered from angina or heart attack. . The main question[s]
      it aims to answer are:

        -  how it different from classical type of ischemic heart disease ( obstructive coronary
           artery disease)

        -  what is frequency and age prevalence of these patient Participants evaluated by history
           , clinical examination, serum troponin and coronary angiography.
    


Intervention name(s): CORONARY ANGIOGRAPHY
Intervention type(s): Procedure
Intervention description(s): coronary angiography by femoral or radial artery access
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all patients with clinical features of IHD underwent coronary angiography in CCU of imam
        hussain hospital from January to May of 2021
Interest of HI-RTE Elasticity in Obstetric
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      In obstetric, the investigators can't predict accurately with current means (BISHOP score,
      traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

      If ultrasonography can determine the length, the cervix opening, it can't define its
      flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the
      consistency of the uterine cervix.

      The elastography (elasticity imagery) is an innovating technology. It is a new technology
      currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography
      to measure the tissues answer under pressure.

      Its contribution in obstetric must be estimated to improve patients minimum fare.

      The main target of the investigators study is to estimate the interest of the measure of
      cervix elasticity degree by elastography in prediction of premature birth within a population
      of pregnant women
    


Intervention name(s): The elastography (elasticity imagery)
Intervention type(s): Other
Intervention description(s): This diagnosis mean use the ultrasonography to measure the tissues answer under pressure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women