bioihbjkbjnl/mcl2 huggingface dataset:
Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants at Assiut University Hospital
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Observational [Patient Registry]

Summary: 
      Developmental dysplasia of the hip (DDH), formerly known as congenital dislocation of the
      hip, comprises a spectrum of abnormalities that include abnormal acetabular shape (dysplasia)
      and malposition of the femoral head.
    

Detailed description: 
      The origin and pathogenesis of DDH are multifactorial. Abnormal laxity of the ligaments and
      hip capsule is seen in patients with DDH. The maternal hormone relaxin may also be a factor.
      Extreme hip flexion with knee extension, as in the breech position, tends to promote femoral
      head dislocation and leads to the shortening and contracture of the iliopsoas muscle.

      It was previously reported that DDH was the underlying aetiology in about 25 % of the
      performed hip replacements under the age of 40 years and the initial diagnosis age ranged
      from 0 to 39 years, with a mean of 8 years in these patients.

      The main purpose of a newborn hip screening program is to detect DDH as early as possible, so
      that early treatment can be given and the need for surgical treatment as well as the
      development of residual hip dysplasia can be avoided.

      Ultrasonography offers distinct advantages compared with other imaging techniques: unlike
      plain radiography, it can distinguish the cartilaginous components of the acetabulum and the
      femoral head from other soft tissue structures, real-time US permits multiplanar examinations
      that can early determine the position of the femoral head in respect to the acetabulum; thus
      it provides the same type of information that can be obtained with arthrography, computerized
      tomography, or magnetic resonance imaging, but at lower cost, although ultrasonography is
      more expensive than plain radiography, it doesn't require sedation and doesn't involve
      ionizing radiation, unlike other techniques and it allows observation of changes in hip
      position with movement.
    

Intervention name(s): ultrasound examination of the hip joint
Intervention type(s): Other
Intervention description(s): US examination by US machine , Midray model DP-2200 made in China , with a high frequency (5-10 MHZ) linear transducer using the previously described Graf method for assessment of both hip joints.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All infants under the age of 6 months attending Pediatric Orthopedic outpatient clinics at
        Assiut university hospital in the period between 1st of January 2017 to 30th of December
        2017.
Fatty Liver Disease in Obese Children
Condition: Obesity; Nonalcoholic Fatty Liver Disease; Cardiovascular Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Although weight reduction through physical activity-based interventions is the mainstay
      therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and
      typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies.
      Although convincing data from animal studies and a few adult human studies on the benefits of
      a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD
      have emerged, studies in children are scarce. Therefore, the aim of the study is to test the
      use NAC as an innovative approach to attenuate the progression of NAFD in obese children with
      biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat
      and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with
      NAFLD.
    

Detailed description: 
      Physical activity (PA)-induced weight reduction, the suggested therapy for noalcoholic liver
      disease (NAFLD), is difficult and its maintenance is typically unsuccessful in children,
      affirming the acute need for alternative/adjunct therapies. Although few promising approaches
      have been reported, the benefits are incongruent and mostly marginal. N-acetyl cysteine
      (NAC), a derivative of the natural amino acid, cysteine, appears to be promising as an
      adjunct therapy to PA. Animal and a few adult human studies suggest NAC-induced attenuation
      of liver abnormalities, oxidative stress, insulin resistance and inflammation. The primary
      aim of the proposal is to determine in obese children with biopsy proven NASH and elevated
      liver enzymes the effect of NAC at two different doses on liver fat using magnetic resonance
      imaging (MRI), liver enzymes and risk factors of cardiometabolic disease. We hypothesize that
      NAC will produce beneficial effect on these parameters.
    

Intervention name(s): N-acetyl cysteine 600 mg once/day; N-acetyl cysteine 600mg twice/day; Placebo twice/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): NAC 600 mg once/day + Placebo once/day for 16 weeks; N-acetyl cysteine 600 mg twice/day for 16 weeks; Placebo capsules twice/day for 16 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fatty liver; obesity; children; oxidative stress; antioxidants
A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to further evaluate the PK characteristics of PF-04856883.
    


Intervention name(s): PF-04856883; PF-04856883; PF-04856883; PF-04856883
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Dose A; Dose B; Dose C; Dose D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
Condition: Stroke
MeSH terms: Stroke; Paralysis
Study type: Interventional

Summary: 
      Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an
      easily applied innovative solution to rehabilitation, because the hand can perform grasp and
      release activities wearing the device by mean of a flexible and light orthosis. Our objective
      on this research was to the robotic assisted motion and activity in additional to
      physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
    

Detailed description: 
      The investigators evaluated the effectiveness of a robotic-assisted motion and activity in
      additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand
      paralysis. A randomized controlled trial. The experimental group received a passive
      mobilization of the hand through the robotic device Gloreha and control group received a PT
      and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation.
      Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth
      Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of
      the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All
      measures were collected at baseline and end of the intervention (3 weeks).
    

Intervention name(s): Experimental group; Control group; traditional rehabilitation
Intervention type(s): Device; Device; Device
Intervention description(s): Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.; Physiotherapy and occupational therapy.; Assisted stretching, shoulder and arm exercises, and functional reaching tasks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand; Paralysis; Stroke
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-labeled, cross-over design, pharmacokinetic study, to determine the
      pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and
      ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in
      healthy volunteers, aged 55-75, and in good general health.
    

Detailed description: 
      This is an open-labeled, cross-over design, pharmacokinetic study, where 24 subjects will be
      randomly assigned to receive treatment regimen A-B or B-A on two consecutive days of dosing.

      Two dosing groups are planned for the study :

        -  Group 1 (n=12)

        -  Group 2 (n=12)

      Each group will be admitted to the Phase I Unit the evening before dosing and will initiate
      dosing the next morning for 2-days of consecutive treatment (A-B, or B-A). Both groups will
      undergo identical study related procedures, except those subjects that consent to CSF
      collection on Day 1 of dosing.

      Dose regimen A consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a
      single oral tablet dose of ALZT-OP1b.

      Dose regimen B consists of two oral inhaled doses of ALZT-OP1a, not more than 2 minutes
      apart, via dry powder inhaler + two oral tablet doses of ALZT-OP1b.

      Plasma Collection, All Subjects (n=24) 1 mL blood samples will be collected at T: 0, 5, 10,
      15, 30, 1 hr, 2 hr, 4 hr, and 6 hours, following ALZT-OP1 administration (Days 1 and 2).

      CSF Collection, Sub-group (n=12) A sub-group of 12 subjects will be consented for CSF
      collection.

      1 mL of CSF will be collected at T: 0, 5 min, 30 min, 2 hr, and 4 hours, following ALZT-OP1
      administration (Day 1 only).
    

Intervention name(s): ALZT-OP1a; ALZT-OP1b; Dry Powder Inhaler
Intervention type(s): Drug; Drug; Device
Intervention description(s): Mast cell stabilizer; anti-inflammatory; The inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study.
Other intervention name(s): Cromolyn, Intal; ibuprofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Haemophilus influenzae is an important pathogen which can cause primary infection and
      respiratory viral infection in infants and leaded to secondary infections. The infection of
      haemophilus is a major cause of morbidity and mortality in infants and children. At present,
      the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children
      will produce antibody of protection after 3 doses. Because Hib vaccine can prevent
      meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib
      bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune
      programming.

      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent
      years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus
      polysaccharide vaccine with a relatively poor immune response in the infants under the age of
      two, and the remaining 60% with a low antibody level and a short duration.

      According to the present immunization schedule, to reach the median level of antibody levels
      there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,
      to provide high levels of long-term protection and to reduce the number of injections.

      The objective of this study is to evaluate the safety of the group A, C polysaccharide
      meningococcal and type b haemophilus Influenzal Conjugate vaccine.
    


Intervention name(s): 0.5ml/dose for a person; 0.5ml/dose for a person
Intervention type(s): Biological; Biological
Intervention description(s): group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0; group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Conjugate vaccine
Influence of Renal Function on the Circadian Variation of Cardiac Troponin
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction.
      Whereas the diagnosis is based on an increase and/or decrease in the concentrations of
      cardiac troponins with at least one value above the 99th percentile value of the reference
      population together with the evidence of ischemia, serial sampling is needed. Knowledge of
      the variation in cardiac troponin levels over time in individuals in a normal rest state (not
      during an acute myocardial infarction), also called the biological variation, is important
      regarding the interpretation of the serial cardiac troponin levels. A recent study by our
      group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is
      important regarding the interpretation of the serial cardiac troponin levels.

      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The
      mechanism of the elevated concentration of cTn in these subjects is still unclear. It is
      hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it
      is not clear whether renal function affects the biological variation and circadian rhythm of
      cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with
      impaired renal function creates the opportunity to assess the effect of renal clearance on
      the circadian rhythm of cardiac troponins.
    


Sampling method: Probability Sample
Study population: 
        Individuals with chronic kidney disease (CKD) stage 3 and 4
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
Condition: Multiple Sclerosis; Stroke
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The specific aim of the study in our example is to conduct a feasibility translational
      home-based exercise trial established in the LEADERS (R2) project with the TExt-ME
      tele-exercise training system for participants with neurologic disability. We hypothesize
      that participants in this home-based tele-exercise training program will achieve similar
      gains in health and function outcomes as the onsite exercise training program. Further, there
      will be no difference in adverse side effects (safety) between the home-based and onsite
      exercise treatment groups.
    

Detailed description: 
      TExT-ME is a home-based tele-exercise study providing a novel exercise program to
      participants with neurologic disabilities. The exercise curriculum is a Movement 2 Music
      (M2M) program developed during phase 2 of the grant (clinicaltrials.gov identifier
      NCT02533882). The exercise exercise classes are taught by trained dance instructors and are
      composed of a set of exercises tailored to the specific needs and capabilities of adults with
      neurologic disability. Each set of exercises is performed to high and low tempo music based
      on the individual's baseline level of function, with adjustments made to increase or decrease
      intensity if needed. The class consists of several training components: a) warmup (10 min.)
      to increase range of motion; strength/balance (15-20 min), aerobics (25-30 min. with rest
      periods as necessary); cool down (5 min).

      The TExT-ME training and monitoring system is a user-centered design (UCD) involving a
      tele-exercise coach (e.g., a trained research staff person) interacting remotely with a
      participant in their home using video conferencing programs. Participants wear monitors to
      maintain safe levels of exercise and provide feedback regarding exercise intensity to the
      instructors. Self-reported indicators of exercise intensity are also collected using rating
      of perceived exertion.
    

Intervention name(s): Movement to Music
Intervention type(s): Behavioral
Intervention description(s): The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.
Other intervention name(s): M2M
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate Effects of Gargle Phonation in Voice
Condition: Voice Disorders; Muscle Tension Dysphonia; Speech Therapy
MeSH terms: Dysphonia; Hoarseness; Voice Disorders; Communication Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess subjects with muscle tension dysphonia for perceived
      effort and acoustic effects of gargle phonation compared to baseline and a sham water
      swallow.
    

Detailed description: 
      This study assesses perceived effort following baseline talking, water swallows and gargle
      phonation. In addition to perceived effort, acoustic and perceptual analyses will be
      conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual
      Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).
    

Intervention name(s): Gargle Phonation; Water swallow
Intervention type(s): Other; Other
Intervention description(s): Subjects will gargle water while making sound; Subjects will hold water in their mouth for 5 seconds and swallow
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EVP-6124 Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after
      a single oral dose in subjects with mild, moderate and severe renal impairment compared with
      subjects with normal renal function.
    


Intervention name(s): Experimental: EVP-6124
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Safety
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid
      arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of
      various treatment regimens in early RA. Methods: This is a randomized open-labeled trial.
      Patients were randomised into three groups. In group A, patients were treated with single
      drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of
      DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received
      combination therapy as in group B and 3 pulses of methylprednisolone intravenously.
    

Detailed description: 
      Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid
      arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of
      various treatment regimens in early RA. Patients were divided into three groups. In group A,
      patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were
      treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine).
      The patients in Group C received combination therapy as in group B and 3 pulses of
      methylprednisolone intravenously.
    

Intervention name(s): Combination Steroid; Methotrexate; Combination
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methylprednisolone 1000 mg intravenous for 3 days Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg twice daily Sulfasalazine 2000 to 3000 mg per day; Methotrexate 15 to 25 mg PO per week; Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
Other intervention name(s): Methylprednisolone 1000 mg intravenous for 3 days; Methotrexate 15 to 25 mg PO per week; Methotrexate 15 to 25 mg PO per week; Hydroxychloroquine 200 mg Twice daily; Sulfasalazine 2000 to 3000 mg per day
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Methylprednisolone; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Steroid
Essential Fatty Acids During Complementary Feeding
Condition: Obesity; Growth; Metabolic Syndrome; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and
      body composition, intestinal health and microbiotic composition, immune function and risk
      markers for later diseases in 9-18 months old infants and toddlers.
    


Intervention name(s): Fish Oil; Sunflower Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age; Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: n-3 LCPUFA; Fish oil; essential fatty acids; infant growth; obesity; Intestinal microbiota
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Condition: Pancreatic Cancer Resectable
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as
      postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1
      resection.
    

Detailed description: 
      The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
    

Intervention name(s): mFOLFORINOX
Intervention type(s): Drug
Intervention description(s): Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment