cyrilzakka/clinical-trials huggingface dataset:
Natural History of Duchenne Muscular Dystrophy

Baseline Study on Duchenne Muscular Dystrophy (DMD) in view to collect data on the natural disease course in a cohort in young male subjects aged from 5 to 9 Years over a period of 6 to 36 months using disease appropriate evaluations.

Study duration from FPFV: Q1 2019 to LPLV: Q3 2023

Primary Ojectives:

* To assess the natural disease course using standardized and disease appropriate evaluations over a period of 6 to 36 months in a cohort of young male subjects aged from 5 to 9 years at inclusion and diagnosed for Duchenne Muscular Dystrophy (DMD).
* To record a baseline period prior to the setup of an AAV gene therapy dose escalation phase I/II First in Man clinical study.

Secondary Objectives:

* To identify clinical, imaging and/or laboratory parameters that could be predictive indicators of the disease course in DMD, within the selected range of age.
* To identify the best outcome measure(s) for further clinical trial assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. 5 to 9 years old inclusive
3. Body-Weight \< or = 75th percentile of BMI body-mass index scale (according to validated scale in force in the country site)
4. Diagnosis of DMD based upon Gene testing positive with detailed genotyping
5. Able to achieve:

   * NSAA (North Star Ambulatory Assessment) scale \> or =18 (with a maximum of 2 points difference between inclusion and screening visits) and/or:
   * Gowers test \< or =7 sec
   * 6 Minute Walk Test (6MWT) \> or = 350 meters at screening visit (M1) and at inclusion visit (M0) with the distance being 20% of each other
6. Ongoing corticosteroid therapy or initiation of corticosteroid therapy according to standard of care in the previous 3 months
7. Signed informed consent by at least one parent(s) or both parents or legal guardian representative(s), when applicable and according to the country regulation
8. Affiliated Beneficiary of the National Health Care scheme

   Exclusion Criteria:
9. Cardiomyopathy based on physical cardiological examination and echocardiography with Left Ventricular Ejection Fraction (LVEF) below 55%
10. Respiratory Assistance: need for either a diurnal and/or a nocturnal ventilation
11. Any co-morbidity (ies) and or previous or planned surgical event(s) which may interfere with DMD natural evolution and or evaluation of outcomes designed to assess DMD Natural History
12. Muscle testing: inability to cooperate with
13. Nuclear Magnetic Resonance Imaging (NMRI): metal implants in regions of interest for the study
14. Unwilling and/or unable to comply with all the study protocol requirements and or procedures
15. Previous inclusion to another clinical trial with an Investigational Medicinal Product (IMP), within the 3 months (or IMP washout period) prior to the screening visit of the study
16. Concomitant participation to any other clinical trial
Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Eligibility Criteria:
Inclusion Criteria:

* Participants with plasma HCV RNA level \>10,000 IU/L for the two groups.
* Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
* Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria:

* coinfected with hepatitis B virus or human immunodeficiency virus infection,
* any cause of liver disease other than HCV GT4 infection;
* liver decompensation,
* hepatocellular carcinoma,
* major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C \>9)
* Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count \<50,000 cells/mm3)
Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People

Urinary incontinence is an increasing medical and socio-economical problem. 44% of the elderly (\>65 years) women and 28% of the elderly men suffer from unwilling urine loss. Moreover, this percentages increase with age. Incontinence is a problem with multiple physical, psychological, and financial effects. In addition incontinence has a important impact on the family and healthcare professionals surrounding the elderly.

The problem of urinary incontinence is complex and multifactorial. Moreover, diagnostic guidelines are inconsistent leading to a high amount of technical interventions to diagnose and to specify the type of incontinence.

Aim of this study is to create a short form of necessary technical investigations to diagnose and evaluate urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* \>= 65 years
* Every type of incontinence: stress, urge, mixed.

Exclusion Criteria:

* Patients with an indwelling urinary catheter are doing clean intermittent catheterization are excluded from the study protocol
* Patients with dementia are excluded from the study, based on N-Cog evaluation
The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block

The aim of this study is to determine the minimum effective concentration of local anesthetic (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

The study is based on biased coin design, and the concentration of LA for the next patient is determined by the result of the last one. In the case of block failure, the concentration will be increased by 0.025%. Conversely, block success will result in either a reduction in concentration by 0.025% (probability 11%) or no change in concentration (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEC90 is calculated by isotonic regression.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years
2. ASA 1-3
3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

1. inability to consent to the study
2. pregnancy
3. allergy to local anesthetics
4. preexisting neuropathy or coagulopathy
5. prior surgery in the supraclavicular region
Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit

This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.

Our overarching goal is to promote safe medication use/adherence for high-risk infants, by leveraging health literacy approaches and mobile technology to reinforce provider counseling and support parent medication management after discharge from the NICU. We will adapt/integrate evidence-based strategies studied in less complex populations, for this vulnerable group. The HELPix (Health Education and Literacy for Parents) pictogram-based intervention, developed by our team, incorporates these strategies, with sizeable improvements found in medication knowledge, dosing errors, and adherence in outpatient general pediatric settings, but to date, HELPix has not been studied in NICU settings

Eligibility Criteria:
Inclusion Criteria:

1. English or Spanish-speaking
2. 18 years of age and older
3. Child discharged home with a Rx for \>1 daily liquid medication (other than multivitamin)
4. Primary person who will administers child's medications.
5. Willingness and ability to participate

Exclusion Criteria:

1. Does not have a working phone number
2. Does not have access to internet (via computer/smartphone)
3. Does not have a mobile phone that receives texts.
4. Not able to return to the hospital for their child's follow-up visit
5. Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener
6. Uncorrectable hearing impairment
Active Surveillance for Low-risk Papillary Thyroid Carcinoma

This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
* subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.

Exclusion Criteria:

* subjects who are unable or unwilling to attend regular follow-ups..
* subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.


Eligibility Criteria:
Inclusion Criteria:

* Positive ANA result at visit 1
* Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
* Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
* If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.

Exclusion Criteria:

* Patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study
* Active severe SLE disease activity which involves the central nervous system (CNS) (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
* Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher World Health Organization (WHO) nephritis) or serum creatinine \>2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day
* Patients with a history of anti-phospholipid antibody syndrome AND use of oral anticoagulants or anti-platelet treatment
* Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection
Investigation of Pulse Waves, Channel Entries, and Food Attributes in Healthy Subjects With Different Constitutions

In traditional Chinese medicine (TCM), hot- and cold-attribute of food ingredients are a major part of dietary therapy. "Eight Principles" including cold/hot, repletion/vacuity, yin/yang and exterior/interior are used for diagnose by Chinese medical doctors. From the perspective of TCM, all constitutions, diseases, herbal medicine and foods can be divided into these two major categories, i.e., cold and hot. Therefore, dietary therapy claims that the attributes of foods should be used to oppose our constitutions in order to harmonize organ functions and maintain human vitality. The true benefit of dietary therapy is considered to be the reestablishment of a harmonious balance between cold and hot, or repletion and vacuity, within the human body.

Previous studies reported that the capillary red blood cell (RBC) velocity in nail fold microcirculation (NFM) of the subjects with hot constitution accelerated significantly after taking the hot attribute aged ginger tea, which might be the result of elevated vagal activity leading to arteriole dilation in these subjects. In contrast, in subjects with cold constitution, capillary RBC velocity decelerated significantly and skin temperature decreased markedly after taking the cold-attribute coconut water, which might have been induced by sympathetic nerve activation causing the arteriole to be constricted. As a result, the use of capillary RBC velocity of NFM measured by laser Doppler anemometer may be a promising way to classify attributes of food ingredients commonly used in Chinese medicine dietary therapy in accordance with different personal constitutions.

Accordingly, it will be a worthwhile task to establish a modern scientific methodology to define the attributes of food ingredients. The aim of this project is to investigate the relationship between food attributes and the physiological signals produced in healthy young subjects with different constitutions. In the first year of this project, investigators are starting to determine the pulse waves produced in healthy subjects with different constitutions by a Smart Pulse Wave Health Evaluation System (S-PULSE). Then, investigators will investigate the relationship between food attributes, channel entries and the physiological signals. Hopefully, the results will have a leverage on the powerful integration capacity within National Taiwan University (NTU) campus to build a hub for global TCM cloud.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult over twenty years old

Exclusion Criteria:

* Severe hypertension
* Cardiovascular diseases
Preventing Falls Through Enhanced Pharmaceutical Care

The objective of the proposed study is to reduce the incidence of falls and fall-related injuries among community-dwelling older adults by better utilizing community pharmacists to advise patients and physicians on medication management.

Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States. Past research suggests that individuals taking four or more prescription medications are at increased risk for falls. CNS-active drugs (e.g., benzodiazepines), in particular, have been associated with increased risk. Research also suggests that interventions to reduce inappropriate medications can reduce the risk of falls. This finding comes primarily from multifaceted interventions, however, and the impact of medication modification, by itself, remains largely unknown.

This study is using a a randomized controlled clinical trial design to evaluate a falls prevention program targeting community-dwelling older adults through community pharmacies. The study focuses on individuals at high risk for future falls. Individuals in the intervention group receive an in-depth consultation concerning their current medications, conducted by a community pharmacist. The consultation is designed to elicit medication-related problems (e.g., orthostatic hypotension, daytime sedation). Problems identified during the consultation, and therapeutic recommendations designed to address these problems, are communicated to the prescribing physician. With physician approval, appropriate modifications are made to the patient's medication regimen. The primary study endpoints are: time to first fall and proportion of individuals who fall during the one-year follow-up period.

Two primary hypotheses will be tested.

1. Compared to individuals in the control group, individuals in the intervention group will experience a 30% reduction in the hazard of falling (hazard ratio=0.70) for time to first fall following randomization.
2. Compared to individuals in the control group, 25% fewer people in the intervention group will experience a fall during the one-year follow-up period.

If the intervention is effective in reducing falls, these effects should be mediated by improvements in the overall quality of medication use. Thus, we will also assess effects of the intervention on: change in the number of inappropriate medications prescribed and change in the number of CNS-active medications prescribed.

One secondary hypotheses will be tested.

1. Compared to individuals in the control group, individuals in the intervention group will experience a 40% reduction in the use of high-risk medications during the one-year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Currently taking at least four prescription medications
* Currently taking at least one high risk medication
* At least one fall during 12 month period before study entry
* Able to speak and read English

Exclusion Criteria:

* Resident of a long-term care facility
* Cognitive impairment
* Housebound
Plavix, Prasugrel and Drug Eluting Stents Pilot Trial

* The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation.
* In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur.
* The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Subject presenting for clinically indicated PCI with implantation of at least one drug-eluting stent.
* No planned use of Glycoprotein IIb/IIIa inhibitors during PCI procedure.
* Subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily.
* Willing to participate and sign an informed consent.

Exclusion Criteria:

* Subject older than 75 years of age.
* Subject weight is 60 kg or less.
* Subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to PCI or abciximab within 14 days before or during PCI.
* Subject taking warfarin or with clinical indication to resume warfarin post PCI for any indication.
* Subject currently requiring daily treatment with NSAID or COX2 inhibitors.
* Subject with a known platelet disorder.
* Subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma.
* Subject with a history of a stroke or TIA
* Subject with pre-PCI hematocrit or platelet count outside the ranges validated for Verify Now P2Y12 test (33-52% and 119.000-502.000/μL, respectively).
* Subject with a history of hepatic impairment
* Subject with known NYHA Class III or greater for heart failure.
* Inability of subject to provide informed consent.
* Subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or ASA, which would result in inability of patient to adhere to trial protocol.
* Presence of valvular heart disease left main coronary artery stenosis or urgent need for CABG.
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).


Eligibility Criteria:
Inclusion Criteria:

* Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \[AHI\]\>10 or AHI\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \[SpO2\] nadir \<=75%).
* All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
* Post adenotonsillectomy or those with contraindications to tonsillectomy.
* Tonsil size 2+ or smaller.
* Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.

Exclusion Criteria:

* AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
* Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
* Active Coronavirus (COVID) 19 infections
* End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
* Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
* Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
* Moderate/severe tracheobronchomalacia
* Need for anticoagulative therapy
* Bleeding disorder
* Restrictive thoracic disorders