cyrilzakka/clinical-trials huggingface dataset:
Effects of Maze Activities in Down's Syndrome

Down's Syndrome is due to the chromosomal disorder in 47 chromosomes instead of 46, socalled as Trisomy 21. The syndrome has several clinical symptoms including Cardiovascular,neurological, orthopedic, hormonal, cognitive and visual perceptual impairments. These childrenhave Developmental Delay. Children have hypermobility of joints, hypotonicity or ligamentous laxity, light to moderate obesity, due to underdeveloped respiratory and cardiovascular systemandshortstaturewhichleadtodecreaseinfunctionalambulation.Due to the low level of physical fitness, theseindividuals shows limitation in performing the functional tasks of daily living. The fundamental motor skill is Walking that facilitates the child to interact with the environment and helps indeveloping, social, motor and cognitive skills. Due to their delayed milestones and due to the irintellectual disability, environmental exposure is limited which hampers this fundamental skill.Hence it is necessary to asses the functional ambulation in these children.

This is a Randomized Controlled Trial that will be conducted in Rising Sun Institute Of Special Children. 26 participants will be allocated randomly into 2 groups Group A will receive the conventional interventions of Down's Syndrome but the group B will receive the mobility training with Standardized Walking Obstacle Course (SWOC). Tool used for this research will be a Standardized Walking Obstacle Course (SWOC) (that is used to measure stability and speed during gait in terms of time, number of steps, number of stumbles and number of steps off the path for each participant) and Timed up and go test (Valid for the functional mobility assessment of the children with DS). The data will be analyzed by SPSS version 21

This study will be a randomized control trail used to compare the Effects of Maze Activities on Mobility in Children With Down's Syndrome. Subjects with Down's syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using time up and go test and Standardized Walking Obstacle Course (SWOC). Subjects in group A will receive the conventional intervention of gait training and Group B will receive the training on Standardized walking obstacle course.

Eligibility Criteria:
Inclusion Criteria:

* •Age 6 to 12 years of downs's syndrome children

  * Ambulatory Child who can walk without any assistive device(6)
  * Should follow commands and can perform 30 sec walk test.(6)

Exclusion Criteria:

* •Any congenital Cardiac Anomaly

  * Visual and Hearing Deficits
  * Any surgical intervention for the last 6 months
Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

To test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.

One hundred mothers participating in the California Border Healthy Start (CBHS) program will be randomly assigned to the physical contact group or the control group. Mothers in the physical contact group will be provided with an infant carrier to use from birth to facilitate increased mother-infant physical contact. In the control group, mothers will be provided with an infant carrier, but will not receive the carrier until postpartum week 24, once study measures have been collected. This type of multiple-baseline design will allow the investigators to objectively assess the effect of physical contact during the first six months, but will also ensure that mothers in both groups have the opportunity to benefit from the potentially positive intervention of a high quality infant carrier to promote increased mother-infant physical contact. The two groups will be compared on: 1) likelihood of exclusive breastfeeding, 2) extent of breastfeeding exclusivity (proportion of feeds that are breastmilk versus formula or other), 3) likelihood of initiating feeding in response to hunger cues versus crying (i.e., maternal responsiveness during feeding), 4) maternal score on the Edinburgh Postnatal Depression Scale (EPDS), 5) prevalence of breastfeeding difficulties, 6) score on the Mother-Infant Bonding Scale, and 7) beliefs about breastfeeding and infant care.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, participants:

* Must be a current participant in the CBHS program
* Must be 18 years of age or older
* Must be currently pregnant
* Must be fluent in either Spanish or English
* Must have consistent access to a smartphone with internet access (to fill out surveys and feeding logs)
* Must have a functioning email address Must be willing to share certain personal information with the researchers

Exclusion Criteria:

* Having a birth that does not result in a live, healthy, singleton infant.
Immune Cells in Inflammatory Arthritis With Coronaviruses, Including COVID-19

A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective.

This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus.

When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.


Eligibility Criteria:
Inclusion Criteria:

* Has previously taken part in either the BRAGGSS or National Repository Healthy Volunteer Study
* Has agreed to be contacted abut future research projects
* Has previously provided a blood sample for either the BRAGGSS or National Repository Healthy Volunteer Study
* Is willing to complete the informed consent form, registration slip, questionnaire and provide a 40ml blood sample
* Has a good written understanding of English

Exclusion Criteria:

* Has not previously taken part in either the BRAGGSS or National Repository Healthy Volunteer Study
* Has not agreed to be contacted abut future research projects
* Has not previously provided a blood sample for either the BRAGGSS or National Repository Healthy Volunteer Study
* Is not willing to complete the informed consent form, registration slip, questionnaire and provide a 40ml blood sample
* Has not got a good written understanding of English
Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

The purpose of this study in to compare the efficacy of treatment of diabetic macular edema (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus Ranibizumab (Lucentis®).

It is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of DME. Will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.

Interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in Goiania Eye Institute(Instituto de Olhos de Goiânia)

Patients will be divided into four groups:

* In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 following the application.
* In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 subsequent
* The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.
* In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.

Eligibility Criteria:
Inclusion Criteria:

* patients with Diabetic macular edema

Exclusion Criteria:

* patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers

This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age(yr)between 18 and 45
* Body mass index(BMI)between 20 and 28
* sign informed consent

Exclusion Criteria:

* Known hypersensitivity to somatropin or any other components of the study drug
* Organic lesion in heart, liver, kidney or any other major organs
* History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
* Alcoholic, smokers or drug abusers
* Blood donation, or massive blood loss due to injury or surgery within 3 months
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Renal NCE-MRI in Healthy Volunteers

Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.

Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA), phase-contrast MRI), which could be used in combination with structural MRI in a single acquisition session, have been identified to investigate in more detail renal function and structure, opening the possibility to estimate local renal diffusion and blood perfusion, beyond providing high-resolution anatomical accuracy.

Preliminary to the identification of novel imaging biomarkers of renal disease progression, perfusion and diffusion MR sequences need to be optimized for the renal compartment. Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and diffusion changes in pathological kidneys as compared to normal and physiological condition.

The objective of this study is to provide normal control NCE-MRI sequences to be used as reference for the investigation of perfusion and diffusion changes in the kidney of patients affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal dominant polycystic kidney disease).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 and ≤59 years ;
* Healthy volunteers;
* Written informed consent.

Exclusion Criteria:

* Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment;
* Pregnancy (due to safety reasons).
Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns

This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 (or age of consent) and less than 70 at the time of inclusion.
* The subject is healthy and compliant with good oral hygiene.
* The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
* Obtained informed consent from the subject.
* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
* The subject is available for the 5-year term of the investigation.

Exclusion Criteria:

* The subject is not able to give her/his informed consent to participate.
* Alcohol or drug abuse as noted in patient records or in patient history.
* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
* An existing condition where acceptable retention of the restoration is impossible to attain
* Mobility of the tooth to be restored.
* Pathologic pocket formation of 4 mm or greater around the tooth to be restored.
* Severe bruxism or other destructive habits.
* Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
* Health conditions, which do not permit the restorative procedure.
Ultrasound Measurement of Quadriceps Shortening During Neuromuscular Electrical Stimulation in Critically Ill Patients

ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement.

This study aims to investigate the accuracy of an early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation to diagnose future ICU-Aw in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for at least 24 hours

Exclusion Criteria:

* Decision to withhold life-sustaining treatment
* Pregnancy
* Degenerative neurological pathology with disabling muscle weakness
* Pace Maker
* Inability to communicate
* Chronic loss of autonomy described by the patient's family
* Guardianship
Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers

Thrombotic biomarkers and angiographic characteristics were compared among the de novo patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV) and the control.


Eligibility Criteria:
Inclusion Criteria:

* CSC

  * neurosensory detachment in optical coherence tomography (OCT)
  * focal leakage in fluorescein angiography (FAG) and/or late choroidal hyperpermeability in indocyanine green angiography (ICGA)
* PCV

  * subretinal and/or sub-retinal pigment epithelial fluid in OCT
  * branching vascular network and/or polyps in ICGA
* Control

  * epiretinal membrane (ERM)
  * without underlying systemic, ophthalmic disease other than ERM

Exclusion Criteria:

* Previous history of using steroid (oral, topical)
* Previous history of CSC/PCV
* Previous history or evidence of intraocular inflammation including uveitis
* Co-existing retinal or choroidal diseases
* History of allergic reaction to fluorescein or indocyanine green dye
* Underlying systemic conditions that could affect the thrombotic profiles (e.g. diabetes, hypertension, metabolic syndrome, coronary artery disease, cerebrovascular diseases, stroke, chronic renal failure, current smoker, pregnancy, sleep disorder)
Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia

The purpose of this study is to compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

Patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. The patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. Recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent pterygium

Exclusion Criteria:

* Less than 15 year of age
* Symblepharon
* Glaucoma,
* Ocular Allergy
* Ocular surface disorders
Radial Versus Femoral Secondary Access During TAVI

The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).

The R-TAVI study is a prospective, single institution, pilot study in which eligible TAVI patients will be randomized pre-procedurally to receive either secondary radial artery (RA) access or femoral artery (FA) access during TAVI. Our study will take place over a projected 18 month enrollment period.

Eligibility Criteria:
Inclusion Criteria:

1) Patient meets eligibility for TAVR as decided upon by pre-TAVR testing (Echo, cardiac catheterization, CTA TAVR, 2 CT surgical consults, heart team discussion). 2) Undergoing TAVR procedure and follow-up at Carilion Clinic Cardiology Roanoke Memorial Hospital (CRMH) 3) Patient's secondary vascular access can be performed femorally OR radially, as determined by TAVR operator after review of pre-TAVR CT scan imaging.

4) Interventional Cardiologist performing the TAVR agrees to consider patient for enrollment.

5) Patient provides consent 6) Age ≥ 18 years old 7) No evidence of precluding arterial disease of both femoral arteries 8) No evidence of precluding arterial disease of right radial and subclavian arteries 9) Must have palpable pulses in both radial arteries

Exclusion Criteria:

1. Review of pre-TAVR CT scan imaging deems patient unsuitable for radial OR femoral secondary access based on presence of excessive calcification, stenosis, or tortuosity of the femoral, subclavian, or innominate arteries.
2. Valve implantation (primary access) planned via alternative vascular access (trans-caval, axillary, carotid, direct aortic, trans-apical)-as determined by implanting Interventional Cardiologist/TAVR operator.
3. Prior coronary artery bypass graft surgery in which a radial artery graft was harvested and used as a conduit.
4. Patients on hemodialysis OR with arteriovenous fistulas.
5. Interventional Cardiologist performing the TAVR declines patient consideration in the study.
6. Patient declines consent.
7. Urgent or emergent TAVI cases
8. Patient is already participating in another clinical research study
Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria

Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 85 years
* Patients with nosocomial infection justifying Colistin.

Exclusion Criteria:

* Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration
* Known hypersensitivity to Colistin or products of the polymyxin family
* Personal and family history for myasthenia
* Positive serology for HBV, HCV and HIV
* Positive pregnancy test or currently lactating
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery

The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for thoracoscopic surgery
* Patients aged ≤ 6 months of age

Exclusion Criteria:

* Patients presenting for any procedure other than thoracoscopic surgery
* Patients aged \> 6 months of age
A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations

This is a multicentre, observational, descriptive estimate of the proportion of participants with psoriatic arthritis among psoriasis participants attending dermatology clinics selected for this study. In addition, this study will involve full psychometric assessment of the Early psoriatic screening questionnaire (EARP) questionnaire with the aim of identifying and appropriately referring participants to a rheumatologist for review if their EARP score is 3 or greater at Screening (i.e. \>= 3 at Visit 1).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be a man or woman aged 18 to 65 years of age, inclusive
* The patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history \[19\])
* The patient must be able to read and write in the target language (English, Mandarin or Korean; or other relevant target languages)
* Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* An established diagnosis of psoriatic arthritis
* Ever have received systemic treatment with a disease modifying antirheumatic drug (DMARD) for arthritis or spondylitis (inflammatory back pain)
* Ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
* A history of employment in or are currently employed in the healthcare industry; or
* Participated in the translation and linguistic validation of the EARP questionnaire