cyrilzakka/clinical-trials huggingface dataset:
Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease

The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients after 52 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age at the time of signing informed consent.
* Patients with Crohn's disease who have undergone an ileocecal/ileocolic resection (L1 or L3). The study and the treatment must be initiated within the two first weeks after the resection (+/- 5 days).
* Patients with surgical reconstruction by ileocolic anastomosis.
* Women of childbearing age must not be breastfeeding and must have a negative urine pregnancy test and must agree to use contraceptive methods with a \<1% failure rate (e.g., sexual abstinence, oral contraceptives, double barrier methods, intrauterine devices), unless they only have one partner who is sterile.
* Patients who have signed and dated the informed consent form before performing any specific screening study procedure.

Exclusion Criteria:

* Resection that requieres Temporal ileostomy.
* Urgency resection which doesn´t permit the initial assessment protocol completion.
* Resection due to inactive short indolent stenosis (\<10 cm).
* Resection with mucosal macroscopic residual disease in anastomosis.
* Previous intolerance or adverse reaction (moderate or severe) to adalimumab or azathioprine.
* Any contraindications or unwillingness to perform the scheduled colonoscopies or resonances.
* Contraindications to Adalimumab treatment, among which the following are included: active tuberculosis, severe infections such as sepsis or opportunistic infections, moderate or severe heart failure (NYHA class III or IV), central nervous system demyelinating diseases, history of malignant neoplasm or autoimmune diseases.
* Severe associated Extraintestinal manifestations.
* Previous postoperative recurrence prevention treatments with adalimumab, asathiprine o mercaptopurine which resulted in failure.
* Any other disease or patient condition that according to investigator criteria, inadequates patient´s participation in the study.
Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters

The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable
* Spontaneously breathing newborns

Exclusion Criteria:

* Congenital heart defects or anomalies of central nervous system
* Prematurity below 32 GA
* Respiratory distress
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).

Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.

All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.

All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged in 3-59 years old.
* Had not received vaccination of Influenza vaccine in the past half of years.
* Had not infected with Influenza virus.
* This trail has been agreed by volunteers or his/her legal guardian.
* Volunteers or his/her legal guardian will fellow this trail protocol.

Exclusion Criteria:

* People from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.)
* People with fever before vaccination, temperature higher than 37.0 ℃
* Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
* People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
* According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials.
* Acute infectious disease or acute attack of chronic disease before inoculation
* People get any vaccine within 14 days before the trial.
* People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months.
* People with epilepsy or a history of mental illness
Pathogenesis of Youth Onset Type 2 Diabetes and Prediabetes

Type 2 Diabetes (T2D) in obese youth is often preceded by a prediabetic state called: Impaired Glucose Tolerance (IGT), which is associated with a pre-existing defect in insulin secretion. This study intends to determine if genetic factors are associated with defects in insulin secretion, the incretin system and hepatic insulin resistance in obese adolescents. The long-term goal of this study is to generate information on both the genetics as well as the pathophysiology of Type 2 Diabetes in Youth, which ultimately might guide the investigators towards better preventive and treatment avenues.

The Specific Aims of this study are:

Aim 1a. To delineate the effects of TCF7L2 rs7903146 on functional Beta-Cell Capacity in obese adolescents with Impaired Glucose Tolerance (IGT) and pre-IGT.

Aim 1b. To determine if the risk genotype in TCF7L2 is associated with worsening in beta cell function longitudinally, thereby affecting changes in glucose tolerance.

Aim 2. To examine the functional effect of the rs7903146 variant in the TCF7L2 gene on a) incretin effect in obese adolescents with IGT and pre-IGT.

Aim 3. To determine the functional effects of TCF7L2 rs7903146 SNP on hepatic glucose fluxes in obese adolescents with IGT and pre-IGT.

Eligibility Criteria:
Inclusion Criteria:

* Good general health, taking no medication on a chronic basis;
* Age 12 to 18 yrs, in puberty (girls and boys: Tanner stage II - IV),
* BMI (BMI \>85th%) indicating obesity,
* Girls who are menstruating must have a negative pregnancy test during the study and, when possible, be in the follicular phase during infusion study visits (The follicular phase will be identified according to the last menstrual period record and/or according to the oral contraceptive assumption schedule. The investigators will not perform ovulation testing or hormonal assays);
* Subject must have normal liver and kidney function, amylase and lipase levels.
* Pre-IGT or IGT
* TT or CC genotype.

Exclusion Criteria:

* Baseline creatinine \>1.0 mg;
* Pregnancy;
* Presence of endocrinopathies (e.g. Cushing syndrome);
* Cardiac, renal or pulmonary or other chronic illness;
* Adolescents with psychiatric disorder or with substance abuse history and taking the drugs that affect glucose metabolism, such as any form of steroids, antipsychotics, progesterone preparations, and others.
Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

This study investigates the ability of ultrasound to measure the volume of a brain hemorrhage in the acute phase after hospital admission.

It is known that approximately 30% of patients admitted with a brain hemorrhage will suffer from enlargement of the hematoma within the first hours after admission.

In this study the investigators measure the volume of the hematoma every 30 minutes up to 6 hours after admission and every 2 hours between 6-12 hours.

This study investigates the use of transcranial ultrasound (TCU) for the surveillance of patients with intracerebral hemorrhages. Using transcranial ultrasound makes it possible to visualize and follow the bleeding progression through 3 points of the scull where the bone is thin enough to allow the penetration of sound waves. This can be done at bedside. Today the investigators do not know for sure if clinical parameters determine a haematoma expansion. TCU will allow us to follow the haematoma progression serially in the acute phase and relate the haematoma expansion to parameters like blood pressure, neurological status (NIHSS-score) and radiological signs of ongoing bleeding (spot signs) on CT-angiogram (CTA).

Hypothesis:

1. Bedside ultrasound volume assessment is accurate in estimating the haematoma volume compared to computer tomography (CT) and can dynamically document the haematoma expansion.
2. The haematoma expansion is accompanied by neurological deterioration and happens only with patients with CT demonstrated spot signs.
3. The haematoma expansion is observed with patients with high blood pressure.

Aim of study:

1. To validate the accuracy of ultrasound (US) compared to CT in estimating haematoma volume with ICH patients.
2. To measure ICH volume serially in the acute phase using US and up to 12 hours aiming at:

   * Describing the timing of the haematoma expansion.
   * Relating to neurological deterioration, systemic blood pressure and detection of spot signs on CTA.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Bispebjerg Hospital stroke unit with CT demonstrated spontaneous ICH
* Hospital admission within 4,5 hours after symptom onset
* CTA on admission
* GCS\>8 (non-comatose)

Exclusion Criteria:

* Lack of informed consent
* Underlying Pathology (tumor, AVM, aneurism)
* Lack of temporal bone window
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations

An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye.

The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch \& Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* male or female, at least 18 years of age
* no ocular abnormality other than refractive error
* patient in generally good \& stable overall health
* has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam
* corneal topography must be normal, as judged by the investigator
* topical anesthesia and mydriatics must be tolerated
* patient must be able to fixate steadily
* ability to understand and provide informed consent to participate in this study

Exclusion Criteria:

* history of ocular surgery
* history of ocular trauma, infection, disease, or abnormality other than refractive error
* myopia or hyperopia \> 7.0 D, astigmatism \>3.0 D
* uncorrectable visual acuity below 20/20
* abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage
* pupil sizes below 6.0 mm under mydriasis
* iris problems including, but not limited to, coloboma and previous iris surgery
* ocular media problems, corneal, lens and/or vitreous opacities including, but not limited to cataract
* ocular movement abnormalities including, but not limited to, strabismus or nystagmus
* phenol red thread test (Zone Quick-Menicon Ltd) less than 9 mm/15 seconds
* pregnancy and lactation
Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)

The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC

The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .

The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 50 years old
* Regular corneal astigmatism \>1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
* Regular corneal astigmatism \<2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
* Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
* Group 2: patients after cataract surgery with Ankoris implanted in both eyes
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• - Irregular astigmatism

* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* IOL spherical equivalent power lower than 10 D or greater than 30D
* Complicated surgery
Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic

The goal of this prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the Hôpital Jean-Talon.

The main questions it aims to answer are: 1. To describe the models of care at the Hôpital Jean-Talon orthopedic outpatient clinic; 2. To assess change in pain, disability, quality of life and pain catastrophizing at 6, 12 and 26 weeks after the initial evaluation; 3. To assess interprofessional collaboration between the advanced practice physiotherapists and orthopedic surgeons; 4. To assess patient satisfaction with care; 5. To assess waiting time before an initial consultation.

Researchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.


Eligibility Criteria:
Inclusion Criteria:

* Adults with peripheral musculoskeletal disorders
* New consultation at the Hôpital Jean-Talon orthopedic outpatient clinic
* Legally able to consent
* Understand and speak French or English
* Beneficiaries of the provincial universal health insurance coverage (RAMQ)

Exclusion Criteria:

* Patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).
Erenumab For Treatment of Hemicrania Continua

This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.


Eligibility Criteria:
Inclusion Criteria

* Adults over the age of 18-66
* At least a 12 month history of hemicrania continua (unremitting subtype) according to International Classification of Headache Disorders, 3rd Edition (ICHD-3)1
* Previous or current complete response to indomethacin
* Stable preventive treatment for at least 2 months and no anticipated need to adjust/add current headache prevention treatment

Exclusion Criteria

* Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used for at least 1 week
* Pregnant or lactating subjects
* Use of barbiturate or opioid \>6 days per month; history of chronic migraine
* History of previous trigeminal-autonomic cephalalgia
* History within previous 2 months of interventional procedure for headache (occipital or other extracranial nerve block, sphenopalatine ganglion block, cervical facet block, facet rhizotomy)
* History of cranial nerve/rhizolysis
* Botulinumtoxin injection with previous 4 months
* Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase
Club Fit: Physical Activity and Healthy Eating at an After School Program

Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program.

Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.


Eligibility Criteria:
Inclusion Criteria:

- Active Boys \& Girls Club participation, which was defined as expected Club attendance at least twice weekly.

Exclusion Criteria:

- None
Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms

This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.

Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.

Secondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Breast cancer survivors:

1. Female BCS
2. ≥ 21 years of age and older
3. Ability to provide written consent and HIPAA authorization
4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.

   Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
5. Identify cognitive concerns (select yes)

Inclusion Criteria for Colorectal cancer survivors:

1. Male or female CRC survivors
2. Ability to provide written consent and HIPAA authorization
3. ≥ 21 years of age and older
4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC
5. Identify cognitive concerns (select yes)

Exclusion Criteria:

1. Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
2. Unable to read and understand English to complete survey questionnaires.
Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis

This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.

The aims include first, to quantify the posture and physical activity of patients in the community before and after scoliosis treatment and compare to age-matched controls. Patients undergoing bracing or surgery for scoliosis will wear novel low-profile electronic monitors for 4 days prior to and at one year after initiation of treatment. Accelerometer data from the 4 activity monitors are combined for a comprehensive profile of daily activity, above and beyond that of a typical pedometer. Analysis will show a participant's % active time vs. static, % time sitting vs. lying down vs. standing vs. walking, total number of steps taken per day, and cadence of walking during each activity bout. The amount of total daily time spent lying, sitting, standing, walking and running will be quantified using specialized processing algorithms developed at Mayo Clinic. Results will be compared to a group of age- and BMI-matched control patients with healed forearm fractures.

Second, to determine changes in the mechanical properties of the paraspinal skeletal musculature (muscles along the spine) in scoliosis patient before and after treatment with brace or spinal surgery.

Shear Wave Elastography (SWUE) is a technique that uses ultrasound, a non-invasive imaging technique, to detect mechanical properties of tissues. Using SWUE, the stiffness in the paraspinal muscles will be obtained by acquiring Shear modulus measurements, reported in kilo Pascal (kPa) units. 10 measurements will be obtained for each muscle and a region of interest (ROI) will be placed in the displayed elastogram or color map from each measurement to obtain a "kPa" value. A mean shear modulus or stiffness will be obtained by averaging all 10 results. The measurements from each ROI are derived using software built in the ultrasound equipment.

The change in paraspinal skeletal muscle stiffness will be assessed and compared to normal controls to determine characteristics of spinal musculature in scoliosis patients and the impact of treatment with bracing or surgery.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 9 to16 years of age
* Scoliosis/Surgery group; has severe scoliosis curves requiring posterior spinal fusion surgery
* Scoliosis/Brace group; has scoliosis curves requiring brace treatment for at least the next year
* The Control group will be aged matched participants who have healed forearm fractures and will be matched to case patients by age, gender, and Body Mass Index (BMI). These children will be considered normal subjects for both the accelerometers and the Shear Wave Elastography (SWUE)

Exclusion Criteria:

- Patients with underlying muscle conditions or neuromuscular scoliosis