cyrilzakka/clinical-trials huggingface dataset:
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
3. Previously tolerated clinical treatment with caffeine
4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
5. Parental consent to enroll in pilot study

Exclusion Criteria:

1. Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
4. Anticipated inability to meet protocol requirements
Glucose Metabolism After Partial Pancreatectomy

This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.

Eligibility Criteria:
Inclusion Criteria:

* partial pancreatectomy

Exclusion Criteria:

* total pancreatectomy
* incomplete testing
* follow-up loss
* death within 1 year
Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic population, particularly amongst runners. The standard of care treatment for PFPS is a comprehensive active rehabilitation program. Eighty percent of patients with PFPS report improvement in their symptoms with such a program. Unfortunately, the remaining twenty percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the enormous number of individuals running for fitness, PFPS represents a significant challenge to public health as the investigators strive to encourage active living in our society.

A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has been suggested in scientific literature. Given that intra-articular viscosupplementation (hyaluronic acid) injections have shown clinically significant symptom improvement in knee osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial for therapy-resistant PFPS.

Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely movable joints (such as the knee). It is believed to contribute to lubrication and cushioning in these joints. The composition of synovial fluid within arthritic joints is altered, resulting in reduced fluid viscosity and elasticity. One modern formulation of hyaluronic acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a single injection and will be utilized in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-45
2. Previously diagnosed with PFPS that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist.
3. Retropatellar or peripatellar knee pain for a minimum of 2 months
4. Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion
5. Pain with patellar grind test on clinical examination
6. Visual Analog Scale (VAS) \> 4/10 with patellofemoral joint loading activities
7. Normal knee x-ray

Exclusion Criteria:

1. X-ray evidence of osteoarthritis or fracture
2. Meniscal or ligamentous injury suspected clinical examination
3. Previous knee surgery
4. History of patellar instability or positive patellar apprehension test
5. Any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.)
6. Known allergy to avian products
7. Previous knee injection within the last 3 months
8. Pregnant or breastfeeding
Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children.

Preoperative preparation Preoperative evaluation of pulmonary ventilation function and enhanced CT examination of the lungs were performed. Respiratory symptoms should be improved first in case of complicated respiratory infection. ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method Intraoperative fluorescence thoracoscopic imaging was used, and focal resection was performed. All patients were placed in lateral decubitus position under general anesthesia, and single lung ventilation was selected. A low flow rate (1-2 L/min) and low CO2 pressure (4-5 mmHg) were maintained in the thorax to establish an artificial pneumothorax. The observation hole is in the 7th or 8th intercostal space of the midaxillary line, and the two operating holes are in the 4th or 5th intercostal space of the anterior axillary line and the 8th or 9th intercostal space of the posterior axillary line, respectively. 30 degrees 10 mm fluorescence thoracoscope. After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed. Smaller blood vessels could be cut by Ligasure or ultrasonic knife directly, and thicker blood vessels and bronchi should be cut by Hemolock until the lesion resection was completed. After the lesion was removed, the chest was rinsed with warm normal saline, and the lung tissue section was carefully examined to confirm that there was no active bleeding and air leakage, and the lung was well dilated. The intercostal nerve was blocked under thoracoscopic vision. Finally, the thoracic closed drainage tube was placed in the midaxillary line puncture hole and the incision was closed.

Post-operation follow-up All patients undergo outpatient follow-up 3-6 months after surgery, including pulmonary CT and pulmonary ventilation function measurements, and comparison of VT (tidal volume), Ti/Te suction/exhalation time ratio, TPTEF/TE (peak time ratio) and VPEF/VE (peak volume ratio) before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* children with congenital lung malformations diagnosed by CT or MRI scan

Exclusion Criteria:

* 1. ages \<3 months and \>14 years 2. complicated other life-threatening disease; 3. complicated severely pulmonary infection
Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training

This study looks at the comfort of interventional and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in interventional radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters.

PRIMARY OBJECTIVE:

I. To measure trainee comfort performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device.

OUTLINE:

Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device.

Eligibility Criteria:
Inclusion Criteria:

- Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body Mass Index (BMI) of 18 to 32 inclusive
* Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
* Glucosuria
* Abnormal liver function tests
Influence of Alcohol Marketing Stimuli in Adults With Regular Alcohol Consumption

Alcohol use is the second leading cause of preventable death after smoking. The Evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Society of Alcoology is alarmed by these developments.

Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To investigator knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with moderate to severe alcohol use disorders (beyond 3 out of 11 criteria on the DSM-5 scale)
* Non-opposition of the patient

Exclusion Criteria:

* Minor patient
* Patient who has already participated in phase 1 of the project
* Non-comprehension of the written French language
* Refusal to participate in the study
* Patient of legal age, deprived of liberty by a judicial or administrative decision or unable to express their consent
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)

This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.

Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.

Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.

Eligibility Criteria:
Inclusion Criteria:

* Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
* Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
* Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
* Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
* Subject requires only a single repair per proper digital nerve branch

Exclusion Criteria:

* Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
* Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
* Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve
* Subject has debris due to injury of the affected hand where contamination cannot be ruled out.
* Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
* Subject has an infection of the area around the nerve defect.
* Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease
* Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
* Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
* Subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results.
The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth

The woman's body undergoes many physiological changes during pregnancy, which can cause muscle weakness and postpartum joint instability. In addition, the intensive care of the baby sometimes involves extreme body postures and mechanical loading on the hands, which are considered as ergonomic risk factors. Therefore, postpartum women may be particularly vulnerable to musculoskeletal disorders (MSDs). As far as we know, there is no evidence-based intervention on this issue.

The study will be conducted in the Obstetrics Departments at the Sheba Medical Center. After approval by the Helsinki Committee at the Medical Center all subjects who meet the inclusion criteria will be asked to sign an informed consent form for participation in the study.

The first data collection point will be in the early days after birth, when the subjects are still hospitalized. All the subjects will fill out a demographic questionnaire and two more questionnaires regarding the prevalence and intensity of MSD. The REBA, a standardized observation will be conducted to identify the level of ergonomic risk during the performance of two tasks of baby care .

The REBA will be analyzed by a therapist who is blinded to the participants group belonging.

The participants will be assigned into two groups, intervention group and control group. Number of birth and participant age will be adjusted between the groups. The intervention group will participate in a workshop regarding ergonomic principles in baby care. A brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, participants in the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message, along with a request to report the intensity of pain. The control group will not receive the intervention at this time but will also be asked to fill in the scale at the same time points.

Three months after delivery, all subjects will complete the questionnaires regarding the prevalence and intensity of MSD. The REBA will be performed in order to identify the ergonomic risk level during the performance of the same two tasks of baby care. At this point, the control group will receive the intervention in the format of the brochure and videos sent via email or WhatsApp.

The final data collection will be six to twelve months after delivery when all subjects will complete the same questionnaires and a recurrent REBA standardized observation in order to identify the ergonomic risk level during the performance of the same two baby-care tasks will be performed for the last time.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-40
* Hospitalized in a maternity ward in a hospital after the birth of one baby
* Delivery occurred after 37 weeks' gestation

Exclusion Criteria:

* Women with previous orthopedic or rheumatic problems
* Women with neuropathic problems due to non-gestational diabetes
* Women with neurological diseases.
Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans

The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis and sarcopenia in African Americans.

The rationale for this study is the need to proactively address health disparities associated with age-related skeletal muscle dysfunction. Age-related changes in muscle may be characterized by sarcopenia (i.e., loss of muscle mass) and/or myosteatosis (i.e., excessive intramuscular adipose tissue). These changes may result in physical impairments that may be exacerbated by the lack of a formal screening and diagnosis process for older adults in standard healthcare settings. Myosteatosis may compound the effects of sarcopenia and play a significant role the age-related functional decline and higher incidence of type 2 diabetes observed in African Americans in comparison to other ethnic/racial groups. The initial phase of the study will involve the assessment of older African Americans (n = 70) to characterize muscle size and quality in comparison to a younger reference group (n = 70). Participants randomly selected from the older subject pool will be assigned to either the Eccentric Exercise Group or the Concentric Exercise Group for 12 weeks of a supervised strengthening exercise regimen.

Eligibility Criteria:
Inclusion Criteria:

* An African American adult.
* Between 18 and 30 years of age, or between 65 and 85 years of age.
* Able to independently walk at home and in your community (use of an assistive device like a cane or a walker is acceptable).

Exclusion Criteria:

* Uncontrolled hypertension or other cardiovascular disease.
* A Body Mass Index of 32.5 or above may be an exclusion criterion if the X-ray technician determines that dimensions of the scanning bed are not adequate for a reliable examination.
* A musculoskeletal condition that would stop you from performing the physical assessment tests.
* Muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury).
* Moderate to severe sepsis (blood infection) or edema (such as swelling of a limb).
* Been hospitalized over the last three months.
* History of a broken arm or leg bone because of osteoporosis.
Validity and Reliability of Smartphone Inclinometer Application for Measurement of Cervical Range of Motion

Nowadays, smartphone technology provides opportunities for assessing and treating patients in clinical facilities and during the follow-up of the patient's progress. To date, many studies have assessed the validity and reliability of the smartphone application against universal goniometer for various joint motions, for instance, the spinal column, knee, and ankle. This study aims to determine the validity and reliability of smartphone inclinometer application for measurement of cervical region range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 33 years.
* Both genders.
* Subjects that are cooperative to follow my instructions

Exclusion Criteria:

* Subjects with severe spinal pathology.
* Pregnancy and lactation.
* Any musculoskeletal diseases that affect the cervical spine.
* Any neurological diseases that affect the cervical spine.
* History of trauma in the cervical spine.
* Signs of cervical radiculopathy.
* Signs of cervical myelopathy.
* Signs of serious pathology.
* subjects have a pacemaker or any other medical equipment that the magnet might have compromised.
Functional and Clinical Benefits of PCI in Patients With CTO

The purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining CTCA with low-dose stress-only SPECT vs. coronary angiography for detecting haemodynamic relevant coronary lesions; and second to determine the effects of PCI on cardiac perfusion, cardiac function and quality of life in patients with CTO lesion in left anterior descending (LAD) coronary artery.

Noninvasive imaging modalities have shown high diagnostic accuracy in the detection of coronary artery lesions, and for the estimation of their hemodynamic relevance.Thus, noninvasive assessment of myocardial perfusion defects may be preferred for patients with chronic total occlusion (CTO).

In particular, myocardial perfusion is measured with single photon emission CT (SPECT).Multislice coronary CT angiography (CCTA) with dual-source scanners reveals the anatomic location of coronary artery disease (CAD). These two techniques assess distinct aspects of heart morphology and function parameters of the heart, and should therefore be regarded as complementary rather than competing methods.Taking this into consideration, decisions regarding whether invasive revascularization therapy is adequate or not and which strategy is the best for long-term survival cannot be supported by anatomic information alone. Therefore, noninvasive complementary imaging of structure and perfusion, in conjunction with three-dimensional (3D) image fusion, has emerged as a technique for reliable allocation of perfusion defects to their supplying coronary artery.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for enrolment in this study if coronary angiography showed a CTO (at least for 3 months and confirmed by angiography and/or history of earlier MI).

Exclusion Criteria:

* Hypersensitivity to iodinated contrast agent, cardiomyopathy, non-sinus rhythm, severe valvular heart disease, NYHA functional class IV heart failure at baseline, previous coronary bypass surgery, renal insufficiency, severe lung and liver disease or cancer.