cyrilzakka/clinical-trials huggingface dataset:
Sickle Cell, Pain and Mediterranean Diet

The goal of this study is to compare pain levels in individuals with Sickle Cell Disease while following the Mediterranean Diet to pain levels while following their usual diet.

This is an exploratory, randomized, crossover-controlled feeding study of a 4-week Mediterranean Diet or usual diet control among 24 adults with sickle cell disease and chronic pain (30 will be recruited, with an estimated 24 participants completing the study).

Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease Diagnosis
* Chronic non-vaso-occlusive pain experienced on average ≥ 3 days per week for \> 6 months (based on a response of "Most days," "Every day," or "Some days" and not "Never" to the question "In the past 6 months, how often have you had pain?")
* Ability to speak, read, write, and understand English
* A Mediterranean Eating Pattern for Americans (MEPA-III) score \<13, indicating that they do not follow a Mediterranean diet.

Exclusion Criteria:

* Having taken systemic antimicrobials (to treat an infection in the previous 4 weeks)
* History of colon cancer or inflammatory bowel disease (given potential untoward effects on the gut microbiome)
* History of Clostridium difficile infection in the preceding 12 weeks; (4) unable to agree to maintain physical activity at the current level for the duration of the study
* Currently following a Mediterranean diet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a Mediterranean diet
* Lack of access to a space to safely store and reheat food items
* Living in a facility that provides meals.
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.


Eligibility Criteria:
Inclusion Criteria:

* Adult male subjects, at least 18 years of age, who are willing to participate in the study
* Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator

Exclusion Criteria:

* Previous history of NAION
* Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
* History of glaucoma in either one or both eyes
* History of multiple sclerosis or diagnostic testing evidence of optic neuritis
* Have dementia or other reasons for memory impairment in the opinion of the investigator
* Have participated in other non-observational studies within 3 months of NAION onset
Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support.

The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi.

The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU.

It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.

Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors:

* Very Low birth weight (\< 1500 g)
* Gestational age \< 32 weeks
* NCPAP duration \> 5 days
* NICU stay of \> 14 days

However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP.

Interventions indicated as protective are:

* Appropriate size of mask or nasal prongs and headbands
* Use of hydrocolloid as nasal barrier dressing
* A frequent alternation of the NCPAP device (nasal prongs or mask)
* A frequent assessment of skin integrity In this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. The NICU clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present.

Hence, aim of this study is:

- To asses the effectiveness of specific nursing care interventions on the incidence of pressure injuries due to NCPAP support in neonates admitted to NICU.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed from both parents or legally authorized representative
* Infants receiving noninvasive respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) or Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV)

Exclusion Criteria:

* Pre-existing nasal lesion
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain

The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual Care-Opiate (UC-O), dose/timing as per Burn Center protocol).

Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) are funding this RCT for the following reasons:

Primary Aims:

1. To evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care across a 7-day study period and 30 day outcome period.
2. To evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and 30 day outcome period.

and

Secondary Aims:

1. To determine the short and long term effect of the Ketamine Augmentation Condition versus the Usual Care Condition on symptoms and syndromes of posttraumatic stress disorder and of depression,
2. To evaluate several established and hypothesized moderators of the relationship between the Ketamine Augmentation Condition versus the Usual Care Condition on: 1) pain severity reported during wound care, 2) opiate use during wound care, 3) posttraumatic stress and 4) depression.

Eligibility Criteria:
Inclusion Criteria:

* Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
* English speaking
* pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
* estimated length of stay greater than or equal to 5 days

Exclusion Criteria:

* requiring endotracheal intubation and sedation,
* severe hearing impairment,
* cognitive impairment status - Mini-Mental State Examination (MMSE) \</=20,
* diminished capacity unable to provide informed consent;
* Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
* Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
Heart Rate Monitoring by Wearable Devices in Graves' Disease

A multi center randomized controlled study including 3 arms (wearable device group, control group 1, control group 2). This study is to investigate clinical feasibility of heart rate monitoring using wearable devices to detect disease recurrence in the patients who discontinue anti-thyroid drugs in remission state.

A multi center randomized controlled study including 3 arms (wearable device group, control group 1, control group 2).

Study participants: Patients with Graves' disease who are planned to discontinue anti-thyroid drugs in remission state Wearable device group: Participants use wearable device and their heart rate and activity are monitored. If their resting heart rate (rHR) increase beyond the set range or they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If their rHR stay within set range and they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs.

Control group 1: Participants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs.

Control group 2: Participants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 3 and 6 months after discontinuing anti-thyroid drugs.

A period to detecting disease recurrence, thyroid function test and Hyperthyroid Symptom Scale (HSS) at the time of disease recurrence, and the number of hospital visit and medical cost until detecting disease recurrence will be compared among 3 groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Graves' disease who are being treated with anti-thyroid drugs (ATDs) and planned to discontinue ATDs
* Those who have who have continued to administer ATDs for more than 1 year
* Those who showed normal findings on thyroid function tests while maintaining stable doses of ATDs in the last 3 months
* Those who can use wearable devices and smartphone apps to work with during the research period

Exclusion Criteria:

* Those with heart disease, such as arrhythmia, that can affect heart rate
* Those who are taking medications that may affect their heart rate
* Those who researchers deemed unsuitable for participation
A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women
* Fasting plasma glucose \>= 130 mg/dL
* HbA1c \>=6.5% and \>10.0%

Exclusion Criteria:

* You have a history of type I diabetes
* You are on a weight loss program with ongoing weight loss or taking weight loss medication
* You have had surgery within 30 days
* You hvae hepatitis B or C.
Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents

This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Research suggests that approximately one in five children meets criteria for a major depressive episode by the end of high school. These children are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Thus, the potential benefits of effective and highly transportable depression prevention programs are enormous. The Penn Resiliency Program (PRP) is a school-based group intervention that teaches cognitive behavioral and social problem-solving skills to young adolescents. This study will examine the effectiveness of PRP in preventing symptoms of depression and anxiety among a group of young adolescents.

Participants in this open label study will be randomly assigned to one of three groups: adolescent only PRP, adolescent plus parent PRP, or no treatment control. In adolescent PRP, students will be taught cognitive and behavioral problem solving skills by school counselors and teachers. Parents in PRP will be taught to model and reinforce the skills taught in the adolescent program. Participants in the adolescent program will attend twelve 90-minute group sessions after school hours. Participants in the parent program will attend six 90-minute group sessions. Adolescent participants will attend booster sessions twice per year for 2 to 3 years after the initial treatment has ended. Parents will attend one booster session per year during the follow-up phase. Adolescents' depression and anxiety symptoms will be assessed through questionnaires at baseline, post-treatment, and 6-month intervals for 2 to 3 years following the intervention. Adolescents will also complete questionnaires about their coping behaviors, feelings of hopelessness, and several other outcomes related to depression and anxiety in adolescence. Data will be collected once per year from parents and teachers. Adolescent participants will also be assessed for depression and anxiety disorders each year the child is in the study.

Eligibility Criteria:
Inclusion Criteria:

* Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting)

Exclusion Criteria:

* Not a student in a participating school
* Not a student in grades six through eight
Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction

This study will measure the impact of treatment with Viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS), including minor depressive symptoms but excluding any form of psychotic disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men above age of majority with ED (SHIM score less than 21)
* Beck Depression Inventory II score between 14 and 28

Exclusion Criteria:

* Subjects with symptoms of mania or major depressive disorders as demonstrated by the Mini International Neuropsychiatric Interview (MINI)
* Subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months
Using Ultrasound for Bougie Insertion in Difficult Airway Management

Difficult airway management remains one of the biggest challenges in anesthesia practice. The Gum elastic bougie, an intubation tool, is frequently used to facilitate intubation in difficult situations. Recently, ultrasound-guided airway management has been used as a potential method to improve the intubation process. This study aims to compare the efficacy of ultrasound-guided bougie insertion with the conventional method regarding the duration of endotracheal tube (ETT) insertion and the number of attempts required in a difficult intubation population.

The goal of this clinical trial is to learn if using ultrasound during bougie insertion in difficult airway patients will improve the success rate and reduce the time of insertion. The main questions it aims to answer are:

Does using ultrasound reduce the number of insertion attempts? Does using ultrasound reduce the duration of bougie insertion?

Researchers will compare the ultrasound-guided technique to the conventional bougie insertion method. They will also assess both groups' hemodynamic parameters during and after the procedure and the success rate from the first trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 15 -75 years.
* Elective surgical operation.
* ASA (American Society of Anesthesiologists) physical status I-III.
* Predicted difficult airway.

Exclusion Criteria:

* Emergency intubations.
* Patients with contraindications to the use of bougie.
* Patients with a known allergy to local anesthetics or ultrasound gel.
* Pregnancy.
* Craniofacial anomaly
* Patients with obstructive sleep apnea
* BMI \> 35.
* Patient with gastroesophageal reflux disease.
Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)

This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis. Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose escalation format.

This will be a non-randomized, open label, Phase 1/2 dose escalation study.

Up to 27 participants will be enrolled. Each participant will receive the study agent by intravitreal injection in one eye on a single occasion. Enrollment will begin with the lowest dose and will proceed to higher doses only after review of safety data by a Data and Safety Monitoring Committee (DSMC). Participants in the dose escalation phase will be ≥ 18 years of age. After the maximum tolerated dose is identified individuals ≥ 6 years of age will be enrolled.

Safety will be measured by the number and proportion of participants experiencing adverse events and immune response to RS1. Efficacy will be measured by evaluation of changes in visual function and schisis cavity size.

Eligibility Criteria:
Inclusion Criteria include:

1. Retinal disease consistent with a diagnosis of XLRS and documented mutations in the RS1 gene
2. Male individual at least 18 years of age (dose escalation phase) or at least 6 years of age (maximum tolerated dose phase),
3. Able to perform tests of visual and retinal function,
4. Visual acuity specified for each group
5. Not treated with CAIs currently or within 3 months prior to study enrollment,
6. Have acceptable laboratory parameters.

Exclusion Criteria include:

1. Prior receipt of any AAV gene therapy product,
2. Pre-existing eye conditions that would preclude the planned intravitreal injection or interfere with interpretation of study endpoints or complications of vector administration.
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis

The purpose of the study is to assess short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for diagnosis and to evaluate its effectiveness

The study non randomized, opened, controlled. Cardiovascular Magnetic - resonance imaging reveals both ischemic and non-ischemic causes of acute coronary syndrome. Currently, it is the best method for Imaging and damage assessment of myocardial viability in coronary atherosclerosis and noncoronary injuries (V.Yu.Usov 2012).

Taking into account the results of previous (D. Kawecki, B. Morawiec, P. Monney, 2015) research, it can be concluded that the introduction of cardiovascular magnetic resonance imaging into routine practice will change the structure of morbidity among patients with acute coronary syndrome and non obstructive coronary atherosclerosis . The research was conducted on small groups of patients, and therefore further data acquisition is required.

It is planned to study 200 patients with acute coronary syndrome. On admission, they will receive the standard treatment of ACS with and without ST elevation. Within 72 hours they will performed diagnostic coronary angiography. If in case of non stenotic atherosclerosis of coronary artery (normal / stenosis \< 50%) patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome. At 30 days, 6 months, 12 months the researchers will assess the clinical condition of the patients, perform cardiac ultrasound for the evaluation of myocardial contractile function, evaluate the incidence rate of secondary endpoints

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years at time of randomization (18 years and older)
* acute coronary syndrome
* no obstructive coronary atherosclerosis (normal coronary artety/ plaques \<50%) is based on the results of coronary angiography for 3 days of admission
* written the informed consent to participate in research

Exclusion Criteria:

* patients previously undergone endovascular / surgical revascularization of coronary artery
* severe comorbidity
* Contacts/Locations
Time - Lapse Analysis of Frozen Embryos

A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they received after thawing, their proper rooting and live birth after thawing.


Eligibility Criteria:
Inclusion Criteria:

* All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center

Exclusion Criteria:

* Lack of proper data