cyrilzakka/clinical-trials huggingface dataset:
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.

Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.

The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with temporal lobe epilepsy (TLE)
* Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.

Arm 2: Patient with TLE seizure-free for 12 months or more

Exclusion Criteria:

* Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
* Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers
Partners PrEP Program

Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.


Eligibility Criteria:
Inclusion Criteria:

For both members of the couple

* Age ≥18 years
* Able and willing to provide informed consent
* Sexually active with each other
* Willing to engage with the clinic system as a couple

For HIV-positive members of the couples (index participants)

* HIV-positive, according to national HIV testing algorithm
* Recent diagnosis as a member in an HIV serodiscordant couple
* Not currently enrolled in an HIV treatment clinical trial

For HIV-negative members of the couples (partner participants)

* HIV-negative, according to national HIV testing algorithm
* Recent diagnosis as a member in an HIV serodiscordant couple
* Not currently enrolled in an HIV treatment clinical trial
* Not currently using PrEP
* Eligible for PrEP, according to WHO or Ugandan national guidelines

Exclusion Criteria:

- Otherwise not eligible based on the above inclusion criteria
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.

The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.

The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).


Eligibility Criteria:
Inclusion Criteria:

* Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
* Presence of clinical jaundice and / or biological cholestasis (GGT\> 3N)
* Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
* Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
* No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
* Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
* Patients aged 18 to 85
* Patient who gave his consent to participate in the study
* No contraindication to anesthesia (ASA 1, 2,3)
* Patient affiliated to a social security scheme (beneficiary or beneficiary)
* Absence of pregnancy and current contraception in women of childbearing age

Exclusion Criteria:

* Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
* Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
* History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
* Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
* History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
* Non-passable stenosis of the main bile duct
* Severe coagulopathy, thrombocytopenia \<75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
* Anesthetic contraindication (ASA 4)
* Inability to obtain informed consent
* person deprived of liberty
A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population

This study was a multicenter, open, observational study and was divided into two stages; Stage I study includes patients with suspected asthma to observe the diagnostic value and safety of Methacholine Choline Provocation Test. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.

This study was a multicenter, open, observational study. The study was divided into two stages; the first stage of the study included a population with suspected asthma and performed a bronchial provocation test, and cumulative provocation dose when forced expiratory volume in one second (FEV1) fell by 20% (PD20 ) data were recorded. Subjects with positive excitation were treated as asthma for 3 months and treatment was considered effective to confirm the diagnosis of asthma. Sensitivity, specificity, and reliability of the methacholine choline provocation test were calculated, and cutoff values were obtained by exploratory analysis based on PD20 values. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.

Eligibility Criteria:
Inclusion Criteria:

Stage I study:

* clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test
* Basal lung function FEV1 ≥ 60%
* Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
* Not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc.

Stage II study:

* Basal lung function FEV1 ≥ 60%
* Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations

Exclusion Criteria:

* Have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months
* Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria
* Severe impairment of basal pulmonary ventilation (FEV1 \< 60% of expected value %, or \< 1 L in adults)
* Poor cooperation with basal pulmonary function tests that do not meet quality control requirements
* Other conditions that make a bronchial provocation test or pulmonary ventilation function test inappropriate (e.g., recent presence of severe cardiovascular disease, seizures, uncontrolled hypertension, etc.)
Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery

To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.

This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Eligibility Criteria:
Inclusion Criteria:

included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection

Exclusion Criteria:

(a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
The CUSA Clarity Soft Tissue Removal Study

To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures. This will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery
* Subject is an appropriate candidate to receive use of the CUSA® Clarity Ultrasonic Surgical Aspirator System product for soft tissue removal during surgery, per the study surgeon
* Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable.

Exclusion Criteria:

* Subject is currently pregnant or plans to become pregnant prior to the study index surgery
* Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
* Subject's surgical plan includes utilizing CUSA® Clarity Ultrasonic Surgical Aspirator System for the removal of uterine fibroids
* Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.
* Intra-operative exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults

The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body weight/ body fat in the overweight and obese adult population.

Polyphenols are phytochemicals widely available in plants, and may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. Animal and in vitro studies have demonstrated that cocoa and dark chocolate may exert anti-obesity effects mainly due to the polyphenol effect on glucose and fatty acid metabolism. Human studies have showed that regular chocolate eaters have a lower body weight compared to non regular eaters, and that DC promotes satiety and reduces cravings. The aim of this pilot study is to investigate the effect of polyphenol-rich DC on body weight in the overweight and obese adult population, when incorporated into a non-restricted diet. Twenty-eight apparently healthy volunteers will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of twelve weeks. Participants will be asked to make three appointments and one follow-up appointment to the university clinical lab. Anthropometric measurements (height, weight, waist circumference, body fat percentage) will be taken during each visit. Compliance will be defined by the intake of 85 % or more of the chocolate weekly, and will be tested by the measure of total polyphenols in a 24-hour urine sample before, during and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary, a Food Frequency questionnaire assessment for polyphenol intake and a physical activity questionnaire will be collected before the start of the study and every four weeks. A follow-up appointment (four weeks after the end of intervention) will check if any differences in anthropometric measures have been maintained. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor. This study will have novel findings and will be the basis for a future larger trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* BMI between 25-35
* Males and Females
* Age: 18-65 years

Exclusion Criteria:

* Participants with cardiovascular diseases, hypertension or diabetes
* Participants taking any medications that affect insulin, cholesterol, triglycerides or Blood pressure
* Participants who recently participated or are currently on a weight management program
* Participants with regular consumption of cocoa or DC (\> 1 serving/week)
Evaluating Dysphagia in Neonates With CHD

The overall goal of this study is to describe the oral motor skills of neonates born with congenital heart defects, both before and after cardiac surgery, and to evaluate current measures of feeding motor skills and feeding readiness in this population using the Neonatal Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale.

The specific aims are to:

1. Describe the oral motor skills of infants with CHD before surgery as compared with normal full-term newborn (\>37 weeks) using the NOMAS
2. Describe the oral motor skills of infants with CHD after surgery as compared with those same infants before surgery using the NOMAS.
3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B. Quality of Nippling Scale at the 1st post- operative feeding evaluation)
4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have dysfunctional sucking patterns before surgical repair as compared to normal newborns. This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be utilized to predict that many infants with CHD will not be ready for oral feedings, however most of those patients will go on to successfully take oral feedings.


Eligibility Criteria:
Inclusion Criteria:

* Full-term newborns with normal physical exam that are delivered \> 37 weeks gestation (healthy newborn arm).

or

* Newborn with CHD born \> 37 weeks gestation, are hemodynamically stable and who require surgical correction in the first 30 days of life (CHD arm).

Exclusion Criteria:

* Full-term newborn arm
* Newborn admitted into the NICU
* Genetic syndromes
* Congenital abnormalities or signs of developmental delay

  · Infants with CHD arm
* Newborn requiring intubation prior to evaluation (Note: Infants with CHD with genetic or other malformations not specifically mentioned will not be excluded due to their prevalence in this population)
* Down Syndrome
* Trisomy 13, Trisomy 18
* Congenital anomalies of facial structure or musculature specifically cleft lip, hard or soft palate
Realizing Opportunities for Self-Supported Improvement (ROSSI)

This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes Research Institute (PCORI) and will test an adapted priority-based patient navigation versus care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or referred from, University of Rochester Medical Center providers. The goal is to improve patient safety, depression, and health function over the course of 12 months. In the Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested in our first UR PCORI grant, in addition to meeting with a social worker, patients will work with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed over the course of the next 6 months to navigate services and overcome barriers. In addition, patients will receive referrals to other professionals based on their prioritization and meet with the CHW at the time and place of their choice. Patients in the Care as Usual- Social Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for intake and referrals, does a needs assessment, and offers safety planning in referral.


Eligibility Criteria:
Inclusion Criteria:

Subjects must be English speaking URMC patients, who are 18 years of age or older, and/or the non-offending parent on a CPS report for a URMC pediatrics patient, and who have experienced an IPV or emotional abuse event within the past 3 months.

IPV is defined as endorsing any of the following items:

1. Slapped, kicked, pushed, choked, or punched?
2. Forced or coerced to have sex?
3. Threatened you with a knife or gun to scare or hurt you?
4. Made you feel afraid that you would be physically hurt?
5. Repeatedly used words, yelled, or screamed in a way that frightened you?
6. Threatened you, put you down, or made you feel rejected? Yes No Additional inclusion criteria include depression based on PHQ-9 score of \>10.

Exclusion Criteria:

* Subjects are ineligible if they have active psychosis or alcohol or substance dependence based on 3 months threshold on the Mini-International Neuropsychiatric Interview (MINI).
* Additionally, patients who are unable to understand the consent form or study procedures, are imminently suicidal, or are currently working with a CHW will be excluded.
A Study of LY3314814 in Healthy Participants

The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females
* Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

Exclusion Criteria:

* Have a history of significant ophthalmic disease
* Have vitiligo or any other clinically significant disorder of skin pigmentation
* Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed
Finding Gab in the Treatment of Heart Failure in Assiut University Hospital

Analyze the epidemiology and outcome of all patients with heart failure with reduced ejection fraction (HFrEF) presented to Asyut university hospital (AUH) and to identify factors associated with mortality and all-cause hospitalization at a duration of 6 months follow-up.

Heart failure (HF) is nowadays an important health problem and associated with high use of resources and healthcare cost, but the prevalence of heart failure is increasing due to better care and treatment of HF and to the aging of the population. Epidemiology of HF is changing and shifting towards a higher prevalence of patients with HF with preserved ejection fraction. Moreover, the outcome of HF is grim. The mortality rate is high and hospitalizations are frequent and associated with worse outcomes. The majority of studies that analyzed HF outcomes have focused on HF hospitalizations. However, in patients with HF, all-cause hospitalizations can affect up to 23-58% of the patients at 1-year follow-up and non-cardiovascular hospitalizations are associated with risk of subsequent mortality similar to cardiovascular hospitalizations. Despite the evidence that all-cause hospitalizations are detrimental in HF patients, few studies have analyzed whether the factors associated with all-cause and HF-hospitalizations are different in HF patients.

However, the characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve the management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome

Eligibility Criteria:
Inclusion Criteria:

- All patients \> 18 years of age with left ventricular ejection fraction (LVEF) \< 40 % with symptoms and signs of heart failure (according to ESC guidelines of acute and chronic heart failure 2016).

Exclusion Criteria:

* patients more than 80 years old