cyrilzakka/clinical-trials huggingface dataset:
Impact of Pulsatile Cardio-Pulmonary Bypass (CPB) on Vital Organ Recovery

This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery.

The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

* Patients older than 17 years will be excluded.
Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture

Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least \>=21y of age
* Provision of informed consent
* Totally edentulous arch requiring or wearing mandibular complete denture
* Tooth in implant sites must have been extracted at least 4 months before the implant placement.
* Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone
* Implant insertion torque \>=20Ncm
* No need for bone augmentation procedures

Exclusion Criteria:

* Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation.
* Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids.
* History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection
* Use of investigational drugs or devices within 30 days of study period,
* Alcoholism or drug abuse and heavy smokers \> 10 cigarettes a day.
* Local factors such as

  * untreated periodontitis,
  * erosive lichen planus,
  * local irradiation history,
  * osseous lesion,
  * unhealed extraction socket,
  * intraoral infection,
  * lack of primary stability
  * inadequate oral hygiene
* Simultaneous participation in another clinical study
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.


Eligibility Criteria:
Inclusion Criteria:

* Females who are \>21 years of age
* Females who provide informed consent

Exclusion Criteria:

* Known pregnant
* Cervical cytology specimen collected within the last 4 months
* Prior complete or partial hysterectomy involving removal of cervix
* Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
* Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
* Enrolled in a cervical disease diagnostic trial since 2007.
Post-surgical Delirium in Patients Undergoing Open Heart Surgery.

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done.

Discussion Results of the study will be discussed compared to other studies.

References

1-Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5.

Eligibility Criteria:
Inclusion Criteria:Adult patients undergoing open heart surgery. -

Exclusion Criteria: Children, patient refusal.

-
Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"

The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage.


Eligibility Criteria:
Main inclusion criteria for patient enrollment were: ability to provide an informed consent; age \>/=18 years; any benignant or malignant ERCP indication.

All subjects were excluded from the study:

* Patients who have already undergone endoscopic sphincterotomy
* Patients unable to express informed consent
* Pregnant or breastfeeding women
* Patients with anatomical post-surgical alterations of the upper gastrointestinal (GI) tract
Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates

Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Scientific societies recommend a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this context, patients with FEV1 or less than 80% of the predicted value are subjected to a more thorough evaluation of the physical physical capacity by cardiopulmonary exercise test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max \<35% of predicted values or \<10ml/kg/min, or a postoperative predicted value of DLCO or FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35% or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli et al 2009).

For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent of the resection. In this group of patients, other parameters measured with CPET could be used to optimize the selection of patients given the inability of some the inability of some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of physical capacity.

The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters classically used in classically used in heart failure and have recently been shown to be independent prognostic factors as independent prognostic factors for 90-day and 2-year mortality after anatomical lung resection. Moreover, these factors do not depend on the maximality of the test and could again help us to risk-stratify for a sub-maximal and therefore not optimal test.


Eligibility Criteria:
Inclusion Criteria: Lobectomy or Segmentectomy or Wedge Resection for Non-Small Cell Lung cancer

- Performed CPET

Exclusion Criteria:

* pulmonary resection for diagnostic
* pneumonectomies and any extensive resections (chest wall-associated resections, Pancoast tumors, resection of the atrium or superior vena cava, resection of the diaphragm, spinal resection, pleuro-pneumonectomy, tracheal sleeve pneumonectomy, intrapericardial pneumonectomy), as well as metastases, benign lesions, and any other non-oncologic pulmonary resections
Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication.

In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Known diagnosis of Epilepsy
* Expected to experience seizures during the period of the study as determined by the PI.
* Able to meet with the Sponsor representative at home

Exclusion Criteria:

* Trauma/broken skin on forehead.
* Patient can not follow or comply with instructions
* Patients who are unable to independently provide an informed consent
* Patients with major psychiatric co-morbidities
* Patients with psychogenic non-epileptic seizures
OCTA in Patients With Primary Open-angle Glaucoma

Is to investigate retinal microvascular changes in primary open angle glaucoma patients using Optical Coherence Tomography Angiography.

Optical coherence tomography angiography (OCT-A) is a non-invasive imaging technique developed to visualize vascular networks in the retina and choroid. It utilizes low-coherence interferometry to measure changes in backscattered signal to differentiate areas of blood flow from areas of static tissue.

OCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.

Glaucoma is the first cause of irreversible blindness and represents approximately 15% of all causes of blindness . This makes it a real public health problem. In 2020, glaucoma affected about 80 million people worldwide, with nearly 75% of open-angle glaucoma Primary open-angle glaucoma (POAG) is a chronic, progressive, blinding, irreversible optic neuropathy characterized by damage to the optic nerve head and retinal nerve fibers with subsequent visual field defects ,elevated intraocular pressure (IOP) is a crucial glaucoma risk factor that causes direct damage to RGCs and the optic nerve . Moreover, glaucomatous retinsl ganglion cells loss occurs as well in people with normal IOP, implying mechanisms behind pressure-mediated damage. RGCs death may be due to the reduced blood supply and microvasculature dysfunction may be essential in glaucoma pathogenesis .

One hypothesis is that POAG is categorized by impaired chemical endothelial signaling between both: a) the inner wall Schlemm's canal endothelial cells as well as endothelial cells located in the ciliary body and the posterior longitudinal muscle that helps to set outflow resistance and b) the ocular vascular endothelial cell and underlying luminal smooth muscle for vessels supplying the retinal ganglion cells (RGCs). This hypothesis could explain why POAG occurs across a spectrum of IOP but it does not consider the role systemic endothelial cell dysfunction may play in the disease.

The non-invasive technique of OCT angiography (OCTA) can image and quantify both large vessels and the microvasculature of the optic nerve head (ONH), retina and choroid layers . Using the OCTA technique, reduced vessel density (VD) was observed in the ONH, peripapillary area and macula, predominantly in primary open-angle glaucoma (POAG)

Eligibility Criteria:
Inclusion Criteria:

- clinical diagnosis of Primary open angle glaucoma.

Exclusion Criteria:

* media opacity
* poor fixation due to advanced disease
* associated vascular retinopathy
* chronic uveitis
* optic nerve disease due to other etiologies
A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients

This open, multi-center, multiple ascending dose study was designed to evaluate the safety, tolerability, preliminary efficacy and PK/PD of BDB-001 injection in patients with mild, or general COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* 18≤ age ≤60, 18 kg/m2 ≤BMI ≤28 kg/m2, male or female;
* Diagnosed with 2019-nCoV infection and classified clinically as mild or general;
* Agreed not to participate in other clinical studies before completing this study;
* With the subject's consent and signed informed consent form by the subject or his/her legal representative.

Exclusion Criteria:

* Diagnosed with 2019-nCoV infection and classified clinically as severe or critical severe; severe pneumonia or acute respiratory distress syndrome, sepsis and septic shock;
* The disease would deteriorate significantly within 48 hours judged by the investigators;
* Immunodeficiency or immune related diseases not suitable for participation judged by the investigators (such as autoimmune diseases, IgG4 related diseases, allergic alveolitis, vasculitis, etc);
* Lymphocyte count \<0.5×109/L;
* Neutropenia history (neutrophil absolute count was less than 2×109/L in adults), except for infection;
* D- dimer \>2000 µg/L;
* Severe history of lung diseases, such as chronic obstructive pulmonary disease, lung cancer, tuberculosis, etc., history of heart disease: unstable angina pectoris, myocardial infarction, cardiac surgery, cardiac function≥ grade 3 (NYHA classification), serious history of liver disease (such as Child Pugh score ≥grade C), serious renal disease history, such as renal insufficiency (GFR ≤ 15ml/min/1.73m2), etc;
* The subjects used the following drugs within 2 weeks (including 2 weeks) before screening:

  1. Calcineurin inhibitors (such as cyclosporin and tacrolimus);
  2. Proliferation inhibitors (such as everolimus, sirolimus, etc);
  3. anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc);
* Pregnant or lactating women.
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.

Tuberous sclerosis complex (TSC) is caused by mutations in tuberous sclerosis complex 1 (TSC 1) and tuberous sclerosis complex 2 (TSC 2) leading to overactivation of the mammilian target of rapamycin (mTOR) pathway resulting in multiorgan disease. Specifically, patients are at risk for autism, epilepsy, intellectual disability, renal cysts, tuberous sclerosis associated neuropsychiatric disorder (TAND), lymphangioleiomyomatosis (LAM), and benign tumors throughout the body including subependymal giant cell astrocytomas (SEGAs), renal and liver angiomyolipomas (AMLs), and cardiac rhabdomyomas (rhabdomyomas).

Sporadic LAM occurs mostly in women and many patients with LAM have TSC gene mutations.

The purpose of this study is to gather information to help clinicians develop evidence-based guidance for the care of TSC and LAM patients during pregnancy and to provide screening recommendations for fetal TSC.

Participants will be asked to complete monthly online surveys screening for changes in the pregnancy, maternal health/medication changes, and other care. For infants enrolled after birth, clinical data will be collected and reviewed for up to 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

* A pregnant woman with a clinical or genetic diagnosis of TSC as determined by the 2021 Consensus Guidelines (1)
* A pregnant woman with a diagnosis of LAM
* A pregnant woman with a variant of uncertain significance in TSC 1 or TSC 2
* A pregnant woman who is pregnant and the fetus has a 50% chance of TSC as deemed by the PI or Sub-Is
* A pregnant woman whose fetus is found to have concern for TSC secondary to rhabdomyomas, tubers, or congenital subependymal giant cell astrocytoma.
* An infant born to an enrolled individual.

Exclusion Criteria:

* A pregnant woman without TSC who has used preimplantation genetic testing for TSC unless qualifies under inclusion criteria #4.
* Infants diagnosed with TSC whose birth mother was not enrolled.
TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)

The primary objective of this pilot intervention study is to build upon the Connecting and Reflecting Experience (CARE) clinical trial \[Clinical Trials Number: NCT04580459\] and evaluate the acceptability, feasibility, and preliminary outcomes of CARE when implemented via tele-health among caregivers of transgender and nonbinary (TGNB) youth (TGNB-CARE).

The main questions it aims to answer are:

* To determine the feasibility and acceptability of the CARE treatment adaptation for caregivers of TGNB youth following the 12-session, mentalizing-focused, group parenting intervention. The study team hypothesizes that the adaptation and implementation of the CARE intervention will be found to be feasible and acceptable for study participants.
* To assess whether self-reported parenting stress and stressors, parental acceptance, parental reflective functioning, parent positive feelings, and perceived interpersonal support improve among study participants following the 12-session, mentalizing-focused, group parenting intervention. The study team hypothesizes that the CARE treatment group adaptation will show improvements across these outcomes.

Caregivers will be asked to complete surveys at baseline (T0), following their first session (T1), and at post-intervention (T2). A feedback interview will also be completed at T2.


Eligibility Criteria:
Inclusion Criteria:

* Adult caregivers (mothers, fathers, primary caregivers, or legal guardians) who are English-speaking (as the research assessments and intervention will be conducted in English).
* Participants will be caregivers who:

  1. have a TGNB child who is receiving psychiatric services, has a mental health diagnosis, and/or has a diagnosis of gender dysphoria and is receiving medical or behavioral health services through Montefiore Medical Center and
  2. express interest in receiving a parenting intervention delivered via telehealth services through Montefiore Medical Center.

In addition, subjects will:

1. endorse past or current tension and/or interpersonal stress related to their child's gender identity and/or
2. express interest in receiving support in the context of gender-affirming parenting.

Exclusion Criteria:

* Caregiver has severe mental illness or significant cognitive impairment
* Additionally, caregivers who have participated in prior or current CARE groups or have participated in any parenting support groups in the past year will be excluded from participation.
Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.

In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Health male or female non-melanoma patients or volunteers
* 18 years or older with a life expectancy greater than 6 months
* Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
* Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
* Must have never smoked or has not smoked for at least 6 months
* Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form

Exclusion Criteria:

* Patients/healthy volunteers not meeting all of the above selection criteria.
* Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
* Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
* Patients not willing to comply with protocol requirements