cyrilzakka/clinical-trials huggingface dataset:
Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Previous studies have shown that women on anti-seizure medications are not informed about the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs) and certain hormonal contraceptive. The goal of this proposed study is to develop and assess the efficacy of an educational handout for participants on the ways AEDs and certain hormonal contraceptives can interact to alter effectiveness of the medications. Reproductive age women (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient agrees to participate, she will be given a knowledge exam prior to the clinic appointment to establish baseline understanding of hormonal contraceptive and AED interactions and then the participant will be randomized to receive the intervention (educational handout) or the standard of care (no educational handout). Those in participants in the intervention group will read an educational handout on hormonal contraceptives/AED interactions. Those in the standard care group will not receive this handout and the same knowledge exam will be re-administered to all of the participants after they have completed their appointments to check for knowledge comprehension and short-term knowledge retention. A same-day post-test questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED interactions with their gynecologist, neurologist or primary care physician.


Eligibility Criteria:
Inclusion Criteria:

* Age of participants: 18-45 years old
* Gender of participants: Female
* Ethnic Background: No limitation, will include minorities
* Health Status: on at least one antiepileptic medication
* Sexually active with men
* English speaking

Exclusion Criteria:

* Currently Pregnant
* History of hysterectomy or sterilization procedure
* Removal of both ovaries
* Cannot read or comprehend English language
* Unable to provide informed consent
* Attempting to become pregnant
* Not sexually active with men
* No active telephone number for follow-up contact
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

The primary objectives of this study are to evaluate the effect of sustained virologic response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS) and on neurocognition as measured by neurocognitive tests. This study will also evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.

During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit, participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Chronic genotype 1 HCV infection
* Screening laboratory values within defined thresholds
* Use of protocol-specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria:

* Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol. Current or prior history of any of the following:

  * Hepatic decompensation
  * Solid organ transplantation
  * Significant pulmonary or cardiac disease
  * Chronic liver disease of a non-HCV etiology
  * Hepatocellular carcinoma (HCC)
  * Infection with hepatitis B virus (HBV)
  * Infection with human immunodeficiency virus (HIV)
  * History of recent epilepsy (within 2 years of screening) or cerebral vascular accident (CVA)
  * Structural brain damage
* Presence of cirrhosis
* Contraindication to MRI
* Pregnant or nursing female
* Prior treatment NS5A directly-acting antiviral agent. Any interferon (IFN)-containing regimen within 8 weeks of Screening
Frailty and Postoperative Outcomes After Emergency General Surgery

The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.


Eligibility Criteria:
Inclusion Criteria:

* All residents of Ontario aged more than 65 years on their surgery date with valid provincial health insurance who have an emergency general surgery procedure (large bowel surgery, small bowel surgery, cholecystectomy, control of hemorrhage from duodenal ulcer, lysis of adhesions, appendectomy, laparotomy)

Exclusion Criteria:

* No valid provincial health insurance
Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency

This was an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly progressive lysosomal acid lipase deficiency (LAL-D). Eligible participants received once-weekly infusions of sebelipase alfa for up to 3 years.

Lysosomal acid lipase deficiency is a rare autosomal recessive lipid storage disorder that is caused by a marked decrease or complete absence of the LAL enzyme, leading to the accumulation of lipids, predominately cholesteryl esters and triglycerides, in various tissues and cell types. In the liver, accumulation of lipids in hepatocytes and macrophages leads to hepatomegaly, fibrosis, cirrhosis, liver dysfunction, and hepatic failure. In the small intestine, lipid-laden macrophage accumulation in the lamina propria leads to profound malabsorption.

Lysosomal acid lipase deficiency presenting in infancy is an extremely rare form of the disease characterized by profound malabsorption, growth failure, and hepatic failure that is usually fatal within the first 6 months of life.

Eligibility Criteria:
Inclusion Criteria:

1. Participant's parent or legal guardian (if applicable) consent to participation in the study
2. Confirmation of documented decreased LAL activity relative to the normal range of the lab performing the assay or confirmation of LAL-D diagnosis as determined by a Sponsor-approved central laboratory
3. Substantial clinical concerns, in the opinion of Investigator and Sponsor, of rapid disease progression requiring urgent medical intervention including, but not restricted to the following:

   * Marked abdominal distension and hepatomegaly
   * Failure to thrive
   * Disturbance of coagulation
   * Severe anemia
   * Sibling with rapidly progressive course of LAL-D

Exclusion Criteria:

1. Clinically important concurrent disease
2. Participant was \> 8 months of age at the time of first dosing
3. Participant received an investigational medicinal product other than sebelipase alfa within 14 days prior to the first dose of sebelipase alfa in this study
4. Myeloablative preparation, or other systemic pre-transplant conditioning, for hematopoietic stem cell or liver transplantation
5. Previous hematopoietic stem cell or liver transplant
6. Known hypersensitivity to eggs
C-arm Cone Beam CTP Guided Cerebrovascular Interventions

The study objective for the Phase 2 of this research is to demonstrate and confirm the substantial time savings that can be obtained using cone beam computed tomography (CB-CT) for both complete image acquisition and rapid image reconstruction in a Direct to Angio paradigm (One Stop Shop) for selected acute ischemic stroke (AIS) patients.

Phase 2 of this research is aimed at validating the feasibility and time savings of bringing selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. In order to make this phase of the study more robust and to reduce bias on image assessment we will prospectively randomize the patients in a 2:1 fashion to either direct to angio for CB-CT imaging or MD-CT imaging in the emergency room. A total of 60 CB-CT subjects and 30 MD-CT subjects will comprise this cohort. Entrance criteria will be identical to those in Phase 1, except the NIHSS must be greater than 8 which is clinically correlative with a likely large vessel occlusion and, since this is standard of care imaging for acute ischemic stroke, GFR will be removed as an exclusionary criteria.

The Phase 1 of this research was registered to NCT03232151.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute ischemic stroke presenting within 24 hours of onset
2. Patients that present with a large artery occlusion
3. Adults 18 years of age or older.
4. Patients of childbearing potential must not be pregnant.
5. National Institutes of Health Stroke Scale (NIHSS) of \<8
6. No severe co-morbidities

Exclusion Criteria:

1. Patients that are pregnant
2. History of severe renal disease (e.g. stage 4-5)
3. History of renal transplant
Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis

Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.

The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).

The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.

The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of cystic fibrosis
* Patients with Pulmonary transplant between 01/01/2004 and 31/12/2014
* Patients followed-up in one of the two pulmonary transplantation centers in the Rhône-Alpes region (Lyon, Grenoble)

Exclusion Criteria:

* Patients followed in Rhône Alpes but transplanted elsewhere in France will not be included.
* Patient refusing to participate in the study
Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child

This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.

This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.

The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Local or regional breast cancer recently diagnosed
* Able to read and write English
* Has one or more school age child(ren) living at home
* Married to a man or in a committed long-term intimate relationship with a male partner

Exclusion Criteria:

* Non-English speaking
* Advanced stage breast cancer
* Not recently diagnosed
* Single mother
Association of Thyroid Autoimmunity and Chronic Urticaria

Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.

There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* skin itching for more than 6 months

Exclusion Criteria:

* pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection
Intubation and Extubation Over 48 Hours Mechanical Ventilation

The purpose of this study is to determine how often ventilator associated pneumonia happens in the current intensive care units, and how types of endotracheal tube affect its occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years old
* Mechanically ventilated over 48 hours in the ICU

Exclusion Criteria:

* Mask ventilation
* Tracheostomy
Cognitive Rehabilitation in Post-COVID-19 Syndrome

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to individuals experiencing cognitive impairments that limit everyday activities in post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of individuals with PCS. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to an inactive control group, on activity performance, subjective and objective cognition, and quality of life in a sample of individuals who self-report PCS and cognitive impairment.

Post-COVID-19 symptoms (PCS) cognitive symptoms require the rehabilitation community to investigate ways to: (1) reduce the functional impact of the symptoms on daily life and (2) support individuals with PCS to establish new habits to improve and maintain health. While the cognitive impairment associated with PCS has not been well evaluated, it is similar of cognitive symptoms seen in other conditions. Metacognitive strategy training (MCST) approaches are an evidence-based practice standard for improving capacity to self-manage chronic cognitive symptoms and reduce their functional impact on everyday life activities.

The CO-OP approach is an MCST intervention in which participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies for engaging in an activity. Existing evidence with other populations suggests that CO-OP has more of a positive effect on improving activity performance and cognition than remediation/retraining-based approaches. These effects have been demonstrated in individuals with mild cognitive impairment that mirrors that found in PCS. The overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognitive function, and quality of life in individuals with PCS.

Eligibility Criteria:
Inclusion Criteria:

* self-reported cognitive symptoms persisting for at least 6 weeks following COVID-19 infection (Cognitive Failures Questionnaire (CFQ) score \>43)
* self-identified activity performance goals per the Canadian Occupational Performance Measure (COPM)
* documented prior diagnosis of COVID-19
* read, write, and speak English fluently
* ability to provide valid informed electronic consent

Exclusion Criteria:

* diagnosis of severe neurological or psychiatric condition(s)
* dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA)
* untreated sleep apnea (≥5 on the STOPBANG)
* prior cancer treatment
* severe depressive symptoms (\>21 on the Patient Health Questionnaire-9)
Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD

Pro-Kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.

Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Children with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to normalize the PA serum levels by oral PA food supplementation in hemodialysis patients in order to mitigate chronic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Body weight: \> 30kg
* CKD G5 treated with hemodialysis
* Continuous hemodialysis treatment for \> 3 months
* Clinical stable condition
* Manifestation of CKD within childhood (\<18 years)

Exclusion Criteria:

* Disease or dysfunctions, which disqualifies the patient
* Incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study
* Acute infections
* Immunosuppressive therapy within the last 12 weeks before the start of the study
* Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study
* Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study
* Malignant diseases
* Pregnancy
* chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease
* alcohol- or drug abuse
* parallel participation on other interventional trials
A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

This is a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) or stage 5 chronic kidney disease (CKD5) participants in Part 1, of multiple subcutaneous doses in CKD4 or CKD5 participants in Part 2, and of a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease in Part 3. The primary hypothesis is that, in Part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 or CKD5 participants is at least 11300 nM\*hr.


Eligibility Criteria:
Inclusion Criteria:

* At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3).
* Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m\^2.

Exclusion Criteria:

* Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.
* Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.
* Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months.
* Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
* Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
* Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.
* Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
* Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit.
* Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
* Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.
Characterization of Myocardial Infarction Scar Using Magnetic Resonance Imaging

The goal of this monocentric observationnal study is to describe the characteristics of the myocardial infarction scar in terms of transmurality in residual LVEF\>35% patients.

The primary objective is to determine the frequency of the criterion "intramural scar ≥1.47cm2" (measured by MRI) in patients who presented with myocardial infarction with residual LVEF≥35%.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years ;
* History of acute coronary syndrome prior to inclusion and having undergone cardiac MRI;
* LVEF \>35% measured at least 6 weeks post-IDM by echocardiography or MRI;

Exclusion Criteria:

- Patient with an implantable cardiac device (implantable cardioverter defibrillator or pacemaker) prior to MRI.
uChek Pilot Study for Urinalysis in the Antenatal Care Setting

A prospective observational study to test the feasibility of smartphone enabled uChek urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess attitudes of clinicians towards uChek as a new technology for urinalysis.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.

Exclusion Criteria:

* Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.