cyrilzakka/clinical-trials huggingface dataset:
Research on the Environment and Children's Health: Retinoblastoma

The purpose of the research study is to learn more about the causes of retinoblastoma and to identify possible risk factors in the parents of patients with retinoblastoma. This kind of study is called an epidemiology study and is often done by interviewing people with and without the disease. In the case of a childhood disease, the researchers ask about experiences of the parents and children before the disease developed.

The purpose of the study is to investigate the role of paternal exposures in the etiology of sporadic heritable retinoblastoma (RBL). The study has a matched case-control design with a sample size of 255 pairs. Cases will be children with sporadic heritable (RBL) identified from eight hospitals that together treat most of the RBL patients in the U.S. and Canada. We will use regional controls matched on year of birth and state/province of residence identified by randomdigit-dialing (RDD). Fathers and mothers of cases and controls will be interviewed by telephone about their occupational, medical, dietary, and personal exposures before the index child's conception. Blood samples will be obtained on cases and their parents for DNA isolation. The case's DNA will be used to characterize the disease-causing RB1 mutation. The parent's DNA will be used to detect the few instances in which a parent also has the RB1 mutation, i.e., the child's RBL is familial rather than sporadic.

Eligibility Criteria:
Inclusion Criteria:

* Cases will be children with sporadic heritable RBL, i.e., bilateral RBL without a family history of the disorder.
* Cases will be diagnosed with retinoblastoma in an approximately 7-year period, beginning January 1, 1998 and continuing until the sample size is reached.
* The case family must reside in the continental U.S., Alaska, or Canada.
* The case family must have a telephone in the household.
* The patient's physician must give permission to contact the parents of the case.
* The biologic father or mother of the case must be available and consent to be interviewed.
* The father or mother must speak English or Spanish.
* Genetic counseling regarding RB1 gene mutation analysis must be done prior to registration onto study.

Exclusion Criteria:

- Cases that do not meet the above criteria will be ineligible to participate and excluded from the study.
Live-streaming Vs Face-to-face Teaching Method Effectiveness in Training Surgical Clerkship

The goal of this observational study is to assess objectively whether teaching for simple wound sutures via Live-Streaming (LS) using Go-pro® has the same effectiveness as the traditional Face-to-face (FTF) teaching. The main question it aims to answer is whether training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training.

After initially doing pre-test, participants will be randomized into two groups: LS and FTF. After teaching exposure, the participants will be given 1 week period of self-training to master the skill (as such procedural skills require a period of self training before we examine the effect of teaching exposure). Afterwards, they underwent post-test again with the previously same examiner, using the same OSCE rubric to avoid bias. Researchers will compare if the LS and FTF groups to see if training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training.


Eligibility Criteria:
Inclusion Criteria:

* Surgery clerkships
* Willing to participate voluntarily and give consent to the study

Exclusion Criteria:

* Participants who drop out between 1 week period of pre-test and post-test
* Participants not willing to be involved in the teaching exposure
A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus lamivudine to patients who have never taken anti-HIV drugs.

Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
* Life expectancy of at least 12 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current bilateral peripheral neuropathy greater than or equal to Grade 2.
* Proven or suspected acute hepatitis due to any cause.
* Recurrent episodes of moderate to severe diarrhea, or vomiting lasting for more than 4 days within 3 months prior to dosing.
* Hypersensitivity to any component of the formulation of efavirenz, stavudine, or lamivudine.
* Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
* Any clinically significant disease (other than HIV infection) or clinically significant findings found during the screening of medical history or physical examination.
* Any malignancy that requires systemic therapy.
* Any active AIDS-defining opportunistic infection or disease.

Concurrent Medication:

Excluded:

Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.

Patients with the following prior conditions are excluded:

* History of acute or chronic pancreatitis.
* A life expectancy of less than 12 months.
* Difficulty swallowing capsules/tablets.
* Inability to communicate effectively with study personnel.

Prior Medication:

Excluded:

* Any other experimental drug within 30 days of introducing study treatment.
* Vaccination within 3 weeks of screening visit.
* Any prior antiretroviral therapy.
* Interferon started within 30 days of initiating study treatment.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.
Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)

This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.


Eligibility Criteria:
Inclusion criteria:

* Hyperlipidemic
* On therapy for hyperlipidemia for \>=3 months without achieving target lipid values

Exclusion criteria:

* Hypersensitivity or intolerance to hypolipemics
* Significant myopathy or rhabdomiolysis probably caused by hypolipemics
* Uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)
Cerebrovascular Reactivity in Hepatic Encephalopathy

It has been observed that patients with cirrhosis present a generalized state of vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On progression of the disease, vascular regulation is mismatched, causing altered systemic blood flow and lose in the cerebrovascular reactivity.

The investigators hypothesize that the altered cerebrovascular reactivity induces neurological disturbances related to hepatic encephalopathy and, therefore, the existence of a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.

There is no bibliography that evidenciates a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy. There are however, papers that reveal generalized systemic vasoconstriction in patients with cirrhosis and others that affirm the presence of vascular disregulation and altered reactivity in the Middle Cerebral Artery in cirrhotic patients. In the other hand, there is published data that correlates the neurological manifestations of diseases characterised by altered blood flow and cerebrovascular reactivity with the degree of the vascular disregulation itself, identified by US Doppler. However, there are no studies correlating transcranial US Doppler findings of cerebrovascular reactivity and hepatic encephalopathy in patients with cirrhosis. Giving its importance to the chance of revealing a new way of pathophysiology and therefore, early therapeutic management.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Liver Cirrhosis

Exclusion Criteria:

* Personal history of surgery in the last 4 weeks
* Diagnosis of Diabetes Mellitus, Hypertension, COPD or liver metabolic diseases (Wilson's disease and hemochromatosis)
* Personal history of stroke and/or cancer
* Use of neuropsychiatric drugs
* Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and Attention-deficit hyperactivity disorder)
* Thyroid disorders without replacement therapy
* Hepatic or renal transplant
* Alcoholism with active ingest of alcohol in the last 6 months
* Pregnancy
* Labour turn-overs
Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer

Phase II trial of Neoadjuvant \[FEC100\]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced breast cancer
A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Clinically documented primary brain tumor for which surgical resection is indicated.
* Age 18 years and older.
* ECOG Performance status less than or equal to 2.
* Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria:

* Receipt of an investigational agent within 30 days.
* Allergy to ALA or similar compounds.
* Personal or family history of porphyria.
* Uncontrolled intercurrent illness.
* Inability to comply with the protocol.
* Pregnancy, breastfeeding.
Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries

The study aims to validate neutrophil function, immature granulocyte and plasma free DNA levels as predictive diagnostic biomarkers of sepsis in burn patients. Inclusion criteria includes healthy volunteers, patients aged 5-15 years old with burns affecting 20% or less Total Body Surface Area (TBSA) and patients aged 16 or above with burns affecting \>15% TBSA. The study involves taking blood, tissue and urine samples.

The initial cohort for SIFTI-2 will be generated from patients attending the Birmingham Burns Centre at Queen Elizabeth Hospital Birmingham (QEHB) and Birmingham Children's Hospital (BCH). The cohort will be comprised of patients with moderate and severe burns (injury to more than 15% of the body surface area \[TBSA\] in adults and 20% TBSA in children). The investigators currently treat between 30-40 patients in this category each year. In order to thoroughly characterise the longitudinal neutrophil response to burn injury and to investigate its potential relationship with outcome post-burn, the ivestigators will measure the genomic, phenotypic and functional response of peripheral blood neutrophils across time in burn-injured patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1-15 years admitted with a ≥20%TBSA
* Patients aged 16 and over admitted with a ≥15% TBSA
* Patients presented within 24 hours of thermal injury

Exclusion Criteria:

* Associated multiple injuries with Injury severity score \> 25
* Decision not to treat made on admission due to the severity of the injury
* Patients with chemical and deep electrical burns
* Premorbid conditions
* Active Malignancy
* Patients receiving glucocorticoid treatment
* Multiple limb amputations
* Patients with known long term infections (i.e., Hepatitis B \& C, Human Immune Deficiency \[HIV\])
Identification of Vulnerability Factors in the Course of Pemphigus Patients

The bullous pemphigoid treatment is based on corticosteroids continued for several years. Pemphigus causes some patients a psychological impact and sometimes major vulnerability that can occur not only at diagnosis but also at later stages of disease progression. Our hypothesis is that these episodes of vulnerability may be under four kinds of factors that may be connected to the plurality of the history of these patients, and the resources they can mobilize throughout this experience, generating inequality in management and "work" around the disease.

The originality of the project lies in its multidisciplinary approach (dermatology, psychology, sociology). No such study has yet been carried out in the pemphigus who has been the subject of a very small number of works in sociology or psychology. The only studies are studies of quality of life with no longitudinal follow-up. The perspective of qualitative and quantitative data, sociological and psychological approaches, should allow more innovative and adapted to the medico-social and psychological care of patients with pemphigus approaches. The purpose of this study is to identify the determinants leading to moments of vulnerability in the course of patients with pemphigus in order to be able to offer preventive or corrective actions to improve the experience of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient major
* Patients with pemphigus vulgaris, diagnosed on a combination of:

  1. clinical signs and
  2. histological image above basal epithelial detachment with intra acantholysis,
  3. direct immunofluorescence showing deposition of Immunoglobulin G and / or C3 to the surface of keratinocytes
* Join a social security scheme
* patient has been informed and have signed consent to participate in the study

Exclusion Criteria:

* Person placed under judicial protection,
* Patient without liberty by administrative or judicial decision,
* Patient participating in another trial for the duration of monitoring.
Using Fluorescence Angiography to Detect Occult Shock

The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).

Hypoperfusion may be multifactorial, due to hemorrhage, shock or other disease processes resulting in either capillary leak into the interstitium or profound vasodilatation. Currently, diagnosis of hypoperfusion depends on indirect markers of perfusion such as lactate, blood pressure, creatinine, urine output, and mental status. These are all late signs of hypoperfusion as they are precursors to impending system failure. In this study, the focus will be on one of the most common causes of hypoperfusion in the surgical population; sepsis and septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis arm inclusion criteria:
* Diagnosis of severe sepsis and septic shock.
* Sepsis is defined as at least two of the following signs and symptoms (SIRS) that are both present and new to the patient and suspicion of new infection:

  * Hyperthermia \>38.3°C or Hypothermia \<36°C
  * Tachycardia \>90 bpm
  * Tachypnea \>20 bpm
  * Leukocytosis (\>12,000 μL-1) or Leukopenia (\<4,000 μL-1) or \>10% bands.
  * Hyperglycemia (\>120 mg/dl) in the absence of diabetes.
  * Severe sepsis includes SIRS and at least one of the following signs of hypoperfusion or organ dysfunction that is new and not explained by other known etiology of organ dysfunction:
  * Hypotension (\<90/60 or MAP \<65)
  * Lactate \>2
  * Areas of mottled skin or capillary refill \>3 seconds
  * Creatinine \>2.0 mg/dl
  * Disseminated intravascular coagulation (DIC), Platelet count \<100,000
  * Acute renal failure or urine output \<0.5 ml/kg/hr for at least 2 hours
* Hepatic dysfunction as evidenced by:

  * Bilirubin \>2 or INR \>1.5
  * Cardiac dysfunction
  * Acute lung injury or ARDS
* Control arm inclusion criteria:

  * Do not have diagnosis of sepsis, severe sepsis, or septic shock
  * Are not on vasopressors
  * Are normo-thermic

Exclusion Criteria:

* Sepsis arm exclusion criteria:

  * Pregnant
  * Iodide allergy
  * Burns
* Control arm exclusion criteria:

  * Pregnant
  * Iodide allergy
  * Burns
  * Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.
COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)

This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.

This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.

The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

group 1: cases

* Patients with MIS-C (following SARS CoV-2 infection)
* Hospitalised between the 01 sep 2021 and 30 apr 2022
* Under 18 years of age
* Not vaccinated for SARS-CoV-2

group 2: controls

* Patients not hospitalised, treated by outpatient care
* With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022
* Matched with a case on age (+/- 6 months), gender and country
* Not vaccinated for SARS-CoV-2

Exclusion Criteria:

- Refusal to participate by patient relative or legal representative
Retrograde Intrarenal Surgery Low Risk Trial

In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.

This study focuses on flexible ureteroscopic lithotripsy, a procedure commonly used to treat kidney stones and stones in the upper part of the ureter. This surgery is popular because it is minimally invasive and considered very safe. However, there is no clear agreement on whether or which antibiotics should be given to patients before the surgery to prevent infections.

Taiwan is one of the regions in the world with a high rate of urinary tract stones, and because of this, it is especially important to ensure that the best practices are followed to prevent infections during and after the surgery. Currently, there are no official guidelines in Taiwan on which antibiotics should be used before flexible ureteroscopic lithotripsy.

This study aims to compare different types of single-dose antibiotics given before the surgery to see if one is more effective than others in preventing infections. By looking at how different antibiotics perform, the study hopes to provide clearer guidance for doctors in choosing the best antibiotic treatment for patients, ultimately improving patient care and reducing the risk of infections after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Stone diameter \< 3 cm or stone area \< 900 mm2
* Preoperative(2 weeks) negative urine culture
* No active symptoms , including fever, dysuria, urinary frequency, urgency)
* Urinalysis WBC \< 10/HPF

Exclusion Criteria:

* Immunocompromised
* Poor control Diabetes mellitus
* Allergy to antibiotics
* Ureteric stents or Foley catheter present
* Ureteric stricture
* Renal or urethral deformity
* Antibiotic treatment for urinary tract infection in the preceding 4 weeks
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome

The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention

Exclusion Criteria:

* Age \<18 years
* Known coagulopathy, bleeding diathesis, or active bleeding
* History of recent gastrointestinal or genitourinary bleeding within 2 months
* Previous therapy with clopidogrel, prasugrel, or ticagrelor
* Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
* Major surgery within 6 weeks
* History of intracranial bleeding or intracraneal neoplasm
* Suspected aortic dissection
* Chronic obstructive pulmonary disease
* Severe hemodynamic instability or cardiogenic shock
* Resuscitated cardiac arrest
* Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days
* Life expectancy \<1 year
* Known severe liver or renal disease, GFR estimated by CKD-EPI \<30 ml/min/1.73 m2
* Known HIV treatment
* Hemoglobin \<10 g/dL
* Platelet count \<100,000/L
* Pregnancy
* Known allergy to ticagrelor
* Refusal to sign informed consent
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.


Eligibility Criteria:
Inclusion Criteria:

Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels \> 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.

Exclusion Criteria:

Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency