cyrilzakka/clinical-trials huggingface dataset:
What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters

the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate

the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate.

Eligibility Criteria:
Inclusion Criteria:

* all patient who received fibrinogen concentrate

Exclusion Criteria:

* none
A Model for Genetic Susceptibility: Melanoma

The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others are. To do this we will compare people who have had more than one melanoma to people who have had only one melanoma and to people who are similar but who have not developed melanoma.

People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Each person has many ways to repair normal damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect the way the skin itself reacts to the sun. We want to find out which genes have normal changes in them and lead to different responses to exposures, such as the sun. We also want to find out if sun habits are related to the way these genes work.

The purpose of this study is to better understand genetic susceptibility to melanoma and the interactions of specific polymorphisms with each other and with environmental factors.

To accomplish this, buccal swabs or blood specimens from patients with melanoma (either single primary or multiple primary) have been collected. Specimens will be prepared in the Epidemiology Laboratory at MSKCC. They will be analyzed at MSKCC for INK4A (and functional assays for DNA repair capacity when blood is available) and the melanocortin gene (MC1R), at the University of North Carolina for polymorphisms in DNA repair genes and immune function genes, at the University of Pennsylvania for polymorphisms in the melanocortin receptor gene (MC1R) and immune function genes, and at the University of California (Irvine) for polymorphisms in metabolizing genes (P450's and GST's). Samples will be banked at MSKCC and the University of New Mexico. In order to perform this study, subjects from population-based registries in the United States (New Jersey, North Carolina, Michigan, San Diego/Imperial Counties), Canada (Cancer Care Ontario, British Columbia), Italy (Turin), Australia (New South Wales, Tasmania), were interviewed, asked to provide blood or buccal swab samples and asked to provide permission to obtain and review slides of their primary melanoma. This study is now closed to accrual.

Eligibility Criteria:
Inclusion Criteria:

- The subject must have a histologically confirmed invasive first primary melanoma newly diagnosed between January 1, 2000 and December 31, 2000.

OR the subject must have a histologically confirmed invasive or in situ second primary melanoma newly diagnosed between January 1, 1998 and December 31, 2003. One of the earlier primaries must be invasive melanoma OR the subject must be a randomly ascertained control from the general.

- The patient must be a resident of a one of the specific geographic areas participating in this study.

Exclusion Criteria:

* Subjects who do not speak English or Italian
* Subject is unable to sign informed consent
* Subject is unable to participate in telephone interview
Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.

This trial is conducted in Europe. The aim of this trial is, to investigate the effect of upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 18.5-39.9 kg/m\^2 (both inclusive)
* Subjects diagnosed clinically with type 2 diabetes mellitus for at least 180 days prior to the first screening visit
* For subjects with upper gastrointestinal (GI) disease: Diagnosed with chronic gastritis and/or gastroesophageal reflux disease (GERD) at screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Unable or unwilling to refrain from smoking during the in-patient periods
* Any blood draw in excess of 50 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within 90 days of the first screening visit
Trottinettes Urgences 2019-2020

The purpose of the study was to evaluate the risk, consequences and epidemiology of electric scooter accidents admitted to the emergency room at St. Pierre University Hospital.

This prospective observational study aims to include any patient admitted to the Adult Emergency Department of St.Pierre University Hospital Brussels following an accident related to the use of an electric scooter in order to describe and understand the epidemiology, complications and treatment of injuries associated with this means of transport.

It is intended to include all accidents occurring in the emergency room during the period from 01/06/2019 to 30/06/2020.

All patients over the age of 16 years with traumatic injuries due to an accident related to the use of an electric scooter were included in the study.

Upon admission to the Emergency Department, patients over 16 years of age who accepted were included in the study. The objectives of the study were firstly to describe the context and incidence of scooter accidents, and secondly to understand the epidemiology, complications and treatment of injuries associated with this means of transport and finally, to estimate the economic impact assessed by the number of days of post-traumatic work disability, the need for access to more specialised and therefore more expensive care (operating theatre interventions, scanner-type radiological examinations or hospitalisation in intensive care units).

The data analyzed were based on :

1) the time and day of the accident, 2) the time of presentation at the hospital (same day or after the accident), 3) the mechanism of the accident, whether there were one or two people on the scooter, 4) the use or non-use of the protective helmet, 5) the influence of alcohol ; 6) the mode of arrival at the emergency room (type of ambulance or by one's own means); 7) the injury assessment, paraclinical examinations; 8) treatments; 9) hospitalization or not; 10) temporary work interruptions .

Eligibility Criteria:
Inclusion criteria:

* All patients with traumatic lesion following electric sccoter accident
* Be able to agree to participate in the study

Exclusion Criteria:

* \< 16 years
* Unconscious
* Being unable to agree to participate in the study
Parental Satisfaction of Hall Technique Versus SDF in the Management of Carious Primary Molars

* The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp.
* primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4
* secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

dental caries is a critical disease that affects primary teeth in early childhood. It occurs through interaction between acid-producing bacteria and carbohydrates on tooth surface. progression of caries depends on several factors such as type of diet, oral hygiene, cariogenic bacterial load and salivary flow. to control caries, the life style of a child should be improved by having healthy non-cariogenic diet and proper oral hygiene.

caries can be treated by advanced non-invasive methods such as: Hall technique and Silver diamine fluoride which are based on controlling the acidic medium of a cariogenic biofilm without removal of caries thus, arresting the progression of demineralization and restoring the function of diseased molars.

The first report on Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique through a more simplified method.

Previous studies have recommended silver diamine fluoride (SDF) to arrest early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention.

The trial is seeking the measurement of effectiveness of two modalities (Hall \& SDF techniques) to achieve best acceptable treatment for caries in developing countries which have high caries index.

Eligibility Criteria:
Inclusion Criteria:

* 1 age: from 4 to 6 years old
* 2 primary molars with enamel/dentin caries without pulp exposure

Exclusion Criteria:

* 1 signs and symptoms of necrosis
* 2 root caries
* 3 spontaneous pain
Liposomal Doxorubicin in Treating Patients With Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Estimate the objective response rate of patients with hormone refractory prostate cancer treated with doxorubicin HCl liposome. II. Determine the toxic effects (including any cumulative cardiotoxicity) of this regimen in these patients. III. Assess the effect of this regimen on pain and quality of life of these patients.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 50 evaluable patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory prostate cancer Castrate serum testosterone levels less than 30 mg/dL occurring at least 4 weeks since prior flutamide or at least 6 weeks since prior bicalutamide Measurable or evaluable progressive disease Rising PSA involving two determinations (one at least 20 ng/mL if PSA is sole criterion) at least two weeks apart OR Increasing measurable or evaluable disease OR New metastasis

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatic insufficiency Renal: Creatinine no greater than 2.0 mg/dL No renal failure Cardiovascular: Cardiac ejection fraction at least 50% by radionuclide ventriculogram No myocardial infarction within the past year No active angina No congestive heart failure No arrhythmias requiring medication Other: No active peptic ulcers No uncontrolled infection or other serious medical condition that would prevent compliance with chemotherapy No uncontrolled diabetes No spinal cord compression or carcinomatous meningitis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy Concurrent gonadotropin-releasing hormone analogue allowed Radiotherapy: At least 2 months since prior radiotherapy (not to a measurable lesion) Concurrent palliative radiotherapy allowed Surgery: Not specified
Qualitative Research on Women With Congenital Adrenal Hyperplasia

This qualitative interview-based study will investigate the impact that living with congenital adrenal hyperplasia has for women in the following areas: health-related quality of life (HRQL), psychological health, and health-seeking behaviors.

Congenital Adrenal Hyperplasia is a chronic-illness requiring life-long treatment and is caused by an inherited enzyme deficiency that leads to an overproduction of hormones produced by the adrenal glands, which in turn, masculinizes the female genitalia before birth. While the mechanisms by which CAH influences physiological development are understood, the impact of this hormonal elevation on health-related quality of life (HRQL), psychological health, and health-seeking behaviors is less clear. This study is guided by three research questions: (1) how does CAH influence HRQL domains (physical, functional, emotional and interpersonally), (2) how does CAH influence the mental health of women diagnosed with CAH, and (3) how does CAH influence decisions to seek help from a counselor? Semi-structured qualitative interviews will be conducted with women with CAH. Interviews will be analyzed through the Consensual Qualitative Research (CQR) methodology.

Eligibility Criteria:
Inclusion Criteria:

* 46XX, Females
* Diagnosed by a physician with CAH (either simple-virilizing or salt-losing types)
* Willing to complete a brief demographic questionnaire and participate in an hour long telephone interview

Exclusion Criteria:

* Non-classical or late-onset CAH
Perimenopausal Estrogen Replacement Therapy Study

Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in women after the menopause. Depression has been associated with an increased risk for CVD morbidity and mortality. Even histories of recurrent depression in euthymic individuals are associated with elevated CV risk. Understanding the depression-CVD link may have particular relevance for women since women experience depression at a rate twice that of men. Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both CVD and depression in women. The perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the pathophysiology of CV risk and depression in women.

The primary objective of this study is to examine the prophylactic role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. The investigators predict that women susceptible to depression will be particularly vulnerable to the acceleration of CVD in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of CV risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* must be between 45 and 60 years of age
* must be in the menopause transition (irregular/ absent menstrual cycles or hot flashes)
* must be are medically healthy

Exclusion Criteria:

- currently taking antidepressant medication
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery.

Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.


Eligibility Criteria:
Inclusion Criteria:

* Macular pathology

Exclusion Criteria:

* No prior vitreoretinal surgery
Natural History Study of Children With Metachromatic Leukodystrophy

The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).

Metachromatic leukodystrophy (MLD) is an inherited, autosomal recessive disorder of lipid metabolism characterized by deficient activity of the lysosomal enzyme, arylsulfatase A (ASA). MLD is a rare genetic disease that occurs in most parts of the world. The estimated overall incidence of the disease in the western world is approximately 1 in 100,000 live births.

This study is a multicenter, observational, longitudinal study that plans to enroll up to 30 patients with onset of MLD-related signs and symptoms prior to 30 months of age and who are less than 12 years of age. Patients will participate in this study for approximately 114 weeks (Screening through Follow-up) and will be assessed at defined intervals for disease status.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of MLD by both:

   * arylsulfatase A (ASA) deficiency by assay in leukocytes AND
   * elevated sulfatide in urine
2. Appearance of the first symptoms of disease at or before 30 months of age.
3. A GMFM-88 total (percent) score greater than or equal to 40 at the screening examination.
4. The patient is less than 12 years of age at the time of enrollment.
5. The patient and his/her parent or legally authorized representative(s) must have the ability to comply with the clinical protocol.
6. Patient's parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the patient.

Exclusion Criteria:

1. History of hematopoietic stem cell transplantation.
2. The patient has any known or suspected hypersensitivity to agents used for anesthesia or is thought to be at an unacceptably high risk for associated potential complications of airway compromise or other conditions.
3. Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
4. The patient is enrolled in another clinical study that involves the use of any investigational product (drug or device) within 30 days prior to study enrollment or at any time during the study.
Artificial Intelligence for Detecting Retinal Diseases

The objective of this study is to apply an artificial intelligence algorithm to diagnose multi retinal diseases from fundus photography. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

The objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Eligibility Criteria:
Inclusion Criteria:

* fundus photography around 45° field which covers optic disc and macula
* complete identification information

Exclusion Criteria:

* insufficient information for diagnosis.
Increasing Colorectal Cancer Screening in Urban African American Communities Via Churches

This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body \& Soul program, a program to increase fruit and vegetable intake. The investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.


Eligibility Criteria:
Inclusion Criteria:

* Members of African-American churches who are at least 50 years old.

Exclusion Criteria:

* Non-members of African-American churches; members who are under 50 years of age.
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Robotic or Video-Assisted Lung Resection for All Indications

Exclusion Criteria:

* Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
* Extra-Thoracic Procedures
* Hypersensitivity to Amide Local Analgesia
* Cardiac Conduction Abnormalities
* Hepatic Dysfunction
* Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage