cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice.

In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 12 to 60 years.
* Parasitologically proven CL due to L. tropica.
* History of failure to at least one full course of systemic Glucantime.
* In general good health based on history and physical examination.
* Number of lesion at most 4.
* Lesion size less than 3 cm.
* Signed informed consent voluntarily and knowingly.

  * Guardian's signature for volunteer less than 18 years old.

Exclusion Criteria:

* Pregnant or lactating women and those who are planning to be pregnant in next 60 days.
* Use of other types of treatment for CL.
* Involvement in any other drug or vaccine trial during the study period.
* Known heart, kidney, liver diseases based on history and physical exam. Abnormal ECG.
Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices

The aim of this study is to evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging, for the prevention of surgical wound hematoma of cardiac implementable electronic devices in patients undergoing chronic oral anticoagulant therapy and/or oral antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients under oral anticoagulation and/or antiplatelet treatment who were going to undergo implantation of an implanted device cardiac stimulation or generator replacement due to battery depletion

Exclusion Criteria:

* insertion of drainage in the wound,
* non-compliance with the pre-surgical antithrombotic protocol
* INR in a high therapeutic range (\>3.5)
* Do not follow-up in the same hospital
* Coagulation and hemostasis disorders
* Replacement of devices due to alterations in the operation unrelated to the battery.
Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks

Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist.

Improved adherence and better quality of procedures are postulated with involvement of social contacts.

The overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks.

These are three sub-projects:

Project 1: Involves recruiting 400 patients referred for colonoscopy by their primary care physicians

Project 2: Involves recruiting 400 patients scheduled for colonoscopy by their endoscopist

Project 3: Involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for out-patient colonoscopy by primary care physicians
* Patients scheduled for out-patient screening colonoscopy
* Patients scheduled for out-patient upper endoscopy

Exclusion Criteria:

* Patients who were referred for colorectal cancer (CRC) screening as in-patients
* Patients with personal history of familial adenomatous polyposis syndrome (FAP)
* Patients with family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC)
* Patients with inflammatory bowel disease
* Patients with Crohn's disease
* Patients with ulcerative colitis
* Patients with personal history of CRC
* Patients who have had colonic resection
Imaging of Vitreous Opacities in a Canadian Population

The goal of this clinical trial is to capture imaging data of eye floaters in the population to build an imaging database to learn more about them in. Participants will imaged with an investigational ophthalmic imaging device to capture images of their floaters.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Symptomatic vitreous opacities (floaters) in vision
* Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

* Younger than 18 years of age
* Presence of vitreous hemorrhage
* Cataract Grade 3 and above
* Opacification of lens, cornea, or vitreous
* Diagnosis of narrow angle glaucoma
* Refractive error is outside the range of -6D to+3D
* Astigmatism is outside the range of +/-2D of cylinder
Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?

This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 65 years old, with a history of hypertension.

Exclusion Criteria:

* Patients less than 65 years old or without a history of hypertension.
Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder

This study will examine whether semaglutide may improve cognitive function in individuals with major depressive disorder (MDD).

This is a 16-week, placebo-controlled, randomized, double-blind, clinical trial, involving 60 overweight individuals with MDD and pre-treatment cognitive dysfunction. Study participants will receive one of the following study interventions in addition to 'standard of care' treatment: once-daily semaglutide, initiated at 3 mg/day for 4 weeks, increased to 7 mg/day for 4 more weeks and titrated to 14 mg/day for the subsequent 8 weeks; or matching placebo. Participants will be assessed to examine the effect of semaglutide on their cognitive function.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent before study-related activity
2. Individuals between the ages of 18 and 60 who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD
3. Overweight (i.e. BMI ≥ 25 kg/m2)
4. Below-average (i.e. \>1 SD below norm) performance in the Trail Making Test-B (TMTB)

Exclusion Criteria:

1. Current, or in the past 4 weeks, treatment with other oral hypoglycemic agents and/or insulin
2. Diagnosis of possible or probable Alzheimer's Disease, Mild Cognitive Impairment, or any other dementia
3. History of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration
4. Severe mood episode, defined as a Hamilton Depression Rating Scale (HAMD-17) score of \>23
5. Actively suicidal or evaluated as being a suicide risk (operationalized as a score of ≥3 on HAMD-17 suicide item and/or by clinical assessment).
6. Substance use disorder within 3 months before screening or a positive baseline toxicology screen
7. DSM-5 diagnosis of obsessive compulsive disorder, posttraumatic stress disorder (current or within the last year), or borderline personality disorder as assessed by a study investigator
8. Presence of absolute or relative contraindication to semaglutide (e.g. hypersensitivity to semaglutide, hepatic impairment, renal impairment with chronic kidney disease stage 3 and above, personal or familial history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2)
9. History of diabetic retinopathy
10. History of pancreatitis or pancreatic cancer
11. Presence of clinically unstable general medical illness
12. Pregnancy or breastfeeding women
Prevention of Coronary Aneurysms in Kawasaki Syndrome

To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.

BACKGROUND:

Kawasaki Syndrome is an acute febrile illness that occurs predominantly in previously healthy young children. It is of unknown etiology and was first described in Japan in 1967. The illness carries an acute mortality rate of approximately 3 percent. The Centers for Disease Control defines Kawasaki Syndrome as a fever lasting five or more days for which no explanation can be found. Patients also must have at least four of the following symptoms: bilateral conjunctival infection; infected or fissured lips, pharynx, or a 'strawberry tongue'; erythema of the palms or soles, or edema of the hands or feet, or generalized or periungual desquamation; rash; and cervical lymphadenopathy.

Coronary artery aneurysms occur in 15-20 percent of children with the illness. In the past, no treatment had been shown to be effective in preventing this complication. Investigators in Japan began to use IVGG to reduce the aneurysm formation. Preliminary results showing the usefulness of this therapy led to a multicenter trial in Japan in which 400 mg/kg/day of IVGG were given for five days to children also receiving aspirin for the condition. Results of the Japanese trial showed that within 29 days of the onset of the disease, coronary artery dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of the IVGG and aspirin-treated children.

DESIGN NARRATIVE:

Phase I was randomized, unblinded and stratified by age, sex, and center. Subjects were randomized to receive either 80 to 120 mg/kg/day of aspirin through day 14 of illness, subsequently reduced to 3 to 5 mg/kg/day as a single daily dose or to 400 mg/kg/day of intravenous gamma globulin for four consecutive days plus aspirin as above. Primary endpoint was formation of aneurysms as demonstrated by echocardiograms. Follow-up was for 7 weeks.

Phase II of the trial began enrollment of 549 patients in May 1986 and ended enrollment in November 1989. Two hundred and seventy six children were randomized to receive 400 mg/kg of intravenous gamma globulin over four consecutive days. Two hundred and seventy-three received a single infusion of 2 g/kg of body weight over 10 hours. Both treatment groups received 100 mg/kg of aspirin per day through day 14 and then 3 to 5 mg/kg per day. The primary outcome variables were the presence or absence of coronary artery abnormalities evident at the two week and seven week follow-up examinations. Echocardiograms were obtained for 523 children at the two week visit and for 520 children at the seven week visit.

Eligibility Criteria:
Boys and girls who met the CDC criteria for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Health, ambulatory male and female subjects between 18 to 55 years of age inclusive
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), naproxen sodium, NSAIDs, acetaminophen, DPH HCL, and similar pharmacological agents or components of the products
* History of hypersensitivity to any of the food products in the standardized breakfast or cannot consume all food/beverage items contained in the standardized breakfast
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the Dosing Periods, other than trial treatment
* Use of any over-the-counter or prescription medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
* Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or 1-2 weeks after treatment
* Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
* History of gastrointestinal bleeding or perforation, related to previous NSAID therapy or active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
* Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws

Systematically compare the phenotype and genotype of epithelial odontogenic tumors in children and adults with a clinical, radiographic, pathologic and molecular level.

Either:

establish an observatory of this multidisciplinary tumor establish a tumor bank annotated scale unparalleled testing pathophysiological hypotheses search for prognostic factors.

This is an observational study with retrospective and prospective parts. In retrospective part be included the Patients followed between 1992 and January 2011.

In prospective part will follow the Patients will be included after the starting of study.

There are 2 centers :

1. st center is in the service of Stomatology and Maxillofacial Surgery in the Pitie Salpetriere Hospital.
2. nd center is in the service of Maxillofacial Surgery in hospital Armand Trousseau.

Number of patients include in the part retrospective :

Center N°1-300adults Center N°2-90childrens

Number of patients include in the part prospective :

Center N°1- 90 Center N°2- 30

Duration of study is 3 years Duration of inclusion is 32 months Each patient will be followed for 4 months and for further up to 3 years from the first patient included.

We envision a next circuit : obtaining consent, preoperative consultation,surgery, postoperative consultation N°1, postoperative consultation N°2, genetics consultation and monitoring of patients in 6;12;18;24 months from surgery of tumor and limited in 3 years from th 1st patient included.

Eligibility Criteria:
Inclusion criteria

1. Patient with an osteolytic lesion of the jaws
2. Patient with epithelial odontogenic tumor:

   keratocysts ameloblastoma Pindborg tumor or calcifying (ESWT) Epidermoid (Squamous Odontogenic Tumor SOT) Clear cell (Clear Odontogenic Tumor Cells CCOT)
3. Patient monitoring in the period 1992 to January 2011 at the Trousseau Hospital (children) or at the Pitie Salpetriere (adult)
4. Patient aged 5 years or more
5. Adult patient who had signed informed consent
6. Holders of parental authority of minor patient were informed and signed consent

Non inclusion criteria

1. Patient with an osteolytic lesion of dental origin inflammatory (adjacent teeth decayed, non-living mortified)
2. Patient with a cyst fissure (nasopalatine, symphyseal or globulomaxillary)
3. Patient with arteriovenous malformation, vascular
4. Patient with cons-indication to MRI
5. Patient not affiliated with a social security scheme (beneficiary or assignee)
6. Pregnant woman
7. Patient in his history of hypersensitivity to salts of gadolinium
8. Patient receiving a measure of legal protection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia

The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM.

The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Known HIV infection with stable HIV therapy for ≥ 6 months
* Cluster of differentiation 4 (CD4) ≥ 250 cells/mm\^3 for ≥ 6 months
* HIV viral load ≤ 50 copies/mL at screening and ≤ 200 copies/mL for ≥ 6 months
* Subject on stable lipid-lowering therapy for ≥ 4 weeks prior to randomization and not expected to change during the duration of study
* For subjects with known clinical atherosclerotic cardiovascular disease (ASCVD), fasting LDL-C of ≥ 70 mg/dL or non-high density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL. For subjects without known clinical ASCVD: fasting LDL-C of ≥ 100 mg/dL or non-HDL-C of ≥ 130 mg/dL
* Fasting triglycerides ≤ 600 mg/dL (6.8 mmol/L)

Exclusion Criteria:

* Taking a combination of background lipid-lowering therapy and HIV therapy known to have significant drug-drug interaction
* New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction (LVEF) \< 30%
* Known opportunistic infection/acquired immunodeficiency syndrome (AIDS) defining illness within 1 year prior to randomization
* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months
* Type 1 diabetes, new-onset or poorly controlled type 2 diabetes
* Uncontrolled hypertension
* Taken a cholesteryl ester transfer protein inhibitor in the last 12 months
* Moderate to severe renal dysfunction
* Persistent active liver disease or hepatic dysfunction (Stable chronic hepatitis C of at least 1 year duration prior to randomization is allowed)
* Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization

Other exclusion criteria may apply.
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
* Elevated testosterone levels
* General good health
* Off of current medications which may confound response to study medications

Exclusion Criteria:

* Pregnancy
* Lactose Intolerance
* Medical Contraindications
* Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
* Diabetes, liver, heart, kidney or uncorrected thyroid disease