cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer.

This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined.

Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology.

Secondary objectives

* To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
* To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.

Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.

Eligibility Criteria:
Inclusion Criteria:

* All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.

Exclusion Criteria:

* Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent.
* Minor or major patient under guardianship
* Pregnant or breastfeeding woman
Carcinogenicity Study of Bupropion

There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility Criteria:
Inclusion Criteria:

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Exclusion Criteria:

* Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer.
* Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period)
* Any antidepressant use within 6 months of January 1, 1996
Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.

Evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving as determined by self-report and cocaine-positive urine samples.

Eligibility Criteria:
.Inclusion Criteria:

1. Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence
2. Used cocaine at least four days in the past month
3. Individuals must be in good general health
4. Individuals must be capable of giving informed consent and capable of complying with study procedures
5. Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

1. Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
2. Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
3. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
4. Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
5. Individuals with current suicidal risk
6. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP \> 140, diastolic blood pressure \> 90, or heart rate \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases (\< 3x upper limit of normal are acceptable), or uncontrolled diabetes
8. Individuals with a history of seizures, hyperthyroidism and/or glaucoma
9. History of allergic reaction to study medication
10. Women who are pregnant or nursing
11. Currently being prescribed psychotropic medication by another physician (other than sleep medication)
12. Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* The patient is skeletally mature.
* The patient qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: Primary Arthritis (e.g. Degenerative Disease), Secondary Arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved), or Systemic Arthritis of the ankle (e.g. Rheumatoid Arthritis, Hemochromatosis).
* The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
* The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.

Exclusion Criteria:

* The patient is Morbidly Obese (defined by Body Mass Index (BMI) \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
* The patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
* The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
* The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
* The patient is pregnant or plans to become pregnant during the follow up period.
* The patient has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors.
* The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection

Background and Aims

* H.pylori is a common human pathogen by which almost 50% of the world population is infected. According to the accepted guidelines, once H.pylori infection has been diagnosed,first line therapy with three drugs should be given. The triple treatment includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is only 70-80%.
* Curcumin has many beneficial merits and it was also been demonstrated to be efficient in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether addition of Curcumin to the standard triple therapy will increase the eradication rate of H.pylori infection.

Methods

* 150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology department and will be positive for H.pylori according to urease test and then by gastric biopsy, will be included. The patients will be randomized to two different treatments, according to binomial distribution. 75 patients will be treated with the standard triple therapy for 10 days and the other 75, will be treated for 10 days, with triple therapy combined with Curcumin that will be given three times a day.
* During the treatment the patients will complete an adverse effect's questionnaires. 6 weeks after the completion of the treatment the patients will undergo urea breath test to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds or proton-pump-inhibitor until the second urea-breath-test.
* We will compare the eradication rate and the adverse effects between the two groups by using SPSS


Eligibility Criteria:
Inclusion Criteria:

* positivity for Helicobacter pylori by urease test and gastric biopsy

Exclusion Criteria:

* prior treatment for H. pylori
* allergy to penicillin
* gastric outlet obstruction
* pregnancy or breast feeding
* inability to understand the informed consent
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and 2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum concentration (peak) and time to peak) and bioavailability of a single intranasal dose in pediatric patients.

Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC) and other pediatric institutions. This compound is delivered intravenously or intranasally for sedation in children with and without congenital heart disease. Intranasal DEX, though very effective for sedation, has significant variability in its onset and peak effect. Patient care will be significantly improved if factors that determine this variability in onset and peak effect can be determined. Investigators will determine the important early clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour bioavailability of intranasal DEX in children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery.
* The subject must be a candidate to receive DEX. A physician member of the Division of Cardiac Anesthesiology, not involved in the study, will make this decision.
* The subject's legally authorized representative has given written informed consent to participate in the study.

Exclusion Criteria:

* Post-natal age (PNA) \< 6 months
* The subject is allergic to or has a contraindication to DEX
* Severely depressed ventricular function (ejection fraction 30% or less) on preoperative echocardiogram
* The subject has high risk cardiac conduction system disease at the discretion of the attending anesthesiologist or cardiologist.
* The subject has a hemodynamically significant coarctation or other left heart outflow obstruction
* The subject has received digoxin, beta-adrenergic antagonist, or calcium-channel antagonist on the day of the study
* The subject has received DEX within 1 week of the study date (information obtained from: parent or Medical record)
* Subject have nasal/respiratory symptoms which in the opinion of the Principal investigator, may affect intranasal drug absorption.
Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid

The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.

Glioblastoma is the most common primitive cerebral tumor. Currently its optimal treatment is based on a multidisciplinary approach combining an initial surgical resection, if feasible, then Stupp protocol. Stupp protocol consists of two phases: first phase involves external radiotherapy with concomitant oral temozolomide at a dose of 75mg/m2 per day for about six weeks. After 4 weeks of therapy break, maintenance phase begins with temozolomide alone, for a period of 6 cycles (1 cycle = 5 days over 28). The dose of temozolomide is 150mg/m2 on the first cycle followed by 200 mg/m2. One major limiting toxicity of temozolomide is hematologic, especially thrombocytopenia. They occur in around 15 and 20% of patients in maintenance phase. Thrombocytopenia has an impact on the schedule of Stupp protocol such as dose reduction or even early discontinuation. Currently no predictive marker of thrombocytopenia in the maintenance phase was identified. Such marker could be of major interest to adapt biological and clinical follow-up by patient in maintenance phase. We conduct a retrospective analysis on a cohort of patients suffering from glioblastoma and treated with Stupp protocol. We found that a decrease in platelet count during the radio-chemotherapy phase could be highly predictive of protocol changes in maintenance phase of temozolomide due to thrombocytopenia. The main objective of GLIOPLAK is to prospectively confirm the predictive value of this test and to evaluate the prognostic impact of the occurrence of thrombocytopenia \<100,000/mm3. Secondary objective of GLIOPLAK are to describe all limiting toxicities in maintenance phase, to constitute a prospective biological collection and to collect biological samples to perform pharmacological analysis (pharmacogenomics and pharmacokinetics parameters).

Eligibility Criteria:
Inclusion Criteria:

* Age Superior to 18 years
* Inform consent form signed
* Newly diagnosed (histologically) glioblastoma
* Stupp protocol treatment
* with social insurance

Exclusion Criteria:

* Not inform consent form signed
* participation to another clinical trial
* other cancer
* background of hematological pathology
* patient under guardianship, curatorship
A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.

The duration of the dose reduction phase will be 12 months. This phase will have two stage of 6 months, respectively.

The dose of imatinib, nilotinib, dasatinib or bosutinib will be reduced by 25-50% on the first stage, and by another 25% on the second stage.

* The initial dose of imatinib will be 400 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
* The initial dose of nilotinib will be 300 or 400 mg twice daily. The dose will be reduced by 400 mg daily on the first stage, by 200 mg daily - on the second stage.
* The initial dose of dasatinib will be 100 or 140 mg daily. The dose will be reduced by 50 mg daily on the first stage, by 25 mg daily - on the second stage.
* The initial dose of bosutinib will be 500 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.

All patients with stable deep molecular response (at least 2 years) will be included in treatment free remission phase (TFR-phase). The duration of TFR-phase will be 24 months.

The CML patients can enter the study already on reduced doses TKI, if they will meet the inclusion criteria.

It is possible to include patients, who have already received therapy with reduced doses of TKI. The duration of TKI therapy with reduced doses of 1 stage should be at least 6 months, if TKI doses meet of stage 1. The duration of TKI therapy with reduced doses of 2 stage should be for at least 6 months and the general duration of TKI therapy with reduced doses should be for at least 12 months, if TKI doses meet of stage 2.

Eligibility Criteria:
Inclusion Criteria:

1. CML in chronic phase.
2. TKI treatment for at least 3 years.
3. DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years
4. At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR
5. Written Informed Consent
6. CML patients with DMR for at least 1 years and MMR for at least 2 years after STOP TKI in anamnesis.

For patients who are on the reduced dose TKI (1 stage) at the time of inclusion in the study

1. The duration of therapy at reduced doses of TKI phase I is at least 6 months.

For patients on the reduced dose TKI (2 stage, before TFR phase) at the time of inclusion in the study

1. DMR (BCR-ABL≤0.01%) for at least 2 years
2. The duration of therapy at reduced doses of TKI phase 1 is for at least 6 months, the total duration of therapy at reduced doses is for at least 12 months.

Exclusion Criteria:

1. Age under 18
2. ECOG \>2
3. CML in accelerated phase or blast crisis at any time
4. Lack of Written Informed Consent
5. Pregnant or lactating women
6. Incapacity
Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation

The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.

Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.

At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.

The study will last 5 years and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Kidney transplant recipients
* eGFR\>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
* cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/2018.
* Obtaining Informed Consent to Participation.

Exclusion Criteria:

* Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
* Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)
Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis

Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood. The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.

Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood . The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Sufficiently documented medical record.
* Informed patients who did not object to participating in the research, or for deceased patients, did not object to the use of their data.
* Cases: Patients followed for confirmed chronic beryllium disease by expert teams based on the ATS 2014 criteria, i.e., a history of exposure to beryllium, positivity of two abnormal lymphocyte proliferation tests (LPT) in blood and/or an abnormal LPT in bronchoalveolar lavage, granuloma found in pulmonary biopsy associated by compatible clinical, radiological or spirometric abnormalities.
* Controls: Patients followed for sarcoidosis according to the ATS/ERS/WASOG criteria, i.e., (i) a compatible presentation, (ii) the presence of non-necrotizing granulomatosis in one or more tissues (except Löfgren's syndrome or Heerfordt syndrome), (iii) and exclusion of alternative causes of granulomatous diseases with pulmonary parenchymal involvement on thoracic CT and/or chest radiography.
* Controls: without occupational exposure to beryllium.

Exclusion Criteria:

* Patients under trustee.