cyrilzakka/clinical-trials huggingface dataset:
Apixaban in Hemodialysis

This study aims to determine the effects of end-stage renal disease on the pharmacokinetics, pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days. The concentration of the drug will be measured with repetitive blood tests the first and the eighth day of administration (non-dialysis days). The same blood tests will be repeated before, during, and after dialysis on dialysis days. If the study shows inadequate or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily dose.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* end-stage renal disease on stable hemodialysis treatment (3 weekly sessions of 4 hours) for at least 6 months
* no residual kidney function
* non-valvular atrial fibrillation

Exclusion Criteria:

* age ≥80 years
* Body mass index (BMI)\<21 or BMI\>40
* active bleeding
* high bleeding risk (HAS BLED score \>3)
* active malignancy
* psychiatric disorders
* decompensated thyroid disorders
* decompensated heart failure
* acute myocardial infarction-cerebrovascular accident-head trauma in the last 3 months
* previous history of venous thromboembolic disease in the last 6 months
* previous history of coagulopathy already treated by vitamin K antagonists (VKAs) or novel oral anticoagulants
* uncorrected rhythm or conduction disturbances
* dual antiplatelet therapy
* known liver disease or elevated transaminases \> 2x upper limit of normal
* Hemoglobin \< 90 g/l
* platelets \< 100,000 /ml
* known hypersensitivity to apixaban
* treatment with a potent inhibitor or inducer of the cytochrome P450 3A4 and/or P-glycoprotein
* absence of effective contraception where applicable
* drug or alcohol abuse
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old

Background: Compared to term-born peers, very preterm children generally perform poorly in executive functions, with a significant impact on learning at school and quality of life. These EF deficits are related to microstructural abnormalities in white matter and subcortical brain structure.

Objective: To investigate if an alteration of cerebral metabolism in very premature at term corrected-age correlates to executive dysfunctions at school age.

Design, setting, patients: Very preterm patients eligible for Epirmex underwent cerebral Magnetic Resonance Imaging at term-equivalent age and 1H-MRS using a monovoxel technique. The volumes of interest were the posterior periventricular white matter zone and the basal ganglia and thalamus The ratios of N Acetyl Aspartate (NAA) to Choline (cho), NAA to Creatine(Cre), Cho to Cr, and Lac (Lactate) to Cr were calculated.

Main outcome measures: Survival at 5 ½ years with or without neurodevelopmental disabilities (composed of cerebral palsy, visual, hearing, cognitive deficiency, behavioral difficulties, or developmental coordination disorders) were described. The executive functions were assessed using two indices from the Wechsler Intelligence Scale measured in the EPIPAGE 2 cohort at age five-and one-half years: the Working Memory Index (WMI) and the Fluid Reasoning Index (FRI).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria form EPIPAGE2 and EPIRMEX
* Children who underwent spectroscopy with regions of interest analyzed: periventricular zone, gray nuclei, brainstem.
* Children who received a complete cognitive assessment in EPIRMEX (integrated assessment identical to that planned in EPIPAGE2) at age 5 ½.

Non-inclusion Criteria:

* Children with severe karyotype abnormalities.
* Children with central nervous system malformations diagnosed antenatally or on neonatal tests
* Children with severe cerebral palsy or major neurosensory (blindness, profound deafness...) not allowing children to take the tests scheduled at age 5 ½.
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for subjects and partdners
* Men 20-65
* stable monogamous relation at least for 6 mn
* PEDT more than 9
* at least 6 Mn of premature ejaculation Hx
* IELT of =\< 2 min in \>= 75% of evaluable events during 4 week secreening period

Exclusion Criteria:

* Hx of medical or psychiartric illness
* erectile dysfunction (\<21 IIEF EF domain score) or other forms of sexual dysfunction
* Partner sexual dysfunction
* known hypersensitivity to clomipramine and contraindications for clomipramine
The Trio Laser Module for Hair Removal Treatment

The study is aimed to assess the safety and efficacy of hair removal treatments, using the Trio Laser Module (Alma Lasers).

The study will include 36 subjects that will undergo axilla and bikini line hair removal treatments. Safety and efficacy will be evaluated 3- months after the last treatment.


Eligibility Criteria:
Inclusion Criteria:

* Willing to undergo hair removal treatments at the Axilla and the Bikini line.
* Between 18 and 70 years of age.
* Reasonably good health, as defined by the Investigator.
* Agrees to avoid tanning during their participation in this study.
* Agrees to shave the treatment area prior to the treatment visit, according to the investigator's instructions.
* Subjects with dark brown hair.
* Eligible for treatment following a test spot without negative effects.
* Provided written Informed Consent and photo consent.

Exclusion Criteria:

* History of laser hair removal in the treatment area.
* Pregnant, lactating or planning to get pregnant within the study period.
* Unwilling to use a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, if of childbearing age.
* History of photosensitivity or use of medication with photosensitizing properties.
* Active infection in the treatment area.
* History or evidence of any chronic or reoccurring skin disease or disorder affecting the treatment area.
* History of keloid scarring or hypertrophic scar formation.
* Tattoo in the treatment area.
* Subject has been tanning within the past 30 days.
* History of confounding cancerous or pre-cancerous skin lesions in the treatment area.
* History of connective, metabolic or atrophic skin disease.
* Subject has used prohibited therapies, oral prescription medication, or topical meds (steroids) on the treatment area within 30 days prior to enrollment.
* History of autoimmune disorder
A Global Imatinib and Nilotinib Pregnancy Exposure Registry

This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
* Be at least 18 years of age
* Reside in a country supported by the Registry

Exclusion Criteria:

* Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures

Other protocol-defined inclusion/exclusion criteria may apply
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

Hypothesis 1: Blood alcohol concentration will be \<25 mg/100ml (equivalent to a blood alcohol concentration of \<0.025%) after a 1 hour urinary catheter ethanol lock.

Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.

This study involves a confirmatory/refuting approach to the above stated hypothesis. The investigators will test this hypothesis by addressing the following aims/objectives:

Specific Aim 1:

Quantify blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized in the Pediatric Intensive Care Unit.

Specific Aim 2:

Compare cellular components in urinalyses after the introduction of the ethanol locks.

Potential study subjects will be recruited from the Children's Healthcare of Atlanta - Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling urinary catheter for \>48 hours will be included. For this pilot study, the investigators will enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a service other than Critical Care Medicine will have clearance from the primary team prior to approaching for enrollment. The consent process will take place prior to or during the initial 24 hours of urinary catheter placement.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 months - 17 years
* Urinary catheter placed at Children's Healthcare of Atlanta
* Anticipated urinary catheter need for \> 48 hours
* Parent or legal guardian (or patient when applicable) consent for enrollment.

Exclusion Criteria:

* 18 yo or older.
* Urosepsis at time of study enrollment
* Known bladder or genitourinary abnormalities
* Chronic bladder drainage regimen
* Urologic surgeries (as part of the current admission)
* Medical urgency preventing timely administration of the consenting process, or any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
* Anuria or oliguria (\<0.5 cc/kg/hr averaged over the previous 12 hours)
* Other technical considerations that would prevent the timely acquisition of sufficient samples such as (but not limited to) absence of a study team member.
* Parent or legal guardian (or patient when applicable) refuses to sign informed consent.
Robotic Laparoscopic Radical Prostatectomy

This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.

To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent
2. Locally confined, stage T1a, T2a or T2b prostate cancer
3. Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
4. Serum prostate specific antigen equal to or less than 10mg/ml
5. Histologically confirmed adenocarcinoma of the prostate
6. Gleason score equal to or less than 7
7. Life expectancy of greater than 10 years.
8. Prostate size on TRUS measurement less than 40 grams

Exclusion Criteria:

1. Patients who have undergone prior hormone therapy.
2. Patients with a previous transurethral resectioning of the prostate (TURP)
3. History of other cancers other than basal cell carcinoma.
4. Patients with any prior abdominal surgery.
5. Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions)
6. Patients with a large median lobe of the prostate. -

Exclusion Criteria:

-
The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia

Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether or not can reduce the amount of local anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent；
* American Society of Anesthesiologists (ASA)classification:class I\~II;Elective minimally invasive spine surgery；
* Age ≥18 years old, weighing 45 \~ 80 Kg, height 151 \~ 185 cm;
* hypertension within Ⅱ grade, or controlled with drugs within Ⅱ level；
* Diabetes fasting in 8.3mol/L or less

Exclusion Criteria:

* DEX allergy;
* Change anesthesia preoperative or intraoperative ;
* metabolic disorders, anemia has not been corrected;
* recent patients receiving sedatives and antidepressants;
* degenerative diseases of the central nervous elderly persons;
* serious central nervous system diseases (acute stroke, uncontrolled epilepsy, severe dementia);
* hypovolemia; 8) unstable angina or acute myocardial infarction;
* left ventricular ejection fraction less than 30%, heart rate lower than 45bpm;
* II-III degree heart block;
* acute hepatitis or severe liver disease (liver function C level);
* patients with renal insufficiency randomly assigned to receive treatment, but If patients need dialysis test is excluded or interruption ;
ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients

The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).

Over the last ten years, substantial improvements have been made both in terms of diagnostic (immunohistochemistry and molecular biology) and therapeutic. New treatments have been marketed and are now available in clinic.

New therapeutical strategies have been launched and have proved their efficacy in clinical studies or meta-analyses, generally increasing the survival rate of patients by a few months. However, little information still exists on the use and effectiveness of these molecules in clinical practice.

The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years of treatment. This study should improve knowledge of the PLC treatment management in General Hospital Centres.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020\*
* Follow-up by a lung specialist at a General Hospital
* Oral informed consent \* date of collected sample

Exclusion Criteria:

* Age \< 18 years
* Secondary lung cancer
* Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery
* Previous enrolment in the study
* Freedom deprived patient following a legal or administrative decision
* Patient unable to give his(her) consent
Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern

To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

Eligibility Criteria:
Inclusion Criteria:

1. Stable chest pain, typical or atypical angina or anginal equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria:

1. History of myocardial infarction
2. Current myocardial infarct (MI) or acute coronary syndrome
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
4. Any previous coronary revascularization
5. Any individuals with:

   1. Diabetes
   2. Suspected unstable angina
   3. Systemic infections
   4. Systemic inflammatory conditions
6. Any individuals currently taking:

   1. Steroids
   2. Immunosuppressive agents
   3. Chemotherapeutic agents
7. Recipient of any organ transplant
Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2

The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.

Conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. The remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. Currently, the administration of mesenchymal stem cells (MSCs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. Particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. Nevertheless, MSC transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. In the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. In addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). The investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-MSCs is sufficient to stimulate would healing.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 40 and 80 years, inclusive, with Type 1 or 2 diabetes as defined by the American Diabetes Association
* Stable glycemic control
* Transcutaneous oxygen measurement \> 30 mmHg
* Ulcer present at least for 1 month
* Wound size between 0.5 and 5 cm2
* Subjects that require endovascular surgical intervention
* Subjects must have adequate nutrition (albumin level \> 2 g/dL and prealbumin level \> 15 mg/dL)

Exclusion Criteria:

* Previous or current diagnoses with one of the following: cancer, symptomatic coronary artery disease, brain disease, kidney failure, blood disorders
* Taking immunosuppressive and cytotoxic drugs
* Presence of active systemic infection
Counseling on Injectable Contraception and HIV Risk in Tanzania

The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.

The evaluation assessed the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention. The intervention was conducted September-November 2018 in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania. Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention. Univariate and bivariate analyses were used to assess quantitative interview data. Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. Interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.

Eligibility Criteria:
Inclusion Criteria:

* Expressed interest in injectable use
* HIV-negative or unknown HIV status

Exclusion Criteria:

* Positive HIV status known to healthcare provider
The Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms

Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.

Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.

Eligibility Criteria:
Inclusion Criteria:

1. DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms
2. Stenosis caused by atherosclerosis

Exclusion Criteria:

1. patients do not agree
2. Stenosis caused by no atherosclerosis disease
A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct

The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.

The research contents of this study include: patients with insulinoma near the main pancreatic duct in the head and neck of the pancreas were randomly divided into two groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct stent before surgery, and the next day or the next day after surgery, and the den group received enucleation directly. The safety of the two groups was compared, including the evaluation of surgical effect Postoperative complications and long-term prognosis based on follow-up data analysis; At the same time, the differences between the two groups were evaluated from the perspective of health economics.

Eligibility Criteria:
Inclusion Criteria:

* The clinical qualitative diagnosis of insulinoma was clear;
* The localization diagnosis was clear, and it was determined that the tumor was single, located in the head and neck;
* The distance between the tumor and the main pancreatic duct was determined to be ≤ 2mm by preoperative imaging (enhanced CT, MRI, etc.);
* Truly informed and voluntarily participate in this study.

Exclusion Criteria:

* Maximum diameter of the tumor \>2cm proved pathologically
* Severe cardiopulmonary complications before operation
* Combined with other known tumor diseases
* Insulinoma is invasive or has suspicious metastatic lesions
* Previous upper abdominal surgery history
* Refusal or inability to cooperate in the study