cyrilzakka/clinical-trials huggingface dataset:
Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients

Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

Patients with non-valvular atrial fibrillation -treated with dabigatran, rivaroxaban or apixaban - patients affiliated to national social health system -patients who agreed to ethical concerns of the study

Exclusion Criteria:

Patients with consultation or hospitalization that made impossible a veinous punction at the steady state residual concentration time -Patients under guardianship or trusteeship
Molecular Profiling in Lung Cancer Patients

The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.


Eligibility Criteria:
Inclusion Criteria:

* pathologic documentation of non-small cell lung cancer (NSCLC)
* tumor must be accessible by bronchoscopy for tumor tissue sample collection
* patients must have lung cancer with clinical stage IB, II, IIIA
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)

Exclusion Criteria:

* bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
* pregnant or breast feeding patients
* patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
* unwillingness to take folic acid or vitamin B12 supplementation
Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.


Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding the purpose and risks of the study and sign a statement of informed consent
* Male 50-80 years of age
* Presence of LUTS (lower urinary tract symptoms) for at least 3 months
* Prostate volume measured by TRUS (transrectal ultrasound) \> 30 cc
* Qmax \< 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)
* I-PSS (International prostate symptom score) \> 12
* PSA \> 1.0 ng/mL
* Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential
* Able to comply with the prescribed treatment protocol and evaluations

Exclusion Criteria:

* Prior treatment for BPH with alpha-blockers and/or herbal supplements in the past 2 weeks (alpha-blockers and herbal supplements for the treatment of BPH are not allowed during the study). Prior treatment with 5-alpha-reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment.
* Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)
* Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (for subjects with PSA between 4 - 10 ng/mL, prostate cancer must be ruled out to the satisfaction of the Principal Investigator. Subjects with PSA \>10 ng/mL are excluded.)
* Active urinary tract infections (UTI)
* Active cardiac, renal or hepatic disease as evidenced by:

  1. Serum creatinine \> 1.8 mg/dL
  2. ALT or AST \> 2.5x the upper limit of normal at screen
  3. History of active myocardial infarction,unstable cardiac arrhythmias or stroke within 6 months prior to screening
  4. Uncontrolled congestive heart failure
* Uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dL)
* Use of systemic teriods for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
* Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
* Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the investigator,pose an unnaceptabele risk to the subject
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.

Eligibility Criteria:
Inclusion Criteria:

* 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD

Exclusion Criteria:

* Age \> 14 years.
* Patient weighing \< 10 kg.
* History of severe Allergy
* History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
* Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
* Evidence or history of severe, moderate, or uncontrolled systemic disease.
* Inability to follow the prescribed dosing and follow-up schedule.
* Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
* Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
* History of premature birth \<35 weeks' gestation.
* Prior history of stroke in utero or other in utero insult.
Short-term Caregiver Psychotherapy

This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a specifically on the needs of caregivers of people with dementia composed new short-term psychotherapeutical intervention.

This prospective study will be offered to caregivers from the out patient clinic of the Department of Psychosomatic Medicine of the University Rostock Medical Center. In a first pilot study with 10 participants without control group, we tested the feasability and acceptance of the program (completed 2/2015). From 4/2015 a phase IIa study started with 10 participants in the intervention group and 10 in the control groups (will be organized by waiting list). The program consists of two modules of caregiver education followed by ten psychotherapeutic group modules. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module. Primary outcomes are the feasibility, acceptance and the effect on caregiver burden.

Eligibility Criteria:
Inclusion Criteria:

* caregiver of a person with dementia
* willing to participate in all 12 modules of the program

Exclusion Criteria:

* current psychotherapy or antidepressive medication for less than 6 month
* major depression
Ultrasonic Visualization of Obstructive Uropathies in Children

The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.

Relevance. The prevalence of congenital diseases of the genitourinary system is 0.5-7.5 per 1000 newborns; The high prevalence reflects the medical and social significance of the problem and determines the need to search for highly informative and safe diagnostic methods for the child's body, providing timely treatment, restoration of the somatic and social status of children.

Purpose. Development of proposals and recommendations to improve the safety of urological examination of children with obstructive uropathy.

Material and methods. The study is based on the analysis of the results of diagnosis and treatment of 655 children with congenital obstruction of the upper urinary tract. The complex of urological examination included clinical, laboratory, morphological, radiological, ultrasound research methods.

Eligibility Criteria:
Inclusion Criteria:

* 655 children with congenital obstruction of the upper urinary tract

Exclusion Criteria:

* none
Sensor-based Characterization of Depression

This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly.

In this longitudinal study 100 individuals with Major Depressive Disorder (MDD) will be monitored for 12 weeks. Data will include self-report surveys, in-person assessments, physiological features derived by wearable devices and socialization and activity data derived by mobile applications. The study will utilize advanced statistical methods to integrate different sources of passive sensor-based behavioral and physiological data to develop models able to detect depression and predict treatment response.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working smartphone and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.
9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks

Exclusion Criteria:

1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychotic disorder,
3. History of mania or hypomania,
4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Cannot comprehend or communicate in English,
11. Lack of working smartphone or lack of daily access to Internet service,
12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.
Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19

The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Patients that are classified as a "confirmed case" according to criteria established by the Spanish Ministry of Health in its Technical Document updated on March 31, 2020. This defines a "confirmed case" as a case that meets laboratory criteria (Positive PCR test for any of the SARS-CoV-2 genes).
* Patients admitted to ICU.
* Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O.
* Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician.
* Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.

Exclusion Criteria:

* Patients being treated with veno-venous or veno-arterial ECMO
* Patient with therapeutic restrictions due to life support
* Patient who presents a complication that requires surgical intervention.
Combined Treatment for Cocaine-Alcohol Dependence - 1

The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.

This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Give informed consent
* Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
* Be between 18 and 60 years old
* Meet DSM-IV criteria for both current cocaine and alcohol dependence
* Be in acceptable health based on physical exam, lab tests, and EKG
* Have a stable living situation and the availability of at least two locators
* Be able to read and write English at the 6th grade level
* Provide a least one cocaine positive urine during intake
* If female, must agree to use contraception

Exclusion Criteria:

* History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
* Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
* Abnormal liver function test results (both ALT and AST \>3x upper limit normal or either \>5x upper limit normal)
* Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
* Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
* Participating in 12 step meetings more than twice weekly
* Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
* Current dependence on any psychoactive disorder other than nicotine
* Impending incarceration
* Condition of probation or parole requiring reports of drug use to officers of the court
* Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
* Plans to move from the Houston area within the next three months
Endometrial Polyps Regression With Progesterone Therapy

This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle

In premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. According to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. Studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. Up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. Our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment.

Accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle

Eligibility Criteria:
Inclusion Criteria:

* ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
* signed informed consent

Exclusion Criteria:

* estrogenic and\\or progestinic therapy two months before the enrollment
* tamoxifen therapy
* pelvic inflammatory disease
* gynaecologic neoplasia
* previous chemotherapy and radiotherapy
* autoimmune diseases, chronic disease, metabolic, and endocrine (hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease)
* menopause
* Hypogonadotropic hypogonadism
* drugs causing menstrual irregularities
Physiological Response to Salbutamol and Exercise

The scope of the study is to investigate the physiological response to salbutamol and exercise. A particular focus is on the metabolic response and amine metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* VO2max of \>55 ml/min/kg for men and \>50 ml/min/kg for women
* Body mass index (BMI) \< 26

Exclusion Criteria:

* Chronic use of beta2-agonist or allergy towards beta2-agonist
* Serious adverse effects to beta2-agonist
* Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
* Smoking
* Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
* Pregnancy (for women)
Safety and Efficacy Study of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction (STEMI) and Analysis of Current Status of Emergency PCI Green Channel for STEMI Patients in China

This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥18 years and ≤75 of age.
2. Prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) ST-segment elevation ≥ at least 2 leads, with reciprocal ST-segment elevation ≥ 0.05mv and precordial leads ST-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
3. Symptoms ≥ 30 min and ≤12 hours
4. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
5. All lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more Cypher® Sirolimus-Eluting Coronary Stent System or Endeavor® Zotarolimus-Eluting Coronary Stent
6. The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

1. Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
2. Systemic (intravenous) Sirolimus use within 12 months.
3. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
6. Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL.
7. Fibrinolytic therapy for current MI treatment
8. Previous coronary intervention on target vessel or post-CABG vessel disease
9. Transplant patients
10. Patients with EF\<25%
11. Patients with cardiogenic shock; with a life expectancy shorter than 12 months
12. Severe kidney dysfunction: Creatinine level ≥2.0mg/dL or dependence on dialysis.
13. Severe hepatic dysfunction (AST and ALT ≥ 3 times upper normal reference values).
14. The patient is currently, and during the CREST-MI Study, participating in another investigational device or drug study that clinically interferes with the CREST-MI study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the CREST-MI Study once.
15. Severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.