cyrilzakka/clinical-trials huggingface dataset:
Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation

The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.

The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients in preventing cardiotoxicity when administered immediately after transplantation.

The effect of medication will be studied in detail:

i) in global longitudinal strain of left ventricle (GLS), ii) in the volume change of the right and the left ventricle, through the cardiac cycle using 3D echocardiography, iii) in the Myocardial Work Index (MWI) of the left ventricle, with a strain -pressure curve study iv) in the 4D strain of the left atrium, v) in elastic properties of aorta (pulse wave velocity (PWV), central systolic pressure (CSBP-mmHg) and augmentation index (Aix%), vii) in permeability of glycocalyx and viii) in serum biomarker values, namely troponin I high sensitivity and atrial natriuretic peptide (NT-proBNP).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents male and female
* that have just been treated with bone marrow transplantation due to haematological malignancies.

Exclusion Criteria:

* Coronary Artery Disease
* Permanent Atrial Fibrilation
* Signs of Left Ventricular Hypertrophy on electrocardiography or echocardiography
* Left ventricle Ejection Fraction\<50% or segmental wall motion abnormalities of left ventricle
* More than moderate valvular disease
* Primary Myocardiopathy
* Blood Pressure\<90 mmHg
* GFR\<30 ml/min/1,73m2
* Unwilling to recruit
* Uncontrolled Arterial hypertension
Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs

The American Society of Anesthesiologists Task Force on Management, Chronic Pain section, recommended Phenol neurolysis when other techniques have failed to provide adequate pain control. In this study we sought to Compare the pain relieve on a Lower Back and Limbs obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach. The study includes patients who suffers from a chronic low back and/or limbs pain which were referred to be given epidural as a treatment. Control group receives 80 mg Methylprednisolone while the test group receives phenol 8%.


Eligibility Criteria:
Inclusion Criteria: -at least 18 years of age;

* chronic low back pain of at least 12 weeks duration;
* patients which were diagnosed as a candidate for epidural since other techniques have failed to provide adequate pain control
* Sciatica due to Lumbar Disc Herniation
* Neurogenic Claudication due to Lumbar Spinal Stenosis

Exclusion Criteria:

* patients with unbalanced high blood pressure
* patients who can not ley prone
* patients who consumes anti-clotting medications
* patients with bleeding problems
* patients with Diabetes
* patients who suffers from chronic non-specific lower back and limb pain
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.

The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the MOH).

In-hospital morbidity are similarly expected to be lower in the endovascular group. The investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

The following anatomical inclusion criteria must be met:

* Absence of significant angulations (\< 60°) of aorta or of iliac arteries
* Absence of tight stenosis (\>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
* Diameter of target arteries over 5 mm
* Iliac and femoral arteries allowing insertion of the delivery system (\> 7 mm) or suitable for insertion of an access conduit

Exclusion Criteria:

* Limited expected life expectancy
* Emergency cases
* Refuse to participate to the study
Hypersensitivity Reactions During Anesthesia

Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients over age 18 undergoing surgery at Mayo Clinic Florida

Exclusion Criteria:

* Minors under age 18
* Unable to consent
Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts

Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.

Ventricular tachycardia (VT) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in Europe every year. The gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks.

In order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the VT, and then to perform a mapping of its circuit. Once this circuit is clearly defined, ablation of the critical part of the circuit, so called VT isthmus can be performed, using a radiofrequency power. One of the limitations of this technique is that it requires VT induction during the procedure, and that the VT lasts long enough to enable its mapping.

Nancy University Hospital developed a technique using pace mapping to define the VT isthmus even when the VT is not sustained. The pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the VT isthmus.

During this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.

Eligibility Criteria:
Inclusion Criteria:

* Presenting one of these conditions :
* patients undergoing a VT ablation and myocardial infarction history
* patients with myocardial infarction history without VT history
* patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation)

Exclusion Criteria:

* pregnancy
* LVEF (left ventricular ejection fraction ) \<20 %
* hemorrhagic stroke history
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, \>/= 18 years of age
* Histologically confirmed HER2-negative breast cancer
* Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
* Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
* ECOG performance status 0-2
* At least 28 days since prior radiation therapy or surgery and recovery from treatment

Exclusion Criteria:

* Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
* Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
* Inadequate renal function
* Clinically relevant cardio-vascular disease
* Known CNS disease except for treated brain metastases
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
* Pregnant or lactating women
Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) physical status I or II
* Scheduled as live liver donors
* J-shaped incision in the supraumblical region

Exclusion Criteria:

* Patients with a history of psychiatric/neurological illness,
* Hypertensive patients,
* Morbidly obese patients,
* Pregnant and nursing women,
* Patients with known allergic reaction to any of the study medications,
* Patients on recent use of sedatives or analgesics,
* Patients with significant laboratory abnormalities
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.

Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high. The original report from HACA-group reported that hypothermia treated patients had improved survival and neurological outcome. Suprisingly, in that trial normocarbia was not achieved even though the aim was set for ventilatory support as normoventilation. This study aims to investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow, intracranial pressure) and metabolism (microdialysate metabolites). We hypothesize that uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal damage, conversely, further improvement in outcome may be achieved with succesfull ventilatory management. We intend to enroll 10 out-of-hospital cardiac arrest patients succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours. The patients in need of anticoagulation are excluded. We plan to induce mild hypocarbia and hypercarbia during and after induced hypothermia. Metabolic and perfusion data are collected with clinically used methods such as transcranial doppler, intracranial pressure measurement, near infrared spectroscopy, jugular bulb, intracerebral microdialysis).


Eligibility Criteria:
Inclusion Criteria:

succesfull resuscitation of out of hospital cardiac arrest, primary rhytm shockable

Exclusion Criteria:

* known coagulopathy, need of anticoagulation therapy, need of interventional cardiological procedures
Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda

Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for gathering richer and more relevant data through repeated, longitudinal sampling of participants in their natural setting in order to deliver real-time interventions. The main study objective is to conduct a pilot EMAI study in Rakai, Uganda. Secondary objectives are to assess processes, facilitators, and barriers to EMAI. The study will compare behaviors between participants randomized to receive intervention messages and those not receiving messages. To assess EMAI validity and relevance, EMAI-collected behavioral data will be compared with traditional questionnaire-collected data.

After recruitment, participants will be given a smartphone with an application that will collect geospatial coordinates and ask behavioral assessment questions on topics including diet/alcohol, smoking, and sexual behaviors. Participants will have training on the phone and application, demonstrating proficiency with the EMAI interface prior to study start.

Days 1-30, Baseline Behaviors: Participants will complete assessment questions to establish baseline behaviors. This will include twice-daily and weekly behavioral report prompts and participant-initiated event-contingent behavioral reports. After the initial 30 day period, participants will return to the study office to complete a short questionnaire and to be randomized to the second phase of follow-up.

Days 31-90, Randomized Evaluation: Participants will be randomized in a 1:1 ratio to either continue assessment questions only (control arm) or to also begin receiving intervention messages (intervention arm) in response to reported behaviors. Messages will encourage positive behaviors and suggest alternatives to negative behaviors (e.g. "Eating a mixed diet (meats and vegetables) is a healthy way to go."). At 90 days of follow-up, participants will return to the study office to complete a brief questionnaire on behaviors and smartphone experiences.

Study hypotheses are as follows: EMAI can be successfully implemented in Uganda, and participants receiving intervention messaging will have improved self-reported health behaviors compared to controls; EMAI will be feasible and acceptable by this population; and, EMAI-collected data will correlate with traditional questionnaire-collected data.

Outcomes will be assessed using descriptive statistics, multivariate regression and analysis of themes in patient EMAI experience and acceptability.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* literate
* current Rakai Community Cohort Study participant

We will purposely recruit a sample that has a broad range of participant characteristics in our study to optimize diversity of responses and increase study generalizability. Specific variables for which we will target sampling include: gender (\~50% female), age (at least 20% among age groups 18-25, 26-35, \>50), and occupation (at least 20% traders and farmers).

Exclusion Criteria:

* Participants without a listed phone number in the Rakai Community Cohort Study
Chronic Unilateral Lumbar Radicular Pain

Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.


Eligibility Criteria:
Inclusion Criteria:

* \> 6-month history of persistent pain in one leg with back pain.
* Capable of giving informed consent.
* Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.

Exclusion Criteria:

* Previous lumbar spinal surgery.
* Myelopathy.
* Rheumatoid disorders.
* Psychiatric disorders
* Bleeding or coagulation disorders
Natural Microbiota Restoration After C-section Birth

The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.

The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.


Eligibility Criteria:
Inclusion Criteria:

* over the age of legal majority
* delivery by planned C-section at term or vaginal delivery at term
* registered at a social security service

Exclusion Criteria:

* HIV or other STD patients
* immunocompromised patients
* known streptococcus B carriers
* known vaginal or perineal herpes infections
* chronic disease patients (obesity, diabetes, IBD)
* IMC before pregnancy \> 30 kg/m²
* antibiotic treatments one month before delivery
* emergency C-section
* Premature delivery (\<37 amenorrhea weeks)
* hospitalized for more than one week before delivery
* known HVC infections
* for the newborns: every diagnosed anomaly
* patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
* patients deprived of ther liberty by legal or administrative decisions
* patients under an exclusion period from another study
Preconditioning of One-lung Ventilation

To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.

For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia.

Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation.

Thus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery

Eligibility Criteria:
Inclusion Criteria:

* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

Exclusion Criteria:

* Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease
* Thoracic surgery for pneumonectomy
Development and Validation of a Prediction Model for Depression and Anxiety in Perioperative Elderly Adults

Anxiety and depression in later life are highly prevalent, often appear as comorbid disorders, and have many adverse consequences for both the individual and society. Given the disease burden, the large influx of new cases, and the economic costs, efforts should be made to prevent the onset of anxiety and depression in later life. Preventive interventions are likely to become more cost effective when they are targeted at elderly who have been exposed to risk factors known to be predictive of the onset of anxiety and/or depression. As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients

More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients. In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core.

Previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. Therefore, optimizing perioperative mental health management in older patients remains one of the challenges facing clinicians.

Eligibility Criteria:
Inclusion Criteria:

1. elective non-cardiac surgery,
2. American society of Aneshesiologists (ASA) classification Ⅰ \~ Ⅲ,
3. patients over age 65.

Exclusion Criteria:

1. patient refused follow-up study,
2. missing data exceeding 20%,
3. went to ICU or died after surgery,
4. have a history of any mental disorders such as epilepsy, Parkinson's disease, depression, anxiety, sleep disorders, or are currently taking relevant intervention drugs 5) patients with severe deafness, dementia or speech impairment.
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

Food effect part:

To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations.

Caucasian subject part:

To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted state and compare the pharmacokinetics with those observed in Japanese healthy male adults in the food effect part


Eligibility Criteria:
Inclusion Criteria:

1) Written voluntary informed consent to participate in the study; 2) \[Food Effect Part\] Japanese men 20 to \<40 years of age at informed consent; \[Caucasian Subject Part\] Caucasian men 20 to \<40 years of age at informed consent; 3) BMI 18.5 kg/m2 to \<25.0 kg/m2 at screening

Exclusion Criteria:

1. Presence of any disease requiring treatment;
2. History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure);
3. Alcoholism or drug addiction, or any positive result on drug abuse testing;
4. History of or current drug allergy;
5. Any positive result on infectious disease testing. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study;