cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

To determine the effect of three different percutaneous revascularization strategies (Balloon Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication

Endovascular revascularization of the superficial femoral artery (SFA) has become one of the most commonly performed endovascular procedures.The ability to offer the patient an alternative to surgical revascularization, limited by significant morbidity and mortality, with a same-day outpatient percutaneous procedure underlies the popularity of the endovascular approach. Although surgical bypass of the SFA remains the gold standard for revascularization, it is associated with significant morbidity and mortality.Comparative data between cryoplasty, angioplasty or stenting of the SFA will ultimately be required to provide more robust evidence of the efficacy of each mode of therapy.This registry is designed to determine the efficacy of three different percutaneous revascularization strategies (Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Superficial Femoral Artery disease as assessed by angiography
A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.
Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis

The study is designed to quantitate McArdle's sign, an increase in measurable weakness with neck flexion described in patients with multiple sclerosis, and to determine whether it is or is not specific for multiple sclerosis.

Finger strength will be measure using a torque-measuring device designed to quantitate finger extension strength. The device was designed for point of treatment use, patient safety and portability. Strength will be measured in 5 paired trials, first with neck extended and then with neck flexed. Two protocols will be evaluated, one testing isometric strength against a fixed resistance and the second testing strength against dynamic resistance. McArdle's sign is the difference between strength with neck extension and strength with neck flexion.

The data will be digitally registered and dynamic neck position will be recorded electronically in real time. Graphs of dynamic changes in torque versus neck position will be generated and superimposed. Strength will be quantitated using Matlab software.

Consecutive patients with myelopathy of any cause with detectable finger extensor weakness will be studied, either due to MS or due to other cause of myelopathy (other inflammatory, vascular, compressive, neoplastic and other). Additionally, normal controls will be studied as will patients with finger extension weakness due to peripheral nerve lesions.

Eligibility Criteria:
Inclusion Criteria:

* Myelopathy of any cause with finger extension weakness
* Patients with peripheral neuropathy with finger extension weakness
* Healthy controls

Exclusion Criteria:

* Pregnant subjects.
Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis

Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:

* renal hemodynamics (GFR and RPF)
* blood pressure and heart rate
* lithium clearance
* plasma levels of vasoactive hormones

Eligibility Criteria:
Inclusion Criteria:

Healthy controls

* Age 20 to 60 years
* Both men and women
* Weight below 100 kg
* Normal clinical examination and laboratory screening
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

* Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
* P-creatinine \< 250 µmol/L
* Age 20-60 years
* Both men and women
* Fertile women only if using contraception
* Body weight below 100 kg
* Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

* History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
* Current medication
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
* Donation of blood less than 1 month before the experiments

Liver cirrhosis

* Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)

evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma


Eligibility Criteria:
Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent

Exclusion Criteria:

cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease

The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.

The two groups are:

Referent group with one actimetric report at baseline Actimetry group with one actimetric report at baseline and during the follow-up. Using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient.

It is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice:

1 visit before the installation of the pump

1 visit after the pump installation straight after the patient comes out the hospital

1 visit at 6 months

Eligibility Criteria:
Inclusion Criteria:

Adult suffering from Parkinson's disease aged up to 75 years (included) Patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines Patient who chose the OPTIPARK package (ORKYN nurses) Patient willing to wear the actigraphy bracelet as per the protocol Patient who read, understood and signed the consent form.

Exclusion Criteria:

Patient not willing to take part in the study Patient who had a previous set-up of an apomorphine pump Patient with dementia Dependant patients or patients living in institutional care Patient with a temporary pump of apomorphine compromising a six months follow-up Patient with non-major motor fluctuations Patient already enrolled in an interventional study.
Comparison Between Three Types of Stented Pericardial Aortic Valves

This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.

Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.

Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery

Exclusion Criteria:

* no endocarditis
Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD)

The goal of this study is to determine the vulnerability of mood-related neurocircuitry in Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).


Eligibility Criteria:
Inclusion Criteria for STN-DBS subjects:

* Age 40 or older
* DBS STN Surgery in past 2 to 36 months
* Ability to tolerate turning off Stimulators
* Ability to read and comprehend questions
* English speaking

Exclusion Criteria for STN-DBS subjects:

* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)

Inclusion Criteria for Control subject:

* Age 40 or older
* Ability to read and comprehend questions
* English speaking

Exclusion Criteria for Control subject:

* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)
* Plans to have DBS STN surgery in the next 24 months
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects

GSK945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. This study drug has been tested in animals but has never been given to humans. This is a two part study. The purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream The second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults between 18 and 60 years of age.
* Body weight proportional to height.
* Female subjects must be of non-childbearing potential.
* QTc less than 450 msec at screening

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose.
* A positive pre-study alcohol/urine drug screen.
* Use of nicotine-containing products.
* A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result.
* Recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine
Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery

Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.

Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure \[SBP\] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years;
* Scheduled to undergo off-pump CABG surgery.

Exclusion Criteria:

* Refuse to participate;
* Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Chronic kidney disease with a glomerular filtration rate \< 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
* Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
* Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
* Second or emergency surgery;
* Expected survival of less than 24 hours.
A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.


Eligibility Criteria:
Inclusion Criteria: - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - The decision to initiate treatment with commercially available Tresiba® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4 cycles of (R VAD +C) .

The responders more than RP \> 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.

There is an clinical and molecular evaluation of the strategy

Eligibility Criteria:
Inclusion Criteria:

* Mantel cell lymphoma
* CD 20+
* At diagnosis or without anterior chemotherapy
* Age \>18 and \< 66 years
* Ann Arbor ii, III or IV
* ECOG \<3
* contraindication for rituximab treatment
* Informed consent signed
* No cancer anteriory
* Renal and hepatic function compatible with the treatment
* Ventricular Fraction \> 50 % with echographic method and \> 40% with isotopic method

Exclusion Criteria:

* Other type of lymphoma
* age\<18 ou \> 66 years
* Informed consent not signed
* anterior cancer
* Contraindication to rituximab
* Cardiac insufficiency
Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

This study aimed to explore the effect of intravenous (IV) vitamin C on sequential organ failure assessment (SOFA) score among septic patients in intensive care unit (ICU).

"This study was approved by the Ethics and Research Committee of Universitas Indonesia. This study was a randomized clinical trial held from April to July 2019 in Cipto Mangunkusumo Hospital. 33 patients that met the inclusion criteria were included in the study. Subjects were divided into two groups: group A (intervention group, n = 18) received parenteral infusions of 1,5 g/6 hours of vitamin C and 200 mg thiamine, while group B (control group, n = 15) received 200 mg thiamine only. baseline demographic data was recorded on the first day. SOFA score was recorded at baseline, 24 hours, 48 hours, and 72 hours after treatment. Data were analyzed using SPSS (Statistical Package for Social Sciences) software."

Eligibility Criteria:
Inclusion Criteria:

* patients with sepsis diagnosis based on sepsis-3 criteria in the ICU in between 6 hours to 24 hours post resuscitation after sepsis diagnosis

Exclusion Criteria:

* patients with chronic kidney problems on haemodialysis,
* patients with kidney stones or kidney problem within the last 3 months
MACS and Healthy Volunteers Bone Study

Adrenal adenoma is detected in 5-7% of adults and demonstrates mild autonomous cortisol secretion (MACS, dexamethasone suppression test \>1.8 mcg/dl) in 50% of individuals with adenoma. Published reports suggest a 48%-52% 2-year incidence of new vertebral fractures in patients with MACS without any significant changes in bone density measurements. A disproportionate decrease in bone quality versus density or other factors such as sarcopenia potentially contribute to development of new vertebral fractures. Determining which specific abnormalities in the steroid metabolome affect bone density, quality and strength as well as bone remodeling markers and body composition will potentially serve as a diagnostic biomarker of clinical significance.

In this study, we will determine whether patients with MACS (versus healthy age and sex matched controls) demonstrate: 1) decreased bone strength and quality disproportionate to the decrease of bone density and 2) abnormalities in the steroid metabolome correlate with the degree of abnormalities in bone parameters. In a cross-sectional study of 75 patients with MACS and 75 age- and sex-matched healthy controls, we will determine the relationship of the steroid metabolome to measurements of bone density, quality and strength, bone turnover markers, as well as body composition. All patients will be interviewed in regards to their health, to include questions on bone health, frailty, cognition (NIH toolbox), and quality of life. We will measure 1) BMD (bone mineral density) at the lumbar spine, hip and radius and body composition using dual-energy X ray absorptiometry (DXA), 2) radial and tibial bone microstructure by high-resolution peripheral quantitative computed tomography (HR-pQCT), 4) bone turnover markers (osteocalcin, PINP, CTx, sclerostin). 5) Age reader measurement, 6) hand grip measurement, 7) 6 minute walk test. All patients will provide a 24 h urine for steroid metabolome analysis. For primary outcomes, we will determine if steroid metabolome profiling better predicts abnormal bone strength (as measured by trabecular bone volume/tissue volume \[BV/TV\] ratio).

Eligibility Criteria:
Inclusion Criteria:

* Patients with MACS
* Age 18-no maximum
* exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily)
* steroid hormone replacement therapy
* any drug therapy affecting bone metabolism
* recent fracture

Exclusion Criteria:

* exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily)
* steroid hormone replacement therapy ( for adrenal insufficiency, hypogonadism, menopause)
* therapy for osteoporosis
* any drug therapy affecting bone metabolism
* comorbidities affecting steroid metabolome or bone metabolism
* recent fracture