cyrilzakka/clinical-trials huggingface dataset:
Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis

The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.

Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study.

Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes:

A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.

Eligibility Criteria:
Inclusion Criteria:

* Weight \> 50 kg and less than 110 kg
* SVT of the grand saphenous vein for at least 4 cm
* SVT of the small saphenous vein for at least 4 cm
* Collateral SVT of the large saphenous vein of the thigh for at least 4cm

Exclusion Criteria:

* SVT of the grand saphenous vein reaching the saphenofemoral cross (within 3 cm)
* SVT of the small saphenous vein reaching the saphenopopliteal cross
* Documented proximal or distal DVT or pulmonary embolism
* SVT secondary to sclerotherapy
* Pregnancy and puerperium
* uncontrolled arterial hypertension (Systolic pressure \> 180 mmHg and diastolic pressure \> 110 mmHg)
* Active peptic ulcer
* Bacterial endocarditis
* Stroke in the previous 3 months
* Haemorrhagic diathesis
* Thrombocytopenia (platelets \< 100,000/ µL)
* Hypersensitivity to heparin or history of thrombocytopenia induced by heparin
* Creatinine \> 2 mg% (\> 180 µmol/L)
* Heparin therapy (any dose) or anticoagulant therapy for longer than the previous 72 hours
* In-hospital development of SVT
* Previous saphenectomy by any method
* Surgery in the previous 30 days
* Serious liver disease
* Use of dextran, mannitol, thrombolytic treatment, chronic use of NSAID and cortisone-based drugs.
* Active cancer or under chemotherapy or radiotherapy
* Thrombectomy of superficial vein involved
* Refusal to give informed consent
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate

To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).


Eligibility Criteria:
Inclusion criteria:

* Healthy male and female subjects
* Age 18 to 50 years
* Body mass index (BMI) 18.5 to 29.9 kg/m2
* Subjects must be able to understand and comply with study requirements

Exclusion criteria:

- Any relevant deviation from healthy conditions
Physical Activity Level in Patients with Chronic Kidney Disease During COVID-19 Pandemic

In the literature, there are no studies evaluating fear of COVID-19, anxiety, depression, physical activity, fear of movement and quality of life in patients with chronic kidney disease during COVID-19 pandemic. The investigators will evaluate these parameters in patients with chronic kidney disease and compare the findings of healthy individuals during COVID-19 pandemic


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with chronic kidney disease
* Being clinically stable
* Volunteering to participate in the research

Exclusion Criteria:

* Having a cognitive problem
* Not being literate
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.


Eligibility Criteria:
Inclusion Criteria:

* 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria:

* Heart disease, high blood pressure
Rule Out Myocardial Infarction by Computer Assisted Tomography

The goal of this research is to determine noninvasively whether detection of coronary stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost effective. Among the 5.6 million patients with ACP presenting annually in emergency departments (ED) in the United States, a subgroup of two million patients is hospitalized despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a diagnosis of ACS have a significant epicardial coronary artery stenosis ( \>50% luminal narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e. vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary cause of chest pain, these patients could in theory be discharged earlier reducing unnecessary hospital admissions. Recent publications demonstrate high sensitivity and specificity of MDCT for the detection of significant coronary stenosis compared with coronary angiography and the detection of coronary plaque as validated with intravascular ultrasound. Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of significant coronary artery stenosis and plaque and correlate the data with the clinical diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic tests available at the time of MDCT will be used to generate a multivariate prediction function and derive a clinical decision rule. Based on this decision rule we will compare the diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of hospitalizations, and absolute cost of management of patients with acute chest pain compared to standard clinical care and is cost effective.


Eligibility Criteria:
Inclusion Criteria:

* Patients with any episode \> five minutes of chest pain being admitted to rule out acute coronary syndrome

Exclusion Criteria:

* Positive initial troponin or CK-MB tests
* Diagnostic ECG changes (ST- segment elevation or horizontal ST- segment depression in more than two contiguous leads)
* Unstable clinical condition (hemodynamically unstable, ventricular tachycardia, persistent chest pain despite adequate therapy)
* Creatinine Clearance \<50 mL/min
* Known allergy to iodinated contrast agents
* Patients on metformin therapy unable or unwilling to discontinue therapy for 48 hours after CT scan procedure
* Known asthma, reactive airway disease
* Patients currently in atrial fibrillation
* Previous intolerance to beta blocker
* Patients that are referred for coronary angiography/PCI by their PCP or cardiologist.
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients

This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
* At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \< 110 mmHg.

Exclusion Criteria:

* If a single reading for arterial hypertension in msSBP \> 180 mmHg or msDBP \> 110 mmHg at any visit after randomization.
* Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
* Known history of hypotensive symptoms or orthostatic hypotension.
* Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* A history of heart failure (NYHA II-IV).
Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents

We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (TAG), and cholesterol concentrations.

This counterbalanced study consisted of two trials including 1) high fructose (HF) trial and, 2) a high glucose (HG) trial. Each trial was blind to the participant, performed in a random order, and was 15 d in length. During days 1-14 of each trial, the participants consumed either 710 ml per day of a HF-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) for 2-wk (HF trial) or 710 ml per day of a HG-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) for 2-wk (HG trial) on top of their normal diet. In addition, the participants were instructed to maintain their normal physical activity levels during each trial (which were measured with an accelerometer). On day 15 of each trial, the participants reported to the lab after a \~ 11 h overnight fast for metabolic testing. During this testing day, the participants remained in the lab for 12 h and consumed three liquid meals (one meal every 4 h and HF meals during HF trial and HG meals during HG trial), while blood samples were taken every 15 or 30 min throughout the 12 h testing day. During testing, the participants remained physically inactive (\< 3,000 steps).

Eligibility Criteria:
Inclusion Criteria:

males and females 15-20 years of age not participating in an organized sport (non-athletes) no history of heart, lung, kidney, endocrine, or gastrointestinal disease no medications known to alter glucose or lipid metabolism normal fasting blood glucose concentrations (\< 100 mg/dL) normal fasting triglyceride concentrations (\< 150 mg/dL) average daily fructose consumption \< 90th percentile for age and sex

Exclusion Criteria:

athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose
Long-term Effects of Methadone for Cancer Pain

The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.

The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with t methadone for cancer pain in opioid rotation
* Able to fill the questionnaire
* Performance status (PS) from 0 to 2

Exclusion Criteria:

* Patients PS 3
* Unable to sign the informed consent
Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.

Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.

The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.


Eligibility Criteria:
Inclusion Criteria

* 18 years or older
* Be able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
* Have a recognised indication for full colonoscopy after evaluation by a gastroenterologist or surgeon
* Be hospitalized or in the ED of a participating hospital center.
* Need to receive a bowel preparation during hospitalization or the ED stay.
* Be able to complete the follow-up patient response form in French or English

Exclusion Criteria:

* Patient refusal
* A suspected or diagnosed bowel obstruction
* A toxic megacolon
* Ileus
* Decompensated heart failure
* Severe acute renal failure
* Severe electrolyte imbalance
* Previous bowel preparation in the last 7 days
* Pregnancy
* Time of randomization before 9h00 or after 22h00
Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery

After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.

Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.


Eligibility Criteria:
Inclusion Criteria:

Every patient of more than 18 years, programmed for a cardiac surgery ( valve replacement, coronary bypass, aortic surgery) in the service of "Chirurgie Cardio-Thoracique et Vasculaire" (CCTV) of the CHRU of Brest

* and obesity (BMI \> 30 kg/m2
* and/or COPD (stages 1-2 and 3, classification GOLD)
* and/or restrictive syndrome (CPT 80 %)
* and/or cardiac insufficiency (FEVG 55 %)
* and/or syndrome of obesity-hypoventilation not requiring an equipment
* and/or Syndrome of sleep apnea not requiring an equipment

Exclusion Criteria:

* Patients having a contraindication absolved from the NIV
* Patients carrier of a neuro-muscular disease
* Patients carrier of a syndrome of sleep apnea and/or COPD, and sailed
* Hypercapnic patients (with a limit value of PaCO2 \> 55 mm Hg)
* Unaffiliated patients to a social diet of safety
* Patients under guardianship or under guardianship
* Patient who can not follow the NIV program as well as the patients of whom the consent was not collected.
REDUCE LAP-HF RANDOMIZED TRIAL I

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction \>40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

Eligibility Criteria:
Key Inclusion Criteria:

* Chronic symptomatic Heart Failure
* Ongoing stable GDMT HF management and management of potential comorbidities
* Age ≥ 40 years old
* LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction \<30%.
* Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

* MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
* Cardiac Resynchronization Therapy initiated within the past 6 months
* Severe heart failure
* Inability to perform 6 minute walk test (distance \< 50 m), OR 6 minute walk test \> 600m
* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
* Presence of significant valve disease
* Known clinically significant untreated carotid artery stenosis
* Currently requiring dialysis; or estimated-GFR \<25ml/min/1.73 m2 by CKD-Epi equation
Plasma GLP1 and Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Acute myocardial infarction (AMI) is associated with high mortality and its prognosis differed among patients. Primary percutaneous coronary intervention (pPCI) is an effective method to treat AMI. To accurately predict adverse outcomes following pPCI in patients with AMI will help doctors develop precise therapeutic strategy in advance. At present how to predict adverse events before pPCI is still controversial. In our previous studies, the investigators found that glucagon like peptide -1 (GLP-1) can improve cardiac function in patients with AMI after PCI, other studies have reported that plasma GLP-1 levels is negatively correlated with CK-MB in patients with AMI, but the relationship between plasma GLP1 and prognosis of AMI patients after PCI has not been reported, the investigators hypothesized that plasma levels of GLP1 is associated with major adverse cardiovascular events (MACE) after pPCI. The investigators planned to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of acute myocardial infarction to the catheterization laboratory.

Exclusion Criteria:

* Taking drugs of GLP-1 analogue and DPP4 inhibitor
* Cancer patients
MBCT for DM Distress: a Pilot Qusai-experimental Study

Background: Diabetes-related distress (DRD) is very common among people with type II diabetes mellitus (DM). DRD led to poorer DM control and may led to adverse prognosis. Yet, there is no widely accepted or recommended DRD treatment.

Mindfulness was shown to relieve psychological distress in various physical and mental conditions.

Aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (MBCT), which is one of the widely used mindfulness program, is feasible and acceptable and may improve DRD in our Chinese population.

Method: 20 Chinese participants with suboptimally controlled DM and high DRD will be recruited to a 8- week MBCT group. Pre-group and post-group (immediate and 2-month post-group) data including DRD score, quality-of life measures will be compared.


Eligibility Criteria:
Inclusion Criteria:

* received a clinical diagnosis of type II DM
* aged \>=18
* can provide valid consent
* can speak Cantonese
* can read and write simple Chinese
* HbA1c \>7%
* have CDDS score \>=3

Exclusion Criteria:

* diagnosed active mental illness
* have severe hearing loss
* non-Chinese
* have active suicidal ideation as screened by Q9 of PHQ-9
* unwilling to join at least 6 out of 8 session of MBCT
* received mindfulness training in the past year or having regular mindfulness practice
* received psychotherapy last year
* severe physical illness limiting them from coming repeatedly to the group
Efficacy and Safety of NAVIO

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.


Eligibility Criteria:
Inclusion Criteria:

* Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
* High need to obtain pain relief and improve function
* Above 18 years old
* Able and willing to follow instructions
* Informed consent

Exclusion Criteria:

* Active infection in knee
* General infection
* Failure of previous joint replacement
* Post-operative or post traumatic malalignment of the knee/leg
* Pregnancy
* Not able or willing to undergo CT-scan