cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous NTG for US Radial Artery Cannulation

Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients, difficult sampling and problems encountered with noninvasive blood pressure monitoring makes arterial cannulation an essential skill in many situations like surgeries or trans-radial procedures for coronary or carotid interventions.

Radial artery has been preferred over other sites for arterial cannulation due to low incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming to decrease insertion time, increase success rate and decrease related complications


Eligibility Criteria:
Inclusion Criteria:

* morbid obese indicated for radial artery cannuulation

Exclusion Criteria:

* +ve allen test peripheral arterial disease refusal
COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

COLD-MI study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. Acute myocardial infarction is the leading cause of heart failure (HF). It induces myocardial denervation predisposing to ventricular rhythm disorders and death. This denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (HF). In usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. In a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. This suggests that colchicine may reduce myocardial denervation.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 80 year old
* Hospitalization within 12 hours of onset of acute chest pain
* Patient must have suffered a documented acute myocardial infarction
* Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0)
* Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty)

Exclusion Criteria:

* Patients with a history of myocardial infarction prior to the current episode
* Patient in cardiogenic shock or with hemodynamic instability
* Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min)
* Pregnant women or women of childbearing age without contraception
* Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairement
* Association with macrolides (except spiramycin)
* Association with pristinamycin
Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.

The purpose is to examine the additional effect of either yoga or resistance exercise on weight loss weight combined with a standard behavioral weight loss intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 25-55 years of age
3. BMI = 25-35 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Participation in regular exercise (aerobic, yoga or resistance exercise) for \> 20 minutes per day on \> 2 days per week for the last 3 months. (This study is designed to recruit relatively sedentary adults.)
2. Currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication.
3. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
4. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, pregnancy status will also be verified by the pregnancy test that is required for the baseline, 6 and 12 month DEXA).
5. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
6. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
7. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
8. History of myocardial infarction or valvular disease.
9. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population

The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.

Some patient with chronic pelvic or perineal pain, present complex manifestations, comprising pain and dysfunction which does not involved a single organ. The gap between clinical symptoms and pathological signs is a constant feature of these pain syndromes. A possible explanation for these pain syndromes is central sensitization. This sensitization is defined by decrease nociceptive thresholds, a more intense and more prolonged response to nociceptive stimulus, and spatial extension of the painful area. It has been defined by international expert consensus in 2016 a clinical evaluation tool with 10 criteria for sensitization diagnosis: Convergences PP criteria. The aim of this study is to objectivize lower threshold, spatial and temporal diffusion of pain in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) compared to women without sensitization (Convergences PP criteria \< 5). A sensory testing of lower urinary tract, lower rectal tract, vulva and pelvic muscles will be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Women \> 25 years,
* Pelvic or perineal pain since \> 3 months,
* No injury in pelvic imagery or clinical examination that may explain all the pain complaint,
* Patient who can understand the protocol,
* Patient who agreed and signed the informed consent for participation.

Exclusion Criteria:

* Poor understanding of French language,
* Pregnancy or lactation,
* Severe depression (Beck Depression Inventory-Short form \> 16),
* Initial pain estimation at 10 on numeric analog scale,
* Inadequately cooperating,
* Isolated dysmenorrhea,
* Deep endometriosis with rectal or bladder lesion,
* Genital or bladder infection,
* Urogenital tumor history,
* Anorectal surgery history a type of digestive resection,
* Anal stenosis,
* Advanced vaginal prolapse (stage 2 on POP-Q scale),
* Post-traumatic stress disorder history,
* Deprived of liberty (trusteeship, guardianship).
A Study of [14C]-LY3537982 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination as assessed by the investigator.
* Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
An Italian Multicenter Retrospective Observational Study to Assess the Clinical Characteristics and the Outcome of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated with Polatuzumab Vedotin Plus Rituximab (± Bendamustine) Under Named Patient Programme

Study designobservational, non-interventional, retrospective, multicenter study.

The study focusing on information about the effectiveness and safety of polatuzumab vedotin plus rituximab (± bendamustine) in patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) programme in the period between June 2019 and Feb 2020 in Italy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with relapsed or refractory DLBCL who received at least 1 dose of polatuzumab vedotin under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy.
2. Age ≥ 18 years at enrolment.
3. Written informed consent (if applicable).

Exclusion Criteria:

Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics

The purpose of this study is to determine whether using the OWEMR as part of the standard of care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the relationship between glycemic control and the rate of amputation secondary to chronic foot ulcers in Type II Diabetes.

The Online Wound Electronic Medical Record (OWEMR) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. Use of the OWEMR includes digital photography as an objective measurement of wound healing rates.

Eligibility Criteria:
* Signed informed Consent
* Type I or II diabetes\*
* A break in the skin on the foot ≥ 0.5cm2
* 18 yrs of age or older
* Hemoglobin A1c value within the last 120 days
* No use of Investigational Agents /Devices on study or within 30 days prior to enrollment
* Subjects who will be locally available for the next 6 months
Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

This protocol aims at assessing the efficacy of performing catheter ablation for atrial fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF) catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3 months after the procedure will be performed in both groups. MRI analysis will detect ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare the number of gaps in the laser catheter and the RF group. The secondary endpoint of the study is recurrence of AF after 12 months. The target population of the study is patients with paroxysmal or persistent AF undergoing AF ablation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical recurrent AF, refractary or intolerant to at least 1 antiarrhythmic drub who are scheduled to undergo ablation of pulmonary veins (PV)
* Signed consent form.

Exclusion Criteria:

* Being under 18 years old
* Any contraindication for ablation procedure
* Impossibility to acquire DE-MRI because of contraindication (e.g. severely impaired renal function) or patient unwillingness
Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery

A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective Cardiac or Thoracic Surgery.
* Age \> 18 years of age.

Exclusion Criteria:

* Patients with a clinical suspicion or a documented history of DVT/PE
* Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
* Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
* Documented allergy to heparin, desirudin, or lepirudin
* Patients with a history of coagulation disorder
* Platelet count\< 100 X109 /dl
* Active bleeding
* Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min
* Patients with a baseline coagulopathy (INR \> 1.5 or aPTT \> 45 sec)
* Patients with liver disease
* Pregnancy
* Patients who require ventricular assist devices before or after surgery
Study of Velcade and Thalidomide in Patients With Myelodysplasia

The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.

Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.

This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Myelodysplastic syndrome with a IPSS score of 0.5 or greater
* May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
* ECOG performance status of 0-2
* Life expectancy greater than 3 months
* Total bilirubin \</+ 2xULN
* ALT and AST \</+ 3xULN
* Calculated creatinine clearance \> 30 ml/min
* Use of appropriate method of contraception during the study
* ANC \> 0.5 x 10(9)
* Platelet count \> 30 x 10(9)
* Consideration of treatment with 5 azacytidine is encouraged by not required

Exclusion Criteria:

* Ejection fraction \< 40%
* myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Women who are pregnant or breast-feeding
* Major surgery within 4 weeks prior to enrollment
* \>/= grade 2 peripheral neuropathy within 14 days prior to enrollment
* Uncontrolled intercurrent illness
* Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
* Hypersensitivity to bortezomib, boron, or mannitol
* Received an investigational drug within 14 days of enrollment
Prospective Cohort of Kidney Transplanted Patients Receiving an Extended Releasing Tacrolimus-Everolimus Association

The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.

The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients informed and giving his agreement to the use of every collected data
* Patients with kidney transplantation for at least one year and being treated with the immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus
* Patients whose investigators decides to switch from Prograf ® to an Envarsus ®-Everolimus association

Exclusion Criteria:

* Other transplantation
* Drug or alcohol abuse
* Patients unable to understand the purpose or modalities of this study, unable to give his agreement or unable to stick to the protocol
* Patients on an interventionnal protocol when included
A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women with idiopathic Parkinson's disease
2. Subjects must experience motor fluctuations associated with LD/CD dosing
3. Modified Hoehn and Yahr stage \< 5
4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
5. Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
6. Subjects must be age 30 or older.
7. Subjects must be willing and able to give informed consent.

Exclusion Criteria:

1. Subjects with a clinically significant or unstable medical or surgical condition
2. Subjects with clinically significant psychiatric illness.
3. Pre-menopausal women, not using birth control method.
4. Subjects who have taken experimental medications within 60 days prior to baseline.
5. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
Lagged Relationships Between Sleep, Balance, and Cognition in Older Adults

This study investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and cognition.

The study is designed to assess the relationships between sleep quality, balance capabilities, and cognitive functions in older adults. Using a longitudinal approach, participants will be monitored over six weeks with the help of wearable technology (OURA ring) and standardized assessments. Weekly in-person visits will include balance assessments using the Mini-BESTest and mobility tests such as the Timed Up and Go (TUG) test. Cognitive functions will be evaluated using the NIH Toolbox Cognitive Battery. The study aims to identify key sleep indicators that influence balance and cognition, ultimately contributing to improved strategies for maintaining the health and well-being of older adults.

Eligibility Criteria:
Inclusion Criteria:

Healthy older adults aged 65 and above English-speaking Independent in daily activities Able to walk independently or with minimal assistance (cane or walker) Willing to perform weekly assessments in balance and cognition at the University of Florida, Technology for Occupational Performance Lab

Exclusion Criteria:

Severe cognitive impairment (e.g., diagnosed dementia) Severe sleep disorders (e.g., sleep apnea requiring CPAP) Significant neurological conditions (e.g., Parkinson disease, stroke) Unstable medical conditions (e.g., uncontrolled hypertension, recent surgeries)
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or generalized anxiety disorder (GAD). The main questions it aims to answer are:

1. Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?
2. Which factors have a minimal causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?

Participants already undergoing TMS as part of their treatment plan for MDD/GAD answer survey questions about their symptoms before, during, and up to 1 year post-treatment. Factors affecting clinical outcomes such as stimulation parameters, behavioral factors, physiological factors, patient characteristics, and pharmacological factors, are also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnosis of major depressive disorder (MDD) and/or generalized anxiety disorder (GAD)
* Are receiving outpatient care,
* Voluntarily provide competent consent for treatment,
* Are 12 years of age or older,
* Are able to adhere to the weekly assessment schedule for primary outcome measures,
* Have been assessed by their prescribing physician as suitable candidates for TMS treatment in terms of safety and presenting indication,
* Have consented to undergo a therapeutic course of TMS treatment at one of the participating clinic sites,
* Are able to communicate in the English language.

Exclusion Criteria:

* Have been found to have any contraindication to TMS treatment by their prescribing physician,
* Are considered unsuitable for outpatient care due to illness severity or other factors in the opinion of their prescribing physician,
* Have active suicidal intent or plan,
* Are unable to adhere to or decline participation in the weekly assessment schedule for primary outcome measures,
* Lack the ability to communicate in the English language.