cyrilzakka/clinical-trials huggingface dataset:
Temperature and Analgesia Monitoring During Cardial Parmonary Bypass

1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
2. effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

In this study,

1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
2. Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Eligibility Criteria:
Inclusion Criteria:

* undergoing coronary artery bypass surgery

Exclusion Criteria:

* change the surgery planning during the operation
The Efficacy Of The Wavelight Mydon Laser for Hair Removal And Treatment of Leg Veins

This study is being done to compare the efficacy of an FDA cleared laser device with other similar systems in the market for the treatment of leg veins and hair removal in patients with darker skin type.

The specific aim of the study is to determine the efficacy of this FDA approved laser for hair removal and treatment of leg veins in female patients having darker skin types (Fitzpatrick Skin type III-VI) and compare it with the efficacy of other similar commercial units available in the U.S.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients of Asian and darker skin type greater than or equal to 18 years of age.
2. Ability to give informed consent.

Exclusion Criteria:

1. Pregnancy.
2. Taking medications that are photosensitizing.
3. History of skin disease in the area to be treated over the last 6 months.
4. Ongoing cutaneous lupus erythematosus, morphea, alopecia areata, or severe folliculitis.
5. History of keloidal or hypertrophic scarring.
6. Have inadequate hair growth in the test area of axilla.
7. Have unrealistic expectations of the treatment.
8. Co-existing severe emotional, medical or surgical illness leading to the inability to meet the follow-up requirements.
Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

The current study is designed to estimate the effect of rifampin (600 mg orally every 24 hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects (of non-childbearing potential)

Exclusion Criteria:

* Clinically significant disease or condition
* Recent serious infection
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects

This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Females must be of non-child bearing potential and either at least 1 year post menopausal (FSH ≥40 IU/L), or have documented hysterectomy (with or without bilateral oophrectomy) at least 6 months prior to study day
* Subjects willing to defer receiving prophylactic immunizations (e.g. influenza or pneumococcal vaccines) during the study.
* Absolute lymphocyte count must be greater than or equal to the lower limit of the laboratory reference range.
* Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, , pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab) or hepatitis C antibodies (HCV).
* Clinically significant abnormality on chest X-ray performed at screening or within 3 months of screening date; or history of tuberculosis or active or latent or inadequately treated infection.
Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects

The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols.

The absorption (blood) of collagen peptides from bovine, fish and porcine source in different sizes and administered together with foods of different polyphenol content will be assessed. Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration will be determined to estimate the impact of different sources, different peptide sized any food matrix.

The following objectives will be evaluated exploratory by comparison of pharmacokinetic parameters from the concentration time curve of hydroxyproline, a key marker of collagen type I, between:

* different sources of collagen peptides (bovine, fish, porcine)
* different sizes of collagen peptides from cattle
* food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food matrix 1 vs. food matrix 2).

Additionally, concentration time curves of further amino acids will be assessed descriptively.

Eligibility Criteria:
Main Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Sex: female and male (50 % of each gender)
* Age: 18-50 years
* BMI ≥19 and ≤28 kg/m²
* Nonsmoker

Main Exclusion Criteria:

* Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
* Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
* Application of corticoids (intravenously, orally or intraarticularly) and other immune-suppressing drug (within last 2 weeks)
* Blood donation within 1 month prior to study start or during study
* Regular intake of drugs or supplements possibly interfering with this study (Glucosamine, chondroitin sulfate, hyaluronic acid, omega-3, folic acid, curcumin/turmeric, Boswellia serrata, collagen, Vitamin D) within 2 weeks prior to study start or during study
* Intake of anticoagulants like Heparin, Marcumar etc.
* Coffee consumption \>3 cups / day
* History of hypersensitivity to fish
Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)

The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).

Patients with chronic refractory ITP are eligible for a 6- to 12-week therapeutic trial. After 24 months of treatment, patients who continue to demonstrate a sustained response, in the investigator's judgment, will be offered the opportunity to receive ongoing therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study.
* Patients may be male or female, between the ages of 18 75. Men, if sexually active, must agree to use at least one medically acceptable form of birth control. Women of childbearing potential must have a negative urine pregnancy test, and agree to use two independent methods of birth control, if sexually active.
* Patients must have a diagnosis of chronic refractory ITP for at least 3 months. Chronic refractory ITP is defined as:

  1. Platelet count \< 30,000/mm3 consistently for 3 months (except for transient nonsustained responses to various therapeutic regimens). There must be at least three separate platelet counts (below 30,000/mm3) over this period, with at least one extending back to three months or more prior to patient entry into the study.
  2. The following conditions will have been excluded either by history or appropriate laboratory investigation: HIV infection (see below), lymphoproliferative disorders, myelodysplasia, SLE, drug-induced or alloimmune thrombocytopenia, or dysglobulinemias.
  3. The patient must have tried at least two typical regimens for the treatment of ITP (George et al., Blood, 1996; Practice Guidelines, American Society of Hematology). At least 50% of the enrolled patients will not be known to be refractory to IVIg. Patients may or may not have been treated with IVIg in the past.
* Subjects must test negative for HIV, HBV, and HCV by standard serologic tests within the previous six months.

Exclusion Criteria:

* Patients who have a history or presence of substantial or clinically significant respiratory, gastrointestinal, renal, hepatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorders that, in the Investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug are excluded. Specifically excluded are lymphoma/chronic lymphocytic leukemia, hepatitis, or HIV associated with ITP.
* Patients who have a history of relevant drug hypersensitivity are excluded.
* Patients who have a history of substance abuse, drug addiction or alcoholism are excluded.
* Patients with the following laboratory abnormalities: a leukocyte count \< 2,500/mm3, a neutrophil count of \< 1,800/mm3, lymphocyte count \< 750/mm3, Hgb \< 10 g/L, or transaminase levels (ALT, AST) \> 1.5xULN are excluded.
-Oleoyl Glycerol is a GPR119 Agonist and Signals GLP-1 Release in Humans.

The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1 and GIP.

We have found a new ligand for the GPR 119 receptor. This study evaluate the impact of this ligand on the incretion hormone responses, beta cell function and gall bladder function in healthy young men.

Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
* Normal hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT\> 2x normal level)
* Nephropathy (s-creatinin \>130 microM or albuminuria)
* Relatives with type 2 diabetes
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer

The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall bladder and bile duct cancer.

Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil (DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
3. Prior neo-adjuvant or adjuvant therapy (including radiation therapy) is allowed provided it was completed at least 4 weeks before documented disease recurrence or metastasis.
4. Discontinuation of radiation therapy at least 3 weeks prior to Day 1 of Cycle 1. Radiation therapy will not be allowed while a subject is on study except for palliative radiation therapy to non-target lesions administered following consultation with the Medical Monitor.
5. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
6. Nne or more measurable target lesion(s) according to RECIST. Measurable lesion(s) must be outside of previous radiation field or demonstrate clear radiographic progression on serial imaging if within previous treatment field.
7. ECOG performance status less than or equal to 2.
8. Life expectancy greater or equal to 3 months.

Exclusion Criteria:

1. Central nervous system metastasis.
2. Bony metastasis as the sole metastasis.
3. Received prior chemotherapy or anti-angiogenesis agents including bevacizumab or erbitux or radiation therapy other than in a neo-adjuvant or adjuvant setting. No concomitant chemotherapy, anti-tumor biologic therapy, or radiation therapy is allowed.
4. If nitrosoureas or mitomycin C were used as neo-adjuvant or adjuvant therapy, then at least 6 weeks should have elapsed prior to treatment with DAVFU.
5. Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
6. Congestive heart failure (Class III or IV in the NYHA functional classification system) or any other medical condition that would preclude the IV administration of up to approximately 200 mL of fluid over 30-60 minutes.
7. Unresolved biliary tract obstruction.
8. Known or clinically suspected infection with HIV.
9. Subject has a known intolerance to 5- FU.
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, aged 18 years and older
* Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
* Eastern Cooperative Oncology Group Performance Status score of 0-2

Key Exclusion Criteria:

* Pleural Effusion
* Uncontrolled cardiovascular disease
* Significant bleeding disorder unrelated to CML
* Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
Patient Satisfaction and Quality of Life Impact - PecFent®

National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged ≥18 years) with cancer
* Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain
Standardized Goal-Directed Vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale

Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated.

The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for a clinically indicated TTE and bubble study

Exclusion Criteria:

* Inability to provide informed consent
* Inability to insert an IV line
* Inability to perform a Self-Directed Valsalva maneuver
* Patient wishing to keep his mask on
Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre

Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.

Prospective multicentre open-label study of mechanically ventilated intensive care patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study
* Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation
* Equipped with a central venous line in the superior vena cava territory and an arterial catheter.
* Whose state of health justifies vascular filling

Exclusion Criteria:

* Patient under legal protection, guardianship or curatorship
* Pregnant or breastfeeding woman
* Patient not affiliated to the French social security system
* Contraindication to the realization of an alveolar recruitment maneuver
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon

This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.

This prospective double-blind randomized control trial seeks to compare a single formulation of BoNT, aboboutlinum toxin A (Dysport), to a placebo saline group, studying the effect of BoNT on Raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from BoNT.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult between 18 and 80 years of age
* Must have health insurance
* Must have a current diagnosis of Raynaud's phenomenon

Exclusion Criteria:

* Allergy to abobotulinum toxin A or its components
* Diagnosis of myasthenia gravis
* Previously received abobotulinum toxin vaccine
* Previously undergone upper extremity vascular surgery (including surgical sympathectomy)
* Currently receiving aminoglycoside antibiotics
* Received abobotulinum toxin A treatment in either hand in the past 6 months
* Pregnant women
* Women currently breastfeeding
* Current tobacco smoker (use in the past 12 months)
* Unable to read and speak English
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.

The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia. The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events. Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes.

The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE Trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing PCI, aged 30-80 years with any clinical presentation
2. Angiographic criteria: presence of ≥ 2 de novo target lesions\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)

Angiographic criteria target lesion\* (all criteria I-IV should be applicable):

I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)

\*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.

Exclusion Criteria:

1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
2. Lesion located in a grafted segment or in a vein graft
3. In-stent restenosis lesions
4. Left main trifurcation
5. Left main lesion stand-alone (without other lesions)
6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
7. Chronic total occlusion
8. Spontaneous coronary dissection
9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years
10. Patients with left ventricle (LV) function less than 30%
11. Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
12. Life expectancy less than 3 years