cyrilzakka/clinical-trials huggingface dataset:
A Study Of PF-04620110 As A Modified-Release Formulation In Healthy Overweight Or Obese Subjects

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 27 to 35 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be more than 18 years of age
* referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).

Exclusion Criteria:

* on warfarin
* on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time \>150 at time of procedure -on cilostazol
* on persantine
* on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
* on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry
* undergoing coronary angiography via radial access
* undergoing planned diagnostic coronary angiography only
* unable to tolerate dual anti-platelet therapy
* with known allergy to CM
* received CM within 24 hours of coronary angiography
* on dialysis
* do not consent or are unable to give consent
* are participating in another competing study.
HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Eligibility Criteria:
Inclusion Criteria:

* HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
* Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
* Able to understand the study procedures and willing to sign informed consent

Exclusion Criteria:

* Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
* Pregnancy.
* Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
* Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
* Unwillingness to participate in study procedures, including Mental Health referral and intervention.
* Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
* Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Candidate for External Beam Radiotherapy
* ECOG performance status 0-2

Exclusion Criteria:

* Patients with Metastatic Prostate Cancer
* Patients with Kidney \& Liver dysfunction
* Gastrointestinal disorders such as IBD, reflux and peptic ulcers
* Any adverse reaction to curcumin
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease

Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease

Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life.

In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.

Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation.

This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart disease with stable status defined by last operation \>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion
* Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,
* Patient aged 1 to 5 years.
* No previous medical diagnosis of NDD
* Parental or legal guardian's consent.
* Social security affiliation (for France only)

Exclusion Criteria:

* Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network)
* Neurodevelopmental status evaluation within the last 6 months.
Follow-up Study of the RAI-Treated Hyperthyroid Patients

Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism.

The study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (RAI) with those of an age- and gender-matched reference population in a long-term follow-up study.

A population-based cohort study was conducted among 2611 hyperthyroid patients treated with RAI between 1969 and 2002 in Tampere University Hospital, and among 2611 reference subjects. A reference group was randomly selected, with an age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment.

The causes of hospitalization as well as the diagnosis and date of hospital admission were obtained from the nationwide Hospital Discharge Register (HILMO) maintained by the Research and Development Centre for Welfare and Health (STAKES) using a computerized record linkage, with the personal identification number as the key. The HILMO database covers all dates and causes of hospitalization (hospital admission requiring an overnight stay) of the Finnish citizens since January 1969. New events were analyzed as the main outcome, including only the first hospitalization due to a given indication. The special focus was on the cardiovascular morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002
* Controls: age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment
Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Eligibility Criteria:
Inclusion Criteria:

Age is 18\~70 years old; Expected survival period of\>12 weeks; Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging; Patients with refractory multiple myeloma; Patients with multiple myeloma recurrence; ALT and AST \<3 times normal; bilirubin \<2.0mg / dl; Quality of survival score (KPS)\> 50%; The patient has no serious heart, liver, kidney and other diseases; Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy; Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions; Blood can be obtained intravenously, without other contraindications to leukapheresis; Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months; Infectious diseases (such as HIV, active tuberculosis, etc.); Active hepatitis B or hepatitis C infection; Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold); Abnormal vital signs, and unable to cooperate with the examination; Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation; Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2; Subjects with a systemic infection or a severe local infection requiring anti-infective treatment; Subjects with severe autoimmune disease; The doctor believes there were other reasons for inclusion
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.


Eligibility Criteria:
Inclusion Criteria:

* patient 18 years or older
* colonoscopy for screening or surveillance of polyps or disease of colon
* anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

* patient unable to provide informed consent
* patient found unfit for standard colonoscopy or anoscopy with biopsies
Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation

Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.

Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel and to improve the support with centralized monitoring in the FreeO2 group.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized for COPD exacerbation
* 40 Years and older
* Former or current smoker greater than or equal to 10 pack-years
* Suspicion or diagnosis of COPD at the hospitalisation
* Acute dyspnea or acute aggravation of dyspnea
* Respiratory rate greater than or equal to 20 breaths/min
* Patient needs an oxygen therapy by nasal cannula with oxygen delivered between 0.5 to 8L/min to hold SpO2 greater than or equal to 92%

Exclusion Criteria:

* Imminent indications for intubation
* FreeO2 system is unavailable at the moment of randomization
* Patient in isolation (barrier nursing) to the inclusion
* Patient participates to another clinical trial without possibility of co-enrollment
* Patient with diagnosis of sleep apnea
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.

The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.


Eligibility Criteria:
Inclusion Criteria:

* Lower back surgery
* Age \[18-80\]
* ASA group I-III
* free and painless movement of the neck (including flexion, extension and rotation)

Exclusion Criteria:

* Pain during neck movement as mentioned under inclusion criteria.
* known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
* any stenosis of the carotid vessels or known symptoms associated with such
* BMI \> 35
Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Hypothesis:

Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus.

Aims:

In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated:

1. to optimize the technique of intra-operative electrical vagus nerve stimulation
2. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
3. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal carcinoma eligible for open rectal resection
* Age between 18 and 70 years

Exclusion Criteria:

* Preoperative therapeutic abdominal radiation
* Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis)
* American Society of Anesthesiologists physical-health status classification (ASA-PS) \>3
* Poorly regulated diabetes (\>200 mg/dl (=11mmol/l))
Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer

The purpose of this study is to determine the efficacy of combination of docetaxel, oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.

Docetaxel is an anti-microtubule agent. Docetaxel is an active agent for gastric cancer, with response rate (RR) of 20-24% as a single agent and RR of 37-40% as a combination therapy with 5-FU and/or cisplatin.

S-1 is a new oral dihydropyrimidine dehydrogenase (DPD) inhibitory fluoropyrimidine (DIF). In two late phase II studies of S-1 for advanced gastric cancer, RR was 45%, with very low (2%) incidence of grade 3 toxicity.

Recent phase I/II trial of the combination of docetaxel and S-1 in patients with advanced gastric cancer suggests that repeated 3-4 week cycles of S-1 60-80mg/m2 /day for 14 days combined with docetaxel 40-75mg/m2 is feasible.

Oxaliplatin, diaminocyclohexane-platinum, is an alkylating agent inhibiting DNA replication. Comparing to cisplatin or carboplatin, oxaliplatin appear to be more effective and has a more favorable toxicity profile. Phase II studies of the combination of docetaxel and oxaliplatin in patients with advanced gastric cancer suggests that docetaxel 60 or 75mg/m2 combined with oxaliplatin 130 or 80mg/m2 every 3 weeks is feasible.

Recent dose finding study of the combination of docetaxel, oxaliplatin and S-1 (DOS) in patients with advanced gastric cancer suggests that docetaxel 52.5mg/m2 on day 1 and oxaliplatin 105mg/m2 on day 1 combined with S-1 80mg/m2 on day1 to day 14 every 3 weeks is feasible.

Docetaxel, S-1 and oxaliplatin have distinct mechanisms of action and no overlapped key toxicities. Furthermore, fluoropyrimidine and docetaxel or oxaliplatin have shown synergism in vivo studies and in clinical trials. Based on these results, the combination of DOS is a reasonable candidate of new chemotherapeutic regimen for the advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred
* Unresectable, locally advanced or metastatic
* At least one uni-dimensional measurable lesion by RECIST criteria
* Age 18 to 70 years old
* ECOG performance status ≤2
* Estimated life expectancy ≥3 months
* Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL),
* Adequate kidney function (creatinine \<1.5 mg/dL)
* Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels \<2 times the upper normal limit
* Written informed consent

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Previous history of chemotherapy (exception: adjuvant chemotherapy)
* Presence of CNS metastasis, psychosis, or seizure
* Obvious bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Peripheral neuropathy (NCI CTC \>= Grade I)
* Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization

Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.

Study Design: A prospective, randomized, controlled trial.

Background : Liver cancer is a serious disease with a high death rate. One of the treatment modalities for liver cancer is TACE. Patients always scare of the first TACE due to their lack of knowledge and inadequate comprehension of the procedure. Hence, they crave to have a good quality in nursing service. Researcher would like to compare the effectiveness knowledge between Video and Handbook regarding patients' health education.

Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.

Study Design: A prospective, randomized, controlled trial.

Setting: Chulabhorn Hospital, Bangkok, THAILAND.

Methods : Eighty liver cancer patients are included in the study. They are systematically computerized and randomized into two groups - an experiment or video group (N 40) and a control or Handbook group (N = 40). A 40-item exam is performed to test the patients' knowledge before (x score), after (y score) and 60 days (z score) after the procedure. The 15-min study was taken in an isolated room. The points of interest are the effectiveness of medias on learning achievement and relative growth of knowledge. The relative growth of knowledge (G1, G2 score) was calculated as follows:

G1 = 100 (Y-X)/(F-X) % ; G2 = 100 (Z-X)/(F-X)%

Retention of knowledge (R) = 100 - (G1 - G2) %

Where G = Relative growth of knowledge R = Retention of knowledge X = Pre-test score Y = Post-test score Z = Final-test score F = Total score

Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 75 years
* Willing to participate the study
* 1st TACE
* Can comprehend all information in video or handbook
* No trouble of hearing
* Can complete the 40-item test

Exclusion Criteria:

* Have psychological/mental problems