cyrilzakka/clinical-trials huggingface dataset:
Effects of Intranasal Oxytocin and Vasopressin on Social Behavior

The purpose of this study is to investigate the role of a one-time intranasal administration of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and altruism in a healthy population of student controls.


Eligibility Criteria:
Inclusion Criteria:

* healthy controls

Exclusion Criteria:

* Past or present psychiatric, neurological, endocrinological or severe chronic medical illness.
* Use of medications or drugs that would interfere with study results. This includes steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous.
* history of drug or alcohol addiction
* Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. All females will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.
Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of "aspirin resistance" in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of "aspirin resistance" will be higher among diabetics compared to other patients and to healthy individuals.

A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term "aspirin resistance" has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of "aspirin resistance" was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic heart disease verified by coronary angiogram (group:"CAD")
* treatment with aspirin 75 mg/d for at least the previous 7 days(groups: "CAD" and "Previous myocardial infarction")
* type II diabetes mellitus (\~50% of groups: "CAD" and "Previous myocardial infarction")
* ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: "Previous myocardial infarction").

Exclusion Criteria:

* treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function.
* ischemic vascular event within the previous 12 months
* revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
* intake of NSAIDs within 1 week of myocardial infarction (group: "Previous myocardial infarction").
* platelet count \< 120 x 10\^9/l
* previous myocardial infarction (group: "CAD").
* not able to give informed consent
Autonomic Dysfunction in Patients With Pectus Excavatum.

Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.

Since pectus excavatum can cause cardiac arrhythmia, the cardiac autonomic function in participants with pectus excavatum might be impaired. However, to our knowledge, there is no any study to evaluate the cardiac autonomic function in participants with pectus excavatum.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of pectus excavatum
2. Agree to receive Nuss surgery to correct pectus excavatum

Exclusion criteria:

1. Major medical disease (asthma, heart failure, renal disease)
2. Known psychiatric disease
3. Known sleep-disordered breathing
4. Skeletal disease
5. Major surgery within 6 months
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery

Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.

To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :

1. Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and wall shear stress in a control population and in three groups of subjects to RA progressively increasing risk: asymptomatic subjects without symptomatic subjects LV dysfunction, symptomatic patients with LV dysfunction. The factors favoring the appearance of fibrosis observed in MRI will be analyzed on all subjects.
2. To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
3. Monitoring compliance with the distribution of markers of fibrosis and wall stress estimated on Initial MRI are factors of aggravation or not improved function and / or remodeling remote myocardial. Public hospitals in Paris

Eligibility Criteria:
PATIENTS :

Inclusion Criteria:

* Echocardiography considered as normal and / or age-related
* Patients who have received prior clinical examination
* Patient receiving a social security scheme or entitled, or CMU
* After having giving written informed consent.
* Patients symptomatic with indication of surgery (group surgery) or not

Exclusion Criteria:

* With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation
* Heart valve surgery history (aortic, mitral, tricuspid and pulmonary).
* Indication for cardiac surgery other than on the aortic valve.
* Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy.
* Patients with severe renal insufficiency with a clearance \<30 ml / min estimated by the Cockcroft \& Gault formula.
* Patient who cannot be followed over the duration of a year.

CONTROLS (healthy volunteers)

Inclusion criteria:

* Normal EKG
* Echocardiography considered normal and / or age-related
* Patients who have received prior clinical examination
* Patient receiving a french national social security
* After having obtain written informed consent.

Criteria for non-inclusion

* History of known or detectable infarction on EKG
* Known primary or secondary cardiomyopathy or detectable on echocardiography
* Thoracic radiotherapy or chemotherapy history
* Subject with usual contra-indications of MRI: claustrophobia, metallic objects.
* Patients with significant renal insufficiency with a clearance \<90 ml / min estimated by the Cockcroft \& Gault formula.
* Subject who could be planned for 2 CMR within two weeks
The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms

The main hypothesis of this study is that peripheral magnetic neuromodulation can correct the symptoms of lower urinary tract in men. We assume that under the influence of t peripheral magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and a urination diary, as well as the objective parameters, assessed by non-invasive urodynamic studies, will be improved. This study will use standard protocols built into the BTL Emsella magnetic stimulator.

The aim of the study is to test the hypothesis that the use of the peripheral magnetic stimulation in men with lower urinary tract symptoms will help to reduce subjective and objective clinical symptoms and improve the quality of life of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. Signed informed consent;
3. The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.

Exclusion Criteria:

1. The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).
2. Convulsive attacks in the anamnesis;
3. Taking medications that may trigger the risk of seizures;
4. The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)
5. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
6. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
7. The postvoid residual volume (more than 50 ml);
8. The concentration of prostate specific antigen (PSA) in the blood is more than 4.0 ng / ml;
9. The presence of urinary tract infection;
10. A history of cancer of the pelvic floor organs;
A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study

Studies have shown that there is a significant association between serum bilirubin concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in humans between serum bilirubin and DNA markers has been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in more than three hundred families. Serum bilirubin was measured in the first and second exams of the Framingham Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of serum bilirubin.

Many studies showed that there is a significant relationship between serum bilirubin levels and risk of coronary artery disease (CAD). We carried out a genome-wide scan for quantitative trait loci of serum bilirubin through the 330 extended Framingham families and found significant evidence of linkage of serum bilirubin to chromosome 2q telomere where an important candidate gene, Uridine diphosphate glycosyltransferase 1 gene (UGT1A1), resides. The purposes of this protocol are to confirm linkage between serum bilirubin and UGT1A1, mathematical modeling and association studies between the genotypes of UGT1A1 and CAD.

Eligibility Criteria:
* INCLUSION CRITERIA:

The study population will include the members of the 330 Framingham Study families and 1888 random individuals.

The Original Cohort will also be included.
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU

The current study hypothesizes that the use of Intravenous intensive insulin therapy (IV-IIT) may be beneficial than IV conventional insulin therapy (IV-CIT) for improving the outcome of non-diabetic surgical patients had postoperative (PO) stress hyperglycemia (PSH).

All postoperative patients who will be admitted to surgical ICU and develop (PSH) will be eligible for evaluation for inclusion and exclusion criteria.

Prior to initiation of IV-IT (insulin therapy), blood samples will be obtained to estimate base-line Blood Glucose level (BG). BG will be estimated hourly during IV-IT to guard against development of hypoglycemic episodes. The assigned IV-IT will continue till reaching the target BG for each group and then will be stopped and patients will be shifted to subcutaneous (sc)-IT. During maintenance sc-IT, BG level will be estimated 6-hourly to assure maintenance of BG within the desired range, otherwise if hyperglycemia recurred or its induced complications as hyperglycemic ketoacidosis or hyperosmolar coma or infectious complications developed, IV-IT will be resumed and BG will be followed-up hourly. The same sequence of follow-up will be continued till stability of BG at the targeted level. IV-IT will be provided as following :

Conventional insulin therapy (CIT) will be provided as a continuous infusion of 50 IU of Actrapid HM in 50 ml of 0.9% sodium chloride using a pump. Infusion will be adjusted to achieve BG level in range of 180-200 mg/dl.

Intensive insulin therapy (IIT) will be provided as an insulin infusion at rate of 1 mU/kg/min and will be adjusted to achieve target BG level in range of 80-110 mg/dl.

Eligibility Criteria:
Inclusion Criteria:

* All postoperative patients who will be admitted to surgical ICU and developed Post Surgical Hyperglycemia will be eligible for evaluation for inclusion and exclusion criteria

Exclusion Criteria:

* All patients having diabetes mellitus, history of preoperative stress hyperglycemia, endocrinopathies, obesity defined as body mass index (BMI) \>30 kg/m2, age younger than 18 years, renal impairment or maintenance on renal replacement therapy and liver diseases.
Crestal Bone Loss in Mandibular Telescopic Overdentures. Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings.

The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.

All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.


Eligibility Criteria:
Inclusion Criteria:

1. Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
2. Adequate amount of interarch space of at least 12mm.
3. Age range from 55 to 75 years old age.

Exclusion Criteria:

1. Systemic and metabolic diseases that may affect osseointegration.
2. Patients receiving bisphosphonates therapy.
3. Patients under radiotherapy or chemotherapy.
Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern.

Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization.

There is no randomized comparison of this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
* Written informed consent

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Previous stenting of the SFA
* Popliteal stenosis \>70%
* Severe renal insufficiency
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 2 months old infants on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
* Able to attend all scheduled visits and to comply with all trial procedures
* Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Subjects with congenital or acquired immunodeficiency in the child's surrounding
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any vaccination in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following the trial vaccination
* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
* Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
* History of seizures
* Febrile or acute illness on the day of inclusion.
Use of Lapis Judaicus to Dissolve Kidney Stones

The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan.

It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Mentally competent
* Medically effective birth control if fertile female
* History of calcium containing stone AND current quantifiable stone
* Able to comply with protocol

Exclusion Criteria:

* Prisoner
* Pregnant
* CKD
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease

Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells.

PRIMARY OBJECTIVES:

I. Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease.

II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL) expression on patients' peripheral blood lymphocytes.

OUTLINE: Patients are stratified according to disease characteristics: low grade non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large, diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.

Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease
* Maximum of 4 previous treatment regimens
* Measurable disease
* No CNS involvement
* Performance status - Zubrod 0-1
* Performance status - Karnofsky 80-100%
* At least 12 weeks
* Platelet count at least 75,000/mm\^3
* Absolute neutrophil count greater than 1500/mm\^3
* Lymphocyte count greater than 500/mm\^3
* Hemoglobin at least 8.0 g/dL
* Bilirubin less than 1.5 mg/dL
* SGOT/SGPT less than 2 times normal
* Creatinine no greater than 1.6 mg/dL
* Creatinine clearance at least 60 mL/min
* No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias
* No severe pulmonary disease including dyspnea with moderate to severe exertion
* HIV negative
* No active infection
* Not pregnant or nursing
* Fertile patients must use adequate contraception
* No clinically significant autoimmune disease (e.g. rheumatoid arthritis)
* No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
* No prior allogeneic bone marrow or stem cell transplant
* At least 3 weeks since prior biologic therapy for lymphoma
* At least 3 weeks since prior chemotherapy for lymphoma
* No concurrent steroid therapy
* At least 3 weeks since prior endocrine therapy for lymphoma
* At least 3 weeks since prior radiotherapy for lymphoma
* At least 2 weeks since prior surgery
The Effect of Circadian Rhythms on Norctrend Index in Anesthesia

The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia.

It has been reported that circadian rhythm has many aspects of influence on human body. But little is knew about the circadian rhythm affect on Narcotrend index (made in Germany) in total intravenous anesthesia .The investigators' study is to find the relationship between them.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
* ability to compliance the research plan;
* volunteered and signed for the study ;
* receive surgery and general anesthesia

Exclusion Criteria:

* ASA\>Ⅱ;
* Head or facial surgery
* can't collaborate;