cyrilzakka/clinical-trials huggingface dataset:
Rapid Assessment of Esophageal Adenocarcinoma Risk Test

This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the Cytosponge test and time to follow up endoscopy, if indicated.

The incidence of esophageal adenocarcinoma (EAC) has risen over the past half century and continues to have a dismal prognosis. Even though it has been established that Barrett's esophagus (BE) is the precursor lesion to EAC, more than 90% of EAC patients are never diagnosed with BE beforehand. Thus, the opportunity is missed to identify most patients at high risk for EAC who could benefit from surveillance and early endoscopic therapy, which in turn may lower EAC mortality. Upper endoscopy is the only means to diagnose BE, yet widespread endoscopic screening is impractical and expensive. There is an urgent need to develop minimally-invasive methods of BE screening that can be easily performed in the primary care setting to allow for efficient and cost-effective interventions to decrease EAC mortality.

Eligibility Criteria:
Inclusion Criteria:

Males:

Ages 50-75 and at least one of the following:

* Gastro-esophageal reflux disease (GERD)\* or
* Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
* Both body mass index (BMI) ≥30 or
* A history of cigarette smoking (at least 10 pack years)

Females:

Ages 50-75 and GERD\* and at least one of the following:

* Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
* BMI ≥30 or
* A history of cigarette smoking (at least 10 pack years)

Exclusion Criteria:

* History of gastric or esophageal cancer
* History of esophageal surgery
* Known untreated esophageal stricture or uninvestigated dysphagia
* Previous upper endoscopy within 10 years
* Cancer within 3 years except for non-melanoma skin cancer
* Portal hypertension, with or without known varices
* Uncontrolled coagulopathy
* Uncontrolled major comorbid illness
* Inability to tolerate or contraindication to upper endoscopy
* Inability to give informed consent

GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* BK positive
* adult
* ok to participed to research

Exclusion Criteria:

* under guardianship
* under curatorship
* opposed to research
* deprived of liberty
Laser Treatment of Tattoos With Pico Laser

The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.

The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

A multicenter study.

Eligibility Criteria:
Inclusion Criteria:

1. Has Fitzpatrick skin type I-IV
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them
3. Is willing to consent to participate in the study
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure
2. Has an active sun tan
3. Has Fitzpatrick skin type V or VI
4. Has active localized or systemic infection
5. Is taking medication(s) for which sunlight is a contraindication
6. Has a history of squamous cell carcinoma or melanoma
7. Has a history of keloid scarring
8. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
9. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
10. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period
11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine
Fetal HIV Transmission Risk and Duration of Membrane Rupture

In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes.

In developed countries, HIV infection is now considered a chronic disease and thus the life expectancy of people infected with HIV is approaching that of the general population. Therefore many HIV positive women are choosing to pursue pregnancies. An important concern for antenatal and intrapartum management is decreasing the risk of vertical transmission. With the use of highly active antiretroviral therapy (HAART) and intrapartum IV zidovudine (ZDV) the risk of transmission is decreased significantly, however there is some debate surrounding optimal mode of delivery. Possible mechanisms leading to perinatal transmission include transfusion of the mother's blood to the fetus during labour contractions, infection after rupture of membranes and direct contact of the fetus with infected secretions or blood from the maternal genital tract.

When maternal viral load is detectable, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and other governing bodies recommend that elective cesarean section be performed for delivery as there is a 12-fold increased risk of perinatal transmission. However, the evidence suggests that for women at very low risk of transmission, such as those with an undetectable viral load and on HAART, the benefit of transmission reduction provided by cesarean section may be negligible.

The question of length of time of rupture of membranes prior to delivery and transmission risk has been a source of controversy, especially in the context of women on suppressive therapy (HAART) with an undetectable viral load. Traditional thinking has stated that the length of time of rupture of membranes should not be longer than 4 hours, as the benefit of cesarean section is lost after this time. However, this thinking is based on data where maternal viral loads were not known and only intrapartum IV ZDV was used. Many practitioners believe that in women with undetectable viral loads, virally suppressed on HAART, the safest route of delivery is vaginal, irrespective of length of time of rupture of membranes.

This is a retrospective cohort study which plans to examine the mode of delivery and median length of time of rupture of membranes for HIV positive women in two downtown academic institutions in Toronto.

Eligibility Criteria:
Inclusion Criteria:

* all HIV positive women from January 2000

Exclusion Criteria:

* women not on HAART and who were not receiving intrapartum intravenous zidovudine
Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.

Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with RCBPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.

This study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 years prior to study entry
* Has experienced an index depressive episode
* Received treatment with medication to stabilize mood for at least 6 months prior to study entry
* Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

Exclusion Criteria:

* Unable/unwilling to participate in psychiatric interviews
Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease

To construct a standardized stepped nutritional treatment process for inpatients with inflammatory bowel disease, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc.

Nutrition therapy of inflammatory bowel disease should follow the principle of sequential treatment of nutrition, which is the preferred scheme with enteral nutrition, from slow to fast, from weak to strong, from the elements to the whole protein on the steps of the gradual transition, in order to improve enteral nutrition in patients with tolerance and compliance and improve patient quality of life and long-term survival rate, reduce the social burden of disease, patients with good economic and social benefits.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease

Exclusion Criteria:

* nothing
Intramedullary Femoral Reaming, Human Study

To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

Eligibility Criteria:
Inclusion Criteria:

* femoral shaft fracture suitable for intramedullary nailing
* \< 24 hours postinjury

Exclusion Criteria:

* previous fracture of the femur
* pathological fracture
* femur deformities
* pregnancy
* previous intramedullary nailing or external fixation
Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery

Children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. A main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.


Eligibility Criteria:
Inclusion Criteria:

* Parents with children undergoing ear-nose-throat surgery in the study period

Exclusion Criteria:

* Parents who do not speak nor read Norwegian.
* Parents who do not want to participate
Medical Evaluation of Scanner in Coronary Syndrome

Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

Eligibility Criteria:
Inclusion Criteria:

* Patients' ≥18 years, of both sexes
* Coronary angiography in patients with suspected of known CAD, instable clinical conditions.
* Clinical status allowing performance of coronary angiography 48 à 72h after CT examination
* Informed consent signed by patient

Exclusion Criteria:

* Patients in whom clinical status does not allow delayed coronary angiography
* Irregular heart rate, in particular atrial fibrillation
* Renal insufficiency (serum creatinine \>150 µmol/l
* Radiology examination with use of iodin agent with 48h before) CT coronary
* K now intolerance to iodin agents
* Patients unable to hold breathing \< 20 seconds
* Pregnancy
Xeomin Cosmetic in the Management of Masseter

The goal of this study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using Xeomin Cosmetic.

Background: Xeomin Cosmetic has been used previously in the management of masseteric hypertrophy. However, a standardized injection technique has not been established. The goal of the present study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using Xeomin Cosmetic.

Methods: Thirty female patients with masseteric hypertrophy were recruited and evenly randomized to receive bilateral treatments of either 1) a single injection technique (SIT), or 2) a multi-injection technique (MIT). Improvement of masseteric hypertrophy was assessed at Week 16 using standardized measurements and photographs. Patients completed a 5-point satisfaction questionnaire while physicians the global aesthetic improvement scale (GAIS) and 10-point photonumeric masseter prominence rating scale.

Eligibility Criteria:
Inclusion Criteria:

1. At the time of consent, women over the age of 18 years old.
2. Patients with established hypertrophy of the masseters, palpable and visible.
3. Accepted the obligation not to receive any other facial procedures through the 6-month follow-up.
4. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits.
5. No previous facial fillers for a period of 6 months prior to this study.
6. No previous facial fillers along the jawline for 18 months
7. Capable of providing informed consent.
8. No previous botulinum toxin type A treatment for masseteric hypertrophy in the last 12 months.

Exclusion Criteria:

1. Current Pregnancy or lactation
2. Hypersensitivity to Xeomin
3. Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome)
4. Presence of infection at the site of injection
5. Inability to comply with follow-up and abstain from facial injections during the study period
6. Patients with a score of 2 or greater on the Merz Aesthetics Scale for the Jawline
Proton Beam Therapy for Chondrosarcoma

The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.

Patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain.

Pathology will be confirmed prior to discussion of the study.

If you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays, and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.

If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.

After the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, until the study is completed. At these visits, you will have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. For the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. These tests could last from 1-2 hours. You will also have eye exams performed by an ophthalmologist from MD Anderson and hearing exams. It is anticipated that it will take about 5 years to complete this study.

This is an investigational study. The proton beam center and its treatment are approved by the FDA for patient use. A total of up to 15 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
2. Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
3. The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease
4. Karnofsky Performance status greater than or equal to 60
5. Signed informed consent

Exclusion Criteria:

1. Previous irradiation of the skull base
2. Documented evidence of disseminated metastatic disease
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients

The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.

patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.

The second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.

Eligibility Criteria:
Inclusion Criteria:

* With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* Diagnosed with TLE according to the criteria of the International League Against Epilepsy
* Literates had sign an informed consent
* Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression

Exclusion Criteria:

* Patients with high risk of suicide who required hospitalization
* Patients who abused or are dependent on drugs
* Those with a history of head trauma six months prior to the interview
* Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
* Patients who have previously received CBT
* Patients who have started, an antidepressant drug the last 8 weeks
Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood

This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by evaluating how the results compare to those obtained from laboratory hexokinase method. The study results will be the basis for the regulatory submission and registration of the Nova StatStrip® glucose hospital meter and test strips in testing the neonatal capillary whole blood specimens to the China Food and Drug Administration (CFDA).

Good clinical practice indicates that the performance of a point-of-care glucose monitoring test system be validated before clinical use. It is therefore important to perform a method comparison study to determine how the results obtained from a type of glucose monitoring test system compare to those from a laboratory hexokinase method.


Eligibility Criteria:
Inclusion Criteria:

* Subject is within 28 days after birth.
* The legal representative of the Subject agrees to sign two copies of the Informed Consent Form.
* The Subject's capillary whole blood needs to be drawn via heel stick for routine clinical laboratory testing according to the prescription.
* The legal representative of the Subject agrees that the Subject provides 300 µL capillary whole blood for glucose and haematocrit testing in addition to routine clinical laboratory testing.

Exclusion Criteria:

* Subject/legal representative is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products;
* Subject has already participated in this study.