cyrilzakka/clinical-trials huggingface dataset:
Impact of Low Dose Fluoroscopy in Ureteroscopy

One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study.

Several studies support an association between increasing cancer risk with increasing exposure to radiation. Typical radiation exposure for a patient submitted to ureteroscopy ranges from 2.5 to 100 mSv. The International Commission on Radiological Protection recommends an annual occupational radiation exposure limit of no more than 50 mSv per year. One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* ureteral stone from 5 mm to 20 mm in diameter by CT scan

Exclusion Criteria:

* abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system
Evaluation of the Proliferative Activities of Insulin Analogues in Primary Human Tumor Cells

Recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.During the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. In this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Endometrial and Colon Cancer

Exclusion Criteria:

* None
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopy independent from indication
* Age ≥ 18
* Patient is able to provide informed consent for the procedure

Exclusion Criteria:

* Inflammatory Bowel Disease stenosis
* Pregnant of nursing patient
* Acute diverticulitis
* Active Inflammatory Bowel Disease
* Age ≤ 18
* Coagulation disorder (INR\>1.4 , Thrombocytes \< 50000/µl)
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

This trial studies the effect of pegloticase in reducing uric acid levels in patients with hyperuricemia (high blood levels of uric acid) caused by tumor lysis syndrome. Tumor lysis syndrome occurs when the breakdown products of cancer cells, such as uric acid, enter the blood stream. High levels of uric acid in blood may cause kidney damage and reduce kidney function. The goal of this trial is to learn if pegloticase may lower uric acid levels in blood when given to cancer patients with hyperuricemia caused by tumor lysis syndrome.

PRIMARY OBJECTIVE:

I. To collect preliminary data on the effectiveness of a single dose of pegloticase in lowering serum uric acid levels to less than 6.0 mg/dl within 24 hours in patients with hyperuricemia in the setting of tumor lysis syndrome.

SECONDARY OBJECTIVES:

I. To assess the effect of pegloticase on renal function in patients with hyperuricemia in the setting of tumor lysis syndrome as measured by changes in serum creatinine/estimated glomerular filtration rate (eGFR) and urine output.

II. To estimate the rate of renal replacement therapy initiation for acute kidney injury secondary to tumor lysis syndrome among patients treated with pegloticase.

OUTLINE:

Patients receive pegloticase intravenously (IV) over 120 minutes. Patients whose serum uric acid does not drop below 6 mg/dL within 24 hours receive a second dose of pegloticase IV over 120 minutes on day 2. Patients whose serum uric acid does not drop below 6 mg/dL after two doses of pegloticase receive standard of care rasburicase IV once daily (QD) for 5 days.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Signed informed consent prior to any study specific procedures (patient or caregiver)
2. Male or female 18 years of age or older
3. In the investigator's opinion, expected survival of at least 1 month
4. Deemed stable by the investigator
5. Serum Uric Acid ≥ 6 mg/dL
6. Risk for tumor lysis syndrome based on the MD Anderson TLS risk score

Exclusion Criteria:

Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled:

1. Inability or refusal to give informed consent (patient or caregiver)
2. Subject unwilling to take study medication
3. Known allergy to uricase
4. Pregnant
5. Breastfeeding
6. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
7. Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions.
8. Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators are undertaking a multicenter, randomized, double blinded placebo-controlled trial of 240 primary ITP adult patients from 8 medical centers in China. One part of the participants are randomly selected to receive caffeic acid tablets (given orally at a dose of 900mg per day for 3 consecutive months), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo.

Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

* 1.Meet the diagnostic criteria for immune thrombocytopenia; 2.Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years; 3.To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations; 4.Willing and able to sign written informed consent

Exclusion Criteria:

* 1.Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit 2.Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit 3.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study 4.Current HIV infection or hepatitis B virus or hepatitis C virus infections 5.Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 6.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period 7.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test 8.Patients who are deemed unsuitable for the study by the investigator
Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.

The purpose of the study is to evaluate efficacy and safety of direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.

Allogenic haematopoietic stem cell transplantation is an established treatment option for haematologic malignancies, especially leukaemias and lymphomas, providing curative potential. The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is nowadays the most common source of stem cells. Routinely used route of stem cell transplantation is intravenous infusion via central venous catheter. Based on the animal studies, only 10-15% of intravenously transplanted stem cells migrate to haematopoietic sites while the rest is lost in other organs. Results of studies of direct intrabone allogenic cord-blood cells transplantation in humans confirm that this route of transplantation is associated with less probability of graft failure and moreover may reduce risk of graft-versus-host disease and malignancy relapse. For those purposes in the current study we investigate intrabone route of allogenic peripheral blood stem cell transplantation. Our intention is to achieve fast engraftment and minimize risk of relapse and graft graft-versus-host disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Diagnosis of leukaemia or lymphoma
* Indication for allogenic stem cell transplantation according to European Group for Blood and Marrow Transplantation guidelines
* HLA-matched sibling donor qualified for peripheral blood stem cell donation
* Performance status WHO 0-1
* Written informed consent

Exclusion Criteria:

* Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine \>1.5 upper normal limit; LVEF \<45%
* Active infection
* Unstable diabetes
* Psychiatric diseases
* Obesity or anatomical obstacle for direct intrabone transplantation
Lymphovascular Abnormalities Under Tattoos

The number of tattooed people is increasing and some complications secondary to tattoos suggest that the lymphatic vascular system might be implicated in their pathogenesis. Abnormalities have been described at the level of the lymph nodes draining the tattooed areas but nothing was reported about the lymphatic vessels under tattoos. This is the aim of the present work.

19 subjects with 20 tattooed skin surfaces were enrolled after written informed consent and the lymphvascular drainage under the tattooed surface was studied using one near infrared camera device after one intradermal injection of Indocyanine Green.

Eligibility Criteria:
Inclusion Criteria:

* presence of one tattoo at the level of one limb
* written informed consent

Exclusion Criteria:

1. History of iodine allergy or anaphylactic reactions to insect bites or medication;
2. Hyperthyroidism;
3. Severe cardiac or pulmonary disease;
4. Significant renal failure (creatinine \> 400 μmol/l);
5. Pregnancy;
6. any known disease of the skin (such as psoriasis);
7. any disease known to affect the cutaneous tissues (such as diabetes);
8. any previous operation and/or trauma at the level of tattooed limb;
9. familial history of lower limb edemas:
10. skin infection after the tattoo
The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae

This study hopes to determine if a negative pressure dressing is superior to a traditional dressing for speeding fistula closure after laparotomy. This study has a broad variety of implications. Patient safety is a paramount concern: Investigators hope to identify a superior method of wound management which minimizes risk for skin breakdown, sepsis, and morbidity. In addition, patient satisfaction would be improved with a method for faster wound healing. Finally,implications exist in the realm of a cost-benefit analysis, for example, although the VAC method is more costly, it may save money if it speeds healing and prevents the need for reoperation. Alternatively, if the VAC method is not shown to be beneficial, physicians can avoid using a more costly device with no proven benefit.

Investigators are planning a superiority trial to show that VAC use speeds the closure of enterocutaneous fistulae over routine gravity drainage. The investigators' design is a randomized controlled trial with two arms. One of the arms (non-VAC) will include patients assigned to a system of ECFoutput management which does not involve negative pressure (for example, an ostomy bag placed over the fistula, wet to dry dressing changes, etc..), and the second arm (VAC) will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .

The fistula vac is made from standard sponge supplies and negative pressure suction devices. Initial placement will be by the bedside physician in the intensive care unit, the ward, or in the clinic. The patient will be taught basic wound care, and as is typical for those outpatients with wound VACs, a home nursing aide will be arranged. Those randomized to no VAC therapy will have ostomy bags or wet to dry dressings placed on the skin with no negative pressure applied. Again, initial application will be performed by the bedside physician or a wound care nurse. The patient will be taught wound care, with assistance provided as necessary.

Once a fistula is noted to have closed (effluent = 0cc/day) the dressings or VAC will be discontinued, and the date of fistula closure noted.

Eligibility Criteria:
Inclusion Criteria:

* post-laparotomy patient developing a new enterocutaneous fistula

Exclusion Criteria:

* patient with a prior history of abdominal radiation
* patient with a distal obstruction, any entero-atmospheric fistula, or any patient with a history of intra-abdominal or metastatic cancer.
Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder

Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is made usually in the late stage of this condition. One of the treatment methods of pain accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a safe procedure with a small percentage of complications, nevertheless it is often use as the last stage in pain management what significantly decreases its effectiveness.

The aim of this study is to determinate the effect of invasive pain treatment (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT questionnaires), and suffering (measured with PRISM projection test), the use of painkillers during the disease and patients' overall survival. Moreover the investigators want to check if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined with better therapeutic effect of this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pancreatic cancer
* Age over 18 years
* Signed informed consent to participate in the study

Exclusion Criteria:

* Age under 18 years
* Intellectual inability to fill the questionnaires
* Co-occurrence of a disease in which significant chronic pain exists, which was recognized before the onset of pancreatic cancer
NSAIDs Treatment in Children With Pleuropneumonia

The purpose of this study is to evaluate the influence of routine NSAIDs treatment for hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in conjunction with adequate antibiotic therapy).


Eligibility Criteria:
Inclusion Criteria:

* age less than 18 years
* admission in Schneider childrenMC of Israel, wards a/c
* clinical diagnosis of pneumonia with evidence of pleural effusion on chest X-ray
* parental informed consent
* follow-up ability after discharge

Exclusion Criteria:

* pneumonia secondary to foreign body aspiration
* immune deficiency
* chronic lung disease other than asthma (CF, CLD of prematurity, Familial Dysautonomia, etc)
* significant premorbidity (organ failure, rheumatic disease, etc)
* endotracheal/endobronchial devices including tracheostomy.
* parental refusal to participate in the study.
The Establishment and Application of the New Labor Progress Centered System of Reducing Cesarean Section Rates in China

1. To describe the average labor curve and establish new labor progression standards.
2. Cesarean section rates: Based on big data, the investigator will introduce the international advanced Robson class method and identify the appropriate level of cesarean section rate for each type population.
3. Establishment of "Chinese maternal-fetal medical collaboration network" and APP to promote natural childbirth.

1. To describe the average labor curve and establish new labor progression standards. The investigator will investigate the current characteristics of obstetric population and the labor progression with obstetric intervention in China. The investigator compare the different effects of traditional labor progression management model, new labor progression management model and active labor progression management model on labor outcomes. Based on the best outcomes of maternity and infants, the investigator will establish and modify new labor progression which is suitable for Chinese.
2. Cesarean section rates: Based on big data, the investigator will introduce the international advanced Robson class method and identify the appropriate level of cesarean section rate for each type population.the investigator compare cesarean section rates of different level hospitals and evaluate the effects of reducing cesarean section rates. The investigator also analyze the risk factors of cesarean section rates of the ten Robson classification, which will provide basis for reducing cesarean section rates under the new strategy.
3. Establishment of "Chinese maternal-fetal medical collaboration network" and mobile application software (APP) to promote natural childbirth: The investigator establish perinatal data center using the hospital information system (HIS) system of hospital. The investigator predict the cesarean section rates and relative factors using the Robson classification method, and propose the new strategy of reducing cesarean section rates. Meanwhile, the investigator develop the quality management system toolkit which can help clinicians standardize behavior and improve obstetric safety.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese pregnant women
2. singleton
3. head position
4. 37 weeks + 0 day - 41weeks + 6 days
5. primipara
6. low-risk pregnancy
7. vaginal delivery willingness
8. vaginal cervix \<7 cm after labor

Exclusion Criteria:

1. multiple pregnancy
2. non-head position
3. stillbirth
4. selective cesarean section
5. prenatal cesarean section
6. age \<18 years
7. previous childbirth history
8. pregnancy complications
9. important fetal malformations.
An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice

The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 20 to 80 years old.
* Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
* Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Exclusion Criteria:

* Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
* Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
* Patients participating in any other protocol