cyrilzakka/clinical-trials huggingface dataset:
Simple Technique to Improve Diagnostic Yield in EUS-FNA

Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and staging of pancreatic cancer. One potential limitation is contamination when needle traverses the gastrointestinal tract under continuous negative pressure. Gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. We propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decrease gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe from the biopsy channel after a specimen is obtained eliminates any remaining negative pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA specimens, and will lead to improved diagnostic accuracy of this important clinical technique.

Endoscopic ultrasound (EUS) has evolved into a minimally invasive diagnostic and staging method. The addition of fine needle aspiration (FNA) increases the accuracy of EUS in the diagnosis and staging of pancreatic malignancies. An ultrasound probe attached to the end of the endoscope allows real-time direct visualization by means of ultrasound transmission. During the FNA process a needle is advanced through the biopsy channel of the endoscope and into the target lesion. In order to obtain a tissue specimen of a suspicious pancreatic lesion, an FNA needle must traverse either the stomach or duodenum to access the pancreatic mass. Once the needle has entered the target lesion a syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. Negative pressure is released from the syringe and the stop cock is closed to the syringe. However, due to the relatively long length of the needle there is is significant remaining negative pressure at the needle tip. This leads to aspiration of surrounding material including GI mucosal contamination into the needle while removing it from the target lesion.

Contamination of the FNA specimen from gastric or duodenal epithelium can occur with continued negative pressure at the needle tip upon withdrawal of the needle out of the target lesion. While EUS-FNA has a high specificity (96%), sensitivity (87%), and accuracy (94%), gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. Based on clinical experience, we propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decreasing gastrointestinal tract contamination.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Not pregnant
* Can give consent
* Patients with suspicious GI lesions in need of tissue diagnosis by means of EUS/FNA

Exclusion Criteria:

* Pregnant
* Age \< 18
* Cannot give consent
* EUS not technically possible
Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?

To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Willing to return for follow up visit

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Unwilling to return for follow up
* Wounds less than 3 cm in length
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers 17 and under)
* Pregnant women
* Prisoners
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-cholesterol greater than or equal to 100 mg/dL at screening
* Men and nonpregnant, nonlactating women
* Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily

Exclusion Criteria:

* Fasting blood triglycerides greater than or equal to 500 mg/dL
* Body Mass Index (BMI) greater than or equal to 50 kg/m2
* Recent history of clinically significant cardiovascular disease
* Use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.
Understanding Physician Work Motivation

Development and validation of a measure of physician work motivation.

Not that long ago, most physicians were solo practitioners. Today, more physicians are working in large, integrated delivery systems, and many are employed by hospitals and multispecialty group practices. These dramatic changes in the physician work environment raise important questions on how evolving physician payment and care delivery models support or undermine your motivation and ability to deliver high-quality patient care.

To evaluate the impact of workplace changes on what motivates physician to deliver good patient care, this study aims to develop an accurate measure of physician work motivation. Simultaneously, the investigators plan to test hypotheses on the role of various workplace and psychological factors in physicians' work motivation. Namely, the investigators hypothesize that:

20 to 25% of the variance in work motivation is explained by psychological needs satisfaction; 5 to 10% of the variance in self-reported overall health status and depression is explained by work motivation; 5% of the variation in work motivation is explained by work that is seen as a calling; and 5 to 10% of the variation in medicine viewed as a calling is explained by the learning environment.

Eligibility Criteria:
Inclusion Criteria:

* practicing physicians in all medical specialties
* resident physicians in all medical specialties
* fourth year medical students in US allopathic medical schools

Exclusion Criteria:

* physicians without an active medical license.
* resident physicians without an active medical license.
* fourth year medical students in US osteopathic medical schools
Cost-effectiveness of Reduction Mammaplasty

Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and decrease of the functional capacity and of the self-esteem. The economical evaluations are destined to esteem the costs in alternative ways of attendance to the health, comparing, for instance, clinical strategies with surgical strategies.

OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.

1. Design: This is a primary, prospective, analytical, controlled study in humans.
2. Settings: Data will be collected at the Plastic Surgery and Orthopedic and Traumatology Outpatient Clinics of the Samuel Libânio General Hospital (Hospital das Clínicas Samuel Libânio, HCSL), Pouso Alegre, MG, Brazil, in july/2008-december 2009.
3. Participants: Fifty women with breast hypertrophy (25 study group and 25 control group) according to the Sacchini index,12 aged 18 to 59 years, were consecutively selected to participate in this study.

   Pregnant women, and patients who gave birth or were breastfeeding less than one year before the beginning of the study, as well as patients with uncontrolled systemic diseases, acute diseases, breast asymmetry, who had undergone breast or spine surgery, and who had body-mass index (BMI) lower than 18.5 kg/m2 (low body weight) or greater than 30 kg/m2 (obese women) were excluded from the study.
4. Instruments: Pain intensity in the cervical, dorsal and lumbar regions of the back has been assessed using a visual analogue scale (VAS). also will be used SF36, HAQ 20 and SF-6D.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast hypertrophy according to the Sacchini index

Exclusion Criteria:

* Pregnant women
* Patients who gave birth or were breastfeeding less than one year before the beginning of the study
* Patients with uncontrolled systemic diseases, acute diseases, or breast asymmetry
* Patients who had undergone breast or spine surgery
* Patients who had body-mass index (BMI) lower than 18.5 kg/m2 (low body weight) or greater than 30 kg/m2 (obese women)
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel

Analysis of tumor tissue (which is already available in pathology) and collection of saliva/stool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated
* Patients who are cisplatin-unfit for chemotherapy, defined as:

  * ECOG 2
  * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases
  * Calculated creatinine clearance of ≤50ml/min
  * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \< 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension
  * Poor nutritional status BMI \< 16kg/m²
  * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.
  * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes
  * Age ≥ 18 years
  * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it

Exclusion Criteria:

* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion
* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)
* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment
* Persistent drug or medication abuse
* Patients who are unwilling or unable to comply with the protocol and receive treatment
* Patients who are unsuitable for participation in the study due to a language barrier
Oxytocin and Eating

In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Male
* Age: 21-45 years
* Normal weight: Body mass index of 18.5 to 22.9
* Have had a stable weight for the past 3 months (less than 5kg)
* Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)
* Have habitual sleep of 6.5-8.5 hours
* Have English as first language (or fluent in spoken and written English)

Exclusion Criteria:

* Symptoms / history of any major medical condition, including:

  * Bariatric surgery or surgical obesity treatment
  * Diabetes
  * Cardiovascular disease
  * Thyroid disease
  * Anaemia
  * Psychiatric disorders
  * Eating disorders
* Excessive exercise (running \> 40 km or exercising \> 10 hr in a week)
* Currently on a special diet or trying deliberately to restrict food intake
* Currently on a weight loss program
* Smoking or substance abuse
* Use of medications that can affect weight (e.g., steroids, approved weight-loss drugs)
Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

Hypoglycemia occurs frequently during intensive blood glucose control in critically ill patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment, e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment. Therefore we investigate neurocognitive function in patients who had hypoglycemias during their intensive care stay and compare the results to patients without hypoglycaemia whose medical conditions are matched to the hypoglycaemia patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients

Exclusion Criteria:

* clinical diagnosis of diabetes mellitus
* brain injury of any kind prior to or upon ICU-admission
* pre-existing mental or psychiatric disorder
* terminal kidney or liver failure prior admission
* drug abuse,
* CPR \> 5 min
* HIV
* Lues
Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.

The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
7. Following up treatment side effects while taking the medications.
8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
9. Assessing patient compliance to different regimens during the final visit.
10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
11. Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive stool antigen test result for H. pylori
* Patients recently diagnosed with H. pylori infection and did not receive any treatment

Exclusion Criteria:

* Patients sensitive to any of the regimens' components
* Patients who had received a previous eradication therapy and still show positive test results
* Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
* Patients with gastric malignancy or who underwent previous gastric surgery
* Pregnancy and lactation
* Patients with major concomitant diseases, including psychic disorders
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation

The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.

* Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
* Sirolimus will continue for approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
* Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
* Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
* During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.

Eligibility Criteria:
Inclusion Criteria:

* Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
* Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
* Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
* Myelodysplastic syndromes or myeloproliferative diseases
* Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
* Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
* Matched unrelated donor.
* Age 18-55 years at the time of stem cell transplantation
* ECOG performance status 0-2
* Life expectancy of 100 days without stem cell transplantation
* Total bilirubin \< 2.0 mg/dl
* AST \< 90 IU
* Serum creatinine \< 2.0 mg/dl
* Ejection fraction \> 40% by echocardiogram or gated nuclear medicine study.

Exclusion Criteria:

* Uncontrolled infection
* Forced vital capacity or DLCO \< 50% predicted for age
* Uncontrolled hypertension
* Prior hematopoietic stem cell transplant
* Evidence of HIV infection or active Hepatitis B or C infection
* Cholesterol \> 300 mg/dl
* Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
Fetal Viability Estimation in Egypt

Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* pregnant females age from 18- 40 years old
* preterm delivery before completing 38 weeks of gestation
* singleton or multiple gestation
* fetuses with congenital anomalies

Exclusion Criteria:

* refusal to get enrolled in the study
Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.

All elderly patients aged 65 and above who are hospitalised from nursing home or sheltered housing facilities to the Orthopaedic Surgery Ward at Aarhus University Hospital with hip fracture and treated operatively, are eligible for this study. According to sample size calculations 284 patients are needed. Informed consent or deputy informed consent, if the patient is cognitively impaired, is needed. Inclusion is dependent on a haemoglobin measure between 6 and 7 mmol/l 6 days after surgery at the latest. Randomization will be computerised. Randomization will determine intervention with blood transfusion and the measurement of haemoglobin is blinded to the patient, relatives, and endpoint assessor. Both transfusion groups will receive blood when haemoglobin is less than 6 mmol/l, as recommended by the Danish Health and Medicine Authority. Geriatric and Orthopaedic Team (GO-team), consisting of following trained specialists: physiotherapist, nurse, and physician, will conduct medical evaluations, including blood transfusions, from admission until 30 days after surgery. The GO-team will work on weekdays both at the Orthopaedic surgery ward and in the patients home immediately after discharge. In accordance with Aarhus Blood Bank's instructions, blood transfusions are given both under hospitalisation, in the nursing homes and in the sheltered housings. Outcomes are functional ability and mortality during 90 days, and overall quality of life (OQoL) after 30 days and 1 year. The association between physical recovery and OQoL are tested.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hip fracture
* Surgery treatment
* Living in nursing homes or sheltered housing facilities
* Haemoglobin level between 6 and 7 mmol/l latest 6th day after surgery
* Written consent

Exclusion Criteria:

* Active cancer
* Pathological fracture
* The patient is against blood transfusion
Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korea

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by anticholinergic drugs.


Eligibility Criteria:
Inclusion Criteria:

-Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.

Exclusion Criteria:

-None.
MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).

Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.

A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.


Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer with the indication for robot assisted radical cystectomy
* Ileal conduit ad modum Bricker as planned urinary diversion
* Ability to understand the participant information orally and in writing
* Signed consent form

Exclusion Criteria:

* Previous abdominal or pelvic radiotherapy
* Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
* Urostomy planned on the left side of the abdomen
* Single kidney
* Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
* Pregnancy