cyrilzakka/clinical-trials huggingface dataset:
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder). By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (feeling sick to your stomach, feeling drowsy/sleepy, blockage/lack of movement in the intestines, inability to completely empty the bladder, unusually slow or shallow breathing).

The specific aim of this study is to compare the difference between the pain control methods in achieving the following:

1. Decreased opioid requirements
2. Improved postoperative VAS pain scores
3. Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression)
4. Decreased hospital length of stay (LOS)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cystectomy for bladder cancer
* ASA class 1, 2, 3 or 4
* Age 18 or older, male or female
* Desires Regional anesthesia for postoperative pain control

Exclusion Criteria:

* Any contraindication for thoracic epidural.
* History of substance abuse in the past 6 months.
* Patients on more than 30mg morphine equivalents of opioids daily.
* Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine, Hydromorphone).
* Postoperative intubation.
* Any patient with history of neuropathic bowel or bladder dysfunction
Blueberry Consumption and Type 2 Diabetes

Lifestyle strategies that include dietary modification, such as consumption of a plant-based diet, are well recognized in disease prevention and may improve type 2 diabetes. Various components of a plant-based diet may contribute to its beneficial health effects, but there has been keen interest in the possibility that plant polyphenols may have a role. Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are few human clinical trials evaluating the beneficial health effects of blueberries in populations with type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 45 to 75 years at beginning of study
* BMI \>25 kg/m2
* HbA1C \> 6.5 and \< 9
* Medical diagnosis of type 2 diabetes for at least 6 months

Exclusion Criteria:

* Use of insulin
* Presence of chronic kidney disease (GFR \< 45 mL/min), liver cirrhosis, gastrointestinal disease, pancreatic disease, or malabsorption syndromes
* Weight loss of \>10% of body weight over the last 6 months; routine participation in heavy exercise
* Heavy smokers (\>20 cigarettes per day)
* Unable or unwilling to give informed consent or communicate with study staff
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigators may interfere with study participation or the ability to follow the intervention protocol
* Allergies to blueberries or blueberry products
Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury

Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.


Eligibility Criteria:
Inclusion Criteria:

adult non-cardiac, non-obsteric, non- kidney elective surgery patients

Exclusion Criteria:

patients aged \<18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP \<100 mmHg
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.

In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.

Eligibility Criteria:
Inclusion Criteria:

* Men or women \> 21 years of age
* Any Race/Ethnicity
* Pre- or Stage I hypertension (BP \>= 120/80 and \<= 159/99)

Exclusion Criteria:

* Diabetes mellitus
* Renal impairment (serum creatinine \> 1.4 mg/dL)
* Any heart diseases such as congestive heart failure or sustained arrhythmia
* Chronic NSAID use
* Treatment with diuretics
* Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week
* Esophageal-gastric ulcer
* Chronic diarrhea
* Hyperkalemia (serum \> 4.6 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K \> 5.0 meq/L for patient not on ACE inhibitors or ARBs)
* Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) above upper limit of normal range)
* Subjects who require any potassium supplement on a regular basis from any reasons
* Pregnancy
* History of major depression, bipolar disorder, or schizophrenia
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra)
* Received 1 or 2 prior treatment regimens for advanced or metastatic disease
* Confirmed radiologic disease progression during or following recent treatment
* Mandatory biopsy is required during screening
* Measurable disease per RECIST v1.1
* Adequate organ function
* ECOG 0 or 1

Exclusion Criteria:

* Prior treatment with a PARP inhibitor
* Symptomatic and/or untreated CNS metastases
* Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
Cardiac Magnetic Resonance in Children With Muscular Dystrophy

This protocol will exploit novel state of the art cardiovascular magnetic resonance techniques to examine important changes in the heart in children with muscular dystrophy. The purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* Participant enrolled in the CINRG study: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy

Exclusion Criteria:

* Pregnant woman (when uncertain, participants will undergo urine testing) or lactating women
* Decompensated congestive heart failure (unable to lie flat during CMR)
* Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min)
* Contra-indications to Magnetic Resonance Imaging:

  * Cardiac pacemaker or implantable defibrillator
  * Cerebral aneurysm clip
  * Neural stimulator
  * Metallic ocular foreign body
  * Harrington-rod
  * Any implanted device (i.e. insulin pump, drug infusion device)
  * Claustrophobia
  * Metal shrapnel or bullet
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day.

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
* Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

* Not applicable
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* HbA1c (glycosylated haemoglobin) below or equal to 8.5%
* Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
* BMI (body mass index) below 35 kg/m\^2

Exclusion Criteria:

* Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
* Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
* Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
* Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

Longitudinal, observational cohort study to evaluate changes in left atrial (LA) reservoir function during exercise and overall exertional capacity in patients following catheter ablation for paroxysmal atrial fibrillation (AF).

EXCLAMATORY is a longitudinal observational cohort clinical research study to evaluate the effects of catheter ablation for paroxysmal atrial fibrillation on left atrial and left ventricular performance during exercise, as well as effects on overall exercise capacity

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of paroxysmal AF
* Left ventricular ejection fraction ≥50%
* Scheduled for catheter ablation
* Able to speak, hear, and read English
* Willing and able to provide informed consent

Exclusion Criteria:

* Persistent or permanent AF
* Prior ablation (catheter based or surgical) for AF
* Significant sinus node dysfunction
* Implanted pacemaker or defibrillator
* Contraindication to or inability to complete cardiovascular magnetic resonance study
* Contraindication to or inability to complete exercise testing
* Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Severe left ventricular hypertrophy
* Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:

  * Hypertrophic cardiomyopathy
  * Cardiac amyloidosis
  * Constrictive pericarditis
* Pulmonary arterial hypertension
* Prior cardiac surgery
* Active pregnancy
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
* Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
* Patients who are experiencing acute exacerbation of psychotic symptoms

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
DIAGNOSIS, TREATMENT AND OUTCOME OF LUNG CANCER PATIENTS

Observational, prospective clinical research, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Turkey

In Turkey, non-small cell lung cancer (NSCLC) is the most common cause of cancer-related death in men and one of the most common causes of cancer-related deaths in women. Because of the heterogeneity of NSCLC or SCLC, it is crucial to characterize the biology of the tumor as exact as possible, to predict the course of disease as accurate as possible, and to determine the optimal therapeutic algorithm as early as possible after initial diagnostic work-up.

These efforts are an obligatory part of the initial diagnostics, since thorough knowledge of the biology of the disease and the resulting therapeutic options ensure optimal care of Volunteers with NSCLC or SCLC. The aim of REGISTURK is to set up a national clinical research platform to document molecular testing, treatment and course of disease of patients with NSCLC or SCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Patient histopathologically diagnosed with non-small cell lung cancer or small cell lung cancer
2. Written informed consent no later than six weeks after start of first-line treatment
3. Age ≥ 18 years

Exclusion Criteria:

* Volunteers participating in a research program for non-small cell or small cell lung cancer that includes interventions outside of routine clinical trial
Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL).

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring.

The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital(WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients with a previous gastric resection, and 4) patients without an informed consent.

Eligibility Criteria:
Inclusion Criteria:

* On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion Criteria:

* Patients with severe complications which were possible to prolong hospital stay
* Patients who were diagnosed inadequacy for this study by a physician
* Patients who could not be placed a pancreatic stent tube
* Patients without an informed consent.
In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation

Using an adult lung bench model of non invasive ventilation, the aim of the study is to compare an experimental system of breath-synchronized vibrating mesh nebulizer to a conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and lost doses.


Eligibility Criteria:
Inclusion Criteria:

* Not applicable (in vitro study)

Exclusion Criteria:

* hypersensitivity (allergic) reactions to aminoglycosides
Management of Cervical Intraepithelial Neoplasia Grade 2

The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.

The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Eligibility Criteria:
Inclusion Criteria:

* Histological CIN2 diagnosis

Exclusion Criteria:

* Previous CIN treatment
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers

This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18 - 32 kg/m2, inclusive
* Female subjects: must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal (amenorrhea duration of 12 months)
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology
* Resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
* Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
* All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
* Willingness to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to drug administration
* Use of tobacco products (less than 60 days prior to drug administration)
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (paracetamol) is permitted on discretion of the MI.
* Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.
* Donation of more than 100 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study.
* Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
* Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
* Positive screen on HBsAg
* Positive screen on anti HCV
* Positive screen on anti HIV 1/2
* Illness within 5 days prior to (the first) drug administration
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a medical trial in the previous year