cyrilzakka/clinical-trials huggingface dataset:
Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* Performance status \<2 (ECOG, appendix II)
* Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis

Exclusion Criteria:

* Prior pelvic irradiation
* Inflammatory bowel disease
* Evidence of distant metastasis
* Performance status \>2
The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function

Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.


Eligibility Criteria:
Inclusion Criteria:

* Physical education students

Exclusion Criteria:

* All others
The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation

This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients.

The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is undergoing de novo pulmonary vein isolation procedure.
2. Participant is willing and able to give informed consent for participation in the study.
3. Male or Female, ≥18 years of age.

Exclusion Criteria:

1. Previous percutaneous or open surgical procedure involving the left atrium
2. Pregnancy (current or currently planning)
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 and ≤ 75 years of age.
* Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
* Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
* No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
* American Society of Anesthesiology score (ASA) class I, II, or III.
* Written informed consent.

Exclusion Criteria:

* Patients ≤ 18 and ≥ 75 years of age.
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
* History of allergy to iodine agents.
* History of other malignant disease within past five years.
* Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
* Patients intraoperatively/postoperatively confirmed as T4b.
* Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
Reproducibility of Acute Caffeine Effect

Introduction: Various studies have evaluated and verified the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, all experimental investigations designed so far have been based on the comparison of the \&#34;caffeine\&#34; and \&#34;placebo\&#34; conditions in a single trial, not considering the reproducibility and variability of caffeine in multiple trials.

Objectives: The present study aims to evaluate the reproducibility and replicability of the acute effect of caffeine intake on energy metabolism and the muscular production of force, power and endurance, according to sex (men vs women) and type of exercise ( bench press vs squat).


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 18 and ≤ 35 years.
* Body Mass Index (BMI) \&amp;lt; 25 kg/m².
* Resistance-trained individuals (\&amp;gt; 2 years of structured trained).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
* Participants must be able to perform the tests described in the following section.

Exclusion Criteria:

* History of neuromuscular diseases, heart diseases, or diseases that may affect liver or muscle metabolism.
* Use of drugs, other stimulants or sport supplements that interfere with the the study dietary supplement.
* Sedentary habits (\&amp;lt;150 min/week of moderate exercise).
* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
* Performing strenuous exercise during the 48 hours prior to the tests.
* Failure to replicate the same food intake on the two days of the experiments.
* Consuming caffeine or any other stimulant after 6 pm the day before the training or tests, to avoid headaches, discomfort, or lethargy among regular caffeine consumers.
Induction of Labor in Morbidly Obese Patients

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI \>40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.

The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI \>40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
* Speaks English or Spanish
* Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
* Age 18 years old or older
* Viable, single, cephalic fetus
* Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm
* Contractions \< 5 per 10 minutes

Exclusion Criteria:

* History of cesarean delivery
* Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
* Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
* Contraindications to labor (cardiac, neurosurgical, need for cesarean)
* Age \< 18yo
* Fetal growth restriction with abnormal umbilical artery Doppler indices
* Cervical dilation \>5 cm
* Contractions \>5 per 10 minutes
* Significant vaginal bleeding with concern for placental abruption
* Non-reassuring fetal status or fetal heart rate decelerations
* Fetal demise or major fetal anomaly
* Inability to give consent
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients

Most high risk keratoplasties are currently performed under systemic immunosuppression. Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile, administered for around 6 months. Due to potentially severe adverse effects, new immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous application only twice following transplantation. Basiliximab has already been demonstrated effective in kidney transplantation.

This investigation is a prospective, randomized clinical trial on orthotopic, high-risk penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary endpoint is graft rejection. Secondary endpoint is clear graft survival.


Eligibility Criteria:
Inclusion Criteria:

* high risk keratoplasty

Exclusion Criteria:

* normal risk keratoplasty
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is:

• Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ?

Participants will:

* sign the informed consent to enroll in the clinical trial.
* will agree to be treated by PCI
* will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.

If there is a comparison group:

Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients underwent PCI.
* Patent radial access (distal and conventional)
* Patients who agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Cardiogenic shock.
* Previous coronary artery bypass grafting (CABG).
* Absence of palpable radial pulse.
* Arteriovenous fistula for hemodialysis.
* Previous radial artery occlusion.
Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes

The aim of this study is to investigate the incidence and possible causes of obscured or disrupted cone outer segment tips line at fovea in spectral-domain optical coherence tomography images of normal eyes.

Thirty-seven eyes of 37 individuals without eye diseases were included in this study. Optical Coherence Tomography (OCT) images were taken using Cirrus HD-OCT (Carl Zeiss Meditec) with 5 line raster and high-definition 5 line raster modes. Images with signal strength weaker than 5/10 were excluded. Distinction of COST line and the integrity of COST line, external limiting membrane, and the photoreceptor inner segment and outer segment junction at the fovea were recorded. Demographic data, refractive error of the eyes, signal strengths of the OCT images were acquired for analysis.

Eligibility Criteria:
Inclusion Criteria:

* individuals without eye diseases

Exclusion Criteria:

* individuals with eye diseases
A Study of a Pelvic Floor Muscle Exercise Program Before and After Radical Prostatectomy

The researchers are doing this study to find out if a PFME program to reduce urinary incontinence after radical prostatectomy is feasible for people with prostate cancer. The researchers will track how many participants join the study, follow the program, and stay in the study. They will also evaluate how people feel about their experience and satisfaction with participating in this program through interviews. They will also measure participants' quality of life by filling out questionnaires, and we will study whether the program shows promise in reducing urinary incontinence.

Radical prostatectomy sometimes causes incontinence after the surgery. The researchers think that by teaching PFME and strengthening and improving control of the pelvic floor muscles, PFME training before and after radical prostatectomy may help reduce incontinence and/or reduce how long incontinence lasts.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years with prostate cancer scheduled for radical prostatectomy at MSK

Exclusion Criteria:

* Previous radiotherapy for prostate cancer
* Urinary incontinence at baseline before radical prostatectomy
* Inability to participate in study activities (exercise program, imaging, and questionnaires) because of:

  * Comorbidity(-ies) and/or
  * Geographic location and/or
  * Communication barrier(s)
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients

The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of muscle pain which usually develops after exercising.

Delayed Onset Muscle Soreness is a common painful sensation experienced by individuals who have been recently inactive and begin with an unaccustomed exercise protocol. Branched Chained Amino Acids have been found as a useful supplement for promoting muscle recovery following exercise; however the effects of this supplement have not been investigated amongst individuals with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* The subjects with diabetes must have been diagnosed with diabetes at least one year before the onset of the study
* At least 6 weeks of physical inactivity in the upper body
* BMI less than 40

Exclusion Criteria:

* For the Diabetics, hemoglobin A1c levels over 13
* Pregnant
* Have Cardiovascular diseases
* Have Hepatic diseases
* Are diagnosed with Rhabdomyolysis
* Recent upper limb injuries
* Upper limb neuropathy
* Blood Pressure levels over 140/90, or lower than 90/60
* Are on High doses of alpha or beta agonist/antagonists, and take any types of NSAID's, Cox 2 inhibitors, Calcium channel blockers, Pre-Gabalin's, or Pain reducers
SEPSIS 3 Critera for Risk Stratification in Emergency Patients

Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.

Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection


Eligibility Criteria:
Inclusion Criteria:

* Adult that present to the emergency department
* Diagnosis of infection by the treating emergency physician

Exclusion Criteria:

* Refuse to participate
* pregnancy
* prisoner
* Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)
Study of Early Enteral Dextrose in Sepsis

This study is a prospective single-center randomized double-blinded placebo-controlled clinical trial testing the effects of early enteral dextrose as a therapeutic agent in critically ill patients with sepsis. Primary outcomes are differences in circulating plasma levels of the pro-inflammatory cytokine IL-6 to be tested 24 hours after the start of enteral infusion. Secondary outcomes include differences in circulating incretin hormone levels, differences in other pro-inflammatory cytokines including IL-1β and TNF-α, changes in intestinal microbial composition and function after intervention, glycemic control and variability as assessed by capillary blood glucose measurements and exogenous insulin dosing during the intervention period, and clinical outcomes including intensive care unit (ICU) and hospital stay and in-hospital mortality.

The central objective of this research project is to determine how early caloric support impacts inflammatory and metabolic outcomes in the acute phase of sepsis. Preliminary data from our mouse models suggest that provision of dextrose via an intravenous route, even at low levels early in the course of sepsis, markedly impairs glucose tolerance and decreases insulin sensitivity and insulin secretion. In contrast, provision of low-level dextrose by the enteral route at identical levels during the early phase of sepsis is associated with decreased inflammation, increased secretion of beneficial intestine-derived incretin hormones, and significant improvements in glucose metabolism. The goals of this clinical study are to translate findings on the beneficial role of early enteral dextrose in a pilot interventional trial in critically-ill patients with sepsis. This clinical trial will provide further insight into the optimal timing and route of early caloric support in the care of septic patients-an area of clinical practice that will benefit from further studies in fundamental biology and clear guidelines for physicians.

Eligibility Criteria:
Inclusion Criteria:

1. New presentation of sepsis characterized by a confirmed or suspected infection, with an acute increase from baseline in a modified Sepsis-Related Organ Failure Assessment (SOFA) score of greater than or equal to 2 points. If baseline values are unknown, baseline SOFA score of 0 will be assumed.
2. Available enteral access defined by: (1) an existing nasogastric or orogastric tube, (2) plans to place a nasogastric or orogastric tube, or (3) an existing percutaneous endoscopic gastrostomy (PEG) tube.
3. Less than 48 hours since meeting criteria for sepsis.
4. Expected to stay at least 24 hours in the ICU.

Exclusion Criteria:

1. Pre-existing continuous enteral tube feed use prior to study entry.
2. Diabetic ketoacidosis or diabetic hyperosmolar hyperglycemic syndrome.
3. Previously enrolled in this study within the same hospital admission.
4. ICU physician request to exclude patient based on clinical assessment.
TVNS and Upper GI Motility

To study the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract, in healthy subjects.

Hypothesis: We hypothesize that tVNS will induce on average an excess of 1 additional phase III contraction of antral origin in the fasted period compared to sham stimulation.

Healthy volunteers (n=12) will be recruited, both male and female, aged aged 18-55 years old. Participants will arrive after an overnight fast at the GI physiology unit ('functiekamer') of the Maastricht University Medical Center, where they will be inserted an antroduodenal manometry catheter through the nose into the duodenum under fluoroscopy control. The high-resolution catheter contains 36 transducers spaced at 1-cm intervals (Unisensor AG, Attikon, Switzerland). Using this catheter, stomach and duodenum motility patterns will be recorded for 8 hours.

Participants will undergo tVNS (cymba concha of the left ear) alternated with sham (a non-conducting electrode) in a blinded pre-randomized fashion using 2 blocks of 4 hours during the 8-hour registration period. In addition, blood samples will be taken at baseline and at intervals of 30 minutes during the 8-hour test period. Levels of the GI hormones motilin and PP will be measured as surrogate markers of vagal efferent influence on GI motor function.

Autonomic parameters will be registered using pulse plethysmography. A wearable device (Shimmer3 GSR Sensor) will also be used to measure heart rate variability and skin conductance. Heart rate variability is regarded as a parameter reflecting cardiac parasympathetic activity.(33, 34) The root mean square of successive differences (RMSSD) is a commonly utilized and thoroughly validated measure of heart (and pulse) rate variability. (35, 36).

After the 8-hour registration period, all measurement equipment and the iv. cannula is removed. Participants are provided a meal voucher to be consumed at the hospital visitor's restaurant, whereafter the test day is finished.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).
* Age between 18 and 55 years.
* Ability to understand and speak the Dutch language.

Exclusion Criteria:

* Pregnancy or lactation.
* Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility
* Not meeting the inclusion criteria above.
* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional of hierarchical position with regards to any of the study team members or their department.
Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.

Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary.

A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years,
* both sexes,
* respectablee pancreaticoduodenal tumors, or chronic pancreatitis

Exclusion Criteria:

* \<18 years,
* Patients who underwent total pancreatectomies,
* Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.