cyrilzakka/clinical-trials huggingface dataset:
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer

RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer.

PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage I kidney cancer.

OBJECTIVES:

Primary

* Determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage I renal cortical tumor and normal contralateral kidney.

Secondary

* Determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery.
* Determine the 1-year disease-specific and overall survival of these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo warm ischemia followed by partial nephrectomy.
* Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine samples are collected periodically after nephrectomy to assess renal function.

Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solitary renal cortical tumor

  * Tumor size ≤ 4 cm
* Candidate for open partial nephrectomy

  * Expected ischemia time \< 45 minutes
* Normal renal function, defined as glomerular filtration rate (GFR) \> 60 mL/min
* No evidence of distant metastasis
* No evidence of local invasion of adjacent structures, including the adrenal gland
* No evidence of tumor extension into the renal venous system
* No evidence of ureteral obstruction on MAG-3 renal scan
* No family history of renal cancer

PATIENT CHARACTERISTICS:

* ECOG performance status 0
* Life expectancy \> 5 years
* No prior malignancy, except for non-melanomatous skin cancer

PRIOR CONCURRENT THERAPY:

* Not specified
REduction of Physical Inactivity Facing the CAncer

Study 1:

The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

Study 2:

Because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer.

The investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients.

These promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.

Eligibility Criteria:
Inclusion Criteria:

* PS 0-3
* Patients with breast cancer undergoing chemotherapy treatment
* neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer
* Sedentary Patients (physical activity score of Dijon less than or equal to 20)

Exclusion Criteria:

* Patients with PS greater than 3
* Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures
A Phase 1/ Phase 2 Study of TTHX1114(NM141)

Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study

This is a prospective, multi-center, randomized, masked, vehicle-controlled, dose-escalation study that will include an observational (no intervention) sub-study. Eligible subjects with moderate to severe corneal endothelial dystrophy (defined as Endothelial Cell Density \< 2000 mm\^2) in at least one eye will be enrolled and randomized.

Eligibility Criteria:
Key Inclusion Criteria:

* Fuchs Endothelial Corneal Dystrophy, pseudophakic bullous keratopathy, or endothelial dysfunction/ insufficiency due to surgical intervention diagnosed more than 6 months prior to Study Day 0
* Central endothelial cell count of \< 2000 mm\^2 in at least one eye as determined by the central reading facility

Key Exclusion Criteria:

* Conditions that would impair examination of the anterior chamber structure
* Documented repeated elevated intra ocular pressure (in either eye)
* Corneal transplant (in either eye)
* Posterior Polymorphous Corneal Dystrophy (PPCD)
* History of uveitis or herpetic keratitis
* Cataract surgery within the past 3 months
* Refractive surgery (in the Study Eye)
* Anterior Chamber IOL placement (in the Study Eye)
* Active extra-ocular inflammation from any non-infectious or infectious cause within the past 6 months
* Expected or planned ocular surgery within the next 3 months
* Use of cytotoxic chemotherapy within the last 1 month
* Treatment with a rho kinase inhibitor within the last 3 months
* Use of cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution in the last 30 days
* Systemic or ophthalmic corticosteroid use in the 30 days prior to Study Day 0 unless approved by the Medical Monitor
* History of significant allergy, hypersensitivity, or intolerance to any drug compound, food, or other substance
* Unwilling to use birth control
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer

Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46\~56% and a median survival time of 14.0\~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
* ECOG performance status 0-1
* Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
* D2 lymph node dissection with R0 surgery
* Signed informed consent

Exclusion Criteria:

* Subjects with documented distant metastasis.
* Malabsorption syndrome or disease significantly affecting gastrointestinal function
* Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
* History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
* Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy
Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.

Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists.

Subjects who meet the inclusion criteria will be recruited to participate in the clinical trial and perform the exercise sessions.

The cyclists in the study will have to make 7 visits to the laboratory. At the first visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis. And in the next 6 visits they will have to perform a sustained intensity exercise with different environmental conditions according to the combination of temperature, humidity and intensity.

Eligibility Criteria:
Inclusion Criteria:

* Male cyclists with more than two years of cycling experience.
* Perform tests without fatigue.
* Road bike training at least twice a week.

Exclusion Criteria:

* Participants with chronic illness.
* Have a long-term injury that prevents you from training in the previous month.
* Inability to understand informed consent.
* Use of diuretics in the month prior to or during the measurement period.
EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use

The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.

Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.

The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume \>85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:

  1. Patient age 18 years and older
  2. English language speaking
  3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
  4. own a cell phone with text messaging capabilities
  5. the patient is the person primarily responsible for administering medication

Exclusion Criteria:

* Subjects will be excluded from the study if any of the following conditions are met:

  1. Aged \<18
  2. non-English speaking
  3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
  4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
  5. admitted to hospital
  6. unable to complete follow up phone interviews
  7. pregnant
Define Predictors for Posttransplant Diabetes Mellitus Study

The primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0).

In order to create such model, we will start by identifying individual predictor variables at the day of transplantation and subsequently explore the optimal combination of these predictors in multivariable models.

Secondary objectives include:

* Compare the performance of the model based on predictor variables at day 0 with existing models for prediction of PTDM (Chakkera, San Antonio Diabetes Prediction Model and Framingham Offspring Study Diabetes Mellitus algorithm)
* Explore the glucose level evolution during the first 2 weeks after transplantation using continuous glucose monitoring, and its relationship with baseline patient characteristics and immunosuppressant drug use.
* Evaluate the added value of incorporating information on glucose levels in the first and second weeks post-transplant to improve the PTDM prediction model.
* Identify predictors for early post-transplant hyperglycemia (first 2 weeks post-transplantation)
* Explore the correlation between early post-transplant hyperglycemia (fasting glycemia, pre-dinner glycemia) and PTDM at 3 months


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) with end stage kidney disease undergoing kidney transplantation with a deceased or living donor
* Signed informed consent
* Initial therapy with at least tacrolimus and corticosteroids

Exclusion Criteria:

* Patients with a diagnosis of diabetes mellitus (either type 1 or type 2) prior to kidney transplantation
* Treatment with GLP1-RA for weight losing purposes
* Patients receiving a multi-organ transplantation
* ABO incompatibility
Therapy With New Oral Anticoagulants

The aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population.

Current guidelines for the management of patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction has been shown to be an independent predictor of stroke or systemic emboli, but the risk of bleeding with conventional warfarin therapy is also significantly increased.Prevalence of renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA \[6\].NOACs undergoing significant renal secretion such as dabigatran are not recommended for patients with severe renal impairment, and dose adjustment are indicated for patients with milder degrees of renal dysfunction.However, real-world information regarding the usage and outcomes associated with NOAC therapy in patients with renal dysfunction are limited. The investigators plan to prospectively and retrospectively collect data regarding the clinical settings, characteristics, and outcomes of patients with renal dysfunction who have been prescribed apixaban in Israel, using a multicenter secure web-based registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal dysfunction (eGFR \<60 ml\\min\\BSA) who have an indication for treatment with an novel oral anticoagulant agent or VKA
* Patients prescribed apixaban or warfarin at the enrollment center (patients enrolled in a 2:1 ratio)

Exclusion Criteria:

* Valvular AF or presence prosthetic valve
* Dialysis patients
* Contraindications NOACs
* Hepatic dysfunction
* Cognitive impairment
* Clinical necessity to continue administration of potent inhibitors of both CYP3A4 and P-gp - including azole- antimycotics (e.g. ketoconazole, itraconazole) and HIV protease inhibitors (e.g. ritonavir)
Comparison of Fecal Ribonucleic Acid (RNA) Test With Fecal Occult Blood Test (FOBT) for Detecting Colorectal Cancer and Adenoma

Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening, which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there is a need to develop a novel method to improve sensitivity. The investigators reported that Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal RNA test with FOBT for detecting colorectal cancer and adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colorectal cancer or adenoma
* Subjects with no abnormal findings of colon
Prehabilitation and Coronary Artery Bypass Grafting

To evaluate the effects of Prehabilitation Resistance training on frailty and functional capacity in mild to moderate clinically frail patients awaiting Coronary Artery Bypass Grafting) CABG. This study will contribute to describing the effect of resistance training in mild to moderate frails patients and were directed to be the part of cardiac rehabilitation and define the effects of cardiac prehabilitation and to check whether the effects of resistance training or routine training is similar for quality of recovery in mild to moderate frails patients which undergone CABG.

In literature, Coronary Artery Bypass Graft (CABG) is a form of heart surgery that redirects blood around clogged arteries to increase blood flow and oxygen to the heart. During CABG surgery, the surgeon uses a portion of a healthy vessel (either an artery or vein) from the leg, chest, or arm to create a bypass around the clogged artery. During CABG surgery with cardiopulmonary bypass, a heart-lung machine artificially maintains circulation blood and oxygenation while the surgeon operates on the heart. It includes exercise, lifestyle changes, education, and emotional support. It can help improve patient's health and enable them to live a more active life after the patient has had a heart attack or heart surgery or if the patient has long-term heart problems such as heart failure.

The time spent waiting for cardiac surgery to be scheduled is a period of great uncertainty for a patient. There appears to be heightened anxiety regarding the inclusion of physical activity in this time period, mainly as a result of their current cardiac condition or diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective primary isolated coronary artery bypass grafting,

  * Patients with double and triple-vessel coronary artery disease.
  * Mild to moderately frail patients with a clinical frailty score of 5 -6 at the time of accepting surgery at the outpatient cardiothoracic surgical clinic.

Exclusion Criteria:

* Patient with musculoskeletal disability and neurological disability affecting respiratory rate.

  * Patient with renal dysfunction requiring dialysis, use of immunosuppressive treatments during the 30-day period before surgery,
  * Left ventricular ejection fraction \<30%
  * concomitant valve disease
  * Patient having dysrhythmias or pacemaker dependent
  * Those patients who are severely frail (CFS 7-9)
IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.

Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics.

Traditionally spinal or general anesthesia is used in proctological practice. However, the number of studies about using of perianal local anesthesia, both in combination with general anesthesia and as a separate practice has been increasing recently.

Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia. The drugs used for this have some pharmacological differences in the duration of the drug and the form of administration.

The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Patients over 18 years.
3. Symptomatic grade III-IV hemorrhoids.
4. Planned surgery: Milligan-Morgan hemorrhoidectomy.

Exclusion Criteria:

1. Patient's refuse to participate in the study.
2. Pregnancy.
3. Сontraindications or technical inability to perform subarachnoid anesthesia.
4. Decompensated somatic diseases.
5. Inflammation of the perianal region.
Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.

The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.

All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly.

An evaluation will be made one month, 3 months and 6 months after the first visit.

Eligibility Criteria:
Inclusion Criteria:

* MS with urinary symptoms

Exclusion Criteria:

* BPH LUTS
* Bladder cancer
* prostate cancer
* urethral stenosis
PTG-300 in Subjects With Hereditary Hemochromatosis

This study will be conducted at multiple sites and every patient will get treated with PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult hereditary hemochromatosis patients.

This study is a multicenter, open-label study. The objective of the study is to assess the effect of PTG-300 on transferrin saturation (TSAT) and serum iron in adult hereditary hemochromatosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 and older
* Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype testing
* Documented stable phlebotomy for ≥ 6 months
* Screening hemoglobin \>11.5 g/dL
* Documented evidence of prior serum ferritin ≥500 ng/mL
* Serum ferritin \>50 ng/mL and \<300 ng/mL at screening

Exclusion Criteria:

* Clinically meaningful laboratory abnormality
* Receiving iron chelation therapy
* Receiving erythrocytapheresis
* Pregnant or lactating females
* Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infections requiring antimicrobial therapy within 4 weeks of dosing.
* Serious or unstable medical or psychiatric condition that would prevent subject providing informed consent
* Organ damage from iron overload
* Primary or secondary immunodeficiency
* Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection
* Known history of autoimmune/inflammatory diseases
* Any surgical procedures requiring general anesthesia within 1 month prior to screening or planned surgery during study
* History of invasive malignancies within last 2 years, except non-malignant skin cancer and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ
* Receipt of an investigational agent within 30 days of screening