cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section

The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* patient schedule for cesarean section ASA class 1

Exclusion Criteria:

* have contraindication for spinal block
* complicated pregnancy
* have history of drug abuse during pregnancy
* obesity BMI\>35kg./m2
Renal Protocol Protection in CKD Patients

This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* High risk group for developing HCC
* Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
* chronic kidney disease (Estimated GFR \< 60mL/min/1.73m2)

Exclusion Criteria:

* not a high risk group for developing HCC
* congestive hepatopathy
* on dialysis
* no venous access on forearm
* anticipated beam hardening artifact due to prosthesis
* relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR \< 60mL/min/1.73m2)
Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.

This study investigates whether constant cooling of the hands and feet using Hilotherm ChemoCare devices reduces the incidence of (severe) oxaliplatin-induced peripheral neuropathy and pain compared to standard care (i.e. no hand and foot cooling) in patients with gastrointestinal tumors.

Eligibility Criteria:
Most important Eligibility Criteria:

Inclusion Criteria:

* 18 years or older
* Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
* Starting oxaliplatin-based treatment

Exclusion Criteria:

* Already grade 2 or higher peripheral neuropathy

For a more detailed list, see protocol.
Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia

The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus

Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 55yrs
* ASA status less than and equal to 2

Exclusion Criteria:

* Surgery on head and neck
* ASA greater than 3
* Contraindication to nitrous oxide
* Pregnant women
* History of dementia and stroke, or other organic brain disorder
* Prisoner
* Ear surgery
Outcome of Surgery for Idiopathic Macular Holes

Retrospective medical chart review of patients undergoing surgical repair of idiopathic macular hole


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from primary idiopathic macular hole and treated by retinal repair surgery

Exclusion Criteria:

* Presence of other retinal disease
Factors Influencing Risk of Progression of Chronic Kidney Disease

The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the inclusion criteria of the ND-CRIS cohort (long-term follow-up in one of the centers participating in the research, with a GFR \<60mL/min /1.73m2)
* Patients included in the ND-CRIS cohort on the date when the estimate of their GFR is strictly less than 30mL/min/1.73m2 and greater than or equal to 15mL/min/1.73m2 (MDRD equation).

Patients should have at least two measurements of GFR \<30mL/min/1.73m2 to be included, at least one of them greater than or equal to 15mL/min/1.73m2. The date of the first GFR \<30mL/min/ 1.73m2 will be considered as the date of origin.

Exclusion Criteria:

* Patients with GFR ≥30mL / min / 1.73m2 or \<15mL / min / 1.73m2
* Patients who do not meet the inclusion criteria of ND-CRIS cohort (dialysis patients, transplant patients, unfollowed patients)
Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.

Older patients with esophageal cancer are universally intolerant to chemotherapy.

This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients.

Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.

Eligibility Criteria:
Inclusion Criteria:

Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma (Sixth Edition) Clinical Staging Ⅱa to Ⅲ.

Age ≥ 70 years ≤ 85 years old. The ECOG physical state score is 0 to 1. No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.

Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.

Hemoglobin ≥ 100g/L, platelets ≥ 100 \* 10\^9/L, absolute neutrophil count ≥ 1.5 \* 10\^9/L。 Serum creatinine ≤ 1.25 times UNL or creatinine clearance ≥ 60 mL/min. Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, and alkaline phosphatase ≤ 5 times UNL.

No history of interstitial pneumonia or previous interstitial pneumonia. FEV1\>0.8L。

The patient signs a formal informed consent form.

Exclusion Criteria:

Patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial Patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction.

Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.

Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.

Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years.

Researchers believe that some obvious diseases should be excluded from this study.
HPI for Prevention of Hypotension During Cardiac Surgery

Hypotension prediction index (HPI) was applied in various types of non-cardiac surgery with convincing benefits of preventing hypotensive events and clinical sequelae. Although HPI was validated in cardiac surgery, its clinical benefits are not proven yet. We aim to evaluate its effects on intraoperative hypotension and postoperative adverse events in cardiac surgery. In this randomized, single-blind trial, we will enroll adults scheduled for elective primary cardiac surgery under general anesthesia. Participants will be randomly assigned to intraoperative HPI-guided or non-HPI-guided hemodynamic management. The primary endpoint is the time-weighted average intraoperative hypotension below a mean arterial pressure threshold of 65 mmHg. The secondary endpoints are postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* adult
* elective, primary, isolated coronary arterial bypass surgery (CABG) or isolated valve surgery
* provide inform consent.

Exclusion Criteria:

* arrhythmia (e.g., atrial fibrillation, atrial flutter)
* intracardiac shunts
* preoperative inotropic usage
* preoperative supportive devices usage (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, left ventricular assist device, or right ventricular assist device)
* receiving urgent or emergent procedures.
Relationship of Helicobacter Pylori Eradication Therapy and Long-term Outcome in Acute Coronary Syndrome

Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods: To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008 to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital. Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2, the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical indicators. The investigators explored the correlations of Hp eradication therapy with MACE (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to 5 years of follow-up using survival analysis.

This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed acute coronary syndrome according to the 2012 ESC guidlines.
* All the patients took dual antiplatelet therapy after implanting drug eluting stent (DES) during hospitalization and had no any digestive symptoms.

Exclusion Criteria:

* Subjects who had suffered gastrointestinal bleeding within one week.
* Subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated.
* Patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting DES because of ACS during hospitalization were also excluded.
* Those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with Hp infection were excluded because these patients may be taken gastroenterology treatment.
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?

The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

Elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). The interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). It is suggested that the process of intracellular Calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes (4).

A prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). On the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

Eligibility Criteria:
Inclusion Criteria:

* Severe male factor infertility, Average response to COH,

Exclusion Criteria:

* Poor responders,
Clinical Outcome in Uveitis

This study is aimed at investigating the long term clinical outcome of patients with uveitis.

Patients will be included if they are treated for uveitis and have had repeat follow-up. Data will be gathered from the entire length of the patients follow-up.

The main outcome measures will be:

Change from baseline of Best corrected visual acuity (BCVA)at 10 years Causes of vision loss (≤6/15, VL) and severe vision loss (≤6/60, SVL) at 10 years Number of clinical visits at 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Uveitis.

Exclusion Criteria:

* No follow-up data.
Fondaparinux EU-RMP (Adherence)

Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients, fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are managed with thrombolytics or who are initially to receive no other form of reperfusion therapy. The approved prescribing information for fondaparinux in ACS provides recommendations for use in patients undergoing PCI. The purpose of this study is to evaluate physician adherence to this prescribing information in ACS patients treated with fondaparinux and who undergo PCI. The primary endpoint is the proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI). Measurement of the effectiveness or safety of fondaparinux use in ACS patients is not within the scope of this study.

ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Discharge diagnosis of ACS (UA/NSTEMI or STEMI)
* PCI during the hospitalization
* Anticoagulant treatment with fondaparinux

Exclusion Criteria:

* Enrollment at the time of the index hospitalization in a clinical study that could influence ACS treatment practices, specifically the in-hospital use of anticoagulation
A Psychological Intervention for Family Caregivers of Palliative Care Patients

This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden.

A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* To be the main family caregiver of a patient at the end of life, receiven palliative care. In the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family.
* To have signed the informed consent.

Exclusion Criteria:

• To present cognitive impairment.
The Longitudinal Relationship of HU Adherence to HRQOL, Barriers to Adherence and Habit in SCD.

The primary objective of this study is to better understand factors contributing to variations in hydroxyurea (HU) adherence behavior in adolescents and young adults (AYA) with sickle cell disease (SCD). To meet this objective, the researchers will conduct a prospective cohort study to determine the longitudinal relationship between HU adherence and health-related quality of life (HRQOL) overtime among AYA with SCD. The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea, at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. The specific aim for this study is to determine the longitudinal relationship of HU adherence behavior to health-related quality of life, barriers to adherence and habit formation among AYA with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-21 years old
* Any sickle cell disease genotype
* On steady state of hydroxyurea for 2 months
* Own or have access to a smartphone
* Parents of patients that meet the eligibility criteria and are enrolled in the study will be included

Exclusion Criteria:

* Patients with recent hospitalizations within the past 7 days
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study

The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Subject's leading edge of POP is at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0 or Bp ≥ 0 or C ≥ 0 (for prolapse of the apical compartment alone) or C ≥ -½ total vaginal length (for a multi-compartment prolapse that includes the apical compartment).
* Subject is seeking surgical intervention for symptomatic POP, which is defined as experiencing symptoms of vaginal bulging or pelvic heaviness. Vaginal bulge or pelvic heaviness will be considered present if a subject responds "yes" (≥1) to PFDI-20, question 3.
* Subject or subject's legally authorized representative is willing to provide written informed consent.
* Subject is willing and able to comply with the follow-up regimen.

Exclusion Criteria:

* Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only).
* Subject is pregnant or plans to become pregnant during the study.
* Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis.
* Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit).
* Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome).
* Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica).
* Subject has uncontrolled diabetes mellitus (DM).
* Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
* Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
* Subject has taken systemic steroids (within the last month), immunosuppressive or immunomodulatory treatment (within the last 3 months).
* Subject is seeking obliterative vaginal surgery as treatment for POP (colpoclesis).
* Subject is not able to conform to the modified dorsal lithotomy position.
* Subject is currently participating in or plans to participate in another device or drug study during this study.
* Subject is to planning to undergo concurrent surgical treatment of prolapse using mesh other than the MatriStem Pelvic Floor Matrix.
Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women

The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).

PRIMARY OBJECTIVES:

I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1\&-E2, 4-MeOH-E1\&-E2) thought to be involved in the development of breast cancer.

SECONDARY OBJECTIVES:

II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.

III. Describe adherence to the flaxseed intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.

ARM 2: Participants maintain their usual diet for approximately 50 days.

All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).

Eligibility Criteria:
Inclusion Criteria:

1. Women residing in Toronto aged 57-64 years old, and post-menopausal.

Exclusion Criteria:

1. Consumers of flaxseed and soy (including supplements) in the past 6 months.
2. Consumers of sesame oil and sesame seeds in the past 6 months.
3. Women who took antibiotics orally in the past 6 months.
4. Women who took hormone replacement therapy or corticosteroids in the past month.
5. Non-English speaking.
6. Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness.
7. Women who are currently taking blood thinners, such as Warfarin.