cyrilzakka/clinical-trials huggingface dataset:
Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)

Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. There are different hypothesized mechanisms through which metformin does the protective effect. Such as enhancing mitochondrial activity, reduction of ROS and nitric oxide and activation of AMPK.

Chemotherapy can cause a variety of side effects. One of the most common side effects is Chemotherapy induced peripheral neuropathy (CIPN), it commonly caused by Paclitaxel chemotherapy which is usually used in the treatment of breast cancer. Metformin which is known as a safe anti-diabetic drug, was found to have a protective effect on neurons. It gave positive results in chemotherapy induced peripheral neuropathy in mouse models and in some clinical trials

Eligibility Criteria:
Inclusion Criteria:

* Age (18-75) male and female patients
* Scheduled to be treated with single agent Paclitaxel
* Performance status according to Eastern Cooperative oncology group (ECOG) \< 2.
* Patients who are willing and able to review and provide written consent, patients who can read the questionnaires

Exclusion Criteria:

* Previous exposure to chemotherapy drugs that cause neuropathy, patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
* Patients with impaired liver functions or kidney functions.
* Patients with a history of any serious adverse events or interaction or hypersensitivity to Metformin.
* Pregnant or lactating females.
* Patients who are using metformin for any other cause.
* Patients with sensory or motor neuropathy of any grade prior to enrollment.
The Complementary Contributions of Sensory Stimulation and Social Support During Snoezelen Room Therapy on the General Physical and Emotional Health of the Elderly Population: Optimization of the Nursing Home Resources.

Over time, lifespan is extending, the population is aging, and accordingly there is a great demand for hospital beds in nursing homes, increasing attention to this population and the services they receive. Mostly, elderly population living in nursing homes suffers from dementia, Alzheimer, depression, agitation, and other diseases that require multidisciplinary treatment.

In addition to the medical and pharmacological treatments that patients receive to maintain functional medical status, there is a great need for non-pharmacological treatments, that may improve quality of life, mental well-being, and life satisfaction.

There are several treatment approaches of multisensory stimulation environment (MSSE). MSSE in the Snoezelen room therapy recognized as benefiting the patients' physical, mental, and emotional health status. In addition, there is great importance of intervention by social interaction, support, and encouragement.

However, the effect of combined intervention of MSSE in Snoezelen room therapy and social support, has not yet been sufficiently studied in elderly patients in nursing homes. These two interventions - together - are supposed to have an increased effect on physical and mental wellbeing of elderly.


Eligibility Criteria:
Inclusion Criteria:

* Patients living in the Ahuzat Moriah nursing home\\ geriatric nursing hospital in Shefar'am.

Exclusion Criteria:

* Patients with epilepsy and aggressive patients. \*We do not limit the participation of patients whose cognitive level is very low.
Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Malignant Tumor

68Ga-DOTA-dPNE PET/CT imaging was performed on patients with malignant tumors to observe the binding of lesions with the tracer and evaluate the expression of CD73. At the same time, correlation analysis was performed combined with relevant clinical indicators to evaluate the efficacy of 68Ga-DOTA-dPNE in the diagnosis and guidance of malignant tumor patients, and predict the response of targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1: Age: ≥18 years, expected survival ≥12 weeks 2: Without radiotherapy and chemotherapy, surgery or biopsy is feasible to obtain pathological diagnosis 3: Standard Solid Tumor Response Evaluation Criteria (RECIST) version 1.1 with at least one measurable target lesion 4: Obtain written informed consent and be able to follow up

Exclusion Criteria:

- 1: Severe liver and kidney dysfunction. 2: Women who are planning to conceive, pregnant, or breastfeeding, as well as those planning to have children during the study period, are not eligible to participate in this research. Women of childbearing potential must use effective contraception throughout the course of the study.

3: Individuals unable to lie flat for thirty minutes. 4: Suffers from claustrophobia or other mental illnesses 5: Researchers believe that the subject has other conditions that make them unsuitable for inclusion in this study 6: Refuses to join this clinical study
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia

A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs.

A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating, had completed their family size, and were eligible for both treatments were randomized to either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took place six months and 12 months after the treatment, and again five and ten years after the randomization. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs. The amount of menstrual blood loss was objectively measured before treatment and after one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and the five year results in 2004 (JAMA 2004; 291:1456).

Eligibility Criteria:
Inclusion Criteria:

* heavy menstrual bleeding
* 35-49 years
* were menstruating
* had completed their family size
* were eligible for both treatments

Exclusion Criteria:

* submucous fibroids
* endometrial polyps
* ovarian tumours or cysts,
* cervical pathology
* urinary and bowel symptoms or pain due to large fibroids
* lack of indication for hysterectomy
* history of malignancies
* menopause
* severe depression
* metrorrhagia as a main complaint
* previous treatment failure with LNG-IUS
* severe acne
* uterine malformation
Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring

The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.

The SURPRISE study investigates the patients with cryptogenic stroke or transient ischemic attack (TIA), monitoring them with a cardiac loop recorder for up to three years.

it aims at estimating the amount of paroxysmal atrial fibrillation within our population of cryptogenic stroke patients.

Standard workup for a stroke patient does offer cardiac evaluation, but monitoring is limited to the time admitted, often just a few days.

Eligibility Criteria:
Inclusion Criteria:

* Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA;
* \> 18 years of age,
* the ability to provide a written consent

Exclusion Criteria:

* prior or known AFIB
* AF found during work up including 24 hour telemetric monitoring.
Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).


Eligibility Criteria:
Inclusion Criteria:

* Rare tumor
* metastatic disease or locally advanced disease, inoperable, with no standard treatment
* At least 28 days since the prior treatment
* Measurable disease with at least one measurable lesion

Exclusion Criteria:

* Medullary insufficiency
* Cystitis, haemorrhagic cystitis
* Hepatic porphyria
Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

Phase II Clinical Trial to Assess the dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (MSCs) in Severe Renal Systemic Lupus Erythematosus (SLE).

Phase IIa trial of escalating doses of intravenous (i.v.) MSCs in active SLE, followed by a Phase IIb, triple blind, controlled assessment of the selected MSC dosing versus Placebo, in SLE patients receiving Standard of Care Therapy for Severe Renal Disease,

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling 1997 updated American College of Rheumatology (ACR) Criteria or 2012 SLICC Classification Criteria for SLE
* Seropositive for antinuclear (≥1:80) and/or anti-DNA antibodies
* Fulfilling following criteria for active renal disease:

Class III or IV proliferative disease (ISN/RPS) Renal Biopsy within 12 months plus...

Active Urinary Sediment (\> 5 red blood cells/high-power field and/or \>8 white blood cells/high-power field and/or cylindruria during the current flare).

UPC ratio ≥ 1

Exclusion Criteria:

* Estimated GFR \< 40ml/min/m2
* Addition during prior 3 months of randomization of: Bolus methylprednisolone or new immunosuppressive drug or intravenous immunoglobulin (IVIG) or Plasmapheresis.
* Addition during prior 6 months of randomization of Cyclophosphamide
* Addition during prior 12 months of randomization of Biological anti-B cell therapy
* Coexisting uncontrolled morbidity; Pregnancy or planned Pregnancy within next 12 months; uncontrolled infection or neoplastic disease. Pending unresolved surgical indication.
Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
* Able to comprehend and have signed a statement of informed consent
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

Exclusion Criteria:

* There are no exclusion criteria for this study
Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.

Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Eligibility Criteria:
Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix

The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.

This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing clinically indicated vaginal speculum examination.
* Subject has had at least 1 prior vaginal deliver \> 20 weeks gestational age.
* Able to read and speak English.

Exclusion Criteria:

* Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
* Menopausal or using hormone replacement therapy.
* Genital atrophy.
* Chronic pelvic pain, dyspareunia, or interstitial cystitis.
Diagnostic Value of Electrocardiographic St-t Wave Changes in Patients With Chronic Stable Angina

The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a well-established role in the diagnosis of (CAD). Many studies have found that the admission of ECG provides important prognostic information in patients admitted with chest pain. For instance, T wave inversion in anterior or inferior location and or ST-segment depression has been associated with high incidence of CAD.

The aim of the work will be directed to study the diagnostic value of electrocardiographic ST-T wave changes in lead aVL in patients with chronic stable angina

The ECG findings vary considerably, depending importantly on four major factors: (1) the duration of the ischemic process (acute versus evolving or chronic) ; (2) its extent (large versus small) ; (3) its topography (anterior versus inferior-posterior and right ventricular) ; (4) the presence of other underlying conditions (e.g. LBBB, WPW or pacemaker pattern) that can mask or alters the classic pattern.

The resting electrocardiogram is normal in approximately half of patients with chronic stable angina pectoris, and even patients with severe CAD may have a normal tracing at rest. A normal resting ECG suggesting a normal LV function and it is unusual finding in a patient with an extensive previous infarction.

The most common electrocardiographic abnormalities in patients with chronic CAD are non specific ST-Twave changes with or without abnormal Q waves. In addition to myocardial ischemia, other conditions that can produce ST-T wave abnormalities include LV hypertrophy or dilation, electrolyte abnormalities, neurogenic effects, and anti-arrhythmic drugs.

In patients with known CAD, however, the occurrence of ST-T wave abnormalities on the resting ECG may correlate with the severity of the underlying heart disease. This association may explain the adverse association of ST-Twave changes with prognosis of these patients. In contrast, a normal resting ECG is more favorable long-term prognostic sign in patients with suspected or definite CAD.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted at the Alexandria university hospitals or referred from secondary hospitals with documented CAD as proved by non invasive tests

Exclusion Criteria:

* Clinical situations that may result in secondary aVL lead T wave inversion and /or ST segment depression from analysis as Bundle branch block either left or right, aortic stenosis, left ventricular hypertrophy and strain and paced ventricular rhythms.
Natural History Study of Patients With Chronic Myelogenous Leukemia

RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care.

PURPOSE: This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.

OBJECTIVES:

* Determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (CML).
* Determine the natural history of patients with CML who achieve response to imatinib mesylate.
* Determine the health perceptions, symptoms, insurance issues, and work issues of these patients.
* Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients.
* Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients.

OUTLINE: This is a longitudinal, prospective, cohort study.

Patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years.

Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be examined in the future in gene array studies and mutation analyses.

Eligibility Criteria:
Age 18 years and over Diagnosis within one year of enrollment
Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).

Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.

In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above).

Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.

Eligibility Criteria:
Inclusion Criteria:

* 7- 18 years old
* type 1 diabetes mellitus for over 1 year
* treatment with insulin pump with bolus calculator function
* HbA1c \< 10%
* expressed written informed consent

Exclusion Criteria:

* recall the consent
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients

This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo

This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Multi-system blunt trauma patients
* Ages 18 through 65 years, inclusive
* Admission to ICU
* Nasogastric or nasoenteric feeding tube in place
* Intention of primary medical team to feed the patient enterally

Exclusion Criteria:

* Expected mortality within 48 hours
* Intracranial hemorrhage
* Pregnant or breast feeding
* Patient, surrogate, or physician not committed to full support
* Refractory shock
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction
* Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days
* Current gastrointestinal bleeding
* Requirement for vasopressors
Community Benefit of No-charge Calcium Score Screening Program

Current approaches in primary prevention for cardiovascular disease are based on probabilistic approaches to estimate risk, using many of the widely available cardiovascular risks scores, with over 100 such scoring systems currently available throughout the world. The rationale for this practice is to select those individuals at greatest risk for more intense targets, reduce risk of treatment to those at minimal risk, and to maximize the cost-effectiveness of treatment. A recent Cochrane Systematic Review assessed the practice of using risk scores to select individuals for the primary prevention of cardiovascular disease. 3 The principal finding of the systematic review was that there was little or no effect of providing clinicians with cardiovascular risk scores when compared to standard of care (5.4% versus 5.3%; relative risk 1.01, 95% confidence intervals 0.95 to 1.08). The authors concluded that there is major uncertainty whether current strategies for providing risk scores and called for further research to address this concern. Extent of coronary artery calcium (CAC) is a strong risk marker for coronary events, with evidence mainly derived from observational studies and from prospective non-randomized studies. CAC, although endorsed for intermediate risk patients, is not widely adopted due to barriers in reimbursement. The cost of the test ranges between 100 and 300 USD in the United States, which may have limited the wide adoption of the test. Whether reducing the cost burden for CAC increases utilization for routine screening and its influence on physician practices and downstream testing is largely unknown. University Hospitals started offering low charge CAC (99$) since 2014. In 2017, University Hospitals started offering CAC for no charge for patients to improve access to this test, which has not traditionally been covered by insurance companies. The impact of no-charge CAC has never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Received Coronary Artery Calcium (CAC) CT scan at University Hospitals starting in January 1, 2014.

Exclusion Criteria:

-