cyrilzakka/clinical-trials huggingface dataset:
Association of Hepatitis C Virus With Breast Cancer

Hepatitis C viral infection is a major health problem in Egypt. The management of breast cancer patients is often complicated by the presence of associated HCV infection. This study aims at investigating the epidemiological association of the two conditions. It will also investigate the possible correlation with treatment outcome.

Breast cancer is the most common cancer in adult Egyptian females. The world's highest prevalence of hepatitis C virus is found in Egypt. Several investigators examined the epidemiological association of HCV with breast cancer. Published literature reports conflicting results regarding the HCV association with breast cancer incidence. Population-based studies from HCV-endemic area demonstrated increased breast cancer incidence in HCV-positive women younger than 50 years. On the other hand, population studies from HCV-low prevalence regions failed to detect an association of the virus with breast cancer.

HCV seropositive patients constitute a large sector of oncology patients treated in Egyptian practice. HCV infection with or without clinically-significant liver disease impose several therapeutic, social and logistic problems. Recently, investigators from Mansoura University reported their findings among breast cancerpatients. According to these data, HCV-positive breast cancer patients had several markers of disease aggression such as large tumor size, high tumor grade and nodal infiltration. Moreover, HCV-NS4 (non-structural protein-4) blood levels positively correlated with the level of the known breast cancer marker CA15-3.

In the current study, the investigators will investigate the incidence of HCV seropositivity in breast cancer patients and an age-matched control group. The study also examines the association of HCV status on the patients' baseline characteristics such as tumor stage and grade and with patients' treatment plan and treatment outcome.

Specifically, the aims of the study are the following:

1. To test if HCV seropositivity is associated with breast cancer diagnosis in Egyptian population.
2. To test if HCV-positive patients harbour more aggressive breast tumors.
3. To test if HCV-positivity affects management decision in breast cancer patients.
4. To test if HCV-positive patients suffer more frequent adverse effects to breast cancer treatment.
5. To compare disease-free survival of HCV seropositive breast cancer patients vs. seronegative patients.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven invasive breast cancer.

Exclusion Criteria:

* Patients with unknown viral marker status.
* Patients who did not complete their management at OCMU.
* Patients with multiple cancer diagnoses.
* Patients with virus-unrelated hepatic pathology.
Characterization of Anti-FGFR3 Antibodies

Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.

However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

In and out patients evaluated for a sensory neuropathy meeting the inclusion and non-inclusion criteria will be proposed to enter the study

At inclusion the SSN diagnostic score is calculated and a blood sample is tested for anti-FGFR3 antibody.

Follow up: Patients positive for anti-FGFR3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. A blood sample is taken at 6 and 12 months.

A subgroup of patients negative for anti-FGFR3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* A :Patients Male or female patient aged 18 years or more

Patients with a clinically pure sensory peripheral neuropathy including :

* idiopathic or dysimmune sensory neuronopathies
* idiopathic or dysimmune distal axonal sensory neuropathy
* sensory chronic inflammatory demyelinating polyradiculoneuropathy
* idiopathic or dysimmune small fiber neuropathies
* idiopathic or dysimmune trigeminal nerve neuropathy
* positive to antibodies anti-FGFR3

B :Controls Male or female patient aged 18 years or more

Patients with a clinically pure sensory peripheral neuropathy including :

* idiopathic or dysimmune sensory neuronopathies
* idiopathic or dysimmune distal axonal sensory neuropathy
* sensory chronic inflammatory demyelinating polyradiculoneuropathy
* idiopathic or dysimmune small fiber neuropathies
* idiopathic or dysimmune trigeminal nerve neuropathy
* negative to antibodies anti-FGFR3

Exclusion Criteria:

* -Motor or sensory-motor neuropathies
* Genetic, toxic, paraneoplasic neuropathies
* Diabetic Neuropathy.
* Neuropathy with Anti-MAG or anti-ganglioside IgM.
* Pregnant or breastfeeding woman
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.


Eligibility Criteria:
Inclusion Criteria:

* Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
* Male or female \> 18 years
* Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
* Adequate organ function

Exclusion Criteria:

* Uncontrolled hypertension or diabetes;
* Pregnant female;
* Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence

The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.

Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* women
* age \> 18 years
* stress, urge or mixed incontinence with indication of perineal reeducation
* follow in gynecology

Exclusion Criteria:

* incontinence due to neurological disorders
* younger than 18 years old
* pregnancy
* patient with pace-maker
* patient with gynecological cancer
* patient who don't understand the electrical stimulation procedure
Chronic Hepatitis Intervention Project for Drug Users

The purpose of this study is to determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C among out of treatment injecting drug users.

This 4.5-year community-based study is a randomized field experiment that uses a two-group design. Participants are randomized into either an Educational intervention group or a Motivational intervention group. We are comparing the effectiveness of the Motivational intervention with the Educational intervention. We are also estimating the costs and evaluating the cost-effectiveness of the Motivational intervention relative to the Educational intervention.

We have the following aims and related hypotheses:

Aim 1: To compare the effectiveness of a 6-session personalized motivational intervention to a 6-session educational intervention in terms of injection risk, sexual behavior, alcohol use, and knowledge and perception related to HBV and HCV; H1. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no injection risk at 6- and 12-month follow-up interviews. No injection risk is operationally defined as either no injections in the past 30 days, or no direct or indirect sharing of syringes and other injection equipment in the past 30 days.

H2. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no sexual risk at 6- and 12-month follow-up interviews. No sexual risk is operationally defined as either no sex (oral, vaginal, or anal) in the past 30 days, or no unprotected oral, vaginal, or anal sex in the past 30 days.

H3. Relative to the Educational intervention group, the Motivational intervention group will report greater decreases in frequency of alcohol consumption and quantity of alcohol consumed. Frequency of alcohol consumption is defined as "number of days drank alcohol in the past 30 days," and quantity of alcohol consumed is defined as "the average number of drinks per drinking day during the past 30 days." H4. Relative to the Educational intervention group, participants in the Motivational intervention group will report greater increases in knowledge and more accurate perceptions of severity of disease and efficacy of protective actions regarding hepatitis B and C at Session 3.

Aim 2: To estimate the cost and cost-effectiveness of a 6-session personalized motivational intervention relative to a 6-session educational intervention.

H5. The Motivational Intervention will cost more than the Educational Intervention, but will be cost-effective at eliminating injection risk behavior and sexual risk behavior and at reducing alcohol use

Eligibility Criteria:
Inclusion Criteria:

* minimum age of 18 years injected illicit drugs within last 30 days

Exclusion Criteria:

* participated in formal substance treatment in last 30 days
Effect of Resistive Exercise on Insomnia in Post Menopausal Women

the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women

Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week

Eligibility Criteria:
Inclusion Criteria:

1. age from 50 to 65 years
2. non smokers
3. BMI 25:29.9
4. post menopausal women suffer from insomnia

Exclusion Criteria:

1. post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia
2. women on hormone replacement therapy
3. those with diagnosed osteoporosis
Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery

The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.


Eligibility Criteria:
Inclusion Criteria:

* information and consent of the patient,
* age greater than or equal to 18 years,
* affiliation to a social security system,
* benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
* not being under legal protection.

Exclusion Criteria:

* Refusal to participate,
* language barriers that are incompatible with a reliable assessment
* use of beta-blockers, including eye drops
* use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
* use of psychotropic drugs, anxiolytics.
Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.

The purpose of this study is to measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers.

Type 2 diabetes is an up rising disease that makes it a major public health problem. While 221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. It is well recognized that regular consumption of fruits and vegetables can lower the incidence of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory diseases. Recently, Drs Desjardins, Abrams and Marette's research team discovered a high amount of a sesquiterpene in berries. This molecule is recognized for its ability to improve glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese mice. The aim of this study is to determine the effect of a polyphenol rich berries extract mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* 40-65 year old
* non-smoking
* overweight (BMI\>27)
* insulin resistant (fasting insulin \>90pmol/L, with fasting glycemia \< 7,0 mmol/L and \< 11,1 mmol/L after a 120-min oral glucose tolerance test)

Exclusion Criteria:

* diabetes
* chronic diseases
* taking drugs that could affect glucose or lipids metabolism
* major surgery 3 months prior to the study
* weight variation of ±10% 6 months prior to the study
* strawberry or cranberry allergy
* consumption of berries rich in polyphenol and/or wine more then 3 times per week
A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
* MMSE score of \>10 and \<26.
* Patients who were under ChE inhibitor treatment and experienced adverse events.
* Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion Criteria:

* Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
* Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
* History of allergy to topical products containing any of the constitution of the patches.
* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
* Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
* Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply
Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds

50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.

25 patients suffering from non healing wounds which have non typical features for the clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of the wound.

Another 25 patients suffering from non healing wounds with typical features for the clinical diagnosis will undergo biopsy of the wound.

The hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as BCC, SCC, vasculitis etc. and that some clinical features should raise our suspicion for these occult etiologies.

Eligibility Criteria:
Inclusion Criteria:

* patients with non-healing wounds (for \> 6 weeks)
* consent to be included in the study
* age 18-85

Exclusion Criteria:

* patients taking anti coagulant therapy
* patients taking steroids or immunosuppressive therapy
* pregnancy
* pace maker
Effects of Aerobic Exercise During the Early Rehabilitation After Ischemic Stroke

The goal of this clinical trial is to study the effects of aerobic exercise during the early rehabilitation after ischemic stroke. The main questions it aims to answer are:

* How is the recovery of motor function affected by regularly walking during the first 90 days after an ischemic stroke?
* Does regularly walking during the first 90 days after ischemic stroke affect cognition, physical comfort and the immune system? Participants will exert a heart rate controlled walking programme of walking 3-5 times 30-45 minutes per week. Researchers will compare the recovery of the walking group to a control group without any demands regarding physical exercise.

From animal experiments we know that wheel running has a positive impact on functional recovery after experimental stroke. We aim to translate this observations from our animal experiments into the clinic. Therefore, patients will be included shortly after ischemic stroke and start an aerobic exercise programme during the first 14 days after the event. At baseline visit the participants receive a neuropsychological testing with the focus on cognition, fatigue and depressive symptoms. Furthermore, we perform blood sampling for analysis of the activation state of the peripheral immune system. The patients receive a lactate ergometry with measurement of the 3 mmol lactate threshold to define the optimal heart rate range for their walking exercise. We perform the fugl-meyer assessment for the upper and the lower extremity.

For correlation with training-induced structural changes participants receive cerebral magnetic resonance imaging to assess the density of axonal fibre tracts (assessed by MRI-DTI). During the following 90 days participants in the intervention group are instructed to walk 3-5 times for 30-45 minutes per week and control the exercise intensity by optical heart rate measurement via smartwatch. The daily step count will be protocolled by the intervention and the control group. Participants will measure their resting heart rate in the morning before getting up to prevent overexercising. The assessments of the baseline visit will be repeated after 90 days.

Eligibility Criteria:
Inclusion Criteria:

* initial NIHSS or NIHSS determined at the moment of maximum deterioration 1-18
* age \> 18
* ischemic stroke
* pre-stroke independence
* sufficient motivation / patient's desire to cooperate / exercise for 3-5x/week for 30-45 min

Exclusion Criteria:

* transient ischemic attack
* premorbid motor disability / musculoskeletal injury / severe arthritis impairing degree of movement
* balance and transfer function that requires assistance
* cardiac disease not allowing to perform aerobic training
* inability to give informed consent
Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;

1. The effect of receiving blinded placebo, compared to no treatment; and
2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

As per Brief Summary

Eligibility Criteria:
Inclusion criteria:

* Suspected or known cold
* At least one of the following cold symptoms:

nasal discharge, nasal congestion, sneezing, or sore throat

* Enrolled in school, for children 12 to 17 years of age

Exclusion criteria:

* Pregnancy;
* Symptom duration \> 36 hrs
* Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
* Anticipated need for symptom-relieving meds during cold
* Autoimmune/deficiency disease
* History of allergic rhinitis with current eye itching/sneezing
* History of asthma w/current cough/SOB
* Prior study entry
* Allergy to Echinacea
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
* Never taken antiarrhythmic drugs or at most a pill in the pocket approach
* Willingness, ability and commitment to participate in baseline and follow-up evaluations

Exclusion Criteria:

* Paroxysmal AF for more than three years
* An episode of atrial fibrillation that lasted more than seven days within the past six months
* Persistent/permanent atrial fibrillation
* Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
* Documented atrial flutter
* Structural heart disease of clinical significance including:

  * Cardiac surgery within six months of screening
  * Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction \<30% as measured by echocardiography or catheterization
  * Unstable angina
  * Myocardial infarction within six months of screening
  * Surgically corrected atrial septal defect with a patch or closure device
  * LA size \> 40mm
* Any prior ablation of the pulmonary veins
* Enrollment in any other ongoing protocol
* Untreatable allergy to contrast media
* Pregnancy
* Any contraindication to cardiac catheterization
* Prosthetic mitral heart valve
* Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
* Contraindication to coumadin or heparin
* History of pulmonary embolus or stroke within one year of screening
* Acute pulmonary edema
* Atrial clot on TEE regardless of the patient's anticoagulation medication status