cyrilzakka/clinical-trials huggingface dataset:
The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients over 18 years of age with pathologically confirmed breast cancer.
2. Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
3. Patients having an eastern cooperative oncology group (ECOG) score more than 2

Exclusion Criteria:

1. Patients with signs and symptoms of clinical neuropathy at baseline.
2. Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
4. Patients who have previously received chemotherapy.
5. Hepatic impaired patients.
6. Patient with history of allergy to hesperidin.
7. Patients with history of allergy to diosmin.
8. Renal impaired patients.
9. Patient inadherent to paclitaxel.
10. Patients inadherent to the administered hesperidin and diosmin during the study period.
Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following total knee replacement. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

Despite the recent advances in the understanding of pain mechanisms and the introduction of new drugs and new techniques in the postoperative management, pain after total knee arthroplasty (TKA) is still an unresolved issue. It affects the quality of life and rehabilitation of an important percentage of patients undergoing TKA. A recent study looked at the percentage of patients with chronic knee pain after knee replacement at a minimum of one year following surgery in 272 patients, 107 patients (nearly 40%) reported that they still had persistent pain at one-plus year following surgery. Central sensitization is now well established as an integral factor in many chronic pain states, including the commonly occurring knee and back pain. Many patients undergoing TKA are likely to have a significant degree of Central Sensitization, therefore the likely hood of high pain levels postoperative and persistent long standing pain after TKA is increased in this patient population.

Pulsed shortwave therapy negates central sensitization by imputing new

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for knee osteoarthritis;
* Planned spinal anesthesia; American Society of Anesthesiologists (ASA) physical status I-II;
* Scheduled for unilateral TKA;
* Patients aged 50 to 80 years old.
* Willingness to give written informed consent and willingness to participate in and comply with the study.

Exclusion Criteria:

* Unwillingness of the patient;
* Presence of neuropathic pain or sensory disorders in the leg to be operated on;
* Intolerance to the study drugs;
* Failure of spinal anesthesia;
* Previous major knee surgery, re-operation or trauma to the knee within the study period.
Validation of an iPhone-based Event Recorder for Arrhythmia Detection

In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.

Hypothesis:

1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
2. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.


Eligibility Criteria:
Inclusion Criteria:

Patients \>18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.

Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.

Exclusion Criteria:

1. Patients \<18 years of age.
2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
3. Patients with NYHA class IV heart failure.
4. Patients with unstable angina.
5. Patients with syncope as the presenting symptom.
6. Patients unable to or unwilling to use the device.
Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease

Clinical features in patients with the familial early onset forms and the sporadic forms of Alzheimers disease are similar, although the course of deterioration may be different. It would be very informative to examine the drug response of patients with Alzheimers disease by a certain genotype to find evidence favouring genotype-specific drug responses that may indicate genetically defined phenotypic differences in alzheimers disease.


Eligibility Criteria:
Inclusion Criteria:

* Meets the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) criteria for Alzheimers disease, regardless of date of diagnosis relative to study entry date.
* Has an Alzheimers disease status of mild to moderate, as classified by a Mini Mental State Examination (MMSE) score of 16 - 26 inclusive at screening.
* Post-menopausal females defined as menopause is defined as \>6 months without menstrual period with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
* Women who are on HRT (hormone replacement therapy) treatment, and have not been confirmed as post-menopausal should be advised to use contraception.
* Has a permanent caregiver who is willing to attend all visits, oversee the subjects compliance with protocol-specified procedures and study medication, and report on subjects status. (Subjects living alone or in a nursing home are not eligible).

Exclusion Criteria:

* Has a history of or suffers from claustrophobia.
* Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for at least 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis).
* Has a history or presence of other neurological or other medical conditions that may influence the outcome or analysis of the PET scan results. Examples of such conditions include, but are not limited to stroke, traumatic brain injury, epilepsy or space occupying lesions.
* History of Type I or Type II diabetes mellitus.
* Fasting plasma glucose level \>126 mg/dL (\>7.0 mmol/L) or HbA1c \>6.2%.
* History or clinical/laboratory evidence of moderate congestive heart failure defined by the New York Heart Association criteria (class II-IV.
Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy

RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing colonoscopy to study in the laboratory may help doctors learn more about colon cancer and identify biomarkers related to colon cancer in the future.

PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer biomarker studies in patients undergoing colonoscopy.

OBJECTIVES:

* Collect blood and tissue samples (including polyps, abnormal growths, cancer, and normal tissue) from patients undergoing colonoscopy.

OUTLINE: Patients undergo blood and tissue sample collection during colonoscopy. Samples are stored for future biomarker proteomic profiling.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Scheduled for colonoscopy as routine screening or for a specific problem

PATIENT CHARACTERISTICS:

* Not pregnant

PRIOR CONCURRENT THERAPY:

* No concurrent participation in a clinical trial to treat cancer or prevent cancer recurrence
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection

The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.

Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 37 weeks
* Emergency cesarean section
* Regional Anesthesia

Exclusion Criteria:

* Elective cesarean section
* Fever of unknown origin at admission
* Twin pregnancy
* Chorioamnionitis
* Acute fetal distress that requires general anesthesia
* Immunocompromise
* Maternal Lung/Respiratory Disease
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole.

Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female out-patients aged 18-80
* Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group
* RLSRS score \> 15
* RLS symptoms present at least 2 to 3 days per week within the last 3 months
* Written informed consent

Exclusion Criteria:

* Women of childbearing potential without adequate contraception, or breastfeeding
* Concomitant or previous pharmacologically therapy of RLS
* Clinically significant renal disease, and/or hepatic disease
* Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen
* Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease
* History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures
* Presence of any sleep disorder
* History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction
* History of or clinical signs of malign neoplasm
* Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated
* Allergic to pramipexole or its excipients
Hand Massage and Play Activity in the Elderly

There is no study found that examined the effects of hand massage and play activity on the loneliness, comfort and psychological well-being of the elderly in nursing homes. This study was planned as a pretest-posttest randomized controlled dual center study in order to examine the effects of hand massage and play activity on loneliness, comfort and psychological well-being in the elderly. 60 elderly people living in two nursing homes in Mersin city center will form the sample of the study. The sample will consist of three groups as hand massage group, game activity group and control group. The data were using the "Elderly Information Form", "Standardized Mini-Mental Test", "Loneliness Scale fort he Elderly", "General Comfort Scale", "Warwick-Edinburgh Mental Well-Being Scale", "Hand Massage" and "Play Activity (Jenga) will be collected. Hand massage group will be applied hand massage for 20 minutes for four weeks; the game activity group will play Jenga (game activity) for one hour a week. The control group will receive the institution's standart of care. Frequency, number, mean, Student's test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation Analysis will be used in the analysis of the data. As a result of this research, the effects and benefits of hand massage and play activity on the loneliness, comfort and psychological well-being levels of the elderly living in nursing homes will be determined, and it is anticipated that these effects and benefits will be included in evidence-based guidlines.


Eligibility Criteria:
Inclusion Criteria:

1. Be in the age range of 65-84 years
2. Being literate
3. No visual or hearing impairment
4. Ability to communicate verbally
5. Loss of sensation in the hand, arthritis, phlebitis, inflammation, eczema and fracture, etc. absence
6. Absence of any finger or limb loss
7. A score of 25 and above on the Standardized Mini Mental Test
8. Not having been diagnosed with a mental illness such as Parkinson's, Alzheimer's or major depression
9. Staying in a nursing home for at least three weeks
10. Agreeing to participate in the research

Exclusion Criteria:

1. Being 85 years or older
2. Having sensory problems in the hands
3. Having hand and nail deformities
4. Having an open wound or burn on the hands
5. Loss of limbs in fingers
6. Don't have neuropathy
Evaluation of the Corneal Endothelial Cell Layer by Specular Microscopy in Patients With Thyroid Eye Disease

To investigate corneal endothelial cell layer damage by specular microscopy in patients with thyroid eye disease

Thyroid eye disease is a common periorbital autoimmune inflammatory disease .It significantly impairs quality of the life ,causes cosmetic defects ,and could be sight-threatening ,especially when optic nerve or the cornea is affected.Classic manifestations of thyroid eye disease include proptosis ,lid retraction ,lagophthalmos,optic neuropathy and restrictive extraocular myopathy.In addition to the affection of the orbital and lacrimal glands ,the corneal endothelium has showen morphological changes in patients with thyroid eye disease .corneal endothelium is the innermost corneal layer facing the anterior chamber and is known for maintaining corneal transparency by its pump-leak function .corneal transparency is crucial for optimal vision . severe damage to corneal endothelium can induce corneal opacification .resulting in corneal edema and subsequently vision loss. That is because there are thyroxine receptors in all layers of the conea. And the autoantibodies to TSH receptors usually attach to them causing damage to the cornea.Specular microscopy is one of the best investigative procedure used to assess changes in the corneal endothelium due to thyroid eye disease.Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the characteristics of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid eye disease whom diagnosis was established based on bartley diagnostic criteria .

Exclusion Criteria:

* participates with systemic diseases other than HT such as

  1. diabetes mellitus
  2. previous ocular surgery or laser therapy.
  3. history of corneal disease.
  4. history of trauma.
  5. history of glaucoma
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms

The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic).

The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years.
* Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system.
* Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.

Exclusion Criteria:

* Subject is diagnosed as multiple aneurysms.
* Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation.
* mRS score≥3.
* Hunt and Hess classification≥4.
* Subject has emergency ruptured aneurysms and needs assisting stent.
* The target aneurysm has received endovascular embolization or surgical treatment.
* The aneurysm carrier artery has severe stenosis.
* PLT\<60×109/L or INR\>1.5.
* Subject has nonfunction of important organs or other severe diseases.
* Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment.
* Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication.
* History of allergies to platinum and tungsten.
* Expected life \<12 months.
* Pregnant or lactating women.
* Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent .
* Other circumstances judged by researchers are not suitable for enrollment .
Phase IIIB Subcutaneous Missed Dose Study

The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis
* Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
* On background methotrexate at least 3 months (≥10mg weekly)
* Must be able to self injection or allow a care giver to do it for them
* Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate

Exclusion Criteria:

* Participants who had prior exposure to abatacept or CTLA-4 Ig
* Received treatment with rituximab.
* Participants who have received treatment with leflunomide within 1 year of screening
* Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.
Effects of Ocular Electroacupuncture on Abducens Nerve Palsy

The purpose of the study is to testify the efficacy of treating abducens nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for abducens nerve palsy (ANP), through treating ANP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by abducens nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility Criteria:
Criteria: Inclusion criteria;

1. patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;
2. patient in stable condition after treatment for primary disease;
3. age between 18 to 80 years old without gender limitation;
4. haven't received acupuncture intervention for ANP before;
5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to ANP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
3. those with serious medical conditions that might limit their participation;
4. those with eye or other location with serious infections;
5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;
6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
7. who had participate in other clinical trials, which may affect the results.
Value of Fecal Calprotectin

For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin levels will be compared between patients with and without a diagnosis of IBD and the sensitivity, specificity and accuracy will be determined. For the secondary aim - the correlation between calprotectin levels and disease activity - in patients with IBD selected from this cohort, we will determine the association between calprotectin levels and clinical IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease score, pathological activity) and radiological features (bowel wall thickening, enhancement, edema, mesenteric inflammation).


Eligibility Criteria:
Inclusion Criteria:

* Calprotectin assay at IU in last 12 months
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke

Cardiovascular disease is the world's leading cause of death. Atherothrombosis is a common cause of ischemic stroke.

A strong epidemiological link has been established between periodontitis and the risk of stroke. It shares common risk factors with atherothrombosis, and its severe form is associated with low-grade systemic inflammation and daily low-intensity bacteremia. Atherothrombosis is a frequent cause of ischemic stroke.

Periodontal bacteria have been found within atheromatous plaques, correlated with a greater risk of rupture.

Thus, periodontitis could be a modifiable risk factor for atherothrombosis and future vascular events: its early diagnosis and treatment could have a major impact on cardiovascular prevention.

Hypothesis: In patients with periodontitis who have had an ischemic stroke, periodontal treatment may reduce atherosclerotic plaque activity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Minor ischemic stroke of the anterior circulation (NIHSS ≤ 5) of atherothrombotic origin according to the TOAST scale \<30 days
* Atheroma plaque of the ipsilateral carotid bulb \>30% not eligible for intervention (endarterectomy or angioplasty-stenting)
* Severe periodontitis (stage 3 or 4)
* Signed informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* \< 6 teeth
* Without independent oral hygiene
* Contraindications to PET scan
* Known allergy to fluoro-deoxyglucose and its excipient
* Immunosuppressive treatment
* Uncontrolled diabetes
* High risk of infective endocarditis
* Organ transplant pending
* Progressive infectious diseases
* Active smoking not stopped
* Patient deprived of liberty by judicial or administrative decision
* Patient under legal protection (guardianship, curatorship)
* Participation in another interventional research involving humans or being in the exclusion period following previous research involving humans
* Pregnant or breastfeeding woman Patient under AME (state medical aid)