cyrilzakka/clinical-trials huggingface dataset:
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

The aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis.

Other objectives of the study include:

* Describing the association between the initial proteomic profile and:

  * the histological types and hormonal receptors status of the breast cancer,
  * the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification (Lack of evidence / possible / probable / confirmed) ,
  * the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification, combined with histological type and hormonal receptors status.
* Evaluate the prognostic value of the proteomic profiling for overall survival, according to the EANO-ESMO classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment,
* Evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment,
* Evaluate the association between the proteomic profile and the EANO-ESMO classification at least 3 months after the initial EANO-ESMO classification,
* Evaluate the evolution of the proteomic profile 3 months after the initial EANO-ESMO classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the EANO-ESMO response if applicable,
* Compare the proteomic profiles issued from cerebrospinal fluid and blood

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven breast cancer
* Patient with suspected metastatic leptomeningitis
* Age ≥ 18 years
* Patient covered by the French social security regime
* Signed written informed consent

Exclusion Criteria:

* History of cancer other than the one being treated
* Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
* Pregnant or breastfeeding patient
Gabapentin and Neural Mobilization Pain Reduction Effect Compared to Only Gabapentine

In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical gabapentin treatment will be compared to those produced by gabapentin (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral gabapentin treatment, to those effects produced by a gabapentin (only) treatment. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive)
Pharmacist Enhanced Service for Cardiovascular Risk Reduction

Pharmacist services such as medication review, counselling and treatment adherence clinics can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a step-wedge, cluster randomized controlled trial will be held in primary care centers of the public health system of Malaysia. Participants who have a high risk of cardiovascular risk factors currently seeking care in primary care will be recruited. Control group will receive usual care and the intervention arm will be seen by a pharmacist prior to their follow-up, with a comprehensive medication review, counselling and dietary advice consultations every month for three months. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy, interview skills, educational techniques, and develop personalized plan for every participant. The investigators plan to randomize up to 2100 participants who are currently receiving care in the primary care clinics in the district of Petaling by modifying the current workflow in primary care, whereby the investigators aim to get participants who are at high risk to undergo counselling as well as a medication review with proper pharmaceutical care delivered to them prior to seeking their medical doctor to receive care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes
* Patients with chronic kidney disease (eGFR \<60ml/min/1.73m2)
* Patients with established atherosclerotic vascular disease (via patient health records or selfreport) including cerebrovascular disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral arterial disease (symptomatic and/or ankle brachial index \<0.9)
* Primary prevention patients with multiple risk factors and Framingham risk score \>30%

Exclusion Criteria:

* Unwilling to participate/sign consent form
* Unwilling or unable to participate in regular follow-up visits
* Pregnancy
* Undergoing existing medication therapy adherence clinic conducted by the Pharmacy Unit
Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention, by an observational, prospective real-world study in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3).

To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.

An observational, prospective real-world study. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.

Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of episodic migraine with or without aura for more than one year prior to study entry
* evidence of 4-14 migraine days per month during the last trimester prior to screening
* participants may had been either treatment- naive or not suitable for or had failed previous migraine pharmacological prophylactic treatments
* were able to fully understand protocol and study information provided by the investigators.
* enrolled patients should take no other preventive treatment or use any other migraine prophylactic method during the three months before entering the study and throughout the study period.

Exclusion Criteria:

* older than 50 years of age at migraine onset
* evidence of MOH
* pregnant or nursing females
* history of tension-type, cluster or hemiplegic headache
* history of severe anaphylactic reactions to any of the intervention's ingredients
* evidence of severe systemic diseases
* history or evidence of major psychiatric disorder.
Response of Korean Medicine Hospital to COVID-19

The objectives of this study are to report the response strategy to prevent COVID-19 spread implemented at a Korean medicine hospital, and the satisfaction survey results regarding its preventive measures.

The objectives of this study are (1) to report the response strategy to prevent COVID-19 spread implemented at a Korean medicine hospital situated in Seoul, Korea, (2) to describe patient visit trends compared to the number of confirmed COVID-19 cases during the COVID-19 peak in February - April 2020, and (3) to provide results of a satisfaction survey regarding its preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients hospitalized at Jaseng Hospital of Korean medicine during March 23-25, 2020
* Outpatients visiting Jaseng Hospital of Korean medicine during March 23-25, 2020

Exclusion Criteria:

* Visitors visiting Jaseng Hospital of Korean medicine during March 23-25, 2020 for purposes other than treatment
Respiratory Muscle Exercise Training in COPD Patients

COPD patients often suffer from dyspnea and exercise intolerance which lower their quality of life.The aim of this proposed study is to examine the effectiveness of multi-respiratory muscle training on respiratory function of COPD patients.

The respiratory muscle training is an important part of pulmonary rehabilitation. Subjects will be recruited from the chest medicine clinic of a medical center in Northern Taiwan, randomly assigned to control and experimental groups by severity status for a 12-week muscle training intervention.The outcome measures will be performed to evaluate respiratory function, depression status and quality of life at baseline, 4, 8 and 12 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Obstructive Pulmonary Disease
* Must be stable
* Never participate in respiratory muscle trainig program

Exclusion Criteria:

* Infection or acute excerbation condition
* Abdominal surgical
* Severe neuromuscular, cardiac disease or dementia
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).

The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.

The total study participation time per subject is about 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 through 49 years of age.
* Subjects having provided informed consent.
* Individuals in good health

Exclusion Criteria:

* Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
* Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors

This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.


Eligibility Criteria:
Inclusion Criteria:

* age ≥50 years old
* receives post-stroke care with Saint Luke's Neurological Consultants
* prescribed at least 1, once a day, antithrombotic medication
* able to provide informed consent
* able to open an electronic cap
* able to self-administer medications
* has or has access to a telephone
* has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).

Exclusion Criteria:

-
Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block

A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure.

The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .

The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.

Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block, if participants meet in- and exclusion criteria and provide written informed consent.

Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.

Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).

Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.

When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).

Eligibility Criteria:
Inclusion Criteria:

* women,
* 18years and older
* American Society of Anesthesiologists 1, 2,3,
* planned for radical mastectomy.

Exclusion Criteria:

* Neurological problems (central and peripheral)
* Bilateral mastectomy
* Body Mass Index \> 33,
* Absolute contra-indication for ketorolac.
* Allergy/over-sensitiveness to levobupivacaine or local anesthetics of the same class
* Allergy/over-sensitiveness to dexmedetomidine or other alpha2 agonists (clonidine)
* Anatomic variations of the breast, pectoral region or axilla, noticed at clinical examination, including a pacemaker, Implantable Cardioverter Defibrillator, Port-a-Cath or other implantable device on the side that needs surgery.
* Participation in an other clinical trial within a period of four weeks before the beginning of this trial.
* Coagulopathy
* Infection or abcess in the region where the Block will be placed.
* Pregnancy
Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida

Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.


Eligibility Criteria:
Inclusion Criteria:

* Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number

Exclusion Criteria:

* Adults assigned as female at birth age 0-17
* Adults assigned as female at birth age \> 65
* Adults assigned as male at birth
* Adults assigned as female at birth without a Mayo Clinic medical record number
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.

This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients with upper urinary tract calculi surgery and/or ESWL within 3 months；
* Stone free or had residual stone fragments with a less than 4 mm diamete；
* 18-70 years of age; the gender is not limited；
* Agree to take effective contraceptive measures during the study period, and female of childbearing age whose pregnancy test is negative；
* Subjects with no mental illness and language dysfunction, can understand the situation of the study and have signed informed consent.

Exclusion Criteria:

* Patients with infectious stones, medical stones and urinary tract obstruction；
* Patients with hyperkalemia (K+\>5.5mmol/L) (or patients with factors or disease that can cause hyperkalemia), because the further increase in blood potassium can lead to cardiac arrest. These factors include disease or strenuous exercise, chronic renal failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency, extensive tissue failure. Patients who takes potassium sparing diuretics (such as triamterene, spironolactone, amiloride)；
* Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting, diarrhea, delayed gastric emptying, intestinal obstruction, etc.；
* Combined with cardiovascular, liver, kidney, hematopoietic system, such as severe primary disease, or known to affect the survival of serious diseases (such as cancer or AIDS), or patients with with disabilities mentally or legally；
* Patients with renal insufficiency (1.2 times the upper limit of the normal value of serum creatinine and urea nitrogen)；
* The recent (within 6 months) with family planners；
* Allergic to this product；
* To participate in other clinical trials in the past three months.
Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine

This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging (DTI) and tractography will yield useful information in patients suspected of having cervical spine disc herniation to provide imaging confirmation of whether or not disease is progressing and to assess response to treatment (regardless of treatment provided).

Conventional MRI (magnetic resonance imaging) is used to confirm disc herniation of the cervical spine. Symptoms of the condition can change before they can be seen by conventional MR images. Therefore, very little gross change can be seen by conventional MRI even after 6 weeks of treatment, either medical or surgical. This study will investigate whether newer MRI techniques, diffusion tensor imaging (DTI) and tractography, are useful in demonstrating gross changes or assessing response to treatment.

Consenting patients referred for clinically indicated cervical spine MRI by their treating physicians to confirm cervical disc herniation will receive an additional MRI sequence, diffusion tensor imaging. This will provide a baseline. The DTI sequence will add five minutes to the procedure. Participants will return at 6 weeks for a follow up MRI of the cervical spine to include DTI and tractography. Participants will be asked to complete an anonymized questionnaire at enrollment and at follow up to provide information regarding their condition.

MRI is a non-invasive diagnostic study of minimal risk which uses magnets instead of ionizing radiation to acquire images. The images are then assembled by computer. Diffusion tensor imaging (DTI) uses water diffusion to visualize structures in the brain and nervous system. Tractography is performed using DTI and computer post-processing to track the fiber bundles which exist in the brain and spinal cord and visualize them as two and three dimensional images. Both techniques allow radiologists to detect abnormalities, in this case, cervical spine disc herniation.

The follow up studies will be compared to the baseline studies to determine which demonstrates the highest sensitivity and specificity in identifying cervical spine abnormalities in general and cervical spine herniation in particular.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of having cervical spine herniation.

Exclusion Criteria:

* Patients not suspected of having cervical spine herniation.
* Patients in which MRI is contraindicated (patients with embedded metallic objects, including pacemakers, surgical clips, spinal cord stimulators, or prosthetic heart valves.)
* Patients requiring general anesthesia or conscious sedation--sedation would increase risk to participants.