cyrilzakka/clinical-trials huggingface dataset:
Effects of Training on Central Auditory Function in Multiple Sclerosis

The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).

Five general types of evaluations will be employed over multiple study sessions at the National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will review the subject's medical history and perform a neurologic exam to confirm MS diagnosis. Second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. Additionally, subjects will complete a case history and series of hearing handicap inventories. Third, a battery of behavioral procedures will be used to characterize central auditory processing. Fourth, auditory evoked potential studies will be performed. Emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging (MRI) evaluation to determine sites and amount of neural degeneration.

Eligibility Criteria:
Inclusion Criteria:

* age 21-65 years;
* a clinical or laboratory supported diagnosis of "definite" MS;
* a diagnosis of relapsing-remitting, primary progressive, or secondary progressive MS;
* a Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive;
* no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and
* a brain MRI scan that shows at least three white-matter lesions on T2-weighted images consistent with MS

Exclusion Criteria:

* current major disease or disorder other than MS (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes);
* other neurological conditions that could interfere with the ability to respond to tests and questionnaires;
* non-native speaker of English (since test materials are presented in English);
* pregnant (due to potential negative effects on the fetus during fMRI);
* more than a mild degree (less than a 40 dB HL four-frequency pure-tone average \[PTA\]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact CAP test results);
* metal implants (due to fMRI constraints); and
* left-handedness
RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes

RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating patients with myelodysplastic syndromes.

OBJECTIVES:

Primary

* Determine the clinical activity (improvement in erythroid response and/or improvement in other cytopenias, bone marrow morphology/cytogenetics) of RAD001(everolimus) in patients with low or intermediate-1 risk myelodysplastic syndromes.
* Assess the toxicity of this drug in these patients.

Secondary

* Examine laboratory correlates (S6K1 levels, angiogenesis pre- and post-treatment) and determine how these correlates correspond to dosing and clinical activity of RAD001(everolimus).
* Evaluate the presence of HLA-DR15 and cytotoxic T-cell populations in patients pre- and post-treatment and correlate this with response to treatment.
* Examine the incidence of the null GSTT-1 phenotype in myelodysplastic syndromes patients and correlate this with response to RAD001(everolimus).

OUTLINE: Patients receive oral RAD001(everolimus) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or relapse.

Blood samples are collected periodically during study. Samples are analyzed for S6K1 activity, effector T cells by flow cytometry, GSTT-1 by PCR, and HLA-DR15 levels.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Low or intermediate-1 risk myelodysplastic syndromes by International Prognostic Scoring System (IPSS) criteria

  * IPSS score \< 1.5
* Requiring transfusion of 2 units of red blood cells at least once a month (four weeks prior to accrual on study)
* High levels of endogenous epoetin alfa (i.e., \> 200 mU/mL)

  * Unlikely to respond to epoetin alfa, or has a documented clinical non-response to epoetin alfa (at a dose of ≥ 40,000 U weekly) or darbepoetin alfa (at a dose \> 200 mcg every other week) (i.e., \< 2 g/dL increase in hemoglobin and no decrease in transfusion requirements after at least 4 weeks of treatment)
* No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

* ECOG Performance Status of 0-2
* Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal
* Serum creatinine ≤ 2 times upper limits of normal
* No clinically significant anemia due to iron, B12, or folate deficiencies; autoimmune or hereditary hemolysis; or gastrointestinal bleeding
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior treatment (including growth factors)
* No chronic use (\> 2 weeks) of physiologic doses of a corticosteroid agent (dose equivalent to \> 10 mg/day of prednisone) within 28 days of the first day of study drug
* No concurrent use of another investigational agent
* No concurrent therapy with any cytotoxic drugs, steroids, or growth factors
A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2
* Patients must be planning to receive standard of car e neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org)
* Patients must have histologically or cytologically confirmed invasive breast cancer that is either triple-negative or HER2+ (regardless of hormone receptor status)

Exclusion Criteria:

* Patients with any uncontrolled intercurrent illness.
* Patients who have any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant
* History of egg allergy
* Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine.
* History of Guillain-Barré syndrome
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.

ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.

Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.

The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing ERCP above the age of 18 years

Exclusion Criteria:

* Patient with Billroth II gastrectomy
* Known previous sphincterotomy
* Active acute pancreatitis before ERCP
* Ongoing acute cholangitis before ERCP
* Hypotension (systolic blood pressure \< 100 mmHg)
* Second-degree and third-degree atrioventricular block
* Heart failure
* Glaucoma
* Obstructive uropathy
* Impaired renal function (serum creatinine \> 133μmol/L)
* Pregnant or breastfeeding women
Myocarditis After SARS-CoV2-Vaccination

Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.

SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.

Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.

Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 Vaccine-associated Myocarditis (\< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).

Exclusion Criteria:

* missing individual consent
Maximal Repair Versus Bridging Reconstruction with BioBrace®

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.


Eligibility Criteria:
Inclusion Criteria:

* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
* over 18 years of age

Exclusion Criteria:

* glenohumeral osteoarthritis
* Western Ontario rotator cuff score \>60
* uncontrolled diabetes (Hgb A1C \>7%)
* pregnant
* local or systemic infection
* inability to cooperate with and/or comprehend post-operative instructions
* MRI proven non-vascular sites
* poor nutritional state (Alb \<30 g/L)
* cancer
* paralysis of the shoulder
* contracture of the shoulder
* patients unable to provide informed consent for the study
Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.

Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.

Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.

Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.

Usual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.

Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.

Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome

Exclusion Criteria:

* GI pathology (organic disease)
* Co-morbid pain disorders
Prospective Research of Outcomes After Salpingo-oophorectomy

PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO.

The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.


Eligibility Criteria:
Inclusion Criteria:

* BRCA mutation 1/2 or "Variant suspected deleterious" mutation.
* Female
* Age 35-50 years
* Able to undergo RRSO
* Speaks English
* Able to give informed consent

Exclusion Criteria:

* Prior history of bilateral oophorectomy
* BRCA 1/2 deleterious mutation
* Plans to move out of geographic region in next 3 years
* Unable to travel to study visits
Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6 and 12 months after the first IVIG course. Responder/No responder status will be defined at 3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample will be collected to assess early changes of transcriptome. The CIDP diagnosis and responder/no responder status will be confirmed by an independent committee. The transcriptome of the patients will be individually analyzed and compared regarding Responder/Non responder status to a control groups of 20 healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
* first line of treatment
* treatment with intravenous immunoglobulin required
* healthy subjects matched for age and gender

Exclusion Criteria:

For CIDP patients

* uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)

For healthy subjects:

any chronic or autoimmune disease

For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy
Extrapulmonary Presentations of COVID-19 Patients

An observational study about the extrapulmonary presentations of COVID-19 patients during the second wave of the pandemic.

a prospective observational study that aimed at

1. provide an overview about the prevalence of extra-pulmonary presentation of COVID-19 during the second wave of the pandemic and
2. Detection of the most frequent affected systems with comparison between the pulmonary and extrapulmonary presentation of COVID 19 as regard patient demographics, comorbidity and level of care needed.

Eligibility Criteria:
Inclusion Criteria:

* all patient with confirmed covid 19 disease presented to our health facility during the second wave of the pandemic

Exclusion Criteria:

* other diagnosis than covid 19 as a primary cause of presentation of the patient
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To

To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC).

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.
Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)

For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well established. Mainly three techniques are currently applied:

* no closure at all
* extracorporal suturing of the gap
* intracorporal suturing of the gap

All three techniques have been applied at our hospital. Patients who received laparoscopic hernia repair between 2006 and 2011 will be identified from the patient database and will be contacted by phone to inquire about the outcome and the satisfaction of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* hernia repair between 2006 and 2011
* laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
* patient agrees to be surveyed by phone

Exclusion Criteria:

* Patient rejects participation in survey
* patient already rejected use of his/her data for research purposes at admittance to surgery
Alternative Surveillance Program for Patients With High Risk Group of HCC

In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared


Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis B or C
* Child-Pugh classification A
* HCC risk score \>= -2.04
* have not diagnosed with HCC
* on surveillance program using US and negative on previous US within 6-8 months of enrollment
* sign informed consent

Exclusion Criteria:

* younger than 40 years or older than 70 years old
* history of HCC
* severe GFR or on HD/PD due to renal failure
* contra-indication of MRI
* congestive hepatopathy
* iron deposition
* pregnancy or nursing mother
* non-viral hepatitis or liver cirrhosis
CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease

A severe outbreak of Chikungunya fever has been reported at La Réunion Island (France) in 2005-2006. Chikungunya is a viral disease. Chikungunya virus is an alphavirus transmitted to humans by the bite of infected mosquitoes, usually of the genus Aedes (Aedes albopictus in La Réunion).

To date, more than 266,000 cases were estimated to have occurred in the island (760,000 inhabitants). Most of cases are expressed as a mild disease, with intense fever and arthralgias, with rare but serious complications (encephalitis, liver, cardiac or renal failures.) having required a hospitalization in an intensive care unit. 273 of such serious cases (immediately life threatening condition) have been reported among the cases, in patients aged over 10 days (59% were 65+ age old). Chikungunya was proven in 246 serious cases; 101 patients had comorbidities, and 27% of confirmed cases eventually died. In addition 44 cases of mother-to-child infections were reported and 40 were confirmed (one died).

To date, in 248 death certificates, chikungunya was reported as the direct or indirect cause of death, with a median age of 79, range 0-102, and a sex-ratio (M/F) of 0.95. InVS, in collaboration with Inserm (French NIH) also reported (by June 6, 2006) a significant excess of mortality (from all causes) during the major outbreak which occurred from December, 2005 (+10%) to April, 2006 (10.1%), with a peak of excess mortality reached in February (+34.4%), concommitant to the peak of incidence.

Today, there is no antiviral treatment against Chikungunya. We showed from ex-vivo studies (in a sensitive model of cells culture to the viral infection) that chloroquine provides a significant inhibition on the replication of the Chikungunya virus. This efficacy seemed also to be reached at a plasmatic concentration of similar order of magnitude as recommended for treating malaria with this drug.

This trial aims to assess efficacy and safety of chloroquine as as therapeutic treatment of chikungunya disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of more than 18 years and less than 66 years (men and nonpregnant women, without counter-indications) voluntary to take part in of the study, residing at the Reunion Island, having a body weight equal to or higher than 60 kg for a clinical chikungunya disease diagnosed within less than 48 hours.

Exclusion Criteria:

* Pregnant Women
* More than 66 years old
* body weight less than 60 kg
* without counter-indications to chloroquine
* Renal Insufficiency
* Retinopathy
* Coeliac disease