cyrilzakka/clinical-trials huggingface dataset:
Influenza Virus - A Multicenter Registry

The investigators purpose is to prospectively characterize influenza infections over a 3 year period in transplant patients using a registry system. The investigators plan to generate robust data on clinical features of upper and lower respiratory disease, antiviral therapy and its effects on disease outcome, as well as quantitative virologic data on shedding and antiviral resistance. The investigators also will study the long term sequelae of influenza infections and look at development of rejection.

This study will be a prospective, multi-center study conducted at investigator sites who comprise the Influenza in Transplant collaborative study group. This includes over 30 centers from across North America and Europe. The co-ordinating center will be the University of Alberta. We will aim to enrol 300 patients in the registry over a 3 year period.

The following information will be gathered:

1. Clinical Information

   * Baseline demographic information about the transplant (including immunosuppression, graft function)
   * Comorbidities such as diabetes, obesity, chronic lung disease
   * Symptoms of infection, radiologic features of infections
   * Antiviral use
   * History of vaccination
   * Outcomes such as hospitalization, ICU admission, mechanical ventilation, death
   * Long term outcomes: allograft function, chronic respiratory disease
   * Laboratory parameters including lymphocyte count, immunoglobulin levels, renal function
   * Adverse events - all serious adverse events occurring during the study (till day 180) will be reported. These include: a) hospitalization; b) congenital deformity; c) death; d) disability; and e) other adverse events the investigator considers serious. Pregnancy during the follow-up period will also be reported.
2. Virology

   * Method of diagnosis (DFA, viral culture, PCR)
   * Subtype of influenza virus (ie HxNx)
   * Viral Shedding by serial NP swabs at day 0 (diagnosis), 3, 6, 11, 18, 28 (weekly thereafter if shedding persists)
   * Quantitative PCR of NP swabs (centrally at University of Alberta)
   * Antiviral resistance testing at first and last positive swabs
3. Immunology - Serum collection at disease onset and 4-6 weeks afterwards for

   * Serology against circulating influenza viruses
   * Production of HLA alloantibodies

Significance:

Despite the recognized importance of influenza in transplant patients, there is actually very limited prospective data. This registry will represent the largest prospective data collection on influenza in transplant patients and will provide invaluable data on the clinical presentations, antiviral efficacy and other parameters related to influenza.

Eligibility Criteria:
Inclusion Criteria:

* Solid organ transplant recipients on at least one immunosuppressive medication
* Hematopoietic stem cell transplant recipients - allogeneic or autologous
* Pediatric or Adult
* Diagnosis of influenza infection by standard laboratory technique

Exclusion Criteria:

not able to comply with the protocol
Evaluation of Levator Injuries Using Transvaginal Endosonography

Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.

In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.

3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.

The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.

The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women who have not delivered previously
2. Singleton pregnancy
3. Maternal age \> 18 years and
4. No previous pregnancies \>20 weeks of gestation
5. Ability to read and understand English.

Exclusion Criteria:

1. Pregnant women who have delivered previously
2. Multiple pregnancies
A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy

This is a non-randomized, open-label, dose-escalating Phase Ia study performed at a single center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of intravitreous administration of RNA-144101 in patients with geographic atrophy (GA).


Eligibility Criteria:
Inclusion Criteria:

* Males and females of all races and ethnicities between the ages of 50-99
* Female subjects must be 1-year postmenopausal or surgically sterilized and must have negative serum pregnancy test
* Subjects must have GA from AMD in one or both eyes:
* The study eye will be the eye that meets all inclusion/exclusion criteria
* If both eyes meet criteria, then the eye with the smaller GA lesion will be studied
* If the GA lesions are equal in size, then the eye with the best-corrected visual acuity (BCVA) will chosen as the study eye
* If both eyes have the same lesion size and same BCVA, the right eye will be chosen
* Subjects must have the following GA criteria for inclusion:
* GA lesions with an area \> 2.5mm2 and ≤ 20mm2 as determine by fluorescein angiography and fundus autofluorescence
* A clear view to the fundus must be present in order to easily examine the study eye at baseline
* BCVA In the study eye between 20/20 and 20/100 as measured on Snellen chart or 85-50 letters by ETDRS
* Willing and able to provide signed informed consent prior to any study participation

Exclusion Criteria:

* GA due to a disease other than AMD
* Pregnancy or lactation
* Treatment of any systemic infection
* Autofluorescence pattern marked at none, focal or patchy
* Ocular surgery in the study eye in the previous 6 months.
* Presence or history of choroidal neovascularization (wet AMD) in the study eye
* Any inflammatory (autoimmune, uveitis) or neovascular (diabetic retinopathy) disease of the retina
* Any history of glaucoma or disc cupping in the study eye
* Any history of severe dry eye disease
* High myopia \> - 8D or high hyperopia \> +8D in the study eye
* Presence of life-threatening disease
* Abnormal basal metabolic panel or liver function tests
* Current alcohol or other substance abuse
* Unwilling or unable to provide signed informed consent for any study procedures
Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia

The goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy.

Pregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations

The goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy.

Pregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations inclusion criteria: singleton pregnancies at term, suspected fetal macrosomia (\>4000 gr in non GDM and \>3800 gr. in GDM cases exclusion criteria-fetal anomaly, PPROM, multiple gestation The radiologist and the sonographer will be blinded to the fetal weight estimation and to the other estimation done

Eligibility Criteria:
Inclusion Criteria:

singleton pregnancy at term, suspected fetal macrosomia,

Exclusion Criteria:

* fetal anomaly multiple pregnancy PROM
Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-45 and able to give voluntary written informed consent;
* Regular menstrual periods of 24-35 days in length;
* Body mass index 18.5 to 30 kg/m2;
* No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;
* Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;
* Must be willing and able to participate in at least three of the four challenge paradigms.

Exclusion Criteria:

* Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
* Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);
* Current treatment with psychoactive medication;
* Diabetes controlled by means other than diet;
* Use of steroid contraceptives (any method involving hormones) within the previous 4 months;
* Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on any particular occasion; must be willing to abstain from alcohol consumption for 48 hours prior to each 1H-MRS scan;
* Implanted metallic devices.
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Eligibility Criteria:
Inclusion Criteria:

Clinical:

* Diabetic patients with active treatment (oral agent or insulin)
* Patients with angina and documented ischemia or patients with documented silent ischemia
* Patients who are eligible for intracoronary stenting
* Age \> 20 years, \< 75 years

Angiographic:

* De novo lesion
* Percent diameter stenosis ≥ 50%
* Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy
2. Pregnant state
3. Known hypersensitivity or contra-indication to contrast agent and heparin
4. Limited life-expectancy (less than 1 year)
5. ST-elevation acute myocardial infraction requiring primary stenting
6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels
7. Hematological disease (Neutropenia \< 3000/mm3), Thrombocytopenia \< 100,000/mm3)
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal
9. Renal dysfunction, creatinine ≥ 2.0mg/dL
10. Contraindication to aspirin, clopidogrel or cilostazol
11. Contraindication to Paclitaxel or everolimus
12. Left ventricular ejection fraction \< 30%
13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
14. Non-cardiac co-morbid conditions are present with life expectancy \< 1 year or that may result in protocol non-compliance (per site investigator's medical judgment for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
MR Characterisation/Localisation of Breast Cancer

Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision.

Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven invasive ductal carcinoma of the breast
* Unifocal disease
* Patient proceeding to mastectomy

Exclusion Criteria:

* Multifocal disease
* Previous surgery to ipsilateral breast
* Neoadjuvant chemotherapy
* Ferromagnetic implants
* Claustrophobia
* Cup size DD or greater
Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.

VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession

Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects.

Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively.

Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.

Eligibility Criteria:
Inclusion Criteria:

- Age (18-55) Miller's classI and II multiple GR width of KG\>2 mm

Exclusion Criteria:

* Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV
Screening and Management of Hyperuricemia in Patients with Chronic Medical Diseases in Assiut University Hospital

In this study, we aimed to evaluate patients with chronic medical diseases in Assiut university hospitals for -Detection of asymptomatic hyperuricemia .

* Early identification of associated comorbidities .
* Management of indicated hyperurecimia .

Hyperuricemia is classically defined as a serum uric acid (SUA) of more than 7.0 mg/dL in men or more than 6.0 mg/dL in women . Asymptomatic hyperuricemia is a condition, where patients have elevated levels of SUA, yet do not exhibit symptoms or signs of monosodium urate crystal deposition, such as gout attacks, urolithiasis, or uric acid nephropathy . SUA can be elevated 10 to 15 years before clinical manifestations of gout . Up to 21% of the general population and 25% of hospitalized patients are estimated to have asymptomatic hyperuricemia .

Uric acid excretion mostly occurs via the kidneys, so decreased glomerular filtration rates in chronic kidney (CKD) patients contribute to the population increase in hyperuricemia. Conversely, studies suggest that hyperuricemia may contribute to CKD , raising the possibility that urate-lowering therapies (ULTs) could be useful in slowing CKD progression . There was no independent association between hyperuricemia and systemic arterial hypertension. Also, hyperuricemia has been reported as an independent risk factor for both coronary artery disease, congestive heart failure and diabetes mellitus.

So efforts should be made to recognize individuals at risk of hyperuricemia by evaluating dietary habits, family history, and lifestyle factors, and regularly monitor SUA levels. As well as, management strategies, including lifestyle modifications, pharmacotherapy, and dietary interventions, to effectively control SUA and reduce the risk of associated complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older who were diagnosed with chronic medical diseases as diabetes mellitus , hypertension , obesity , metabolic syndrome , chronic kidney disease and cardiovascular disease (ischemic cardiomyopathy, heart failure ,coronary arteries disease) .

Exclusion Criteria:

* patients under the age of 18.
* patients kown to have gouty arthritis
* patients with acute kidney disease .
* patients receiving thiazide diuretics.
* patients with tumour lysis syndrome .
Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.

By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.

In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.

Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Patients with loss of unrepairable substance by conventional techniques shreds, at the front

Exclusion Criteria:

* Facial lesions repaired by conventional reconstructive surgery techniques
* History of malignancy in remission for less than 5 years
* Malignant neoplasm undergoing changes
* Severe psychiatric history
* Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
* Patients above a grade 1 in the classification NYHA ( New York Heart Association )
* insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria
* Severe hypertension
Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels

The aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level.

Individuals aged 18-75 with post-stroke hemiplegia or hemiparesis, a minimum Functional Ambulation Scale score of 2, and no major neurological or rheumatological pathology affecting the musculoskeletal system other than stroke (e.g., Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.), as well as those without diseases affecting balance (e.g., Parkinson's, Cerebral trauma, Meniere's disease, ear infection, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis), and not using medications that disrupt balance, will be included in the study. Detailed medical histories will be obtained from all included patients and/or caregivers, and comprehensive musculoskeletal examinations will be conducted. Patient information, including name, surname, age, gender, occupation, education level, marital status, body mass index, duration of illness, stroke type, affected side, dominant side, and comorbidities, will be recorded.

All included patients in the study will be assessed by the same physician using the Functional Ambulation Scale, Community Integration Questionnaire , Mini-BESTest (Mini-Balance Evaluation Systems Test), balance assessment on the Hur Smart balance device, The Timed Up and Go Test , Tinetti Balance and Gait Test, Vas Kinesiophobia Scale., and Tampa Kinesiophobia Scale.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 75 years old
* Having experienced post-stroke hemiplegia or hemiparesis
* Scoring at level 2 or above on the Functional Ambulation Classification
* Being willing to participate in the study and signing the consent forms"

Exclusion Criteria:

* Patients who cannot undergo mental evaluation, are unable to complete scales, are illiterate, or have aphasia
* Having major neurological or rheumatological pathologies affecting the musculoskeletal system other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.)
* Patients with diseases affecting balance (Parkinson's, Cerebral trauma, Meniere's disease, ear infections, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis, etc.)
* Patients using medications that may disrupt balance
Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies.

Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis.

Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment
* Age \>/= 18 years
* ECOG 0 or 1
* Life expectancy \>/= 12 weeks
* Grade \</=1 for all adverse effects related to previous therapy or surgery (except for alopecia)
* Appropriate organic functions as defined:
* ASAT and ALAT \</= 2.5xLSN or ASAT and ALAT \</= 5xLSN in case of inappropriate hepatic function due to the underlying disease
* Bilirubin \</= 1.5xLSN
* Albumin \>/= 3.0 g/dL
* Neutrophil counts (PNN) \>/= 1 500/mL
* Platelets \>/= 100 000/mL
* Hemoglobin \>/= 9.0 g/dL
* Creatinin \</= 1.5xLSN
* Cooperative patients able to respect the protocol

Exclusion Criteria:

* Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion
* Previous treatment with an association of mTOR inhibitor or EGFR inhibitor
* Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated
* Grade \>/= 2 nephropathy according to NCI CTCAE
* Current treatment with curative dose of coumadin or heparin of low molecular weight
* Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis.
* Presence of one og those pathologies during the last 12 months before the inclusion:
* myocardial infarction
* angina pectoris
* bypass of coronal or peripheral arteries
* heart failure
* stroke
* cerebral bleeding
* pulmonary embolism
* Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start
* Uncontrolled high blood pressure (\>150/100mhHg)
* Grade \>/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC \>450 msec for male or \>470 msec for female.
* Patients HIV positive
* Pregnant or breastfeeding woman
* Patients with psychiatric disorder
* Active alcoholism
* Previous pulmonary interstitial disease
* Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment