cyrilzakka/clinical-trials huggingface dataset:
Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer

The purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.

The objectives of this study are to assess the utility of quantitative Magnetic Resonance Imaging (MRI) in assessment of response to neo-adjuvant chemotherapy in breast cancer. Magnetic Resonance (MR) Fingerprinting based relaxometry allows quantification of T1 and T2 relaxation times of tumor and normal breast tissue. Response to chemotherapy is associated with measurable changes in these properties and may be used to predict treatment response earlier than conventional MRI. The study team hypothesize that 3D MRF before, during and after chemotherapy can provide additional quantitative information about changes during treatment and may predict early response to chemotherapy.

During visit 1, 3D MR Fingerprinting images will be added to the clinical MRI scan before start of chemotherapy. The additional research images will take less than 20 minutes to acquire During visit 2, patients will be scheduled for a research only non-contrast 3D MR Fingerprinting scan 7-10 days after the first cycle of chemotherapy. Acquisition of images will take approximately 30 minutes.

During visit 3, if the treating physician orders a clinical MRI scan within 1 month of the end of chemotherapy treatment, the investigators will add a 3D MR Fingerprinting sequence to the clinical scan. The additional research images will take less than 20 minutes to acquire. If the patient is not scheduled for a clinical scan within 1 month of the end of chemotherapy treatment, the investigators will contact the patient to schedule a research only 3D MR Fingerprinting scan. The study team would like to administer IV gadolinium contrast for research purposes. Patients will be reconsented prior to the research only scan to determine whether or not they will receive IV contrast. If the patient declines administration of contrast for the post treatment scan, the study team will perform a non-contrast scan. Acquisition of images will take 30-45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven cases of breast cancer

Exclusion Criteria:

* Patients with onlybenign lesion
* Patients with onlyductal carcinomain situ (DCIS)
* Patients with recurrent/ residual breast cancer in same breast
* Pregnant women
* Lactating Women6.Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator
* Patients with contraindications for MRIdue to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
* Known history of severe claustrophobia
* Patients under the age of 18
* For patients with known history of allergic reaction to MR contrast material or abnormal kidney function (GFR \< 40 mL/ min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed in these patients.
Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* First stroke attack
* Within 3 months after stroke onset
* Supratentorial stroke
* Unilateral stroke

Exclusion Criteria:

* Bilateral stroke
* infratentorial stroke
* Cognitive disabilities or serious psychiatric illness.
* Difficulty in walking due to orthopedic problems.
Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases

measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.

measuring difference in biting force using i-load device with followup period of 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.
2. Mean age of 50-75 years of age.
3. The edentulous ridges should be covered by firm healthy mucosa.
4. Systemically free; no history of diabetes, chemotherapy, and radiotherapy.
5. Co-operative patients.

Exclusion Criteria:

1. Patients with severely resorbed maxillary ridge
2. Previous history of radiotherapy or chemotherapy.
3. Patients with xerostomia
4. Patients with neuromuscular and hormonal disorders
5. Patients with severe bony or soft tissue undercuts
6. Patients with large tongue
7. Patients with limited mouth opening
8. Patients with known history of allergy, especially to acrylic resin
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks

This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.

HAE is characterized by recurrent localized angioedema caused by uncontrolled activation of the complement and contact systems due to a congenital deficiency of functional C1 inhibitor.

rhC1INH has been developed to offer a more widely available therapeutic alternative to the existing plasma-derived C1INH (pdC1INH) products that have been used in the treatment of acute angioedema attacks patients with HAE.

Patients who have qualified for enrollment in advance and who present to a study center within 5 hours of onset of an attack will be evaluated for eligibility. 75 eligible patients will be randomized (3:2) to receive an intravenous infusion of rhC1INH or saline in a double-blind fashion. Open-label rhC1INH may be provided as rescue medication to patients who do not experience the beginning of relief within 4 hours or who experience life-threatening oropharyngeal-laryngeal angioedema symptoms.

Any patient having received a randomized treatment will be allowed to receive treatment with rhC1INH in an open-label fashion for subsequent eligible attacks.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 13 years
* Signed written informed consent
* Clear clinical and laboratory diagnosis of HAE with baseline plasma level of functional C1INH of less than 50% of normal
* Willingness and ability to comply with all protocol procedures
* Clinical symptoms of an eligible HAE attack with onset less than 5 hours before the time of initial evaluation

Exclusion Criteria:

* Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH), or positive anti-rabbit dander IgE test (cut off \>0.35 kU/L; ImmunoCap® assay; Phadia or equivalent).
* A diagnosis of acquired C1INH deficiency (AAE)
* Pregnancy, or breastfeeding, or current intention to become pregnant
* Treatment with any investigational drug in the past 30 days
* Known or suspected addiction to drug and/or alcohol abuse
* Suspicion for an alternate explanation of the symptoms other than acute HAE attack
Structured Treatment Interruption for HIV Patients With Virologic Failure

The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.

Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.

To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.

Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.

Interventions:

Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.

Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* On therapy with a triple ARV that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days.
* Virologic failure while on the combination as defined by a plasma HIV RNA \> 1000 copies/mL measured on 2 occasions at least 4 weeks apart.
* HIV RNA \<500,000 copies/mL.
* CD4 cell count must be \> 50/mm3
* Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.
* The patient has at least two new ARV available based on history, and at least two of these new agents will be included in the new salvage regimen.

Exclusion Criteria:

* Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.
* Pregnancy or breast feeding.
* Patients with any of the following abnormal laboratory test results at screening:· Hemoglobin\<80 g/L, neutrophil count\<750 cells/mL, Platelet\<20,000 /mL· AST or ALT \> 5X Upper Limit of Normal (ULN)· Creatinine \> 250 umol/L
* End stage organ disease
* Patient with malignancy receiving systemic chemotherapy
* Patient has need for immune modulators (interleukin, interferon, GMCSF etc) or prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)
Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks

This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years
* A Body Mass Index lower than 35 Hg/m2
* Patients with organ-confined prostate cancer
* Signed informed consent

Exclusion Criteria:

* Contraindications for Laparoscopy
Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose

The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.

Usually management of conventional extra corporeal circulation takes place under a loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds. This empirical approach based on patient weight date from the 1960's and does not take into account materials improvement and different individual sensitivities; several studies have demonstrated than a result at least as effective could be obtained with heparin lower doses, and without increasing thromboembolic morbid events for patients.

Patients are randomly assigned into one of 2 groups one day before surgery. First group receive unfractionated heparin conventional dose during the MECC, second group receive half of the conventional dose. All surgery is performed by the same team and using same equipment. Regular blood tests are carried out before, during and after surgery. Blood loss, transfusion needs, rhythm disorders, stay duration in intensive care and total hospitalization length is finally reported. The follow-up period through the 30th postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* single or multiple coronary bypass
* written and informed consent
* repair or replacement of artic leaflet
* platelet suppressive agents stopped since at least 7 days
* anticoagulants stopped since at least 3 days

Exclusion Criteria:

* Thoracic surgery antecedent
* ASA 4
* carotid stenosis \> 75%
* Hb \< 10,5 g/l
* chronic hepatic failure
* thromboembolic antecedent
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
2. Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4. Adequate hepatic function
5. Adequate renal function
6. Adequate bone marrow function
7. Provide signed informed consent
8. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
2. Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
3. Prior treatment with other immune modulating anti-cancer agents
4. Untreated or active brain metastases or spinal cord compression
5. Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
6. Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria will apply
The Diabetic Foot Ulcer Registry

This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Eligibility Criteria:
Inclusion Criteria:

* All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria:

* None
Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital

ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac malformations including tetrology of fallot ,double- outlet right ventricle(RV),transposition of great vessles,aortic coartication or interruption ,and truncus arteriosus


Eligibility Criteria:
Inclusion Criteria:

* all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies

Exclusion Criteria:

-
Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven biliary adenocarinoma
2. Age \> 18
3. Evaluable disease
4. ECOG performance status of 2 or better
5. No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
6. Adequate bone marrow function A. WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL B. Hemoglobin \>9.0 g/dL C. Platelets \> 100,000/µL
7. Adequate kidney function (creatinine\<1.5 mg/dL)
8. Adequate liver function (bilirubin\<1.5 mg/dL \[\< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction\], transaminases levels\<3 times the upper normal limit, and serum albumin of \>2.5 mg/dL)
9. No serious medical or psychological condition that would preclude study treatment
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Other tumor type than adenocarcinoma
2. Evidence of GI bleeding or GI obstruction
3. Presence or history of CNS metastasis
4. Pregnancy or breastfeeding
5. Other serious illness or medical conditions
6. Axial skeletal radiotherapy within 6 months
7. Neuropathy grade 2 or worse
Different Administration Routes of Dexmedetomidine on Postoperative Delirium

Intravenous dexmedetomidine has been reported to decrease the occurrence of postoperative delirium (POD) in elderly patients. Nevertheless, some previous studies have indicated that intratracheal dexmedetomidine and intranasal dexmedetomidine are also effective and convenient. The current study aimed to compare the effect of different administration routes of dexmedetomidine on POD in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

Older than 65 years; General anesthesia for more than two hours;

Exclusion Criteria:

-
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).

Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .

Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years
* Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
* Patients \>=45 kg
* Affiliated member of the Social Security system

Exclusion Criteria:

* Patients with an undetermined colitis
* Patients with a non established diagnosis of CD
* Women of childbearing age without a method of contraception
* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
* Pregnant women, breastfeeding women

  -- Age \< 18 years
* Persons under legal protection
* Person who does not have the capacity to consent
* Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).
Hereditary AngioEdema, Neurobiology and Psychopathology

Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of HAE

Exclusion Criteria:

* Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
* Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
* Ongoing allergies.
* Night work over the past 15 days.
* Vigorous physical activity or alcohol consumption (the day before the assessment).
* Women in follicular phase of menstrual cycle.
Knowledge of Vital Pulp Therapy in Permanent Teeth Among a Group of Dental Students in Egypt

Conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in Egypt. This will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth.


Eligibility Criteria:
Inclusion Criteria:

* Dental students who live in Egypt.
* Dental students who are willing to participate
* Fifth-year students.

Exclusion Criteria:

-Responses with incomplete information