cyrilzakka/clinical-trials huggingface dataset:
Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS

This project aims to determine the feasibility of delivering a comprehensive behavioral lifestyle intervention including dietary and exercise components via an evidence based, internet-delivered telehealth coaching platform. Further, investigators will gather preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic risk factors after participation in the intervention. The outcomes will inform the design of a larger randomized controlled trial.


Eligibility Criteria:
Inclusion criteria:

1. Relapsing-Remitting Multiple Sclerosis
2. On disease modifying treatment for 6 months
3. No relapse within the previous 30 days
4. Self-identify as not currently meeting recommendations for healthy diet and physical activity
5. Ambulatory with or without assistance
6. Reliable access to the internet via computer or smartphone
7. Be responsible for their personal food preparation or have input into the food prepared for them

Exclusion criteria

1. Unstable cardiovascular disease
2. Unstable renal disease
3. Unstable pulmonary disease
4. Physician does not approve participation
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

The objective of this study is to evaluate oxidative stress and/or inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.

We will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with Gaucher disease. Fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. These samples will be processed to separate plasma from red blood cells and frozen until assays are performed. Standardized immunoassay methods and LC/MS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.

Eligibility Criteria:
Inclusion criteria:

1. All participants must be 18 years or older.
2. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator.
4. GD subjects must be stable on a specific ERT and/or SRT therapy at a specific dose (for e.g. on a units/kg basis) for at least 2 years or be naïve to these therapies (no therapy for 2 years).
5. GD1 patients, who have had a change in therapy i.e. a change in dose or switch from one drug to another, can be enrolled after at least 6 months have elapsed since the change and is considered stable in the opinion of the clinician providing care to the patient.
6. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.

Exclusion Criteria:

1. Medically unstable conditions in any group as determined by the investigators
2. Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.
3. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception
4. History of asthma that is presently being treated
5. Subjects who cannot or are unwilling to have blood drawn
6. Unable to adhere to study protocol for whatever reason
Surgeons' Satisfaction With the Surgical Training Program in Egypt

In Egypt, the evidence for quality processes has not been established yet in the current training programs for surgery residents. There are no published articles discussing career satisfaction among surgical residents. Therefore, we are going to conduct a self-designed survey in Egyptian university hospitals to measure residents' satisfaction and display views about their undergraduate surgical education, surgical education during internship year, post-graduate training program, and extracurricular activity during medical school.


Eligibility Criteria:
Inclusion Criteria:

* We will include the Egyptian academic surgeons, within their first 8 years after their graduation. We will include surgeons in general surgery and other surgery subspecialties such as orthopedic surgery, neurosurgery, urology, and plastic surgery

Exclusion Criteria:

* We will exclude surgeons who received part of their training program abroad.
Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes

Type 2 Diabetes Mellitus (T2DM) is the most common chronic lifestyle-related disorder with a significant impact on quality and healthcare expenditures. Insufficient glycemic control and low fitness level prior to a surgical intervention results in more postoperative complications which leads to a longer hospitalization, higher costs and mortality. A prehabilitation intervention in persons with T2DM prior to surgery should be aimed to improve glucose regulation and translate into better outcomes. However, the classic interventions such as Combined Lifestyle Intervention are labor-intensive and require a high degree of organization and therefore are not used as standard care. The use of biofeedback can provide a solution to this. Biofeedback with a continuous glucose sensor in combination with lifestyle monitoring by activity trackers and coaching prior to surgery is a promising but unexplored prehabilitation strategy. The Nursing Prehabilitation Intervention Supported with Technology for vascular Surgery in People with Type 2 Diabetes (VITAAAL) intervention is a form of blended care. It focuses on improving vitality and glycemic control before surgery with the Diameter application, using intermittently scanned glucose monitoring, nutrition habits and physical activity blended with coaching from a nurse practitioner (NP) diabetes. Because VITAAAL is a novel intervention, the aim of this pilot study is to investigate its usability and feasibility. The pilot study consists of three phases. After the first phase, a specific prehabilitation module will be designed and programmed in the Diameter app. This module will be based on the results and experiences in phase one. In phase two and three the patients will use the adjusted version of the Diameter app that contains implemented findings of the previous phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM who need a scheduled vascular surgery, consisting of AAA surgery endovascular or classical abdominal approach, aortic stenosis surgery or Fontaine II.
* Aged 18 years or older
* Being familiar with using an Android smartphone (version 5.0 or higher);
* Participant can understand and weigh up information provided by researcher and can understand what the consequences of participation are.

Exclusion Criteria:

* Need for acute vascular surgery
* Dependency on renal replacement therapy
* Known with (pre)proliferative diabetic retinopathy with or without macula oedema.
* Any general diseases or mental disorder rendering participation in the study impossible
* Drug abuse
* Insufficient mastery of the Dutch language
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.

30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.

Eligibility Criteria:
Inclusion Criteria:

1. Currently 34 weeks pregnant or within 6 weeks postpartum
2. At least 18 years of age
3. Singleton or twin gestation
4. Patient or family sign informed consent
5. Diagnosis of eclampsia
6. Able to obtain MRI scanning within 24hours of hosp admit and/or seizure

Exclusion Criteria:

1. Neither pregnant nor within first 6 weeks postpartum
2. Patient or family unable to sign informed consent
3. Less than 18 years of age
4. Triplet or higher order gestation
5. Unable to obtain MRI scanning within 24 hours of hospital admission (
6. Diagnosis of cerebral hemorrhage
7. Patient in whom MRI is contraindicated
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study

The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.

This is a multi-center feasibility study intended to collect information on changes in intra-thoracic impedance measurements from CRT-D devices. In order to obtain an intra-thoracic impedance measurement, the device delivers a subthreshold impulse that measures the resistance between two electrodes.

At the programmed interval, measurements will be obtained between six different lead configurations.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) or have a previously implanted St. Jude Medical (SJM) CRT-D system capable of enabling the diagnostic impedance monitoring feature with implant occurring within the last 14 days
2. Have had at least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of ≥100% over a 24 hour period
3. Have the ability to maintain a patient diary for recording daily weights, symptoms related to heart failure, changes in diuretic therapy, and any unscheduled clinic or hospital visits
4. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Be less than 18 years of age
2. Have had a recent myocardial infarction, unstable angina or cardiac revascularization within 40 days of enrollment
3. Have had a recent Cerebrovascular Accident or Transient Ischemic Attack within three months of enrollment
4. Have a contraindication for an emergency thoracotomy
5. Have an indication that requires programming device in atrial pacing mode
6. Have permanent (chronic) atrial fibrillation
7. Have a capped or inactive right atrial or right ventricular pacing/defibrillator lead
8. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
9. Be pregnant or planning a pregnancy in the next 6-months
10. Be currently participating in a clinical investigation that includes an active treatment arm
11. Have a life expectancy of less than six months due to any condition
A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.


Eligibility Criteria:
Inclusion Criteria:

* The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
* The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
* The study participant has a body weight ≥50 kg and body mass index within the range \[18 to 30\] kg/m\^2 (inclusive)
* The study participant is male

Exclusion Criteria:

* The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
* The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
* The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
* The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
* The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.0 x upper limit of normal (ULN)
* The study participant has bilirubin \>1.0 x ULN (isolated bilirubin \>1.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 %)
* The study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities
* The study participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
* The study participant has made a blood or plasma donation or has had a comparable blood loss (\>450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted
Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer

The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

This study is aimed at improving the outcome of resectable non PET responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.
* No distant metastases.
* Signed written informed consent.
* Age less than 75 years.
* Potentially resectable tumor (radiological evidence of resection with no residual disease).
* ECOG 0 to 2.
* Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.
* Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml

Exclusion Criteria:

1. Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up
2. Prior treatment with other anti cancer therapy or radiation therapy.
3. Legal incapacity.
4. Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.
5. Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.
Registering Genomics and Imaging of Tumors (ReGIT)

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.

Eligibility Criteria:
Inclusion Criteria

1. Subject is between 18 and 89 years of age.
2. Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI\*.
3. Subject is treatment-naïve for the above condition.
4. Subject is planning to undergo surgical resection and biopsy of their brain tumor.
5. Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
6. Subject is able to read and write in English.
7. Subject is able to lay supine for up to 80 minutes.
8. Subject is able to hold still during MRI procedures.
9. Subject or their LAR has signed the consent form for participation in the study.

Exclusion Criteria

1. Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
2. Subject has serious unstable medical or mental illness.
3. Subject has insufficient tissue to acquire at least two biopsy samples during resection.
4. Subject has a medical contraindication to any element of the study procedures.
5. Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
6. Subject is pregnant.\*\*
7. Subject is at high risk for NSF (eGFR\<60 or serum creatine \>1.3) and cannot follow the weight-based dosing protocol for Gadavist.\*\*\*
A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.


Eligibility Criteria:
Eligibility Criteria:

1. Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.

   Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
2. Measurable disease is not required, but all disease will be carefully evaluated.
3. Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
4. Patients must have not received prior chemotherapy or radiotherapy.
5. Patients must have performance status of \>60%
6. Patients must have a WBC count of \>3.5, an ANC count \>1500 and a platlet count of \>100,000.
7. The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
8. Patient must be free of significant infection or other severe complicating medical illness.
9. Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.
Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft.

Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. Different protocols are applied to process the extracted tooth for obtaining the graft material and investigations are needed to assess the protocol with the best outcome.

Autogenous graft is widely accepted as the gold standard for grafting procedures(Sakkas et al. 2017). And since the introduction of autogenous dentin graft for alveolar ridge preservation by Kim et al. clinically (Y.-K. Kim et al. 2010), it has increasingly attracted attention and teeth are no longer seen only as a waste. Tooth dentin has a chemical composition similar to that of alveolar bone; the inorganic content is 70%-75%, organic content 20%, and water content 10%, whereas alveolar bone has proportions of 65%, 25%, and 10% respectively(Y.-K. Kim et al. 2013). The similarity in chemical composition between dentin and alveolar bone, as well as its content of growth factors such as bone morphogenetic proteins (BMPs), made the dentin a successful graft for filing alveolar bone defects of same patient(Y.-K. Kim et al. 2010, Nampo et al. 2010, Y.-K. Kim et al. 2013) .

The technique proposed by Kim et al includes demineralization of the dentin as it reduces minerals content, exposes collagen fibrils and increases BMPs released thus promoting the process of osteogenesis(Y.-K. Kim et al. 2010). However, demineralisation step is time-consuming, taking several days, which challenges same visit application. As a result, two main approaches have been developed to overcome this obstacle. One approach is to maintain the demineralization step but with improving the technique to shorten the processing time(MURATA et al. 2010, E.-S. Kim 2015, Kabir et al. 2015). On the other hand, many investigators have used the whole tooth without demineralization and reported satisfactory clinical outcome(Gideon Hallel et al. 2014, Valdec et al. 2017). Hence, more investigations are needed to evaluate the technique with the best outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-restorable non-molar teeth
* Patients \> 18 years old
* Motivated patients who are willing to continue the follow-up period

Exclusion Criteria:

* Compromised alveolar socket that is not contained to support graft material
* smokers and alcoholic patients.
* Patients with systemic conditions that may compromise hard tissue healing (i.e. poorly controlled diabetes, autoimmune diseases).
* Local infection at the site of extraction.
* Teeth with root canal filling.