cyrilzakka/clinical-trials huggingface dataset:
Arterial Wall Calcium Load in Pseudoxanthoma Elasticum

Quantification and preferential sites of arterial wall calcification within the coronary and lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2 diabetics and Chronic Kidney disease.

In a previous work we have observed that patients suffering from PXE, a soft-tissue calcifying inherited autosomal disease, exhibited specific structural and functionnal features within the peripheral arteries. We now want to quantify and determine the preferential sites of the arterial wall calcification (Agatston score) between these patients compared to diabetics and patients with chronic renal insufficiency with mediacalcosis.

All variables will be collected from a cohort of PXE monitored in our PXE Health and Care centre at the university hospital of Angers. Quantification of the arterial wall calcium load will be performed using helicoidal CT-scan. These variables will be compared to the same measurements performed in type 2 diabetic and chronic kidney disease patients paired by age and gender.

Eligibility Criteria:
Inclusion Criteria:

* Patients with phenotypically and genotypically-proven PXE
* Type 2 diabetic patients with mediacalcosis (i.e. Ankle Brachial Index \> 1.30)
* Patients with a chronic kidney disease (CKD), before kidney transplantation
* All patients should be affiliated to a Health care system

Exclusion Criteria:

* Patient with unproved PXE
* Patient under the age of 18 yrs
* Patient unwilling to participate to the study
* Pregnant women
* Patient not affiliated to a Health care system
Effects of Virtual Reality on Brain Hemodynamic Activity in Chronic Pain

Virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. The main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. Virtual reality systems allow the individuals to feel themselves in a different environment and shift their attention to the game they are playing or the virtual world created rather than the pain they feel. This is thought to be the main mechanism of pain control. However, the cortical mechanism of the reduction in pain caused by virtual reality methods, especially in individuals with chronic pain, has not been fully elucidated.

It is predicted that the integration of virtual reality methods into treatment protocols will gradually increase by time, especially as a result of the reflection of technological developments in clinical practice. At this point, fNIRS, which enables the assessment of the functionality of brain areas during movement, has the potential to reveal the response of the effect provided by virtual reality technology in the prefrontal cortex.

The aims of our study were to examine brain hemodynamic activity during the experience of non-immersive and immersive virtual reality environments and the change in pain intensity after virtual reality applications in individuals with rheumatic diseases with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis,
* Right hand dominant,

Exclusion criteria:

* A history of acute pain up to 3 days prior to the date of evaluation,
* Any psychiatric and neurological diagnosis,
* Have a cognitive problem that prevents them from adapting to the working procedure,
* Using centrally acting medications and anti-depressants.
* Presence of neuropathic pain,
* Presence of vision or hearing problems,
* Any psychiatric and neurological diagnosis
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG

The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are:

* What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis?
* Can EUS-PPG serve as a reliable and less invasive alternative to HVPG for assessing portal pressure?
* What are the safety outcomes associated with EUS-PPG compared to HVPG?

Researchers will compare EUS-PPG measurements with HVPG measurements within the same patients to assess whether EUS-PPG provides accurate and clinically comparable portal pressure readings while reducing procedural risks.

Participants will:

* Be adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
* Undergo both EUS-PPG and HVPG measurements within a seven-day window to allow for direct comparison of results.
* Receive standard clinical care for their condition, including routine diagnostic evaluations and portal hypertension management as needed.
* Be monitored for safety outcomes, including adverse events such as bleeding, infection, perforation, and any other complications related to the procedure.
* Provide relevant demographic and clinical data, including liver disease history, Child-Pugh and MELD scores, and portal hypertension-related complications such as varices or ascites.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
* Subjects who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
* Subjects capable of giving signed informed consent.

Exclusion Criteria:

* Pregnancy.
* Significant bleeding risk (International Normalized Ratio (INR) \> 1.5 OR platelet count \< 50000).
* Presence of active gastrointestinal bleeding at the time of screening
* History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
* Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
* Subjects having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
* Hepatocellular carcinoma not meeting Milan Criteria.
* Presence of portal vein thrombosis or another suspected component of presinusoidal portal hypertension.
* Presence of extra-hepatic cancer, terminal disease, or severe comorbidities significantly limiting life expectancy or affecting study participation.
* Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.


Eligibility Criteria:
Inclusion Criteria:

1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
2. Modified Hoehn and Yahr in the OFF state of II-IV.
3. Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
4. Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off.
5. Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
6. Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
7. At least 30 years of age and able to give written informed consent.

Exclusion Criteria:

1. Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
2. Treatment with MAO inhibitors except selegiline.
3. Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
4. Neurosurgical operation for Parkinson's disease.
5. Atypical parkinsonism or secondary parkinsonism variants.
6. Diagnosis of cancer or evidence of continued disease within 5 years.
7. Clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
8. Mini-Mental Status Examination score of 25 or less.
9. History of drug or alcohol abuse or dependence within 2 years.
10. History of psychotic illness or seizures.
11. Clinically relevant depression disorder.
12. History of neuroleptic malignant syndrome.
13. Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
Studying Use-Dependent Plasticity

Recent studies suggest that when patients learn a new motor movement, it may cause a change in the way the nerves act in the area of the brain that controls that movement. This change is called use-dependent plasticity.

The purpose of this study is to determine the direction and extent of the changes that take place in the brain areas that control movement in the untrained finger after the training of the opposite finger. The study outcomes may help researchers to develop rehabilitation strategies for people who have suffered brain injuries.

Eighteen healthy adults age 18 years or older will be enrolled in this study. Participants will undergo a clinical exam and then come back to the Clinical Center three times for sessions that will last approximately 2 hours each. For each session, participants' forearms will be immobilized and a small electronic device will be attached to each index finger so that researchers can measure their movements. Participants will be asked to move either index finger and to observe and concentrate on its movement. Investigators will perform transcranial magnetic stimulation (TMS) before and after these motor exercises. For TMS, a wire coil is held over the scalp and a brief electrical current passes through the coil, creating a magnetic pulse that electrically stimulates the brain.

Motor training consisting of repetition of unilateral finger movements leads to use-dependent plasticity (UDP) in the contralateral primary motor cortex, M1, in normal volunteers. It is conceivable that motor training in one hand, in addition to changes in the contralateral M1, could elicit plastic changes in the ipsilateral M1. The purpose of this study is to test this hypothesis: Training consisting of repetition of a unilateral finger movement elicits plastic changes in the cortical representation of the homonymous untrained finger in the ipsilateral M1. The study will be performed on normal volunteers and will consist of three to five separate training sessions. The endpoint measure will be, for each session, the change in the direction of the movements evoked by TMS in the untrained index finger as a function of the opposite index finger.

Eligibility Criteria:
* INCLUSION CRITERIA:

Only healthy volunteers 18 years or older will be included in this protocol. Handedness will be assessed by the Edinburgh Inventory Scale. All experimental sessions will be studied on outpatient basis. Normal Volunteers with right-handedness will be eligible to participate.

EXCLUSION CRITERIA:

Subjects with the history of epilepsy, surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neural stimulators, cochlear implants, history of drug abuse, psychiatric illness (depression), hypertension or use of medications that influence synaptic plasticity, will be excluded as evaluated by the investigator.
Tadalafil as Adjuvant Therapy for DMD

This project will assess the vascular responsiveness in leg muscles of boys with Duchenne muscular dystrophy (DMD) to one single dose of tadalafil, a common vasodilator drug, using non-invasive techniques (MRI or Doppler ultrasound) and exercise testing. These findings will provide proof of concept for a subsequent intervention study to demonstrate efficacy of longer-term tadalafil to counter sympathetic vasoconstriction and slow disease progression in DMD. It will also inform whether a group of patients do not respond to the drug.

This project will target up to 25 ambulatory boys with DMD aged 7-13 years. Because the vascular impact of tadalafil is immediate, we will confirm that the drug target is valid target in lower extremities by assessing the change in post-exercise microvascular perfusion using Blood Oxygen Level-Dependent (BOLD) MRI or change in post-exercise hyperemia using Doppler ultrasonography. We will also assess the functional impact of the drug through exercise testing. Patients will be randomized to undergo the above-mentioned assessments with or without the study drug on two separate visits. Time function tests, MRI-based fat fraction and inflammation measurements will also be obtained in all patients, thus characterizing disease severity and provide a sampling of information on whether a subset of patients do not respond to the drug. This information may be used to inform future trials as to the appropriate target population for PDE5i as well as account for potential failures in a previously published phase 3 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DMD confirmed by 1) clinical history with features before the age of five, 2) physical examination, 3) elevated serum creatine kinase level and 4) absence of dystrophin expression, as determined by immunostaining or Western blot (\<2%) and/or DNA confirmation of dystrophin mutation.
* Minimum entry age of 7.0 years
* Ambulatory

Exclusion Criteria:

* Older than 13.0 years of age
* Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
* Presence of unstable medical problems
* Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
* Contraindications to Tadalafil (use of nitrates, alpha-adrenergic blockers, other PDE5A inhibitors)
Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt

Evaluation of the efficacy of the AstrazenicaCovid 19 vaccine to develop IgG antibody and its level based on th12 weeks program. Also to follow the changes of markers of coagulation (D-dimer) after vaccination compared to the basic level. A cardiology consultant will follow D-Dimer results to be managed properly if there is a need. As it is expected to receive Sinopharm vaccine there will be comparison between results of the two types of vaccine. To our knowledge this will be the first study done on Egyptian population.

SARS-CoV-2 has been in the human population for more than a year now, causing severe disease in some and resulting in a pandemic that continues to put severe strain on economies and healthcare infrastructures worldwide. Vaccination is considered as one of the greatest successes in medical history. Based on prior experience with the development of SARS-CoV vaccines, all COVID-19 vaccines must be subjected to the tests for protective effects and harmful risks derived from antibody-dependent enhancement that may contribute to augmented infectivity and/or eosinophilic infiltration. The SARS-CoV-2 vaccine is now being developed urgently in several different ways.

In the UK, the first three vaccines have emergency use authorization, and a national rollout is in progress. Many other countries are also instigating large scale vaccination programmes. Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus (SARS-CoV-2) in different populations is essential .

The UK government recently decided to extend the interval between the first dose of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines from 3 weeks to 12 weeks to maximise the number of people receiving the initial dose, despite the trials only providing vaccine efficacy data based on a schedule of 21 days between doses.

Many reports were raised claiming Astrazenica vaccine for the development of vascular thrombosis and studies are not finalized regarding this issue .

China is regarded as one of the world's leading countries in SARS-CoV-2 vaccine development, up to date the last inactivated vaccine international clinical (Phase III) trial was launched in the United Arab Emirates by Sinopharm China National Biotec Group (CNBG).The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced.

Eligibility Criteria:
Inclusion Criteria:

* All male and female above 18 years

Exclusion Criteria:

* age below 18 years -pregnancy-
* fever
* IGM positive for covid 19
Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

Dental implants are regarded as a standard of care in restoring missing teeth. Although there is a high prevalence of diabetics who receive dental implants, the relationship between dental implants and diabetes has not clearly been investigated.

A total of 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who have dental implants were recruited. The purposes of this research study were: (1) to evaluate diabetes patients to determine risk factors for bone loss at dental implants and teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present in saliva and blood serum, comparing the two groups.

OBJECTIVE:

Regulators of peri-implant bone loss in patients with diabetes appear to involve multiple risk factors that have not been clearly elucidated. This study was conducted to explore putative local etiologic factors on implant bone loss in relation to type 2 diabetes mellitus, including clinical, microbial, salivary biomarker, and psychosocial factors.

MATERIALS AND METHODS:

Thirty-two subjects (divided into type 2 diabetes mellitus and non-diabetic controls), having at least one functional implant and six teeth, were enrolled in a 1-year longitudinal investigation. Analyses of clinical measurements and standardized intra-oral radiographs, saliva and serum biomarkers (via protein arrays for 20 selected markers), and plaque biofilm (via qPCR for eight periodontal pathogens) were performed at baseline and 1 year. In addition, the subjects were asked to respond to questionnaires to assess behavioral and psychosocial variables.

Eligibility Criteria:
Inclusion Criteria:

* be at least 40 years old
* have at least one dental implant that has been in function for at least 6 months
* have at least 6 natural teeth
* have good general oral health
* not be pregnant or breastfeeding or planning to become pregnant within the next year
* if you are a pre-menopausal woman you or your male partner must be surgically sterile or you must be using reliable birth control (i.e., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) now and throughout the study or abstain from sex throughout the study

Exclusion Criteria:

* not have an active oral infection, including periodontitis and rampant caries
* not have a history of chronic systemic illness or infection, history of oral cancer, life expectancy of less than 5 years
* not have had cancer treatment in the last 12 months
Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation

Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and (ii) to create if needed a specific cREE formula for ALS patients.

Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo, Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new REE formula was created using multiple linear regression according to sex, age, FFM and FM. Accuracy of this formula was assessed in a validation sample.


Eligibility Criteria:
Inclusion Criteria:

* ALS diagnosed patients according to Airlie House criteria
* treated with riluzole
* respiratory quotient (RQ) of patients in indirect calorimetry (IC) should be in between 0.7 and 0.87

Exclusion Criteria:

-
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer

The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
* Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at Duke Cancer Institute. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
* ECOG performance status of 0-1
* Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided.

Exclusion Criteria:

* Treated with prior neurotoxic chemotherapeutic agents
* Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis

Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis

20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination

Eligibility Criteria:
Inclusion Criteria:

* bleeding from radiation proctitis

Exclusion Criteria:

* pregnancy bleeding diathesis