cyrilzakka/clinical-trials huggingface dataset:
Prevalence, Risk Factors and Outcomes of Pediatric Vascular Thrombosis

This study is aimed to identify the prevalence, risk factors and outcomes of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications .

Thrombosis is a blood clot that develops within veins or sometimes arteries in the body.

Occur most commonly in the inferior and superior vena cava, their major tributaries, the deep veins of the extremities, the splanchnic veins, as well as the cerebral venous sinuses.

The incidence of venous thromboembolism (VTE) increases with age. In the pediatric population (0-18 years) the incidence is approximately 0.7-2.1 cases per 100,000 children,1-3 while in the adult population the incidence is 100-150 per 100,000.4

Risk factors include the presence of central venous lines, trauma, major surgery followed by bedrest, immobilization, infection (cellulitis, osteomyelitis, phlebitis), cancer chemotherapy, inflammatory bowel disease, nephrotic syndrome, obesity, dehydration, and total parenteral nutrition.

Patients with vascular thromboembolism present with various symptoms depending on site of thrombosis , symptoms include swelling, redness, pain , low-grade fever In cases that develop pulmonary embolism they experience chest pain and shortness of breath that begin suddenly

Diagnosis of vascular thromboembolism include combination of signs and symptoms together with laboratory investigations that include routine lab investigations, D-dimer , protein s , protein C and antithrombin lll also imaging studies as Doppler US , MSCT with angiography and MRV

Vascular thrombosis mainly treated with anticoagulant therapy with subcutaneous injection of low molecular weight heparin These medications prevent the clot from growing and decrease the risk of its breaking apart and causing further complications Other treatments may include wearing compression stockings and applying warm packs to improve blood flow and pain caused by the clot

Eligibility Criteria:
Inclusion Criteria :

* Age : From 1day to 18 years.
* Sex : Both genders.
* Confirmed diagnosed cases, either Symptomatic or asymptomatic venous and arterial thromboembolism established by an imaging study.
* All patients admitted to the different units of children hospital including surgical unit.

Exclusion Criteria :

* Age more than 18 years.
* Patient Known to have Sickle cell disease.
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity

This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.
* Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent

Exclusion Criteria:

* Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
* Any prior obesity surgery or currently present gastrointestinal implant.
* Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
* Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
* Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Calcitonin above or equal to 50 ng/L
* History of pancreatitis (acute or chronic)
Effects of Individualized iTBS on Upper Limb Function After Stroke

The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass:

Enhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS.

Long-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration.

Neural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function.

Post-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations.

The research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.

This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.

Participants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. aging from 18-80
2. diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months
3. upper extremity impairment
4. with mini-mental state examination\>15
5. agree to participate in this study and sigh the informed consent

Exclusion Criteria:

1. with stroke history
2. have metal device within the body
3. with history of upper extremity trauma,fracture, and/or burn
4. serious conditions and can not finish the examination and treatment
The Effect of Low-Level Laser Stimulation on Hearing Thresholds

The purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. The treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. The laser beams are cool to the touch, and do not cause discomfort. Each laser treatment will last approximately 4 minutes. Three treatments will be applied three times within the course of one week. Hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. Results will be analyzed to determine the effect of the laser treatment on hearing.

Low-level laser therapy has been practiced for about 20 years in Europe and is beginning to be practiced in the US. Theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. The effects of low-level laser therapy on hearing have not been well studied. It has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. Studies of low-level laser stimulation of cochleae utilizing microscopy, PET imaging, and MRI suggest potential therapeutic benefit to hearing. While preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.

Eligibility Criteria:
Inclusion Criteria:

* bilateral sensorineural hearing loss
* normal middle ear status

Exclusion Criteria:

* pregnant or lactating
* serious mental health illness or medical/psychiatric hospitalization
* treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
* taking Aspirin, Ibuprofen, Naprosyn, Aleve
* taking any Quinine-related drugs
* taking any loop diuretics
* have a developmental disability or cognitive impairment
* history of drug abuse
* involved in litigation or claim related to hearing loss
* regularly exposed to significant occupational or recreational noise
* have a photosensitivity disorder
* have a retinal disease
EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem

Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway?

Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC
* Participants willing and able to give informed consent for participation in the study.

Clinicians:

* Staff at participating sites involved in the diagnostic pathway for people with suspected HNC.

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria.
Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \>2500m on pulmonary arterial pressure (PAP) assessed at 3200 m.

Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \>30 mmHg will be recruited for this project. Highlanders permanently living at HA \>2500 m will have echocardiografy to assess PAP near their living altitude in Aksay at 3200 m with and without 10L/min supplemental oxygen therapy (SOT) via face mask.

Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription

This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.

The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.

Eligibility Criteria:
Inclusion Criteria:

* Any major ambulatory surgery patient with general anesthesia.

Exclusion Criteria:

* Pregnancy.
* Minor patient.
* ASA score \> 3.
* lack of general anesthesia.
* General anesthesia combined with locoregional anesthesia.
* Contraindication to ambulatory surgery.
* Chronic pain.
* chronic analgesic consumption.
* no indication of non steroidal anti-inflammatory drug, paracetamol with codeine and morphine.
* Active or old drug addiction.
* Cognitive disorders or dementia.
* Serious psychiatric disorders.
* Patient under curatorship or tutorship.
* No social protection
* Misunderstanding of the French language
* Patient participating in another trial
Shanghai Diabetic Eye Study in Diabetics

The purpose of the Shanghai Diabetic Eye Study (SDES) was to guide and regulate eye health screening of two hundred thousand people with diabetes in the communities in 16 districts in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to form a "screening, finding, referral, follow-up and health management" diabetic eye disease working mode, integrate medical care and precaution closely, promote the classified management and referral, reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance. At the same time, we will also improve the device configuration of eye health screening and relevant personnel training mechanism in the community health service centers, thus upgrading the level of eye disease prevention and treatment in Shanghai.

Community-based cross-sectional samples of the archives management of adults with diabetes aged 35 years and above in 241 community health service centers (CHSC) in 16 districts in Shanghai, were obtained through proportional sampling (32%). Field screening, remote diagnosis, comprehensive assessment, referral, and eye health management of diabetics were the main study processes. Field screening mainly included visual acuity assessment, autorefraction examination, and non-mydriatic fundus photography. The designated medical institutions (DMI) of each district are responsible for the remote diagnosis and comprehensive assessment of diabetic eye diseases, especially diabetic retinopathy (DR), based on comprehensive evaluation of eye and general condition through the remote reading system (RRS) and Shanghai eye health information service system (SEHISS). The staff of CHSC urged the referral objects promptly for further diagnosis and treatment in DMI. According to the diagnosis after clinically confirmed, all the study participants will be recommended appropriate eye health management

Eligibility Criteria:
Inclusion Criteria:

* The target population included the adults with diabetes aged 35 years and above under archives management, residing in Shanghai.

Exclusion Criteria:

* \<35 years old;
* Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.
Sacubitril/Valsartan in Resistant Hypertension

The present study aims to evaluate the antihypertensive effect of sacubitril/valsartan in patients with resistant hypertension compared to the use of recommended and optimized antihypertensive therapy, through a randomized clinical trial, over 12 weeks.

Worldwide, millions of people are affected by the arterial hypertension system (SAH), so that the presence of resistant hypertension (RH) significantly influences a high cardiovascular morbidity and mortality compared to those with controlled SAH, thus corroborating the need for the development of agents antihypertensive drugs with favorable efficacy and safety profiles. It is known that they are currently using the combined therapy recommended for this group of patients, among them, a significant portion of individuals with RH are unable to achieve the goal of BP control (\>140/90 mmHg) even though in regular use, being subject to the greatest risk of cardiovascular outcomes and morbidity and mortality. Approved by the FDA for use in heart failure with reduced ejection fraction with beneficial effects on morbidity and mortality, identified in previous studies, the sacubitril/valsartan molecule (LCZ696) or Entresto® is a molecular complex composed of the sacubitril prodrug activated after ingestion in sacubitrilate - neprilysin inhibitor - associated with valsartan, an angiotensin II type-1 (AT1) receptor antagonist, with vasodilating action, capable of reducing BP, sympathetic tone, with antifibrotic and anti-hypertrophic effects, in addition to natriuresis and diuresis. Considering the knowledge gap to the benefits to LCZ696 in the control of blood pressure in resistant hypertension, the objective of the present study is to evaluate the efficacy (reduction of ambulatory systolic and diastolic blood pressure) and safety (adverse events, hospitalization and cardiovascular death) of the use of sacubitril/valsartan in comparison to the antihypertensive therapy recommended and optimized by the current guidelines, in patients diagnosed with RH, over12 weeks, through a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, over 18;
* Diagnosed with resistant hypertension (using three or more antihypertensive agents of different classes - eg. angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, calcium channel blockers, loop and thiazide diuretics or potassium-sparing diuretics), at least 4 weeks before recruitment, with a BP that remains above the goal of 140/90 mmHg.

Exclusion Criteria:

* Secondary and treatable hypertension;
* History of angioedema; significant cerebrovascular disease;
* Active liver disease (alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of the normal range and)
* Kidney dialysis or kidney transplantation or serum creatinine\> 1.5 times the upper limit of the normal range or CrCl \<30 mL/min;
* Previous or current diagnosis of heart failure;
* Malignancy;
* Any significant laboratory abnormalities such as serum potassium \> 5.5 mmol/L.
Use of Graft Tensioner Device in ACL (Knee) Repair

Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.


Eligibility Criteria:
Inclusion Criteria:

Torn ACL amenable to surgery

Exclusion Criteria:
Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity.

Data were analyzed with the generalized linear mixed-effects models.

Primary endpoint was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded as secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

* aged between 18 and 65 years old.
* Absence of pregnancy
* Belonging to a Health Insurance Coverage by the French Social Security Program or equivalent, proved by a European Health Insurance Card (EHIC).
* Medically fit to fly after a JAR FCL3 - Class 2 examination

Exclusion Criteria before the flight

* positive pregnancy test on flight day
* anxiety
* non-participation in flight safety briefing

Exclusion Criteria during the flight

* failure to follow safety guidelines
* occurence of motion sickness during the procedure
Paracétamol PMB by Sublingual et Buccal Routes

Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal.

The per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.

Crossover study, double-blind, randomized, controlled versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* Aged over 18 years and not more than 50 years.
* Males or female
* Values of vital signs before administration of the test products:
* PAS between 100-140 mm Hg
* PAD between 50-90 mm Hg
* Radial pulse between 45-90 beats per minute
* Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories

Exclusion Criteria:

* Contraindications to the administration of paracetamol
* Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
* Pathology evolutionary time of the review for inclusion.
* Binge drinking, smoking (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
* Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing.
* Topic having all breaches of the oral mucosa (aphtes. ..).