cyrilzakka/clinical-trials huggingface dataset:
Quantifying Viral Load in Respiratory Particles That Are Generated by Children and Adults With COVID-19 Infection

The study will be a prospective cohort design to determine if children generate aerosols that harbor a viral load similar to adults. Prior to beginning enrollment, researchers may recruit up to 10 participants (adults or children who meet inclusion criteria for the main study) to perform a small pilot to optimize our cold chain and laboratory procedures.

The study will include children and adults who are confirmed SARS-CoV-2 positive and aim for a total sample size of at least 10 children and 10 adults.

Hypothesis: As children have a high viral load in the nasopharynx, we hypothesize that children generate aerosols that contain SARS-CoV-2 virus.

Aim: To estimate the viral load in aerosols generated from children with COVID-19 infection, and to compare the viral load contained in aerosols from children with aerosols from adults

For children and adults who are admitted to MGH, study staff will perform:

Step 1: A nasal and oral swab will be obtained to establish the nasopharyngeal viral load.

Step 2: Study staff will use the CCI and/or UPAS to collect aerosol samples for viral load. Staff will sample the room aerosol for 30 minutes while the participant does not wear a mask, and then if the participant is interested, staff will sample room aerosol while the participant wears different types of masks. If the participant does not tolerate wearing a surgical mask, or if the providers believe this is contraindicated, researchers will forego this portion of the study procedures. If an accompanying family member chooses to stay in the patient room during testing, they will be provided with an N95 respirator.

Step 3: Staff will ask participants to repeat these steps and provide a sample each day that they are having symptoms of COVID-19. The study may conduct serial sampling, where participants could be asked to provide a sample each day that they are having symptoms of COVID-19 up until discharge, or once symptoms resolve. Once symptoms resolve or the patient is discharged, sampling will be complete.

Eligibility Criteria:
Inclusion criteria:

* SARS-CoV-2 PCR positive in the last fourteen days
* Symptomatic with typical symptoms of COVID-19, including fever, cough, nasal congestion, rhinorrhea, anosmia, ageusia, shortness of breath, chest pain, fatigue, myalgias, or other atypical symptoms with documentation of that symptom OR
* Asymptomatic with laboratory confirmation of cycle threshold value \< 30.

Exclusion criteria:

* Chronic respiratory disease or neuromuscular condition associated with severely reduced lung function defined as FEV1 or FVC \<50% predicted, or requiring chronic supplemental oxygen or respiratory support
* On current respiratory support via supplemental oxygen, non-invasive ventilation, or invasive mechanical ventilation
Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease (CKD).

The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patient that underwent coronary angiography
* T2DM
* CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
* Alprostadil naive, or not on Alprostadil treatment for at least 14 days
* Withdrawal metformin or aminophylline for 48h before angiography

Exclusion Criteria:

* serum Cr. More than 3 mg/dl
* electrolyte and acid-base imbalance
* pulmonary edema
* allergy to Alprostadil
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction

This study is perfored to investigate the efficacy of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for acute postoperative pain after nasal closed reduction surgery.

To investigate the treatment of postoperative pain after nasal closed reduction surgery, we plan to investigate the effect of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for the patinets undergoing nasal closed reduction under general aensthesia, compaing to the control group (normal saline spray and normal saline-soaked nasal packing).

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to receive nasal reduction surgery under general aensthesia

Exclusion Criteria:

* concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Diagnosis of Ulcerative Colitis
* Acute Severe Colitis according to the Truelove and Witt's Criteria
* Steroid refractory according to the Oxford Criteria

Exclusion Criteria:

* Participant unable to consent for themselves
* Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
* Crohn's disease
* Participants with enteric infection confirmed on stool microscopy, culture or toxin
* Haemodynamic instability (mean arterial pressure \<60) and not responsive to fluids
* Participants with clinically significant Cytomegalovirus infection (positive inclusion bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver function tests)
* Participants who are pregnant or currently breast-feeding
* Participants with current malignancy, excluding basal cell carcinoma
* Participants with flat low or high grade colonic dysplasia; sporadic adenomas permitted
* Participants with serious co-morbidities including: Immunodeficiency; Myocardial infarction or acute stroke within the last 3 months; Moderate or severe heart failure (New York Heart Association class III or IV); Active or suspected tuberculosis; Renal failure; Hepatic failure; other severe infections
* Participants with history of hypersensitivity to infliximab or infliximab biosimilar
* Participants who have received other immunosuppressive agents including but not limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins (Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors (Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters (Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents (eg. Ustekinumab) within 6 months of screening
A Study of SHR-1802 in Patients With Advanced Solid Tumor

To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Has a life expectancy≥ 3 months;
4. At least one measurable lesion according to RECIST v1.1;
5. Pathologically confirmed advanced solid tumor;
6. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Have received prior therapy with camrelizumab, and famitinib;
2. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
3. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
4. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
5. Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
6. Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment;
7. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
Effects of Espresso on Platelet Aggregability in Patients with Coronary Artery Disease

Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.

30 patients with coronary artery disease (proven by previous coronary angiography) will be selected at the Heart Institute (InCor USP) for the study. Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, one group will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days and another group will start with decaffeinated coffee followed by caffeinated. All participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). The investigators will evaluate platelet aggregation by Multiplate® (ASPI, ADP and arachidonic acid) and by optical aggregometry (ADP and arachidonic acid).

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 80 years;
* Coronary artery disease documented by coronary angiography;
* Use of aspirin 100mg.

Exclusion Criteria:

* Serum creatinine dosage \> 2.5 mg/dl;
* Hemoglobin \<12 g/% for men and \<11 g/% for women;
* Platelets \<100,000 or \>400,000/mm3;
* Leukocytosis \>12,000/mm3;
* Fasting glycemia \>126mg/dl;
* Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) with values above the upper limits of normality;
* Consumption of more than 30 grams of alcohol per day;
* Active smoking or ex-smoking for less than 2 years;
* Use of P2Y12 inhibitor;
* Ventricular dysfunction (left ventricular ejection fraction \<45%).
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA

This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using ViTAA (The Sponsor) aortic mapping technology.

This a prospective, multi-center, registry of patients that are being assessed with the ViTAA software. Patients will be enrolled at selected North American centers in the US and Canada. The Registry will enroll patients from the following two populations:

* patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair (EVAR);
* patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is aged 18 years or over
2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
3. Patient meets on-IFU criteria for endovascular reconstruction

Exclusion Criteria:

1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
3. Patients with previous aortic reconstruction in the involved segment.
4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
5. Patient has a sensitivity to contrast imaging agents.
6. Patient has aortic dissection.
7. Patient has atrial fibrillation.
8. Patient has arrhythmia.
Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.

The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.


Eligibility Criteria:
Inclusion Criteria:

Night VOC Group:

* night VOC ≥ 2 in the previous year
* written informed consent

Daytime VOC Group:

* VOC no nocturnal
* diurnal VOC ≥ 2 in the previous year
* written informed consent

Slightly symptomatic group:

* no hospitalization for VOC
* written informed consent

Exclusion Criteria:

* Taking opioids
* Taking medication that alters sleep (antidepressants, benzodiazepines ...)
* Known history of sleep apnea syndrome
* Known history of serious psychiatric disorder
* Recent vaso-occlusive crisis (within 3 weeks)
* Changes in background treatment (Hydrea or exchange transfusions) in the past 12 months
* Inactive affiliation to social security
* Under legal protection
* A female who is pregnant or breastfeeding
* Prisoners
* Emergency situation
* Refusing to participate in the study
Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome

This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS). The study aims to determine whether moderate-intensity statins can provide comparable benefits to high-intensity statins, particularly for patients at higher risk of adverse effects from higher doses. The findings may inform treatment decisions and reduce financial and clinical burdens on patients.

Statins are the cornerstone of therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. Current guidelines recommend high-intensity statins for patients with ACS to lower LDL-C levels by 50% or more. However, emerging evidence suggests that the benefits of lowering LDL-C may be independent of the statin dose and type.

This randomized controlled trial investigates the effectiveness of moderate-intensity statins compared to high-intensity statins in reducing LDL-C levels among local populations. The study also explores whether moderate-intensity statins can mitigate adverse effects, such as myopathy or liver dysfunction, commonly associated with high-intensity statin therapy, particularly in populations with lower baseline LDL-C levels and high statin responsiveness.

Participants will be randomly assigned to receive either high-intensity or moderate-intensity statin therapy. The primary outcome measure is the percentage of participants achieving an LDL-C reduction of ≥50% after three months of treatment. Secondary outcomes include the frequency of adverse effects, adherence to therapy, and changes in liver function tests (LFTs) and creatine phosphokinase (CPK) levels.

The study will contribute to understanding the role of moderate-intensity statins in managing LDL-C levels and guide future clinical practices for patient subgroups at risk of adverse effects from high-intensity therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 25 and 85 years.
* Both males and females.
* Diagnosed with acute coronary syndrome as defined in the operational definitions.

Exclusion Criteria:

* History of adverse reactions to statins (e.g., hypersensitivity, myopathy, acute renal failure).
* Current acute liver disease.
* Pregnant or breastfeeding women.
* Participants already on statin therapy
Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy

The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation.

Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough.

Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials.

There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition.

The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound.

The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used .

In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.


Eligibility Criteria:
Inclusion Criteria:

* Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision .

Exclusion Criteria:

* Patients who had previous laparotomy.
* patients who underwent laparotomy through incisions other than midline incisions.
Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus

Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients


Eligibility Criteria:
Inclusion Criteria:

* All patients must be diagnosed as having mild to moderate Hallux valgus (with Hallux valgus angle between 15-40 degrees)
* patients aging between 18-60 .
* patients must report pain and limited function .
* patients must report that they are not undergoing physiotherapy , not using orthosis , dynamic splinting exercises for Hallux valgus

Exclusion Criteria:

* Patients diagnosed with systematic diseases such as rheumatoid arthritis .
* Cognitive or mental illness.
* Hallux rigidus or limitus .
* History of surgery to foot of Hallux .
* Previous use of foot orthosis .
Efficacy of Amantadine Treatment in COVID-19 Patients

Demonstration of the efficacy of amantadine over placebo in the population of patients with moderate or severe COVID-19 in the initial stage of the disease treated in the hospital

Use of high-doses of amantadine in hospitalized patients in the early phase of moderate or severe COVID-19, compared to placebo, will shorten the duration of the disease and reduce the risk of death and treatment with invasive mechanical ventilation in Intensive Care Units (ICU).

Eligibility Criteria:
Inclusion Criteria:

1. Age of respondents - 18 years and older.
2. Confirmation of SARS-CoV-2 infection by PCR
3. Hospitalized patient with COVID-19, defined according to the following criteria (all of the following criteria must be present):

   1. radiological (X-ray of klp or TK klp) features of pneumonia,
   2. blood saturation (SaO2) measured at rest in the absence of oxygen \<95%,
   3. it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive).
4. Time up to 10 days from the onset of COVID-19 symptoms. The onset of COVID-19 symptoms is the first day on which the first symptom typical for SARS-CoV-2 or COVID-19 infection (in the opinion of the attending physician at the center) occurred, such as: fever, cough, shortness of breath, changes in taste or smell , muscle pain, chest pain, diarrhea, nausea, vomiting, sore throat, nasal congestion.

Exclusion Criteria:

1. Pregnancy or lactation
2. Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular:

   a) comorbidities: i) clinically significant hepatic or renal insufficiency; ii) epilepsy or seizures (current or history of); iii) psychiatric or somatic diseases (present or in a history of agitation or confusion, delirium syndromes or exogenous psychoses); iv) cardiovascular diseases such as: severe congestive heart failure, cardiomyopathy, myocarditis, grade II-IV AV block, bradycardia, QT prolongation, perceived U waves or family history of congenital long QT syndrome, severe ventricular arrhythmias a history of heart (including torsade de pointes); v) diseases or conditions that significantly reduce the immunity of a patient (e.g. solid organ transplant, bone marrow transplantation (BMT), AIDS, immune biologics and / or high-dose steroids (\> 20 mg prednisone daily).

   b) hypersensitivity to any component of the preparation, c) parallel use of drugs that prolong the QT interval, d) hypokalemia or hypomagnesaemia, e) untreated angle-closure glaucoma, f) use of amantadine currently or in the last 3 months prior to study inclusion; g) participation in another clinical program