cyrilzakka/clinical-trials huggingface dataset:
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.


Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in the trial must meet all of the following criteria.

* Confirmed COVID-19 pneumonia
* Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
* Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count \<1,000/uL
* Age ≥ 18 years
* Completed informed consent

Exclusion Criteria:

Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:

* Known allergy or hypersensitivity to sirolimus
* Inability or refusal to provide informed consent
* Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
* Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
* Pregnant women
* Breast feeding
* On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
* Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):

  * History of liver cirrhosis
  * End stage renal disease or need for renal replacement therapy
  * Decompensated heart failure
  * Known active tuberculosis or history of incompletely treated tuberculosis
  * Uncontrolled systemic bacterial or fungal infections
  * Active viral infection other than COVID-19
The Management of RT-induced Hyposalivation Using LLLT

The primary purpose is to evaluate the effectiveness of photobiomodulation laser application in the management of patients with radiotherapy-induced hyposalivation. Secondary, to assess the changes in the scores of the patient's oral health-related quality of life using validated measurements.

Head and neck cancer is a general term used to describe epithelial malignancies in the oral cavity, paranasal sinuses, nasal cavity, pharynx, and larynx. These malignancies are often presented as squamous cell carcinoma (SCC) of the head and neck with tobacco and alcohol consumption remaining the two main risk factors. In addition, human papillomavirus has been identified as another risk factor in a limited subset of these malignancies. More specifically, oral cancer accounts for 2%-4% of all cancer worldwide with 90% of these cases presented as SSC worldwide compared to 44.8% in Saudi Arabia. Clinically, patients often presented with white and/or red patches, hoarseness, non-healed ulcers, throat pain, and painless cervical lump which may persist for more than 3 weeks period.

Most head \& neck cancer patients who received radiotherapy are likely to experience xerostomia and salivary glands hypofunction, mucositis, and possibly the loss of taste.

Furthermore, the effect of hyposalivation is not only limited to taste dysfunction but also associated with opportunistic infections, difficulty in chewing and speaking, rapid progression of caries, and oral mucositis. All these secondary complications are usually associated with pain and discomfort which will heavily affect the patient quality of life if they are untreated. Treatment options include moisturizing agents or artificial saliva which have a palliative effect however they are not preferred nor accepted by most patients.

The outcome of low-level laser therapy usage on cancer patients is well documented and well established in the literature. The vast majority of the results suggest that this therapy is an effective treatment option to stimulate salivary glands flow and decrease xerostomia/hyposalivation symptoms. In the present study, the efficiency of this treatment option will be tested as well as the changes in the patient's quality of life during and after the radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and above
* Clinically diagnosed with hyposalivation \[an unstimulated salivary flow rate of ≤ 0.1ml per minute\] (31) due to recent radiation therapy of SCC of the head and neck.

Exclusion Criteria:

* Individuals with systemic diseases that could affect the salivary glands function such as (e.g. Sjogren syndrome) and medications (e.g. beta-blockers and diuretics for hypertension).
* Individuals who had an allergy to toluidine blue stain.
Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France

Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries were eligible to complete a confidential questionnaire about geophagy, which was defined as eating soil or clay. Descriptive analysis was performed.

Eligibility Criteria:
inclusion criteria : All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries
Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.

Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.

Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).

This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.

This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial.

Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.

The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients.

If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.

Eligibility Criteria:
Inclusion Criteria:

* out-of-hospital cardiac arrest
* non-traumatic cardiac arrest
* less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support
* advanced cardiac life support is established and can be continued

Exclusion Criteria:

* traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches
* accidental hypothermia with temperature \< 32 0C
* suspected cerebral hemorrhage as etiology of the arrest
* suspected non-traumatic hemorrhage as etiology of the arrest
* pregnancy, obvious or suspected
* patient included to the study site's E-CPR protocol
* other factors as decided by the treatment team (environmental factors, safety factors and others)
Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients

To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.

To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients

Exclusion Criteria:

* ICU patients who could not receiving enteral nutrition
HIV-1 and Brain Interaction on Smoking Comorbidity

People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand these pathways using translational brain imaging and HIV-1 reactivation studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects in HIV-1 infection from cellular to brain circuitry levels.

Smoking remains the leading cause of preventable morbidity and mortality in the United States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. The study will directly address neurological complication of this HIV-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between ages 18-60 in good health
2. Ability to give written informed consent
3. For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more
4. For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation

Exclusion Criteria:

1. Inability to sign informed consent
2. Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
3. Any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history
4. Current substance-induced psychiatric disorders
5. Significant alcohol or other drug use, other than nicotine dependence or marijuana use
6. Gross structural abnormalities and/or have a history of syncope
7. Positive urine pregnancy tests
8. Any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor,
9. For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and other opportunistic disease
10. For people living with HIV: on active treatment of hepatitis C virus (HCV)
Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain.

The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing heart surgery on cardiopulmonary bypass
2. Patients aged 18 years to 80 years

Exclusion Criteria:

1. Inability to give informed consent
2. Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) \<60 mmHg or FEV1\<50% predicted)
3. Prior receipt of chemotherapy or radiation therapy or immunotherapy
4. left ventricular ejection fraction less than 30%
5. preoperative use of inotropics or mechanical assist device
6. Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio)
7. Patients with known renal failure with a GFR\<30 mL/min/1.73 m2
8. recent myocardial infarction (within 7 days)
9. Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature\>38℃)
10. Significant peripheral arterial disease affecting the upper limbs
11. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.


Eligibility Criteria:
Inclusion Criteria:

* All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria:

* Other protocol-defined inclusion / exclusion criteria may apply
Amlodipine 10mg Drug Use Investigation

In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.

All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
* The subjects who had not achieved target BP

Exclusion Criteria:

* Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)

Study Objectives:

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.

1. Primary Endpoint

   The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.
2. Secondary Endpoints

   * Time to resuming normal activities
   * Presence/absence of chronic pain at 3 and 6 months, measured by BPI
   * 30, 90, 180 day opiate use (Y/N)
   * MDASI on post-operative days 7, 30, 90, 180
   * Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180
   * Daily pain score during hospitalization
   * Length of hospital stay
   * Need for opioids at discharge
   * Whether medication is stopped prior to day 25, and if so when and for what reason.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
* Must have device with email capabilities for follow up survey

Exclusion Criteria:

* Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
* Renal impairment requiring dialysis
* Allergy to Gabapentin
Non Invasive Diagnostic of Endometrial Receptivity

The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors undergoing controlled ovarian stimulation
* Regular menstrual cycles
* no abnormal karyotype
* generally healthy
* BMI 19-29 Kg/m2 (both inclusive)
* 18 to 35 years old.

Exclusion criteria:

-patients diagnosed with endometriosis and/or endometritis.
Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes

This study is conducted in Europe. The aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the Slovak Republic.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics

In more than one-in-five cases of out-of-hospital cardiac arrest, airways are blocked by vomit and blood. Sometimes, paramedics cannot clear the airway using methods they have been taught. If the airway cannot be cleared, the patient will die.

Usually, these patients will have a breathing tube placed into their windpipe (intubation), as this provides protection from vomit and blood. To do this, the paramedic needs to be able to see the entrance to the windpipe.

A new method of clearing the airway called SALAD has been used in patients to help insert a breathing tube, but it is not known whether the method can help paramedics. This study will use a manikin to see if paramedics can insert a breathing tube more often on their first attempt, using SALAD.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* HCPC registered paramedic employed by Yorkshire Ambulance Service
* Authorised to intubate within Yorkshire Ambulance Service
* No SALAD training in the last 3 months

Exclusion Criteria:

* Not an HCPC registered paramedic employed by Yorkshire Ambulance Service
* Not authorised to intubate within Yorkshire Ambulance Service
* Allergy to artificial 'vomit' ingredients
* Unwilling to provide consent
* SALAD training in the last 3 months
Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis

The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841

Eligibility Criteria:
Inclusion Criteria:

* infants less than 24 months of age with first episode of wheezing.

Exclusion Criteria:

* age\>24 months,
* previous episode of wheezing,
* chronic cardiac and pulmonary disease,
* immunodeficiency,
* accompanying respiratory failure,
* requiring mechanical ventilation,
* inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
* premature infants born at less than 34 weeks gestation.