cyrilzakka/clinical-trials huggingface dataset:
IgM-enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis

The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic and aggregometric measurements of patients with severe sepsis.

Before the change of the standard operating procedure (SOP) with the implementation of the application of IgM-enriched immunoglobulins to patients with severe sepsis and septic shock conventional inflammatory and coagulation parameters, viscoelastic and aggregometric measurements as well as the endotoxin activity was measured in 15 patients. After the change of SOP the same parameters were recorded for additional 15 patients.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* proven or suspected severe sepsis or septic shock
* written consent of the patient or a legal person in charge

Exclusion Criteria:

* Pregnancy
* anticoagulation other than heparin
* Inherited coagulopathy or thrombophilia
Clinical Evaluation of the PowerGlide™ Pro Midline Catheter

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases. The selected patients are in need of a long-term i.v. therapy for reasons as antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.

Eligibility Criteria:
Inclusion Criteria:

* need for i.v. therapy longer than 7 days
* poor peripheral vein status
* Administration of alprostadil

Exclusion Criteria:

* pending dialysis
* allergy to catheter material
* minor age
* life threatening conditions
* requirement for central venous catheter
Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.

The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.

After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).

Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Female, over 18 years of age;
2. Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
3. pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
4. ECOG≤ 2;
5. Expected survival time ≥3 months;
6. The subjects were able to understand the study process and voluntarily joined the study.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with severe or uncontrolled infections;
3. Patients who are allergic or intolerant to the investigational drug;
4. Patients who are enrolled in or within a month of another clinical trial.
Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).

Patients that arrive to the sonographic unit of the gynecological department with a diagnosis of ovarian mass will have a sonographic examination that include: Trans-vaginal +- trans-abdominal ultrasound with Doppler and three dimensional sonographic exam. anamnestic data will be collected and serum test for CA 125, HE4 and CEA. The management of the specific patient will be according to the department protocol, regardless the study data. The investigators will collect data about operation outcome and histological results of women that will be operated. Women that won't be operated on will be followed up every 6 months by the study team.

At the end of the study a statistical analysis will be made to create a sensitive and specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

* Pregnant women
* Known gynecologic malignancy
EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19

The goal of this clinical trial is to test the effect of Rehacom on depression and Quality of life in post covid -19 patients. The main question it aims to answer is:

• Is a cognitive rehabilitation therapy will improve depression and quality of life in patients with post COVID-19? Researchers will compare Rehacom with exercise therapy to see if rehacom can improve depression and quality of life in patients with post COVID-19 neuropsychological problems.

Purpose of the study:

* To investigate the effect of cognitive rehabilitation therapy on depression in post COVID-19 patients.
* To investigate the effect of cognitive rehabilitation therapy on quality of life in post COVID-19 patients.

Significance of the study:

•There is growing evidence that individuals with COVID-19 disease can develop a range of neurological complications including cognitive and neuropsychiatric symptoms . Cognitive rehabilitation essential in improving quality of life with Introduction of new neuropsychological rehabilitation tools based on the latest developments in computer sciences.

This study aims to investigate the RehaCom as a cognitive rehabilitation program on depression and quality of life in patients suffer from post COVID-19 neuropsychological problems.

Eligibility Criteria:
Inclusion Criteria:

* All patients will be selected according to following criteria:

  1. Patients from both genders (male and female).
  2. The age of participants ranged from 30 to 45 years .
  3. The patients had score more than 24 according to Mini mental state examination (MMSE).
  4. Patient muscle power not less than grade 3 .
  5. Patients are ambulant.
  6. Patients with confirmation of previous covid19 infection PCR TEST.
  7. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic.
  8. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes.
  9. Patients are "long-haulers" those who history of probable or confirmed SARS-CoV-2 infection; usually within three months from the onset of COVID-19, and last more than two months

Exclusion Criteria:

* The patients will be excluded if they have any of the following:

  1. Patient previously diagnosed with depression and currently taking medication.
  2. patient had prior cognitive impairment.
  3. Illiterate patients.
  4. patient had experienced another major stressful event (e.g., divorce, bereavement) in the past year.
  5. Checking comorbidities (sum of hypertension, diabetes, arrhythmia, myocardial infarction, Chronic Obstructive Pulmonary Disease/Asthma.
  6. Mild cognitive impairment, dementia, other neurodegenerative diseases, stroke, depression,
  7. Osteoarthritis , low back pain and prevalence of polypharmacy (5 or more drugs) at admission.
Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke

This study protocol aims to prevent the need for renal replacement therapy in patients with rhabdomyolysis secondary to heatstroke. It is based on previous studies showing that bicarbonate infusion reduces renal failure in similar contexts. The intervention will be conducted at the General Hospital of Mexicali during the summer, targeting the prevention of renal failure and reducing the necessity for renal replacement therapy.

The present study protocol explores the possibility of preventing the need for renal replacement therapy in patients who develop rhabdomyolysis secondary to heatstroke. This is based on previous studies that have used bicarbonate infusion in the context of rhabdomyolysis secondary to compartment syndrome, finding a lower incidence of renal failure. Due to the aforementioned, we propose to carry out a similar intervention at the General Hospital of Mexicali, where there is a significant incidence of heatstroke during the summer months. The aim is to determine whether this intervention is useful in preventing the development of renal failure and the requirement for renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the General Hospital of Mexicali with the diagnosis of heat stroke.
* Meeting the operational definition (exposure to heat, body temperature at admission greater than 40 degrees Celsius).
* CPK level greater than 1000 U/L.
* Having informed consent from the patient or the legally responsible adult.

Exclusion Criteria:

* Exclusion of the heat stroke diagnosis during their evaluation.
* Lack of serum creatinine levels at the time of admission to the protocol.
GrouP O WholE BlooD : StoragE LeSion ImpacT and InfLammation

"Etablissement Français du Sang" (EFS) prepares labile blood products from blood donations that are separated by type (red blood cells, plasma and platelets).

The "Centre de Transfusion Sanguine des Armées" (CTSA) produces an innovative labile blood product, LTO-WB, corresponding to group O leukocyte-free whole blood.

The objective of the PEDESTAL EFS study is to compare the inflammatory and biological characteristics of blood products prepared by the EFS vs. the labile blood product prepared by the CTSA.

Hemorrhage is one of the main causes of preventable death among soldiers in combat. Currently, the majority of patients receive blood components (red blood cells, platelets, plasma) rather than whole blood. These factors lead doctors deployed on external operations (OPEX) to use plasma, RBCs and platelets. However, platelet concentrates may not be available on missions, as their storage conditions and shelf life are not always compatible with OPEX logistics. The only solutions to this problem is to use group O leucocyte-depleted whole blood without hemolysin (or Low Titer O Whole Blood, LTOWB), which provides the three elements in physiological proportions. However, while studies have shown this product to be effective in stopping bleeding, its inflammatory potential, linked to the presence of platelets, has not yet been investigated. Indeed, in addition to their hemostatic role, platelets are also involved in inflammation.

The main objective of our research project is to deploy in vitro and in vivo tools to compare LTOWB, focusing on its inflammatory component with conventional and well-mastered transfusion products for (1) platelet-related inflammation (LTOWB vs. Buffy coat pooled platelet concentrate or single donor apheresis platelet concentrates), (2) RBC-related inflammation (LTOWB vs. RBC concentrates) and (3) other circulating inflammatory molecules (LTOWB vs. fresh frozen plasma).

The definition of biomarkers is essential to optimize the use of these products, depending on the therapeutic indication. Linking these biomarkers with the effectiveness of transfusions will help to determine the risk/benefit ratio of transfusions that may be required in rural and austere environments, such as OPEX in comparison to civilian transfusion medicine.

Eligibility Criteria:
Inclusion Criteria:

Self-referred donors eligible for blood donation (whole blood and/or platelet/plasma apheresis), meeting the following inclusion criteria:

* Be in good health
* Weigh at least 50 kg
* Must be between 18 and 70 years of age for whole blood donation and between 18 and 65 years of age for plasma/platelet donation by apheresis.

Exclusion Criteria:

Subjects ineligible to donate blood
Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The purpose of this study was to investigate and compare the efficacy of esketamine sedation and fentanyl sedation in pediatric dental patients


Eligibility Criteria:
Inclusion Criteria:

* Age 6-14 years old.

  * Oral out-patient sedative treatment in our hospital.

    * BMI between 18 to 30 kg/m2. ④. ASA: I-II degree. ⑤. Sign the informed consent.

Exclusion Criteria:

* Patients who are allergic to esketamine, opioids, propofol, or have contraindications for these drug use.

  * Patients with mental illness or who are unable to cooperate.

    * Patients who have abnormal reaction to midazolam. ④. Patients who suffer from Apnea. ⑤. Patients who refuse to sign informed consent. ⑥. Patients who participated in other clinical trials within 4 weeks.
The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients

The projects investigate if treatment with isocapnic hyperventilation can eliminate methanol from the body in a similar manner to dialysis. This is achieved by administering the antidote (fomepizole) and let the patient breathe on a isocapnic hyperventilation device while samples of blood, urine and maybe the breath are collected to measure the contents of methanol and its metabolites.

Isocapnic hyperventilation (iHV) The normal physiology breathing is a careful balance between the number of breaths per minute (rate/min) and the depth of each breath (tidal volume, Vt). Together they make up the minute ventilation (MV), where MV= rate x Vt). To maintain stable homeostasis in the organism, the minute ventilation is closely regulated to maintain adequate uptake of oxygen and adequate elimination of the carbon dioxide (CO2) that is produced by the metabolism. Too low minute ventilation leads to a buildup of CO2 and decrease in blood pH (respiratory acidosis), while hyperventilation (too high minute ventilation) leads to an excess loss of CO2 and increase in blood pH (respiratory alkalosis). The same mechanism will also enable the organism to compensate any metabolic disturbances (up to a certain point): A metabolic acidosis will be counteracted by a hyperventilation, whereas a metabolic alkalosis will be counteracted by a hypoventilation, both with the ultimate goal of keeping the acidity (as given by the pH) as closely regulated as possible.

The concept of isocapnic hyperventilation (iHV) allows the person to hyperventilate while keeping the CO2 within normal limits at the same time. The ClearMate (Thornhill Research Inc., Canada) adds CO2 to the inspired air to compensate to the increased loss induced by the increased minute ventilation. This means that hyperventilation can occur, and a wash-out of volatile substances such as methanol will happen without disrupting the important CO2 balance.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, men \& women diagnosed with methanol poisoning
* Serum-methanol ≥ 50 mg/dL (16 mM)
* pH ≥ 7.0, and correctable by bicarbonate infusion
* no (newly developed) visual disturbances

Exclusion Criteria:

* Acidosis requiring haemodialysis (pH \<7.0), or acidosis that is not responding in spite of aggressive buffer (bicarbonate) treatment within maximum 1-2 hours.
* Comatose patients
* Newly developed visual disturbances
* ADH not fully blocked with antidotes, and not responding to additional dosing of fomepizole. Will be identified by a continuous or increasing anion gap (AG) or Base Excess (BE) on the blood gas machine.
Different PEEP Settings of COVID-19 Induced ARDS

This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2\<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.

After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients with mechanical ventilation
* PO2/FIO2\<300mmHg
* ages\>18 years

Exclusion Criteria:

* pneumothorax
* pregnant
* hemodynamics is unstable
Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control.

Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner.

Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed.

At the conclusion of the study, unblinding will occur.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Diagnosed with scleroderma.
* Symptoms of Raynaud's syndrome affecting both hands (not necessarily to equal extents)
* Ability to return/be available for follow-up evaluations
* Able and willing to give informed consent
* Able to speak and read in the English language.

Exclusion Criteria:

* A history of Myasthenia gravis.
* Reported allergy or hypersensitivity to any Botulinum toxin preparation.
* Active infection in either hand.
* Patients who have ever received Botulinum toxin vaccine.
* Pregnant or lactating women.
* Females unable or unwilling to maintain abstinence or use contraception for 28 days following the injections.
* Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomies.
* Current use of any aminoglycoside antibiotic
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).

Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver.

Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .

Eligibility Criteria:
Inclusion Criteria:

* Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.
* History of abnormal LFTs
* Documented history of chronic liver disease
* Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder
* Fatty liver disease
* Subjects 18 years of age or older
* Subject must be able to hold anticoagulants as per institutional standard of care
* Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia.
* Subjects (or the subjects Legally Authorized Representative \[LAR\]) that have agreed to participate in the study and have signed Informed Consent
* Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included.

Exclusion Criteria

* Subjects that are unable to tolerate anesthesia for the procedure
* Subjects 17 or under
* Subjects whose anticoagulants cannot be held
* Subjects who cannot have or refuse EUS guided procedure
* Subjects who are pregnant
* INR \>1.5
* Platelets 50,000 or less
* Subjects requiring control of bleeding on initial upper endoscopy
* Subjects requiring endoscopic mucosal resection
* Subjects with large volume ascites
* Subjects requiring pancreatic biopsies