cyrilzakka/clinical-trials huggingface dataset:
The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery

The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.

Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Scheduled for primary unilateral hip arthroplasty
* Able to give consent

Exclusion Criteria:

* Allergy towards adrenaline
* Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
* Current treatment with tricyclic antidepressants
* Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
* Acute coronary syndrome / myocardial infarction within the previous 6 months.
* not willing to accept blood transfusion
* Participation in other clinical trial within previous 30 days
* Women of childbearing age (without menopause for at least 12 months)
* Glaucoma
* Pheochromocytoma
* Low serum K+ (\< 3.0 mmol/L)
* Thyrotoxicosis
* Digoxin intoxication
* Alcohol og drug abuse (investigators judgement)
RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.


Eligibility Criteria:
Inclusion criteria

1. Age between 18 to 75 years old.
2. Ocular adnexal MALT lymphoma with a comprehensive diagnosis based on pathology, clinical manifestations, and biological characteristics according to the WHO classification of tumors of hematopoietic and lymphoid tissues.
3. Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma without involvement of intraconal compartment are included.
4. Willing to participate the trial and sign the informed consent form.

Exclusion criteria

1. Based on the TNM staging of ocular adnexal lymphoma (Table 1), patients staged as T2/T3 with involvement of intraconal compartment and patients staged as T4.
2. Patients who have previously received local or systemic radiation, chemotherapy, or drug treatment specifically for ocular adnexal MALT lymphoma.
3. Presence of cataract and is anticipated to require surgical treatment within a certain period after enrollment; existing cataract affects visual field testing and fundoscopic examination; vision affected by cataract is \<20/40.
4. In addition to the need for treatment of ocular adnexal MALT lymphoma, there is a requirement for other ocular procedures (e.g., full-thickness corneal transplant or retinal surgery) or an anticipated need for another emergent ocular surgery.
5. Complicated with other ocular diseases: including corneal abnormalities or existing corneal infections, iridocorneal endothelial syndrome, anterior segment dysgenesis, true microphthalmos, uveitis, glaucoma, ocular trauma, and retinal disorders such as central retinal vein occlusion, central retinal artery occlusion, retinal detachment, etc.
6. The statue of HBV or HIV infection.
7. Need for long-term use of local or systemic steroids.
8. Patients already enrolled in other drug clinical trials.
9. Pregnant or breastfeeding women.
10. Serious systemic diseases: advanced cardiac disease, kidney disease, respiratory disease, or other malignant tumors, etc.
11. Inability to understand the research content.

If both eyes of a patient meet the inclusion criteria, the right eye will be selected for participation in the study, while the left eye will receive the same treatment, but its data will not be included in this research. Each patient can have only one eye participating in the study. If both eyes of a patient meet the inclusion criteria and the patient is randomized to the ISRT group, the eye with the larger lesion or with more symptomatic disease is treated first, and in the case of well tolerability, the other eye is irradiated.
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity.

In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage heart disease, listed for heart transplantation
* already received standard treatment based on patient condition
* are receiving guideline recommended pharmacologic therapy
* able to follow protocol procedures
* assigned the informed consent
* do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).

Exclusion Criteria:

* UNOS 1a or 1b patients
* already receive NMES at femoris area in last 6 weeks before admission
* Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
* Cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent
* End Stage Renal Disease
* Uncontrolled arrhythmia's or 3rd degree AV heart block
* Those with wounds over area of proper placement of electrodes
Post-Operative Myocardial Incident & Atrial Fibrillation

To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation

Exclusion Criteria:

* pregnant woman
* urgent surgery or intervention
* not able to consent to the protocol
Analysis of a Short Assessment of Post Intensive Care Syndrome (PICS)

To present a proposal for a set of outcome measurement instruments (OMIs) of post intensive care syndrome (PICS) in settings of outpatient healthcare service.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years, whose intensive care treatment has already been completed

  * The patients were interviewed in the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as in the pain clinic of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Exclusion Criteria:

Patients with a legal guardian or authorized representative
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?

To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.

Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* Able to understand protocol and agree to 3 visits
* Any type of glaucoma
* Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy accepted
* Naïve: No prior glaucoma treatment (medical or surgical)
* If patient non-compliant, must be off meds 3 months
* Xalatan: At least one month use

Exclusion Criteria:

* Both Groups: Any history of ocular surface disease
* Dry eye syndrome or prior Restasis use
* Prior ocular surgery other than cataract extractions
* Uveitis or other inflammatory disease of the eye or adnexa
* Systemic medications that might influence ocular inflammation
* Any active inflammation or infection
* Pregnancy or intention to become pregnant
* Naïve: Prior use of topical glaucoma medication unless off for 3 months.
* Use of preserved artificial tear preparations in last 30 days and more than one year history of chronic use
* Xalatan: Prior use of Travatan or Travatan Z
Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

This study aims to use convalescent plasma as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19 patients on mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or more.
* Patient with Covid-19 confirmed with nuclear acid testing
* Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19.
* Diagnosed with acute respiratory distress syndrome.
* Informed consent.

Exclusion Criteria:

* No consent.
* Symptoms for a period longer than 20 days.
* Not detectable by acid nuclear testing within 48 hours prior to elegibility.
* Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
* History of severe adverse events or anaphylaxis to plasma components
Correct Tip Position of Central Venous Catheters

Patients, ages between 18-70 years, who require central venous catheter will be enrolled for the study. Central venous catheter will be inserted using patient's height formula by Seldinger technique. Anterioposterior chest radiography will be used to assess the correct tip position. Catheters that are below the carina more than 1 cm, will be pulled back for repositioning. Catheters that are above the carina more than 1 cm, will be changed by another catheter. The investigators aim to evaluate the formula for correct tip positioning for central venous catheters

Central venous catheters are used for fluid infusion, nutrition, blood transfusion, hemodynamic monitorization in both intensive care unit and operating room. The superior vena cava and right atrium (SVC-RA) junction is considered the optimal position for central venous catheter tip. Carina corresponds to the SVC-RA junction on chest radiograph. Catheter tips, 1 cm above and 1 cm below the carina are considered as the correct position. 18-70 years old patients will be enrolled for the study. Central venous catheters will be inserted via internal jugular vein or subclavian vein using patient's height formula by Seldinger technique. Postprocedural (within 6 hours) chest radiograph will be used to evaluate the correct tip position from the Picture Archiving and Communication System. This formula was described by Peres. If the tip of the catheter is below the carina more than 1 cm, it will be pulled back for repositioning. If the tip of the catheter is above the carina more than 1 cm, another catheter will be inserted. The formula is height (cm)/10 for right internal jugular vein, height(cm)/10-2 for right subclavian vein, height(cm)/10+4 for left internal jugular vein and height(cm)/10+2 for left subclavian vein. Number of the correct and incorrect position of central venous catheter tips will be noted.

The investigators aim to evaluate the reliability and efficiency of Peres' formula for the correct tip position.

Eligibility Criteria:
Inclusion Criteria:

* Central venous catheterization of patients, ages between 18 and 70

Exclusion Criteria:

* Patient's refusal
* Pathology of carotid artery
* Anatomical deformity of the neck (scar, mass effect, multiple central venous catheterization)
* Chest deformities (pectus excavatum, pectus carinatum)
Pain After Laparoscopic Cholecystectomy

To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.

PURPOSE

To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Scheduled for ambulatory surgery
3. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
4. Allergy to any of the study medications or anesthetic agents
5. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
6. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
7. Patient or surgeon refusal
Single Ascending Dose Study of CM326 in Healthy Volunteers

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy adult male participant,18 to 65 years of age, inclusive.
* Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
* History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
* Males must abstain from sex or use highly effective methods of birth control.
* Having given written informed consent prior to undertaking any study-related procedure.

Key Exclusion Criteria:

* Positive for HIV, or Hepatitis B, or C.
* Positive result on urine drug screen.
* Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
* With any condition that inappropriate for entry into this study.
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)

It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.

This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.

Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.

Eligibility Criteria:
Inclusion Criteria:

* Children 12-17 years of age
* Physician diagnosed asthma for at least 6 months
* Long term controller medication for at least 4 weeks if any being used
* Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
* EIB diagnosed by a positive exercise challenge at screening
* Forced expiratory volume in 1 second (FEV1) greater than 70% of predicted at screening visit

Exclusion Criteria:

* History of cardiac dysfunction
* Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
* Upper respiratory infection in the last 4 weeks
* Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
* Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
* Pregnancy or lactation
* History of paradoxical bronchospasm with any beta-agonist
* Obesity defined as BMI greater than 30 kg/m2
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

The goal of this clinical trial is to learn if nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. It will also learn about the safety of these nutritional supplements.

Researchers will compare the combination of nutritional supplements and behavioral intervention, to behavioral intervention alone, to see if nutritional supplements work to treat autism.

Participants will receive the combination of nutritional supplements and behavioral interventions or solely behavioral interventions for 3 months. And they will visit the clinic at the beginning of the trial (baseline) and after the 3-month intervention period for examinations.

This is an open-label clinical trial aimed at investigating whether nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. Participants will be randomly assigned to either the experimental group or the control group.

Participants in the experimental group will receive the combination of nutritional supplements, including Vitamin B1, Vitamin B2, folic acid, Mecobalamin, Vitamin D3, Choline, and Coenzyme Q10, along with the behavioral interventions, for a period of three months. Participants in the control group will only undergo behavioral interventions.

during the intervention period, the clinical symptoms, metabolomics of bio-specimens, and potential adverse effects will be closely monitored.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2.5 and 6 years old
* Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition (ADOS-2）
* CARS total score ≥ 30
* Obtaining informed consent from the legal guardian

Exclusion Criteria:

* History of neurological diseases such as epilepsy
* History of congenital diseases such as hearing, visual impairment
* Diagnosed with metabolic disorders such as hypophosphatemic rickets
* Diagnosed with genetic or chromosomal abnormalities
* Brain structural abnormalities detected by MRI which required surgical intervention
* Currently participating in other clinical trials
* Received any new intervention within 8 weeks prior to enrollment
Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects

The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of different dosages of deferiprone in subjects with or without HIV infection.

Three cohorts were enrolled: two of individuals who were asymptomatically infected with HIV and one of healthy volunteers. Dosages were as follows:

* Cohort 1 (asymptomatic HIV infected subjects): 33 mg/kg deferiprone three times daily for a total of 99 mg/kg/day
* Cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day
* Cohort 3 (asymptomatic HIV infected subjects): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years and ≤ 60 years.
* Absolute neutrophil count (ANC) of \>1000/mm3 for African black population and ≥ 1600/mm3 for all other races.
* For Cohort 2: HIV-negative
* For Cohorts 1 and 3: HIV-1 positive; CD4 count of at least 300/mm3; HIV-1 RNA copies (viral load) \>10 000 copies/mL serum; and current physical health stable and not requiring antiretroviral treatment
* For Cohorts 1 and 3: Chest x-ray showing absence of active infectious diseases (such as tuberculosis, viral or atypical bacteria or parasitic infection).

Exclusion Criteria:

* Presence of any severe concomitant disease.
* History of or current, recurrent or recent (4 weeks) febrile disease.
* History of opportunistic infections, neoplasm or AIDS-defining conditions.
* Inability to discontinue any medication from screening onwards, or for at least 2 weeks before the first admission; in particular any antiviral or therapy with immunosuppressive activity.
* Significant liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 2.5 times the upper normal limit.
* Significant kidney impairment: serum creatinine ≥ two times the upper normal limit.
* Any concomitant disorder or resultant therapy likely to have interfered with subject compliance or with study procedures.
* Known hypersensitivity to any of the test materials or related compounds.
* Positive test for Hepatitis B and/or C antibodies.
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
* History of seizures or epilepsy.