cyrilzakka/clinical-trials huggingface dataset:
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield, in civilian life, or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought.

Shock is a leading cause of death among American forces in battle, with many trauma victims dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the body's vital organs and tissues. Specifically, hemorrhagic shock results when blood vessels are physically damaged while septic shock results when microbes or microbial products enter the blood stream. Despite advances in medical science, including the development of improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the United States, is treated today largely as he or she would have been treated in 1970.

The overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield (medical corpsmen, combat medics), in civilian life (Emergency Medical System), or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. This might be a Fire Support Specialist (FIST) team in a combat theater or a trauma center in the civilian health care system.

Eligibility Criteria:
Inclusion Criteria:

* Blunt or penetrating trauma patients who meet Truman Medical Center criteria for a trauma activation.
* These patients will typically be in shock and have blunt injuries or penetrating trauma.
* Patients must be alert, awake, oriented, and responsive and be English speaking males or females between the ages 21-65.

Exclusion Criteria:

* traumatic cardiac arrest patients,
* pregnant patients,
* interhospital transfer patients,
* non-English speaking patients,
* patients with suspected or confirmed Human Immunodeficiency Virus (HIV) or AIDs based on clear history,
* prior laboratory tests, or strong clinical suspicion; patients with clinical evidence of impaired mental function;
* patients with continuing hypotension or tachycardia after resuscitation;
* patients with blood alcohol in excess of 80mg/dl;
* signs suggestive of coagulopathy;
* allergy to glutamine;
* liver disease or renal disease.
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease

A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).

The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
2. Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
3. Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
4. Hemoglobin \>7.5 g/dL with or without clinical symptoms;
5. Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
6. Signed and dated informed written consent by the subject or his/her legally authorized representative;

Exclusion Criteria:

1. In the judgment of the investigator the patient is not a good candidate for the study;
2. Blood transfusion with in the last 90 days from date of Screening;
3. Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
4. Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
5. Concurrent or prior treatment within 90 days of Screening with an investigational medication;
6. Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening;
7. Evidence or history of regular alcohol abuse;
8. Screening laboratory result(s) determined to be clinically significant by the investigator;
9. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency;
10. Screening laboratory result or laboratory results performed within one year indicating positivity for hepatitis B surface antigens, hepatitis B core antibodies, or hepatitis C antibodies;
11. Uncontrolled Diabetes Mellitus (Patients with HbA1c \> 9% at screening)
Assessment of POCD After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen

Postoperative cognitive decline (POCD) is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. The robot-assisted radical cystectomy (RARC) is increasingly utilized. In patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can increase the cerebral blood flow, the excessive cerebral perfusion can lead to encephalemia, which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. The goal of the current study is to investigate the combined effect of this position and CO2 pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.

Postoperative cognitive decline (POCD) is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. It is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. It is supposed to be associated with numerous factors such as ages, trauma, inflammation, surgical stress, position, fluid, MBP, artificial pneumoperitoneum , PCO2, FiO2.

The robot-assisted radical cystectomy (RARC) is increasingly utilized. In patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can increase the cerebral blood flow, there were studies showed that the excessive cerebral perfusion can lead to encephalemia, which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. Contemporary, intraoperative fluid restriction, a relatively long time of operation and surgical stress may also contribute to POCD.

The goal of the current study is to investigate the combined effect of this position and CO2 pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Above age of 55
* Will undergo the robot-assisted radical cystectomy
* informed consent, volunteered to participate in this experiment, ASA I - III

Exclusion Criteria:

* Audio and visual impairment, illiteracy
* Existing severe central nervous system disease
* Patients with central nervous system disease or surgery , resulted in severe sequelae
* Alcohol dependence
* Take psychotropic medications
* Preoperative MMSE score was less than 24
Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer.

OBJECTIVES:

* Determine the safety and toxicity of doxorubicin, gemcitabine, and filgrastim (G-CSF) followed by ifosfamide, paclitaxel, cisplatin, and G-CSF in patients with metastatic or locally advanced transitional cell carcinoma of the urothelium.
* Determine the efficacy of this regimen in this patient population.

OUTLINE: This is a dose-escalation study of gemcitabine.

Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 3-11. Treatment repeats every 2 weeks for 5 courses.

After completion of the fifth course, patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and G-CSF SC daily on days 6-17. Treatment repeats every 3-4 weeks for 4 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for phase I and a maximum of 10 patients will be accrued for phase II within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed transitional cell carcinoma of the urothelium
* Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR
* Evaluable disease, defined as T3b or T4a bladder tumors

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 150,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 times normal
* SGOT less than 2 times normal

Renal:

* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease
* No serious cardiac arrhythmias, including first, second, or third degree heart block
* LVEF at least 50%

Other:

* No uncontrolled infection
* No other active malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Fertile patients must use effective barrier contraception before, during, and for 6 months after study and are encouraged to continue for 2 years or longer after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior systemic chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 3 weeks since prior radiotherapy

Surgery:

* See Disease Characteristics
The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks

Bubble tea drinks contain tea and tapioca pearls. Chewing tapioca pearls in bubble tea drinks may increase salivary components. Because of its proteins, inorganic components, and enzymes, saliva plays an important role in the body's defense against bacteria and viruses. This study aims to analyze the effect of chewing the tapioca pearls in bubble tea drinks on salivary C-reactive protein (CRP) and calcium (Ca) levels.

Sixty saliva samples were collected from 15 subjects. The inclusion criterion was 18-25 years of age. The exclusion criteria were receiving medication, using dentures, a history of dry mouth, smoking and systemic disease. In the first week of the experiment, subjects drank bubble tea as the intervention group. In the second week, the same subjects drank tea without pearls as the control group. Each subject drank the bubble tea for 5 minutes per day over 3 days. Saliva samples were collected on the first day before bubble tea consumption (pretest) and on the third day after tea consumption (posttest). Saliva collection was performed in the morning (09:00 a.m.-12:00 p.m.) for 1 minute. Salivary CRP levels were measured using an ELISA kit, and Ca levels were determined using a test kit.

Eligibility Criteria:
Inclusion Criteria:

* good Oral Hygiene Index-Simplified (OHI-S) score

Exclusion Criteria:

* taking medication
* a history of dry mouth
* smoking
* systemic disease
Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position

Anorectal surgeries are of the commonest elective surgeries that are performed worldwide under different types of anaesthesia. The aim of this prospective interventional study was to compare the use of general anaesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

Anorectal surgeries are of the most frequently performed procedures worldwide. These procedures are commonly performed in prone position as it offers sufficient exposure and provides enough surgical space. Choosing the suitable anesthetic technique will help in reducing perioperative complications in patients undergoing surgical procedures in prone position, by taking into consideration changes in cardiovascular and pulmonary physiology, airway management, and proper positioning for the prevention of direct and indirect pressure injuries. The aim of this prospective interventional controlled study was to compare the use of general anesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective anorectal surgery (perianal fistula surgery, haemorrhoidectomy, perianal abscess, pilonidal sinus, anal fissure or evaluation under anaesthesia).
* patients older than 16-years old.
* patients who have ASA score I-III.
* Patients whose BMI is less than 35 kg/m2.

Exclusion Criteria:

* any patient who refused to participate in the study.
* patients with surgeries for anal or rectal tumors.
* any patient with expected surgery's duration more than 90 minutes
* patients with uncontrolled respiratory conditions
* any patient whose preoperative assessment was suggestive of possibility of difficult airway.
Myocardial Infarction With ST-Elevation

Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age eligible for randomization in the MICU
* Infarct within 6 hours from symptoms onset
* Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
* Signed informed consent form

Exclusion Criteria:

* Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
* Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
* Hemorrhagic stroke within 2 years
* Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
* venous aneurysm
* Recent intracranial or intraspinal surgery or trauma (within two months)
* Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month
* Known coagulation anomaly
* Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment
Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.

Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time.


Eligibility Criteria:
Inclusion Criteria:

* Work leave due to a sprain of ankle

Exclusion Criteria:

* (none)
Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin

The investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

In 2002 we adapted the protocol described by Van den Berghe et al. for use in our own surgical intensive care unit (SICU) with a target blood glucose range from 80 to 120mg/dL. After five years of implementation, we were able to achieve a mean BG of 117 mg/dL in the SICU. 2% of glucose values were \<60 mg/dL in the SICU. Given the concern of safety while optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure.

We will investigate whether a computer-based algorithm for the titration of IV insulin will translate to better clinical outcomes and less hypoglycemia. Therefore, we will conduct a prospective randomized trial comparing the Glucommander, a computer-based algorithm with our Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or transplant surgery. This computer based algorithm was invented in 1984 in Atlanta by Dr. Davidson and Dr. Steed who have used it in a variety of applications of IV insulin.

Eligibility Criteria:
Inclusion Criteria:

* s/p open heart or kidney or liver transplant surgery

Exclusion Criteria:

* admission blood glucose less than 120 mg/dl
Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.

In France, the burden of osteoporotic fractures has been studied using cross sectional data from the French hospital national database. The availability of fracture liaison service in the main French cities allows the recruitment of a high number of these targeted patients. A large national multicenter, longitudinal, prospective cohort of patients hospitalized for severe osteoporotic fracture, the CROSS cohort ("Cohorte sur les Risques d'une OStéoporose Sévère"), in order to update data on prognosis (refracture, mortality), epidemiology and of severe osteoporotic fractures.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged above 60 years, living in France and hospitalized for severe fragility fractures in response to low-energy trauma (e.g., a fall from standing height).
* Vertebral fractures have to be confirmed by an X ray examination.
* To be eligible for the study the patient has to be included and interviewed within 12 weeks of the fracture event's diagnosis. Note : patients in guardianship or curatorship can be included in this protocol.
* Informed and free consent given and form signed and dated

Exclusion Criteria:

* Non severe fracture (for example wrist fracture), pathological fractures, high trauma fractures and per prosthetic fractures.
* Non registration with a social security scheme (holder or beneficiary).
Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD

The aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD: FEV1 \< 80 % and FEV1/FVC \< 0.7;
* Able to communicate in English
* Clinically stable

Exclusion Criteria:

* predominant co-morbidities or treatments that might influence the results of exercise testing
Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health.

This study will evaluate the changes in sexual function, reproductive function and mental health of male patients discharged from the hospital with COVID-19, and the impact of SARS-CoV-2 on male reproductive health and mental health compared with healthy people during the same period. In addition, men's semen examination reports before and after the new coronavirus pneumonia event will be collected and compared to assess the impact of the event on the quality of men's semen. Also, This study will test the SARS-CoV-2 nucleic acid of the urogenital system of male patients discharged with COVID-19 to provide evidence for the effect of the new coronavirus on the male reproductive system.

This study will test SARS-CoV-2 nucleic acids in urine, prostate fluid, and semen of participants with COVID-19 at the first follow-up. All participants will be followed up for 1 year. During follow-up, International Index of Erectile Function-5 (IIEF-5), Quality Evaluation Questionnaire (QEQ), symptom list chart-90 (SCL-90) questionnaire evaluation and sexual function related examinations (including nocturnal penile tumescence, color duplex ultrasonography, etc. ) and fertility-related examinations (including sex hormones, semen routine examinations, etc.) will be performed to assess the changes in male sexual function, reproductive function and mental health of male patients discharged with COVID-19, and the impact of SARS-CoV-2 on male reproductive and mental health. In addition, collect male semen examination reports from April to December in 2017-2020 to evaluate the impact of new coronavirus pneumonia incidents on male semen quality.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 18, ≤ 60 years old;
2. Have a fixed sex partner and regular sex life;
3. No previous infectious diseases, chronic diseases, tumor history, and male sexual function and fertility diseases;
4. Normal erectile function, IIEF-5 score\> 21 points;
5. Have complete clinical information and contact information；
6. Understand and sign the informed consent form.

Exclusion Criteria:

1. Hypertension, diabetes, coronary heart disease, hyperlipidemia and other chronic diseases；
2. Past history of endocrine diseases such as hypopituitarism, hypogonadism, abnormal thyroid function, etc;
3. Past history of mumps virus infection;
4. Past history of bladder cancer, prostate cancer, brain spine injury, testicular injury, pelvic fracture, urethral injury and history of surgical treatment;
5. Severe cardiovascular and cerebrovascular diseases, severe lung diseases, severe hepatitis;
6. Past psychological or mental illness;
7. Contact information not available.