cyrilzakka/clinical-trials huggingface dataset:
Digital Capillary Refill for Monitoring of Sepsis

Observational study for monitoring of capillary refill time in sepsis

This is an observational studying assessing changes in capillary refill time over the course of sepsis treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical evidence of a known or suspected infection and orders written for administration of IV antibiotics
2. Hypotension as defined by the need for any vasopressor (and 1 liter of fluid already administered) OR respiratory failure defined by assisted ventilation (includes mechanical ventilation and BIPAP), CPAP, or greater than or equal to 6 liters/minute of supplemental oxygen

Exclusion Criteria:

1. No consent/inability to obtain consent from the participant or a legally authorized representative
2. Diagnosis of cirrhosis by medical chart review
3. Liver transplant recipient
4. AST or ALT greater than five times upper limit of normal
5. Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
6. Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring
7. Hypersensitivity to Acetaminophen or Vitamin C
8. Patient, surrogate or physician not committed to full support (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
9. Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
10. Current active kidney stone
11. Known history of oxalate kidney stones or history of oxalate nephropathy
12. Kidney transplant recipient
13. Use of home oxygen for chronic cardiopulmonary disease
14. Moribund patient not expected to survive 24 hours
15. Underlying malignancy or other condition with estimated life expectancy of less than 1 month
16. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
17. Prisoner
18. Enrollment in another critical care based pharmacologic interventional trial
19. Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.

In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.

The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
* No mutations in the KRAS gene.
* Resistance to 5-FU, oxaliplatin and irinotecan.
* Age ≥18 years.
* PS 0-2.
* Measurable disease according to RECIST criteria.
* Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
* Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
* Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
* Oral and written informed consent.

Exclusion Criteria:

* Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
* Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
* Verified or clinically suspected CNS metastasis.
* Other experimental treatment.
* Serious medical disease according to investigator's judgement.
* Pregnant or breastfeeding women.
* Hypersensitivity to the active substance or to one or more of the auxiliary substances.
* Patients with interstitial pneumonitis or pulmonary fibrosis.
Ultralow Dose PAH Binary Mixture Study

Evaluation of the pharmacokinetics for \[14C\]-benzo\[a\]pyrene (\[14C\]-BaP) and metabolites in plasma and urine over 48 hours following a 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene.

The pharmacokinetics for \[14C\]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over 48 hours following oral doses of 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene. Metabolite profiles and kinetics of elimination are predicted to be consistent with a BaP physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de minimus risk.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-65 (inclusive)
* If female, must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure
* Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
* Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)

Exclusion Criteria:

* Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker
* Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)
* History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)
* Current or history of kidney or liver disease
* Prior high-dose 14C exposure from medical tests. (micro-dose 14C exposure not exclusionary)
* Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)
* Regular use of indole-3-carbinol or DIM dietary supplements
Computed Tomographic Angiography or Conventional Coronary Angiography in Clinical Decision Making

Patients planned for elective conventional coronary angiography will undergo CT coronary angiography (Dual Source CT) in order to assess the correlation of stenosis detection and therapeutic advice between conventional and CT coronary angiography. We hypothesize that their is a good correlation between conventional and CT coronary angiography for stenosis detection and therapeutic advice.


Eligibility Criteria:
Inclusion Criteria:

* Over 50 years of age
* Scheduled for elective coronary angiography

Exclusion Criteria:

* Patients with known iodine allergy
* Severe renal insufficiency (creatinine levels \> 120 micromol/L)
* Hyperthyroidism
* Cardiac arrhythmias
* Unstable clinical condition
* Inability to follow breath-hold commands
* Previous PCI or CABG were excluded.
SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings

The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings.

Noise in the SpO2 signal is most often caused by artifacts, such as movement artifacts, reduced perfusion, additional light and others. These artifacts can be partially removed from the SpO2 signal by different pulse oximeter settings, specifically the sensitivity mode and averaging time. It is known that when a longer averaging time is set, the measured signal contains fewer artifacts, on the other hand there is an increased risk of missing short desaturation. The aim of this work is to characterize the noise in the SpO2 signal depending on the set averaging time of the pulse oximeter based on experimental data from healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers from the Czech Technical University

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension
Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.

A randomised study with an historical control group.

Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).

Only high-volume physicians who have passed a ultrasound course are allowed to include patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible

Exclusion Criteria:

* Abnormal pulse oxymetry test
* If severe lower-extremity calcification is known to exclude femoral access
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics

The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.

The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.

Patients will provide biological samples before and during their treatment, and clinical data will be collected.

The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:

* Response to treatment
* Clinical benefit parameters such as PFS and OS.
* Adverse events to immune check inhibitor therapy
* Biological mechanisms involved in response or resistance to immune check inhibitor therapy.

Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.

Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.

Samples will be analysed as follows -

* Proteomic features (Plasma proteomics)
* Epigenetic patterns (cell free DNA)
* ctDNA mutation analysis
* PBMC subpopulations
* Microbiome profiling (Stool)

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures.
* Male or female aged at least 18 years.
* ECOG PS - 0/1-2.

Exclusion Criteria:

* Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
* Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Antimicrobial Stewardship for Primary Care Pediatricians

The purpose of the study is to determine if physician education coupled with audit and feedback of antibiotic prescribing can improve antibiotic prescribing by primary care clinicians.

Using a large, diverse pediatric primary care network sharing a comprehensive electronic health record (EHR), a cluster-randomized trial will be performed to determine the effectiveness of an outpatient antimicrobial stewardship bundle, including treatment guidelines coupled with audit and feedback of physician prescribing, to curb inappropriate antibiotic prescribing for respiratory tract infections.

Aim 1: To determine the impact of an outpatient antimicrobial stewardship bundle within a pediatric primary care network on antibiotic prescribing for conditions for which antibiotics are not indicated.

Hypothesis: Antimicrobial stewardship will decrease rates of antibiotic prescribing for conditions for which antibiotics are not indicated.

Aim 2: To determine the impact of an outpatient antimicrobial stewardship bundle within a pediatric primary care network on broad-spectrum antibiotic prescribing for conditions for which narrow-spectrum antibiotics are indicated.

Hypothesis: Antimicrobial stewardship will decrease the rate of broad-spectrum antibiotic prescribing for conditions for which narrow-spectrum antibiotics are indicated.

Eligibility Criteria:
Inclusion Criteria:

* Primary care pediatric practices within the CHOP Care Network

Exclusion Criteria:

* Academic primary care pediatric practices within the CHOP Care Network
* Providers entering a practice after the start of the intervention
* Providers with less than 25 antibiotic prescriptions in the 6 months prior to the start of the intervention
HEAL-LAA Clinical Trial

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Subject is of legal age to participate in the study.
* Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
* Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
* Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
* Subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

* Subject has a documented life expectancy of less than 6 months.
* Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
* Intracardiac thrombus is present.
* An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
* The LAA anatomy will not accommodate a Closure Device.
* The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
* Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
* There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
* Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine

The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.

Patients with severe headaches often come to the emergency department seeking relief from their symptoms. There is some dating suggesting that over the counter treatment options are not inferior to treatment options offered in emergency departments. Patients presenting to the Einstein Emergency Department with IHS criteria for migraine headache will be approached by research associate and offered to participate in a randomized double blind study comparing excedrin migraine to compazine. Patients will be randomized by the hospital pharmacy. The pharmacy will distribute one of two packets, one containing prochlorperazine 10mg and 2 placebo tablets, the other containing 2 generic AAC tablets without scoring (acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet) and a placebo syringe. Patients will be monitored for improvement of pain, change in vital signs, and adverse events for two hours after receiving drugs. At 24 hours, the patients will be called back to access if they experienced any side effects from the time of discharge, and if they would take this medicine again if they experienced another migraine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Headache must meet the IHS criteria for migraine or probable migraine

  * 2 out of 4 of following:

    * Unilateral location
    * Throbbing (pulsating) quality
    * Moderate to severe intensity (inhibits/prohibits daily activities)
    * Exacerbation with moderate activity or mild activity
  * During HA, at least 1 out of 3 of following:

    * Nausea and/or vomiting
    * Photophobia
    * Phonophobia

Exclusion Criteria:

* Known allergy to study medications
* Pregnancy
* \< 18 years old
* Inability to provide written, informed consent
* Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
* History of peptic ulcer disease
* History of liver failure
* History of coagulopathy
* Gastrointestinal bleeding within the last 3 months
* Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications
* Ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of ASA or acetaminophen (\> 100mg/kg for ASA or acetaminophen)
* Vomiting within one hour of receiving oral study medications.
To Study the Impact of Stopping Therapy in Patients of CML With Molecular Remission

Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.

While a large number of studies which have stopped TKI therapy in similar patients exist in Europe and USA, no such study has been done on Indian or other south Asian population. Almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their TKI therapy, their remission state is regained once the TKI therapy is restarted.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of CML on TKI (Imatinib) therapy for more than 5 years
2. Patients who have been in complete molecular response (MR 4.5 +) for at least three years

Exclusion Criteria:

1. Patients who ever had blast crisis
2. Patients achieving molecular response with second generation TKI due to failure of Imatinib
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses.

Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Ability to provide informed consent
* Availability for follow up visits

Exclusion Criteria:

* Active or recent malignancy (within last 2 years)
* Pregnancy or breast-feeding
* Inability to provide informed consent
Fibrin Sealant for Cholangiotomy Closure Study

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.

A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.

The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.

When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.

Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.

If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.

All postoperative complications are registered according to the Clavien-Dindo system.

Eligibility Criteria:
Inclusion Criteria:

* Gallbladder disease

Exclusion Criteria:

* Cancer/Tumor