cyrilzakka/clinical-trials huggingface dataset:
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection

Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.It was marketed for the first time in 1945 and widely used for its convenience, biocompatibility, and bactericide from that time. It is currently available in many commercial products, while manufactured using either a regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has been well documented using in vitro test and animal models, and ONRCG was seemingly superior to ORCG in terms of hemostasis. However, no clinical study has been performed to verify. Therefore, the objective of this prospective randomized study is to assess the hemostatic efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local bleeding in patients undergoing hepatic resection.

Representative liver resected surface (prominent bleeding site) was applied the ply of gauze with several seconds of even finger gentle press under aseptic conditions, then it was untouched and observed for 10 min. Vascular occlusion of the liver was allowed if necessary, but was open for evaluation of hemostatic efficacy. Hemostatic time began to calculate when gauze was applied. Time to hemostasis was recorded in seconds and the maximum time to hemostasis was 600 seconds. Hemostasis success was achieved based on there was no visible bleeding or minimal ooze from the resection wound.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient with informed consent
* Adults aged between 18 to 75 and do not plan to have child within 1 year after the surgery
* Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
* Minor to moderate (oozing/diffuse) bleeding from the incisal area after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, vascular clips, or point electrocautery

Exclusion Criteria:

* Indication for emergency surgery
* Participate in other clinical trials in the past 3 months
* Obvious hematologic disorder (as judged by the investigator from anemia and coagulation dysfunction)
* Patients with brain disease, abnormal judgment or mental disorder that does not cooperate with the researcher
* Patients with asthma or allergies
* Patients with severe cardiac disease, metabolic disease or endocrine disorders
* Immunodeficient patients (AIDS)
* Pregnancy, breastfeeding females
* Skin infection in the field of the targeted incisional area
Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS

To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery

A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.

Eligibility Criteria:
Inclusion Criteria:

(1) Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.

Exclusion Criteria:

1. Age \< or = 45;
2. Treated by mastectomy;
3. Surgical margins of \<1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
4. Tumour size \>2.5cm;
5. Any invasive breast cancer including micro invasion;
6. Histological evidence of multifocality (defined as having more than one distinct focus of DCIS with \>5mm of intervening benign breast tissue in one quadrant of the breast);
7. Any associated lobular carcinoma in situ;
8. Previous diagnosis of ipsilateral invasive carcinoma or DCIS of the breast;
9. Any contraindication for whole breast irradiation such as chronic heart or lung disease or previous ipsilateral chest wall radiotherapy;
10. Physician/patient unwilling to comply with study protocol; and
11. Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Barriers to Referring Adolescent Women for Etonogestrel Implant.

This study seeks to understand how much pediatric providers in Central Florida know about the etonogestrel contraceptive implant. The investigators also seek to understand the barriers that may prevent them from referring adolescent women for this highly effective and recommended method of contraception. Finally the study will consider if an expanded education and coaching improves their ability to referring patients for this method of birth control.

This study is comprised of two phases. During the first phase 500 medical providers who provide care to adolescents will be recruited to complete a 30 question anonymous survey that evaluates their attitudes towards recommending and referring for adolescent women for the etonogestrel contraceptive device. This survey will also test participant's knowledge of indications, side effects and side effect management related to this contraceptive device as well.

During phase 2, 100 pediatric providers will be randomized to two groups. One group will receive standard continuing medical education on the use of the etonogestrel device in adolescents focusing on themes that emerged as knowledge deficits in phase 1. The other group will receive standard continuing medical education plus continued coaching on management of medication side effects. The referring patterns of physicians in each group will be studied.

Eligibility Criteria:
Inclusion Criteria:

* A primary care provider that cares for children under the age of 18. This includes physician's assistants, advanced nurse practitioners, residents or fellows, and physicians in pediatrics, internal medicine, and family medicine.
* Must currently be practicing in Central Florida.
* Be able to speak and write in English
* For phase two of the study an additional requirement is that you must have a medical license to practice independently in the state of Florida.

Exclusion Criteria:

* Not a primary care provider who cares for children.
* A pediatric provider who only provides specialty care
* Not able to speak or write in English
* For phase two of study does not have a medical license to practice independenly in the State of Florida.
Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C

Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate with histological stages of liver fibrosis in hepatitis C patients, so it has a good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

Exclusion Criteria:

* liver decompensation child younger than 3 years patients with hepatitis B infection
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
4. Subject is able to comply with motion management guidelines.
5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:

   1. White blood cell count: ≥ 3.0 x 109/L
   2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
   3. Platelets: ≥ 100 x 109/L
   4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
   5. AST and ALT: ≤ 3.0 times institutional upper normal limit
   6. Serum creatinine: \< 1.5 times ULN e
   7. INR: \< 1.5
   8. Serum pregnancy: Negative
   9. Hemoglobin: ≥ 8.0 g/dl
8. Zubrod Performance Status 0-2
9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
10. Life expectancy of at least 9 months

Exclusion Criteria:

1. Patients for whom radiotherapy is contraindicated
2. Previous thoracic or abdominal radiotherapy
3. Any GI abnormality that would interfere with the ability to access the injection site
4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening
6. Active gastroduodenal ulcer or uncontrolled watery diarrhea
7. History of Chronic Renal Failure.
8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
10. Unable to comply with the study requirements or follow-up schedule.
11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.
Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral support for methamphetamine use disorder (MUD). Participants have a diagnosis of methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.

The objective of this study is to determine the safety of psilocybin in adult participants with MUD.

Eligible participants will be adults with methamphetamine use disorder recruited from the community. After physical and psychological screening, and at least 6 hours of psychological support for the psilocybin dosing, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Session Room at the University of Wisconsin School of Pharmacy. After eight hours of observation in the dosing room, the participant will stay overnight in the hospital Clinical Research Unit, and complete an integration session with at least one of the session facilitators before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation.

Participants who decide not to proceed to the second dose will complete two additional integration sessions and study measures through the two-month follow-up.

If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the "More Information" section at the bottom of this record.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of methamphetamine use disorder

Exclusion Criteria:

* Positive urine pregnancy at any time point during screening or study participation
* Inadequately treated hypertension, defined as 2 blood pressure readings, 10 minutes apart, of greater than 140/90 mmHg systolic/diastolic
* Current acute coronary syndrome or angina
* History of heart transplant or stroke
* Current use of and inability or unwillingness to taper off of medications that may interact with psilocybin
* Current insulin dependence, due to Type I or Type II diabetes
The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years old
* Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose \>140 mg/dL OR impaired fasting glucose: fasting glucose \> or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c \> or = 5.7%
* Abdominal obesity: waist circumference \>102 cm (men) and \>88 cm (women)
* Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria:

* Type 2 diabetes
* Current use of glycemic control medications within one month of randomization
* Fasting glucose \>126 mg/dL
* Current use of weight loss medication
* Previous weight loss surgery
* History of severe gastrointestinal disease
* Standard clinical contraindications to exenatide or metformin therapy
* Unstable angina
* Heart failure
* Stroke or coronary artery bypass graft within 3 months of screening
* Women who are currently pregnant or planning to become pregnant
* Breastfeeding women
* Clinically significant liver disease
* Creatinine \> 1.5 mg/dL
* Hepatic function greater than 3 times upper limit of normal
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent
Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors

The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.

The main questions it aims to answer are:

* Safety of PEF treatment of early-stage unreseectable NSCLC patients.
* Locoregional control of ablated lesions.
* Survival and quality of life assessment of early-stage unreseectable NSCLC patients.


Eligibility Criteria:
Inclusion criteria (all requirements must be met at the same time):

1. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.

Exclusion criteria (if any of the above conditions are met, the patient will be excluded):

1. The subject cannot tolerate or refuses general anesthesia;
2. Has a history of severe allergic reactions;
3. Has contraindications to bronchoscopy or refuses bronchoscopy;

5. Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR\>1.5 or APTT\>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets \<50×10\^9/L; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.
Fluid Management of Acute Decompensated Heart Failure Subjects Treated with Reprieve Decongestion Management System (DMS)

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Prior use of loop diuretics within 30 says prior to admission.
4. ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter.
2. Hemodynamic instability.
3. Dyspnea due primarily to non-cardiac causes.
4. Acute infection with evidence of systemic involvement.
5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
7. Inability to follow instructions or comply with follow-up procedures.
8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
9. Severe electrolyte abnormalities.
10. Presence of active coronavirus disease 2019 (COVID-19) infection.
11. Enrollment in another interventional trial during the index hospitalization.
12. Inability to return for follow-up study visits.
13. Life expectancy less than 3 months.
14. Women who are pregnant or intend to become pregnant.
A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)

This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study
* Has a body mass index (BMI) within the range of 18 to 30 kg/m\^2
* Possesses a valid driver's license for 3 years or more with at least 5000 km/year on average within the last 3 years
* Is capable of driving a manual transmission vehicle and is willing to drive on a highway
* Is judged to be in good health
* Has a regular sleep pattern
* Is not visually impaired

Exclusion Criteria:

* Has a history of a persistent sleep abnormality
* Has neurological disease/cognitive impairment
* Has a history of cataplexy
* Is a regular user of sedative-hypnotic agents
* Is allergic to zopiclone
* Has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study start and will travel across 3 or more time zones throughout study duration
* Works a night shift and is not able to avoid night shift work within 1 week before each treatment visit
* Is pregnant or nursing
* Does not qualify as a proficient driver according to the driving instructors evaluation of subject's driving on the driving test practice session
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
* Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria:

* AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
* Having absences seizures
* Having had status epileptics within the year prior to inclusion
* Having a progressive neurological or systematic disorder
* Having known significant renal or hepatic dysfunction
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.


Eligibility Criteria:
Inclusion Criteria:

- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,

Exclusion Criteria:

Pregnant or breast feeding, Type 1 diabetes

Other protocol criteria apply