cyrilzakka/clinical-trials huggingface dataset:
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* Are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents
* Adult males and females ≥18 years of age
* Female subjects must be post-menopausal. Post-menopausal status is defined as any of the following: natural menopause with menses \>1 year ago; radiation induced oophorectomy with last menses \>1 year ago; chemotherapy induced menopause with 1 year interval since last menses
* Willing and able to comply with all protocol requirements including follow-up
* Subject must have a haemoglobin ≥ 9.0 g/dL at screening
* Subject must have a platelet count ≥ 100,000/mm3 at screening
* Subject is undergoing a planned open liver resection
* Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit
* During the surgery, the subject presents an identified target bleeding site (TBS) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats
* During the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator

Exclusion Criteria:

* Subject is undergoing emergency surgical procedure
* Recipient of a liver transplant
* Females of child-bearing potential
* Active infection at the time of the liver resection
* International Normalized Ratio (INR) \> 2.0 or APTT ratio \> 2.0 at screening
* Fibrinogen level \< 1.5g/L at screening
* History of thromboembolic disease and/or thrombophilia
* Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator
* A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the IMP
* Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study
* Current known or suspected alcohol and/or drug abuse or dependence at the time of screening
* Any concurrent medical, surgical, or psychiatric condition that may, in the investigator's opinion, affect the subject's willingness or ability to meet all study requirements during the study duration
* During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate
* Subject is taking any prohibited medications
* BMI at screening of ≥35
Pacific Northwest Udall Center (PANUC) Clinical Core

This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar neurological disorder through obtaining longitudinal clinical and neuropsychological data. The long term goal is to have a well-characterized subject population to contribute to our understanding of the natural history, diagnosis and ultimate treatment of cognitive impairment in patients with PD and similar disorders.

The Pacific Northwest Udall Center (PANUC) Clinical Core has recruited and characterized a cohort of more than 600 individuals with Parkinson's disease (PD) during the initial funding period. Data from the PANUC Clinical Core, in collaboration with other Udall Centers and other academic medical centers, have helped confirm apolipoprotein E (APOE) (1) and glucocerebrosidase (glucosidase, beta, acid or GBA) (2)as genes that increase the risk and modify the phenotype (1) of cognitive decline in PD. Understanding the mechanisms underlying these gene effects is the focus of this renewal application, and the Clinical Core will provide well-characterized PD and control subjects of appropriate genotypes for PANUC projects. In addition, the majority of the existing cohort will be retained for additional longitudinal clinical and neuropsychological testing follow-up to support ongoing genetic and biomarker studies, with a refined battery of tests and a uniform biannual frequency of visits designed to maximize efficiency. Balance and gait testing (already piloted at the Portland site) will be added to the test battery for the entire cohort as an innovation that is thought to reflect higher order CNS function closely related to cognition. This innovation leverages the expertise of Dr. Horak, an investigator introduced to the PANUC by way of PANUC Pilot Award funding during the last funding period. As in the current cycle, Clinical Core subjects will be followed in identical fashion at two sites: one at UW directed by Dr. Hu, and the other at OHSU directed by Core Leader Dr. Quinn. Project 3 leader Dr. Horak will oversee balance and gait testing at OHSU and Dr. Kelly will oversee balance and gait testing at UW.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson disease
* Over 18 years of age

Exclusion Criteria:

- Under 18 years of age
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy

RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia.

PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.

OBJECTIVES:

* To determine the correlation between supplemental sulforaphane (broccoli sprout extract) dose and concentrations of sulforaphane and its metabolites in blood and urine samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
* To determine the effect of this supplement on biomarkers of prognosis in these patients.
* To determine the effect of this supplement on HDAC inhibition in peripheral blood cell and normal and cancerous breast tissue samples from these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Sulforaphane Supplement: Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
* Placebo: Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.

Blood and urine samples are collected at baseline and after completion of study treatment for laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or lumpectomy) also undergo breast tissue sample collection at baseline and at the time of surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and apoptosis (TUNEL assay).

Patients complete questionnaires at baseline and periodically during study about their dietary history, family history, cruciferous vegetable intake, adverse events, and dietary and medication changes.

After completion of study therapy, patients are followed at/around 30 days.

Eligibility Criteria:
INCLUSION CRITERIA:

* Diagnostic mammogram
* English speaking

EXCLUSION CRITERIA:

* Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test)
* No biopsy referral after diagnostic mammogram
* Patient reported breast feeding
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* History of or active liver disease or baseline total bilirubin greater than institutional upper limit of normal
* Patient reported allergy or sensitivity to cruciferous vegetables
* Use of oral antibiotics within three months prior to randomization
* Oral steroid therapy at enrollment
* Current therapy with valproate acid or SAHA
* Current use of nutrient supplements or herbal remedies containing sulforaphane and unwillingness or inability to quit 72 hours prior to randomization and for the duration of the trial
* Radiation for currently-diagnosed disease prior to or during study supplementation
* Chemotherapy for currently-diagnosed disease prior to or during study supplementation
Instruction to Compress Chest Approximately 6-7cm for Healthcare Provider in Hospital

Unlikely the other element for high quality chest compression during Cardiopulmonary resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth (CCD) is influenced by surface on which the patient is placed, especially in hospital. For solving this problem, to place the patient on rigid surface, use a backboard that might decrease the mattress compression, receive a feedback that reflects the mattress compression depth (MCD) using dual accelerometer or magnetic sensor have been proposed. As the other solution, we hypothesized that training of 6-7cm CCD for healthcare providers improve accurate CCD during cardiopulmonary resuscitation when manikin is placed on mattress in hospital.


Eligibility Criteria:
Inclusion Criteria:

* Medical students, Healthy

Exclusion Criteria:

* Heart, wrist, and low back disease
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy

This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.


Eligibility Criteria:
Major Inclusion Criteria:

* BMI: 27 to 45 kg/m2
* Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
* Stable life-style, i.e. diet \& physical activity, as determined by the Investigator
* Stable metformin daily dose ≥1000 mg for at least 3 months
* Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations

This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal status
* Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
* Subject with an intact uterus

Exclusion Criteria:

* In accordance with existing labelling for estrogen/progestogen combinations
* Body Mass Index (BMI) \> 35.0 kg/m2
* Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
* Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin
A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Comparing LASIK outcomes using two femtosecond lasers

Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria:

* Subjects under the age of 21
* Subjects over the age of 60
* Subjects with corneal ectatic disorders
Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

The overarching goal of this study is to decrease disparities and increase access to continuous glucose monitoring (CGM) for patients with diabetes, regardless of where people receive their diabetes care. This study aims to evaluate the effectiveness of three implementation strategies for CGM in primary care practices in an efficient, sustainable, and scalable fashion. The investigators will also perform economic analysis of the implementation strategies.

This 3-year study will compare practices that implement CGM with (a) an evidence-based educational module only, (b) an educational module plus practice facilitation support, or (c) a virtual CGM initiation clinic for patients. There will be up to 30 practices in each group for a possible total of 90 primary care practices. The investigators expect to enroll up to 500 patient participants across these 90 practices and to compare outcomes among patients from each study arm.

This comparison will help investigators to understand the different implementation strategies and their ability to help primary care practice adopt, implement, and maintain CGM for their patients. The information the investigators collect will also help to understand how patients in these primary care practices experience initiation and use of CGM. The results will help to develop strategies and tools to train more primary care practices to offer CGM more widely to patients for whom it is recommended, especially for those where access to specialty care is limited.


Eligibility Criteria:
Inclusion Criteria:

* Between ages of 18 and 89 years
* Has diagnosis of type 1 diabetes or type 2 diabetes
* Recommended by primary care clinician to use continuous glucose monitoring to manage diabetes
* Ability to read or speak English or Spanish

Exclusion Criteria:

* Pregnant women
* Younger than 18 years of age
* Older than 89 years of age
Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery

To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.

Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain

Eligibility Criteria:
Inclusion Criteria:

* Patient who undergoing gynecologic laparoscopic surgery
* Patient who agrees to participate in this study
* Patient able to speak and understand Thai
* Patient able to complete the questionnaire

Exclusion Criteria:

* Patient with history of allergy in any kind anesthetic drug
* Patient who pregnant
* Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
* Patient whom the surgery is withhold or canceled
* Patient whom the surgery is converted to laparotomy
Effects of a Computer Game on Activity Choices

The study seeks to discover whether peer rejection increases the value of food relative to peer interaction in overweight individuals. After playing a computer game that randomly simulates peer rejection or peer acceptance, participants will play another computer game that will assess the value of food and social interactions.

Overweight individuals may be more likely to resort to food in moments of distress and less likely to choose to interact with a peer to reestablish their sense of belongingness.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-50
* Adults with a BMI greater than or equal to 18.5
* Adults must report at least a moderate liking of study foods used

Exclusion Criteria:

* Adults should have no psychopathology
* Adults should have no developmental disabilities
* Adults should have no cold or upper respiratory distress that could influence their activities
* Adults should have not be taking medications that could affect their food intake
* Adults should have no dietary restrictions
* Adults should have no food allergies
The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy

This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.

Major depressive disorder (MDD) is a psychiatric condition with high morbidity, disability, suicide and recurrence rate and become the hot and difficult topics in the medical study. Given the unsatisfactory response rates of many FDA-approved antidepressants, acupuncture is increasingly considered an important alternative therapy. A large number of clinical trials have confirmed that acupuncture is a generally safe, effective, and well-tolerated therapy for depression, but for MDD, the acupuncture clinical trials were only reported out of China. According to the clinical symptoms in patients with MDD, the chief TCM patterns are liver qi constraint and heart yang insufficiency, and the secondary TCM patterns are blood stasis, qi and blood deficiency. So we propose to combine acupuncture with moxibustion and select Baihui (DU20), shenting(DU24), Neiguan (PC6), Hegu (LI4), Taichong (LV3), Zusanli(ST36), Zhongwan (RN 12) and Gaunyuan (RN4) to Soothe the Liver, regulating the heart, warm the yang qi, boost qi and invigorate blood for MDD. We hypothesize that the acupuncture's antidepressant effect is based on the neural network reconstructing mechanism through studying the cerebral cortex function, hippocampal synaptic plasticity, Neurons electrophysiological change. We will employ multi-disciplinary methods in neuropsychology, neuroimaging, computer science, and electrophysiology to explore the important mechanism underlying acupuncture and moxibustion treating MDD.

Eligibility Criteria:
Inclusion Criteria:

* diagnostic criteria of CCMD-3 and DSM-4 depression;
* the score of PHQ-9 should be equal to or more than 15 points; the score of Hamilton Depression Rating Scale should be more than 18 points;
* without any drug treatment over the past 3 months
Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion

Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.


Eligibility Criteria:
Inclusion Criteria:

* Female adult
* Who has benefited from contraceptive counseling
* The choice of an IUD (hormonal or copper)
* Having signed a written informed consent.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Pre-existing dizzying sensations
* Severe facial wounds
* History of epilepsy
* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.

The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.

Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)

Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.

Nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Critically ill with necessity to mechanic ventilation
* Hospitalized at the ICU of our institution
* Started sedation protocol (propofol/remifentanil or propofol/sufentanil)
* Approved informed consent by family member or relative.

Exclusion Criteria:

* Known eye deformity or extented ophthalmologic surgery in history
* Severe traumatic brain injury of fulminant stroke
* Known (poly)neuropathy of complicated diabetes
* Need for continuously curarization
* Hemodynamic instability
Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT

Eltrombopag may improve the cell collection available for Autologous Stem Cell Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT will increase the number of blood cells collected and reduce the number of times blood needs to be collected. This study will also determine the highest dose of Eltrombopag that can be used without causing serious side effects.

Subjects will receive standard treatment for autologous stem cell transplant. Subjects will be assigned to receive no Eltrombopag or one of three dose levels of Eltrombopag. Subjects will receive oral Eltrombopag on days 2-15 of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma
* Stable or responsive disease after at least 2 cycles of conventional chemotherapy
* Slated to undergo autologous peripheral blood stem cell transplant
* Normal organ and marrow function

Exclusion Criteria:

* Myocardial infarction within 6 months of treatment
* Receiving other study agents
* Pregnant or breastfeeding
* Uncontrolled intercurrent illness
* Evidence of active or recent history of thromboembolic disease
* Previous history of primary platelet disorder or bleeding disorder
* History of a different malignancy unless disease free for at least 5 years