cyrilzakka/clinical-trials huggingface dataset:
Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

The primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post operative Quality of Life will also be collected at several time points. The total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. The survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. The primary endpoint is the mean difference in post operative pain VAS scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects between ages 18-86 years old
* Subject provided written consent
* Preoperative diagnosis of stage i or II endometrial cancer
* Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University
* Subject should be expected to be able to use and tolerate opioids for pain management
* Pre operative health is graded as ASA I-III
* ECOG(Eastern Cooperative Oncology Group)Performance status 0-3
* Subject willing to comply with scheduled visits

Exclusion Criteria:

* Subject is prisoner, pregnant, or under age 18 or over age 85
* Hypersensitivity to opioids
* subject is breastfeeding
* Preoperative Health grade ASA IV-V
* ECOG Performance Status 4-5
* History of receiving prior chemotherapy or radiation therapy
* Subject schedule for additional procedures at the same time as the surgical staging
* Subject with pain related illness that to the PI discretion would interfere with study assessments.
* Known history of alcohol, analgesic, or narcotic abuse within 12 months.
* Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit.
* Require and/or receive chronic analgesic therapy for any pain related condition
* Severe acute or chronic medical or psychiatric condition that would interfere with the study results.
Multi-Cancer Early Detection (MCED) of Firefighters

This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Currently employed as a firefighter, full-time or part-time
* Taking part in Vincere's First Responder Cancer Screening Program
* Able to donate blood and urine sample
* Able to provide informed consent to participate in the study

Exclusion Criteria:

* Deemed medically unfit for sample donation
* Personal history of cancer in the last 5 years (with the exception of non-melanoma skin cancer)
Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery

The aims of this three-year study are to:

1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
2. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Eligibility Criteria:
Inclusion Criteria:

* patients with pancreatic cancer and are going to receive surgery.

Exclusion Criteria:

* poor functional status
Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.


Eligibility Criteria:
Inclusion Criteria:

* Patient with IBD (Crohn's disease, ulcerative colitis or unclassified chronic colitis) since at least 6 months.
* Computer and internet access at home.
* Consent to adhere to a physical activity program.
* Assent of the child to participation in the research protocol.
* Informed consent of parents or legal guardian.
* Patient benefiting from national health.

Exclusion Criteria:

* At time of inclusion, acute intercurrent events which may lead to a decrease in physical activity (according to the judgment of the investigator) as fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions.
* Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity.
* Refusal of the child to participate to the protocol.
* Refusal of one of the child's parents to participate in the protocol.
* Predictable lack of compliance to study procedures (especially to the physical activity program).
* Child with visual impairment.
* Participation in another interventional study.
* Pregnant or lactating women.
* Patient under protection of justice.
Evaluation of the Sanitary Safety of a Healthcare Professional Conference Held 9-11 June 2021 in Paris

The COVID-SRLF study will evaluate the sanitary safety of the French Intensive Care Society (FICS) annual meeting held in Paris Congress Center from June 9th to June 11th 2021 in the Coronavirus Disease 2019 (COVID-2019) pandemic situation. The primary objective is to determine the proportion of attendees with a positive antigenic COVID-19 screening test at day 7 (+/- 1) of their participation to the meeting. This rate will be compared to a cohort of health care professionals (medical doctors and paramedical professionals) from the same hospital ward as the attendees but who did not attend the meeting (stratified on centers, gender, age (\< and \>= 40 years, vaccination status (0, 1 or 2 doses) and socio-professional status (medical doctor, nurse, nurse assistant).


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professional healthy volunteer
* Absence of COVID-19 symptoms in the 2 weeks prior to inclusion
* Not being a COVID-19 contact case in the 2 weeks prior to inclusion
* Participation to at least one day of the FICS annual meeting (June 9-11 2021)

Exclusion Criteria:

* Non-healthcare professional (exhibitors, congress center employees)
* Refusal to participate to the study
* Person under legal protection
* Absence of social security affiliation
Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of \<63 days will be offered the option of participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age less than or equal to 63 days
* General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
* Willing to provide an address and/or telephone number for purposes of follow-up.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
* IUD in place
* Chronic renal failure
* Concurrent long-term corticosteroid therapy
* History of allergy to mifepristone, misoprostol or other prostaglandin
* Hemorrhagic disorders or concurrent anticoagulant
Study of the Efficacy and Safety of MEDI4893

Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients


Eligibility Criteria:
Inclusion Criteria:

* Colonized with Staphylococcus aureus, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

* Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients.
The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae

Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.

The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the striae distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.

Eligibility Criteria:
Inclusion Criteria:

* The striae distensae
* Age ≤ 35 years old

Exclusion Criteria:

* Skin allergy
* Cicatricial diathesis
* Skin inflammation or wound
* Platelet dysfunction syndrome
* Take anticoagulant drugs
* Acute or chronic infection
* Chronic liver disease
* Active vitiligo, psoriasis, systemic lupus erythematosus
Study of the Potential of a Macronutrient Balanced Normocaloric Diet to Treat Lifestyle Diseases

One of today's major health problem in the western world is related to lifestyle. Lifestyle diseases include obesity, type 2 diabetes, cardiovascular diseases and different types of cancers. For many years, a low-fat diet has been recommended to reduce obesity and lifestyle diseases, but replacing fat with carbohydrates has lead to an increase of these diseases. Overweight is associated with a chronical low-degree inflammation, and later studies have shown that carbohydrates have an effect on the mechanisms of inflammation. Previous studies in the investigators group has shown that in healthy, but slightly overweight persons, a balanced diet of lower carbohydrate content regulates the gene expression in a manner that leads to less inflammation. In this study the investigators will look at morbid obese women (BMI\>35) to see if the same, balanced diet can improve the inflammatory profile of the women.

The hypothesis of this proposal is that a carbohydrate-rich diet may cause a major deregulation of hormonal balance, causing both acute and chronic systemic inflammatory reactions mediated by white blood cells. We furthermore postulate that a carbohydrate-rich diet is a major risk factor in the development of obesity and life style diseases directly resulting from chronic systemic inflammation. We therefore want to use an integrated multidisciplinary systems biology approach to identify the hormones, genes and pathways specifically responding to a dietary carbohydrate reduction, to develop biomarkers that can be used for risk assessment, to identify molecular pathways and build mathematical models that describe the link between diet and inflammation, and use this knowledge to provide personalised dietary advice.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35 kg/m2

Exclusion Criteria:

* Allergies (fish, nuts, eggs)
* Patient under treatment/using medicine that can influence results
* Pregnancy and lactation
Mild Depression 2 Week Observational Study

The purpose of this study is to assess whether the dysphoric-like depressive characteristics observed in people with epilepsy are unique to this patient population in comparison to three control groups: Mild Depression (enrolled at Stanford University), Migraine Headaches (enrolled at Long Island Jewish Medical Center), and Multiple Sclerosis (enrolled at Rush University Medical Center).

This is a multicenter study consisting of a Screen and Retest phase conducted in two separate days separated by a two-week period. After providing written informed consent and meeting protocol-defined inclusion criteria at Screen, patients will be administered the Wide Range Achievement Test 3 (WRAT3) to ensure adequate word reading ability with which to complete the self-report forms. Patients who achieve a satisfactory score will be interviewed using the Mini International Neuropsychiatric Interview (MINI). Afterwards, each patient will first complete the 46 item Mood and Anxiety Symptom List in Epilepsy (MAS-E) and then five additional questionnaires in random order. Patients will also be given the opportunity to be rated by a proxy (e.g., caregiver, family member, friend) who will also complete the MAS-E.

Patients will return the completed documents to the investigator and be given an additional MAS-E to take home. In the Retest phase, patients will be asked to complete the MAS-E again exactly 14 days from the date of the Screen visit. The proxy will also be given an additional MAS-E and be asked to complete the MAS-E exactly 14 days from completion of the first MAS-E. The documents shall be returned to the clinic via U.S. mail on the same day of completion. It is not necessary to have a proxy to participate in this study.

Total study participation takes 2 weeks and approximately one visit to the clinic for the screening visit.

Eligibility Criteria:
Inclusion Criteria::

" Male or female 18 years of age or older. " Presence of a Depressive disorder that presents as a dysthymic or minor depressive disorder and whose score on the Beck Depression Inventory (BDI) range between 11 and 20. Patients with major depression will be excluded.

" Is currently on stable doses of medications i.e., no change in treatment in the previous 30 days.

" Achieves a satisfactory score on the WRAT3 (standard score is \> 69). " Is capable of completing the self-reporting questionnaires. " Is willing and able to provide written informed consent and comply with the study protocol\&#xA; Exclusion Criteria:" Presence of a clinically significant comorbidity of an unstable or progressive nature (e.g., psychosis, delirium) that could, in the opinion of the investigator, prevent completion of the questionnaires or warrant immediate medical intervention.

" Participation in an investigational trial within the past 30 days. " Inability to communicate well with site study personnel, e.g. inability to read or understand English, poor mental development or impaired brain function.

" Patients with a clinical picture that meets criterion of major depression.
Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.

Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.

Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
MRI Outcomes of VersaWrap Verve Protector Following Surgery

The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.

This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 and ≤65 at time of surgery
2. Patients undergoing lumbar decompression bilaterally at one level from L4-S1
3. Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.

Exclusion Criteria:

1. Non-English speaking
2. Known allergy or sensitivity to citrate, alginate or hyaluronate
3. Known allergy or sensitivity to MRI contrast dye
4. Known to experience claustrophobia
5. Pregnant or breastfeeding at time of surgery
6. Incarcerated at time of surgery
7. Prior lumbar surgery at the index level
8. Conjunction device use at index level (i.e., Barricade)\*
9. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol \*Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable
Innate Immune Response in COPD

The purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD.

The airways of COPD patients are often colonized with bacteria leading to increased airway inflammation. This study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.

In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses were measured in whole blood ex vivo. We used PAMPs derived from microbial products recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced cytokine levels in blood from patients with and without severe COPD, and for subjects with and without chronic bronchitis.

Eligibility Criteria:
Inclusion Criteria:

* post-bronchodilator FEV1/FVC \<0.7
* FEV1 \< 80%
* \> 10 pack-years tobacco smoking
* no respiratory illnesses or prednisone or antibiotics in the last 4 weeks

Exclusion Criteria:

* Primary diagnosis of asthma
* \> 15% change in FEV1
* Chronic inflammatory or infectious disease
* Cancer
* Autoimmune disease
* Chronic renal failure with a creatinine \> 1.5
* Chronic liver disease
* Chronic antibiotic use

Note: Due to difficulty recruiting patients after 6 participants were enrolled, the exclusion criteria were modified to allow patients with \> 15% change in FEV1. The exclusion criteria were also changed to allow chronic renal failure not requiring dialysis, and non-metastatic cancer provided there was no diagnosis of lung cancer.
Implementation of Telemedicine for Patient With Lower Extremity Wounds

The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.

This is a clustered trial where patients identified as having lower extremity ulcers with peripheral artery disease and diabetes are given the option to be seen by specialty care providers through telemedicine vs. normal standard in person referral. The study is being conducted in rural areas where there are no in person vascular surgery providers. The aim of the study is to determine if patient activation affects likelihood to use telemedicine and if use of telemedicine can expedite speciality care.

Eligibility Criteria:
Inclusion Criteria:

* Patient with the diagnosis of a lower extremity ulcer that has been present for longer than 2 weeks
* Must be willing to complete the patient activation survey
* Must be willing to have the study personnel call them to check in on their status

Exclusion Criteria:

* Patients that do not have a telephone