cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Concurrent Endometrial Carcinoma in Patients With a Curettage Diagnosis of Endometrial Hyperplasia

Objective: To examine the risk factors for coexisting endometrial carcinoma in patients with endometrial hyperplasia.

Method: Seventy-seven patients who received hysterectomy for endometrial hyperplasia were enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial carcinoma group (20) depending on the final pathology. Clinical variables were analyzed.

We retrospectively reviewed the cases of seventy-seven patients who had hysterectomies for endometrial hyperplasia between January 1996 and September 2006 at the Department of Obstetrics and Gynecology, National Taiwan University Hospital. A preoperative pathologic diagnosis of endometrial hyperplasia was obtained by D\&C (dilation and curettage) in all patients. Twenty of them were diagnosed as having endometrial carcinoma in their hysterectomy specimens. All of the specimens were reviewed by a gynecologic pathologist.

Depending on the final pathologic reports of hysterectomy, we divided the seventy-seven patients into two groups - the non-endometrial carcinoma group and the endometrial carcinoma group. Fifty-seven of the studied patients were in the non-endometrial carcinoma group and twenty were in the endometrial carcinoma group. As already mentioned above, we investigated them by clinical parameters including age, menopausal status, obstetrical history, medical history of diabetes and hypertension, BMI (body mass index) and preoperative pathology of D\&C.

The clinical and pathologic characteristics of the twenty patients diagnosed as having endometrial carcinoma postoperatively were also reviewed. Initial manifestation, histological grading of the carcinoma, the depth of myometrial invasion, with or without adjuvant radiotherapy and recurrence were included. The histological grading of endometrial carcinoma was based on FIGO ( International Federation of Gynecology and Obstetrics ) definitions. The BMIs of the patients with endometrial carcinoma were also analyzed by the receiver operating characteristic curve. The Research and Ethics Committee of National Taiwan University Hospital approved this study.

Statistical analyses were performed with the Independent-Samples T test and the Mann-Whitney test. Subsequently, multivariate analysis of risk factors was also employed with Binary logistic regression model to obtain the adjusted odds ratio (OR) and 95% confidence interval (CI) for selective variables. P\<0.05 was defined as significant.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial hyperplasia patient having hysterectomy with or without bilateral salpingo-oophorectomy

Exclusion Criteria:

* none
Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

The purpose of this registry is to assess clinical outcomes, and different factors that may affect these clinical outcomes such as systems of care, associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.

This is a prospective, multi-center, non-randomized, observational registry of acute ischemic stroke patients that have or will undergo treatment with the use of a Covidien market-released neurothrombectomy device (as the initial device used to remove the thrombus) within 8 hours of stroke symptom onset, at the discretion of the investigator and independent of participation in this registry. This registry may enroll up to 1000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies.
* Patient has experienced an acute ischemic stroke due to large intracranial vessel occlusion (with associated symptoms) and has been or will be treated with a Covidien market-released neurothrombectomy device, as the initial device used to remove the thrombus.
* Treatment within 8 hours of stroke onset.
* Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset.
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30.

Exclusion Criteria:

* Concurrent participation in a multicenter randomized study.
Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas

Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas

The extended multivisceral resection of retroperitoneum is the standard treatment for primary retroperitoneal soft tissue sarcomas. This procedure also includes the removal of the healthy adrenal gland ipsilateral to the tumor site.

The investigators think that a such extended surgical approach together with the removal of the adrenal gland may lead to a state of acute adrenal insufficiency and related hemodynamic instability.

In order to recognize this condition the investigators use a low dose ACTH test (Synacthen test) during the 1° and 10° post-operative days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age\> 18 years)
* Diagnosis of retroperitoneal sarcoma
* Adrenalectomy enbloc included in multivisceral resection
* Voluntary informed written consent

Exclusion Criteria:

* Recurrent and / or metastatic disease
* Patient chronically treated with corticosteroids
* Primary disorders of adrenal gland
* Basal serum cortisol values ≤ 7 µg / dL
* Clinically significant heart disease
* Altered TSH
Post-Market Study of Low-flow ECCO2R Using PrismaLung+

PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age is ≥ 18 years old
2. Patient is expected to receive ECCO2R for a minimum of 24 hours
3. Patient has mild or moderate ARDS according to the Berlin definition:

   * 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and
   * Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and
   * Respiratory failure not fully explained by cardiac failure or fluid overload
4. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.

Exclusion Criteria:

1. Patients body weight \< 30 kg
2. Patients with a contraindication for systemic anticoagulation with heparin
3. Patients with a platelet count \< 50,000/µL
4. Patients on MV \> 7 days
5. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
6. Current or history of heparin-induced thrombocytopenia
7. Patients who are pregnant and/or breastfeeding
8. Patients not expected to survive the duration of the planned study treatment period (24 hours)
9. Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
Bariatric Surgery on NASH

The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.

Non-alcoholic fatty liver disease (NAFLD) is an increasing health care problem closely related to obesity and has become the most common cause of chronic liver disease in developed countries. Today, bariatric surgery is the most efficient treatment of morbid obesity in terms of a rapid and sustained loss of weight. In addition, bariatric surgery is accompanied by improvement of weight-related comorbidities including features of the metabolic syndrome and possibly regression of the entire NAFLD spectrum.

The study is designed as an observational study including 40 patients referred to laparoscopic bariatric surgery (either RYGB or SG). The primary endpoint is change in NAFLD activity score (NAS) in serial liver biopsies collected from participants. Additional tests include blood samples, anthropometry measurements, Fibroscan and full body dual-energy X-ray absorptiometry (DEXA) scan performed together with each biopsy.

This unique model of serial liver biopsies in morbidly obese patients referred to bariatric surgery (RYGB or SG), combined with state-of-the-art technologies and bioinformatics, will provide important information about the effects of weight loss on NASH. The results will improve our understanding of the underlying mechanisms with the potential of identifying new potential NASH targets or diagnostic biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI≥35 kg/m2) individuals referred for bariatric surgery, either RYGB or SG
* Age between 18 and 60 years at the time of inclusion
* Evidence of potential NASH with fibrosis
* Willing to give informed consent and comply with all study procedures

Exclusion Criteria:

* Type 1 diabetes
* Alcohol consumption ≥20 g/day for women or ≥30 g/day for men over a two-year period prior to inclusion
* Clinically significant kidney function impairment or other laboratory findings at time of screening leading to the diagnosis of clinically relevant disorders
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation
* Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
* Planned elective surgery (other than bariatric surgery) during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment
* Pregnancy or desire to become pregnant during the study period
* Any ongoing medication that the investigator evaluates would interfere with trial participation including anticoagulant medication, and medication that could cause NAFLD
* Contraindications to liver biopsy
* Other causes of liver disease than NAFLD, including viral hepatitis, Wilsons disease, cystic fibrosis, coeliac disease and alpha-1 antitrypsin deficiency.
Characteristics of Intestinal Microbiome Following Pancreatic Surgery

The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.

The primary objectives of the study are:

1. To explore and describe any differences in the gut microbiota especially Shannon diversity index
2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.

Participants will be asked to complete the following:

* Three-day food, bowel and medication diary (see Protocol appendix 5)
* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)
* Quality of life questionnaire (see Protocol appendix 7)
* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged equal to or greater than 18 years) having had pancreatoduodenectomy (Whipple's) surgery between April 2018 - December 2023 for curative intent and received post-operative clinical management at Royal Prince Alfred Hospital, (post-surgical participants), and
* Healthy adults matched by age, sex, body mass index and smoking status

Exclusion Criteria:

* Aged less than 18 years
* Are unable to complete the questionnaires or testing due to language or cognitive limitations
* Have active or recurring pancreatic cancer, or where the surgery was for non-curative intent
* Have other gastrointestinal conditions that could affect gut symptoms or microbiome such as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or are currently pregnant or breastfeeding
* Are currently taking medications or diet that can affect gut symptoms or microbiome
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ages 18 years and older.
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.

Exclusion Criteria:

1. Individuals recently vaccinated against influenza
2. Subjects with contraindications to receive influenza vaccine
3. Please contact the site for additional eligibility criteria
Registry of Patients Living with Type 1 Diabetes

A registry of individuals with type 1 diabetes open to all patients with type 1 diabetes living in Canada will be established. The objective of this registry will be to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc.

Participation to the registry is divided in 3 phases. The first phase is mandatory for all participants. Phases 2 and 3 are optional.

The objective of phase 1 is to draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It takes about 10 minutes to answer the questionnaire. If the participant uses a continuous glucose monitor and agrees, the participant is invited to send the latest report of the continuous glucose monitor.

The objective of phase 2 is to characterize the causes, experience and consequences of hypoglycemia. Phase 2 also involves, if the participant accepts and live in the province of Quebec or Alberta, to provide the research team with their latest blood and urine tests as well as their list of medications.

The objective of phase 3 is to collect information on diabetes and hypoglycemia treatment, hyperglycemia management, sleep habits, depression, physical activity and the benefits of technologies to reduce the frequency of hypoglycemia. Phase 3 also involves, if the participant agrees, answering a food questionnaire, wearing a step counter, measuring waist circumference

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes
* Living in Canada

Exclusion Criteria:

* Type 2 diabetes
* Gestational diabetes
Homelessness Prevention: Psychiatric Care With Representative Payeeship

Money management is a neglected issue in maintaining persons with mental illness in the community. This randomized controlled trial (RCT) assessed whether a community-based representative payee program, i.e., money management of Social Security and/or VA benefits, coordinated with VA psychiatric care (CO-RP) could be more effective than customary treatment for veterans who had no representative payee.

Background:

Money management is a neglected issue in maintaining persons with mental illness in the community. This randomized controlled trial (RCT) assessed whether a community-based representative payee program, i.e., money management of Social Security and/or VA benefits, coordinated with VA psychiatric care (CO-RP) could be more effective than customary treatment for veterans who had no representative payee.

Objectives:

After 184 subjects were randomly assigned to CO-RP experimental group or customary care control group, hypotheses were that the CO-RP group would experience: 1) more frequent enrollment in the representative payee program, 2) improved residential status, 3) improved health-related quality of life, including less mental illness symptomatology, 4) less substance abuse, 5) improved money management.

Methods:

Six-month interviews were completed on 152 of 184 possible subjects (83%) and 12-month interviews were completed on 149 of 184 possible subjects (81%). The six and twelve-month outcomes were analyzed with analysis of covariance using data from the baseline pretest.

Status:

Completed.

Eligibility Criteria:
Inclusion Criteria:

Severe mental illness; Inability to manage money; VA patient

Exclusion Criteria:
Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.

This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).


Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 years and above.
* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
* History of AD for ≥1 year.
* AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
* Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

* AD lesion(s) on scalp at screening and/or baseline.
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
* Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
* Use of tanning beds or phototherapy within 4 weeks prior to baseline.
* Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
* Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
* Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
* Receipt of live attenuated vaccines within 4 weeks prior to baseline.
* Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
* History of any active skin infection within 1 week prior to baseline.
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic cancer
* Other available therapies have failed to cure the cancer
* The cancer that has no proven effective therapy
* The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
* Able to swallow capsules

Exclusion Criteria:

* Have active cancer in the brain or spinal cord
* Have an active infection of any kind (fungal, viral, or bacterial)
* Have a cancer of the blood
* Are pregnant or breastfeeding
* Have some types of eye problems or impairments
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women

This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman
* Body Mass Index (BMI) between 18.0-30.0 kg/m\^2 (both inclusive)
* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
* Impaired renal function
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Known or suspected allergy to trial products or related products
* Pregnant or positive pregnancy test at screening or nursing mother
* Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
* Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
* History of alcoholism or drug abuse
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator