cyrilzakka/clinical-trials huggingface dataset:
Observational Study on Endometrial Stromal Tumors

Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options.

This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices.

The study will also review the diagnosis by a central expert pathologist in order to its confirmation

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014
* Informed consent signature

Exclusion Criteria:

* patients with different diagnosis from EST
Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

This dose response study is proposed to explore the extent to which Nexium increases endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after transplant.

Islet transplantation has been shown to effectively treat type 1 diabetes by stabilizing blood glucose control while reducing/eliminating the need for exogenous insulin injections. However, for reasons still not fully understood, islet graft function tends to decline with time after transplant. Gastrin has been identified as a growth factor capable of stimulating islet cell expansion. Proton pump inhibitors are known to increase endogenous gastrin concentrations. This dose response study is proposed to explore the extent to which Nexium increases endogenous gastrin concentrations in healthy volunteers and to assess whether Nexium treatment may be useful in expanding islet cells in patients with type 1 diabetes. Three Nexium dose levels will be tested to determine the optimal dose for increasing plasma gastrin levels. The effect of Nexium on plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* healthy
* free of clinical signs of diabetes, peptic ulcer, liver or kidney disease,autoimmune disease, or any acute chronic infection.

Exclusion Criteria:

* history or clinical signs of diabetes
* history of liver or kidney disease
* positive H-pylori status
* currently using a proton pump inhibitor
* prior hypersensitivity to Nexium
* pregnant or breastfeeding women
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers

Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500 mg administered together


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
2. Age 21 to 50 years (inclusive)
3. Body mass index (BMI) 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
10. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
12. Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
13. Drug abuse
14. Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
15. Any laboratory value outside the reference range of clinical relevance
16. Inability to comply with dietary regimen of trial site

    For female subjects of childbearing potential only:
17. Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
18. No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, or surgical sterilization (including hysterectomy).
19. Lactation
A Pilot Study Investigating the Detection of Episodes of Severe Patient-Ventilator Asynchrony

The goal of this study is to determine what percent of severe patient-ventilator asynchrony is detected in mechanically ventilated patients in the adult ICU and to determine delays in detecting those asynchronies by the staff that were correctly identified, and whether asynchrony status recorded during intermittent assessments by respiratory therapists is representative of periods in between such assessments.

This is a prospective observational study. All decisions about ventilator settings, mode of ventilation, and sedative doses are determined by the critical care team attending to the patient. Patients will be enrolled within 6 hours after intubation and will be studied continuously until extubation. Patients will be monitored for asynchrony using Syncron-E tablets provided by Autonomous Healthcare. However, clinical staff will be blinded to the results of the tablet, and hence, there will be no change to clinical care.

Asynchrony index (which captures the fraction of breaths with asynchrony) will be calculated every minute by the Syncron-E tablet. The assessment of respiratory therapists at the time of ventilator checks will also be recorded including the following information: i) entering/exiting the room , ii) existence of a severe asynchrony episode based on the respiratory therapist's assessment and its type. Clinical staff will record the start of any severe asynchrony episode that they detect. Data related to the administrations of sedatives and anesthetics as well as major interventions (excluding any PHI) will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring intensive care unit admission
* Patients requiring invasive mechanical ventilation expected to last more than 24 hours
* Patients ventilated on PCV, PSV, VCV, or VC+ ventilation modes

Exclusion Criteria:

* Any patient not meeting inclusion criteria.
* Any patient receiving muscle relaxant (paralytics) for more than 24 hours.
* Any patient receiving inverse ratio ventilation.
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility

A promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa). This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan).

PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness.

\[18F\]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other modality for localization of the site of recurrence. Applications that show promise and require further investigation include the characterization and risk stratification of primary PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved identification of patients with oligometastatic disease.

The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort of patients at CHUM and establish the repeatability of the technique before investigating it more widely.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Metastatic prostate cancer.
* At least 18 years of age
* Standard imaging (bone scan, CT abdo/pelvis/chest) within 6 weeks of consent.

Exclusion Criteria:

-
Volatile Organic Compounds as Markers of Acute Rejection in Lung Transplant

The aim of research is to identify markers of acute rejection by VOC analysis in exhaled breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies and patients with no acute rejection. Exhaled breath will be collected for VOC analysis woth electronic nose and mass spectrometry. VOC profiles will be compared between the two groups of patients.

Prospective single-center study. A single visit, no follow-up. The visit will take place before or within five days from date of transbronchial biopsies (BTB). It will include a noninvasive collection of exhaled breath for VOC analysis. VOC analysis will be conducted using two types of devices: "electronic nose" and mass spectrometry.

200 bi-lung transplanted patients will be enrolled and divided into two groups.

* Group A, Acute rejection: 100 patients. Diagnosis of acute rejection retained on transbronchial biopsies or functional anomalies with the necessity of modifying the immunosuppressive regimen.
* Group B, control: 100 patients. Patients without respiratory functional abnormality and normal transbronchial biopsy.

VOC, detected by electronic nose and identified by mass spectrometry, will be compared between patients with a confirmed diagnosis of acute rejection (group A) and patients without rejection (control group B)

The duration of participation of each patient is 1 day. The duration of the inclusion period is estimated at 54 months from the first inclusion. The expected total duration of the research is 54 months

Eligibility Criteria:
Inclusion Criteria:

* Bi-pulmonary transplant patient
* Acute rejection group: Patients with transbronchial biopsies performed as part of their usual follow-up or for functional abnormality ; Diagnosis of acute rejection retained on the following arguments: histological lesions of cellular rejection or histological lesions of humoral rejection or normal histology but diagnosis of "functional rejection" retained and immunosuppressive treatment indicated
* Control group: Patients benefiting from systematically programmed transbronchial biopsies as part of post-transplant follow-up with normal histology and absence of functional respiratory abnormality

Exclusion Criteria:

* Patient unable to realize a vital capacity measure
* Neoplasia currently treated
* Unresolved acute bronchial complication (stenosis or dehiscence)
* Immunosuppressive treatment of acute rejection already begun
* Patient who has already participated in the protocol and already included in one of the two study groups
The Effect of Interpersonal Relationships Psychotherapy on Breast Cancer Patients

This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk.

There are not enough studies showing the effect of IPT, which is an evidence-based psychotherapy that works on problem areas such as role change that may occur with the disease and provides support for recognizing and using social support mechanisms, on cancer patients. This study is thought to make a significant contribution to the literature, especially in terms of making family support, which has an important place in social support systems, available to patients, intervening in interpersonal emotion regulation problems that may occur in patients and affecting depression levels.

Eligibility Criteria:
Includes Criteria

* Ability to communicate in Turkish
* Diagnosed with Stage-II and Stage-III breast cancer
* Continuing outpatient treatment
* Four points on the Primary Care Depression Screening Scale
* Internet connection
* Has a phone that can use the zoom app to continue conversations to be
* To be able to use the Zoom app

Exclusion Criteria

* Being a pediatric oncology/hematology patient
* Diagnosed with stage -IV breast cancer
* Taking psychopharmacological medication
* To have received KIPT within the last year
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints

The purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested case-control studies for each endpoint of interest

This is a post-authorisation safety study (PASS) of new users of aclidinium bromide, fixed dose aclidinium bromide/formoterol fumarate dihydrate, and other inhaled medications frequently used by patients with COPD

The plan is for the PASS study to be conducted on one population-based automated health database; the initial candidate database is the CRPD in the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

1. Have at least 1 year of enrolment in the electronic database. In the CPRD, only patients with permanent registration status in "up to standard" participant general practices will be included in the cohort.
2. Be aged 40 years or older.
3. Have a recorded diagnosis of COPD.
4. Have not been prescribed a study medication of interest during the 6 months before the date of the first prescription for that specific study medication.

Exclusion Criteria:

1. Patients with cancer or other serious, non-cardiovascular, life-threatening conditions or indicators of severe comorbidity will be excluded from the study cohort.
2. Subjects who will be potentially excluded are those with the following conditions recorded in the database at any time before the date of cohort entry: cancer, HIV, respiratory failure, end-stage renal disease or dialysis, organ transplantation, drug or alcohol abuse, coma, congenital abnormalities of the heart or great arteries.
Small Changes a One Year Protocol for Weight Management

A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme.

A quasi-experimental design. With one arm focussed on 'treatment as usual' and the other on Motivational Interviewing. Subjects were not randomly assigned but treated as two separate cohorts one Running October 2011-October 2012 using the Treatment as usual and a separate cohort running from October 2012 to October -2013 using motivational interviewing as the approach for treatment.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass index equal to or greater than 30 kgm2
The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-50 yr
2. BMI\<30
3. Females had to use oral contraceptive treatment or IUD.

Exclusion Criteria:

1. Clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or endocrine organs
2. Abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine, blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase)
3. Albuminuria or glucosuria
4. cancer
5. arterial hypertension
6. alcohol abuse
7. medical treatment, except contraceptives
8. pregnancy or breast feeding
9. blood donation one month before the study.
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting

This study will assess the efficacy of the text messaging (SMS-based) disease management intervention to improve adherence to stimulants in adults with Attention Deficit/Hyperactivity Disorder (ADHD) within the Partners primary and psychiatry care settings.

Participants in the study will receive customized text messages twice a day, every day, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults ages 18-55 years
* Receipt of a prescription for stimulant medication by their primary care physician or psychiatrist
* Proficient in English
* Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge planned text messages

Exclusion Criteria:

* Investigator and his/her immediate family
* Unwilling/unable to comply with study procedures
SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study

The investigators hypothesize that children are less likely to become infected in the school environment, compared to the household or outside the school setting. Primary schools do not play a major role in SARS-CoV-2 spreading. They hypothesize that incidence level in schools is mainly a consequence of community transmission. The incidence level in household and that the secondary attack rate in schools remains at least 5 times lower that the transmission level in households.


Eligibility Criteria:
Inclusion Criteria:

* All children and school attenders from selected schools was invited to participate

Exclusion Criteria:

* Refusal to provide written informed consent before enrolment
Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients

In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.


Eligibility Criteria:
Inclusion Criteria:

Patients (\> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH:

* Immobilization
* History of VTE
* Acute inflammation
* Heart failure (NYHA class III or IV)
* Respiratory failure

Exclusion Criteria:

* Indication for LMWH or UFH at therapeutic dosages
* Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction)
* Contraindication for the treatment with LMWH
* Major surgery within the last 4 weeks; minor surgery within the last week
* Thrombocytopenia (\< 100.000/μl)
* Prolonged prothrombin time
* Prolonged activated partial thromboplastin time (aPTT)
* History of heparin-induced thrombocytopenia
* Bodyweight \< 50 kg or \> 100 kg
* Renal insufficiency (creatinine \> 2 mg/dl)
The DDI Study of SP2086 and Simvastatin

The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or Simvastatin
Efficacy of Plyometric Training Isometric Strength Training on Quadriceps Strength and Functional Performance.

This study aims to investigate the influence of an eight-week plyometric and quadriceps strength training program on muscular strength, sprint, and functional performance in collegiate football players.

Sixty collegiate football players aged 18-25 years were recruited, at the university campus. All of them were randomly divided into two experimental and control groups that participated in training for six weeks on alternate days (i.e., three sessions per week), and one control group (n=30) did not train. The control group was instructed to maintain regular activities and avoid any strenuous physical activity during the study.

Under the Declaration of Helsinki, participants were informed about the study's possible risks and benefits, and all participants signed informed consent before participation in the study. The ethical sub-committee of the College of applied medical science, Majmaah, Saudi Arabia approved this study (Ethics Number: MUREC-Jan. 25/COM-2021 / 19-5).

Eligibility Criteria:
Inclusion Criteria:

• Young players aged between 18 and 25 years required frequent sprinting

Exclusion Criteria:

* Current injury to the lower limb.
* Surgery affecting lower limb function.
* Any cardio-respiratory diseases.
* Impairments of the spine or lower extremities.
Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

The overall goal of this study is to evaluate the feasibility of conducting a randomized controlled trial comparing a standardized dialysis strategy versus usual care (dialysis prescription ordered by each patient's primary nephrologist) in patients with AKI-receiving dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Received ≥2 sessions of any dialysis modality for presumed AKI
* Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments

Exclusion Criteria:

1. Receipt of dialysis for ≥90 days
2. Known baseline estimated glomerular filtration rate (eGFR) \<15mL/min/1.73m2
3. Strong clinical suspicion of urinary tract obstruction, rapidly progressive glomerulonephritis (RPGN), vasculitis, thrombotic microangiopathy (TMA), myeloma related cast nephropathy, or acute interstitial nephritis (AIN) as the underlying cause of AKI
4. Receipt of any dialysis prior to the current admission within the past 2 months
5. Kidney transplant within the past 12 months
6. Pregnant