cyrilzakka/clinical-trials huggingface dataset:
Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients

The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases:

1. Neuropsychological evaluation of general cognitive abilities
2. Identification and measurement of specific biomarker levels
3. Correlation among hypertension, cognitive abilities and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Males or females diagnosed with arterial hypertension between 40 and 65 years of age;
* Written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Precedent acute myocardial infarction (AMI);
* Previous stroke and/or transient ischemic attack (TIA);
* Previous or concomitant neurologic or psychiatric pathologies;
* Neurologic or psychiatric pharmacological therapy.
Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS

This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery.

H0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments

Objective: To evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery. As secondary objectives, the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS insertion, the level of discomfort associated with the insertion procedure and the ease of insertion of the LNG-IUS will be evaluated.

Design: open randomized controlled trial Setting: Outpatient contraceptive services Patients: 100 women who want to use the LNG-IUS Interventions: 100 women will be randomized into two groups: a) use of a NSAID (ibuprofen, 400 mg) 1 hour before the LNG-IUS insertion; and b) 2% lidocaine intracervical injection. These women will be evaluated immediately after the LNG-IUS insertion, and then 2 hours and 6 hours after it.

Main outcome measures: Two pain scales will be used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort from the procedure (as rated by the patient). Multivariate logistic regression will be performed to analyze the predictors associated with moderate/severe pain.

Eligibility Criteria:
Inclusion Criteria:

* patients who wanted to use the LNG-IUS as a contraceptive
* age between 18 and 45 years
* nulliparity
* absence of previous vaginal delivery

Exclusion Criteria:

* women in categories 3 and/or 4 for LNG-IUS use according to the medical eligibility criteria of the World Health Organization
* illicit drug and/or alcohol users
* women with allergies or contraindications to NSAIDs or lidocaine
* chronic pelvic pain of any etiology
* abnormalities in the cervix (such as fibrosis or isthmus-cervical incompetence)
* previous abortion with or without uterine curettage
* psychiatric disorders
* continued use of medications that could interfere with the pain threshold
Questionnaire for the Assessment of Risk Factors Associated with Endometriosis in Adolescent Women with Endometriosis

A number of risk factors that may be associated with endometriosis in adolescents (medical history and symptoms) are reported in the literature, but no overall estimate of disease risk has been developed.

Providing a tool for assessing risk factors associated with endometriosis in adolescents by estimating disease risk could aid the clinician in diagnosis and reduce diagnostic delay

Although more than 60% of adult women with endometriosis report that their painful symptoms appeared before the age of 20, early diagnosis, particularly in adolescent girls, is still a challenge for doctors. The reasons for this delay include inadequate knowledge of the disease among healthcare professionals, the social and health normalisation of menstrual pain, and the peculiar aspects of the disease in adolescent patients. The adolescent patient with endometriosis presents particular anamnestic, familial and personal risk factors, as well as peculiar symptoms such as non-specific abdominal pain, acyclic pelvic pain, gastrointestinal symptoms, migraine, in addition to those classically reported in adulthood.

It may therefore be useful to identify a predictive model of the onset of endometriosis based on the risk factors currently recognised in the literature (anamnestic data) and on the results of a questionnaire to be submitted to adult women (aged between 20 and 50 years), with endometriosis (group 1) and without a diagnosis of endometriosis (group 2), concerning symptoms experienced in adolescence

Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing age between 20 and 50 years
* Clinical and ultrasound diagnosis of endometriosis for the study group and exclusion of endometriosis for the control group (examination and ultrasound performed according to the IDEA study criteria)
* Acquisition of informed consent for participation in the study and processing of personal data

Exclusion Criteria:

- Women suffering from other conditions responsible for pelvic pain (uterine fibromatosis, current or previous pelvic inflammatory disease, ovarian cysts of a non-endometriotic nature, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis)
Venous Thrombo-embolic Complication prévention in Pelvic Surgery

Pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous thrombo embolic complications and 0.5% to 10% of pulmonary embolism. The ST JOSEPH's Hospital have almost 60 cases per year . Following a fatal pulmonary embolism per operatory the team has set up a venous exploratory protocol before surgery.

This protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic scanner in the 48hours before surgery.

The aim is to evaluate this new protocol efficacy on prevention of thrombo embolic complications in pelvic fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* pelvic fracture with surgery indication
* age above 18 years

Exclusion Criteria:

* pelvic fracture without surgery indication
Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone Agonist Therapy for Prostate Cancer

The purpose of this research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and responds to insulin. The investigators will evaluate the changes in insulin sensitivity during and after GnRH agonist treatment for prostate cancer. The investigators are assessing the possibility that treatment-related insulin resistance may contribute to the risk of diabetes and/or cardiovascular disease in men with prostate cancer.

* The study will be divided into 2 groups: one group (Cohort A) will consist of men undergoing GnRH agonist therapy for at least 24 months. The second group (Cohort B) will consist of men undergoing the same treatment but who are scheduled to receive only 6 months of treatment.
* The following tests and procedures will be performed when the participant joins the study, then at 3, 6, 12 and 24 months thereafter. (All visits will take place at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital.) Height and weight; blood and urine samples; Oral Glucose Tolerance Test (OGTT), Dual energy X-ray Absorptiometry scan; medical history; and physical examinations.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate, clinical stage M0
* Scheduled to initiate GnRH agonist therapy with intended treatment duration of greater than 24 months (Group A)
* Scheduled for radiation therapy and neoadjuvant GnRH agonist therapy with intended 6 month duration of treatment (Group B)
* Karnofsky Performance Status 90 or 100
* Local or local-regional disease (Group B)

Exclusion Criteria:

* Prior hormone therapy (GnRH agonist or antiandrogen)
* History of bilateral orchiectomy
* Known diabetes mellitus or glucose intolerance
* Current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)

Primary Objective:

1. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI.
2. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age;
* Patients must be able to provide informed consent;
* Histologically proven low-grade or intermediate-grade prostate cancer (PC)
* Scheduled to undergo targeted local therapy (HDR brachytherapy).

Exclusion Criteria:

* Inability to lie still for the entire imaging time;
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance;
* Metallic implants (contraindicated for MRI).
Anticoagulants Comparative Benefit-risk Ratio in Real Life

The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.

The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013


Eligibility Criteria:
Inclusion criteria:

Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA

Exclusion criteria:

None
Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.


Eligibility Criteria:
Inclusion Criteria:

* Participants 0-18 years old, with
* Clinically indicated flexible bronchoscopy has been performed

Exclusion Criteria:

* Pregnancy or breastfeeding
* Unable to undergo CT scanning without sedation
* Patients with tracheostomy
Investigating Medical Research Trends in Osteoarthritis Clinical Trials

Clinical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future osteoarthritis patients during clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of osteoarthritis.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Pregnant or lactating woman
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
Degarelix Before Radical Prostatectomy

The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy.

The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7 days after administration of degarelix).

Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate/high risk prostate cancer
* Patient eligible for and wanting surgery

Exclusion Criteria:

* Inability to consent
* Previous thromboembolism/arrhythmias
* contraindication to degarelix or surgery
Extended Follow-Up After Islet Transplantation in T1D

The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.

After islet-cell transplantation in the CIT studies\*, each subject receives maintenance immunosuppressive medications.

The purpose of this protocol is to collect additional follow-up for safety and efficacy from CIT subjects with graft function after their completion in their CIT parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their CIT parent study.

\*CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received an islet transplant during participation in the following Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)
* A functioning pancreatic islet graft (e.g., absence of graft failure as defined in parent study) requiring immunosuppression
* Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation
* Ability to provide written informed consent
* Resident of the United States of America
* Documentation of the existence or lack of health insurance coverage and whether immunosuppressants are covered.

Exclusion Criteria:

* For female subjects-Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation
* For male subjects-Intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
* Received an islet transplant in a non-CIT research study
* Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks.

This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Participant is aged \>= 12 years at the time of the last documented HAE attack in the eligibility period.
* Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II.
* Participant had initiated LTP with lanadelumab during the eligibility period.
* Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations).

Exclusion Criteria:

* Participant was enrolled in a therapeutic investigational drug or device trial during the observation period.
* Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.
"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population

Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome.

A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.

Objectives

1) To examine whether the extension and degree of microangiopathy is an independent risk factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate whether a new score based on the extension and the degree of microangiopathy will permit us to improve the current methods used to identify patients at risk of CVD and its outcomes. 4) To determine whether the presence and the degree of NAFLD is an independent Cardiovascular disease risk factor and represent and extra-value to the score based on the extension and the degree of microangiopathy.

Secondary objectives:

1) To examine the usefulness of selected serum biomarkers in identifying diabetic patients at risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3) To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular involvement vs. index of generalized endothelial dysfunction)

Eligibility Criteria:
Inclusion Criteria:

* a) Age from 50-79 years; b) History of type 2diabetes of at least one year. Diabetes will be defined following the American Diabetic Association criteria: fasting glucose level of at least 126 mg/dl \[7.0 mmol/l\] in two separate analyses, a non-fasting glucose level of at least 200 mg/dl \[11.1 mmol/l\] or a self-reported history of physician-diagnosed diabetes or treatment for diabetes

Exclusion Criteria:

* a) Past medical history of Cardiovascular event; b) Type 1 diabetes; c) Contraindication for PET-CT or MRI d) Other concomitant disease associated with a short life expectancy
Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.

This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.

Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Appropriate candidate for uncomplicated bilateral LASIK surgery
* Gender: Males and Females.
* Age: 21 to 39 years of age.
* Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.
* If currently wearing contact lenses:

  * Soft CTL wearers discontinue for minimum 3 days
  * RGP CTL wearers discontinue for 1 month per decade of wear
  * Stable refraction (2 consecutive manifest refractions within 0.25 SE)
  * Stable K readings (2 consecutive K readings in 2 consecutive visits)
* Residual bed thickness 250um or greater
* Willing and able to comply with scheduled visits and other study procedures.
* Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Subjects with history of previous ocular surgery.
* Subjects with topographic evidence of keratoconus, or ectasia.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
* Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.