cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Measurement: Should Technique Define Targets?

Hypertension is the single most important risk factor for cardiovascular disease and death, yet blood pressure itself is highly influenced by technique and device. Hence, the target blood pressure could vary materially based on BP technique and device used. In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

Hypertension is the single most important risk factor for cardiovascular disease and death. Over the last several decades many classes of blood pressure lowering drugs have been discovered. These allow physicians to achieve optimal blood pressure and prevent adverse cardiovascular outcomes in most patients. However, the optimal blood pressure level has changed over time, and most recently has been decreased to 120 mm Hg, on the basis of clinical trials. These trials used a specific rigorous method of blood pressure measurement (patient alone in room, enforced period of rest, average of multiple readings) that is currently not the standard of practice in most clinics. Blood pressure itself is highly influenced by technique and device. In particular the length of resting time (if any), and whether it is measured with device requiring medical personnel presence in the room or not. For the same individual, the difference between blood pressure taken with and without rest could be 10 mmHg, and presence vs absence of medical personnel in the room during rest and/or BP assessment could be another 10 mmHg. Hence, the target blood pressure could vary materially based on BP technique and device used. As it is unlikely that all physicians can change their practice overnight and embrace blood pressure device allowing for standard resting time and unattended blood assessment, a comparative pragmatic study of the blood pressure technique and devices endorsed by Hypertension Canada and used in Canada is desirable to avoid either over- or under-treatment of Canadian patients with hypertension.

In the present study, the investigators will compare 4 different methods of measuring blood pressure in the office (casual, resting average of 3 readings with nurse present or absent for resting period, and average of 5 readings) as well as a 24 hour ambulatory measurement in 90 patients. The results of this study will help and enable practicing family physicians and specialists in Canada to target BP for their patients based on algorithm and method of assessment of BP they use in their offices.

Eligibility Criteria:
Inclusion Criteria:

* All patients being followed in the Renal Hypertension Clinic will be eligible for enrollment

Exclusion Criteria:

* Inability to do oscillometric measures (eg., arrhythmia, pain, device reporting error)
* inability to consent the patient
Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.

This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.


Eligibility Criteria:
Subjects with prostate cancer

Inclusion Criteria:

* Males 18-80 years of age
* Biopsy-confirmed prostate cancer
* Scheduled within 2 weeks for prostatectomy
* Signed informed consent

Exclusion Criteria:

* Presence or history of another cancer diagnosis, with the exception of certain skin cancers
* Currently treated with finasteride (Proscar®, Propecia®), dutasteride (Avodart®) or anti-androgen therapy (Lupron®)
* Participated in a clinical study with an investigational drug within 2 weeks of the screening visit.

Subjects with benign prostatic hypertrophy

Inclusion Criteria:

* Males 18-80 years of age
* Diagnosis of BPH made by clinical symptoms (e.g., enlarged prostate, dribbling urine stream, frequent and urgent urination)
* Scheduled within 2 weeks for TURP
* Signed informed consent

Exclusion Criteria:

* Presence or history of any cancer diagnosis, with the exception of certain skin cancers
* Currently treated with finasteride (Proscar®, Propecia®) or dutasteride (Avodart®)
* Participated in a clinical study with an investigational drug within 2 weeks of the screening visit.

Subjects with bladder/kidney stones

Inclusion Criteria:

* Males or females 18-80 years of age
* Diagnosed with bladder/kidney stones
* Scheduled within 2 weeks for cystoscopy
* Signed informed consent

Exclusion Criteria:

* Presence or history of any cancer diagnosis, with the exception of certain skin cancers
* Participated in a clinical study with an investigational drug within 2 weeks of the screening visit.
A Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Multiple Sclerosis.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Multiple Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).

Diagnosis of Multiple Sclerosis.

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population

The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery.

The aim of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population presenting for cardiac catheterization and undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Thienopyridine resistance will be measured by flow cytometry of the vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or the VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.

A secondary objective of this study is to correlate a variety of genetic polymorphisms with levels of platelet reactivity.

Eligibility Criteria:
Inclusion Criteria:

1. Patient \>18 years old.
2. PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.
3. CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.
4. Treated with a loading dose of clopidogrel or prasugrel at least 6 hours prior to the blood draw, or on a maintenance dose of clopidogrel or prasugrel for a minimum of 5 days.
5. Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel;
2. Use of a glycoprotein (GP) IIb/IIIa within 8 hours of the blood draw;
3. Patient known to be pregnant or lactating;
4. Patient with known history of bleeding diathesis or currently active bleeding;
5. Platelet count \<100,000/mm the day of the blood draw;
6. Hematocrit \<25% the day of the blood draw;
7. On warfarin therapy at the time of the blood draw;
8. Known blood transfusion within the preceding 10 days of the blood draw;
9. Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
10. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed.

Use of proton pump inhibitors (PPIs) is frequent among renal transplant recipients due to the common use of glucocorticoids in immunosuppresive regimens after transplantation. Reduced kidney functions and hypomagnesemia with the use of PPIs have been reported in various patient populations. However, few studies examined the effects of PPIs on kidney transplant recipients. Therefore, the aim of this study is to investigate the effects of PPI and/or histamine H2 receptor antagonist use on serum magnesium levels, allograft functions and survival in kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI).
* Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA).
* Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA).
* Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment).

Exclusion Criteria:

* Patients who are unwilling or unable to consent.
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients

Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge.

The investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients with hypoxemic respiratory failure.
* Admitted to ICU.
* Mechanical ventilation or high flow nasal cannula

Exclusion Criteria:

* Neurologic patients with brainsteam affection.
Effect of Exercises on Dentists' Body Functions

The aim of the study is to compare the effects of supervised exercises, video based exercises and control group on muscle strength, muscle endurance, pain and upper extremity function in dentists with musculoskeletal pain. Participants were randomly divided into 3 groups: Supervised exercise group (SEG), video based exercise group (VEG) and control group (CG). Both SEG and VEG were given same exercises but SEG did the exercises with a experienced physiotherapist while VEG did it through videos 3 days a week for 12 weeks. CG was only given postural education.


Eligibility Criteria:
Inclusion Criteria:

* working as an active dentist for at least 3 years
* Having nonspecific neck pain more than 3 months

Exclusion Criteria:

* any operation in neck area
Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy

Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.

A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
* Proper family acceptance and commitment level.
* Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
* Maximum user weight of 35 kg.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
* Shoe size 27-33 (EU)

Exclusion Criteria:

* More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
* Intensive rehabilitation during the study.
* Imposibility of the family to fulfill treatment calendar.
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
* More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
* Necessity to walk with 10º of hip abduction.
* Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
* Severe skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Severe rigid orthopedic deformities of the spine and/or lower limbs.
* Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
* Conditions that provoke exercise intolerance.
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
* Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Tanezumab in Osteoarthritis of the Knee

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
* Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
* Pain level and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
* Must agree to the contraceptive requirements of the protocol if applicable.
* Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion Criteria:

* Pregnancy or intent to become pregnant during the study
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
inContAlert: Machine Learning Algorithms for Individual Bladder Filling Level Prediction

The aim of this study is to evaluate the bladder filling level of the study participants using the inContAlert sensor. The generated data will be used for the evaluation and optimization of the machine learning algorithms to be able to make precise predictions about the individual bladder fill level.

In particular, the hypothesis that the bladder filling level can be estimated by the algorithm will be tested. When testing the hypothesis, it should be determined which deviation (measured by the mean absolute percentage error) of the estimation/prediction differs from the actual value (obtained by measuring the urine output using a measuring cup in combination with kitchen scales).


Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* Missing informed consent
MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II

MOTHIF II is a non-interventional, multicenter, retrospective, observational data collection in seven French Haemophilia Treatment Centers of the BERHLINGO network. In the context of the arrival of new extended half-life products, the MOTHIF II study aims to describe the changes in therapeutic management of patients with hemophilia A \& B, following the provision of FVIII and FIX extended half-life factors in France; it will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

Treatment regimens for haemophiliacs patients treated with clotting factors will be analysed globally for the patients of the two periods, by subgroup:

* type of hemophilia: A or B
* severity: severe, moderate, mild
* history of inhibitors

and then for each subgroup:

* by regimen: 1) Prophylaxis 2) On demand 3) ITI
* by type of clotting factors: FVIII or FIX or by-passing agents, plasma-derived or recombinant, standard or extended half-life clotting factors, INN

Will also be included in the analyse:

* demographic data: age (years)
* clinical data: weight (kgs) if available
* treatment data: regimen, consumptions (number of UI of clotting factors consumed on the period) and costs of clotting factors (€).

Eligibility Criteria:
Inclusion Criteria:

* All patients hemophiliac A or B, with or without inhibitors, included in the Nhemo (7 centres) and the Behrlingo database, treated with factor 8 or factor 9 products or by-passing agents
* All Hemophilia A or B patients of any severity without inhibitors, included in the NHEMO database and the BEHRLINGO database, without any treatment by clotting factors
* All Hemophilia A or B patients having given consent to be included in the study (2 times 12 months), during their usual follow-up (consultation...). For the other patients, a derogation from the obligation to inform the patients will be made to the CNIL.

Exclusion Criteria:

* patients under guardianship
A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults

The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.


Eligibility Criteria:
Inclusion Criteria

* Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.
* Participants must be willing and able to complete all study-specific procedures and visits.
* Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).

Exclusion Criteria

* Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator.
* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.
* Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs.
* Other protocol-defined Inclusion/Exclusion criteria apply.