cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

Have the ability to provide written informed consent; Have at baseline , a documented diagnosis of hypertension (as defined in the National High Blood Pressure Education Program 2004); MSBP (mean of 3 measurements) must be ≥95th percentile, and ≤25% above the 95th percentile, for age, gender and height, at baseline; CKD patients must be defined as any of the following criteria: Kidney damage for ≥3 months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifested by one or more of the following features: Abnormalities in the composition of urine, Abnormalities in imaging tests, Abnormalities on kidney biopsy, Estimated eGFR \<60 mL/min/1.73m2 for ≥3 months, with or without the other signs of kidney damage described above; Able to swallow the valsartan solution; Body weight must be ≥8 kg and ≤40 kg at baseline; Must be able to safely washout from other antihypertensive therapy (if applicable) Exclusion criteria AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range; Estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m² (calculated using Modified Schwartz Formula); Serum potassium \>5.3 mmol/L; Uncontrolled diabetes mellitus, as defined by the investigator; Unilateral, bilateral and graft renal artery stenosis; Current diagnosis of heart failure (NYHA Class II-IV); Patients taking any of the following concomitant medications following screening: RAAS blockers other than study drug, Lithium, Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; Non-steroidal anti-inflammatory drugs (NSAIDS), including selective COX-2 inhibitors, acetylsalicylic acid \>3g/day, and non-selective NSAIDs (paracetamol/acetaminophen is permitted); Antidepressant drugs in the class of MAO inhibitors (e.g. phenelzine); Chronic use of stimulant therapy for ADD/ADHD; patients who have coarctation of the aorta with a gradient of ≥30 mmHg; Previous solid organ transplantation except renal transplantation. Renal transplant must have occurred at least 1 year prior to enrollment; Patient must be on stable doses of immunosuppressive therapy and deemed clinically stable by the investigator; Patients known to be positive for the human immunodeficiency virus (HIV) Other protocol defined inclusion/exclusion criteria may apply.
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization \[VRS\]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.

Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF), interest towards preventive pacing treatments is increasing. The importance of this option in the panoply of the preventive tools is fully justified, only by considering the insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical approaches.

Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies, and more generally by stabilizing atrial tissue when potential triggers are appearing.

On top of that, cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools, in terms of sensitivity, specificity and continuity in the monitoring.

Four preventive pacing therapies have already been evaluated, the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 / Vitatron T70 DR.

Eligibility Criteria:
Inclusion Criteria:

* Patient with documented atrial fibrillation: at least one episode of paroxysmal AF documented 6 months prior to inclusion, lasting more than one minute
* Patient with a brady-tachy syndrome or a sick sinus syndrome, with a permanent pacing indication
* Atrial lead with a tip-to-ring interval equal to or less than 12 mm
* Patient who agrees with and has signed the informed consent

Exclusion Criteria:

* Permanent AF
* AF related to a reversible cause
* One electrical cardioversion 6 months prior to inclusion
* Unstable angina
* Myocardial infarction (MI) less than 3 months
* Planned cardiac surgery or performed in the last 3 months
* Congestive heart failure, New York Heart Association (NYHA) class IV
* Life expectancy less than 18 months
* Patient participating in other studies
* Patient not able to follow the FU calendar
* Less than 18 years of age
* Pregnancy
An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery

The purpose of the research is to examine the usefulness of using patient navigators in improving coordination of care between the Breast Examination Center in Harlem (BECH) and the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious breast finding. This study will collect information to improve the role of the Patient Navigator, nonmedical staff that helps coordinate patient care. The study will also collect information to be used to help remove barriers that happen when several different institutions provide care.

This purpose of this protocol is to systematically evaluate the role of Patient Navigators, non-medical personnel who assist in the coordination of care, for women attending a breast cancer screening clinic in Harlem who are found to have a suspicious result. The concept of patient navigation, developed by Dr. Harold Freeman, has been identified as a promising strategy to reduce disparities in health care for minorities and the underserved.

This protocol will evaluate the role of the Patient Navigator in coordinating care for women who are referred to the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) from the Breast Examination Center of Harlem (BECH). To achieve this, we propose four interrelated tasks. First, we will characterize in detail the specific nature of the activities of the Navigators as they remedy barriers to the receipt of breast cancer care. Secondly, we will determine whether the presence of the Navigator minimizes the percentage of patients with significant delays in receipt of necessary care. Third, we will measure patient satisfaction with care and their perceptions of the value of the Navigator. Finally, we will provide a baseline needs assessment of those (eligible) patients requiring pain and palliation services.

Specific Aims:

1. To characterize the role of Patient Navigators by defining the specific tasks and activities they perform in order to eliminate and/or reduce barriers to receipt of cancer care.
2. To evaluate how the presence of a Patient Navigator influences the time intervals from receipt of a suspicious screening mammogram or palpable breast mass to appropriate diagnosis and or treatment.
3. To measure patient's satisfaction with the coordination of care in the presence of a Patient Navigator.
4. To descriptively assess the pain and palliation needs of the population under study.

Eligibility Criteria:
Inclusion Criteria:

* Women with a suspicious screening finding
* Referred from Breast Examination Center of Harlem (BECH)

Exclusion Criteria:

* Women that were not initially seen at Breast Examination Center of Harlem (BECH)
* Women with normal breast screening findings
Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease

The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.


Eligibility Criteria:
Inclusion Criteria:

* UHDRS \< 50
* Age \> 18 years
* Ability to undergo MR scanning
* Covered by french social security

Exclusion Criteria:

* Evidence of psychiatric disorder
* Attendant neurological disorder
* Contraindications to MRI (claustrophobia, metallic or material implants)
* Severe head injury
* Unable to understand the protocol
* Pregnancy
* Failure to give informed consent
* Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
* Unwillingness to be informed in case of abnormal MRI
Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy

Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination.

Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions.

Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship.

CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.


Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
* Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
* Height was above 1 meter.
* Understand verbal command.
* The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.

Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University.

Exclusion Criteria:

* Vertigo or dizziness.
* Epilepsy.
* Osteoporosis.
Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH

This open study will enrol trauma patients admitted to the Trauma Unit, Department of Surgery at Sahlgrenska University Hospital/Sahlgrenska. It will compare patients where TICH has been confirmed by CT (group A) to patients where CT has ruled out TICH (group B). Patients will be asked to participate in the study as early as possible after admission and CT scan. After physical examination, checking inclusion/exclusion criteria, and after informed consent has been acquired, the baseline microwave-based measurement will be performed. The diagnostic procedure is estimated to take 15 min; whereof total subject measurement time will be less than five minutes. Follow-up microwave measurements will be performed in conjunction with any follow-up CTs performed as part of the standard of care, during the hospitalized treatment period. If no follow-up CTs are performed as part of the standard of care, only the baseline microwave measurement will be performed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the last microwave-based investigation is finalized.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to Sahlgrenska University Hospital for trauma care.
* Patient deemed clinically stable.
* Patient should have a Glasgow Coma Scale rating of \> 14
* TICH confirmed (group A) or ruled out (group B) by CT, performed within the latest 12 hours.
* Patient ≥ 18 years of age.
* Patient has signed the Informed Consent Form.

Exclusion Criteria:

* Patient has confirmed or suspected skull fracture.
* Patient has confirmed or suspected cervical spine fracture.
* The diagnostic procedure is deemed to interfere with the standard of care.
* Patient has a shunt or other foreign object implanted intracranially.
* Patient has agraffes/other metal parts, thick (\> 1 cm) bandage, or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
* Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgment.
* Females who are pregnant.
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and above
* Confirmed cervical infection with HPV types 16 and/or 18 at screening
* Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
* Confirmed histologic evidence of cervical HSIL at screening
* Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
* With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
* Normal screening electrocardiogram (ECG)

Exclusion Criteria:

* Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
* Cervical lesion(s) that cannot be fully visualized on colposcopy
* History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
* Treatment for cervical HSIL within 4 weeks prior to screening
* Pregnant, breastfeeding or considering becoming pregnant during the study
* History of previous therapeutic HPV vaccination
* Immunosuppression as a result of underlying illness or treatment
* Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
* Receipt of any non-study, live vaccine within 4 weeks of Day 0
* Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
* Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
* Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
* Less than two acceptable sites available for IM injection
Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients

The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

Exclusion Criteria:

* No active ocular or nasal infection
Inflammation, Diabetes, Ethnicity and Obesity Cohort

Obesity affects over one third of US adults (\>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time.

In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.

The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 350 individuals from various ethnicities, covering a spectrum of weight and Diabetes risk. The study is looking for participants between the ages of 18-75 years that are healthy with or without diabetes with a stable weight. The study will also like to include people who are slated to undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at UCSF.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy individuals between the ages of 18-75 years. These cutoffs are designed to allow inclusion of postmenopausal women, and younger/more active patients who are increasingly undergoing bariatric surgery.
* Patients with either diabetes type 2 or the metabolic syndrome will be included in the cohort.

Exclusion Criteria:

* Participants with chronic kidney disease (\> stage 4)
* Autoimmune/inflammatory disease (e.g., Lupus, Ulcerative Colitis, etc.)
* Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
* Clinically significant liver disease (e.g. Cirrhosis or liver failure)
* Weight \> 450 pounds (DXA scan weight limit)
* History of organ transplant
* Treatment with chemotherapy or radiation therapy at the time of enrollment in study.
* Poorly controlled asthma (participants requiring inhaled glucocorticoids and/or oral glucocorticoids)
* Current nasal corticosteroid use (within the past month)
* Excessive alcohol or substance abuse
* Current use of anabolic steroids or testosterone for bodybuilding purposes. Testosterone use is permitted if prescribed for hypogonadism and dose stable for the past 6 months.
* Patients actively enrolled in interventional trials involving investigational agents
* Pregnant or breast-feeding women
* Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
* History of abnormal clotting
* Previous bariatric surgery
* Anticoagulant use
* Methadone medication
* GLP-1 Medications:

  * Exenatide (Byetta, Bydureon)
  * Liraglutide (Saxenda, Victoza)
  * Semaglutide (Ozempic, Rybelsus, Wegovy)
  * Dulaglutide (Trulicity)
  * Tirzepatide (Mounjaro)
Testing Combined IIT-SIT to Control Mosquito-Borne Diseases At Scale

Mosquito-borne diseases cause suffering for hundreds of millions of people and claim more than 700,000 lives yearly. Diseases such as dengue, Zika, and chikungunya cause symptoms similar to malaria and are endemic in many parts of the world, yet there are no treatments for them nor vaccines for Zika and chikungunya. Mosquito control, particularly of the Aedes aegypti species, is seen as a potentially effective solution to slow or stop the spread of these diseases but has not yet demonstrated significant, sustainable impacts on disease transmission. The investigators will aim to significantly control or eliminate local foci (hot-spots) of dengue, chikungunya and Zika transmission and significantly reduce disease transmission by implementing a combined incompatible and sterile insect technique (IIT-SIT) program based on the release of male Aedes aegypti carrying Wolbachia (wAlbB strain) that have been previously irradiated with X-rays (to minimize the chance of fertile female releases). The investigators will implement a two-arm cluster randomized controlled trial to evaluate the epidemiological and entomological impact of population suppression via IIT-SIT on Aedes-borne diseases in the city of Merida, Mexico. Primary endpoint of the trial is the incidence of laboratory Aedes-borne viruses detected by the passive surveillance system of Mexico. Secondary endpoints will allow estimating the level of suppression of Ae. aegypti populations. This trial design will allow establishing a link between epidemiologic, entomo-virological and entomological indicators to determine the effectiveness of IIT-SIT in real world conditions. The approach is novel because it effectively eliminate vectors, such as urban, outdoor, daytime biting mosquitoes, which are not susceptible to standard vector control approaches, by targeting cryptic and inaccessible mosquito habitats. In addition, the intervention has the below advantages comparing to existing alternatives: (i) highly competitive males are used for release as Wolbachia-infected males have the mating competitiveness equal to wild-type males; (ii) release can continue until population elimination is reached as a low dose of radiation is used to sterilize females for preventing risk of population replacement; (iii) any residual females contaminated in released male pools is resistant to pathogens; (iv) public acceptance of release of Wolbachia-infected males can be easily achieved, because Wolbachia are bacteria naturally presenting in \~50 percent of insect species, and male mosquitoes neither bite nor transmit diseases and can be self-limiting post release; (v) it will not impact non-target species. Successful findings from this study will pave the way for future expansions of the combined IIT-SIT to the entire city and nationwide using a rolling-carpet strategy, which has been successfully demonstrated for area-wide control of screwworm and medfly in Latin America.


Eligibility Criteria:
Inclusion Criteria:

* All residents in the release sites will be included in the studies

Exclusion Criteria:

* No exclusion will be performed.