cyrilzakka/clinical-trials huggingface dataset:
Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.

Study A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days. In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 events/h. Subjects that persisted with excessive leak at the end of the Study A will be invited to Study B.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate and severe obstructive sleep apnea;
* Use of CPAP with a nasal mask;
* 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events

Exclusion Criteria:

* Patients who experience unintentional leakage from the mask/accessories.
* Diagnostic polysomnography examination with a predominance of central apnea;
* Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD;
* Previous surgery for obstructive sleep apnea;
* Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality.

Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ADRD, including clinical assessment and either radiographic or laboratory biomarker assessment
2. Meets NIA-AA clinical dementia criteria
3. Willing to initiate treatment with AchEI for ADRD
4. MoCA score \< 24
5. For females, either age \> 55 years, or Age \< 55 years and at least 12 months since last menstrual period
6. For males, age \> 50 years
7. Geriatric Depression Scale score \< 6

Exclusion Criteria:

1. Currently on acetylcholinesterase inhibitor
2. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab)
3. Use of bisphosphonate within last 2 years
4. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
5. History of disorders associated with osteoporosis: collagen vascular diseases, malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
6. History of hip fracture, hip replacement, or non-ambulatory
7. Long-term use (\>6 months) of corticosteroids
8. History of Parkinson's, HIV, Huntington's disease
9. History of solid organ transplantation
10. Severe kidney impairment (eGFR \< 30 ml/sec),
11. Active malignancy, except non-melanomatous skin cancer
12. 1-year mortality \> 25%, measured by ePrognosis calculator
13. Initiation of investigational or FDA-approved anti-amyloid drug
Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI

This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.

This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.

Eligibility Criteria:
Inclusion Criteria:

1. pathological diagnosis of rectal cancer;
2. received neoadjuvant chemoradiotherapy before surgery;
3. before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.
4. before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin;
5. pre-neoadjuvant clinical stage II/III (AJCC 7th edition);

Exclusion Criteria:

1. simultaneous distant metastatic tumor should be considered at the first diagnosis;
2. patients with distant metastasis were not considered at the initial diagnosis;
3. with other malignant tumors;
4. before neoadjuvant therapy, patients had received other relevant treatments;
5. to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
Postoperative Pain Relief After Major Abdominal Gynecological Surgery

The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.

Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II,
* between the age of 18-69,
* undergoing major gynecological abdominal surgery under general anesthesia

Exclusion Criteria:

* lack of patient consent
* ASA \> III
* sensitivity or contraindication to study drugs
* conditions in which epidural anesthesia is contraindicated
* emergency and urgent surgery
* inability to comprehend pain scale
* any contraindication to the use of patient controlled analgesia (PCA) device.
Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks

An observational study to evaluate the accuracy of a digital cough monitoring tool to reflect the incidence of COVID-19 and other respiratory infections at the community level in the city of Pamplona, Spain.

This is a single-center prospective observational study that pretends to evaluate the accuracy of an acoustic surveillance mobile app to detect individual episodes of cough among a monitored population, as well as the barriers and facilitators that might affect uptake of similar platforms at a population level.

The app in question, Hyfe cough tracker, runs in the background of smartphones, and records short snippets (\<0.5 seconds) of explosive, putative cough sounds. These are then classified as cough or non-cough, using a convolutional neural network (CNN) model, and matched to GPS and time data collected by the smartphone.

The night-time cough of participants will be monitored for a 30-day period, and their clinical records will be reviewed regularly, specifically looking for diagnoses of cough-producing diseases, and with special emphasis on COVID-19.

Cough data will be used to create a heatmap of cough density and geographic distribution. Aggregated cough registries will be used to calculate the coughs per person-hour registered in the cohort. These data will be used to carry out an ARIMA analysis on three parallel time series at the community level: The incidence of respiratory disease in the monitored cohort, in the entire study area (including the Universidad de Navarra, and the neighbouring Cendea de Cizur), and the cough frequency per monitored hours.

Changes in cough frequency will also be compared to other environmental variables such as temperature and pollution level registered in the study area.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 13 or above,
* Own and regularly use a smartphone able to run the cough-tracking system,
* Be willing to install and regularly use it,
* Be current residents of Navarra, and
* Have an active relationship with the university (having interest in the study, or being a student or worker, be a patient with a cough-related diagnosis at the Clínica Universidad de Navarra, or Cizur's health centre).

Exclusion Criteria:

* Inability to accept the privacy policy and terms of use of the cough-tracking system.
* Inability to grant access to medical records.
Cardiovascular Biomarkers in Peripheral Artery Disease.

Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that may increase the risk of acute limb ischemia or amputation. There are no clear molecular associations that could explain the differences in outcomes after endovascular therapy in patients with PAD. The variable outcomes following endovascular therapy may depend, at least in part, on the profile of cytokines involved in inflammatory and atherosclerotic processes.

The goal of this observational study is to evaluate the potential use of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in diabetic patients with PAD and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

* association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse limb events (MALE) after lower extremity revascularization.
* association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse cardiovascular events (MACE) after lower extremity revascularization.

Diabetic patients with CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 before the endovascular procedure.

Incidence of MALE and MACE will be collected in a 12-months follow-up and will be associated with IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years
* diagnosis of T2DM present for a least one year
* Ankle/Brachial Index (ABI) of less than 0.80
* lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
* category 4 or 5 of PAD in accordance with the Rutherford classification
* presence of CLTI requiring endovascular treatment

Exclusion Criteria:

* pregnancy
* acute infections at present or in the previous month
* diabetic foot ulcers with sign of infection or osteomyelitis
* previous lower-limb endovascular or surgical revascularization within the past 3 months
* diabetic peripheral neuropathy
* liver disease with a functional status B or C in accord to Child-Pugh classification
* congenital or acquired thrombophilia
* active autoimmune disease
* active cancer
* organ transplantation
* life expectancy \< 12 months
* contraindication to antiplatelet therapy
* contraindication to endovascular revascularization
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.


Eligibility Criteria:
Inclusion Criteria:

* \<6 months old at time of enrollment, and able to initiate study drug between 3 and 6 months old.
* Born \> 35 weeks gestational age with a clinical diagnosis of HIE at birth, who receive therapeutic hypothermia.
* Post-hypothermia brain MRI with evidence of hypoxic-ischemic brain injury, based on the neuroradiology clinical report. Specifically, participants must have had evidence of a lactate peak by magnetic resonance spectroscopy and/or signal abnormalities by conventional (T1 and/or T2) or diffusion-weighted images consistent with hypoxic-ischemic pattern of injury.
* English- or Spanish-speaking families, as the parents/guardians will be responsible for documenting dose administrations and adverse events.

Exclusion Criteria:

* Known genetic or chromosomal disorder, and in the presence of congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator (PI) or delegate, affect drug metabolism.
* Maternal use of metformin while actively breastfeeding.
* Infant weight below the 10th percentile based on WHO growth charts at the time of study drug initiation.
* Normal post-hypothermia brain MRI, without evidence of ischemic brain injury, based on the neuroradiology clinical report.
* Concomitant use of the following drugs: anti-diabetic drugs (insulin, sulfonylureas), steroids, diuretics (furosemide, chlorothiazide, spironolactone), diazoxide, beta blockers, ACE inhibitors, angiotensin II blockers, calcium channel blockers (including nifedipine), phenytoin, valproic acid, topiramate, cimetidine, corticosteroids, thyroid medications, sympathomimetics, carbonic anhydrase inhibitors, or any antibiotics.
* Any condition or diagnosis, that could in the opinion of the PI or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
Increasing Influenza and Tdap Vaccination of Pregnant Women

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Eligibility Criteria:
Inclusion Criteria:

Patients

* Sex is female
* Pregnant
* identified as being eligible for influenza or Tdap vaccine

Providers

* any provider, nurse or staff associated with the participating sites

Exclusion Criteria:

Patients

* none

Providers

* none
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.


Eligibility Criteria:
Inclusion Criteria:

* 60+ years of Age
* Signed an informed consent prior to the start of study
* Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
* Females must be postmenopausal or have a negative pregnancy test

Exclusion Criteria:

* A history of allergic reaction to any vaccine component (including gelatin or neomycin)
* Prior receipt of any varicella or zoster vaccine
* Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
* Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
* Subject is pregnant or breastfeeding
* Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
* An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
* Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
* Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
* Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
Safety and Tolerability of VGR-R01 for Patients With Bietti Crystalline Dystrophy

A Multicenter, Open-Label, Non-Randomized, Uncontrolled Study of VGR-R01 in Patients with Bietti Crystalline Dystrophy.

VGR-R01 is a novel AAV vector carrying the human CYP4V2 coding sequence. This study is intended to evaluate the safety and tolerability of a single subretinal administration of VGR-R01. All subjects will undergo at least 52 weeks of safety observation and will be encouraged to enroll in an extension study to evaluate the long-term safety of VGR-R01 for a total of five years.

Eligibility Criteria:
Key Inclusion Criteria:

1. Able to provide informed consent and comply with requirements of the study;
2. ≥18 years and \<70 years of age;
3. Confirmed diagnosis of Bietti Crystalline Dystrophy and molecular diagnosis of CYP4V2 mutations (homozygotes or compound heterozygotes);
4. BCVA ≤ 60 ETDRS letters in the study eye.

Key Exclusion Criteria:

1. Have insufficient viable retinal photoreceptor cells based on investigator's decision;
2. Have current ocular or periocular infections, or endophthalmitis;
3. Have any significant ocular disease/disorder other than BCD, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc;
4. Have intraocular surgery history except cataract surgery in the study eye;
5. Have or potentially require of systemic medications that may cause eye injure;
6. Have contraindications for corticosteroids or immunosuppressant;
7. Unwilling or unable to have the planned follow-up;
8. Abnormal coagulation function or other clinically significant abnormal laboratory results;
9. Have malignancies or history of malignancies;
10. History of immunodeficiency (acquired or congenital); Other protocol defined Inclusion/Exclusion criteria may apply.