cyrilzakka/clinical-trials huggingface dataset:
OSA in Pregnant Women With Chronic HTN

The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum service.
* Gestational age 10 weeks, 0 days to 20 weeks, 6 days
* 18 years or older
* English speaking
* They will be enrolled into one of two groups:-Chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group
* The two groups will be matched for body mass index to control for the effect of obesity on OSA diagnosis and HTN.
* Subjects will be not be excluded if they have an established diagnosis of OSA that is not currently being treated.

Exclusion Criteria:

* Being treated for OSA
* On chronic opioids
* On alpha-blockers (which can interfere with the PAT signal)
* Have secondary HTN
* Unwilling to remove nail polish and/or shorten one nail (which can also interfere with the PAT signal)
* Have a severe allergy to latex
* Do not speak English.
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:

* To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
* Which sound processor to select, i.e. BP100 vs BP110
* Improve the fitting process for the sound processor
* Selection of sound processor magnet at time of fitting and over time


Eligibility Criteria:
Inclusion Criteria:

* Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 decibel (dB) hearing level (HL)
* Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 dB hearing level (HL) in the best ear
* Signed informed consent

Exclusion Criteria:

* Uncontrolled diabetes as judged by the investigator
* Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
* Unable to follow investigational procedures, e.g. to complete quality of life scales
* Less than 4mm of soft tissue pre-operatively
* Participation in another investigation with pharmaceuticals and/or device
* Condition that may have an impact on the outcome of the investigation as judged by the investigator
* Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
* Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls

The purpose of this research is to learn more about how children with mental health problems, including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and generalized anxiety disorder (GAD), differ from children without these problems. The investigators want to understand how these 4 groups of children differ in brain activity, function, and structure.

This study has 2 visits (total time \~6 hours):

Visit #1 (2-3 hours), includes: (a) detailed description of study and study consent, (b) interviews about the child's mental health, mood, and behavior, and (c) a screening IQ test (word games, playing with blocks).

If a child fits our study criteria, they will play some special computer games, provide a spit sample for DNA, and parents/children will complete questionnaires.

All children fitting our study criteria, will also be invited to complete visit #2 (2 hours) consisting of a special MRI brain scan at Brown University (Providence, RI). To make sure all children feel comfortable in the MRI, they will spend time in our practice MRI (i.e., "MRI simulator") that looks and sounds just like the real MRI. During the actual MRI, children will play a computerized game in which they can win and lose points. The MRI lasts one and a half hours (at most).

Participants are compensated for their time.

Eligibility Criteria:
General Inclusion Criteria:

* English- speaking,children \& adolescents between the ages of 7- 17
* consenting parent/guardian

General Exclusion Criteria:

* estimated IQ less than 70
* substance/alcohol use or dependence within the last 2 months
* Autism Spectrum Disorders or primary psychosis
* medical/neurological conditions that mimic the psychiatric disorders of interest
* implanted metal (NO BRACES or COCHLEAR IMPLANT)

For inclusion in the Bipolar group, participants:

* have to meet Diagnostic and Statistical Manual, 4th Edition Text Revision (DSM-IV-TR) criteria for BD Type I, including at least one lifetime episode of mania

For inclusion in the ADHD/ADD group, participants:

* meet DSM-IV-TR criteria for any subtype of ADHD or ADD
* can not currently meet diagnostic criteria for bipolar, depressive or anxiety disorders

For inclusion in the Generalized Anxiety Group (GAD), participants:

* have to meet DSM-IV-TR criteria for GAD
* can not currently meet diagnostic criteria for Obsessive Compulsive Disorder (OCD) or Post-Traumatic Stress Disorder (PTSD)

For inclusion in the Healthy Control group, participants:

* can not have a past/current history of psychiatric or substance use disorders
* can not have a first-degree relative (parents, brothers/sisters) with a history of psychiatric illness
Three-Axis Wearable Adaptive Vestibular Stimulator

The purpose of this study is to improve current galvanic vestibular stimulation (GVS) technology to ease the motion sickness often associated with virtual reality (VR) simulation.

The Three-Axis Wearable Adaptive Vestibular Stimulator (3WAVeS) technology that combines galvanic vestibular stimulation (GVS) and Virtual Reality (VR) will not only increase VR-based simulation realism and presence, but will also mitigate the motion sickness often associated with VR simulation by re-coupling the vestibular and ocular inputs to the VR user. Additionally, due to GVS technology's ability to accurately provide continuous inputs to the vestibular system, 3WAVeS can intentionally simulate high-fidelity effects of spatial disorientation for training purposes.

Eligibility Criteria:
Inclusion Criteria:

* For our purposes, participants must be able to consent to participate themselves and be 21 to 55 years of age
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
* No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English.

Exclusion Criteria:

- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent with the date of the patient must be obtained.
* Patient between 18-70 years of age receiving the primary liver.
* Female patients must have a negative pregnancy test prior to the enrolment.
* Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

* Liver re-transplantation patients or received an organ transplantation other than a liver.
* Living-related liver transplantation patient.
* Patient has received an AB0 incompatible donor liver.
* Patient who needs antibody induction therapy.
* Patient with sever infection requiring treatment.
* Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults

Capsaicinoids are defined as alkaloid compounds of the Capsicum genus, they are characterised by the pungent flavor of chili. About the Capsicum genus, there are more than 20 known compounds, including dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin and homocapsaicin. Capsaicin is the most popular compound in the biotechnological food industries. Recent studies has demonstrated the benefits of capsaicin in weight loss, however, the use of this molecule is limited given its high pungent capacity. Pungency develops due to the high affinity of capsaicin for the transient vanilloid potential receptor type 1 (TRPV1), which is primarily responsible for the transmission of pain. In order to eliminate pungency, capsaicin analogs have been developed, such as olvanil, this can become an alternative for its biotechnological and pharmaceutical purposes as an antiobesogenic treatment.

A total of 56 subjects will be invited to be enrolled in a study approaching the properties of a capsaicin analog: olvanil, along with nutritional guidance.

This double blind, randomized, parallel clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. In every visit, all subjects will undergo a body composition analysis as well as blood tests.

This study proposes three objectives for reaching a further understanding of the effects of olvanil:

1. Compare the anthropometric parameters at baseline versus final time between the groups.
2. Compare the clinical parameters at baseline versus final time between groups.
3. Compare the concentrations of the biochemical parameters at baseline versus final time between the groups.

Once the project is finished, the research strategies for new studies will be improved. In the same way, the application of the knowledge generated in it will be encouraged towards the health care of patients with obesity who could attend our service on future occasions. Finally, we would disseminate the knowledge generated in our institutional community, which would increase the impact of the project.

Eligibility Criteria:
Inclusion Criteria:

* 25-59 years of age
* Both sexes
* Subjects who agree to participate in the study and all signed informed consent
* BMI 30 kg/m2 - 39.9 kg/m2

Exclusion Criteria:

* Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, oR hypolipemic drugs
* Diagnosed autoimmune diseases
* Diagnosed cancer
* Pregnancy and breastfeeding
* Suffering from gastritis and hemorrhoids
* Subjects who wish to abandon the study
Obesity and Asthma:a Specific Phenotype

Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or "borderline" airway responsiveness.

It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for which clinical definition and characteristics and optimal management remain to be determined.

The aim of this study was to study the pulmonary physiological and airway inflammatory characteristics and response to treatment of obese women considered to have clinically severe asthma in order to demonstrate that some of these patients have a phenotype that is not that of asthma.

Twenty-five obese women (BMI over 30) and 25 non-obese women (18\>BMI\<25) considered to have severe asthma by their physician and requiring corticosteroids to control their asthma will have the following investigation:

* Respiratory questionnaires focussing on the nature and time-course of symptoms, asthma control criteria, medication use.
* Physical examination, including measures of BMI, waist, hips and ratio waist/hips
* Blood test for Complete Blood Count, blood glucose, total IgE levels and markers of systemic inflammation (C-Reactive Protein, fibrinogen...)
* Spirometry and bronchodilator response.
* Induced sputum analysis and Exhaled Breath Condensate pH to assess airway inflammation.
* Skin prick tests with a battery of common airborne allergens
* Measurement of lung volumes and airway resistance + MIP and MEP.
* Methacholine challenge (up to 16 mg/ml) with Borg scores for breathlessness and chest tightness.

Eligibility Criteria:
Inclusion Criteria:

* Will be women aged 18 years and over
* Will be in good health apart from asthma or obesity as determined by history and physical examination (No other condition that could influence the proposed tests).
* All will be non smokers or ex-smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
* Subjects will have a physician's made diagnosis of severe asthma and treated with corticosteroids.

Exclusion Criteria:

* Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
* Subjects having a co-existing illness that precludes them from the trial.
* Pregnancy or lactation
* Contraindication to the prednisone treatment.
Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus

Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.

Methods:

Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer.

Chronic Kidney Disease (CKD) is a significant global health issue that leads to end-stage renal disease (ESRD) and is associated with rising healthcare costs and high mortality rates. Its prevalence is increasing due to aging populations and the growing rates of diabetes and hypertension. CKD causes severe complications and significantly impairs patients' quality of life. There are notable disparities in CKD incidence and treatment among different socioeconomic groups, and many healthcare systems struggle with the challenges of managing and funding the disease.

In terms of treatment, there is a particular bottleneck in addressing CKD among non-diabetic patients. Currently, the focus for non-diabetic CKD patients is on controlling blood pressure and proteinuria. However, new treatments such as finerenone show promise in reducing CKD progression and cardiovascular risks in diabetic patients. Ongoing research aims to explore the effectiveness of these treatments in non-diabetic CKD patients as well. It is important to note that further studies are required to confirm the safety and efficacy of finerenone in these specific populations.

Eligibility Criteria:
Inclusion Criteria:

* CKD without diabetes

Exclusion Criteria:

* CKD with diabetes
Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease

This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo.

Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have Alzheimer's disease will be selected;
* Are aged ≥50 years;
* Medical assistance provided by the psychiatry service at IPQ;
* Who agree to participate after consent via the Informed Consent Term .

Exclusion Criteria:

* Make regular use of anticoagulants;
* Has skullcap failure, craniectomy without cranioplasty;
* Have a diagnosis of brain neoplasms or any type of nodule in the brain region;
* Have recent brain bleeds or a diagnosis of cerebral arteriovenous malformation;
* Be diagnosed with a type of dementia other than Alzheimer's;
* Have Mild Cognitive Impairment of the Elderly (MCI);
* Have clinical changes that put the test at risk, such as severe cardiorespiratory disorders;
* Has a severe cognitive disorder that makes it impossible to apply therapy or questionnaires;
* It is clinically or socially impossible for the patient to attend IMREA for applications twice a week during the study period;
* Those who disagree to participate after consent via the Informed Consent Term .
Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.

Historically, GFR equations, which predict the measured GFR (mGFR), were developed on patients with native kidneys and were further validated and used in kidney recipients. However, studies have shown significant heterogeneity in the performances of GFR equations when applied in kidney recipients, which may be attributed to variations and intrinsic characteristics specific to the transplant population. We thus made the hypothesis that GFR equations developed on a large, well-phenotyped kidney recipient cohort might achieve good performances in predicting mGFR.

The project therefore aims to:

1. Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
2. Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
3. Evaluate the effects of the new equations on the chronic kidney disease (CKD) prevalence and GFR stage

This study will provide us with data of kidney transplant patients that may allow the development of a new KRS GFR equation.

A new KRS GFR equation that presents with increased performances, as compared to current GFR equations, will improve the GFR calculation in kidney recipients, and therefore improve clinical decisions and the long-term kidney allograft management. Decisions regarding the return to dialysis or placement on the transplant waiting list will be taken with more accuracy and therefore potentially improve the financial allocation of kidney transplantation for the society.

Eligibility Criteria:
Inclusion Criteria:

* Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/2021.
* Men or women over 18 years of age.
* Written informed consent at the time of transplantation for the center database.

Exclusion Criteria:

• Combined transplantation
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.

To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.

To evaluate rate of amputations and recurrence at one year after complete cicatrisation

Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.

Main criterias:

Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).

Secondary criterias:

Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.

Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.

Eligibility Criteria:
Inclusion Criteria:

* Obtained informed consent
* Leg or foot arterial or mixed ulcer older than at least 3 months

Exclusion Criteria:

* No obtained informed consent
* Possibility for surgical treatment (revascularisation)
* Age less than 18
* Pregnancy
* Indication for major amputation (below /above the knee)
* Venous ulcer
* Ulcer with infection and / or necrosis
* Mycotic ulcer