cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are:

* Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP).
* In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA

Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram.

Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.


Eligibility Criteria:
Inclusion Criteria:

* Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable understand and sign "informed consent"
Effect of ANKASCIN 568-P Products Regulating Blood Lipid

This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)

This experiment hopes to understand the effect of long-term consumption of red yeast rice products on blood lipid regulation and high-density lipoprotein cholesterol (HDL-C) elevation and to monitor the changes in the subjects' overall health status. This case is a randomized, double-blind, placebo-controlled trial. It is expected to recruit 80 subjects and randomly assign them to 2 groups to take red yeast rice products or a placebo for 24 weeks. The test group takes one red yeast rice capsule (containing 220 mg ANKASCIN 568-P), the control group took a placebo capsule of similar appearance (containing an equal weight of maltodextrin) every day, and blood samples were collected at 0, 4, and 12, 24, weeks for biochemical analysis and recorded. Subjects' general body position measurement, blood pressure, blood lipids, blood sugar and other related changes, and monitoring of liver, kidney, and thyroid function.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period).
* A sane and communicative adult.
* 18≦BMI≦35.
* Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs.
* Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130\~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL.
* Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
* During the experiment, the daily routine and eating habits should be maintained and not changed deliberately.

Exclusion Criteria:

* Triglyceride TG≧500 mg/dL.
* Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
* Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
* Pregnant or lactating women.
* Those who take traditional Chinese medicine mainly based on red yeast rice.
* Those who have undergone surgery within one month.
* Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.
Ultrasound Assessment of Gastric Content and Volume

Anesthesiologists try to avoid complications with significant peri -operative morbidity and mortality such as bronchoaspiration in patients requiring a surgical procedure under anesthesia. Currently, this is achieved based on experts recommendations from the American Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment of gastric content and volume. This tool allows to individualize each patient and base the decisions objectively. The investigators will assess gastric content and volume by ultrasound in patients who have fasted and require surgery at two University Hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* perioperative fasting time between 8 and 14 hours
* American Society of Anesthesiologists status I, II, III
* Scheduled surgery

Exclusion Criteria:

* Abdominal pathology surgical emergency
* Unable to adopt right lateral decubitus position
* Altered gastrointestinal tract anatomy excluding hiatal hernia
* Body mass index greater than 40
* Patients on enteral nutrition probe or with nasogastric probe
* Pregnancy
Pro-inflammatory Cytokines in Case of Essure®

It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.

The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.

Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.

The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.


Eligibility Criteria:
Inclusion Criteria:

* women over 18
* intervention between January 2021 and November 2022
* person having expressed his non-opposition

Essure group : patient who underwent removal of the Essure® contraceptive implant

Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis

Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship
Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

Virtual Reality technology has revolutionized various fields, and its application in rehabilitation medicine is particularly noteworthy. Virtual Reality provides immersive environments that simulate real-life situations, making it an invaluable tool in the rehabilitation process.

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18, and right-handed;
* first onset, vital signs stable and conscious;
* the dysphagia confirmed by videofluoroscopic swallowing study;
* no cognitive impairment, the mini-mental state examination score: \>17 for those with an illiterate education, \>20 for those with an elementary education, and \>24 for those with a secondary education and above;
* cranial integrity without craniotomy and/or craniectomy;
* patient and/or his/her relative agrees and signs written informed consent.

Exclusion Criteria:

* combined ischemic foci at other sites;
* presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;
* severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;
* infected or broken skin on the head;
* poorly controlled epilepsy;
* poor patient compliance.
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zolpidem or any comparable or similar product.
Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D).

The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.

Objectives:

* Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution.
* Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution.

This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:

* Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information.
* Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).

Eligibility Criteria:
Inclusion Criteria:

* Caregiver of patients with type 1 diabetes under 18 years of age.
* Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.
* Patients with continuous glucose monitoring.
* Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)
* Participants administering insulin treatment to their children
* Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.
* Participants must agree on sharing data on continuous glucose monitoring data of their treated children.
* Participants must sign an informed consent
* Participants must be willing to and install the mobile solution of the study.

Exclusion Criteria:

* Candidates without a smartphone or not being able to interact with it.
* Only one legal guardian per child can participate in the study.
* Participants of SS1 will not take part in SS2.
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.

This is a Phase 1b, open-label, multicenter trial to assess the PK, safety, and tolerability of a single SC dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. Approximately 6 participants (in Cohort 1) and approximately 10 participants (in Cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

1. Thyroid eye disease (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis, and/or inconstant or constant diplopia.
2. Proptosis ≥ 3 mm increase from the participant's baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥ 3 mm above normal for race and gender.
3. Participant must be euthyroid with baseline disease under control or have mild hypo- or hyperthyroidism at Screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial.
4. Does not require immediate surgical ophthalmological intervention.
5. Participants with diabetes must have HbA1c ≤ 8.0% at Screening.

Exclusion Criteria:

1. Decreased best-corrected visual acuity due to optic neuropathy within the last 6 months.
2. Corneal decompensation unresponsive to medical management in the study eye.
3. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
4. Alanine aminotransferase or aspartate aminotransferase \> 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2 at Screening.
5. Use of any steroid (IV, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat infusion reactions.
6. Any treatment with rituximab, tocilizumab, or any other non-steroid immunosuppressive agent within 90 days prior to the first injection of investigational product on Day 1.
7. Any previous treatment with HZN-001 or TEPEZZA (teprotumumab-trbw), including previous enrollment in this trial or participation in a prior TEPEZZA trial.
8. Treatment with any mAb within 3 months prior to Screening.
Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.


Eligibility Criteria:
Inclusion Criteria:

* programmed minimally invasive surgery for:

  * aortic valve replacement
  * mitral valve replacement
  * mitral valve plastic surgery
* adult patient

Exclusion Criteria:

* emergency surgery
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi

Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.

Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* women with HIV infection who are pregnant or up to 2 months postpartum
* English speaking
* able to give informed consent
Telitacicept and Low-dose Steroids in Refractory Myasthenia Gravis

This study is designed to explore the efficacy and safety of Telitacicept combined with low-dose steroids for the treatment of refractory MG, and to investigate related biomarkers such as immunoglobulins, BlyS/APRIL, and AChR-Ab titers, in order to clarify whether Telitacicept can rapidly and effectively help achieve MG treatment goals and assist in steroid reduction.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-85 years, both genders included；
* Meet the diagnostic criteria of the 2020 Chinese MG guidelines, with positive serological testing for AChR-Ab;
* Clinical classification of Type I to Type IVa according to the MGFA;
* Meet the criteria for refractory MG in the 2022 Japanese MG guidelines: poor response to standard treatment, intolerance to standard treatment drugs due to adverse reactions, frequent relapses/exacerbations after reduction of standard treatment drugs, frequent need for rescue treatment due to disease fluctuations, frequent myasthenic crises, and comorbidities that limit the use of standard treatment;
* Patients with unstable symptoms (MG-ADL score ≥6 or QMG ≥8) despite treatment with standard therapeutic regimens before enrollment, defined as follows:

  1. Patients on monotherapy with corticosteroids: a corticosteroid dose ≤60mg/d, and a stable dose for at least 1 month before enrollment;
  2. Patients on combination therapy with corticosteroids and other immunosuppressants: a corticosteroid dose ≤60mg/d, and a stable dose for at least 1 month before enrollment, while other immunosuppressants such as azathioprine, methotrexate, tacrolimus, and mycophenolate mofetil have been stable for 6 months prior to the study start and will remain stable during the study period;
* Patients must provide written informed consent.

Exclusion Criteria:

* Patients with active infections, such as herpes zoster, HIV, active pulmonary tuberculosis, or active hepatitis;
* Patients with thymic tumors or those who have undergone thymectomy within the past 6 months;
* Patients with coexisting malignant tumors;
* Patients with severe hepatic or renal insufficiency;
* Patients who have received intravenous immunoglobulin or undergone plasmapheresis within the last 2 months;
* Patients who have received any live vaccines within the last 3 months or plan to receive any vaccines during the study period;
* Women who are currently pregnant or breastfeeding, and patients who plan to conceive during the trial period;
* Patients with allergies to human-derived biological products;
* Patients who have participated in any clinical trial within the last 28 days or within 5 half-lives of the study medication (whichever is longer);
* Any other patients deemed unsuitable for enrollment by the investigator (e.g., severe psychiatric disorders).
Mental Health eConsults

The purpose of this study is to assess whether electronic consultations between primary care providers and psychiatrists affects mental health services delivered in primary care settings.

This study assesses the effects of electronic consultations (eConsults) between primary care providers and psychiatrists as a way to support the delivery of mental health services in primary care settings. The setting for the study are the primary care clinics of Allina Health.

The study uses a randomized rollout design. Across 45 primary care clinics, half of the clinics will be randomly assigned to receive access to eConsults at the start of the study. The other half of the clinics will provide care-as-usual for nine months, at which point they will also gain access to eConsults. Stratified randomization will be used, with stratification on whether primary care clinics have co-located specialty mental health services.

For primary care clinics that are given access to eConsults, the primary care providers in those clinics will have the option of ordering an eConsult on behalf of their patients, which will include specific questions about a particular patient's care. The request is routed to the service region's psychiatry pool, and the psychiatrists have the option of responding. If they choose to respond, the psychiatrist responds with their recommendations within one business day, and the PCP proceeds with care accordingly. The psychiatrist receives 0.75 work relative value units (wRVUs) for providing this service. All communications for the eConsult are routed through Allina's Epic system. Although patients will not be billed for eConsults over the course of the proposed research, some insurance plans do cover it and evidence of eConsult effectiveness may impel other insurers to cover the service.

The study will have two components. First, the investigators will collect web survey data from the primary care providers to assess how access to eConsults affects providers' perceptions of their support and skill for delivering mental health services to their patients. Second, the investigators will assess the effects of receiving eConsults at the patient level, by using data from the Electronic Medical Record system.

Eligibility Criteria:
Inclusion Criteria:

* For the provider surveys, we will recruit all of the primary care providers who work in Allina's primary care clinics to participate in the surveys
* For the patient-level analysis, we will examine data from all patients seen in Allina's primary care clinics during the study period. We will include children and adults.

Exclusion Criteria:

* We will exclude patients from the patient-level analysis who have opted that their secondary data not be used by Allina for research purposes.