cyrilzakka/clinical-trials huggingface dataset:
Needs Assessment of Long-Term Care for Psychiatric Patients

The quantity and quality of inpatient services for persons with psychiatric illness have been enhanced in the last two decades. Following the enforcement of nationwide health insurance and the Physically and Mentally Disabled Citizens Protection Act, the financial pressure of medical care for psychiatric patients is relieved, and actions related to the protection of patients' human rights have been taken. Nonetheless, problems related to psychiatric illness are not limited to symptoms. Patients' daily functions are affected and it causes continuous pressure on the family. Currently, psychiatric care places more emphasis on inpatient services. Once the patient is discharged from the hospital, related psychiatric services are not widely available, which leads to symptom exacerbation, repeated hospital admissions, increased burden to the family, etc. A provision of continuous long-term care that meets the various needs of psychiatric patients is a critical issue in current psychiatric care.

Based on a three-phase needs assessment model, the purpose of the study is to evaluate the needs of long-term care for psychiatric patients. The first phase will identify the current status of needs from the perspectives of patients and the family, psychiatric professionals, and the system. The second phase will identify the goals of long-term care for psychiatric patients. The goals will be identified by a nominal group, composed of experts related to the field of psychiatric long-term care. The third phase will determine the objectives of long-term care services for psychiatric patients. That is to determine the proper contents of long-term care services for the patients based on the goals identified in the previous phase.

The three-phase needs assessment will be carried out in a two-year period. The results of the study will provide important information to the future planning of long-term care for psychiatric patients.

First, the participants were informed about how to fill in the self-report survey questionnaire. Then the participants began to complete the questionnaire. After finishing it, the participants gave the questionnaire back to the examiner.

Eligibility Criteria:
Inclusion Criteria:

* Psychiatric patient
* Must be able to read Chinese
* Caregivers of psychiatric patients
Health Enhancement And Resilience Training

The purpose of this research study is to examine whether a stress reduction intervention can improve health, mood and biological markers of cellular stress and aging in a group of chronically-stressed maternal caregivers and healthy maternal controls.

This stress-reduction intervention was added into an ongoing observational study in May of 2013. The parent study is a prospective cohort study of the effects of chronic stress in a group of maternal caregivers with children on the autism spectrum and healthy controls whose children have no diagnosis. Study participants are being invited to enroll in a 12-week stress reduction course based on the principles of mindfulness. They will attend four six-hour workshops and participate in 12 weekly hour-long web video conferencing calls to reinforce what is taught in the workshops.

At the beginning and the end of the intervention, they complete self-report measures of psychological well-being and give saliva samples. Since the women are also participating in the longitudinal study, we have other before and after data for them. These include psycho-social measures, body measurements, psycho-physiology measurements, cognitive tests, actigraphy (for sleep), as well as saliva (for hormones), hair (for hormones) and blood (for telomeres, telomerase, gene expression, circulating hormones, inflammation and oxidative stress).

Eligibility Criteria:
Inclusion Criteria:

* Must have at least one child between 2 and 16 at time of enrollment
* Caregivers must have a child diagnosed in that age range diagnosed with an autism spectrum disorder.
* Controls must have a healthy child in that age range. All women must be

Exclusion Criteria:

* Chronic disease, including recent history of cancer
* History of psychiatric disorder, such as bipolar disorder or post-traumatic stress disorder
* Medications, including statins, anti-anxiety drugs, and for controls only anti-depressants.
Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults

Using technology to deliver depression interventions is one way could alleviate the public health burden of depression. The study is testing a mobile app intervention program for depression that uses cognitive behavioral skills and mindfulness. This study seeks to obtain feedback on the intervention and refine the intervention and then test the intervention in a larger study. The mobile app intervention called the Meru Health Ascend program consists of the app and therapist support via messaging within the app.

The Meru Health Ascend program is a guided self-management program that uses a mobile application to deliver content of the intervention. A licensed therapist (Meru Health employed) provides support to participants as needed and reviews practice logs within the app.The 8-week program teaches cognitive behavioral techniques and mindfulness skills with the aim of improving the user's mental health. The platform provides informational videos, skills practices, group discussion, and messaging with the therapist. The Meru Health program enrolls participants in treatment groups that work through the program at the same time and can provide support to on another on the discussion board within the app.

We are conducting two studies in middle aged and older adults with elevated depressive symptoms to evaluate the Meru Health Ascend program. In the first study (study 1), we will examine the feasibility of the intervention in individuals aged 40 years or older with elevated depression symptoms using an iterative case series. Specifically, we will examine the usability of app and materials, dropout and reasons for dropout, and user perceptions of the program.

We will then conduct a proof-of-concept study (study 2) using a nonrandomized pre-post design to examine whether individuals achieve clinically significant reductions in depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Owns a smart phone, resides in California, PHQ-9 score greater than or equal to 10, stable dose of medication (if taking psychotropic), able to read and understand English.

Exclusion Criteria:

* Psychotic disorder, possible cognitive impairment, evidence of problematic drinking behavior, active suicide ideation with a plan, active psychological treatment, bipolar disorder (study 2 only)
Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities

The aim of this study is to evaluate performances of a NIPT test based onto the study of the maternal blood to search known genetic mutations already detected in the family and potentially inherited by the fetus. This test will avoid an invasive prenatal diagnosis in those families with a known genetic risk.

The performance of this test will be evaluated in terms of sensitivity and specificity with an adapted statistic model.

Secondary objectives of the protocol are

* To adapt NIPT to small DNA quantity (5-50 ng)
* To adapt bioinformatics pipeline to low rate of mosaicism
* To develop a tool to quantify the fetal fraction
* To evaluate the robustness of the method

This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.


Eligibility Criteria:
Inclusion Criteria:

* Couple (father, mother) \> 18 ans
* Pregnant woman (\> 12-15 weeks of gestation) with a fetal sampling needed in standard care.
* informed consent obtained
* couple affiliated to the social insurance in France

Exclusion Criteria:

* DNA extraction failure
* Absence of informed consent
* Father or mother placed under judicial protection or under guardianship or tutorship
Comparison of Diagnostic Performances of 3D FLAIR, DIR and PSIR Sequences in Optic Neuritis

Ultimately improve the care of patients suffering from multiple sclerosis (1st cause of acquired non-traumatic disability in adults) and NMO spectrum diseases by using more efficient MRI sequences than the FLAIR sequence commonly used in detection of optic neuritis.

In the literature, many studies have already focused on comparing the sensitivity of detection of white matter demyelination plaques using FLAIR, PSIR or DIR sequences.

Some authors have shown better sensitivity of the PSIR sequence in the detection of demyelinating lesions of the marrow in multiple sclerosis compared to conventional sequences.

Others have shown better performance of the combined use of PSIR and DIR sequences compared to the FLAIR sequence in the detection of cortical lesions in multiple sclerosis.

However, in the context of optic neuritis, few comparative studies comparing these three sequences have been carried out:

A 2022 study showed better diagnostic sensitivity of optic neuritis of the DIR sequence compared to the FLAIR sequence.

A possible better diagnostic performance of a sequence not used in current practice in the detection of optic neuritis (PSIR and DIR sequences), would be possible to justify their use on a larger scale and ultimately improve patient care.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject suffering from multiple sclerosis or an NMO spectrum disease
* Subject having received an MRI including 3D FLAIR, 3D DIR and 3D PSIR sequences
* Brain MRIs of eligible subjects acquired between April 1, 2019 and November 30, 2021.
* No opposition to the reuse of its data for scientific research purposes.

Exclusion Criteria:

* Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
* Artifacts not allowing satisfactory interpretation
Rituximab in Refractory Primary Membranous Nephropathy

Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.


Eligibility Criteria:
Inclusion Criteria:

* Having biopsy-proven primary membranous nephropathy.
* Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
* Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents.

Exclusion Criteria:

* Not providing or withdrawing consent.
A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.

Up to 98% of older patients with myeloid neoplasms experience physical function decline, fatigue, and mood disturbances. Mobile health exercise interventions are promising strategy to prevent physical function decline and improve fatigue and mood disturbances, but older patients with myeloid neoplasms receiving hypomethylating agents are understudied. The proposed study will evaluate a novel mobile health exercise intervention that is adapted to older patients with myeloid neoplasms receiving outpatient hypomethylating agents and investigate whether and how exercise can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age is greater than or equal to 60 years
* Have a diagnosis of MN
* Receiving outpatient chemotherapy (e.g., HMA)
* English speaking
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* No medical contraindications for exercise per oncologist
* Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
* Able to provide informed consent

Exclusion Criteria

Platelet count of 10,000 per microliter or less in the most recent blood draw (due to risk of spontaneous bleeding) prior to transfusion (i.e., patients are allowed to enroll if their platelet count is 10,000 per microliter or less but is scheduled to receive transfusion the day of consent)
Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

Comparison of the prevalence of obstructive sleep apnea (OSA), measured by polysomnography in normal weight patients with central obesity by body mass index (BMI) and waist hip ratio (WHR), with normal weight patients without central obesity by BMI and WHR.

Evaluation of arterial stiffness and vascular age in normal weight patients with central obesity and in normal weight patients without central obesity.

Determination of the exercise response characteristics in OSA patients.

Body composition (the distribution of adipose tissue) appears to be a risk factor for the prevalence of obstructive form of sleep apnea. The investigators expect a higher prevalence of this serious sleep pathology in normal weight patients with central obesity than in normal weight patient without central obesity. In normal weight patients with central obesity also endothelial dysfunctions, abnormal exercise response to dynamic load and abnormal circadian patterns of blood pressure and heart rate can be expected. There are theoretical assumptions for this hypothesis but relevant studies on sufficiently large samples of patients have not been done. The investigators will also compare the lipid profile in normal weight patients with central obesity with those of normal weight patients without central obesity.

Eligibility Criteria:
Inclusion Criteria central obesity group:

* BMI 18.5 - 24.9 kg/m2 for both men and women
* WHR more than 0.9 for men and 0.85 for women
* no history of myocardial infarction, stroke, atrial fibrillation, previous diagnosis of OSA or its treatment.

Inclusion Criteria without central obesity group:

* BMI 18.5 - 24.9 kg/m2 for men and women
* WHR selected from the lowest tertile of WHR distribution for both men and women

Exclusion Criteria:

* acute infection
* known diagnosis of chronic renal or cardiac failure
* taking drugs that affect sleep (stimulants, hypnotics, antidepressants, antipsychotics, anxiolytics, antihistamines, corticosteroids, theophylline, anti-parkinsonic drugs, anticonvulsants, morphine-type analgetics)
Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation

Carotid endarterectomy (CEA) is one of the surgical treatment methods for the reconstruction of arterial stenosis or occlusion. Perioperative stroke, cerebral hemorrhage,hyperperfusion syndrome and death are main complications of CEA. Investigator have established a risk prediction model of the procedure based on vascular characteristics and hemodynamic parameters retrospectively. This prospective study was aimed to verify the predictive ability of CEA comprehensive prediction model through the analysis of patients receiving CEA procedure in the investigator's center in the next two years.

Subjects: In this study, a total of 600-800 patients with severe carotid artery stenosis or occlusion who scheduled for CEA are recruited.

Data collection:

1. The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.
2. CT, MRI and digital subtraction angiography (DSA) were applied pre- and post-procedure to identify the clinical events.

Endpoint: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome within 30-day after the procedure.

Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis. The area under the receiver operating characteristic (ROC) curve and hosmer-lemeshow test were used to evaluate the discrimination and calibration of the risk prediction model.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by color duplex flow imaging (CDFI) and confirmed by CT angiography (CTA) or digital subtraction angiography (DSA).
2. Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
3. MRI and CT were applicated pre- and postoperation.

Exclusion Criteria:

1. Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism, et al.
2. Lack of any imaging evaluation results, such as ultrasound, MRI or CT.
A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 55, inclusive
* Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination
A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain.

The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent
* Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests
* All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended

Exclusion Criteria:

* Participation in other clinical studies within 3 months before screening
* Scheduled for surgery, medical treatment or any hospital admission that would fall within the study
* Use of strong painkillers
* Use of any analgesic within 24 hours before start of study
* Use of a regular course of prescribed medication and/or herbal medicine
* The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas
* A past history of contact dermatitis, psoriasis or keloid
* Any clinically significant ECG abnormality at screening
* A history of drug or other allergy that contraindicates his participation.
* Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
* Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
* A known history of drug or alcohol abuse.
* As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
* Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
* Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.
Ambulatory Geriatric Evaluation - Frailty Intervention Trial

The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

Frail older adults are at increased risk of vulnerability and serious health problems. This leads to increased suffering and higher healthcare utilization. There are major gaps in the knowledge needed to create the most favourable care model for preventing frailty and increasing health-related of life. The purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment and follow up in community-dwelling elderly people can prevent frailty, hospitalisation and adverse effects of frailty, improve health and health-related quality of life, and reduce costs, compared with usual care. In a randomized, controlled trial with 24 months of follow-up, a total of 430 older adults with multimorbidity will be randomized into two groups. The intervention group will receive Comprehensive Geriatric Assessment and follow up and the same standard health care services as the control group. The Comprehensive Geriatric Assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that Sweden's pensioners' organizations have presented in 2010 together with the Swedish Association of Geriatric Medicine. The team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist.

The primary outcome is development of frailty and hospitalization. Secondary outcomes are adverse effects of frailty, health and health-related quality of life and costs. There is a knowledge gap of how health care can identify persons with frailty and risks for frailty and how to meet their specific care needs. The study aims to fill a clinically important knowledge gap that can guide further development of future care for older people with multi-morbidity and frailty. CGA is readily transferable to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Elderly 75 years and above
* Have been hospitalized three or more times in the last 12 months
* Have three or more diagnoses in their medical records according to the International Classification of Diseases (ICD-10)
* Live in their own homes (not nursing home) in the municipality of Norrkoeping
* Accept to participate in the study.

Exclusion criteria:

- Fulfilling the inclusion criteria but living in a special accommodation for the elderly
Blood Pressure Monitor Clinical Test

To monitor the blood pressure level of the patient


Eligibility Criteria:
Inclusion Criteria:

- IEC 60601-1-2

Exclusion Criteria:

-