cyrilzakka/clinical-trials huggingface dataset:
Household Participants

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.

Eligibility Criteria:
Inclusion Criteria:

* Current resident of the household in which an index participant lives
* Willing to complete data collection protocols
* Fluent in written and spoken English

Exclusion Criteria:

-
Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection

This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent emergency colostomy or ileostomy

Exclusion Criteria:

* Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection
Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients

Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis

* the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity.
* the relationship between voluntary muscle strength and mortality
* the relationship between voluntary muscle strength and physical activity

Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis

* the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity.
* the relationship between voluntary muscle strength and mortality
* the relationship between voluntary muscle strength and physical activity

Eligibility Criteria:
Inclusion criteria:

* chronic kidney disease patient with extrarenal replacement therapy by hemodialysis for at least 3 months
* stable clinical condition (absence of infection, stroke or acute decompensation)

Exclusion criteria:

* chronic kidney disease without extrarenal replacement therapy
* history of renal transplantation
Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC)

Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* anterior surgical management (ALIF or LLIF)
* symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
* period from June 2017 to December 2019

Exclusion Criteria:

* Traumatic sprains
* History of decompression after the operated stage
* Operated from a later time at the same time
* Scolioses with Cobb angles greater than 10°
* Patients under judicial protection
* Refusal to participate
Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography

Optical coherence tomography angiography (OCT-A) is a determinant progress to study retinal and choroidal vasculature without using a dye injection. OCT-A yields interesting results in different pathologies such as diabetes mellitus, age-related macular degeneration, hypertension blood pressure, particularly by affecting vascular density. Normative database are necessary to compare OCT-A parameters between patients and controls. However, OCT-A devices from different manufactures may give different values for the same subject. It seems to be obvious that each OCT-A device should have its own normative database. In the literature, OCT-A normative databases are developing using different types of devices, but none is available for Heidelberg OCT-A in Caucasians. The purpose of this project is to create a normative database of retinal microvascularisation using Spectralis Heidelberg optical coherence tomography angiography (OCT-A) ® in normal controls.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary adult subjects or legal representative consenting for minor or subjects under protection
* Intra ocular pression ≤ 21mmHg
* Spherical refraction comprised between - 6 D and +6 D and/or axial length between 21 and 26mm
* Patient affiliated to social security system

Exclusion Criteria:

* Ocular diseases: glaucoma, retinal diseases as diabetic retinopathy, age-related macular degeneration, amblyopia, optic neuropathy
* Diabetes mellitus
* Uncontrolled hypertension blood pressure (\> 140/90)
* Recent ocular surgery (\< 6 months)
* Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity ...)
* OCT-A sufficient quality ≥ 25 (0 = bad quality /40 = excellent quality
* Not consenting patient
* Pathological situation or handicap avoiding good installation
Clinical Decision Support for Atrial Fibrillation and Flutter

Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18y) KPNC members presenting to the ED with a primary ED diagnosis of atrial fibrillation/flutter (AF/FL). Subjects who meet criteria will be identified electronically within the CDSS tool in the electronic health record.

Exclusion Criteria:

* Children (\<18y).
* Non-members of KPNC.
* Patients who were prisoners, pregnant, receiving hospice or palliative care, or who left against medical advice at the index encounter for AF/FL.
Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion:

* 18 years of age or older (younger patients may be enrolled at the discretion of physician)
* Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy
* Signed/dated Informed Consent

Exclusion:

-None
CT Abnormalities Evocative of Lung Infection Are Associated With Lower 18F-FDG Uptake in Confirmed COVID-19 Patients

CT signs that are evocative of lung COVID-19 infections have been extensively described, whereas 18F-FDG-PET signs have not. Our current study aimed to identify specific COVID-19 18F-FDG-PET signs in patients that were (i) suspected to have a lung infection based on 18F-FDG-PET/CT recorded during the COVID-19 outbreak and (ii) whose COVID-19 diagnosis was definitely established or excluded by appropriate viral testing.


Eligibility Criteria:
Inclusion Criteria:

* Patient coming to nuclear medicine for 18F-flurodesoxyglucose (FDG) positron emission tomography computed tomography (PET-CT) with suspicion of lung involvement
* patient affiliated to a social security scheme or equivalent
* adult patient having been informed of the study

Exclusion Criteria:

* patient with a negative covid 19 test
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects

The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

\* Medically healthy based on medical records and study specific assessments

Exclusion Criteria:

\* Presence or history of severe adverse reaction to any drug or drug excipient
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 2 hypertension within protocol limits at randomization
* Patients with type 2 diabetes mellitus with HgA1c less than or equal to 9%
* Patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening

Exclusion Criteria:

* Patients taking 4 or more antihypertensive medications at screening visit
* Patients with uncontrolled BP (\> 140/90 mmHg) while taking 3 or more antihypertensives at their maximum approved doses
* Type 2 diabetes mellitus requiring insulin treatment
* Patients with HgA1c \> 9%
* Patients with known gout
* Known history of cancer within the past 5 years
* Patients who are pregnant or nursing mothers
* Patients who have participated in an investigational clinical trial within the 30 days prior to screening.
* Other protocol-defined inclusion/exclusion criteria may apply
Home-based Balance Training in Adults With Multiple Sclerosis

This single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (MS). The feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3) management (e.g., assessment time), and 4) scientific outcomes (adverse events, intervention acceptability, satisfaction, treatment effects). Moreover, this study aims to evaluate physical function (i.e., balance, mobility, dual-task ability), cognitive function (i.e., cognitive processing speed, verbal memory, visuospatial memory), real-world ambulation (i.e., gait speed, gait variability, gait quantity), and self-report questionnaires (fatigue, fear of falling, walking disability, dual-tasking difficulty). Our proposed intervention is expected to deliver a feasible and accessible exercise modality for balance and cognitive improvement in persons with multiple sclerosis.

Acknowledging the complex system of balance, this home-based balance training aims to address comprehensive balance control components, such as static balance, limit of stability, postural response (reactive balance), anticipatory postural transition, weight shifting, stability in gait, and stepping exercise. These balance components will be encompassed in every session to train balance function comprehensively. Exercise program will be progressed by varying sensory integrations, base of support, and simultaneous motor-cognitive tasks (i.e., dual-task).

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed MS
* Ages 18-75 years
* Patient Determined Disease Steps (PDDS) scale score between 2-5 (i.e., gait disability-late cane)
* Able to participate in exercise (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q+))
* Have a webcam on a device at least the size of a full tablet (i.e., larger than a smartphone)
* Have an exercise supporter (e.g., spouse or family member) who is willing to participate in the intervention
* Not currently participating in any balance-related exercise program

Exclusion Criteria:

* Cognitively unable to read and sign informed consent form and follow verbally delivered screening assessment
* Unable to communicate in English
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with methotrexate (MTX). There will be 3 treatment groups in the study as follows: CNTO148 50 mg group, CNTO 148 100 mg group, and Placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
* Patients who have previously not responded to at least one DMARD (before informed consent is obtained)
* Patients who, if they are on the treatment with a DMARD, the DMARD can be washed out for at least 4 weeks before the first administration
* Patients having at least 6 swollen joints and 6 tender joints at the time of registration and immediately before the first injection

Exclusion Criteria:

* Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
* Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
* Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain
Parenteral Nutrition Therapy in Patients With Incurable Cancer

Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the level of evidence for clinical meaningful effects is weak. Guidelines give few specific recommendations regarding which patients with incurable cancer that should be offered PN treatment. According to the Norwegian prescription database, the use of parenteral nutrition has more than doubled in the period 2004-2015. These numbers do not separate between diagnoses and medical conditions, so the current use of medical nutrition in cancer patients in Norway is not known. The decision to initiate parenteral nutrition is taken at hospitals, whereupon the patient returns home to their respective municipalities and receives follow-up by the home care service. There are often uncertainties about the duration of treatment, as patients' clinical condition can change rapidly. One major challenge health care professionals face is to decide when to end medical nutrition therapy. Patients and relatives may experience fear that discontinuation of medical nutrition accelerates death, while health care professionals often experience that nutrition in many cases does not help and inflicts negatively on patients' condition. This makes communication concerning end of nutritional treatment between health care professionals at several health care levels, patients and their relatives challenging.

There is a need for a stronger evidence base considering the effect of medical nutrition in patients with incurable cancer. To be able to study the effect of PN treatment, more studies on clinical practice of PN treatment to patients with incurable cancer is needed. Aspects like indication for use, dosage and duration of PN treatment is poorly described in the available literature. Thus, the aim of this study is to describe indications for use of PN, duration of treatment, reasons for discontinuation, method of administration, possible benefits and complications as well as survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient with incurable cancer
* Use of parental nutrition in palliative setting

Exclusion Criteria:

* Still alive
Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer

This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.

The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.

The secondary objectives of this study are to determine:

1. Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
2. Negative resection margins (circumferential resection margin) rate.
3. Downstaging rate.
4. Sphincter preservation rate
5. Locoregional and distant failure rate.
6. Overall survival

Eligibility Criteria:
Inclusion Criteria:

1. Patients with resectable or potentially resectable adenocarcinoma of the rectum.
2. Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
3. Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
4. Age greater than 18 years and \< 80 years, ECOG performance status \< 2
5. Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
6. WBC \> 3.5 x109/L, neutrophil count \> 1.5x109/L, platelet count \> 100x109/L, serum bilirubin \< 1.25xULN (upper limit of normal), AST/ALT \< 3x ULN, serum creatinine \< 1.25xULN.
7. Informed consent signed.

Exclusion Criteria:

1. Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
2. History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
3. Pregnancy.
4. Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
5. Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
6. History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
7. Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
8. Patients taking warfarin or other anticoagulating medicine.
MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD

This study mainly explored the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

According to the MDS 2015 clinical diagnostic criteria for Parkinson's disease and the diagnostic criteria for autonomic dysfunction (AutD), the patients were divided into PD with AutD group and PD without AutD group. DCE results, pet-pdrp+18f-dopa data and clinical evaluation (SCOPA-AUT, HRV and sleep EEG) were analyzed; Blood samples were collected to detect MAPT gene polymorphism, oligomers and phosphorylated synuclein. To explore the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for idiopathic PD of MDS 2015
* Age ≥ 45 years old
* Be able to complete various clinical evaluations and scales; Willing to participate in MRI, no contrast agent allergy

Exclusion Criteria:

* Dementia was diagnosed before or 1 year after the onset of motor symptoms
* Single gene form of PD
* Coexisting neuropathological diagnosis considered to affect PD progression
* Known complications affecting BBB (severe infection, cerebral infarction, etc.
* Such as comorbidities known to affect the autonomic nervous system (e.g., diabetes gangliopathy or neuropathy)
* Disturbance of consciousness, serious cerebral hemorrhage or cerebral thrombosis, serious brain tumor or brain surgery history, serious mental illness or other serious nervous system diseases, which are enough to seriously interfere with the subjects' motor and non motor symptoms
* According to the judgment of the researcher, the researcher is unable to complete the research test according to the requirements of the research scheme.