cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Diagnosis of homozygous familial hypercholesterolemia
* Stable lipid-lowering therapies for at least 28 days
* LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
* Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
* Bodyweight of ≥ 40 kg at screening.

Exclusion Criteria:

* LDL or plasma apheresis within 8 weeks prior to randomization
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
* Liver transplant history.
* Uncontrolled hypertension.
* Moderate to severe renal dysfunction.
* Active liver disease or hepatic dysfunction.
* Known sensitivity to any of the products to be administered during dosing
New Hampshire Medicaid Wellness Incentive Program

The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health disparity and increased costs by providing incentivized health promotion programs to overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New Hampshire's 10 regional Community Mental Health Centers (CMHCs).

In the New Hampshire Medicaid Wellness Incentive Program, multiple program options will fall into two categories: (1) Supported Fitness and Weight Management and (2) Supported Smoking Cessation. Eligible participants are able to participate in 1 or both of the programs. The program options for Supported Fitness and Weight Management are: 1. Fitness Club Membership for 12 months, 2. Fitness Club Membership plus weekly meetings with a Health Mentor for 12 months (In SHAPE), 3. Weight Watchers Membership for 12 months, 4. In SHAPE plus Weight Watchers for 12 months. The options for Supported Smoking Cessation are: 1. Prescriber meeting to discuss smoking cessation treatment options, 2. Prescriber meeting plus NH State Tobacco Helpline, 3. Prescriber meeting plus Telephone-based Cognitive Behavioral Therapy for Smoking Cessation. Vouchers for memberships to community fitness centers and formal weight loss programs will be provided, as well as incentives for participation and positive outcomes. An equipoise stratified randomization design will be used to preserve the research benefits of randomization while maintaining the highly valued opportunity for consumer choice. Research assessments will be conducted at baseline, 3 months, 6 months, 9 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria for smoking intervention and weight management intervention:

* Participants must be Medicaid recipients receiving mental health treatment at one of the participating study sites in New Hampshire.
* 18 years or older

Additional Inclusion Criteria for smoking intervention only:

\*Smoking 5 or more cigarettes a day or a carbon monoxide level of 5 or higher at screening.

Additional Inclusion Criteria for weight management only:

\*Body Mass Index of 30 or higher or 25 or higher and sedentary lifestyle.

Exclusion Criteria for both interventions:

* Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
* Nursing home
* Inability to speak or understand English

Additional exclusion Criteria for weight management only:

* Previous participation in the In SHAPE program
* Active eating disorder diagnosis
* Pregnancy

Additional exclusion Criteria for smoking intervention only:

\*Active alcohol or drug dependence with use in the past 30 days
The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care

The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care.

Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received.

This is a randomized-cluster study; participating centers are randomized into experimental and control groups.

The secondary objectives of this study are to compare the impact of the intervention of a dietician on:

* daily and accumulated energy balance at the end of the intensive care unit (ICU) stay
* deficits in protein intake per day, accumulated over 7 days, and accumulated for the ICU stay
* intake of vitamins, trace elements and pharmaco-nutrients per day
* predominant route of nutrition administration (enteral / parenteral / mixed)
* the course of the stay: duration of mechanical ventilation, organ failure, the ICU stay, number of days on antibiotics
* the presence / absence of complications: mortality, on catheter bacteremia, ventilator acquired pneumonia, other infections, bedsores, episodes of hyper-or hypoglycemia
* presence/absence of diarrhea
* costs related to the management of malnourished patients in terms of enteral and parenteral nutritional therapy, dietary supplements, antibiotics and sedatives as well as the costs of ICU stay and those related to diarrhea and sores

Eligibility Criteria:
Inclusion Criteria:

* The patient must be insured or beneficiary of a health insurance plan
* Patients hospitalized in intensive care for an expected period greater than 72 hours, and for whom sufficient eating after 72 hours of hospitalization is deemed unlikely upon admission.
* Patients receiving mechanical ventilation and having at least one organ failure other than respiratory failure, defined by a SOFA score greater than 2.

Exclusion Criteria:

* The patient is under judicial protection
* The patient (or his/her legal representative or "trusted-person") indicates they do not wish to participate in the study
* It is impossible to correctly inform either the patient or his/her "trusted person"
* The patient is participating in another study, or is in an exclusion period determined by another study
* Moribund patients or those for whom death appears imminent (within 24 hours)
* Survival to Day 28 unlikely due to uncontrollable comorbidities
* Patients with advanced directives issued expressing the wish to not be resuscitated
Prognostic Value of Cardial Stress Perfusion Imaging

Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.

Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.

The implications are unknown in terms of the risk of death of the different parameters studied

Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices (medical treatment, myocardial revascularization, ...). The arrival of new solid-state cameras has been a real technological leap for this examination, making it possible to significantly improve the quality of the images and also to drastically reduce the activities of injected radiopharmaceuticals and thus the exposure of patients and staff to ionizing radiation. Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments. The injected activities are reduced up to a third of those injected in the past (this is indeed the case in the population we propose to study).

However, the value of the prognostic stratification obtained with stress myocardial perfusion scans recorded with low activity on semiconductor cameras is not yet known. In particular, the implications are unknown in terms of the risk of death of the different parameters studied (normal or abnormal examination, extent of myocardial ischemia and infarction sequelae, impact on left ventricular function in post-stress and resting states, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Any coronary patient suspected or proven to have had a stress myocardial perfusion tomoscintigraphy performed at the Nancy CHRU and corresponding to a standardized model of expression of results (i.e. more than 10,000 reports).

Exclusion Criteria:

* None
Characteristics to Predict Successful Intubation With the Bonfils Fiberscope

This study is designed to identify patients' features predictive of successful intubation using the Bonfils fiberscope.

Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils fiberscope.

Endotracheal intubation is an important act in the practice of anesthesiology. Direct laryngoscopy is the most commonly used technique to accomplish this task. Airway characteristics predicting difficult intubation with direct laryngoscopy are well defined. Physical findings, such as Mallampati classification or measurements of the thyromental distance, mouth opening, and neck extension have been validated to help anticipate difficult situations. When direct laryngoscopy is strenuous, early conversion to an alternative technique might reduce the risk of airway compromise and associated morbidity.

Many intubation devices are now available and part of the anesthesiologist's task is to select the alternative approach best suited to each patient's specific features. Despite its use for both elective and unexpectedly difficult intubation, predictive criteria for successful airway management with the Bonfils fiberscope have not been proposed.

The purpose of this study is to identify patients' features, if any, that could predict successful intubation when using the Bonfils fiberscope for perioperative orotracheal intubation in an elective surgical population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

* Induction planned without neuromuscular blocking agents
* Need for a rapid sequence induction
Special Drug Use-results Surveillance of Tafinlar/Mekinist

This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.

In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice.

Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set).

Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set)

The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have given written consent to cooperate in this surveillance
2. For patients aged \< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment.
3. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications

Exclusion Criteria:

1. Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance
2. Patients with BRAF-mutation-positive malignant melanoma
3. Patients with BRAF-mutation-positive non-small cell lung cancer
4. Patients with BRAF-mutation-positive hairy cell leukemia
Nurse Graduateness and Patient Outcomes: a Cross Sectional Pilot Study

This research project is relevant to the identification of the relationship, and its significance, between patient morality and a number of demographic, clinical and corporate characteristics. Two separate data sets have been compiled linking the existing intervention and employment data, one focusing on the admitting nurse and another one considering all the nurses involved in each intervention. Several statistical experiments will take place to support or reject the main hypothesis: higher nurse education, satisfaction and staffing levels result to lower patient mortality.

The primary research objective is to investigate the relationship between the education, satisfaction and staffing level of the nurses and the mortality rate across HMC. The relationship between mortality will be investigated against some additional demographic characteristics of the patient and the nurses as well as a umber of clinical parameters like the length of stay and the severity of the interventions. To achieve that data will be retrospectively collected from the Human Resources database containing the nurse education and demographic information and will combine it to the intervention data coming from the clinical information systems of all major public hospitals in Qatar excluding accident and emergency cases to avoid confounding. Rigorous statistical analysis will be conducted to obtain the significance of this relationship within expected confidence intervals. The end result of that process is to find whether there is a significant positive or negative relationship between nurse education and mortality rate.

For confounding purposes Accident and Emergency data have been excluded, we have performed several adjusted and unadjusted Logistic Regression tests and taking into consideration the clustering effect of the data.

Eligibility Criteria:
Exclusion Criteria:

* Accident and emergency patients
* Records with negative length of stay
* Records with incorrect patient demographics
Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent.

Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a gout diagnosis
* Initially receiving at least one anti-gout drug

Exclusion Criteria:

* \<1 year of continuous health insurance enrollment
* Colchicine and NSAID use before the cohort entry date
* Patients with hemodialysis or peritoneal dialysis before the cohort entry date
* Patients with acute kidney injury before the cohort entry date
The Development of Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale

Non-suicidal self-injury (NSSI) is a growing global mental health challenge, distinct from suicidal behavior, with unique risk factors and mechanisms. Existing risk assessment tools do not focus on differentiating NSSI from suicidal self-harm or comprehensively evaluate risk and protective factors specific to NSSI. There is a lack of clinically applicable, validated scales dedicated to assessing NSSI risk, particularly in psychiatric populations. The present study is made to design the Psychiatric Non-Suicidal Self-Injury Risk Assessment Scale, a 39-item scale that evaluates static/dynamic risk factors and protective factors for NSSI in psychiatric patients.

The initial item pool was created through literature review, semi-structured interviews, and group discussions. Two rounds of the Delphi were employed with twenty experts. We analyzed items using critical ratio, correlation coefficient, factor analysis, and Cronbach's α coefficient. Exploratory factor analysis determined item weights, while reliability analyses evaluated internal consistency, test-retest, inter-observer and split-half methods. In the validity analyses, CVI, construct validity and criterion validity were used. ROC curve established the optimal diagnostic threshold and the risk stratification was performed.

Eligibility Criteria:
Inclusion Criteria:

1. Criteria for inclusion in the sample were individuals , diagnosed with various mental disorders according to the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria;
2. Gender is not limited and aged is 12-30 years old;
3. The patient's clinical profile is complete and the medical history is detailed;
4. Informed consent from patients or guardians who signed a consent for.

Exclusion Criteria:

The patient's clinical profile was incomplete and her medical history was not detailed.
BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients

This study aims to determine if patients with higher BMI can tolerate higher doses of Entresto (sacubitril/valsartan) and experience better symptomatic and functional outcomes compared to patients with lower BMI.

This prospective cohort study will enroll heart failure patients with reduced ejection fraction (HFrEF) to evaluate the tolerability and efficacy of Entresto uptitration across different BMI categories (Normal weight, Overweight, Obese, and Very Obese). Primary outcomes include the maximum tolerable dose and incidence of adverse drug reactions. Secondary outcomes include changes in heart failure symptoms, functional capacity measured by the 6-minute walk test, hospitalization rates, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Diagnosed with heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 35%)
* Naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy
* Ability to provide informed consent

Exclusion Criteria:

* Severe renal or hepatic impairment (e.g., eGFR \&lt; 30 mL/min/1.73m², severe liver disease)
* History of angioedema
* Pregnant or breastfeeding women
* Patients with malignancies or other severe comorbid conditions
* Non-compliance with medication regimen
A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.

Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.

The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.

Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-69 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.5 and 38.0 kg/m\^2 (both inclusive)
* Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
* HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
* Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
* Any metformin formulation
* Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 (glucagon-like peptide 1) Receptor Agonists

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
Abatacept Versus Adalimumab Head-to-Head

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
* Methotrexate failure
* Naive to RA biologics
* ≤5 years duration of disease
* Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
* Willingness to self-inject subcutaneous (SC) drug

Exclusion Criteria:

* Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
* History of active or chronic hepatitis
* Cancer in the last 5 years
* History of severe chronic or recurrent bacterial or viral infections
* Risk of tuberculosis
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease