cyrilzakka/clinical-trials huggingface dataset:
INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab in participants with GITR expression in recurrent or metastatic HNSCC who have progressed on or after prior systemic therapy including anti-PD-(L)1 therapy. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2)

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
* Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment Group B (Part 2, expansion): PD-(L)1-naïve.
* ECOG performance status of 0 to 1.
* Measurable disease based on RECIST v1.1.
* Mandatory pre-treatment and on-treatment tumor biopsies.
* GITR-positive tumor confirmed by central laboratory before study treatment start.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mAB for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor.
* Prior treatment with any TNF Super Family agonist therapy.
* Have not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Laboratory and medical history parameters not within the Protocol-defined range before the first administration of study treatment.

Known active HBV or HCV, or Known to be seropositive for HIV.

* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Known active infections requiring systemic treatment.
Taking on Diabetes to Advance You (TODAY)

The program will consist of diabetes self-management sessions, led by an occupational therapist. The sessions will be held in an individualized format. Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes. As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* 18 or older
* patient at the Family Medicine Center in Fort Collins

Exclusion Criteria:

* reading level below 6th grade
* inability to understand written or verbal instructions regarding questionnaires
A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Confirmed moderate or severe rheumatoid arthritis
* Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

Exclusion Criteria:

* Presence of infectious diseases \[tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C\]
* Inadequate hematologic, renal or liver function
* Peptic ulcer disease (in acute phase)
* Pregnant and lactating women
a Bike Application to Support Cardiac Patient

The pilot study will investigate the usability of a mobile cycling application in a cardiac patient population during a one month study period.

The application's effectiveness regarding ability to reduce fear and increase motivation to exercise will be assessed.

This pilot study investigates the use of a mobile cycling application for patients with a cardiac disease that was developed by the Expertise Centre for Digital Media of Hasselt University in collaboration with the Faculty of Medicine \& Life Sciences of Hasselt University. During the pilot study, the use of the cycling application and its impact on fear and motivation of patients with a cardiac disease during the rehabilitation is studied. The cycling application will be used on a smartphone, in combination with a wrist-worn heart rate monitor.

During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment. Through questionnaires and interviews, the patients' experiences with respect to fear and motivation will be collected. Furthermore, the usability of the cycling application is evaluated through these questionnaires and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.
* Patients that have completed the standard cardiac rehabilitation program
* Patients who have access to a computer and a WiFi internet connection
* Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital
* Patients who signed the informed consent document

Exclusion Criteria:

* Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.
* Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.
* Patients with a pacemaker.
* Non-Dutch speaking patients
* Patients who simultaneously participate in another study
Assess Fibrin in Brains With AD/ADRD

The goal of this project is to quantify brain fibrin content using 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to evaluate potential regional differences.

While there are many potential therapeutics being evaluated for Alzheimer's disease and related dementias (ADRD), there is currently no known cure for ADRD and its origin and pathophysiology are still not well understood. However, the association of fibrin with ADRD is becoming increasingly clearer. Up to now it was not possible to quantify brain fibrin in vivo to better elucidate its role in ADRD, but recently, 64Cu-FBP8 was proposed as a tool to detect thrombus anywhere in the body. This unique tool will allow us to non-invasively assess brain fibrin levels in at-risk and ADRD subjects.

The goal of this project is to use 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to assess fibrin levels. It is expected that about 30 people will take part in this research study. 64Cu-FBP8-PET is not currently approved by the U.S. Food and Drug Administration (FDA).

Eligibility Criteria:
Inclusion Criteria:

* Age between 55 and 90 years
* Ability to provide informed consent
* Specific to healthy volunteers: no history of ADRD
* Specific to ADRD subjects: clinical diagnosis of AD - either amnestic or atypical, clinical severity ranging from MCI to moderate dementia (CDR 0.5-2.0), MMSE score greater than or equal to 15 and/or MOCA greater than or equal to 12
* Specific to BAnD subjects: referred through the Brain Aging and Dementia (BAnD) research registry

Exclusion Criteria:

* MR contraindications such as: electrical implants such as cardiac pacemakers or perfusion pumps; ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
* Preexisting medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
* Subjects whose estimated glomerular filtration rate (eGFR) \< 60 mL/min will be excluded from receiving the gadolinium-based contrast agent
* Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)
* 3. In line with published MGH IRB guidelines for pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.
Continue Entecavir Rollover From China

The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
* ALT ≤ 15 x upper limit of normal
* Compensated liver disease

Exclusion Criteria:

* Coinfection with HIV, HCV, or HDV
Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?

Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia before the introduction of antibiotics in the mid-1900s. The purpose of this study is to determine if OMT, when used in conjunction with antibiotics and other usual care, will improve the recovery of elderly pneumonia patients.

This study is a multi-center study conducted across five sites in the United States to determine the efficacy of combining Osteopathic Manipulative Treatment(OMT)with antibiotics as a treatment regimen for elderly patients with pneumonia. The study is a prospective, randomized, controlled clinical trial, in which 360 subjects will be randomly assigned to three different groups to test the primary hypothesis that the combination of OMT and antibiotics will decrease the length of hospital stay for elderly patients with pneumonia. The first group (OMT Group) will receive a series of eight osteopathic manipulative techniques in combination with conventional antibiotic care. The second group (Light Touch Control Group) will receive a light touch mimic treatment in combination with conventional antibiotic care to control for the doctor-patient interaction. The third group (Conventional Care Only Group) will receive only the conventional antibiotic care normally given to elderly patients with pneumonia. The first two groups will receive two 15-20 minute treatments per day, at least six hours apart, for the duration of their stay in the acute care facility.

The primary outcomes for measuring efficacy are: Length of Hospital Stay, Time to Clinical Stability, and Rate of Symptomatic and Functional Recovery. The secondary outcomes are: duration of IV and oral antibiotic usage in the hospital, number of complications and deaths secondary to pneumonia, re-admission rate within 60 days of hospitalization admission date, duration and severity of fever, duration and severity of leukocytosis, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 50 Years old or older
* Subject is hospitalized in an acute care facility
* Subject must exhibit at least two of the classic symptoms of pneumonia, to include:
* Respiration Rate greater than or equal to 25 respirations per minute
* New or increased cough
* Fever greater than or equal to 100.4 degrees F (38 degrees C)
* Pleuritic chest pain
* Worsening of mental or functional status
* Leukocytosis (WBC greater than 12,000 cells per cubic millimeter)
* New or increased physical findings (rales, wheezing, bronchial breath sounds)

Exclusion Criteria:

* Lung abscess
* Advancing pulmonary fibrosis
* Bronchiectasis
* Pulmonary tuberculosis
* Lung Cancer
* Metastatic malignancy
* Uncontrolled metabolic bone disease that places subject at risk for pathologic bone fracture (i.e. Paget's Disease or hypoparathyroidism)
* Acute or unhealed rib or vertebral fracture
* History of pathologic bone fracture
* Previous participants as subject in the study
* Respiratory failure (intubation)
The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia

We aimed to determine the prevalence of HAI in medical Tunisian ICUs. Secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of HAIs.

In Tunisia, there is no national or regional monitoring system of HAI. It is worth noting that HCAIs in intensive care unit (ICU) are more common and life threatening than in general ward because of the frequent use of invasive procedures and multiple therapies.

Controlling this fatal scourge should begin with greater awareness of HAI frequency and ICU ecology. That is why conducting multi-center Tunisian studies is necessary to guide control measurements against HAI and to improve surveillance and infection-control practices. NOSOREA1 study (Tunis Med. 2018 Oct-Nov;96(10-11):731-736) was conducted in 2017 and showed that HAI prevalence within Tunisian ICUs was 25.2% CI 95% \[15-35\]. Five years later, it is high time to update our finding.

Eligibility Criteria:
Inclusion Criteria:

* All patients occupying an ICU bed over a 48-hour period
* Age \>=18 years

Exclusion Criteria:

* no criteria
Correlation Between Sagittal Balance of the Spine and Psychopathological Profile

In this trial, the correlation between the psychopathological profile and sagittal balance unexplored to date spine will be studied. Indeed, a number of patients who benefited from well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly to it. The investigators wonder if there are biomechanical factors or factors of psychopathological order which might influence the effectiveness of treatment. This seems logical for the entire medical community, but it has never been demonstrated in a clinical trial.

The purpose of this study is to find a global diagnostic and standardized tool , easy to use, on psychopathological factors influencing the posture of the patients lombalgia so that in this will be used to use identify upstream surgery, the patients undergoing psychiatric treatment of mood rather than surgical treatment. And thus may economise a surgical operation and its complications and the related expenses.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 70 years ·
* Spine surgery outpatients with or without low back pain with radicular ·- Affiliated to a social security scheme,
* Having signed an informed consent and were informed of the results of the consultation prior to inclusion

Exclusion Criteria:

* Patients having the major diseases of the spine: deformities (scoliosis, kyphosis), tumors, fractures, inflammatory and metabolic ·
* Patients having a spinal surgery history ·
* Patients difficult to inform ( emergency ward patients, patients with difficulties in oral comprehension)
Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?

The study's aim is to determine whether a short video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the actual effectiveness of PMR in comparison with a neutral (no video) control group.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* fluency in the German language to provide informed consent

Exclusion Criteria:

* Chronic illness
* Mental disorder
The Effect of Motivational Interviewing on Anthropometric Measurements, Eating Attitudes, and Cardiometabolic Index in Overweight and Obese Patients

The Effect of Motivational Interviewing on Anthropometric Measurements, Eating Attitudes, and Cardiometabolic Index in Overweight and Obese Patients

Participants were randomly assigned into two groups-an Intervention Group (n = 40) and a Control Group (n = 40)-using block randomization through the website "random.org." Data were collected using a Personal Information Form, the Eating Behavior Disorder Scale, Anthropometric Measurements (body weight, body mass index, waist circumference, waist/hip ratio), and the Cardiometabolic Index. Both groups received routine recommendations, which included a daily caloric restriction of 500 kcal and moderate-intensity aerobic exercise for 30 minutes, five days a week.Motivational interviewing was administered to the intervention group through individual sessions, held once every two weeks, for a total of four sessions, each lasting 15 minutes. The interviews were conducted in the Education Room of the Saltuklu Family Health Center. After the motivational interviewing intervention was completed, post-tests (Eating Behavior Disorder Scale, Anthropometric Measurements, and Cardiometabolic Index) were administered to both groups. All participants were followed for a period of three months.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) in the range of 25 to 34.9 kg/m² was considered as an inclusion criterion
* Being between 20 and 40 years of age (corresponding to the young adulthood period according to Erikson)

  -- Participants were required to be registered with the Saltuklu Family Health Center.
* Willingness to participate in the study and provision of informed consent were required

Exclusion Criteria:

* Current use of medications known to induce weight gain or loss
* Presence of a diagnosed chronic illness
* Pregnancy or being in the lactation period."
Oral Health in Bariatric Patients

As few is known about the oral health of bariatric patients, this study aimed to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

The prevalence of overweight and obesity is increasing since the 1980s. Being associated with several risk factors such as hypertension, hyperinsulinemia and hyperlipidemia, obesity presents an immediate and long-term health risk for diabetes mellitus, heart diseases, osteoarthritis and certain forms of cancer. For the control of obesity several therapy options have been developed: Beside conservative treatments including change of diet and lifestyle, bariatric surgery is considered as a promising option for patients with severe obesity (BMI ≥ 40 kg/m2). Allowing impressive weight loss from 40 to 80% and effective reduction of comorbidities, bariatric surgery shows some negative/adverse effects as well, like kidney problems, hyperparathyroidism, anemia and metabolic bone diseases. For oral health, two facts are particularly important to consider: Firstly, chronic regurgitation reaching the oral cavity is an important risk factor for erosive tooth wear which initially appear as smooth silky-shining glazed surfaces. Further progress is often associated with hypersensitivities and aesthetic deficits. Over time, often substantial loss can been observed, provoking hypersensitivities and aesthetic deficits. Secondly, depending on the type of bariatric surgery, pronounced postoperative metabolic and nutritional changes can be observed which also might influence oral health. Aim of this study is to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* BMI ≥ 25 kg/m2 without or after bariatric surgery

Exclusion Criteria:

* refusal for participation
* age \<18 years
* BMI \<25 kg/m2
Xeltis Pulmonary Valved Conduit Safety and Performance Study

This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.


Eligibility Criteria:
Inclusion Criteria:

1. Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
2. Male or Female.
3. Age \< 22 years.
4. Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both.
5. The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
6. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion Criteria:

1. Need for or presence of prosthetic heart valve at other position
2. Need for concomitant surgical procedures (non-cardiac)
3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
4. Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
5. Active endocarditis
6. Leukopenia, according to local laboratory evaluation of white blood cell count
7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
8. Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
9. Severe chest wall deformity, which would preclude placement of the PV conduit
10. Pulmonary hypertension (right ventricular systolic pressure ≥ half of systemic systolic pressure)
11. Right ventricular outflow tract aneurysm
12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
13. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
14. Patient has chronic inflammatory / autoimmune disease
15. Need for emergency cardiac or vascular surgery or intervention
16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
17. Currently participating, or participated within the last 30 days, in an investigational drug or device study
18. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
19. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
20. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance