cyrilzakka/clinical-trials huggingface dataset:
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Adults between undergoing cardiac surgery involving sternotomy

Exclusion Criteria:

* Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
* existing neurologic deficit in the chest wall;
* remaining intubated at the six hour point after block placement
* weight under 50kg
* undergoing emergency surgical procedures or urgent return to the operating room
* active endocarditis or mediastinitis
* moderate to severe right ventricular function before or after cardiopulmonary bypass
* reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
* reliance on extracorporeal membrane oxygenation
* localized or systemic infection
* chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
* those who are pregnant
Keratoconus - Biomarkers and Questionnaire

The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the investigators examine wether the biomarker levels are in correlation with the disease level and duration of disease.

The questionnaire study focuses on the patients perspective. With a validated questionnaire fore keratoconus patient it examine the patients self.-evaluated visual challenges and quality of life


Eligibility Criteria:
Inclusion Criteria:

* Keratoconus residint in the Central Denmark Region

Exclusion Criteria:

* Other eye diseases
* Ocular traumas.
NOURISH+: Nourishing Our Understanding of Role Modeling to Improve Support and Health

The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+) aimed at reducing the problem of overweight and obesity in children.

Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 5 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity.

Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 5-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).

Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers must be at least 18 years old
* Parents/caregivers must have a child between the ages of 5 and 11 with a BMI \> the 85th percentile, who primarily resides in the caregiver's home
* Parents/caregivers need to speak English, be able to follow basic instructions, and perform simple exercises

Exclusion Criteria:

* Non-ambulatory parents/caregivers
* Pregnant parents/caregivers
* Parents/caregivers who have a medical condition that might be negatively impacted by exercise
* Parents/caregivers who have a psychiatric diagnosis that would impair their ability to respond to assessments or participate in a group
* Parents whose children have a medical or developmental condition that precludes weight loss using conventional diet and exercise methods
A Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology

This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
* Have completed lung cancer operation
* The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

* Patients who disagree to participate this study
KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma

This is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of KD6001 in combination with toripalimab in patients with advanced melanoma.


Eligibility Criteria:
Main Inclusion Criteria:

1. Being voluntary to sign the informed consent form.
2. Male or female, aged ≥ 18 years.
3. Patients whose estimated survival time is more than 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
5. Histologically or cytologically confirmed advanced or metastatic melanoma, and the overall proportion of subjects with mucosal malignant melanoma will not exceed 22%.
6. At least one measurable lesion is used as the target lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
7. The results of laboratory examination during the screening period suggest that the subjects have good organ function.
8. Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
9. Good compliance and follow-up.

Main Exclusion Criteria:

1. Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
2. Received immunotherapy (including PD-1/PD-L1 therapy and cell therapy) within 4 weeks prior to the start of this study.
3. Prior treatment with anti-CTLA-4 antibody.
4. Subjects with an active, known or suspected autoimmune disease.
5. Subjects with hepatitis (nonalcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and liver cirrhosis; active hepatitis B or hepatitis C.
6. Subjects with an active infection requiring systemic treatment.
7. Known history of testing positive for human immunodeficiency virus (HIV).
8. Subjects known to have active tuberculosis (TB).
9. Known to be allergic to KD6001 or Toripalimab and its components.
Home-based Exercise Training in Cardiac Patients

The investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. The primary objectives of this research project are to study the effects of exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute coronary syndrome (ACS) patients.

The subjects of the study will be recruited from the consecutive series of patients of men and women admitted to Oulu University Hospital due to an acute coronary syndrome (ACS). The study population will be randomized into control group (n=25) and study group (n=25) matched with age and gender. For all subjects, clinical status including quality of life questionnaire, exercise capacity and autonomic function measurements will be performed at baseline and after exercise training. Exercise training program is six months for both groups according to current guidelines. All the patients will have a detailed and personalized training prescription. Study group will have virtual augmented reality glasses or computer with training video to motivate and control exercise training prescription at home.

Eligibility Criteria:
Inclusion Criteria:

* Recent (\< 1 month) acute coronary syndrome

Exclusion Criteria:

* New York Heart Association (NYHA) functional classification class IV (heart failure)
* unstable chest pain (angina pectoris, Canadian Cardiovascular Society grading of angina pectoris class 4)
* ST-segment elevation myocardial infarction (STEMI)
* implanted cardioverter defibrillation or pacemaker (or planned)
* chronic atrial fibrillation
* musculoskeletal disorder (unable to participate exercise training)
* participation in competing clinical trial
* severe peripheral atherosclerosis
* retinopathy or neuropathy
* dementia
* life-expectancy due to other serious disease \< 2 years or any other reason why patient is unable or unwilling to provide written informed consent.
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
* Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
* Has a PSA level meeting one of these criteria:

  1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
  2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
  3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir
* Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as \>150 ng/dL
* Has an Eastern Cooperative Oncology Group score of ≤2
* Has a life expectancy of at least one year

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer
* Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
* Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
* Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms)
* Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
* Has a previous history or presence of another malignancy, other than prostate
* Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
* Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Eligibility Criteria:
Inclusion Criteria:

* Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Exclusion Criteria:

* Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

B9991046 is a master protocol that will consist of sub-studies from the following parent studies:

B9991001 - NCT02603432 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991

Eligibility Criteria:
Inclusion Criteria:

1. Any participant who is receiving study treatment and deriving significant clinical benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
2. Participants must agree to follow the reproductive criteria.
3. Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

Exclusion Criteria:

1. Female participants who are pregnant or breastfeeding.
2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Tai Chi and eCB in Women

The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the immune system. Moderate-intensity aerobic exercise has shown to increase circulatory endocannabinoids. In this study, we will study Tai Chi, a mind-body moderate-intensity exercise, intervention for its effects on ECS in women. A pre-post design trial will be conducted on 18 qualified subjects. We will measure plasma eCB levels at baseline, before and after 4th session of Tai Chi. All data will be analyzed statistically at p\<0.05.

The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the immune system. Emerging studies have shown endocannabinoid plays a role in appetite, pain sensation, control of chronic pain, macronutrient metabolism, mood/mood disorder, and regulation of immune cell functions. Moderate-intensity aerobic exercise has shown to increase circulatory endocannabinoids. Moderate-intensity exercise improves cognition, memory, and wellbeing in adults. Exercisers experience decreased tension, depression, and anger. Therefore, these findings in humans suggest a likely relationship for exercise effecting well-being via ECS. In this study, we will study Tai Chi, a mind-body moderate-intensity exercise, intervention for its effects on ECS in women. A pre-post design trial will be conducted on 15 qualified subjects. All subjects will be assigned to Tai Chi group for one week including 3 sessions, 60 minutes per session, on 3 non-consecutive days. We will measure plasma eCB levels at baseline, before and after 4th session of Tai Chi. All data will be analyzed statistically at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women (menopause is defined as the absence of menstrual period for 12 months, not related to pregnancy/lactation, hormonal contraception). Age 40-70 years old with BMI between 25-35 kg/m2.
2. English literacy.

Exclusion Criteria:

1. prior experience with mind-body practice (e.g., TC, Qi Gong, yoga, meditation).
2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation.
3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/ multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance.
4. taking pain/anti-inflammatory and sleep medications within the 3 months before study starts.
5. taking hormone-replacement therapy within the 3 months before study starts.
68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.

The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects of either sex, aged ≥18 years
* Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day
* Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN \[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\], Bilirubin: ≤3 times ULN \[ULN for total bilirubin is 1.3mg/dL\]
* Serum creatinine: Serum creatinine: \<170 μmol/L
* egative pregnancy test in women capable of child-bearing

Exclusion Criteria:

* Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE
* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug
* Pregnant or breast-feeding women
* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)

This study was a single-center, exploratory, randomized controlled trial. First, the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients were evaluated using DSC-MRI to investigate the specific mechanisms of the three vasopressors on cerebral blood flow and oxygen metabolism in brain tissues.

Carotid endarterectomy is a procedure used to remove plaque from the common and internal carotid arteries and improve cerebral perfusion. Clinical studies have demonstrated the effectiveness of this procedure in both symptomatic and asymptomatic patients. intraoperative circulatory management challenges in CEA include the following: ① The incidence of preoperative combined coronary artery disease, hypertension and diabetes mellitus is relatively high in patients undergoing carotid endarterectomy, and there is a pathological basis for systemic vascular injury, increasing the risk of perioperative cardiovascular and cerebrovascular complications, such as myocardial ischemia and stroke. ② During the CEA procedure, the common carotid artery, internal carotid artery and external carotid artery and the superior thyroid artery need to be blocked respectively, the source of blood supply to the cerebral hemisphere on the operated side is reduced and depends only on the Willis circle supply. ③ Carotid sinus pressure receptor pull stimulation causes circulatory fluctuations. During CEA, a relatively high arterial pressure is required to provide adequate cerebral perfusion. However, achieving this target blood pressure level intraoperatively can be challenging due to given conditions, the presence of induction drugs and anesthetics. Therefore, it is particularly important to maintain cerebral hemodynamic stability and ensure tissue perfusion with intraoperative use of vasopressers.

The purpose of this study was to evaluate the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamic in CEA patients using DSC-MRI to investigate the specific mechanisms of the three boosting agents on cerebral blood flow and oxygen metabolism in brain tissues.

Eligibility Criteria:
Inclusion Criteria:

1. age 40-80 years.
2. elective carotid endarterectomy.
3. Signed informed consent

Exclusion Criteria:

1. ASA classification IV - VI.
2. renal failure (estimated glomerular filtration rate less than 60 ml/min.m2).
3. cardiac arrhythmias.
4. Allergy to ephedrine, phenylephrine or norepinephrine, gadobutrol.
5. patients with preoperative TCD suggesting poor temporal window signal.
6. patients with severe carotid artery stenosis with no flow signal detected by TCD
7. Patients with tandem lesions of carotid artery stenosis