cyrilzakka/clinical-trials huggingface dataset:
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.

This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer according to the following steps.

Step 1 will evaluate the dose-limiting toxicities (DLT) of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.

Step 2 will evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed as anaplastic thyroid cancer
2. Unresectable anaplastic thyroid cancer
3. Have measurable lesions defined by the RECIST version 1.1
4. Have adequate organ function
5. Cardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc.
6. Patients who are 20 years or older
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. Ability to swallow oral medications
9. Women of childbearing potential
10. Life expectancy of more than 90 days
11. Have signed written informed consent to participate in this study

Exclusion Criteria:

1. Active brain metastases or leptomeningeal metastases
2. Diverticulitis or Symptomatic ulcerative disease
3. Treatment required complication of systemic infectious disease
4. Medical history of active, known, or suspected autoimmune disease
5. Complication of pulmonary fibrosis or interstitial pneumonitis
6. Medical history of clinically significant cardiovascular disease within 180 days of initial dose as New York Heart Association (NYHA) class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment
7. Regardless of usage of antihypertensive drug, systolic blood pressure \<=140 mm Hg and diastolic blood pressure \<=90 mm Hg
8. Have active double cancer
9. Currently receiving other interventional clinical study treatment
Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* People with type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
* Previously participated in a BG monitor study using the Karajishi TS BGMS (or used a Bayer Contour TS meter)
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
Comparing Between Two Different Restoration

Clinical performance of two different ceramic restoration in patient mouth after 3 years follow up

Comparing two different dental restoration in patient mouth after 3 years follow up by using USPHS criteria

Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene

Exclusion Criteria:

* bad oral hygiene
Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.

Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 y/o
* Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring

Exclusion Criteria:

* Aortic regurgitation grade 3-4
* Uncontrolled Hypertension (MAP \> 130 mmHg)
* Circulatory or cardiac assistance
* Active pacemaker
Mean Systemic Pressure Measurement During Prone Position Surgery

Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Prone position neurosurgery
* High-risk neurosurgery

Exclusion Criteria:

* Emergency surgery
* Pregnancy
Safety Study of Melatonin in Stroke Patients

The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Stroke is the third most common cause of stroke. The cascade of event is separated into hyperacute,,acute,sub-acute and chronic. In the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. Melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. The aim of the study is to prove That the use of Melatonin in a higher dosage may have a anti-destructive effect in stoke.

Eligibility Criteria:
Inclusion Criteria:

* within 72hours of ischemic stroke
* age 18-80
* both gender
* ability to sign consent form

Exclusion Criteria:

* intra-cerebral bleeding
* tumour of brain
* multiple sclerosis
* s/p craniotomy
* known allergy to melatonin
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Pyuria
* Have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug
* Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection
* Normal renal function or moderate renal impairment

Key Exclusion Criteria:

* Confirmed fungal urinary tract infection at the time of randomization
* Known urinary tract infection or colonization with Gram-positive pathogens
* Current cUTI or AP is known to be caused by a pathogen resistant to meropenem
* Female participants of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication
* Any rapidly progressing disease or immediately life-threatening illness
* Documented presence of immunodeficiency or an immunocompromised condition
* Documented or known history of otologic surgery or disease including use of hearing aid, head injury leading to otologic damage, Ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner ear, or family history of hearing loss (excluding age-related hearing loss \[onset after age of 65 years\])
Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis

To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.

Eligibility Criteria:
Inclusion Criteria:

* All patients with CTPV.

Exclusion Criteria:

* Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.
Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery

The purpose of this study is to explore patient perspectives on Advance Care Planning (ACP) prior to cardiac surgery, including perceptions of benefits, drawbacks, and barriers to ACP.

In this study, we plan to interview 40 patients who are scheduled to undergo cardiac surgery about their perspectives on preoperative ACP and discussion of their values, goals of care, and preferences for prolonged care in hospital prior to having surgery. We plan to conduct and audio record one-on-one interviews that are structured around standard questions about ACP. After recordings are completed, we plan to conduct an analysis of the interviews to find common themes and ideas that participants have about preoperative advance care planning. These results will help us understand whether patients value and wish to participate in advance care planning prior to major surgery, and will help to guide the structure and content of preoperative advance care plan programs in the future.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.
* Age \> 18
* English-speaking

Exclusion Criteria:

* Emergency surgery, regardless of indication or procedure
* Minor/percutaneous cardiac procedure
* Lack of decisional capacity due to dementia or other neurocognitive dysfunction
* Previously decided upon advance care directives
* Still considering surgery or not yet booked for an operation
Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder

The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.

This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.

Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.

Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 13 years, 0 months to 19 years, 11 months
* Meet diagnostic criteria for BD by KSADS-PL
* Engaged in, or willing to proceed with, a pharmacotherapy regimen
* At least one parent/guardian with whom the patient lives or regularly interacts (\>5 hours per week) is willing to participate in skills training
* Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

* Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
* A life-threatening medical condition requiring immediate treatment
* Current victim of sexual or physical abuse.
Canadian Network for Autoimmune Liver Disease

CaNAL is a longitudinal observational cohort study of patients diagnosed with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or overlap syndrome. This study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major Canadian centers.

Primary Biliary Cholangitis (PBC) and Autoimmune Hepatitis (AIH) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (HCC) and liver failure requiring liver transplantation or leading to premature death. The rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across Canada will allow new insights. The primary aim of the Canadian Network for Autoimmune Liver Disease is to build a Canadian registry of patients with PBC, AIH, and overlap syndrome. We capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. We will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. We can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. CaNAL will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. CaNAL will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria:

* Less than 18 years of age
Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy between hormone replacement and Tamoxifen combined Of hormone replacement.This is a prospective, randomized placebo-controlled, double-blind clinical trial that includes 120 patients younger than 38 years old with a thin endometrium preparing for frozen embryo transfer. Participants will be randomly assigned (1: 1) into two parallel groups: estrogen replacement and tamoxifen combined with estrogen replacement.Frozen embryo resuscitation transfer cycle for thin endometrium patients。This is the first randomized controlled trial to comparing estrogen and estrogen combined with tamoxifen for endometrial improvement，The results of this study will provide evidence for the efficacy of the strategy of frozen embryo transfer cycle for thin endometrium patients.


Eligibility Criteria:
Inclusion Criteria:

1) Younger than 38 years old, basal serum level of follicle stimulating hormone \<10 IU / L; (2) Endometrium is less than 8mm in at least 2 cycles: superovulation cycle / natural cycle / estrogen replacement therapy / ovarian stimulation cycle; (3) at least 1 high quality frozen embryo; (4) There are no comorbidities that clearly affect pregnancy, such as adenomyosis, endometriosis, and intrauterine adhesions;

Exclusion Criteria:

1. abnormal karyotype;
2. Accompanying other diseases of the uterus: uterine muscular wall myomas that affect the uterine cavity shape, more severe adenomyosis, severe endometriosis, congenital uterine malformations, endometrial tuberculosis, etc .;
3. Contraindications to hormone replacement therapy;
4. Participating in other clinical research;
5. History of previous fundus diseases;
Can Ultrasound Replace Computed Tomography (CT) Scan in Those Unable to Have Computed Tomography (CT) Contrast Agents

Computed tomography (CT) scan, performed with contrast enhancement, is one of the most commonly requested examinations in diagnostic imaging. In a patient with an elevated creatinine or an allergy to contrast agents, the scan may be performed without the benefit of contrast enhancement. Ultrasound (US), performed with contrast agent enhancement does not have any nephrotoxicity and may be performed on patients with CT contrast allergy. The investigators propose that US with Contrast enhanced ultrasound (CEUS) is superior to unenhanced CT scan in this population.

Contrast enhanced computed tomography (CT) is one of the most common investigations performed in any radiology department, used widely in evaluating pathology in any part of the body.

Historically, it is well known that the use of contrast agents for CT scans may result in nephropathy, or renal failure. Nephrotoxicity associated with the injection of CT contrast agents may occasionally occur in healthy individuals and more commonly in those with borderline renal function. If abnormal kidney function is known to exist in a patient sent for CT scan, the examination is performed without the valuable assistance of contrast enhancement. Further, if prior hypersensitivity to the contrast agent for CT scan is known, again, the scan will be performed without the use of contrast agent.

Ultrasound (US) performed conventionally in grayscale and with Doppler is able to evaluate most abdominal and pelvic organs and also provides vascular information related to large vessel blood flow. Contrast enhanced ultrasound (CEUS) provides more precise information on blood flow than is available with Doppler and has been shown to be comparable to CT scan in some circumstances. We believe that a comparison of conventional US, with CEUS, and unenhanced CT scan would clearly favor ultrasound for detection of soft tissue pathology on the basis of its inherent tissue contrast differentiation.

Eligibility Criteria:
Inclusion Criteria:

* unenhanced CT scan of abdomen
* known renal compromise
* known hypersensitivity to CT contrast agents

Exclusion Criteria:

* CT scan performed with contrast agent
Pulmonary Tuberculosis Sequelae in Patients With COPD

It is known that there is a complex relationship between tuberculosis and COPD. Post-tuberculosis airway disease or COPD associated with tuberculosis occurs in a significant portion of tuberculosis patients. However, it was observed that mortality rates and exacerbation rates of COPD patients with tuberculosis sequel were higher. However, the effect of tuberculosis sequela on functional outcomes in COPD patients has not been investigated in the studies.

The aim of this study is to determine whether the previous tuberculosis sequelae has a functional effect on patients with COPD.

This research is planned as a cross-sectional study. It will start within one week following the approval of the ethics committee and will be completed within one year. The universe of the study is S.B.Ü. Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital consists of patients who apply to Pulmonary Rehabilitation Outpatient Clinic. Participants will consist of two different groups: COPD patients with tuberculosis and COPD patients without tuberculosis. The voluntary principle will be taken into account in participating in the research.

Within the scope of the evaluation; Demographic and clinical information of the people who will participate in the study will be recorded, and Thorax CT and PFT examinations performed within the polyclinic service within the last 1 month will be evaluated. Saint George Respiratory Questionaire (SGRQ), 6-minute walk test (6MWT), Medical Research Council Dyspnea Scale (MRC), COPD assessment test (CAT) will be applied to the patients. Regarding the illness histories, the number of hospitalizations and emergency admissions in the last 1 year will be recorded. Detailed tuberculosis anamneses will also be taken from patients with tuberculosis sequelae.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being over 18 years old
* Having thorax CT in the last 1 month
* Having PFT examination performed in the last 1 month

Exclusion Criteria:

* Being in a COPD attack
* The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.
Breast, Omega 3 Free Fatty Acid, Ph 0

Assess the impact of dietary omega 3 free fatty acids breast cancer patients.

Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* ECOG ≤2
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
* Consented for tissue collection on CTRC repository 07-32

Exclusion Criteria:

* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
* History of medical noncompliance
* Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days