cyrilzakka/clinical-trials huggingface dataset:
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
* Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
* Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)

Exclusion Criteria:

* BRAF V600 mutant colorectal cancer
* Active brain metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* History of interstitial lung disease or pneumonitis
* Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
* History of allergy or hypersensitivity to study drug components

Other protocol defined inclusion/exclusion criteria apply
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections

A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.

Surgical site infections are post-operative infections of the incision or organ or space that was included in the surgical field. Incisional surgical site infections (SSIs) are a growing healthcare challenge.

Currently, up to 10% of surgical procedures may be complicated by an SSI \[3\]. Not only do SSIs lead to worse patient outcomes, but they also account for a large proportion of healthcare expenditure.

In the United Kingdom alone, SSIs are estimated to cost the National Health Service 1 billion pounds annually.

The problem is further compounded in low- and middle-income countries (LMICs) where the prevalence of antibiotic-resistant infections is increasing, and national healthcare budgets are strained.

In fact, SSIs are estimated to account for additional costs of up to $30,000 in LMICs.

The global crisis of drug-resistant bacteria has further highlighted the need for more effective perioperative preventive strategies to minimize healthcare-associated resistant infections.

Optimal surgical antisepsis is critical in reducing the incidence of SSIs, and therefore in reducing the use of postoperative antibiotics.

Recently, there has been a renewed interest in using povidone-iodine (PVI) intraoperative wound irrigation to achieve this goal. The choice of PVI is especially suitable for LMICs where the availability of chlorhexidine preparations may be limited by scarce resources.

A possible adjunctive role of pre-wound closure PVI irrigation in reducing incisional SSIs is still unclear.

A meta-analysis by López-Cano et al. analyzed data of 7,601 patients and found a reduction in overall SSI rate. However, the heterogeneity and uncertain quality of most studies limited the synthesis of conclusive evidence.

The possible benefits of irrigating the surface of an open incision include local antimicrobial effect, physical removal of debris and dilution of contamination. Recent guidelines have all emphasized the lack of sufficient evidence on intraoperative use of PVI.

The investigators aim to conduct a randomized controlled trial in Ain Shams University Hospitals to compare the effect of adding PVI wash prior to skin closure to direct wound closure on reducing the rates of SSIs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Open and minimally invasive surgeries
* Emergency (any unplanned admission) and elective (planned admission) surgical procedures
* Clean, Clean-Contaminated, Contaminated, Dirty wounds
* Inclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping

Exclusion Criteria:

* Povidone-iodine allergy
* Surgeries for infected wounds.
* Exclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping.
Circulating Tumor Cells (CTC) in Lung Cancer

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

There are 2 cohorts for this study. Cohort A \& Cohort B are for patient subjects. Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.

The investigators anticipate that most patients who participate in Cohort B will also participate in Cohort A because Cohort A only requires a one-time blood draw at baseline.

Cohort A: 20 patients with NSCLC and 20 patients with SCLC. Blood samples will be collected from eligible patients only once at baseline. These samples will be immediately processed for CTCs and CTC derived xenografts.

Cohort B: 15 patients with NSCLC and 15 patients with SCLC. Blood samples will be collected from eligible patients at baseline just prior to initiation of therapy. Samples will also be collected on day 1 of every cycle of therapy for 4 cycles (typical cycles are 21 days for chemotherapy, 28 days for targeted therapy and 14 days for immune therapy). At the time of initiation of the treatment break, blood samples will be collected. During the treatment break, patients will be followed every 6-12 weeks with imaging studies, and we will collect blood samples at each visit. At the time of disease progression in the event patient goes on best supportive care, the last blood draw will be at the time of this decision as there will unlikely be any further imaging studies going forward. If a patient is found to have disease progression while on active therapy, the next blood draw will be on the first day of the next therapy and time point of subsequent blood draws will depend on the type of therapy the patient receives. The goal is to define whether CTC loads whether CTC loads predict symptoms, response, and disease recurrence.

For Cohorts A \& B: Investigators will make every attempt to time the blood collection to coincide with blood collection for therapeutic purposes in order to minimize discomfort. Blood sample collection will take place either in the outpatient clinic, or while inpatient (at IUSCCC, Indiana University Hospital, or Eskenazi hospital). Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.

Eligibility Criteria:
Inclusion Criteria Cohort A (one-time blood sample) \& Cohort B (multiple blood samples)

* Histologically or cytologically confirmed lung cancer (both non-small cell lung cancer and small cell lung cancer are allowed)
* Stage 4 NSCLC or extensive-stage SCLC
* Newly diagnosed disease with no prior systemic therapy for advanced disease Note: Patients that have received prior adjuvant chemotherapy or prior chemoradiotherapy for earlier stage lung cancer are allowed if treatment was completed ≥3 months.
* Age ≥ 18 years
* Ability to understand and the willingness to sign a written informed consent document

Inclusion of Women and Minorities Both men and women of all races and ethnic groups are eligible for this study.
Isolation Procedure vs. Conventional Procedure During Distal Pancreatectosplenectomy for Pancreatic Cancer

In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.


Eligibility Criteria:
Inclusion Criteria:

* Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer)
* ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
* Age are over 20 years old.
* Able to understand the content of the research and has obtained written consent from the person himself/herself.

Exclusion Criteria:

* Non-resectable pancreatic cancer by image diagnosis at the initial diagnosis
* Cases suspected of portal vein (superior mesenteric vein) invasion
* Patients with severe ischemic heart disease
* Patients with cirrhosis or active hepatitis requiring treatment
* Patients with dyspnea requiring oxygen administration
* Patients undergoing dialysis due to chronic renal failure
* Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary
* Patients with strong suspected paraaortic lymph node metastasis
* Active double cancer thought to affect adverse events and prognosis
* Long-term oral steroids that may affect adverse events
* Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
* Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive intraductal papillary mucinous carcinoma (IPMC) is excluded.
* Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
* Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA

Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization. Although these conditions are well-known clinical problems that can delay early mobilization, relatively few data are available on pathophysiological mechanisms and possible treatments.

Several prospective studies with standardized mobilization procedures have already established that the incidence of POI and POH after THA is 38-42% at 6 hours after surgery.

Previous studies on patients undergoing prostatectomy and THA have also demonstrated that attenuated vasopressor response and a concomitant reduction in cardiac output (CO) and cerebral perfusion during postural changes after surgery contributes to POI and POH. Strategies aiming to reduce the incidence of POI and POH by pain management, vasoconstrictive treatment with alpha-1 receptor agonist, optimized fluid management with goal-directed fluid therapy and reduction of surgical stress-response with pre-operative high-dose glucocorticoid did not solve the problem.

The precise pathophysiological mechanisms of POI and POH remain to be elucidated and this is therefore the aim of the current prospective observational study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Written informed consent
* Patients that speak and understand Danish
* Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

Exclusion Criteria:

* Alcohol and drug abuse
* Cognitive dysfunction
* History of orthostatic hypotension
* Use of anxiolytic or antipsychotic drugs
* Use of opioids
* Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers
* Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics
* Use of Gabapentin
* Arrhythmias or heart failure
* Diabetes mellitus type I
* Diabetes mellitus type II
* History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
* History of cerebral apoplexy or transitory cerebral ischemia
* Dementia
* American Society of Anesthesiologists (ASA) score ≥ 4
EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be completely edentulous.
* Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
* Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
* The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Exclusion Criteria:

* Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
* Patients with active oral infections.
* Patients with history of radiotherapy in head and neck region.
* Patients with poor oral hygiene.
* Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
* Heavy smokers (more than 10 cigarette / day).
Prevalence of NAFLD in T1DM Patients

To determine the prevalence of NAFLD in T1DM patients.


Eligibility Criteria:
Inclusion Criteria:

* T1DM
* ≥ 18 years of age
* Written informed consent obtained

Exclusion Criteria:

* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of liver steatosis
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma

This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.

PRIMARY OBJECTIVES:

I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.

II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.

ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.

After completion of study treatment, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage IB or II cutaneous melanoma
* Primaries on the torso, upper and lower extremities and head and neck region
* Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
* Bilirubin \< 2.0 ng/dl
* Creatinine \< 3.0 ng/dl
* Able to understand the consent competent to sign
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior wide excision with diameter of the excision \> 3 cm
* Primary melanoma arises from the eye or mucus membranes
* Clinical evidence of regional, intransit ,or distant metastases
* Second invasive melanoma
* Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN)
* Patients with primary or secondary immunodeficiencies
* Pregnancy
* Known allergy to sargramostim (GM-CSF)
* History of cardiac disease, in particular, supraventricular tachycardia
A Study of Isoprinosine in Patients With Lymph Node Disease

The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

* Lymphadenopathy.
* Fever.
* Weight loss.
* Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

* T-helper cell (OKT4) numbers and proportions.
* T-suppressor cell (OKT8) numbers and proportions.
* Natural killer (NK) cell activity.
* Lymphocyte blastogenic response to phytohemagglutinin (PHA).
* Lymphocyte blastogenic response to pokeweed mitogen (PWM).
* Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
* Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

* Blood chemistry including serum uric acid (PurposeA-12).
* Complete blood count (CBC).
* Platelet count.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

* Systemic corticosteroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

* Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS

All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.


Eligibility Criteria:
Inclusion Criteria:

* Infants born before 26 weeks at any of the participant hospitals.

Exclusion Criteria:

* received surfactant before LU
* redirection of care
* severe malformations of cromosomopathies
* unable to perform LU
A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients

The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
* Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
* Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

Exclusion Criteria:

* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
* Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
* Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
* Have moderate to severe dementia
* Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator
Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction

Acute Myocardial Infarction (AMI) is a major disease that endangers people's health China. At present, clinical emphasis is given to "treatment" rather than "prevention", and a large number of AMI patients are hospitalized repeatedly without systematic and standardized health management after acute stage, falling into a vicious circle of "treatment without recovery". Nurse-led case management based on multidisciplinary collaboration is a new mode of disease management. In 1994, the United States took the lead in applying case management to the acute and chronic care system, providing comprehensive care services and promoting comprehensive recovery through multidisciplinary collaboration led by case managers. At present, the case management model of cardiovascular disease in Europe and the United States has been mature, but it is still in the exploratory stage in China. Through the establishment and application of nurse-led AMI case management program based on multidisciplinary collaboration, this study wants to establish a novel, standardized, and easy to popularize AMI whole-course prevention and control mode, providing theoretical and research basis for AMI disease management.

There are few domestic studies on cardiovascular disease case management in China, and the studies mainly aimed at the application of case management in out-of-hospital follow-up management. At present, there has been no reports on nurse-led the multidisciplinary whole course case management of AMI patients from admission to discharge, diagnosis and treatment, rehabilitation and secondary prevention. This study would apply case management to the whole course management of AMI patients from admission to 6 months after discharge. Pharmacists, nutritionists, rehabilitation specialists and psychiatrists coordinated by nurse would take the initiative to conduct individualized assessment and health guidance, and case managers would participate in the whole process of inpatient diagnosis and treatment. Coordinating multidisciplinary medical resources to jointly implement diagnosis and treatment and rehabilitation for patients can save medical costs and improve the quality of care.

Eligibility Criteria:
Inclusion Criteria:

* In line with the diagnosis of Chinese 2019 Guidelines for AMI. Age greater than or equal to 18 years old and less than or equal to 75 years old Patients have clear consciousness and agree to participate in this study.

Exclusion Criteria:

* Verbal communication disorders. Patients have a clear history of allergic constitution, and have allergies or intolerance to the drugs recommended by the guidelines (including antiplatelet drugs, ẞ receptor blockers, statins, various antihypertensive and hypoglycemic drugs, etc.).

Patients have severe heart, brain, liver, kidney, motor dysfunction.