cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk

The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics.

The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC) and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant demographic information such as physical characteristics (e.g., ethnicity), family history, and cancer diagnosis will be collected in order to determine if there are relationships between the gene polymorphisms, cancer diagnosis, and these characteristics. By identifying the VDR polymorphisms for the Apa1, Taq1, Bsm1, and Fok1 genes within the participant population and comparing the genotypes to controls, the investigators hope to demonstrate which gene polymorphisms indicate an increased risk for SCC or BCC.

Inclusion- patients with a non-melanoma skin cancer. Participants must be 50 years old or older. Controls- patients without non-melanoma skin cancer and who have no family history of skin cancer. They must also be 50 years old or older; Inclusion for both groups- English speakers and patients at the Kirklin Clinic during the months of our data collection. Exclusion criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or other type of cancer, or who are non-English speakers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-melanoma skin cancer (cases)
* Patients without non-melanoma skin cancer or history of non-melanoma skin cancer (controls)
* Age 50 and older
* Native English speakers
* Patients at Kirklin Clinic

Exclusion Criteria:

* Age less than 50
* Diagnosis of melanoma or other type of cancer
* Non-English speakers
Association Between ORA and Residual Refractive Astigmatism After SMILE

The aim of our study is to analysis and compare the relationship between ORA and postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D) astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Corrected distance visual acuity of both eyes reaches 0.1 logarithm of the minimum angle of resolution (logMAR)
* Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes

Exclusion Criteria:

* Cataract
* Corneal opacities or irregularities
* Dry eye (Schirmer's test I ≤ 5mm)
* Amblyopia
* Coexisting ocular pathologies
* Glaucoma
* Non-dilating pupil
* History of intraocular surgery, laser therapy, or retinopathy
* Optic nerve or macular diseases
* Estimated postoperative cornea residual stromal thickness less than 250 μm
* Pregnancy or under lactation
* Uncontrolled diabetic mellitus or systemic immune disease _Refusal or unable to maintain follow-up
Fetal Heart Rate Pattern After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section

Spinal anesthesia may cause sympathetic blockade which decrease peripheral vascular resistance and bradycardia and then hypotension. Maternal hypotension could cause immediate fetus heart beat (FHB) deceleration and postpartum acidosis. Both intravenous hydration or vasopressor during hypotension could prevent maternal hypotension efficiently. Although there were many articles discussion about maternal hypotension and fetal heart rate variation during epidural labor analgesia, the studies about FHB variation during spinal anesthesia is not much. In one literature in 1960, if maternal blood pressure below 60-80 mmHg, FHB deceleration could happen in 5 minutes. In modern medical management, FHB change during and after spinal anesthesia is an interesting topic. The most relevant study was published by NTUH in 2015, which transformed EKG signal to possible FHB change.

The parturient will have FHB recording for 20 minutes in the day before operation. On the operation day, after proper position by the anesthetic staff (lateral position or sitting position), spinal anesthesia will performed by obstetric anesthesiologist and the lying down for supine position. Before the baby was delivered by cesarean section no FHB will be monitored. The aim of the study is continuous FHB monitor and analysis after spinal anesthesia for 5-10 minutes to improve fetal physiology knowledge and providing basic information for future study.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 20 years
2. Singleton
3. Gestational age above 36 weeks
4. Scheduled Cesarean section at VGHTC
5. Eligible for spinal anesthesia
6. Inform consent

Exclusion Criteria:

1. ASA \> 3
2. Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat
3. Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic
4. Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason
5. Patients cannot make decision for language barrier, education condition or phsycological disease
6. Register in other study already
Elimination of Microemboli During Aortic Valve Replacement

In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Elective aortic valve replacement
* Informed consent
* German language

Exclusion Criteria:

* Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
* Contraindication against MRI assessment
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-G3031 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

• Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).

Exclusion Criteria:

* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

OBJECTIVES:

* Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
* Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
* Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage IIIB, IIIC, or IV melanoma
* HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
* Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm \^3
* Hemoglobin \> 9 g/dL

Hepatic

* Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease

Other

* Prior diagnosis of other cancer allowed
* Not pregnant or nursing
* Weight ≥ 110 pounds
* No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 4 weeks since prior growth factors
* More than 4 weeks since prior allergy shots
* More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
* No prior vaccination with any of the peptides used in this study

Chemotherapy

* More than 4 weeks since prior chemotherapy

Endocrine therapy

* More than 4 weeks since prior steroids

Radiotherapy

* More than 4 weeks since prior radiotherapy

Surgery

* Not specified

Other

* More than 1 month since prior investigational drugs or therapies
* No other concurrent investigational drugs or therapies
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures

This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.

Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.

Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.

Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.

Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ambulatory surgery under general anesthesia
* Expected postoperative pain to be mild-moderate
* Age 18 years or older
* Have an ASA physical status or 1, 2, or 3

Exclusion Criteria:

* Anticipated peripheral or neuraxial nerve block
* Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
* Current chronic opioid or tramadol use
* History of alcohol or opioid abuse
* Known allergy to the study medications
* Pregnancy
* Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
* Treated with any acetaminophen-containing medication in the previous 8 hours
* Treated with MAO inhibitors within 10 days prior to surgery
* Inability to communicate with the investigators and hospital staff
* Known or impaired liver function
Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.


Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for a surgery lasting more than 90 minutes.

Exclusion Criteria:

* Contraindication to sevoflurane, to remifentanil or to morphine.
* Peripheral or central nerve block during and after surgery.
* Ophthalmological disease.
* Peroperative position with no acess to the head.
* Chronic use of medication interfering with pupillary diameter.
* Ambulatory surgery
Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis

To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
* No other infertility factors.
* Normal serum basal hormone levels as well as documented ovulation

Exclusion Criteria:

* Moderate or severe endometriosis
* Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
* Age more than 36 years, BMI more than 30 kg/m2
* women with a previous pregnancy
Relation Between Acute Kidney Injury and Mineral Bone Disease

Relation between acute kidney injury and mineral bone disease

Assiut Medical School Research Proposal Form 2 Part 2: Research Details 2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work).

Numerous studies have evaluated the prevalence and importance of mineral and bone disorders among patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). However, little is known about dysregulated mineral and bone metabolism in acute kidney injury (AKI) \[ Acute kidney injury is the new consensus term for acute renal failure It refers to a clinical syndrome characterised by a rapid (hours to days) decrease in renal excretory function, with the accumulation of products of nitrogen metabolism such as creatinine and urea and other clinically unmeasured waste products. Other common clinical and laboratory manifestations include decreased urine output (not always present), accumulation of metabolic acids, and increased potassium and phosphate concentrations. The term acute kidney injury has replaced acute renal failure to emphasise that a continuum of kidney injury exists that begins long before sufficient loss of excretory kidney function can be measured with standard laboratory tests. The term also suggests a continuum of prognosis, with increasing mortality associated with even small rises in serum creatinine, and additional increases in mortality as creatinine concentration rises. The incidence of acute kidney injury (AKI) is increasing among hospitalized patients . Treating the condition consumes significant amounts of resources even after hospital discharge

. Although AKI was once considered a reversible condition, mounting evidence has indicated that AKI may have a negative impact upon subsequent renal function and long-term prognosis, even if kidney

Eligibility Criteria:
Inclusion Criteria:

* 200 patients with acute kidney injury and their relationship to mineral bone disease.

Exclusion Criteria:

* Non hypertensive
* Non cardiac
* Active malignancy
* Acute or chronic liver disease
* Acute poisoning
* Covid
Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation

We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
2. Patients with CHA2DS2-VASc score \>1

Exclusion Criteria:

1. Patients who failed to successfully implant LAAO
2. Patients who receive new oral anticoagulant less than 6 months without clinical events
3. Patients with mitral stenosis more than mild grade
4. Patients with prosthetic heart valve
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

The aim of our study is to assess the feasibility and benefits of the implementation of an interactive telemonitoring system for earlier detection of COPD exacerbations in a community cohort preventing further deterioration requiring hospital admissions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Aged 40 years or above
* Must be enrolled in health centres from Braga
Kinematics After Total Knee Arthroplasty

The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.

Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique.

Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Primary arthroplasty for treatment of osteoarthritis
* Age between 40 and 80 years old
* Willingness to provide written consent for study participation

Exclusion Criteria:

* Revision arthroplasty
* Pre-operative knee flexion lower than 90 degrees
* Varus knee deformity greater than 15 degrees
* Pre-operative valgus knee deformity
* Presence of infections, highly communicable diseases or metastatic disease
* Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing
* Congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success
* Presence of previous prosthetic knee or hip replacement device
* BMI \> 40
* Pregnant women
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.

The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria.

A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:

* Group 1: cytarabine + idarubicin
* Group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr
* Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr

Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.

Eligibility Criteria:
Inclusion Criteria:

Subjects had to meet all the following criteria to be eligible for enrollment in this study:

1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

Subjects who met any of the following criteria were not eligible for enrollment in this study:

1. Had acute promyelocytic leukemia
2. Had prior chemotherapy for AML.
3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
4. Had central nervous system (CNS) leukemia.