cyrilzakka/clinical-trials huggingface dataset:
Epithelial Thickness Map

In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area.

Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.

Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data.

This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.

In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes.

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary.

The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org.

The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Main outcome variable:

- Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices)

Secondary outcome variables:

* Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices
* Comparison in epithelial thickness between normal and keratoconus eyes
* Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea
* Age 21 and older
* Signed informed consent

Exclusion Criteria:

* Previous ocular surgery
* Associated corneal pathologies (e.g. trauma, edema, scarring)
* In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain

The purpose of this study is to examine the changes in immune function, as measured by biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications for the treatment of moderate to severe cancer pain.

Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little alteration of immune function as measured by biomarkers in the blood of cancer patients with moderate to severe pain.

Biomarkers of immune function will be measured before and after patients receive an intrathecal pain pump for management of cancer pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Evaluation by a pain management physician and confirmation that cancer is the primary etiology of patient's pain
* Moderate to severe pain, as specified by a baseline Pain Rating Score of 5 or above on a scale from 0 (no pain) to 10 (worst pain imaginable) despite current opioid therapy
* Pain management plan (as developed by Interventional Pain Service, patient and primary service) that includes placement of an intrathecal drug delivery system for pain management
* Able and willing to give informed consent

Exclusion Criteria:

* Patients with an expected life expectancy of less than 12 weeks
* Patients not felt be a safe surgical candidate by pain management physician for placement of and intrathecal drug delivery system (IDDS) due to the presence of severe medical comorbidities
* Patients who are not a candidate for intrathecal drug therapy due to coagulopathy, concurrent necessary use of blood thinners, presence of systemic infection, drug allergy to analgesic agent, evidence of CSF obstruction or other technical factor
* Severe or untreated psychiatric disease
* Refusal of informed consent
* Pregnant patients or patients less than 18 years of age
The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery

Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of morbid obesity
* Must be laparoscopic surgery

Exclusion Criteria:

* Usage of anti-coagulant
* Presence of impaired blood clotting
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

Exclusion Criteria:

* History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
* Inability to stop all prior blood pressure medications safely
* Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
* Controlled blood pressure (systolic BP \< 140 mmHg) taking more than 3 antihypertensive medications at screening
* Systolic BP ≥ 140 mmHg and \< 180 mmHg taking more than two antihypertensive medications at screening
* Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
* History of autoimmune diseases
* History of multiple drug allergies
* Liver disease
* Pancreatic injury within 1 year of screening
* Evidence of kidney impairment or history of dialysis
* Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
* Pregnant or nursing (lactating) women
* History of malignancy of any organ system within the past five years
* Any severe, life-threatening disease within the past five years
* History of drug or alcohol abuse within the last 2 years.
* History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
* Type 1 diabetes
* Poorly controlled Type 2 diabetes
* History of heart failure
* Arrhythmia
* Significant valvular heart disease
* Active gout

Other protocol-defined inclusion/exclusion criteria may apply
The Thiamine Administration After Cardiac Surgery Trial

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.

We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.

Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome.

Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest.

Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients.

On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission.

Therefore, the hypothesis of this study is that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December 2021. Written informed consent will be obtained from each patient/ family member participating in the study.

Exclusion Criteria:

* Patients already supplemented with vitamins
* Patients with an allergy to thiamine
* Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively
* Patients with mitochondrial disorders
* Patients with Child Pugh C cirrhosis
* Patients with a history of epilepsy with tonic-clonic movements postoperatively.
* Pregnant patients
Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients

Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.

Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.

Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.

The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.


Eligibility Criteria:
Inclusion Criteria:

1. Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \[5\].
2. Suffering from episodes of exertional leg pain and or exertional ankle edema
3. 18-45 years old
4. On a stable (≥ 2 weeks) dose of oral colchicine therapy
5. Non-smokers

Exclusion Criteria:

1. with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
2. Suffering from muscular or neurological diseases not related to FMF
3. With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
4. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.
Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption

Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.


Eligibility Criteria:
Inclusion Criteria:

* Age:16-50 years
* Pregnancy duration: 14-24weeks
* Spontaneous abortion or medical induced abortion at 14-24weeks

Exclusion Criteria:

* Age less than 16years and more than 50 years
* Surgical termination
* Placenta previa
* Uterine fibroid
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.

This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Metabolic Syndrome (meets 3 of the following 5)
* Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
* Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
* Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
* Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
* Fasting plasma glucose greater than 100 mg/dL

Exclusion Criteria:

* Diabetes
* Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
* Angina or other chest pain that may indicate CHD
* Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
* Known abnormal LFTS greater than 2X ULN
* Smoker, illicit drug use, or excessive alcohol use
* Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
* Pregnancy or planning pregnancy during the study period
* Sensitivity or allergy to fish
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

Eligibility Criteria:
Inclusion Criteria:

Clinical Criteria

* Male or non-pregnant female ≥18 years of age.
* Rutherford Clinical Category 2-5
* Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
* A single de novo or restenotic atherosclerotic lesion \>70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
* Reference vessel diameter ≥4 mm and ≤ 6mm
* Successful wire crossing of lesion
* A patent inflow artery free from significant lesion (\>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)

Exclusion Criteria:

* Pregnant or planning on becoming pregnant in \< 2yrs
* Live expectancy of \<2 years
* Patient actively participating in another investigational device or drug study
* History of hemorrhagic stroke within 3 months
* Previous or planned surgical or interventional procedure within 30 days of index procedure
* Chronic renal insufficiency with creatinine \>2.5 mg/L
* Prior surgery of the target lesion
* Inability to take required study medications
* Anticipated use of IIb/IIIa inhibitor prior to randomization
* Lesion length is \<4 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
* Known inadequate distal outflow
* Significant inflow disease
* Acute or sub-acute thrombus in target vessel
* Severe lesion calcification
* Acute vessel occlusion or sudden symptom onset
* Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
* Prior participation in the current study
Physical Activity and Health Outcomes

Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.

We are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. It is a 4 month study. Our aims are as follows:

Primary Aim: Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Second Primary aim: To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.

Secondary Aim: Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be over the age of 18
2. Have a BMI over 25.0 kg/m2.
3. Have a Minnesota Medical Tiering concerning medical complexity of 3-4.

Exclusion Criteria:

1. Patients will be excluded if they have clinically documented dementia.
2. Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
3. Subjects residing within a correctional institution will be excluded.
4. Subject is a female patient who is currently pregnant.
Healing, Equity, Advocacy and Respect for Mamas

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 3 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a nurse advocate will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Eligibility Criteria:
Inclusion Criteria for Postpartum Women

* Postpartum woman within approximately 2 weeks of delivering a baby of gestational age ≥ 26 weeks in South Carolina.
* Aged 16-49 years old.
* Insured by Medicaid.

Exclusion Criteria for Postpartum Women

* Plans to relocate outside of SC anytime during the postpartum year.
* Plans to discontinue Medicaid health insurance during the postpartum year.
* Speaks a language other than English or Spanish.
* Incarcerated/pending incarceration during peripartum period.
* Currently institutionalized.
* Enrolled in current MUSC study funded by PCORI (#Pro00123833)
* Does not have and/or does not wish to use their personal cell phone for the study.

Inclusion Criteria for Obstetric Providers and Hospital Administrators

- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.

Exclusion Criteria for Obstetric Providers and Hospital Administrators

* Less than 1 month of HEAR 4 Mamas experience if involved in the hospital where participants are recruited from.
* Unable or unwilling to commit to completing surveys or an interview.
* Speaking a language other than English.