cyrilzakka/clinical-trials huggingface dataset:
Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias.

This study evaluated SILC and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.

A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients underwent SILC performed by the same two surgeons.

The study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4).

The exclusion criteria included the following: acute cholecystitis, associated CBD stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. All included patients signed a standard consent form after being informed about the characteristics of the SILC procedure.

The outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard LC (with the same inclusion and exclusion criteria) during the same period.

The primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt.

The study secondary endpoints included the following: duration of surgery (from the start of the incision to skin closure), intraoperative and postoperative complications (30 days), hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale score ranging from 0 to 10).

The following variables were also collected: age, gender, body mass index (BMI) and comorbidities. The anesthetic risk was measured according to the ASA classification system. Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical consultation before scheduled follow-up) were also recorded. All data were collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
* abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4)

Exclusion Criteria:

* acute cholecystitis
* associated common bile duct stones or pancreatitis
* emergency operation for complicated disease
* ASA 4 (American Society of Anesthesiologists)
* pregnancy
* mental illness
* patient refusal and/or absence of informed consent
Microcirculation in Perforator Flaps. Enhancing Tissue Survival

The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Perforator flaps are increasingly used in reconstructive surgery both as pedicled and free flaps, mostly because of reduced donor site morbidity and superior aesthetic result. However, the there is still much to learn about the hemodynamic changes within these flaps.The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Eligibility Criteria:
Inclusion Criteria:

* patients submitted to elective abdominoplasty

Exclusion Criteria:

* body mass index \< 30 kg/m2
* morbidly obese
* patients with comorbidity such as diabetes
* vascular disease
* smokers
* patients \< 18 years, and patients using anti-coagulant therapy
* pregnant
* severe hepatic insufficiency were excluded and a history of allergic reactions to ICG and iodide.
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.

Vitamin D plays an important role in maintaining calcium and phosphate balance in the body and is important for maintenance of bone formation, remodeling, and healing. An extensive literature search indicates that although there is evidence that vitamin D deficiency is associated with fracture risk, there is no evidence of the role of vitamin D deficiency in subsequent failure to heal. The aims of study were to: 1) quantify the rate of hypovitaminosis D in an orthopedic trauma population in the Southeastern United States; 2) determine the rate of nonunion in vitamin D deficient patients, and 3) assess the feasibility of acute high-dose vitamin-D supplementation in hypovitaminosis D patients.

Eligibility Criteria:
Inclusion Criteria:

* presence of a long bone fracture (humerus, femur, or tibia)
* age greater than or equal to 18 years
* ability to follow-up at our clinic for 12 months

Exclusion Criteria:

* pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor, cyst, or Paget's disease)
* open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C (i.e. significant soft-tissue and bone devitalization)
* presence of multiple fractures
* delay in presentation for initial treatment of more than 2 weeks from the time of injury
* preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
* preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
* pregnant patients
* patients who are unable to provide consent for the study
* patients who are unable to swallow due to acuity of illness or physiologic reason
* prisoners who are patients because of their vulnerable population and inability to follow-up
Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female patients 12 years of age and older, as of the Screening Visit (SV).
* General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
* A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
* A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
* Other criteria apply

Key Exclusion Criteria:

* Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
* History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
* Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
* Other criteria apply
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer

The Study Objective is to evaluate the diagnostic efficacy of the liquid biopsy system versus the gold standard mammography (or MRI, or Ultrasound) diagnosis in patients with suspected breast cancer.

Women of the required age group, in case of suspicion of breast cancer, are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands, or MRI. Based on the results of these studies, a biopsy is prescribed to make a final diagnosis. Before a biopsy to diagnose the presence / absence of breast cancer, patients do the blood sampling one time. The blood is processed in the Sponsor's laboratory. The test results are compared with the data obtained from the biopsy. The evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method.

Eligibility Criteria:
Inclusion Criteria:

* Availability of signed and dated informed consent.
* Women from 35 to 65 years old, who are generally healthy, with suspected breast cancer. Or without suspicion of (control group)
* Presence of a documented referral diagnosis of "breast cancer"
* Presence of a documented biopsy referral
* Presence of mammography, ultrasound or MRI of the mammary glands no later than three months.

Exclusion Criteria:

* Pregnancy.
* Any other cancers diagnosed now or previously, with the exception of breast cancer.
* Therapy with cytostatics during the last three months.
* Chemotherapy within the past three months.
* Therapy with hormonal drugs, including all forms of contraceptive drugs.
* Therapy with other prohibited groups of drugs.
* Systolic blood pressure \> 180 mm Hg. and / or diastolic blood pressure \> 120 mm Hg. with repeated measurements.
* Simultaneous participation in another clinical study.
* Relative affiliation to the clinic, for example, the patient is a close relative of the researcher or a dependent person (for example, a clinic employee or student or a sponsor employee).
* A clinically significant condition or laboratory result that, in the opinion of the investigator, threatens the safety of the test subject, may interfere with assessments, or prevent the completion of the study.
* Failure to cooperate to participate in planned procedures, including the following examples: lack of understanding of language, mental illness, inability to visit the clinic.
* Diseases or conditions that may affect the conduct of the study or the interpretation of the results.
* History of organ transplantation.
* Blood transfusions within the last 6 months.
A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)

A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a BMI \< 42 kg/m2
* Subject is taking \>1500 mg metformin per day for at least 8 weeks
* Subject has HbA1c value of 7.0% and \< 11% at screening
* Subject is willing to follow AHA weight maintaining diet and exercise program
* Subject is a nonsmoker for at least 6 months

Exclusion Criteria:

* Subject has type 1 diabetes
* Subject has a history of stroke or chronic seizure
* Subject has a history of neoplastic disease
* Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
* Subject is currently taking 2 or more diabetes medications
* Subject has glaucoma or is blind
* If female, subject is pregnant or breastfeeding
* Subject consumes \> 3 alcoholic beverages per day
* Subject has had major surgery or has donated blood in the last 4 weeks
Open-label Prospective Clinical Trial Evaluating the Safety and Efficacy of Biosynthetic CLP-PEG-MPC Corneal Implants in Patients Undergoing High-risk Deep Anterior Lamellar Keratoplasty.

This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.

This is a prospective open-label clinical trial of patients who will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) corneal transplantation surgery and be followed over 24 months. The primary objective is to demonstrate the safety and tolerability of CLP-PEG-MPC biosynthetic corneal implants. The secondary objective is to examine the preliminary efficacy of these implants to stimulate corneal tissue regeneration, provide optical clarity and improvement of vision. Randomization is not appropriate in a first-in-human pilot study. Blinding is not possible as surgeons can easily tell a cell-free implant apart from a donor allograft.

Eligibility Criteria:
Inclusion Criteria:

1. adult age (18 years or older at the time of subject eligibility visit)
2. able to provide signed, informed consent
3. unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated
4. visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness)
5. presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous DALK graft failure
6. availability for 24 months of postoperative follow-up

Exclusion Criteria:

1. Age under 18 years
2. Inability to give informed consent
3. Previous corneal perforation precluding DALK surgery
4. Endothelial pathology requiring penetrating keratoplasty
5. Limbal stem cell deficiency affection more than 50% of the limbus
6. Previous penetrating or endothelial keratoplasty
7. Bilateral blindness
8. Nystagmus
9. Uncontrolled glaucoma or intraocular pressure
10. Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole)
11. Documented amblyopia of surgical eye
Management of Temporomandibular Disorders (TMD)

Temporomandibular disorders (TMD) are a group of pathologies of the temporomandibular joint, their muscles, and related structures. It is considered a musculoskeletal disorder of the masticatory system, and it has a 25% prevalence in overall population.

In 3% - 7% of the population, pain and dysfunction leads to the need for treatment . The etiology of TMD is multifactorial .

Temporomandibular disorder is characterized by signs and symptoms that include pain, muscle tenderness, joint noises, and a limited range of motion.

The normal distance of mouth opening (inter-incisal distance) is 53 - 58mm. A minimal limit of 40 mm might be used to identify patients with limited aperture, whereas 35 mm is the necessary criteria for diagnosing disc displacement without reduction after unforced maximal aperture .

Due to all symptoms involved, a multidisciplinary approach is recommended for effective management of such cases. Conservative management of TMD treatment includes occlusal splints; physical therapy; oral medication (NSAIDs and muscle relaxants); and orthodontic treatment. Physical therapy is an important option used to reduce pain and inflammation and to improve oral mobility and function.

Phonophoresis is a method which intensifies the delivery of a topical agent into underlying tissues by ultrasound . It has been used with topical application of steroids, salicylate, anesthetic agents, methly nicotinate, NSAID . It is one of the many modalities for the treatment of musculoskeletal disorders.

Corticosteroids are used to reduce inflammation in systemic disease, local tendanitis, myositis, and other soft tissues. While these drugs are most often taken orally, they have also been applied transcutaneously by rubbing, injection, electrical current, or ultrasound. Transcutaneous drug delivery has a faster distribution rate into the system once it diffuses through the outer layer of the skin, quickly reaching the arterioles in the epithelium it is carried out systemically. As the blood moves through the vessels, part of the drug leaks into the surrounding tissues. These advantages have justified researching different methods to enhance transcutaneous delivery, avoiding unnecessary prolonged drug contact.

Eligibility Criteria:
Inclusion Criteria:

* patients 20- 50 years showing TMD
* pain \> 3 on Visual Analog scale (VAS)
* failed pharmacological treatment

Exclusion Criteria:

* electrical stimulator or pacemaker
* cancer or any other severe or mental diseases
* osteoarthritis, inflammation, infection, or radiation on the TMJ articulation,
* joint cement or plastic components on TMJ articulation
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy

The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min using the four variable MDRD (Modification of Diet in Renal Disease Study Group) formula
* Presence of microalbuminuria or proteinuria less than 3.5 g/d
* Diagnosis of hyperlipidemia currently treated with a "statin" drug

Exclusion Criteria:

* Not meeting inclusion criteria
* HDL-C \> 40 mg/dL for men, \> 50 mg/dL for women
* TG (triglycerides) \< 150 mg/dL and \> 800 mg/dL
* Documented intolerance to Niaspan or Aspirin
* Treatment with other lipid-lowering agents (fibrates, BAS \[bile acid sequestrants\], or ezetimibe)
* Elevated transaminases (AST or ALT \>1.3 x ULN)
* Unstable type 2 diabetes (FBG \>200 mg/dL or HbA1c \>9.5%)
* Known seropositivity for Hepatitis B, C, or HIV
* Documented history of malignancy
* Age \< 18 years
* Pregnant women or nursing mothers
* Inability to give informed consent
* Start or change in "statin" dose \< 2 months ago
Safety and Efficacy of Hs-cTnT Protocols

Chest pain is a common presenting complaint among patients in the emergency department (ED). A large portion of patients with chest pain undergo lengthy assessment in the ED or are admitted to rule out acute oronary syndrome (ACS), often with stress testing, creating a substantial health care burden. The new high-sensitivity cardiac troponin assays allow use of shorter time intervals for repeated blood samples and may improve care for chest pain patients. The aim of this cohort is to evaluate high-sentivity troponin based protocols for ruling out and ruling in ACS in the ED.

This is a prospective observational study conducted at Skåne University Hospital (Lund, Sweden). Patients presenting with non-traumatic chest pain and for whom hs-cTnT testing was ordered at presentation will be enrolled between february 2013 to April 2014 after providing written informed consent. Patients with STEMI during index visit and those with severe communication barriers will not be enrolled. Enrolled patients will have a second blood sample for hs-cTnT analyzed 1 h after the first sample. Patients with hemolysis with a hemoglobin concentration \>0.1 g/dl, H-index \>=100 in either the 0- or

1-h sample will be excluded. Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants. Further diagnostic testing and treatment will be performed, as in routine care, at the discretion of the responsible physician.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age
* Presented to the ED with non-traumatic chest pain/discomfort
* Hs-cTnT testing was ordered at presentation

Exclusion Criteria:

* STEMI at presentation
* Severe communication barriers
* Hemolysis with a hemoglobin concentration\>0.1 g/dl, H-index\>=100