cyrilzakka/clinical-trials huggingface dataset:
Scalpel vs Diathermy in Repeat Cesarean Delivery

The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.

It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. A second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain.

1. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas.
2. Women undergoing cesarean delivery will be randomized into two groups: One group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel will be used to achieve the same aim.
3. A standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons preference. All patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler.
4. Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. Blood loss will be calculated by weighing (in grams) the "used" lap sponges and comparing this to the weight (in grams0 of "fresh" lap sponges.
5. Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Multiparous pregnant women 18 - 45 years.
* Gestational ages 37 weeks to 41 weeks,
* Undergoing repeat elective or repeat emergency cesarean deliveries.

Exclusion Criteria:

* Informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation.
* Primary Cesarean deliveries - as these can bias the selection.
* Skin conditions such as infections, psoriasis, and eczema.
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.

Spondylolisthesis is a serious health condition that is often treated with surgery or pain-relieving lumbar epidural steroids. Patients with persistent and debilitating symptoms who have failed to respond to conservative treatment should consider surgery.

Objectives: The aim of this study was to compare the therapeutic efficacy of three ultrasound guided PRP injections of the facet joint capsule to surgical procedures in patients with degenerative spondylolisthesis G1 and their effect on neurogenic pain relief and functional improvement over a one-year follow-up period.

Methods:

A one-year prospective randomised comparative clinical trial was performed on 60 patients with degenerative spondylolisthesis G1 who were randomly assigned to one of two groups: Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals, and Group 2: thirty patients underwent surgery. They were exposed to clinical neuropsychological testing.They were assessed for pain and function using clinical neurological assessments, VAS (Visual Analogue Scale), FRI (Functional Rating Index), Roland Morris, and ODI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with degenerative spondylolithesis Grade 1 were diagnosed based on their clinical and radiological image.
* Patients complained of extreme pain and received medical treatment (NSAIDS) without improvement.

Exclusion Criteria:

* Patients with more than two-level pathological lesions and those who had previously
* Patients undergone lumbar surgery,
* HCV, HBV infected patients,
* patients with local abscesses,
* diabetes mellitus,
* malignancy, pregnancy,
* blood disorders (coagulopathy, thrombocytopenia),
* patients who had previously received local injection of steroid within past 3 weeks
* Patients who had undergone lumbar surgery,
* patients with advanced spondylolithesis, disc prolapse,
* inflammatory or musculoskeletal disorders of the spine.
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus

The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg)
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis

This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of complicated bacteremia or infective endocarditis
* Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci
* Treatment with standard of care antibiotics for 72 hours (h) - 10 days
* Defervescence for at least 24h and clearance of bacteremia from screening pathogen.

Exclusion Criteria:

* Embolic events
* History of prosthetic valve surgery, cardiac device or prosthetic joint
* Left-sided endocarditis due to Staphylococcus aureus (S. aureus)
* Large mobile vegetations (\>10 mm) on mitral valves
* Perivalvular abscess
* Uncomplicated bacteremia due to S. aureus
* Gram-negative bacteria or fungi in blood cultures
* Heart failure associated with infective endocarditis \[Left Ventricular Ejection Fraction (LVEF) \<40%\]
* Intravascular material or removable infection source not intended to be removed within 4 days postrandomization
* Planned valve replacement surgery within 3 days of randomization
* Refractory shock, significant hepatic insufficiency or severe leukopenia \[Absolute Neutrophil Count (ANC) \< 500 cells/mm\^3\]
* Known osteomyelitis
* Hypersensitivity to dalbavancin or other drugs in glycopeptide class
* Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin
* Immunosuppression/immune deficiency
* Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol
* Pregnant or nursing females.
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.


Eligibility Criteria:
Inclusion Criteria:

* Visual acuity impairment caused by macular edema in at least one eye
* Type 1 or type 2 diabetes mellitus
* Stable medication of diabetes in past 3 month

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases
* Laser photocoagulation in the study eye for the last 3 months
* Any history of any intraocular surgery in the study eye within the past 3 months
* Blood pressure \> 160/100 mmHg

Other protocol defined inclusion/exclusion criteria may apply
Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation.

The investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.

Bladder biopsies will be obtained during cystoscopy, conserved in culture medium (DMEM®), digested by dispase and sowed on collagen-coated culture support. Keratinocyte Serum Free Medium (KSFM) will be used for proliferation. Microscopy, immunohistochemistry, RNA extraction, Reverse Transcription and quantitative Polymerase Chain Reaction (RT-qPCR) will be performed during passages. Cell culture conditions will be optimized to improve proliferation and avoid loss of differentiation. The investigators will develop scaffolds based on sodium alginate hydrogels, followed by freeze-drying to generate porous sponges (at -20°C and -80°C). Cultured cells will be associated to these original scaffolds and to other scaffolds, for example alginate hydrogels or Collagen Cell Carrier (CCC), cultivated for 28 days and analyzed. Histological and immunohistological appearance of cellularized scaffolds will be compared to assess the effectiveness of each scaffold for tissue engineering in urothelium.

Cellularized scaffolds will be studied in vitro (Transepithelial Electrical Resistance, impermeability, ability to be stitched, resistance to urine) and in vivo in ectopic location (subcutaneous location in Nude mice) or in orthotopic location (bladder augmentation in small animal).

Eligibility Criteria:
Inclusion Criteria:

* Patient needing a Transurethral Resection of Prostate (TURP)
* Weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams
* Affiliation to a social security system
* Patient over the age of majority
* Patient receiving complete information on research organization without opposition to the use of biological specimen

Exclusion Criteria:

* Patient for whom no TURP is realized during endoscopic procedure
* Patient for whom no resection is realized on the bladder neck
* Patient with prostate weight estimated under 30 grams
* Patient who opposed to the realization of the study
Virtual Reality Mediated Functional Status Assessment in Stroke Patients

The aim of the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. In this study, it was aimed to evaluate the upper extremity and balance functions of stroke patients with the developed software.

This prospective and descriptive study will be conducted with patients diagnosed with stroke. Patients diagnosed with stroke will first be evaluated by an expert physiatrist in a clinical setting to determine their functional status, and then evaluated by a virtual reality mediated software system. The evaluation of a patient will take approximately 1 hour.

Participants diagnosed with stroke will be evaluated in terms of hand and balance functions. The measurement parameters planned to be performed are scales routinely applied in stroke patients. Hand functions of the users will be evaluated with the 'Wooden Box and Block Test' , lower extremity muscle strength and fall risk will be evaluated with the 'Sit and Stand Test for 5 Times', and balance functions will be evaluated with the '360 Degree Rotation Test' . The tests mentioned above will be presented to the users first in the real world and then in the virtual reality environment and an objective functional status assessment will be made.

A total of 30 patients diagnosed with stroke are planned to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-65,
* History of stroke
* Accept to participate in the study,

Exclusion Criteria:

* Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurological deficit,
* Uncontrolled hypertension, diabetes, cardiovascular disease etc.
* Cognitive impairment causing difficulty in performing simple commands
* Epilepsy
* Pregnancy.
Myocardial Perfusion Imaging by 15O-H2O PET/CT

The trial will include 5000 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo the clinical scan as normal.

Data from the scans will be used to determine reference values of the examination.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital

Exclusion Criteria:

* Claustrophobia, severe asthma, younger than 18 years
F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)

PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution. Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic disease either in bone marrow or extramedullary.

F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive study can replace bone marrow biopsy and predict response vs. non response to therapy.


Eligibility Criteria:
Inclusion Criteria:

* new diagnosis of AML

Exclusion Criteria:

* pregnancy
Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.

Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
* Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
* Only teeth with intact buccal bone plate will be considered for this study.
* Patients who are cooperative, motivated and hygiene conscious.
* Patients whose age is \>18 years

Exclusion Criteria:

* Systemic conditions/disease that contraindicated surgery.
* Patients on drugs that may compromise bone healing.
* Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
* Smokers.
* Patients with Psychologic disorder.
* Pregnancy or lactation.
* Presence of acute periodontal or periapical pathology.
B-mode Ultrasound Imaging in Detecting Early Liver Cancer

This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

For Healthy Volunteers

1. Patients over 18 years of age.
2. Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.

For HCC patients

1. Patients over 18 years of age.
2. Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound.

Exclusion Criteria:

For Healthy volunteers

1. Patients who are not likely to comply with the protocol requirements.

For HCC patients

1. Patients should not be taking other Investigational Agents.
2. Concomitant medications for treatment of the target lesion.
Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure

Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be evaluated via a number of demographic lenses in order to find trends that could benefit future Congestive Heart Failure sufferers.


Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States
* Is 18+ years old
* Participant has a diagnosis of congestive heart failure
* Participant has enrolled in an interventional clinical for congestive heart failure (self-reported)

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* No diagnosis of congestive heart failure confirmed
TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have biopsy proven T3 or T4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement
* Patients must be willing to return for follow-up
* Patients must be able to give and sign informed consent
* Patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease
* Life expectancy \> 6 months

Exclusion Criteria:

* Patients with evidence of distant metastatic disease
* Any of the following hematologic abnormalities: hemoglobin (HGB) \< 8.0 gm/dL unable to be corrected with a transfusion; absolute neutrophil count (ANC) \< 1500 cells/mm3; platelets \< 100,000/mm3; activated partial thromboplastin time (APTT) ratio or International Normalized Ratio (INR) \> 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for vector injection or surgery).
* A history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin \> 2.0 mg/dL except for patients with Gilbert's syndrome who must have a direct bilirubin \</= 1.0 mg/dL; AST/ALT \>/= 2.5 times upper limit of normal.
* Renal insufficiency as determined by a serum creatinine \> 2.0 mg/dL
* Patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for rectal cancer
* Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease
* Concurrent second malignancy requiring systemic therapy
* Pregnant or lactating women
* Chronic systemic corticosteroid use
* Prior surgery for rectal cancer
* Patients with history of deep venous thrombosis or pulmonary embolism
* Patients with Doppler evidence of deep venous thrombosis at screening
* Known history of documented coagulopathy or thrombophilic disorders
* Hormone replacement therapy within one month prior to Day 1
* Known history of documented cerebrovascular disease, stroke or transient ischemic attack (TIA)
* Surgery within the last one month, excluding diverting colostomy or ileostomy for obstruction
Relationship-based Care Model in Pediatrics

Aim: To evaluate whether the application of the Relationship-based Care (RBC) model as a treatment called "Take 5 minutes" (T5M) affects the level of anxiety and depression of the parent, the level of the parent perceived quality of nursing care and the work satisfaction of the nursing staff.

Design: Single-blind randomized controlled trial.

Methods: The trial was performed from February to July 2016. The trial was conducted with one intervention (N=101) and one control group (N=90). Nurses applied the RBC model as a treatment, named "Take 5 Minutes", that consisted of dedicating some short time (from 5 to 10 minutes) to the relationship with the parents, using specifically designed communication strategies. The primary outcome was the evaluation of anxiety and depression of parents, the secondary was the parent perceived quality of nursing care.


Eligibility Criteria:
Inclusion Criteria:

* the parents of the children admitted to two Pediatric Units in a nationally renowned university hospital in the North-East of Italy
* had knowledge of the Italian language spoken and written
* were available for participation in the study by signing the informed consent

Exclusion Criteria:

* Parents of hospitalized patients for a duration of less than 4 days