Kornimate/medical-research-clean huggingface dataset:
choose to lose for women-weight loss to reduce breast cancer risk factors

Conditions: Obesity; Overweight

Summary: this study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.

in sum, excess body weight and inactivity have emerged as strong avoidable causes of postmenopausal breast cancer, with the greatest potential for primary prevention occurring during the premenopausal years. however, surprisingly, no study to date has examined the effects of a standard behavioral weight loss intervention on breast cancer risk markers in premenopausal women. understanding the effects of weight loss in premenopausal women is a critical next step in existing research and will inform the development of future breast cancer primary prevention programs. the purpose of this study is to determine the feasibility of recruiting, treating, and retaining 20 overweight/obese women in a 12-week randomized control trial examining feasibility and effects of a behavioral weight loss program on breast cancer risk markers in premenopausal women. participants will be randomly assigned to either a 12-week comprehensive behavioral weight loss program (n=10) or control condition (n=10). all women will be assessed at baseline and after 3 months of treatment.

Eligibility criteria:
inclusion criteria: * premenopausal women * age 30-45 * current bmi of \>25 * english or spanish speaking * 5th grade reading level * menstrual regularity, defined as menstrual cycle length of 27-31 and \< 1 missed period within the past 12 months. exclusion criteria: * current use or recent (\< 6 months) use of oral contraceptives, hormones, or other hormone-influencing medications * pregnant, lactating or planning pregnancy in the next 12 weeks * unwilling and able to location for intervention visits. * serious medical condition requiring the supervision of a physician for exercise and diet * history of eating disorder * history of or current use of drugs * current treatment for serious psychological disorder * donation of blood within past 6 weeks.
maximal effort-dependent respiratory flow rates

Conditions: Lung Function

Summary: the general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

1. reproducibility and reference values in normal subjects: the investigators will propose a method for measurement of the maximal inspiratory flow rates (mifr) and establish their reproducibility in normal subjects. the variability of these inspiratory flow rates will be compared with the variability of effort dependent and non-effort dependent expiratory flow rates. also, reference equations will be drawn up and compared to the only existing set of reference values (2) (needing a revision). 2. reproducibility in disease: the investigators will evaluate the reproducibility of the mifr in patients with neuromuscular diseases (steinert muscular dystrophy, amyotrophic lateral sclerosis) and with upper airway obstruction (tracheal stenosis, thyroid enlargement) and compare to the reproducibility of expiratory flow rates in this population. 3. monitoring of diseases: in the neuromuscular patients mifr will be correlated to the existing parameters used for monitoring of these diseases (respiratory muscle strength, forced vital capacity), with a longitudinal follow-up. in the patients with upper airway obstruction the mifr (quantitative measurement) will be compared to the visual inspection (qualitative interpretation) of the maximal flow-volume loop and also the evolution after a therapeutic intervention (airway stenting, thyroidectomy) will be monitored.

Eligibility criteria:
inclusion criteria: * healthy hospital workers or visitors exclusion criteria: * current smokers or ex-smokers with a history of \> 80 py * presence or history of serious illness or thorax deformity (questionnaire) * recent respiratory tract infection (1 week)

Keywords: lung function inspiratory flow rates
[brainconnexion] - neurodevice phase i trial

Conditions: Tetraplegia; Tetraplegia/Tetraparesis; Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Locked-in Syndrome; Muscular Dystrophies

Summary: this study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.

the goal of this study is to develop a miniaturized wireless implantable neurodevice microsystem that records and transmits signals from the motor cortex of tetraplegic patients, bypassing the damaged nervous tissue, to control an external assistive device that restores some form of independence to patients in terms of communication or mobility.

Eligibility criteria:
inclusion criteria: 1. 21 years old and older 2. tetraparesis 3. written informed consent obtained from the patient or legal representative (in the event where the patient is unable to provide consent) prior to entry into the study in accordance with local ec/irb regulations and/or other application regulations for surrogate consent. 4. able to perform the pre-operation brain computer interface training as judged by the research team. exclusion criteria: 1. significant medical co-morbidities e.g. cardiac disease 2. bleeding disorders 3. any contraindication to surgery 4. other concomitant intracranial pathologies 5. history of seizures or epilepsy disorder 6. complications of coagulopathy 7. surgically unfit 8. significant psychological issues e.g. depression 9. poor psychological support 10. pregnancy 11. no means of communication 12. any disease, in the opinion of the investigator, that is unstable or which could jeopardise the safety of the patient if applicable, psychological assessment may be performed prior to selection as the implantation process will be a long a stressful event, requiring a significant degree of patient cooperation and resilience.
photoacoustic imaging in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers

Conditions: Breast Carcinoma; Healthy Subject; Malignant Soft Tissue Neoplasm; Sarcoma; Skin Carcinoma

Summary: this pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.

primary objectives: i. to define the feasibility of the current photoacoustic imaging (pai) technology in various groups of human subjects. secondary objectives: i. to define the utility of the current pai on various groups of human subjects. ii. when possible, via means of an existing data review, pai will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol. iii. when possible, via means of an existing data review, pai will be compared to pathologic specimens. iv. when possible, via means of an existing data review, pai data will be correlated with outcomes of patients to therapies they receive. outline: participants undergo pai on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.

Eligibility criteria:
inclusion criteria: * all groups: * no restriction on race or ethnic background. * subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure. * healthy volunteers: * no history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period. * no history of diabetes. * no history of cancer to the body site to be imaged. * breast, sarcoma, skin cancer, and superficial malignancy patients: * biopsy-proven aforementioned malignancy. * surgical flap patients: * need for plastic surgery reconstruction with a free or rotational flap. exclusion criteria: * uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * unwilling or unable to follow protocol requirements or provide consent. * any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
effect of mechanical ventilation on the incidence of pneumothorax after subclavian vein catheterization

Conditions: Subclavian Vein Catheterization

Summary: the purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.


Eligibility criteria:
inclusion criteria: * adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization exclusion criteria: * infection over the puncture site * history of prior clavicular fracture * anatomical anomaly of subclavian vein * pneumothorax
t-doc® nxt clinical investigation

Conditions: Incontinence, Urge

Summary: assessing the performance, safety and usability of our next generation t-doc® nxt catheter for performing urodynamic studies


Eligibility criteria:
inclusion criteria: * male and female (adult age 21+) * patients with clinical indication for urodynamics (uds) testing, for any medically necessary reason as per the physician. exclusion criteria: * patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria) * patients who are pregnant * patients with recent (less than 2 weeks) pelvic floor surgery * patients who require the use of a suprapubic catheter * patients with significant cognitive deficiency that prevent the patient from giving informed consent
ultra sound guided fine needle aspiration cytology (fnac) of liver and pancreas tumours

Conditions: Tumors in Liver; Tumors in Pancreas

Summary: patients with tumors in liver or pancreas are randomized to ultrasound (ul)-guided fnac biopsies with guidance method or ul-guided fnac biopsies with free-hand method.


Eligibility criteria:
inclusion criteria: * adult over 18 years * tumors in liver and/or pancreas exclusion criteria: * low coagulation factors * mentally ill patients.

Keywords: liver pancreas cancer tumor fnac
ultrasound imaging measurements of the thoracolumbar fascia

Conditions: Low Back Pain

Summary: in this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique. the overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical, the mechanical and tissue characteristic properties of the thoracolumbar fascia, and to explore the effect of a massage therapy technique on these parameters.

in this prospective proof of concept study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound (us) exam of the thoracolumbar fascia (tlf) of the lower back. a musculoskeletal radiologist will perform the us exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles, obtained during 15 degrees of passive flexion of the lower body using a motorized table. following the us exam, the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique. the us exam will be repeated after the intervention. ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed. post-processing of the us recordings will include assessment of geometrical (thickness), mechanical (percent shear strain between the tlf and the epimysium-muscle complex) and tissue ultrastructure features (the mean intensity μ, the scatterer clustering parameter α and the structure parameter κ of the echo envelope). these features will be compared between patients and volunteers and between the intervention groups.

Eligibility criteria:
inclusion criteria: patient group: * presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (nrs), for at least 6 months; * pain is present at least 50% of the time during the day; asymptomatic group: * no history of low back pain or any other chronic pain limiting activities of daily living or work. exclusion criteria: * history of back surgery; * history of severe back or low extremity injury; * back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.); * corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months; * pregnancy.

Keywords: fascia quantitative ultrasound elastography massage therapy
clinical trial of sb-509 in subjects with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of the study is to evaluate the effects of the investigational drug, sb-509 on progression of the disease in subjects with als

sb-509 contains the gene (dna-a kind of biological "blueprint") for a protein. when a study doctor injects sb-509 into the muscles of your neck, arms and/or legs, the drug enters the muscle and nerve cells around the injection sites and causes these cells to make a protein. this protein causes your cells to increase production of one of your own protein called vascular endothelial growth factor(vegf-a), which may improve the structure and function of nerves and muscles. in addition, there are changes in the levels of 28 additional proteins in your cells. these proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. this increase in your own vegf proteins may protect and repair the damaged nerves and muscles caused by als.

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 85 with clinical diagnosis of als * forced vital capacity (fvc) \> 60% of predicted * less than 3 years of als since the onset of the first symptom with clinical evidence of limb muscle atrophy and weakness. * subjects taking riluzole must have been at a stable dose for at least 30 days with no evidence of toxicity * female of childbearing potential and male of child-creating potential must agree to use a medically acceptable physical barrier (condom, diaphragm, and cervical cap) through the treatment phase and for at least 30 days after the last study treatment. exclusion criteria: * women who are pregnant or currently breast-feeding * dependent upon invasive or non-invasive artificial ventilation * patients with bulbar onset als or with other active neuromuscular/ neurodegenerative diseases. * type 1 or type 2 diabetes. * evidence of chronic or active heart, liver, kidney, or lung diseases, or age-related macular degeneration. * current or history of known immune or immunodeficiency disorders * patients with cognitive impairment with significant decision making incapacity, or major depression, or schizophrenia, or dementia (e.g. alzheimer's disease). * malignancy or history of malignancy, except it has been in complete remission for at least 5 years * pre-cancerous conditions (e.g. barrett's esophagus, dysplasias) or benign tumors which have the potential for significant growth due to vegf stimulation.

Keywords: amyotrophic lateral sclerosis, als, lou gehrig's disease
prospective evaluation of topical analgesia for laceration repair in the emergency department

Conditions: Pain, Acute; Laceration

Summary: the purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

a prospective randomized open clinical trial conducted in two high volume emergency departments in france. adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method. 126 patients are expected to enrol in the study.

Eligibility criteria:
inclusion criteria: * superficial skin laceration requiring a suture exclusion criteria: * known allergy to lidocaine * mucous membrane or eye wound * nose, ear or perineal wound * active hemorrhage in the wound * dirty or infected wound * wound requiring operation room management * distracting pain in an other location * intoxicated or comatose patient * patient under guardianship * contra-indication to lidocaine/prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia * neurologic disorder affecting pain sensitivity * dementia * pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age * absence of signed informed consent * inclusion in an other interventional clinical protocol

Keywords: laceration suture topical anesthesia lidocaine
subtotal cholecystectomy for complicated acute cholecystitis: a multicenter prospective observational study

Conditions: Subtotal Cholecystectomy; Complicated Acute Cholecystitis

Summary: we believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

the first reported subtotal cholecystectomy occurred in 1955. additional case reports and studies have been carried out, further defining this terminology as a method of avoiding misidentification injuries of the biliary system or portal vasculature when critical view of safety cannot be safely achieved. recent data supports the safety of this decision, showing equivalent morbidity rates to total cholecystectomy in a large metanalysis of 1,231 patients. importantly, only 4 of the 30 included studies were prospective in nature, allowing definition variability and inconsistent reporting of outcomes. additional reports showed variable data regarding effect on hospital los, need for secondary intervention (including endoscopic retrograde cholangiopancreatography (ercp), percutaneous drainage bilioma, or completion cholecystectomy), infectious complications, biliary or major vascular injury, and mortality. some studies suggest that while subtotal cholecystectomy is associated with a decreased rate of bile duct injury and a lower conversion to open operation, this comes at the cost of increasing bile leak and recurrent biliary complications. furthermore, the relatively recent distinction between fenestrating and reconstituting subtypes of subtotal cholecystectomy remain ill-defined in many of these studies, and outcomes between the two modalities remain variable across the literature. there is an obvious need for a head-to-head, prospective comparison between these subtypes to determine the safety and efficacy of the chosen intervention. to determine the impact of these differing techniques for subtotal cholecystectomy (namely reconstituting and fenestrating subtypes) as indicated by tokyo criteria (table 1), for the management of the difficult cholecystectomy on short-term and long-term patient outcomes.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * preoperative definitive diagnosis of acute cholecystitis (tokyo guideline: table 1) exclusion criteria: * pregnant patients * prior history of subtotal cholecystectomy * percutaneous cholecystostomy tube in place * preoperative diagnosis other than acute cholecystitis * symptomatic cholelithiasis * gallstone pancreatitis * choledocholithiasis * malignant/benign tumor * others
effect of addition of single dose of oral montelukast to standard treatment in acute asthma in preschool children.

Conditions: Asthma; Acute Asthma

Summary: the purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. a few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. but in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. moreover in preschool children there are no studies on this topic. the investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.

Eligibility criteria:
inclusion criteria: * 6 months to 6 years of age * with at least three episodes of wheezing in the previous 12 months * who presented to the ed with a moderate to severe wheezing episode (defined as a pulmonary index score \[pis\] of 7 to 13 exclusion criteria: * patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day * who had any change in their dose of icss in the past 2 months * who had taken systemic corticosteroid within 1 months * patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.

Keywords: acute asthma children montelukast emergency room
effect of hydration with sodium bicarbonate for long-term clinical outcomes in patients with chronic kidney disease undergoing an emergent coronary procedure

Conditions: Chronic Renal Failure

Summary: this study is to evaluate the efficacy of sodium bicarbonate plus n-acetylcysteine for the prevention of contrast-induced nephropathy.


Eligibility criteria:
inclusion criteria: * patients with chronic renal failure(serum creatinine \>1.1mg/dl) undergoing elective percutaneous coronary intervention exclusion criteria: * administered with sodium bicarbonate and/or n-acetylcysteine and/or contrast media within 72 hours. * pregnancy * congestive heart failure * allergy to sodium bicarbonate and/or n-acetylcysteine * hemodialysis

Keywords: patients with chronic renal failure undergoing elective percutaneous coronary intervention