Kornimate/medical-research-clean huggingface dataset:
pmcf study for adept® in laparoscopicgynecologic surgery

Conditions: Adhesion

Summary: postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. the agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. adept adhesion reduction solution, hereinafter referred to as adept, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. the objective of this study is to evaluate the effectiveness and safety of adept by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.


Eligibility criteria:
inclusion criteria: * adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study. * patients in whom adept® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery. exclusion criteria: * patients who had frank infection in the abdominopelvic cavity at the time of the surgery. * patients who were pregnant or nursing at the time of the surgery.

Keywords: laparoscopic gynecologic surgery adhesion-related morbidities
peri-operative oral pain control following buccal graft urethroplasty

Conditions: Urethral Stricture, Male

Summary: patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. in addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. this has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. no study has looked at superiority of regional pain management in this patient population. this study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial. hypothesis: patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.

this is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). this study will aim to assess three established anesthetic protocols for oral pain control. each study arm holds equal weight. approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care. group 1: current buccal harvest * infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc) * graft site hemostasis with monopolar cautery * no suture closure of graft site group 2: basic buccal procedure + long acting local * infiltration of lidocaine 1% with epinephrine (maximum 10cc) * graft site hemostasis with monopolar cautery * no suture closure of graft site * 0.5% marcaine (maximum 5cc) at case conclusion group 3: basic buccal procedure + buccal block * infiltration of lidocaine 1% with epinephrine (maximum 10cc) * graft site hemostasis with monopolar cautery * no suture closure of graft site * buccal block with 0.5% marcaine (maximum 5cc) at case conclusion

Eligibility criteria:
inclusion criteria: * men, age 18 or older * undergoing anterior urethroplasty with buccal grafting * able to consent exclusion criteria: * taking chronic opiates for pain * diagnosis of chronic pain * prior buccal urethroplasty * vulnerable population (e.g. prisoner) * renal dysfunction or allergy preventing nsaid use * liver dysfunction or allergy preventing tylenol use * medical allergy to local anesthetic * medical allergy to peridex/magic mouthwash * nyha class iii/iv * hematologic condition that excludes patient from surgery * post-operative complication resulting in inpatient stay * anesthetic complication * no buccal site surgical complication

Keywords: buccal urethroplasty urethral stricture urethroplasty buccal block lidocaine
protein turnover in healthy and overuse-diseased tendon

Conditions: Patella; Tendinitis

Summary: the goal of this clinical trial is to examine the regional protein turnover in tendon tissue from patients with chronic patellar tendinopathy and comparing this to healthy controls. further we will examine the effect of resistance training on protein turnover in healthy individuals.


Eligibility criteria:
inclusion criteria: * physical active men and women * body mass index 18,5 - 30 kg/m2 inclusion criteria for the chronic tendinopathy group: * debut of symptom \> 90 days prior to inclusion. * subjective activity related pain in patella tendon. * clinical symptoms of patella tendinopathy. * ultrasound verification of at least 1 in three of the following: enchanced anterior-posterior diameter, increased doppler signal and/or a hypoechoic area in the diseased part of the tendon. exclusion criteria for all participants: * former knee surgery or injuries to the patella tendon. * local injection of corticosteroids within 12 months. * medication that affects protein synthesis in tendon tissue. * former/current use of anabolic steroids or growth hormone. * smoking * known rheumatoid disease or diabetes. * former participation in trials using deuterated water and 15n tracers. * treatment for patella tendinopathy within 3 months.
effect of preoperative estrogen treatment on connective tissues of the pelvic floor

Conditions: Pelvic Organ Prolapse; Menopause

Summary: this is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. postmenopausal women with at least stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. at time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. the investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. the results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.


Eligibility criteria:
inclusion criteria: * women, still with uterus, planning total hysterectomy as part of surgical repair for pelvic organ prolapse * symptomatic anterior and/or apical vaginal prolapse greater than or equal to stage 2 (i.e., bulge extends to at least 1 cm of the hymen or beyond) * women between 1 and 10 years after menopause. menopause is defined as one year of amenorrhea or surgical ovariectomy. * age 40-70 years old * no estrogen replacement therapy in the last 1 month * physically capable of daily application of vaginal cream exclusion criteria: * bmi \>35 * prior surgical repair of prolapse involving the vaginal cuff. * prior total hysterectomy * premenopausal or postmenopausal \>10 years * prior steroid hormone replacement therapy of duration \>1 month (oral or vaginal estrogen, testosterone or corticosteroids) * history of connective tissue disease (ehlers-danlos, marfan, etc) * history of vaginal radiation * contraindications for estrogen replacement therapy (current, or history of, spontaneous deep vein thrombosis, stroke, coronary artery disease, breast or endometrial cancer) * concurrent use of steroid cream for treatment of lichen sclerosis * recent history (within last month) of vaginal infection or vaginitis * current tobacco use

Keywords: pelvic organ prolapse menopause estrogen premarin
adolescent master protocol for participants 18 years of age or older - lite

Conditions: HIV/AIDS

Summary: this is a prospective cohort study designed to define the impact of hiv infection and antiretroviral therapy (art) on young adults with perinatal hiv infection as they transition to adulthood.

this is a prospective cohort study designed to define the impact of hiv infection and antiretroviral therapy (art) on young adults with perinatal hiv infection as they transition to adulthood. the primary objectives of this study are: 1. to identify infectious and non-infectious complications of hiv disease and toxicities resulting from long-term art, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality. 2. to define the impact of hiv infection and art on the long-term clinical outcomes of young adults with perinatal hiv. 3. to define the impact of perinatal hiv infection and art on long-term mental and behavioral health outcomes.

Eligibility criteria:
inclusion criteria: * perinatal hiv infection as documented in the medical record; * at or beyond their 18th birthday at the time of informed consent with no upper age limit; * willingness to provide access to existing medical records; and * willingness to participate and provide legal consent exclusion criteria: * prisoner status

Keywords: hiv/aids, perinatal hiv infection
evaluation of the possibility to delegate glaucoma surveillance to orthoptists in hospital

Conditions: Glaucoma

Summary: glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. the treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. due to the fluctuation of the visual field test and re-test measures, the european recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). the lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. it is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs. this study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. to organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.


Eligibility criteria:
inclusion criteria: * age from 18 years old or more * open-angle glaucoma or ocular hypertension exclusion criteria: * other active ocular pathology * monophthalmic patients * patients requiring a goldmann visual field exam * opposition of the patient to participate to the trial * pregnant women or breastfeeding * patient under juridical protection * lack of affiliation to social security or universal health coverage

Keywords: glaucoma surveillance orthoptist
osa-acs project: association of osa and cpap therapy with outcomes in acs patients

Conditions: Obstructive Sleep Apnea of Adult; Acute Coronary Syndrome

Summary: obstructive sleep apnea (osa) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. compared to the general population, osa occurs more often in patients with acute coronary syndrome (acs). although percutaneous coronary intervention (pci) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index acs remain suboptimal. some preliminary data suggest osa is associated with higher risk of subsequent cardiovascular events in acs patients. however, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. furthermore, a cardioprotective role of osa in the context of acute myocardial infarction (ami), via ischemic preconditioning, has also been postulated. due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of osa with short- and long-term outcomes of patients with acs. whether treatment of osa (eg. continuous positive airway pressure (cpap)) would prevent these events will also be evaluated. moreover, the investigators will assess the potential mechanisms of osa-induced atherosclerosis and myocardial injury in acs patients.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. admission with an acs (including stemi, nstemi, and unstable angina) 3. written informed consent exclusion criteria: 1. cardiogenic shock (systolic blood pressure \<90mmhg) 2. cardiac arrest on admission or during hospitalization 3. severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration \<4h/night) 4. predominantly central sleep apnea (csa, ≥50% central events or central apnea hypopnea index (ahi) ≥10/h) 5. previous or current use of cpap 6. known or planned pregnancy 7. severe comorbidities: eg. malignancy (life expectancy \<2 years) 8. patients who cannot tolerate the sleep study or refuse it

Keywords: obstructive sleep apnea acute coronary syndrome continuous positive airway pressure outcome
transcutaneous electrical spinal cord stimulation for lower limbs

Conditions: Spinal Cord Injury

Summary: this study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

this study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation. the investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. we also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. our research has demonstrated that modifying the activation state of the spinal cord after an injury, or awakening the spinal cord, can benefit people with paralysis years after a spinal cord injury. this method and device have not yet been approved by the fda for the treatment of paralysis and are under investigation. this study if successful will help provide further evidence that could be use to one day to gain fda approval.

Eligibility criteria:
inclusion criteria: sci asia a, b, c * spinal cord injury 1 or more years prior * non progressive cervical or thoracic sci * half of key muscles below neurological level having a motor score of less than 2/5 * ability to commit to home exercises and 16 week participation * stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower extremity rehabilitation or testing activities * not dependent on ventilation support * no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with lower extremity rehabilitation or testing activities * no clinically significant depression or ongoing drug abuse * adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 16 week study period * no current anti-spasticity regimen * must not have received botox injections in the prior six months * be unable to use lower extremity for functional tasks exclusion criteria: * pregnancy * no functional segmental reflexes below the lesion

Keywords: spinal cord injury paralysis rehabilitation assessment theranostics
a study of nilotinib versus imatinib in gist patients

Conditions: Gastrointestinal Stromal Tumor (GIST)

Summary: this study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (gist).


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of gist which is unresectable and/or metastatic and either: * have not received any prior anti-neoplastic therapy other than adjuvant imatinib. note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or * recurrent gist after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies. 2. at least one measurable site of disease on ct/mri scan 3. performance status ≤ 2 (capable of self-care but unable to carry out any work) 4. normal organ, electrolyte and marrow function exclusion criteria: 1. any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable gist whose disease requires therapy while awaiting entry to the study. 2. disease progression during adjuvant therapy with imatinib 3. history of active malignancy (other than gist) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ. 4. impaired cardiac function other protocol-defined inclusion/exclusion criteria may apply

Keywords: unresectable gist metastatic gist nilotinib amn107 imatinib sti571
prospective evaluation of diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration and biopsy (eus-fnab) in the absence of rapid onsite evaluation

Conditions: Pancreatic Cancer

Summary: \ rapid onsite evaluation (rose) of endoscopic ultrasound-guided fine needle aspiration and biopsy (eus-fnab) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of eus-fnab. the practice of rose, however, varies across eus programs in unites states, europe and other areas of world. the investigators have a plan to perform prospective evaluation of the yield of eus-fnab in the absence of rose, in which the adequacy of specimens will be assessed by a single endosonographer. \ all eus-fnab procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during eus-fnab will be also assessed by a same endosonographer. a specimen will be considered adequate if there is an adequate number of representative cells from the lesion. samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. performance characteristics of eus-fnab including sensitivity, specificity, and accuracy will be determined by comparing eus-fnab results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.


Eligibility criteria:
inclusion criteria: * any patients who will undergo eus-fna for the diagnostic evaluation of pancreas lesion exclusion criteria: * patients who refuse to undergo eus-fna
comparison between conventional vs. endoscopic lumbar discectomy

Conditions: Lumbar Disc Herniation

Summary: this study is aimed to compare between the results of conventional lumbar discectomy and the newly used technique in our department; endoscopic lumbar discectomy in neurosurgery department assiut university hospitals, so that we can offer our patients the best service in an updated and minimally invasive way.

lumbar discectomy is one of the most common operation performed worldwide for lumbar-related symptoms. lumbar disc herniation accounts for only 5% of all low back pain problems but is the most common cause of radiating nerve root pain, sciatica. mixter and barr described the first surgical procedure to remove the herniated lumbar disc in 1934 through a laminectomy and durotomy, with later enhancement by semmes, who described approaching the herniated disc through hemilaminectomy and retraction of the dural sac. this became popularized as the "classical discectomy technique. during the latter half of the 19th century, more techniques were developed to remove the herniated disc with minimal invasiveness. the first herniated disc excision using a microscope (microdiscectomy) was performed by yasargil in 1977, which was the standard surgical procedure at the time in 1993, mayer and brock and then in 1997, smith and foley described endoscopic discectomy techniques. with these minimally invasive techniques, authors demonstrated decreased soft tissue manipulation, operative time, blood loss, and hospital stay, allowing early recovery. in this study we try to evaluate clinical and radiological outcomes of percutaneous endoscopic translaminar discectomy at our hospital.

Eligibility criteria:
inclusion criteria: * single level, postero-lateral, denovo lumbar disc herniation including those with migrated and/or sequestrated discs. * l4,5 \&l5,s1 disc prolapse * failure of conservative management after 12 weeks. exclusion criteria: * central, far lateral, recurrent and/or multiple level disc herniation. * lateral recess stenosis or spondylolisthesis. * presence of neurological deficit.

Keywords: lumbar disc herniation endoscopic discectomy open discectomy comparative study translaminar surgery
the effectiveness of self-thoracic spine mobilization on improving sleep quality in patients who have shoulder pain

Conditions: Shoulder Pain Chronic

Summary: this project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to utsw physicians with shoulder pain. the investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each group. the treatment group will also receive instruction to mobilize their thoracic spine and ribs each night before going to sleep.

subjects with a chief complaint of musculoskeletal pain will be recruited from clinics in the departments of internal medicine, family medicine, and orthopedic surgery. subjects will be randomized into either the intervention or control group. the intervention group will receive education on sleep hygiene and instruction to use a foam roller to mobilize the thoracic spine and ribs just before the subject goes to sleep. the control group will receive education on sleep hygiene. valid and reliable measures will be used to assess sleep quality (pittsburgh sleep quality index), pain (numeric pain rating scale), and function (sf-36 and ases), as well as a sleep diary. measures will be taken at baseline as well as two weeks after the subject's enrollment in the study.

Eligibility criteria:
inclusion criteria: * shoulder pain with associated sleeping disturbance * between the ages of 18-89 * present to the clinics in the departments of internal medicine, family medicine, and orthopedic surgery at utsw exclusion criteria: * non-english speakers * chronic pain or rheumatic disorders * unstable psychopathology, cognitive impairment (including dementia) * current or recent history (within 6 months) of substance abuse disorders * recent history of surgery or fracture to the cervical spine, thoracic spine, ribs, or shoulders (within 6 months) * metabolic bone disease (including osteoporosis) * fusion or ankyloses * osteomyelitis, pregnancy, vertebral basilar insufficiency, neoplastic disease, malignancy in the area of treatment * actively treated for sleep disorders (including insomnia) * uncontrolled congestive heart failure, copd, hypertension, or other serious medical illness