Kornimate/medical-research-clean huggingface dataset:
cascade prfm study: the evaluation of cascade platelet-rich fibrin matrix (prfm) on rotator cuff healing

Conditions: Rotator Cuff; Tendon Injuries

Summary: hypothesis: the use of cascade platelet-rich fibrin matrix (prfm) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%. the purpose of this study is to examine the effect of prfm on rotator cuff repairs. since locally applied platelet-derived growth factor (pdgf) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (acl) and medial collateral ligament (mcl) reconstruction, the investigators believe that locally applied prfm will enhance the quality of rotator cuff repairs.


Eligibility criteria:
inclusion criteria: * patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology. * patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair. exclusion criteria: * patients who have undergone revision procedures, mini-open, or open procedures will be excluded.

Keywords: full thickness tendon defect of rotator cuff
ileal conduit versus cutaneous ureterostomy after radical cystectomy

Conditions: Patient Satisfaction; Bladder Cancer

Summary: bladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2% of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in the male population. causative risk factors can be broadly divided into inherited and acquired due to environmental exposure ,tobacco smoking is the most important environmental risk factor for bladder cancer(1). histologically, over 90% of bladder tumors are transitional cell carcinomas. the other subtypes, such as squamous cell and adenocarcinoma, are uncommon and account for 5 and \<2%, respectively(2). radical cystectomy with pelvic lymph node dissection with appropriate urinary diversion remains the mainstay of surgical treatment for muscle invasive bladder cancer and for high risk non muscle invasive disease. select group of patients or those unfit or unwilling for surgery are managed by trimodal therapy utilizing transurethral resection and chemoradiotherapy.(3) the ideal urinary diversion should successfully preserve renal function while managing urinary outflow and minimizing morbidity to the patient(4).several types of urinary diversion are present, continent and incontinent. our study will focus on ileal conduit and cutaneous ureterostomy. although ileal conduit considered the standard method for incontinent urinary diversion, it is associated with early bowel related complications, i.e., bowel obstruction, prolonged ileus, and anastomotic leak which are mainly associated with bowel resection and anastomosis and late complications comprise ureteroenteric stricture, urinary fistula and stomal site complications in 25-60% of patients, including stomal stenosis, retraction, prolapsed, and parastomal herniation. cutaneous ureterostomy may represent a method of choice for elderly and otherwise morbid patients due to its relative short duration and less bowel and metabolic complications but it has a high rate of stomal stenosis making perminant stenting is mandatory(5). cutaneous ureterostomy with separate stomas offers easy exchange of stents not need tertiary center with fluoroscopy or endescopy guidance compared to cutaneous ureterostomy with single stoma and this is preferable in our community.


Eligibility criteria:
inclusion criteria: * patients with bladder cancer eligible for surgery exclusion criteria: * patients who refuse to contribute in this study. * patients who are unfit for surgery. * patients refusing cystectomy. * patients with metastatic or inoperable cancer bladder
the aces study for aseptic pleural effusion

Conditions: Pleural Effusion

Summary: the study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. baseline assessment will include a history and physical, chest imaging and quality of life questionnaires. after aces implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea.

pleural dynamics is the first company to provide a fully implantable automatic effusion shunt that is powered by normal breathing and is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters." the current standard of care, pleurodesis, is often painful, requires an extended hospital stay, and is often unsuccessful requiring additional procedures to manage the effusion1. while an alternate approach-indwelling pleural catheters-exists, it requires that the patient have a portion of the catheter to be external to the chest and requires frequent drainage into proprietary external canisters to relieve symptoms. pleural dynamics' patented aces™ system addresses these shortcomings with its' one-piece, fully implanted system that can be placed during a short hospital stay. this technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief.

Eligibility criteria:
inclusion criteria: 1. recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. symptoms of pe such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. eastern cooperative oncology group (ecog) performance status of 0-3. 4. patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls. exclusion criteria: 1. recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. symptoms of pe such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. eastern cooperative oncology group (ecog) performance status of 0-3. 4. patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

Keywords: pleural effusion malignant pleural effusion ipc
0.5% bupivacaine lower cervical intramuscular injection vs iv medications for headache treatment

Conditions: Headache; Migraine; Tension Headache; Occipital Neuralgia

Summary: headache is a frequent chief complaint among patients presenting to the emergency department (ed), accounting for 2.1 million visits annually in the united states. often, individuals resort to ed care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (iv) medications in the ed, including nsaids, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. in the ed, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ed patient turnover-continues to be a popular area of research in emergency medicine. the investigators plan to evaluate the use of 0.5% bupivacaine cervical im injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the emergency department at north florida hospital.


Eligibility criteria:
inclusion criteria: * patient has to be able to provide own consent * english-speaking only * non traumatic headache with vas pain score of 5 or above out of 10 exclusion criteria: * traumatic headache * confused patients * allergy to bupivacaine * infection over injection site * recent neck surgery * hemodynamically unstable * bleeding disorder * anticoagulation use * pregnant, lactating women * prisoners

Keywords: headache bupivicaine cervical injection paraspinous injection
treatment of epicondylitis by ultrasound-guided local injections of prp (platelet rich plasma)

Conditions: Epicondylitis

Summary: the purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (prp) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).

this was a prospective double-blind placebo-controlled randomized trial. two ultrasound-guided injections of either prp (acp®, arthrex) or saline solution were performed at 4 weeks interval. exclusion criterion was previous corticosteroid infiltration. all infiltrations were performed by dr bernard montalvan. the selection of patients and the evaluation were conducted by dr patrick le goux who did not know which treatment had been allocated to which patient. in the facility, no one apart from the investigators had access to full patient data. an independent company represented by mrs amandine ramseyer was hired to design, follow and carry the statistical analysis of the study. the data she got from the investigators were anonymous. patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months follow-up. secondary criteria were the roles-maudsley score and the assessment of pain on isometric contraction of the extensor carpi radialis brevis and of the extensor digitorum communis. the main evaluation criterion was the relative improvement from baseline to 6 months in pain score on visual analog scale (0-10). intragroup and intergroup intention-to-treat analyses were performed using student's t-tests, applying the last-observation carried forward method. differences of proportions were tested using chi-square. the sample size calculated was 22 patients per group so that this study had a power of 90% with typei error rate α=0.05 to demonstrate a significant greater improvement of the global pain score of at least 10%, in the prp over the placebo group with a standard deviation of 0.10. a "p" value of less than 0.05 was considered to be statistically significant. the spss software (version 19 for windows) was used to perform statistics.

Eligibility criteria:
inclusion criteria: * patients suffering from tennis elbow for less than three months * patients having never received former medical or orthopedic treatment for tennis elbow exclusion criteria: * patients having received any treatment for this specific pathology * evidence of ongoing tumoral affection (controlled by mri) * tennis elbow history * elbow fracture history * associated elbow pathology * inflammatory rheumatic disorders * bleeding disorders * ongoing anticoagulation therapy * allergy to local anesthetic * ongoing or previous cancer affection * pregnancy * diabetes

Keywords: recent lateral humeral epicondylitis platelet-rich plasma infiltration tennis elbow ultrasonography
gluten-free oats and gastrointestinal health in coeliac disease, part 2

Conditions: Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Summary: the research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. the effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. the study is divided into two parts. part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. healthy subjects will be recruited to the study. the aim is to recruit 15 participants for the part 1. the study will be conducted with a cross-over setting, where the subjects will go through exposure meals and smartpill ingestion three times (two different oat products and placebo) in a randomized order. the study meals are identical in appearance and fiber content. after consuming the meal subjects will ingest the smartpill capsule, which will send data on intestinal ph, pressure and temperature to the external portable device. before and during the passage of capsule the subjects will fill a symptom and food diary. the capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. before the oat/placebo exposure the subjects will give a fecal and a blood sample. in addition, 36 hours urine samples will be collected. in part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). recruiting aim for each group is 15 subjects. in addition to dietary data, a blood, and a fecal sample will be collected from the subjects. the gut microbiota will be analyzed from the fecal samples. the metabolic products will be analyzed from the fecal, urine and blood samples. the gut microbiota composition will be analyzed with next-generation dna sequencing techniques.


Eligibility criteria:
inclusion criteria: * celiac disease diagnosed with duodenal biopsy (only celiac groups) * in remission and maintained gluten-free diet \>1 year (only celiac groups) * usage of oats in their diet (only oat-using celiacs and healthy controls) * bmi 18,5 - 30 * normal liver, thyroid and kidney functions exclusion criteria: * medication that majorly affects gi tract (e.g. laxatives, antacids) * antibiotic treatment within the last 6 months * blood donation or participating in another clinical trial within the last month
safety and efficacy of ranibizumab in diabetic macular edema

Conditions: Visual Impairment Due to Diabetic Macular Edema

Summary: 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

Keywords: diabetic macular edema dme proliferative diabetic retinopathy pdr ranibizumab laser
compassionate use of triclabendazole for the treatment of parasites (prior to fda approval; expanded access program)

Conditions: Parasitic Disease

Summary: triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary practice. triclabendazole is considered to be a second-line drug for parasites and is used when other preferred agents cannot be used because they are ineffective or because adverse reactions limit their use. although triclabendazole is widely used in developing countries for the treatment of parasites it is not approved by the fda for this treatment in the us. it is currently being distributed in the us through a special arrangement with the fda and the manufacturer on an individual patient approval basis. this arrangement requires that a single patient investigational new drug (ind) be obtained from fda for each patient requiring triclabendazole. upon approval by fda, the manufacturer (novartis) will ship the drug directly to the prescribing physician.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of parasites whose resistance pattern has indicated resistance to first line agents and sensitivity to triclabendazole or in whom an additional drug needs to be added to their regimen because of inadequate response to existing therapy. * patients with a parasite that is sensitive to triclabendazole and who have experienced an allergic or adverse reaction to other agents that prevent their use. * patients with parasitic disease that has responded to treatment with first line drugs but who experienced allergic or adverse reactions to these agents that has prevented their continued use or who have experienced a relapse in their disease that necessitates the addition, or substitution, of second-line agents * patients who do not qualify for a study using triclabendazole or for whom a study does not exist and thus the patient would not otherwise have access to the drug exclusion criteria: * anyone whose parasitic disease can be adequately treated by other available medications. * anyone who is allergic or who has had a severe adverse reaction to triclabendazole in the past. * pregnant women
safety and performance of the automated fluid shunt in patients with ascites and diuretic resistance

Conditions: Ascites

Summary: to investigate the safety and performance of the automated fluid shunt in patients with ascites and diuretic resistance. study size and duration the primary study population will include 40 patients enrolled and implanted with the novashunt automated fluid shunt (afs) in up to 15 centers in europe.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis. * cirrhosis of any etiology * failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects * dietary sodium restriction \<88meq/d. * serum creatinine levels of ≤ 2.0 mg/dl for at least 7 days before study entry. * total bilirubin levels of less than 3 mg/dl. * expected survival of greater than 6 months * written informed consent * ability to comply with study procedures and ability to operate the device. * women of childbearing age should use adequate contraceptives exclusion criteria: * presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. * presence of peritoneal carcinomatosis * advanced hepatocellular carcinoma, demonstrated by: 1. one tumor that is \>5 cm diameter 2. 3 or more nodules of \>3 cm diameter 3. portal thrombosis * other evidence of a malignant etiology for ascites * evidence of extensive ascites loculation * gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study. * hepatic encephalopathy in the two weeks prior to implant * presence of a tips or surgical portosystemic shunt * presence of budd-chiari syndrome * previous liver transplant * obstructive uropathy * coagulopathy that could not be corrected to a prothrombin time inr \<1.8, * thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3 * any other clinically significant disease that could be adversely affected by study participation judged by the investigator * any condition requiring emergency treatment * pregnancy * patients being in another clinical study that did not reach primary endpoint yet

Keywords: ascites liver cirrhosis
sorafenib as a second line treatment in patients with advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with advanced or metastatic gastric cancer (a/mgc).

up to now, although fu based, cisplatin based and taxane based regimen, and ecf regimen have been suggested as the first line therapy for a/mgc by fda, there is no standard regimen for patients with a/mgc as second line treatment. based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for a/mgc patients as a second line treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ecog performance scale ≤ 2 * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * adequate hepatic, renal, heart, and hematologic functions: * platelets\>80 × 109/l * neutrophil\>2.0 × 109/l * serum creatinine ≤ 1.5mg/dl * total bilirubin within upper limit of normal(uln) * serum transaminase ≤ 2.5 × the uln exclusion criteria: * pregnant or lactating women * concurrent cancer * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * neuropathy, brain, or leptomeningeal involvement * uncontrolled significant comorbid conditions and previous radiotherapy

Keywords: time to progression toxicity overall survival response rate quality of live toxicities
comparison of hybrid and laparoscopic incisional hernia repair

Conditions: Incisional Hernia

Summary: study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation). patients are recruited prospectively from 10 finnish hospitals (oulu, jorvi, hyvinkää, kotka, seinäjoki, valkeakoski, lahti, kuopio, kokkola, loimaa). patients are randomized to operative groups (lap. vs hybrid). follow-up visits are scheduled at 1- and 12-month after surgery. patients are evaluated for their clinical status and an ultrasound scan is performed. qol-questionnaire and pain score (vas) are reported. the primary end-points: * clinically and/or radiologically detected seroma in 1 month control * clinically and/or radiologically detected recurrent hernia in 1 year control the secondary end-points: * peri-and postoperative outcomes/ complications, morbidity, mortality * duration of hospital stay * pain scale (vas) * quality of life (sf/rand36)

hypothesis: using a hybrid method seroma formation and hernia recurrence can be diminished. patient exclusion criteria: age\ 80 y asa \>4 (the american society of anaesthesiologists' classification of physical health) bmi\> 40 a previous mesh repair of the hernia hernia defect size \ 7 cm emergency operation eligible patients are randomized into two operative groups (lap/hybrid). in the laparoscopic group the hernia defect is covered with a parietex composite mesh (using minimum of 5 cm marginals, securestrap fixation instrument and four lifting strings. in hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. after this, a mesh repair is performed laparoscopically.

Eligibility criteria:
inclusion criteria: -patients with incisional hernia exclusion criteria: * bmi \>40 * asa iv * a prior mesh repair * hernia defect size \ 7 cm * emergency operation

Keywords: incisional hernia laparoscopic repair hybrid repair seroma recurrent hernia