Kornimate/medical-research-clean huggingface dataset:
effect of pregabalin on shoulder pain in patients with central sensitization after arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tears; Central Sensitisation; Neuropathic Pain

Summary: this study aims to investigate the effects of pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. although pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. utilizing a list that identifies central sensitization, this study will explore whether pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. a prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair. the study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. the case group will receive standard postoperative medications (nsaids) plus pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without pregabalin.


Eligibility criteria:
inclusion criteria: * age over 19 to under 70 * underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff. * clinical diagnosis of myofascial pain syndrome * central sensitization (central sensitization inventory (csi) score of 40 or above). exclusion criteria: * previous history of pregabalin prescription * hypersensitivity reactions or severe complications after taking pregabalin. * diagnosed with and are being treated for psychiatric disorders * localized infection, sepsis, or previous neurological abnormalities * uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmhg) * liver function abnormalities (aspartate aminotransferase or alanine aminotransferase \&gt;60 iu/litre). * major cardiovascular diseases or renal impairments
thoracic mobility in cystic fibrosis care

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is an inherited, genetic disease of the body's mucus-producing glands that primarily affects the lungs and gastrointestinal tract. there are no studies that have examined anatomical changes, the connection between structure and function in the ribcage and the effect of symptom-relieving manual treatment. the purpose of the study is therefore to investigate chest mobility in people with cf. method the study is conducted in three parts; a / a retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of cf patients. chest configuration will be measured standardized and blinded on computed tomography (ct) images and related to results from spirometry examinations. b / a prospective, consecutive cross-sectional study of the same cohort. the aim is to investigate the extent of stiffness and pain that is examined standardized (number of pain-free / normal moving structures) and its relation to objective examination of respiratory movements, respiratory muscle strength and spirometry. c / a randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms. the treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment. evaluation will be done via the examination protocol in sub-study b / as well as objective measurements of respiratory movements (primary variable), respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention / control period. clinical significance when it comes to cf care, great medical advances have been made and for swedish patients, the physiotherapeutic active treatment has proven to have very good effects. however, there are areas where care can be improved. the results from our study will provide additional breadth to strategies in cf care


Eligibility criteria:
inclusion criteria: * diagnosed with cystic fibrosis * \>18 years of age exclusion criteria: * participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.

Keywords: rib cage range of motion pain spirometry
tranexamic acid after pathological fracture treated with modular arthroplasty

Conditions: Metastases to Bone

Summary: this study assesses the safety and efficacy of txa for patients treated for pathological femur fractures using modular prosthetics.

tranexamic acid is an efficacious medication for curtailing blood loss, haemoglobin drop, and the requirement for transfusions. additionally, it is a secure medication, even when administered to oncology patients receiving reduction haemarthroplasty for pathological femoral fractures.

Eligibility criteria:
inclusion criteria: * patological fracture * arthroplasty using a modular prosthesis. exclusion criteria: * threatened fracture * intraoperative blood transfusion * fracture fixation

Keywords: blood transfusion neoplasm metastasis bone
cannula-based versus needle-based subcision for posttraumatic atrophic facial scars

Conditions: Scar; Atrophy

Summary: this study aims to evaluate the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars

in addition to cosmetic issues, atrophic scars can lead to psychological issues like social isolation, low self-esteem, and embarrassment. subcision (subcutaneous incision-less surgery) has been used for years to treat a variety of skin depressions, including atrophic acne scars and other depressed scars. numerous modifications have been made throughout time to this surgical method to make it easier and more efficient. although needle subcision is a straightforward, simple, useful, and practical procedure, it has many side effects and the overall success in this procedure is mild to moderate. so, in this study we evaluated the effectiveness of cannula- based subcision versus common needle subcision in treatment of posttraumatic atrophic facial scars.

Eligibility criteria:
inclusion criteria: * adult patients (\> 20-years old) with posttraumatic facial scar exclusion criteria: * other types of scars (e.g; postacne scars), pregnancy, lactation, bleeding or coagulation disorders, liability for keloid formation, history of kobnerization, and patients with systemic diseases (cardiac, chronic renal diseases, chronic liver diseases, asthma and hypertension) at the time of recruitment.
incidence of metal failure during first year following transpedicular screws fixation of dorsolumbar spine fracture

Conditions: SPINAL Fracture

Summary: recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up


Eligibility criteria:
inclusion criteria: * adult patients * post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws * with or without decompression exclusion criteria: * pediatric patients * pathological fractures
the usefulness of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent

Conditions: Bile Duct Obstruction; Disorder of Bile Duct Stent; Neoplasms

Summary: the purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Eligibility criteria:
inclusion criteria: * age \> 20 years * the presence of an unresectable malignant biliary obstruction * failed conventional ercp stenting exclusion criteria: * age \< 20 years * an inability to sedate the patient due to advanced heart or pulmonary diseases * a lack of informed consent
a prospective evaluation of glaucoma subjects treated with two second generation istents and one istent supra

Conditions: Glaucoma, Open-Angle

Summary: prospective evaluation of open-angle glaucoma subjects treated with two second generation istents and one istent supra

prospective evaluation of mild to moderate open-angle glaucoma subjects treated with two second generation microbypass stents and one suprachoroidal stent

Eligibility criteria:
inclusion criteria: * phakic or pseudophakic subjects with posterior chamber iols primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis subject on two ocular hypotensive medications medicated screening iop greater than or equal to 18 mm hg and less than or equal to 30 mm hg visual field or optic nerve defect characteristic of glaucoma normal iridocorneal angle anatomy absence of peripheral anterior synechiae mean diurnal iop at baseline between 21 and 45 mm hg exclusion criteria: * subjects with anterior chamber iols prior slt or stent implantation in study eye traumatic, uveitic, or neovascular glaucoma fellow eye bcva worse than 20/200
a randomized study comparing subtotal vs total hysterectomy long term outcomes

Conditions: Fibroid Uterus; Metrorrhagia; Adenomyosis; Benign Gynecologic Neoplasm; Endometriosis; Abnormal Uterine Bleeding

Summary: the goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. the secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence). participants will fill the following questionnaires pre-operatively and at the follow up: * short form 36 (sf36), * euro quality of life 5d-3l (eq 5d-3l) * female sexual function index (fsfi) * patient global impression of improvement (pgi-i) only during the follow-up period.


Eligibility criteria:
inclusion criteria: * age\>18 years * signed informed consent exclusion criteria: * uterine or adnexal pathology suspect for malignancy * abnormal or unknown pap test * patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer t1 n0 m0 grade 1 or 2 without signs of recurrence or activity). * previous radical pelvic surgery or radiotherapy; * age \> 80 years * pregnant patients * desire for further pregnancies * contraindications to general anaesthesia or to the trendelenburg position * refusal to sign informed consent
parameters of 2 phaco tips designs in torsional phacoemulsification

Conditions: Cataract

Summary: to compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.

in this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree kelman tip or reversed mini-flared 30-degree kelman tip. clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (cdva), endothelial cell counts (ecc) and preoperative and 1-day postoperative central corneal thickness (cct). intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (cde) and balanced salt solution volume (bss). the study was performed according to established ethical standards for clinical research institutional review board (irb) of the university of sao paulo in brazil, conducted between november 2010 and february of 2011. all surgeries will be performed at the university of sao paulo. physicians conducting postoperative evaluation will not have access to patients' medical records. exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmhg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.

Eligibility criteria:
inclusion criteria: * patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. exclusion criteria: * previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmhg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to nsaids. enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded

Keywords: kelman tip mini-flared phacoemulsification cataract
comparative trial to investigate the efficacy and safety of desmopressin for the treatment of nocturia in adult men

Conditions: Nocturia

Summary: the purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult men during 12 weeks treatment


Eligibility criteria:
inclusion criteria: * has given written consent prior to any trial-related activity is performed * male sex, aged 20 years or older * at least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period * has given agreement about contraception during the trial exclusion criteria: * suspicion of bladder outlet obstruction or a urine flow of less than 5 ml/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction * a surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months * showing symptoms of any of the following diseases: benign prostatic obstruction; interstitial cystitis; overactive bladder, defined as \>6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; severe stress urinary incontinence * chronic prostatitis/chronic pelvic pain syndrome * psychogenic or habitual polydipsia * urinary retention or a post void residual volume in excess of 150 ml as confirmed by bladder ultrasound performed after suspicion of urinary retention * cancer * a history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years * genito-urinary tract pathology * neurogenic detrusor activity * suspicion or evidence of heart failure * uncontrolled hypertension * uncontrolled diabetes mellitus * hepatobiliary diseases: aspartate aminotransferase \>80 u/l or alanine aminotransferase \>90 u/l; total bilirubin \>1.5 mg/dl * renal insufficiency: serum creatinine level \>1.09 mg/dl; estimated glomerular filtration rate \<50 ml/min * hyponatraemia: serum sodium level \<135 meq/l * central or nephrogenic diabetes insipidus * syndrome of inappropriate antidiuretic hormone * obstructive sleep apnea * previous desmopressin treatment * treatment with another investigational product within the past 3 months * concomitant treatment with any prohibited medication * alcohol or substance abuse * a job or lifestyle that may interfere with regular night-time sleep * a mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial
impedance during cardiac catheterization to build a non-invasive cardiac output algorithm

Conditions: Congenital Heart Disease

Summary: prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.


Eligibility criteria:
inclusion criteria: * scheduled to undergo cardiac catheterization with cardiac output measurement and fick * planned to undergo general anesthesia for cardiac catheterization standard of care * parent/guardian able to provide informed consent exclusion criteria: * not planned for standard of care general anesthesia for cardiac catheterization
alternative dosing and prevention of transfusions (adapt)

Conditions: Sickle Cell Disease

Summary: adapt is a prospective cohort study at jinja regional referral hospital (jrrh) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of pk-guided hydroxyurea dosing.

hypothesis * there will be a 50% reduction in the rate of blood transfusions received during the hydroxyurea treatment period compared with the pre-treatment period. * a pk-guided starting dose will be generated for 80% of participants. * participants on pk-guided hydroxyurea treatment will require 25% fewer blood transfusions during their first year of hydroxyurea than those on dose escalation.

Eligibility criteria:
inclusion criteria: * patients with documented hbss disease * age: ≥ 12 months and ≤ 10 years of age, at the time of enrollment * parent or guardian willing and able to provide informed consent * able to comply with all study related treatments, evaluations, and follow-up exclusion criteria: * current hydroxyurea treatment (or within the past 6 months) * regular blood transfusions (6 or more within the past 12 months) * transfusion within the last 30 days (temporary exclusion) * known malignancy or other known chronic illnesses including but not limited to active tuberculosis, renal disease * current participation in other therapeutic clinical trials, or within 6 months of prior disease-modifying treatments

Keywords: pharmacokinetics hydroxyurea transfusion
pharmacogenetics and cardiovascular events

Conditions: Cardiovascular Diseases; Atrial Fibrillation; Cerebrovascular Accident; Heart Diseases; Myocardial Infarction

Summary: to assess interactions between selected cardiovascular medications and genes in the incidence of heart attack, stroke, and atrial fibrillation, an irregular heartbeat.

background: this complex study will collect additional genetic data for 3 ongoing case-control observational studies of drug-gene interactions in myocardial infarction, stroke, and new-onset atrial fibrillation. this study will add single nucleotide polymorphism (snp) discovery for 16 of 36 candidate genes involving the renin-angiotensin system, sodium transport, adrenergic receptors, and g-proteins, and allow analysis of haplotype data. the study was initiated in response to rfa hl-03-001, ancillary studies in pharmacogenetics. design narrative: the primary aim of this study is to assess interactions between selected cardiovascular medications and the major candidate-gene variants or haplotypes on the incidence of myocardial infarction (mi), stroke and atrial fibrillation (af). the candidate-gene sets-selected on the basis of biology, pharmacology, and information from genome-wide scans-include: (1) 10 genes in the renin-angiotensin system; (2) 10 genes involved in renal sodium transport; (3) 8 genes encoding alpha and beta adrenergic receptors; (4) 8 other genes, including g-proteins, estrogen receptors, and the alpha-1c subunit of the l-type calcium channel. the products of these genes represent the sites of action for many cardiovascular drugs: angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, all classes of diuretics, alpha blockers, beta-blockers, central alpha agonists, calcium antagonists, and estrogens. both hypothesis-testing and hypothesis-generating analyses are planned. for selected single nucleotide polymorphisms (snps) studied in vitro or in small clinical populations, several specific drug-gene interactions are plausible, and these associations will be evaluated in an hypothesis-testing manner. the study used data from previously funded case-control studies which are expected to produce 1053 mi cases, 565 stroke cases and 800 atrial fibrillation cases and 3249 matching controls from the enrollees of group health cooperative. these patients will already have had chart abstractions, pharmacy database searches, telephone interviews and phlebotomy with specimen storage.

Eligibility criteria:
no eligibility criteria
study evaluating agg-523 in subjects with severe osteoarthritis requiring total knee replacement

Conditions: Osteoarthritis

Summary: the main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug agg-523, or its effects, can be measured in urine, blood, or the knee joint. a secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks.

this is a multicenter study of 2 dosing regimens of agg-523, an investigational aggrecanase inhibitor that is taken orally. potential study subjects are those with severe osteoarthritis (oa) of the knee who are scheduled to undergo total joint replacement surgery. study subjects will be randomly assigned to 1 of 2 dosing regimens (once-daily or twice-daily dosing) of either 1800 mg agg-523 or placebo, which will be taken during the 4-week period before having the total knee replacement. the treatments will be assigned using a 4:1 ratio of active to placebo treatment, which means that more subjects will receive the active treatment than the placebo (see below). * agg-523 1800 mg once a day (32 subjects) * agg-523 900 mg twice a day (32 subjects) * placebo once a day (8 subjects) * placebo twice a day (8 subjects) study subjects will have weekly evaluations as outpatients during the 4-week dosing period. the purpose of these evaluations is to monitor for potential complications, ensure compliance with taking the study drug, ask about the use of other medications, and, when necessary, replenish the supply of study drug. these assessments may be conducted by telephone, as a home visit, or by having the subject travel to the clinic for an outpatient office visit. a final (in person) visit will happen 2 weeks after having total knee replacement surgery.

Eligibility criteria:
inclusion criteria: * generally healthy, men or women, at least 55 years old * osteoarthritis of the knee requiring total knee replacement surgery exclusion criteria: * other types of arthritis, like rheumatoid arthritis * recent major surgery (in past 3 months) * recent knee injections (in past 6 months)

Keywords: severe osteoarthritis arthritis