Kornimate/medical-research-clean huggingface dataset:
post-market surveillance study with the hyperion hip endoprosthesis system in defect reconstruction

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Functional Deformities; Pseudoarthrosis; Revision of Endoprosthesis-treated Hips; Fracture, Proximal Humeral; Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies); Femur Fracture; Pseudarthrosis; Trochanteric Fractures; Bridging of Large Bone Defects; Revisions

Summary: the study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. the objective of this study is to obtain survival and clinical outcome data on the hyperion® system in primary and revision total hip arthroplasty.

this multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the hyperion® system. the performance of the hyperion® tha system will be evaluated using standard scoring systems (merle d'aubigné score, hoos score). safety will be evaluated by adverse event reporting. the study will be performed at 6 sites, enrolling in total 70 patients. follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. the scores will be filled in pre-operatively and post-operatively until 5 years. in order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. xrays will be done pre-operatively, immediate post-operatively and at each of the follow-up visits.

Eligibility criteria:
inclusion criteria: * patient age at least 18 years * fully conscious and capable patients * signed informed consent * stationary treatment * merle d'aubigné \ 25 points * patients with at least one of the following indications: indications for primary hip replacement: * non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis) * rheumatoid arthritis * functional deformities * provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies) * treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques revision tha: * revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis) * bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors exclusion criteria: * infections * patients under 18 years * pregnant or breastfeeding patients * known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse * legal incapacity or restricted capacity * participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months * patients who are unable to attend to follow-up

Keywords: revision total hip arthroplasty medical device post market surveillance study primary total hip arthroplasty
treatment of lower transsphincteric perianal fistula: fistulotomy with marsupialization vs open wound

Conditions: Perianal Fistula; Transsphincteric Anal Fistula

Summary: this study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.

this is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. there will be an inclussion visit in which personal information will be recorded and the consent will be signed. randomization will be done after inclusion, following a balanced blocks model. information of the surgery technic won't be available for the investigator. the patients will have a journal in which they'll write their postoperative symptoms. follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. data will be based in clinical examination, patient's diary and medical records. statistical analysis of the primary outcome will be based in a superiority analysis using the mantel-cox test, or in case needed, a multivariate cox regression analysis. the secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.

Eligibility criteria:
inclusion criteria: * low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation. * ability to understand the study, to sign the consent and to complete the follow-up. exclusion criteria: * under 18 years of age. * complex/recurrent fistula. * patients in which by clinical criteria is decided not to perform a fistulotomy. * anorectal malignancy. * crohn's desease. * asa iv or other contraindication for surgery. * inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.

Keywords: low transsphincteric anal fistula fistulotomy marsupialization perianal fistula
efficacy of levetiracetam in essential tremor

Conditions: Essential Tremor

Summary: essential tremor poses one of the greatest therapeutic challenges to neurologists. this study will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of essential tremor.

currently available pharmacological treatments for essential tremor are hampered by relatively low efficacy and intolerable side effects. recent evidence indicates that levetiracetam (lev) may modulate the dopaminergic system. in this regard lev has been shown to reduce l-dopa-induced dyskinesias, tardive dyskinesia and myoclonus, and is relatively well-tolerated in the elderly. previous studies examined the efficacy of lev for the treatment of essential tremor. however, these were either open label or relatively short duration studies. a longer term study of lev for the treatment of essential tremor is therefore warranted. in this randomized, double-blind, placebo-controlled crossover study, ten subjects with essential tremor will be randomly assigned to receive either lev up to a maximum dose of 3000 milligrams (mg) per day or placebo. study drug will be titrated up over 6 weeks and continued at 1500 mg twice daily for an additional 6 weeks. following a 4 week washout period subjects will cross over to the other arm and continued for an additional 12 weeks. subjects will be evaluated monthly by a blinded examining neurologist and research coordinator. at each study visit subjects will receive a neurological examination and will be evaluated using a 16-item scale for tremor and medication side effects. the data derived from study drug vs. placebo groups will be compared using the mann-whitney u and wilcoxon w tests.

Eligibility criteria:
inclusion criteria: * history of tremor for 5 or more years * no other neurological problems exclusion criteria: * prior stroke or other neurological disease, psychiatric problems * history of renal disease * pregnancy

Keywords: tremor writing feeding pouring
the study is being done to see if taking the drug valganciclovir can prevent cmv infection.

Conditions: Bone Marrow Stem Cell Transplant

Summary: this study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (cmv) infections that can occur 100 days or later after transplant.

this study is a phase iii, randomized, double-blind, palacebo-controlled, multicenter study of the drug valganciclovir. this study is to see if taking prophylactic doses of valganciclovir starting 100 days after stem cell transplantation can prevent late cmv from occurring. participants will be randomized (like a flip of a coin) into one of two groups. neither the participant nor the doctor will know which group the participant is in. one group will receive the drug valganciclovir. the other group will receive a pill that looks like valganciclovir, but does not contain any active medicine (a placebo). participants enrolled in the study will take the drug by mouth daily starting at day 100 post stem cell transplant. participants will also have blood samples taken along with their routine blood weekly, until day 270. participants will also be required to return to their routine clinic visits. participants' acquiring an active cmv bloodstream infection at the time of the study will receive ganciclovir by the vein twice a day or a high dose of valganciclovir. participants will be instructed to stop taking the study drug during the treatment time. after active cmv infection can no longer be detected, the treatment will be stopped. patients will start taking the study drug and will be monitored for a cmv bloodstream infection until 270 days after transplant. participants developing symptoms that look like cmv disease (pneumonia, infection of the intestines, eye infection) while on the study drug, will have an examination and lab tests to diagnose the organism. participants that are hospitalized for cmv disease or for any other reason are asked to notify study personnel. participants will need to record study medicine taken in a daily study drug diary. questionnaires will be filled out by the participant throughout the study, they will also be called monthly to see how they are doing and feeling overall. after 270 days, participants will complete the study drug phrase. they will receive follow up phone calls on days 400, 520, and 640 days after transplant to see how they are doing.

Eligibility criteria:
participants who are undergoing allogeneic peripheral blood stem cell, cord blood, or marrow transplantation that are 18 years of age or older, may be eligible to participate in this study.
magnetic resonance imaging and spectroscopy biomarkers for facioscapulohumeral muscular dystrophy

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: the purpose of this research study is to identify and study changes in muscle in people with facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.

this research study is being done to study changes in muscle imaging over time in people with facioscapulohumeral muscular dystrophy (fshd). whole-body magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs) will be used to evaluate skeletal muscle in study participants. this research is being done to assess how changes in muscle imaging correspond to muscle strength and function. qualified participants will be asked to complete 5 study visits over 21 months. each visit will include muscle strength and function testing in addition to the mri/mrs scan. the investigators plan to use mri and mrs in developing outcome measures that can be used in future clinical trials for fshd.

Eligibility criteria:
inclusion criteria: * ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old) * confirmed diagnosis of fshd through genetic testing (participants will be asked to provide copies of genetic testing results) exclusion criteria: * any contraindication to mri scanning * inability to complete a physical examination, including strength measurements

Keywords: fshd magnetic resonance imaging magnetic resonance spectroscopy
improving colonoscopy surveillance for patients with high risk colon polyps

Conditions: Colorectal Carcinoma

Summary: this clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. colorectal cancer (crc) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. one million americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for crc; however, uptake of recommended repeat colonoscopy in 3 years to reduce crc risk is low in this group. this multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

primary objective: i. to increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (hrn) diagnosis. outline: aim 1: participants complete an interview over 20-30 minutes. aim 2: primary care clinics are randomized to 1 of 2 arms. arm i: clinics have the automatic addition of hrn to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records. clinics also call patients to schedule their colonoscopy. providers receive reminders and pending orders for the colonoscopy in the electronic health record. patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center. arm ii: patients receive care according to the clinics' usual care practices.

Eligibility criteria:
inclusion criteria: * aim 1 patients: patients between age 45 and 75 with a hrn diagnosis in the past 5 years * aim 1 patients: 12 patients who did and 12 patients who did not have surveillance colonoscopy * aim 1 providers: primary care providers (pcps) and gastroenterologists (gis) * aim 1 administrators: administrators who are involved in care processes related to crc screening, hrn surveillance, and/or colonoscopy scheduling * aim 2: patients age 45 to 75 diagnosed with a hrn during the pre-specified two-year hrn diagnosis period exclusion criteria: * aim 2: individuals with a personal history of colorectal carcinoma (crc), inflammatory bowel disease (crohn's, ulcerative colitis), or polyposis syndrome * aim 2: hrn cases not confirmed by chart review (human-in-the-loop)
semaglutide to reduce atrial fibrillation burden

Conditions: Atrial Fibrillation; Obesity; Overweight

Summary: atrial fibrillation (af) is the most common arrhythmia worldwide. af is associated with obesity and the co-morbidities of obesity, including hypertension and obstructive sleep apnea (osa) which increase left atrial (la) size and decrease la function. semaglutide, a glucagon-like peptide receptor 1 agonist (glp-1 ra), is currently approved by the food and drug administration for weight loss for individuals with and without diabetes. the effects of pharmacologic weight loss with semaglutide on af are unknown. the investigators plan on conducting a randomized controlled trial of semaglutide versus placebo in individuals with paroxysmal or early persistent af (\>10% af burden on ambulatory monitoring, a previous electrical cardioversion, or af lasting ≥ 7 days but \< 3 months who have a body mass index ≥ 27.0 kg/m2. the trial will last for 52 weeks. the primary outcome will be the change in af burden for 2 weeks, immediately before starting the medication or placebo to two weeks starting at week 50, as determined by an implantable loop recorder or two week ambulatory additional outcomes will be change in epicardial adipose tissue as determined by chest/abdomen/pelvis computed tomography scan at enrollment and at week 52, change in apnea-hypopnea index from baseline sleep study to week 52 sleep study, change in la longitudinal strain from baseline echocardiogram to echocardiogram at 52 weeks, and change on symptom surveys.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old with a bmi ≥ 27 kg/m2 who have paroxysmal af with a ≥ 10% burden on ambulatory monitoring or a previous electrical cardioversion or early persistent af (≥ 7 days, \< 3 months) who are willing to attempt rhythm control. exclusion criteria: * unable to consent * a personal or family history of medullary thyroid carcinoma * a personal or family history of multiple endocrine neoplasia syndrome type 2 * history of allergic reaction to semaglutide or any of its components * currently pregnant or planning to become pregnant * currently breastfeeding * history of acute pancreatitis * history of pancreatic adenocarcinoma * previous or current glp-1 ra use * previous or current use of alternative pharmacologic weight loss agents (phentermine, diethylpropion, orlistat, phentermine-topiramate, bupropion- naltrexone, gelesis100, or setmelanotide) * unable to tolerate anticoagulation * history of bariatric surgery

Keywords: weight loss atrial fibrillation lifestyle modification
clinical observation of recombinant human growth hormone injection assisted ivf-et in the treatment of pcos

Conditions: Polycystic Ovary Syndrome

Summary: observe validity of recombinant human growth hormone injection assisted in ivf-et (in vitro fertilization and embryo transfer) treatment of pcos (polycystic ovary syndrome) patients.


Eligibility criteria:
inclusion criteria: * age between 25 and 35 years old, married female and infertile. * bmi≥25kg/m2. * diagnosed as pcos. * no obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease. * subjects do not take part in other clinical trial study within 3 months. * the subjects sign the informed consent form. exclusion criteria: * bmi\<25kg/m2. * hyperprolactinemia and congenital adrenal cortical hyperplasia. * diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome. * pelvic and peritoneal tumor and tumor secreting hyperandrogenism. * severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis b virus activity. * liver and kidney dysfunction, ast/alt is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level. * diseases affecting outcome of ivf pregnancy, eg, hydrosalpinx, hysteromyoma\>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system. * allergic to e. coli. expression product and its excipients. * being involved in other drug clinical researchers. * the researchers consider who is not suitable for the group.
construction and validation of a score evaluating the residual instability of the patient after ankle ligamentoplasty

Conditions: Ankle Sprains; Ligament Sprain

Summary: the goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the ankle go test score). the main hypothesis of this study is based on the fact that the composite score "ankle go test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty. participants will have to complete 2 questionnaires (faam, alr rs) and to undergoe 4 tests (single leg stance test, side hop test, start excursion balance test, la figure of 8), at 4, 6 and 12 months post surgery. researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the ankle go test score


Eligibility criteria:
inclusion criteria: 1. male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history. 2. age ≥ 18 years 3. patients who's been informed about the study and who didn't express their opposition to participate exclusion criteria: 1. patients with chronic ankle instability, operated or not, contralateral 2. patients under legal protection

Keywords: ligamentoplasty chronic ankle instability score
emergency stroke unit for acute cerebrovascular events ( esu-ace-b )

Conditions: Ischemic Stroke, Acute

Summary: to compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in emergency stroke unit (a new stroke unit based on low-field magnetic resonance imaging).

mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. faster door-to-puncture time (dpt) is associated with significantly better clinical outcomes. with the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. this prospective, multicenter, week-wise randomized controlled trial will compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in emergency stroke unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. can be treated between 4.5-6 hours of symptoms onset\*(\*symptom onset is defined by the "last seen normal" principle); 3. presenting with ischemic stroke symptoms; 4. pre-stroke mrs score 0-1; 5. baseline nihss score ≥ 5; 6. eligible for endovascular thrombectomy; 7. informed consent signed. exclusion criteria: 1. baseline nihss score \< 5; 2. unable to undergo mri because of claustrophobia; 3. patients with cardiac pacemaker/brain pacemaker/insulin pump implantation; 4. definite contraindication for endovascular thrombectomy; 5. patients with postictal hemiparesis (todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate; 6. pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial; 7. participation in other interventional randomized clinical trials within 3 months before enrollment; 8. patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.

Keywords: emergency stroke unit low-field magnetic resonance imaging reperfusion therapy endovascular therapy