Kornimate/medical-research-clean huggingface dataset:
lateralization after intramedullary nailing of intertrochanteric hip fractures, clinical and radiographic outcomes

Conditions: Intertrochanteric Fractures

Summary: intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. this lag screw commonly protrudes during the healing process and may cause implant related pain. this study will help determine if implant related pain is different depending to the lag screw design.

this study compares cephalomedullary fixation of intertrochanteric femur fractures using the arthrex hip nail system with a telescoping lag screw compared to the zimmer natural nail and the smith and nephew intertan. this pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws the primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.

Eligibility criteria:
inclusion criteria: * patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail. * fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available. exclusion criteria: * non-ambulatory prior to injury (patient must do more than only transfers) * cognitive deficiencies that prevent the patient from providing their own informed consent * inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing) * prior fracture to injured hip * prior surgery to injured hip * basi-cervical fracture pattern (fracture that begins above the lesser trochanter and exits medial to the greater trochanter) * patients not treated within 48 hours of admission * chronic or acute infection at site of surgery * language barrier preventing completion of study forms in english * open fracture * fracture related to neoplasm
a study of tabalumab (ly2127399) using two different injection methods in participants with lupus

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - a traditional syringe or a spring loaded syringe for 12 weeks. participants may continue to receive study drug for up to 52 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of lupus. * able and willing to have blood drawn for pk sampling. exclusion criteria: * have severe active lupus nephritis. * have severe active central nervous system (cns) or peripheral neurologic disease or other severe neurologic involvement requiring treatment within approximately 3 months prior to screening. * have received high dose corticosteroid within approximately 1 month prior to baseline. * have initiated or adjusted treatment with immunosuppressant drugs within approximately 1 month prior to baseline. * have received plasmapheresis within approximately 3 months prior to baseline. * have previously received approved or experimental b cell targeted therapies within the last year. * have received any biologic or non-biologic therapy within approximately 3 months or 5 half-lives (whichever is longer). * have a history of severe reaction to any biologic therapy. * have an active or recent infection within approximately 1 month prior to week 0. * have had a serious infection within approximately 3 month or serious bone/joint infection within approximately 6 months prior to baseline. * have evidence of or test positive for active hepatitis b or are positive for hepatitis c or human immunodeficiency virus (hiv). * have evidence of active or latent tuberculosis. * have significant hematological abnormalities.
a safety and efficacy study of oral mdv3100 in chemotherapy-naive patients with progressive metastatic prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.


Eligibility criteria:
randomized, double blind treatment period: inclusion criteria: * histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * ongoing androgen deprivation therapy with a gnrh analogue or bilateral orchiectomy * progressive disease despite androgen deprivation therapy as defined by rising psa levels or progressive soft tissue or bony disease * no prior treatment with cytotoxic chemotherapy * asymptomatic or mildly symptomatic from prostate cancer exclusion criteria: * severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment * known or suspected brain metastasis or active leptomeningeal disease * history of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer open-label treatment period: the following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment. eligible patients must meet all inclusion criteria. * received randomized double-blind treatment in prevail; * open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site; * is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (gnrh) agonist/antagonist or has had a bilateral orchiectomy; the exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. each patient must not meet any of the following criteria: * has taken commercially available enzalutamide (xtandi); * severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment * known or suspected brain metastasis or active leptomeningeal disease

Keywords: progressive metastatic prostate cancer
transapical beating-heart septal myectomy in patient with hypertrophic obstructive cardiomyopathy

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: the primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. this is a prospective, single-arm, single-center, first-in-man study.

surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. however, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. to increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. the whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. after transapical beating-heart septal myectomy, patients is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Eligibility criteria:
inclusion criteria: 1. patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmhg, and maximal ventricular septal wall thickness ≥ 15 mm. 2. patients with heart function of new york heart association ≥ class ii. 3. patients with drug-refractory symptoms or intolerable to pharmaceutical therapies. 4. patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form. exclusion criteria: 1. patients who were pregnant. 2. patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery. 3. patients who had severe heart failure with left ventricle ejection fraction \< 40%. 4. patients whose estimated life expectancy \< 12 m. 5. patient who were non-compliant. 6. patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.

Keywords: hypertrophic obstructive cardiomyopathy septal myectomy systolic anterior motion left ventricle outflow tract obstruction mitral regurgitation transapical off-pump minimally invasive
open label trial of nanodox hydrogel in orthopedic trauma wounds with and without vacuum assisted closure therapy

Conditions: Orthopedic Trauma Wounds

Summary: the purpose of this study is to determine the effect of nanodox™ hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (npwt/vac) with reticulated open cell foam (rocf) dressings.


Eligibility criteria:
inclusion criteria: * be 18 years of age or older * women of childbearing potential must have a negative urine pregnancy test at screening and at baseline * agree to use a double-barrier method of contraception during their participation in this study * condoms (with spermicide) and hormonal contraceptives or * condoms (with spermicide) and intrauterine device or * intrauterine device and hormonal contraceptives or * abstains from sexual intercourse during their participation in this study * is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant * have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 at initial screening * be able to apply study drug to their wound, or have a reliable and capable caregiver do it * subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (tcpo2) of \>30mmhg recorded over intact epidermis at the wound margin. exclusion criteria: * less than 18 years of age * pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control. * allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative * tested positive for a doxycycline-resistant infection * have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months * currently undergoing dialysis for renal failure * have participated in another clinical research trial within the last 30 days * subject has wounds resulting from any cause other than trauma (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult) * active or previous (within 60 days prior to the study screening visit) chemotherapy * active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo * physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits * the investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements. * history of sickle cell anemia * history of infection with human immunodeficiency virus * history of other immunodeficiency disorders * severe anemia - hgb \< 7 g/dl (males) or \< 6.5 (females)
a study on the effect of platelet rich plasma (prp) on osteoarthritis in the thumb base

Conditions: Thumb Osteoarthritis

Summary: randomized comparison between platelet rich plasma (prp) and placebo (saline) for thumb base.osteoarthritis.


Eligibility criteria:
inclusion criteria: * arthritis in the thumb base. * radiological eaton littler class 1-3. * clinical signs of thumb base osteoarthritis: pain at palpation of the cmc-1 joint and pain during provocation/grinding test. exclusion criteria: * rheumatoid arthritis. * ongoing infection in the hand or wrist. * history of gout or pseudo gout. * inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * intra-articular injection in the affected joint within 6 months. * eaton littler class 4 (stt joint involved).
dacarbazine and carmustine in metastatic melanoma

Conditions: Melanoma Metastatic

Summary: the purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.

in this phase ii trial, patients with stage iv melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.

Eligibility criteria:
inclusion criteria: 1. patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy. 2. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 and estimated survival of at least 3 months. 3. patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (\> 2 weeks). 4. absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl; platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; alt and ast must be less than 3 times the upper limit of normal; creatinine must be less than or equal to 1.8 mg/dl. 5. women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken. 6. patient consent must be obtained prior to entrance onto study. 7. patients must have no evidence of significant cardiovascular disease including history of recent (\< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina or cerebrovascular accident. exclusion criteria: 1. evidence of significant cardiovascular disease including history of recent (\< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident. 2. prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy. 3. pregnancy or lactation. 4. prior chemotherapy with carmustine

Keywords: melanoma metastatic
validation of a contactless vital signs measurement sensor

Conditions: Sleep Apnea

Summary: the primary aim of this study is to validate the performance of sleepiz one+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. additionally, the investigators will evaluate sleepiz one+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. participants will undergo measurement with sleepiz one+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.


Eligibility criteria:
inclusion criteria: * age \>18years * ability and consent to undergo electrophysiological routine assessment * informed consent as documented by signature * patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders * ambulatory or stationary patients of klinik lengg exclusion criteria: * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons * cardiac pacemaker or another implanted electrical device * women who are pregnant * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Keywords: respiration sleep
midodrine versus albumin for prevention of paracentesis induced circulatory disturbance

Conditions: Paracentesis-Induced Circulatory Dysfunction

Summary: paracentesis-induced circulatory disturbance (picd) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. however, it may not be cost-effective and has side effects like volume overload and transfusion reactions. therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. the investigators hypothesized that midodrine may be effective in preventing picd in acute on chronic liver failure patients requiring modest paracentesis. this has already been found to be effective in initial studies in decompensated cirrhosis


Eligibility criteria:
inclusion criteria: 1. consecutive patients above 18 years of age who fulfilled asia pacific association of study of liver disease (apasl) criteria for aclf and required paracentesis for moderate to tense ascites were included in the study. 2. acute on chronic liver failure (aclf) was defined as an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dl (85 micromole/l) and coagulopathy (inr ≥ 1.5 or prothrombin activity \< 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality - exclusion criteria: 1. patients with acute kidney injury defined as serum creatine of \> 0.3 mg/dl above the baseline 2. severe cardiopulmonary disease 3. history of urinary retention 4. pheochromocytoma 5. thyrotoxicosis 6. persistent and excessive supine hypertension define by systolic blood pressure \> 150 mm hg 7. pregnant patients 8. unable to give informed consent were excluded from the study -

Keywords: ascites paracentesis-induced circulatory dysfunction paracentesis
wave study- walking and aging in verona study

Conditions: Abdominal Obesity; Metabolic Syndrome; Disability Physical; Sarcopenic Obesity; Hypertension; Overweight and Obesity; Cardiovascular Risk Factor

Summary: monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect of diet with or without nordic walking on weight loss, physical performance and cardiovascular risk factors in overweight and obese population

to examine the impact of a 48-week of diet +/- nordic walking program on physical performance, muscle function, cardiovascular risk factors and arterial stiffness in community-dwelling overweight and obese elderly men and women.

Eligibility criteria:
inclusion criteria: * 60-90 years * males and females . bmi \> 27 kg/m2 * living in verona (italy) * stable weight in the 3 months * not involved in physical exercise programs * informed consent sign exclusion criteria: * cardiovascular disease (unstable angina, recent myocardial infarction, cardiac arrhythmias, heart failure, valvular heart disease, aortic aneurysm, recent intracerebral or subdural hemorrhage, not controlled hypertension) * musculoskeletal disease (symptomatic discal hernia, symptomatic arthrosis, acute articular, tendon or ligament lesions, hip prothesis).
patient specific plates versus conventional miniplates for treatment of mandibular body fractures

Conditions: Mandibular Fractures

Summary: the aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.

the study will be conducted on two groups: intervention group: patient specific three-dimensional titanium plates cbct or ct scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3d) printing. control group: conventional miniplates: in this group two miniplates of titanium mini-system 2.0 mm will be used. the plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. according to champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.

Eligibility criteria:
inclusion criteria: * patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures exclusion criteria: * patients with bilateral mandibular fractures * patients with other mandibular or maxillofacial fractures * comminuted fractures * medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.