Kornimate/medical-research-clean huggingface dataset:
bone microarchitecture in men with hemophilia

Conditions: Severe Hemophilia A; Osteoporosis

Summary: hemophilia a and b are hereditary sex-linked deficiencies of coagulation factors viii and ix characterized by bleeding. their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis. hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention. the hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by high-resolution peripheral quantitative computed tomography (hr-pqct)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (btm) and bone biomarkers). the study aims to assess the difference in low trabecular number (tb.n) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). correlation between btm and tb.n will be also studied. biologic markers of bone remodeling (c-terminal telopeptide of type i collagen (pinp), n-terminal propeptide of type i procollagen (ctx-i), periostin) will be studied.


Eligibility criteria:
inclusion criteria: patients: * men aged 20 to 60 years * severe hemophilia a or b (fviii or fix\<1%) * regular followed up in lyon hemophilia center * ability to give free and informed consent * person capable of actively participating in radiological examinations healthy mens: * aged 20 to 60 years exclusion criteria: * women * not covered by health system * vulnerable (adults unable to consent, protected under guardianship, prisoner) * any blood coagulation abnormality other than severe hemophilia a or b * having one of the following treatments against osteoporosis of more than 6 months : bisphosphonates, denosumab, teriparatide * with a chronical disease having a high impact on bone structure and no related to hemophilia disease, such as cushing or crohn diseases.

Keywords: hemophilia osteoporosis bone microarchitecture bone remodeling
pain-perception during outpatient cystoscopy-a prospective controlled study

Conditions: Urinary Incontinence; Overactive Bladder; Pelvic Organ Prolapse; Recurrent Urinary Tract Infections

Summary: at an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. patients will be called one day after the examination and will be asked about pain and their general state of health. the purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. the investigators will also investigate the difference between anticipated and actual pain perception. the investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. the secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing. according to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the vas - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05. exclusion criteria are: age ≤ 18 years, insufficient ability to understand german, pregnancy and the participation in another clinical study at the same time.


Eligibility criteria:
inclusion criteria: * women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center. exclusion criteria: * age ≤ 18 years * insufficient ability to understand german * pregnancy * participation in another clinical study at the same time
study of the effect of tranexamic acid administered to patients with hip fractures. can blood loss be reduced?

Conditions: Hip Fracture; Anemia

Summary: the effect of tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures. tranexamic acid is a well known drug used in many types of surgery. the investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture. an interim analysis was planned when reaching 60 inclusions. the interim analysis was conducted only on the primary outcome (tbl). a difference in tbl of no less than 500 ml was considered a reason to halt the study. the 0.001 level was chosen as a simple approach to this interim analysis from the haybittle-peto boundary

studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss. postoperative anaemia is associated with a higher morbidity and mortality. we wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.

Eligibility criteria:
inclusion criteria: * patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture. * asa score 3, 2 or 1 exclusion criteria: * allergy for tranexamic acid * clinical signs of acute thromboembolic event * renal function impairment (s-creatinin\>120micromol/l) * active thrombotic disease or dic * k-vitamin antagonist treatment * malignancy * pathological fracture * previously operated in same hip * bw \> 100kg

Keywords: pertrochanteric fracture tranexamic acid postoperative blood loss blood loss hidden blood loss blood transfusions
impact of adjuvant treatment with aromatase inhibitor on sleep disturbances in postmenopausal women with endocrine responsive early breast cancer

Conditions: Endocrine Responsive Early Breast Cancer

Summary: insomnia is common in breast cancer patients during adjuvant therapy with aromatase inhibitor. however it is difficult to establish whether it is due to the knowledge of the disease or the treatment administred. the investigators designed a cohort study in which questionnaires for the assessment of sleep quality (pittsburgh sleep quality index and insomnia severity index), anxiety (state and trait anxiety inventory), depression (beck depression inventory), for the quality of life in general (functional assessment of cancer therapy) and for the evaluation of rls (restless legs syndrome rating scale) will be prospectively administered to patients with early breast cancer at baseline and during adjuvant treatment with aromatase inhibitors. as secondary aims the investigators will also evaluate dietary and lifes' factors, born turn over and bmi.


Eligibility criteria:
inclusion criteria: * women with a histological diagnosis of invasive operated breast cancer (any pt, any pn) * women with more than 60 years * women less than 60 years with amenorrhea for at least 12 months and fsh and estradiol values in the range of menopause * signature of written informed consent. exclusion criteria: * locally advanced or metastatic disease (m1) * a history of breast cancer or other cancers diagnosed in the last 10 years, to exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * history of severe osteoporosis before the diagnosis of breast cancer * bisphosphonate therapy before the diagnosis of breast cancer * other serious medical conditions that could limit the ability of the patient to participate in the study

Keywords: insomnia anxiety depression restless leg syndrome aromatase inhibitor body composition
efficacy and safety of sofosbuvir containing regimens for the treatment of chronic hcv infection in participants with chronic genotype 1, 2, 3, or 6 hcv infection

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (sof) containing regimens for the treatment of chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * chronic genotype 1, 2, 3, or 6 hcv infection * cirrhosis determination; a liver biopsy may be required * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * pregnant or nursing female or male with pregnant female partner * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain resolved skin cancers) * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
nitrogen bubble detection after simulated dives in divers with pfo and after pfo closure

Conditions: Patent Foramen Ovale

Summary: the aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.

the aim of this study is to determine whether catheter-based closure of patent foramen ovale (pfo) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives. ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. divers will be observed after two different dive profiles - dive a (dive to 18 m for 80 min bottom time) and dive b (dive to 50 m for 20 min bottom time), both performed according to us navy air decompression procedure 1996. for both dives two groups will be compared: divers with pfo and divers after previous catheter-based closure of pfo. the study will be observational. sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen. the primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after valsalva maneuver). inclusion criteria are: 1) previously diagnosed pfo or a pfo that has been occluded by a catheter-based procedure, 2) signed informed consent exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study this study will be single-center.

Eligibility criteria:
inclusion criteria: 1. previously diagnosed pfo or a pfo that has been occluded by a catheter-based procedure 2. signed informed consent exclusion criteria: 1. another dive performed in the preceding 24 hours 2. another previously diagnosed right-to-left shunt 3. disagreement to be included in the study

Keywords: patent foramen ovale catheter-based closure nitrogen bubbles decompression sickness
optimal time delay of epinephrine injection with "one-per-mil" tumescent solution

Conditions: Ischemia

Summary: the aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery. hypothesis: 1. epinephine in "one-per-mil" concentration by tumescent injection technique will provide faster decrease in oxygen saturation compared to normal saline solution injected by tumescent technique. 2. epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay. 3. epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

this is a prospective, randomized, double-blind study to measure the optimal time delay of 1:1,000,000 epinephrine in saline solution injected by tumescent technique until maximum vasocontriction in the distal finger is achieved. subjects will be injected in both his ring fingers(distal phalanges, volar side) with randomized solutions, one containing "one-per-mil" tumescent solution and the other containing only normal saline solution; information which both the injector and examiner are blinded from. maximum vasoconstriction of the finger injected is depicted by the lowest oxygen saturation (recorded every minute until 45 minutes using pulse oxymeter).

Eligibility criteria:
inclusion criteria: * willing to join the research * bmi 18.5-23 * healthy individual, no history of blood or coagulation disorders exclusion criteria: * bmi \ 23 * history of blood or coagulation disorder, diabetes mellitus, heavy smoker

Keywords: epinephrine hand ischemia lidocaine upper extremity
lixivaptan in a single subject with intractable pain due to polycystic kidney disease

Conditions: Polycystic Kidney

Summary: abdominal pain, sometimes severe, is a known symptom of polycystic kidney disease (pkd) related to the cystic expansion. this study will investigate whether the vasopressin v2 receptor antagonist lixivaptan can alleviate intractable pain in a pediatric pkd patient who cannot tolerate the related vasopressin v2 receptor antagonist tolvaptan.


Eligibility criteria:
inclusion criteria: 1. capable of understanding the written informed consent/assent. 2. provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements and study-related procedures. 3. at least 15 years of age at the time of screening. 4. subject has been diagnosed with adpkd by modified ravine criteria: * if the subject has a family history of adpkd, a minimum of 3 cysts per kidney by sonography or 5 cysts by computerized tomography or mri; or * if the subject does not have a family history of adpkd, a minimum of 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases. 5. considered by the investigator to be in good health relative to underlying ckd status and clinically stable with respect to underlying ckd, based on medical evaluation that includes medical and surgical history, as well as a complete physical examination including vital signs, ecg, and laboratory test results. exclusion criteria: 1. has a known sensitivity or idiosyncratic reaction to any compound present in lixivaptan or any compound listed as being present in the formulation. 2. is pregnant or breast feeding. 3. has taken any investigational drug or used an investigational device within 30 days or 5 half-lives, whichever is longer, prior to screening. 4. has taken tolvaptan, conivaptan, somatostatin analogs (e.g. lanreotide, pasireotide, octreotide, etc.), mtor kinase inhibitors (e.g. everolimus, sirolimus, etc.), or oral or intravenous antibiotics within 30 days or 5 half-lives, whichever is longer, prior to day 1. 5. has a history of testing positive for hepatitis b surface antigen, hepatitis c, or human immunodeficiency virus (hiv). 6. consumes grapefruit or seville oranges (or their juices, or foods containing their extract) from 7 days prior to the first dose of study medication and until after the final dose. 7. has clinically significant liver disease, or clinically significant liver function abnormalities or serology other than that expected for adpkd with cystic liver disease at baseline. 8. has any clinically significant laboratory abnormalities or concomitant conditions other than adpkd (including treatment for such conditions) that, in the opinion of the investigator, could either interfere with the study drug or pose an unacceptable risk to the subject.
disjunction between patient narrative and formulaic thinking in the doctor

Conditions: Musculoskeletal Diseases

Summary: this study is seeking whether giving or not giving a clinician a card with talking points in the form of a checklist about the patient's story affects the patients care experience or not

during an office visit, the clinician and the patient engage in dialogue and begin a relationship. this traditionally starts with the patient telling their story, which conveys why they decided to seek care. this study will determine the influence of a checklist specifically about the patient's narrative. the checklist will be used during the interview portion of the visit, to remind the clinician to stay curious about the person before them, their experience of the illness, and their explanatory model, and to help ensure that empathic opportunities are not missed.

Eligibility criteria:
inclusion criteria: * new patients * orthopedic visit exclusion criteria: * languages other than english or spanish. * cognitive dysfunction precluding completion of questionnaires.

Keywords: orthopedics
dermabond prineo for total shoulder arthroplasty

Conditions: Surgical Wound; Shoulder Arthritis; Surgical Incision

Summary: this is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with dermabond prineo skin closure system (prineo) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. the prineo system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.


Eligibility criteria:
subjects will be included if: * they are 18 years or older; * they are undergoing primary total shoulder arthroplasty by the principal and co-investigator. * they are willing and have the capacity to provide informed consent; * they expect to continue their post-operative follow up care with their operating surgeons at medical university of south carolina (musc). subjects will be excluded if: * they have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision * they self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive; * they self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach; * their medical record shows that they are hiv positive or otherwise immunocompromised; * their medical record shows a skin abnormality or dermatological condition which affects skin healing; * they report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.
efficacy and safety of donafenib in patients with advanced hepatocellular carcinoma

Conditions: HCC

Summary: donafenib versus sorafenib for advanced hepatocellular cancer.

this phase 3 study of donafenib, an oral multikinase inhibitor that targets raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (hcc).the study is a randomised,controlled,multicentre study.the controlled drug is sorafenib(nexavar).the primary endpoint is overall survival.

Eligibility criteria:
inclusion criteria: * above 18 years old; * patients with measurable, histologically or clinical proven, inoperable hcc; * patients wtih measurable lesion and proved by independent radiology committee(irc); * child-pugh (cp) score of 7 or less； * eastern cooperative oncology group (ecog) performance status score of 2 or less; * patients had not received prior systemic treatments for hcc; * life expectancy at least 3 months; * adequate hepatic and renal function; * adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,); * prothrombin time international normal. exclusion criteria: * patients received operate in 3 months; * patients received transcatheter arterial chemoembolization（tace） in 4 weeks; * patients had received systemic therapy; * patients had prior treatment with sorafenib; * central nervous system(cns) involvement; * severe or mild-degree ascitic fluid; * main portal vein tumor thrombus; * inferior venae cava tumor thrombus.

Keywords: donafeinb sorafenib phase 3 overall survival
impact of pharmacotherapy management in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: in brazil, patients with alzheimer's disease (ad) receiving free drugs of government. even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. the research aims to promote adherence and develop strategies to address drug-related problems (drp's) in ad patients elderly of reference centre for the elderly of araraquara. the clinical parameters will be assessed at the beginning and after the educational intervention period from april 2014 to april 2015.

dementia is characterized by memory loss associated with cognitive impairment, which directly interferes in learning process, social and professional performance, besides being the main cause of dementia or alzheimer's disease (ad). in brazil, patients are medicated for ad through "programa de medicamentos excepcionais" (exceptional drug program) that ensure the patient´s treatment by providing high cost medications. even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. the research aims to promote adherence and develop strategies to address drug-related problems (drp's) in ad patients. for this end, we intend to conduct a descriptive, almost experimental and longitudinal uncontrolled research, from april 2014 to december 2015, at the cria: "centro de referência do idoso de araraquara" (reference centre for the elderly of araraquara). patients included in the research must have a diagnosis of ad and must be using drugs supplied by the "programa de medicamentos excepcionais". for data collection pharmaceutical care will be employed as a technique, carried out through pharmaceutical meetings, including the steps of initial assessment, care plan (pharmaceutical intervention) and results evaluation. the results will be monitored for pharmacotherapy adherence, cognitive assessment and other clinical parameters related to their health problems and resolution of drp's before and after the proposed follow-up.the expected outcomes include knowledge of the medication experiences of ad patients, how they influence the adherence and other drp's and how they can contribute by solving these problems, in addition to the impact evaluation of pharmaceutical care in cognitive improving and other clinical parameters monitored and evaluated individually.

Eligibility criteria:
inclusion criteria: * elderly patients who are assisted in cria, diagnosed with alzheimer's in use of rivastigmine or donepezil or galantamine, assisted by the "program for special drugs". * be resident in the city of araraquara / sp * accept part of pharmacotherapeutic follow-up; * sign the statement of informed consent form (icf). exclusion criteria: * fold over pharmacotherapy follow-up; * being institutionalized; * patients unable to respond to collection instruments mmse and cdr data; * patient without phone contact.

Keywords: elderly, medication adherence,pharmaceutical care