Kornimate/medical-research-clean huggingface dataset:
prevention of hip fractures with soft and hard hip protectors

Conditions: Hip Fractures; Prevention

Summary: the aim of this study is to compliance with and effect of soft and hard hip protectors in norwegian nursing homes.

hip fractures are a major cause of disability and functional limitation. hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem. changing the hip protector's design might give a higher uptake and adherence. the aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in norwegian nursing homes. because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. if the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one. this cluster randomized study is performed in 18 norwegian nursing homes in 2 municipalities. the study started may 15. 2006 and will end november 30. 2006. all permanent residents are invited to participate in the study either as a user of hip protector or as a non user.

Eligibility criteria:
inclusion criteria: * all permanent residents in the the participating nursing homes

Keywords: hip protectors uptake and adherence nursing home residents efficacy prevention
tavis registry - trilogy heart valve system for management of patients with aortic valve disease

Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation; Aortic Valve Stenosis With Insufficiency; Constriction, Pathologic; Aortic Valve Disease; Heart Valve Diseases; Cardiovascular Diseases in Old Age; Ventricular Outflow Obstruction; Aortic Stenosis, Severe

Summary: to collect information about the management of symptomatic severe aortic stenosis (as) and aortic regurgitation (ar) using transcatheter aortic valve replacement (tavi).

aortic stenosis (as) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. aortic regurgitation (ar) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. symptoms of as and ar may include fatigue and shortness of breath. aortic valve disease can affect both elderly and younger populations. tavis registry will collect data from patients suffering from either as or ar using a minimally invasive transcatheter aortic valve implantation procedure.

Eligibility criteria:
inclusion criteria: 1. patients who have signed icf and are indicated by their doctors to be treated with trilogy heart valve system in line with the medical standard of care 2. patients with symptomatic severe aortic regurgitation (ar) or symptomatic, severe aortic stenosis (as), who are at high risk for savr as documented by the heart team and heart team agrees that patient can undergo savr for "bail out"/to address unfavorable circumstances if necessary 3. patients 18 years of age or older 4. patient is willing to participate in the study, provides signed informed consent/data authorization form and authorizes the sharing of data in the study 5. the subject and treating physician agree the subject will return for all required post-procedure follow-up visits exclusion criteria: 1. patients who have known hypersensitivity or contraindication to nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication 2. patients who have active bacterial endocarditis or other active infections 3. pediatric (\<18 years) and/or pregnant/nursing patients 4. congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology 5. previous prosthetic aortic valve (bioprosthesis or mechanical) implant 6. echocardiographic evidence of current left heart thrombus 7. hypertrophic cardiomyopathy with or without obstruction. 8. access vessel characteristics that would preclude safe placement of the jenavalve 20fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \<7mm.

Keywords: trilogy aortic valve disease transcatheter aortic valve replacement (tavr) aortic valve regurgitation
a study of itraconazole in the management of superficial fungal infections in india

Conditions: Mycoses

Summary: the purpose of this study is to estimate the proportion of participants prescribed itraconazole for tinea cruris or tinea corporis who have clinical response after 7 days of treatment.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with tinea cruris or tinea corporis with or without history of treatment * are prescribed itraconazole at 200 milligram/day orally for the treatment of t. cruris or t. corporis and taken once a day * a woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hcg\]) at screening on day -3 to 0 before start of study drug * a woman must be (a) not of childbearing potential (b) of childbearing potential and: practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percentage \[%\] per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 30 days after last dose (that is, the end of relevant systemic exposure) * a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. a male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug exclusion criteria: * history of ventricular dysfunction such as congestive heart failure (chf) or receiving treatment for chf, liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances at any time prior to the start of study * known achlorhydria or on treatment of gastric acidity * presence of other dermatoses, example. psoriasis, seborrhoeic or atopic dermatitis * infected with organism with known or established resistance to itraconazole * co-existing fungal infection of other body area
effect of proactive management of side effects on treatment compliance in malignant melanoma patients on high-dose intron a therapy (study p04600)

Conditions: Melanoma

Summary: patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose intron a for one year. the objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 years * confirmed melanoma * patient has been prescribed intron a therapy for high-risk stage ii \& iii melanoma * intron a therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval) * proper contraception in both male and female subjects and the female partner(s) of male study subjects exclusion criteria: * metastatic disease at the time of diagnosis * other malignancies * history of non compliance to other therapies * pregnancy or breast feeding * previous intron a therapy
a follow-up survey of oral hygiene and health outcomes for women previously enrolled in "ohmom"

Conditions: Gingivitis

Summary: the objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at university of alabama birmingham during the period 2012-2014. additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the ohmom clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * sign an informed consent form and be given a copy * be a former subject in study 2011001 at university of alabama birmingham with a live birth outcome from that study. exclusion criteria: * any medical condition requiring pre-medication prior to dental procedures * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures
effectiveness of efavirenz-based regimen in hiv-1-infected patients with nevirapine hypersensitivity

Conditions: Treatment Failure, HIV or AIDS; CD4 Cell Counts

Summary: the primary objective of this study is to compare the effectiveness of efv-based regimens in hiv-1-infected patients who; (1) were previously allergic to nvp and stopped all arv simultaneously; (2) were previously allergic to nvp and continued the other nrtis for a period of time, i.e. "staggered interruption"; and (3) started efv-based regimens as an initial regimen (as controlled group).


Eligibility criteria:
inclusion criteria: * age 18-70 years old * documented hiv infection * started efv-based regimens between january 2002 and december 2008 at bamrasnaradura infectious diseases institute exclusion criteria: * previously received non-haart regimens such as dual nrtis regimen, azt monotherapy with single-dose nvp in pregnancy patients * previously received protease inhibitor-based regimen * diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, esrd

Keywords: hiv efavirenz nevirapine allergy rash cohort studies, historical retrospective study exanthem antiretroviral agents highly active antiretroviral therapy haart treatment failure
electronic medical record-based nudge to reduce slnb

Conditions: Breast Cancer; Estrogen-receptor-positive Breast Cancer

Summary: the goal of this prospective, historically-controlled, quality improvement project is to determine whether and to what extent an electronic health record (ehr)-based nudge affects rates of sentinel lymph node biopsy (slnb) in older women with er+, early-stage, clinically node negative breast cancer.

society of surgical oncology (sso) adopted a series of choosing wisely recommendations in an effort to reduce low-value surgeries. one such recommendation, first released in 2016, advocates against routine use of sentinel lymph node biopsy (slnb) for axillary staging in older women (≥ 70 years old) with early-stage, estrogen receptor positive (er+), clinically node-negative breast cancer. data supporting this recommendation were largely retrospective in nature as there were no direct randomized trials testing de-escalation of slnb in this population of patients. this has led to variability in de-implementation of slnb, with rates of slnb use still reaching 50%-60% in some centers. to address this, the investigators designed an electronic medical record-based column nudge that flags patients meeting choosing wisely criteria for omission of slnb. this was designed to target surgeons in the moments leading up to the first clinic visit with patients where surgical decision-making is planned. in this study, the investigators deployed the column nudge for a 12 month period. the enrollment number reflects the number of surgeons participating in the study (whom the nudge was deployed to); it is anticipated this group of surgeons will see over 400 patients between the pre-nudge and post-nudge periods.

Eligibility criteria:
inclusion criteria: * early-stage (stages i-iii) breast cancer * clinically node-negative * er+ and/or pr+, her2 not-amplified * non-metastatic at diagnosis exclusion criteria: * under 70 years of age * breast cancer is that is not er+ or pr+

Keywords: sentinel lymph node biopsy axillary surgery
pd-1 immune checkpoint inhibitors and immune-related adverse events: a cohort study

Conditions: Carcinoma, Non-Small-Cell Lung; Immune-Related Adverse Events

Summary: the objective of our study is to assess the risk of immune-related adverse events associated with pd-1 inhibitors use compared to standard chemotherapy use in patients with non small cell lung cancer, using nationwide healthcare database.

this observational, retrospective cohort study will evaluate the risk of immune-related adverse events associated with pd-1 inhibitors use compared to standard chemotherapy use in patients with non small cell lung cancer, using nationwide healthcare database. pd-1 inhibitors will be defined as nivolumab, pembrolizumab, and atezolizumab. standard chemotherapy will be defined as cytotoxic chemotherapy or tyrosine kinase inhibitors (epidermal growth cell receptor (egfr) and anaplastic lymphoma kinase (alk) inhibitors). the investigators will assess exposure on the cohort entry using the intention-to-treat approach with the 6-month exposure risk window from the first pd-1 inhibitor prescription to avoid bias from informative censoring. immune-related adverse events will be defined by using pre-specified algorithms using diagnosis and corticosteroid prescription records (high dose of oral corticosteroids, defined as ≥ 30 mg/day, or systemic corticosteroid injection) to reduce outcome misclassification. the investigators will use a multivariable cox proportional hazard model to estimate hazard ratio (hr) and 95% confidence intervals (ci). the model will be adjusted for pre-existing autoimmunity, history of lung cancer surgery, radiation therapy, tyrosine kinase inhibitor use, and previous systemic corticosteroid use. all analyses will be undertaken using sas 9.4 (sas institute inc., cary, nc, usa).

Eligibility criteria:
inclusion criteria: * individuals who were diagnosed with lung cancer (icd-10: c33-c34) between 2017 and 2018. exclusion criteria: * individuals less than 18 years of age * individuals received any systemic anticancer therapies in 2007 * having no records of prescription of pd-1 inhibitors or standard chemotherapy at least once between 2017 and 2018 * individuals received treatments indicated for small cell lung cancer (etoposide, ifosfamide, irinotecan, belotecan, and topotecan) on or before the first date of standard chemotherapy to restrict study subjects to patients with non small cell lung cancer only.

Keywords: pd-1 inhibitor nivolumab pembrolizumab atezolizumab immune-related adverse events carcinoma, non-small-cell lung
weekly paclitaxel liposome injection plus cisplatin in preoperative treatment of breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the pathological complete response (pcr) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.


Eligibility criteria:
inclusion criteria: * women aged ≥ 18 years and \< 65 years,an estimated life expectancy of at least 12 months * ecog 0-1 * at least one measurable disease according to the recist. histologically confirmed invasive breast cancer, stage ii and iii, no prior systemic or loco-regional treatment of breast cancer * biopsy specimens are available for er, pgr and her2 analysis * adequate bone marrow function: neutrophil ≥ 1.5\*109/l; hb ≥ 100g/l; plt ≥ 100\*109/l * adequate liver function (bilirubin \> 1.0 times upper normal limit \[unl\] and alt and/or ast\> 1.5 unl associated with alkaline phosphatase \> 2.5 unl; * women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study * no obvious main organs dysfunction * patients must be accessible for treatment and follow-up and written informed consent exclusion criteria: * patient is pregnant or breast feeding * inflammatory breast cancer and metastatic breast cancer * patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease * history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic bp \> 180 mmhg or diastolic bp \> 100 mmhg) * has peripheral neuropathy * treatment with any investigational drugs within 30 days before the beginning of study treatment * no psychiatric illness and other situations that would limit compliance of study * with a history of other malignant tumor * known severe hypersensitivity to any drugs in this study
registration study for rare type of pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the knowledge on the rare type of pulmonary hypertension which can not be explained by left heart disease, respiratory disease or congenital heart disease is very limited. investigators aim to setup a national registration study for the rare type of pulmonary hypertension, to understand the natural history, survival, progression, genetic and environmental contributions to disease.

the main research contents of this registration study includes: 1. build a baseline database of the rare type of pulmonary hypertension. collect general information, on-set symptoms and time, laboratory examination, imaging results, right heart catheterization and treatment information. 2. follow up recruited patients at regular intervals（6m\~1y). collect information on change in patients condition, laboratory test and treatment. 3. conduct genetic testing for gene mutation related or hereditary pulmonary hypertension. link the clinical database to genetic database. 4. establish bio-bank for serum/plasma, urine, stool, tissues or cells. 5. establish prognostic study based on the clinical follow-up and genetic database. 6. draw diagnostic and treatment algorithm for the rare type of pulmonary hypertension. controls subjects: blood sample and medical data collected once.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * patients diagnosed as idiopathic pulmonary artery hypertension, hereditary pulmonary artery hypertension, hereditary hemorrhagic telangiectasia associated pulmonary artery hypertension, pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis associated pulmonary artery hypertension, cavernous transformation of portal vein associated pulmonary artery hypertension, special type of congenital heart disease associated pulmonary artery hypertension, chronic thromboembolism pulmonary hypertension. * all patients should have undergone right heart catheterization, diagnosed according to the guideline. exclusion criteria: the participant may not enter the study if any of the following apply: * patients unwilling or unable to provide written consent for participation in the study. * not suffering from the rare type of pulmonary artery hypertension; inclusion criteria-controls * participant is willing and able to give informed consent for participation in the study. * self-reported to be healthy

Keywords: registry pulmonary hypertension survival biomarker whole genome sequencing
treatment strategy of ankle fracture combined with deltoid ligament rupture

Conditions: Ankle Fractures

Summary: ankle fracture is very common which is often combined with deltoid ligament injury. although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. there is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. the main content of the project: 1 achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 study the surgical indications and treatment guidelines by comparative study.

comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament

Eligibility criteria:
inclusion criteria: * ankle fracture with deltoid ligament rupture exclusion criteria: * ankle fracture without deltoid ligament rupture
study of tbl 12 sea cucumber extract for patients with untreated asymptomatic myeloma

Conditions: Multiple Myeloma

Summary: purpose: the purpose of this study is to see if tbl 12, which is a blend of sea cucumber, sea sponge, shark fin, and sea urchin (animals that live in the pacific ocean) as well as sargassum (a plant that lives in the pacific ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are. eligibility: several criteria must be met to be eligible for this study, including but not limited to the following: * a diagnosis of asymptomatic multiple myeloma * adequate cardiac, liver and kidney function * age 18 and older

multiple myeloma is a cancer that evolves from a state known as monoclonal gammopathy of undetermined significance (mgus), defined by parameters of m spike and bone marrow. after evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of hypercalcemia, renal insufficiency, anemia or bone lesions. in asymptomatic myeloma (asxm), there is no standard therapy. thalidomide has been tried in patients with asxm but with significant toxicity. the patients with asxm are evaluable in terms of paraprotein measurements. tbl12 sea cucumber extract has been shown to have a number of antitumor properties preclinically, including antiangiogenesis and direct tumor cytotoxicity. tbl12 has been used by a number of patients as a food supplement without any toxicity detected. we thus propose to determine the clinical activity of this agent in patients with asxm. patients will be given tbl12 at the dose of 2 units of 20 ml each twice per day daily for one year and the effects on the paraprotein noted. clinical effects seen will be correlated with any in vitro changes in angiogenesis in patient bone marrow samples. the results of this trial may form the basis for the use of this nontoxic agent in patients with the prodrome of or with other early cancers.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma * measurable disease * for non-secretors, measurable protein by freelite or plasmacytoma * asymptomatic disease exclusion criteria: * poems syndrome * plasma cell leukemia * receiving steroids greater than the equivalent of 10 mg prednisone * infection not controlled by antibiotics * hiv infection * known active hepatitis b or c

Keywords: asymptomatic
comparison of suture materials on sectio scars (cosmoss)

Conditions: Uterine Scar

Summary: this multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

the study involves 5 health centers (two universities, three private hospitals). patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. operation nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. as the primary result, the istmocele rates will be compared between the study groups.

Eligibility criteria:
inclusion criteria: * 18-40 yrs women * primary elective cesarean section * first delivery * without any systemic diseases exclusion criteria: * emergent delivery * previous c-section history * congenital uterine abnormality

Keywords: cesarean section isthmocele uterine scar suture