Kornimate/medical-research-clean huggingface dataset:
immunohistochemical expression of inhibin beta a (inhba) in colorectal carcinoma

Conditions: Colorectal Cancer

Summary: a retrospective observational study to evaluate immunohistochemical expression of inhibin beta a (inhba) in 60 cases of colorectal carcinoma, and compare levels of its expression to different clinicopathological criteria.

colorectal carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis. inhibin beta a (inhba) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. the aim of this study is to detect expression of inhba in 60 archived formalin-fixed paraffin-embedded tissue blocks of patients suffered from colorectal carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (age, sex, tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).

Eligibility criteria:
inclusion criteria: specimens from patients with colorectal carcinoma. tissue blocks with sufficient material. specimens with sufficient clinical data. exclusion criteria: tissue blocks with insufficient, destroyed or necrotic material. specimens with insufficient clinical data.

Keywords: inhibin beta a colorectal carcinoma immunohistochemistry
capture 2 post-marketing registry

Conditions: Carotid Artery Disease

Summary: the purposes of the registry are: 1) to provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) to provide additional information that the rx acculink™ and rx accunet™ can be used safely by a wide range of physicians under commercial use conditions. 3) to evaluate the adequacy of abbott vascular's physician training program.

capture 2 is an amendment to the capture study and will provide a mechanism for collection of data from the rx acculink and rx accunet systems, when used by a broad group of physicians under commercial use conditions. the original capture study had built-in features that limited the ability to collect on-going real world data because it restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (40 patients per site). capture 2 will not have these restrictions. capture 2 is a descriptive post-approval registry that will be conducted at approximately 400 clinical sites in the united states with open-ended enrollment. the purposes of this registry are: 1) to provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) to provide additional information that the rx acculink carotid stent system and rx accunet embolic protection system (eps) can be used safely by a wide range of physicians under commercial use conditions. 3) to evaluate the adequacy of abbott vascular's physician training program. as with the previous capture study, data will continue to be collected on any rare or unanticipated events that may occur. patients in capture 2 will be followed after the index procedure to 30 days. during the 30 day follow-up period, any occurrence of death, stroke, myocardial infarction (mi), new neurologic events, and device-related adverse events will be reported to abbott vascular.

Eligibility criteria:
inclusion criteria: 1. informed consent for data collection. 2. intent to use the rx acculink and rx accunet to treat carotid artery disease. exclusion criteria: none.

Keywords: carotid, stenting, angioplasty
evaluation of the structure modifying effect of avocado-soybean unsaponifiables in hip osteoarthritis

Conditions: Hip Osteoarthritis

Summary: this study aims to assess the long term (three years) ability of asu (avocado soya unsaponifiable) to slow the decrease of radiographic jsw (joint space width) in hip osteoarthritis (oa). this is a randomized, double blind, comparative, parallel group study versus placebo.

inclusion criteria: primary hip oa, fulfilling acr criteria, patient over 45 y, painful \> 1 year, lequesne's index \> or equal to 3, with minimum jsw at the target hip \> 1 mm and \< 4 mm on pelvic radiograph. primary criterion of efficacy: the main criterion of efficacy is the change of jsw between baseline and end point. jsw is measured on the narrowest joint on pelvic or target hip x ray by blinded reader. randomisation is stratified according jsw at baseline (\ or equal to 2,5 mm). statistical analysis: the full analysis set (fas) is defined by patients with at least one baseline value and one post baseline value. the main analysis is scheduled on fas using a missing at random (mar)with a multiple model repeated measure (mmrm)to take in account missing value. sap (statistical analysis plan) schedule to analyse jsw change as quantitative variable using an ancova and as qualitative variable (progressors defined as jsw loss upper than 0,5 mm) using mantel haentzel test.

Eligibility criteria:
inclusion criteria: * primary oa of hip, * acr criteria, * older than 45 years, * symptomatic painful \> 1 an, * lequesne's index \> or equal to 3, * jsw between 1 and 4 mm on pelvic radiograph. exclusion criteria: * secondary oa.
efficacy and safety of da-9401 on improvement of sperm motility

Conditions: Spermatocele

Summary: this study was conducted to investigate the effects of daily supplementation of allium cepa l. and cuscuta chinensis lam. extract mixtures (da-9401) on improvement of sperm motility.

this study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. twenty subjects were randomly divided into allium cepa l. and cuscuta chinensis lam. extract mixtures (da-9401) or a placebo group. sperm motility profiles before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 20-55 years * sperm motility 40\~69% exclusion criteria: * history of alcohol or substance abuse * participation in any other clinical trials within past 1 months * intense constipation

Keywords: sperm motility, clinical trial , da-9401
digital lifestyle intervention for diabetes/pre-diabetes

Conditions: Type 2 Diabetes; PreDiabetes; Obesity

Summary: the study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called fitness digital (fitd), for individuals with prediabetes or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age 18+ * hong kong resident * can understand chinese and cantonese * have self-reported diagnosis of type 2 diabetes or prediabetes * have a smart phone and able to use a mobile app exclusion criteria: * none

Keywords: intensive lifestyle intervention mhealth ehealth digital intervention efficacy rct
effects of dexmedetomidine on breast cancer cell function in vitro

Conditions: Breast Cancer

Summary: dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. previous studies in cells and animals show that dexmedetomidine may promote cancer growth. using serum from breast cancer surgery patients randomized to receive dexmedetomidine or saline during surgery, we investigated the effects of dexmedetomidine on proliferation, migration and metastasis in mcf-7 breast cancer cells in vitro.

women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and cis atracurium for total intravenous anesthesia. bis value will be controlled between 40-60 during surgery. patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. patients of control group will receive same amount of normal saline. serum will be collected from patients of both groups at before induction and 1h post-surgery. the mcf-7 breast cancer cell line will be treated with patient serum from both groups. the effects of dexmedetomidine on cellular proliferation, migration and metastasis will be measured.

Eligibility criteria:
inclusion criteria: * asa grade i-iii age range of 18 to75 patients diagnosed primary breast cancer(t2-3, n0-2, m0) patients will have elective adenomammectomy exclusion criteria: * with history of breast operation patients diagnosed carcinoma erysipelatodes severe liver, renal, brain or lung disease with history of opioid addiction patients diagnosed metastatic breast cancer
prediction of sepsis after percutaneous nephrolithotomy

Conditions: Percutaneous Nephrolithotomy; Infection; Urolithiasis; Albumin Globulin Ratio

Summary: we aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (pcnl) in patients with unilateral, solitary and proximal ureteral stones.


Eligibility criteria:
inclusion criteria: * (1) pcnl was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years exclusion criteria: * anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)
evaluation of patient and physician reported reasons for switching factor viii replacement therapies

Conditions: Hemophilia A

Summary: this us study will assess hemophilia a patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. for this purpose, this research study will include hemophilia a: 1) patients who have switched from conventional therapy to new fviii products with an improved pk profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new fviii products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. in doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia a and to more fully understand what drives patient switching from a patient perspective and a physician perspective.


Eligibility criteria:
inclusion criteria: inclusion criteria for patients/caregivers in the patient/caregiver study: * patients with hemophilia a (≥ 18 years of age) or caregivers of children with hemophilia a (≥12-\<18 years of age) * group 1: hemophilia a patients/caregivers who have switched to fviii products with improved half-life for the treatment of hemophilia a during the eligibility period. these patients can also include those who have switched back from fviii products with improved half-life to conventional fviii replacement therapy within the data collection period * group 2: hemophilia a patients/caregivers who are considering switching to fviii products with improved half-life within 12 months of the start of the documentation period and have been prescribed prophylaxis regimen of at least 2x/week * able to understand, read, write and speak english * provide electronic informed consent * able to access the internet for at least 20 minutes per day during the data collection period inclusion criteria for physicians: * at least 60% of time spent in direct patient care * board-certified or eligible with a specialty in hematology or hematology-oncology * physicians with a specialty in hematology-oncology must have at least 10% of their practice dedicated to treatment of hemophilia * a minimum of 2 years' experience treating hemophilia a patients inclusion criteria for patients in the physician chart study: * hemophilia a patients age 12 year and over * prior treatment with one of the following fviii replacement products: adynovate, afstyla, eloctate, or kovaltry * patients that have 12 months of medical chart data available; 6 months on conventional therapy and 6 months after switching to fviii products with improved half-life. exclusion criteria: exclusion criteria for patients/caregivers in the patient/caregiver study: - hemophilia a patient initiated fviii products with improved half-life for the treatment at time of diagnosis with hemophilia a. exclusion criteria for physicians: - unwilling to comply with the study protocol
filibuvir in treatment naive hepatitis c virus (hcv) genotype 1 subjects

Conditions: Hepatitis; Hepatitis C

Summary: the primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegifn/rbv) significantly increases the proportion of subjects who achieve a sustained viral response (svr) compared to peginterferon/ribavirin (pegifn/rbv) therapy alone.


Eligibility criteria:
inclusion criteria: * male or female subjects at least 18 years of age. * hcv seropositive. * hcv rna \>10,000 iu/ml at screening. * hcv genotype 1. subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible. * treatment naïve (no prior treatment with ifn alfa +/ rbv regimens or investigational anti-hcv agents). * liver biopsy within two years (24 months) of screening with non-cirrhotic fibrosis classification. for those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization. * ultrasound within 6 months of screening for 1) those subjects with bridging fibrosis or 2) those subjects with afp \>50 and \<100 ng/ml with no evidence of hepatocellular carcinoma. for those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization. exclusion criteria: * co-infection with either hiv or hbv. * evidence of severe or decompensated liver disease. * subjects with liver disease unrelated to hcv infection. * pre-existing medical condition that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling. * laboratory abnormality at screening that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling. * abnormal ecg suggestive of clinically significant cardiac disease or qtc\>450msec. * history of organ transplant. * contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent cyp3a4 inhibitors, sensitive cyp3a4 substrates, cyp3a4 substrates with narrow therapeutic range and cyp3a4 inducers. * active alcohol or substance abuse sufficient, in the investigator's judgment, to prevent adherence to study medication and/or follow up. * pregnant or nursing females. * males whose female partner is pregnant.

Keywords: hepatitis c polymerase inhibitor pf-00868554 filibuvir
reversibility of cardiac conduction disturbances following tavi

Conditions: Aortic Stenosis; Transcatheter Aortic Valve Implantation; Conduction Disturbances

Summary: the management of patients with conduction disturbances (cds) after transcatheter aortic valve implantation (tavi) is unclear, especially in those with de novo electrocardiographic cds (ecg-cds) such as left bundle branch block. in this study, the investigators will evaluate the incidence of retrogradation of infra-hisian cds in patients with de novo ecg-cds and positive electrophysiological study (eps) 3-7 days following tavi. in addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative eps performed 3-7 days following tavi. in this multicenter, longitudinal, prospective study, patients with clinical indication of ep study due to new-onset ecg-cds after tavi will be included. a permanent pacemaker will be implanted in patients with positive eps and a second eps will be performed in 30-45 days. additionally, these patients will undergo 4-week continuous monitoring using the epatch (philips) long-term holter recorder, to identify episodes of paroxysmal complete atrioventricular block. patients with negative ep study will undergo clinical follow-up and continuous monitoring for 4 weeks.


Eligibility criteria:
inclusion criteria: * patients with indication for electrophysiological (ep) study after tavi implantation according to european guidelines. patients must have persistent electrocardiographic conduction disturbances (ecg-cds) that are present from day 2 after tavi implantation (≥ 48h post-procedure): * de novo lbbb with qrs complex \>150ms and/or pr interval ≥240ms. * qrs widening or post-procedural pr lengthening \> 20ms in patients with baseline ecg-cds. exclusion criteria: * patients with previous pacemaker or implantable defibrillator. * patients with baseline complete right bundle branch block. * patients in need of cardiac resynchronization or physiological stimulation following tavi. * valve-in-valve procedures. * tavi procedures in patients with severe aortic insufficiency. * inability to sign the informed consent form.

Keywords: aortic stenosis transcatheter aortic valve implantation conduction disturbances
ossimend ba in posterolateral instrumented lumbar fusion

Conditions: Spinal Disease; Degenerative Disc Disease

Summary: the primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using ossimend bioactive moldable as the bone grafting material

the primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using ossimend bioactive moldable as the bone grafting material. the primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to ossimend bioactive moldable. the secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (ddd) that has failed to respond to nonoperative treatment for at least 6 months. ddd is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include ct, mri, plain x-ray film, discography, myelography, etc. with one or more of the following findings: * instability as defined by \>3mm translation or \>5 degrees angulation * osteophyte formation of facet joints or vertebral endplates * decreased disc height, on average by \>2mm, but dependent upon the spinal level * herniated nucleus pulposus * facet joint degeneration/changes exclusion criteria: 1. subject is under 18 years of age at the time of consent 2. subject has had prior lumbar spine fusion surgery at any level 3. subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy 4. subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 5. subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection 6. subjects under workers compensation or active litigation

Keywords: bone graft lumbar fusion
assessment of capsule endoscopy scoring index (cesi), harvey-bradshaw index (hbi) and biological markers in small bowel crohn's disease (sbcd)

Conditions: Small Bowel Crohn's Disease

Summary: background: small bowel crohn's disease (sbcd) is a chronic relapsing disease, and clinical presentation can vary considerably. patients are frequently assessed by capsule endoscopy (ce), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between ce scoring index (cesi), biological markers, and disease activity indices remain undefined. methods: a prospective study was conducted between october 2008 and february 2011 on 58 established sbcd patients and suspected patients who received a definitive sbcd diagnosis during study. patients underwent complete ce, and were scored according to the cesi (inactive, \ 790) and harvey-bradshaw index (hbi). statistical correlation between cesi, hbi, c-reactive protein (crp), serum albumin, and hemoglobin was assessed. at follow-up (\~9 months), 11 of the patients underwent ce with scoring for cesi, hbi, and crp.

parameters cesi to calculate the cesi, the small bowel was divided into three tertiles. the degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. endoscopic remission was defined as cesi of \<135. mild inflammation was defined as cesi of 135-790, and moderate-severe inflammation as ≥790. hbi hbi was used to assess the clinical disease activity. patients with hbi \>4 were considered to have clinically active disease.\[7\] blood analysis at the time of ce, patients provided a blood sample for measurement of hemoglobin, serum crp, and albumin. hemoglobin (normal ranges: women, 120-160 g/l and men, 140-180 g/l), albumin (normal range: 35-55 g/l), and crp (upper limit of normal: \<8 mg/l) were determined by routine laboratory tests.

Eligibility criteria:
inclusion criteria: * patients with known sbcd or newly diagnosed sbcd * those patients for whom complete ce examination (in which the capsule * reached the cecum within the ce test time) was achieved were retained for study exclusion criteria: * incomplete ce examination * infectious enterocolitis * symptoms related to perianal penetrating disease * gastrointestinal cancer * ulcerative colitis * indeterminate colitis * history of extensive small bowel resection * known cd of the upper gastrointestinal tract or colon * intake of non-steroidal anti-inflammatory drugs (nsaids) (more than two tablets per week) * pregnancy

Keywords: capsule endoscopy scoring index harvey-bradshaw index c-reactive protein serum albumin hemoglobin