Kornimate/medical-research-clean huggingface dataset:
effectiveness of a vaccination program in the community ob/gyn setting

Conditions: Influenza Vaccine; Papillomavirus Infection; Pertussis

Summary: purpose to develop, implement, and evaluate the effectiveness of a program designed to assist community ob/gyns in vaccinating adolescent and adult women against vaccine-preventable diseases. specific aims 1. determine the feasibility of implementing a successful vaccination program for adolescent and adult women in ob/gyn offices by direct assessment of medical personnel \& office staff on their: * attitudes towards vaccination of women against preventable diseases * perceived barriers to implementing a program to vaccinate women in their offices * ideas on how to overcome barriers to successful program implementation * current vaccination practices and office-specific administrative processes 2. design \& implement a program for ob/gyns to vaccinate women against human papillomavirus, influenza, \& pertussis 3. determine the effectiveness of the vaccination program based on * pre- and post-program vaccination rates * program satisfaction amongst ob/gyn providers and office staff * willingness to continue and possibly extend the program to additional vaccines 4. quantify the level of support and resources needed to develop and implement the vaccination program


Eligibility criteria:
inclusion criteria: * 4-5 community ob/gyn practices

Keywords: hpv vaccine tdap vaccine
a dose-finding study comparing insite vision, inc. 101 to vehicle and durasite alone for dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of isv-101 (bromfenac in durasite® ophthalmic solution) compared to vehicle and durasite alone.


Eligibility criteria:
inclusion criteria: 1. volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease. 2. negative pregnancy test prior to the conduct of any protocol-specific procedure. the subject must use effective contraception for the duration of the study. post menopausal is defined as having no menses for at least 12 consecutive months 3. signature of the subject on the informed consent form 4. willing to avoid disallowed medication for the duration of the study. 5. able to self-administer study drug (or have a caregiver available to instill all doses of study drug) 6. able and willing to follow study instructions 7. additional inclusion criteria also apply exclusion criteria: 1. females who are pregnant or nursing. females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study). 2. use of contact lenses during the study. 3. use of any concomitant topical ocular medications except for artificial tears during the dosing period 4. presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents. 5. prior or anticipated concurrent use of an investigational product or device that could confound the findings about dry eye in the study eye. 6. a condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation 7. known hypersensitivity to any component of the study drug or procedural medications 8. participation in any other clinical trial within 30 days prior to screening 9. known hypersensitivity to nsaids 10. any active corneal epithelial/stromal pathology noted in the study eye at the screening visit 11. any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or lasik) 12. cataract surgery within the past year. 13. known contraindication to the study drugs or any of their components

Keywords: dry eye
dose-escalation study of pha-793887 in patients with advanced/metastatic solid tumors

Conditions: Advanced/Metastatic Solid Tumors

Summary: the purpose of this open-label, multi center, phase i study, was to determine the safety profile of pha-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. this was a dose-finding study to determine the maximum tolerated dose and the dose of pha-793887 that can be safely used in phase ii investigations.


Eligibility criteria:
inclusion criteria: * advanced/metastatic solid tumors for which no standard therapy exists * ecog (who) performance status 0-1 * life expectancy of at least 3 months * age ≥ 18 years * adequate liver, pancreas and renal function * acceptable hematologic status * acute toxic effects from prior therapy must be resolved to nci ctcae grade ≤ 1 * treatment with surgery, chemotherapy, or investigational therapy must be completed at least one month prior to treatment initiation (6 weeks for nitrosoureas or mitomycin c and liposomal doxorubicin) * prior radiation therapy allowed in no more than 25% of bone marrow reserve * men and women of child-producing potential must agree upon the use of effective contraceptive methods exclusion criteria: * in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * known brain metastases * major surgery, other than diagnostic surgery, within 4 weeks prior to day 1 * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * pregnant or breast feeding women * known infection with hiv, active hepatitis b or hepatitis c * patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation * history of pancreatitis or disorders making the patient at risk of pancreatitis * previous history or current presence of neurological disorders * patients with pre-existing symptoms of peripheral neuropathy not related to prior anticancer therapy(ies) * concomitant treatment that may be associated with peripheral neuropathy * other severe concurrent conditions that could compromise protocol objectives.
hematuria evaluation trial for subjects with microscopic or gross hematuria to determine the absence or presence of bladder cancer

Conditions: Microscopic or Gross Hematuria

Summary: the purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.


Eligibility criteria:
inclusion criteria: * for those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older. * subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking. * subject must have an intact bladder * subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria. * subject must be able to provide a minimum of 25 ml of urine for study purposes. * urine samples must be available prior to cystoscopy, bladder biopsy, and tur. * subjects must be willing to sign an institutional review board approved written informed consent prior to any study related procedures being performed. exclusion criteria: * subject had a history or current diagnosis of any basal or squamous cell cancer. * subject had a known diagnosis of any autoimmune disease. * subject had known diagnosis of hiv, hcv or hbv * subject had disclosed voluntarily history of or current infection with tb or other systemic disease. * subject is currently pregnant or lactating. * subject had surgery within 30 days prior to enrollment * subject has known allergy to benzalkonium chloride. * subject participated in an investigational drug or device trial within 30 days prior to enrollment.
evaluation of soybean peptides product on regulation of blood pressure effect in humans

Conditions: Hypertension

Summary: this is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. overall, soybean peptide consumption for 8 weeks could successfully reduce mean diastolic and systolic bp through the suppression of angiotensin-converting enzyme (ace) linked to downstream suppression of angiotensin ii formation, which further decreases the sympathetic outflow that leads to hypertension.

this is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. thirty subjects with systolic blood pressure (sbp) between 120 and 159 mm hg and/or diastolic blood pressure (dbp) between 80 and 99 mm hg were randomized to ingest 2 bags of soybean peptides or placebo per day for 8 weeks of a stage. anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (fbg), albumin, total cholesterol (tc), triglyceride (tg), hdl-c, ldl-c, creatinine (cr), blood urea nitrogen (bun), ast, alt) were examined every four weeks.

Eligibility criteria:
inclusion criteria: * eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with sbp between 120 and 159 mmhg and/or dbp between 80 and 99 mmhg as measured in a sitting position exclusion criteria: * subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction; * diastolic blood pressure ≥ 100 mmhg or systolic blood pressure ≥ 160 mmhg; * alcoholic; * us-controlled diabetics; * stoke in past one year; * mental diseases or melancholia; * pregnancy or breast-feeding a child; * renal dysfunction; * allergic to soybean peptides.

Keywords: soybean peptides clinical trial blood preesure sbp dbp
invasive pgt-a embryo selection versus non invasive pgt-a assisted embryo selection

Conditions: Infertility; Aneuploidy; Chromosome Abnormality

Summary: this is a prospective randomised study of the evaluation of the clinical ivf results after invasive pgt-a embryo selection versus non-invasive pgt-a assisted embryo selection in subfertile women.

a randomized prospective study focusing on subfertile women undergoing ivf treatment followed by embryo transfer on the blastocyst stage. women assigned to group a proceed to embryo transfer, after invasive pgt-a embryo selection, while women of group b after non-invasive pgt-a assisted embryo selection. ivf outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

Eligibility criteria:
inclusion criteria: * women who followed ivf treatment * 40 years old or older * single embryo transfer * blastocyst stage cultured embryos exclusion criteria: * women under the age of 40 years * not blastocyst transfer (transfers performed at earlier embryo stage) * double embryotransfer * women who had embryotransfer according to morphological criteria women whose embryos were not time-lapse monitored

Keywords: ivf pgt-a non- invasive pgt-a time lapse embryo selection
prevalence, risk factors and complications of oropharyngeal dysphagia in stroke patients

Conditions: Deglutition Disorders

Summary: oropharyngeal dysphagia (od) is a common morbidity after stroke that disrupts swallowing physiology. the investigators aimed at evaluating the prevalence of oropharyngeal dysphagia (od) after stroke and analysing the risk factors and associated complications.


Eligibility criteria:
inclusion criteria: * patients admitted to hospital with confirmed stroke diagnosis; signed informed consent exclusion criteria: * previous diagnosis of od; transient ischemic attack; and being transferred from another hospital.

Keywords: stroke
comparison of the analgesic efficacy of serratus anterior plane block and intercostal block

Conditions: Rib Fractures; Serratus Anterior Plane Block; Erector Spinae Plane Block; Acute Pain

Summary: more than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. therefore, early provision of adequate analgesia is crucial in the management of these patients. the basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (nsaids), and opioids. however, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. today, the use of ultrasonography (usg) guided block techniques such as erector spinae plane block (espb), serratus anterior plane block (sapb) and intercostal block (icb) has increased. these techniques are considered to be simpler and theoretically safer. although icb is frequently mentioned in the literature, the publications of new plane blocks such as espb and sapb are new and few in number. in this study, sapb and icp to be performed with usg will be evaluated in terms of analgesic effect.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * american society of anesthesiologists physical status i-ii-iii * body mass index between 18-30 kg/m2 * patients with 6 or less rib fractures exclusion criteria: * patient refusing the procedure * history of chronic analgesic or opioid therapy * history of local anesthetic allergy * infection in the intervention area

Keywords: rib fractures serratus anterior plane block erector spinae plane block
different bowel preparations in ct colonography: is diet necessary? a randomized controlled trial

Conditions: Cathartic Colon; Colonic Neoplasms

Summary: the aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.

bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. for this reason, limited bowel preparations have been extensively investigated. usually, they combine the use of low-fibre diet and faecal/fluid tagging. the ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. a low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. the aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. primary outcome is the overall quality of bowel preparation.

Eligibility criteria:
inclusion criteria: * asymptomatic patients (screening patients) * symptomatic patients unwilling to undergo optical colonoscopy (symptomatic patients) * patients with a previous incomplete optical colonoscopy. exclusion criteria: * allergy to macrogol * cognitive behavioral deficits

Keywords: bowel cleansing ctcolonography bowel preparation faecal and fluid tagging
multiple symptoms in cancer patients a cross sectional multi center study

Conditions: Cancer

Summary: this study will assess the occurrence of multiple symptoms in cancer patients of 5 german university hospitals. primary goal of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).

oncology patients experience a variety of symptoms as a result of disease and/or treatment. they often report co-occurrence of symptoms and functional impairments (miaskowski 2007). to evaluate the prevalence of symptoms and identify symptom clusters and the influence of multiple symptoms on hrqol, in and out patients of 5 german university hospitals currently undergoing cancer treatment are recruited. these patients are asked to complete the following instruments: distress thermometer, health related quality of life questionnaire (eortc qlq c30) and md. anderson symptom inventory (mdasi (german version). in a subgroup of two participating hospitals patients, that score ≥ 3/10 (mdasi-subscales for pain, fatigue and/or sleep disorder) are asked to complete additional questionnaires: brief pain inventory (bpi), multidimensional fatigue inventory (mfi), pittsburgh sleep quality index (psqi). the information gained will not be accessible for doctors in charge of the treatment and therefore not influence or alter the participants' treatment regimes. primary endpoint of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder). secondary endpoints are: symptom burden (intensity of symptoms and functional impairments), impact of symptom burden on hrqol. the investigators aim to approve the value of standardized assessment of symptoms in clinical cancer care settings as an important precondition of early treatment and supportive care.

Eligibility criteria:
inclusion criteria: * cancer patients (icd 10) * 18 to 80 years of age * ongoing treatment * informed consent exclusion criteria: * not speaking and writing german

Keywords: cancer symptom burden symptom cluster distress pain fatigue sleep disorder hrqol
prehospital screening to prevent injury and illness

Conditions: All Conditions

Summary: the goal of this project is to prevent injuries and diseases among older adults through the development and evaluation of a novel emergency medical services (ems)-based screening program to identify preventable injuries and diseases and refer the identified injuries and diseases for intervention. to prevent injuries and diseases among older adults, this study specifically aims to: 1. evaluate the feasibility of an ems-based primary prevention program that screens older adults for need of the influenza and pneumococcal vaccine and for risk of falling during emergency medical responses in a rural setting; 2. evaluate the outcome of the emt-implemented screening and education program by performing a 14-day telephone follow-up on older adults cared for by emts. at the conclusion of this award, we will determine if an emt-implemented primary prevention program for older adults is feasible and benefits the community.


Eligibility criteria:
inclusion criteria: * age 65 or older; * request assistance from intervention group ems agency * request assistance from control group ems agency * request assistance between february 2003 and june 2005 exclusion criteria: * institutionalized * previous inclusion in study * unable to communicate in english

Keywords: prevention emergency medical services emergency medical technicians
a study of efficacy and safety of idebenone vs. placebo in prodromal parkinson disease

Conditions: REM Sleep Behavior Disorder; Parkinson Disease

Summary: to investigate whether 24 months of idebenone may reduce the progression from prodromal parkinson disease (ppd) to parkinson disease (pd).

number of people suffered from parkinson disease (pd) is increasing every year. contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed pd emerges. the concept of prodromal parkinson disease (ppd) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. rapid eye movement (rem) sleep behavior disorder and olfactory dysfunction are the most common ppd, and more than one third of patients may progress to pd and other neurodegenerative diseases. mitochondrial injury is one of the pathogenesis of pd. thus we design this trial to investigate whether idebenone, potent coenzyme q10 analogue, could protect ppd develops into pd.

Eligibility criteria:
inclusion criteria: * subjects are voluntary to participate and have signed informed consent * diagnosed as rapid eye movement (rem) sleep behavior disorder by polysomnography exclusion criteria: * subjects are pregnant, breastfeeding, or want to get pregnant or breastfeeding in 2 years * subjects have history of allergy to idebenone * difficulty to communicate * suffering from neurodegenerative diseases * having obvious brain imaging abnormalities (eg. severe brain atrophy, malformation, softening lesions, cerebrovascular disease, intracranial occupancy, giant large benign lesions, etc.) * having severe mental illness (eg. schizophrenia, manic depression, and severe depression) * long-term use of clonidine, dopamine antagonists, and serotonin reuptake inhibitors * suffering from other severe medical conditions * having difficulty in moving and are unable to come to the hospital * having claustrophobia * having contraindications to mri tests * having history of olfactory disorders greater than 10 years * having history of color vision disorders greater than 10 years * life expectancy less than 2 years * having other situations which researchers consider is inappropriate to participate in this study
irinotecan study for cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of the study is to evaluate the efficacy and safety of irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer


Eligibility criteria:
inclusion criteria: * histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented * having measurable lesion(s), without previous radiation therapy. exclusion criteria: * patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria). * patients ever received cisplatin with total dose \> 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.

Keywords: weekly irinotecan(60mg/sqm, d1, 8, 15) in combination with cisplatin (60mg/sqm, d1), squamous cell carcinoma of the uterine cervix