Kornimate/medical-research-clean huggingface dataset:
expectancy as alternative to treatment for cervical intraepithelial neoplasia grade 2 among women 25 - 30 years of age

Conditions: CIN2; Therapy

Summary: in the swedish organised cervical screening program precursors of cervical cancer are detected and treated. most precursor lesions detected by screening heal spontaneously. those who progress do it slowly. there are three levels from light; cin1, moderate; cin2 to severe; cin3. women with cin3 are always treated, regardless of age, according to current clinical guidelines. women with cin2 who are below the age of 25 years are offered active expectance for up to two years because there is good evidence that they will spontaneously heal their lesions (regression) in 40-70% of the cases during that time. method of treatment is today an excisional procedure of the cervix most often by large loop excision of the transformation zone (lletz/leep) treatment increases the risk of premature birth in a future pregnancy. in 2015 about 1800 excisional procedures of the transformation zone of the cervix were performed in the västra götalands regionen (vgr) om sweden. the average age of first-time mothers in sweden is rising and in 2014 it was 29 years. postponed childbearing raises the question whether it is possible to refrain from surgery even for the group of women over 25 years old, with proven cin2. existing studies suggest that cure of cin2 in the age group of and above 25 takes place in the same extent as under 25 years of age.there is lack of evidence concerning clinical follow-up. in a prospective multicenter clinical cohort study (observational study) with careful monitoring, the investigators will examine what proportion of cin2 changes regress spontaneously within two years in women, 25-30 years old, and if human papillomavirus (hpv) type 16 may can be a marker for poor regression in this group. instead of lletz, active expectance is offered to women this age with cin2 in five gynecological clinics in vgr. the study protocol includes gynecologist visits every 6 months for two years, including cytology, colposcopy and directed biopsies of the cervix. power calculation shows 160 women needs to be included, which is expected to occur within one year from the start.

available in swedish

Eligibility criteria:
inclusion criteria: * cin 2 * written consent exclusion criteria: * cin (any grade) not resolved * former treatment of cin * immunomodulating medication * pregnancy (at start of study)

Keywords: neoplasm uterine cervix
the effect of osteopathic treatment in pain and functionality individuals with chronic neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain

the purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain design: a randomized single blind placebo controlled trial will be conducted trial. patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (n=20). participants will receive 8 treatments during 4 weeks. clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment. methods: the primary outcome will be pain measured by 11-point numerical pain rating scale. the secondary outcome will be disability measured by the neck disability index, range of motion measured by cervical range of motion device, pressure pain threshold measured by electronic algometer.

Eligibility criteria:
inclusion criteria: symptoms of chronic neck pain does not specify that persists for more than 3 months exclusion criteria: individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , cancer, neurological diseases, pregnancy. they will be excluded participants who received some form of manipulative treatment in the last three months.
resistance versus balance training in parkinson's disease

Conditions: Parkinson's Disease

Summary: comparison of resistance training versus balance training to improve postural control in patients with parkinson's disease


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease, postural instable exclusion criteria: * cardiopulmonary/metabolic diseases that could interfere with the safe conduct of the study protocol, unstable medication, severe cognitive impairments that do not allow the patients to follow exercise instructions, participation in a resistance or balance training program (beside usual physical therapy), deep brain stimulation.
efficacy and safety of leo 43204 in field treatment of actinic keratosis on balding scalp including 12-month follow-up

Conditions: Actinic Keratosis

Summary: the objective of the trial is to compare the short term efficacy of leo 43204 gel with vehicle gel in ak on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.


Eligibility criteria:
inclusion criteria: * subjects with 5 to 20 clinically typical, visible and discrete aks within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 in2) * subjects with minimum 3 clinically typical, visible and discrete aks within a tracking area of 50 cm2 (8 in2). the tracking area must be within the treatment area exclusion criteria: * location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected bcc or scc * treatment with ingenol mebutate gel in the treatment area within the last 12 months * lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) * history or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
local anesthesia before bulkamid injection

Conditions: Stress Urinary Incontinence; Intrinsic Sphincter Deficiency

Summary: while recommended pre-anesthesia for polyacylamide hydrogel (pahg, bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. this is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before pahg injection.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring pahg * english-speaking * scheduled in outpatient clinic or or without sedation, general, or neuraxial anesthesia exclusion criteria: * pregnancy * neurogenic bladder * pre-existing need for intermittent catheterization or indwelling catheter * bladder or urothelial malignancy * prior radiation to pelvic floor * known allergy/sensitivity to pahg
midazolam drug-drug interaction study with lurasidone hcl

Conditions: Schizophrenia Patients

Summary: a phase i, drug-drug interaction study between midazolam and lurasidone hcl.

lurasidone 120 mg, midazolam 5 mg to compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg. to compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Eligibility criteria:
inclusion criteria: 1. diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders 2. females who participate in this study: are unable to have children -or- are willing to remain abstinent from day -5 to 90 days after discharge; -or- are willing to use an effective method of double-barrier birth control from day -5 to 90 days after discharge. 3. males must be willing to remain sexually abstinent or use an effective method of birth control from day -5 to 90 days after discharge. 4. able and agree to remain off of prior antipsychotic medication for the duration of the study. exclusion criteria: 1. known presence or history of renal or hepatic insufficiency. 2. a history or presence of abnormal electrocardiogram (ecg5. known history or presence of clinically significant intolerance to antipsychotic medications. 3. significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmhg or more and/or drop in diastolic blood pressure of 20 mmhg or more on standing). 4. presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone. 5. participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration. 6. use of concomitant medications that prolong the qt/qtc interval within 14 days prior to day -5 to follow-up including but not limited to those listed in appendix 19.5. 7. received depot neuroleptics unless the last injection was at least 1 treatment cycle before day -5. 8. difficulty fasting or consuming the fda high fat meals. 9. at risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.

Keywords: ddi study between midazolam and lurasidone hcl male and female
analysis of related factors affecting the secondary implantation of intraocular lens in congenital cataract

Conditions: Congenital Cataract

Summary: the ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. and then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.


Eligibility criteria:
inclusion criteria: * patients were diagnosed as congenital cataract without lens after surgery * secondare iols implantation surgery was performed in eye hospital of wenzhou medical university exclusion criteria: * suffers from uveitis, glaucoma and other ocular diseases

Keywords: secondary implantation ciliary sulcus
4% chlorhexidine gluconate daily bathing for prevention of hospital-acquired infections in intensive care settings

Conditions: Hospital Infection

Summary: the study will assess the utility of 4% chlorhexidine gluconate (chg) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. one group will be daily bathed with 4% chg and the other group with standard soap.


Eligibility criteria:
inclusion criteria: * admission to the intensive care unit (icu) or to the post-operative cardiosurgical icu (pc-icu) * icu/pc-icu stay for at least 1 night exclusion criteria: * known allergy to chlorhexidine * burns, toxic epidermal necrolysis or stevens-johnson syndrome as admission diagnosis * pregnancy

Keywords: 4% chlorhexidine gluconate infection control
quality of life after transanal total mesorectal excision compared to traditional total mesorectal excision

Conditions: Rectal Cancer; Quality of Life; Functional Outcome; Surgery

Summary: the improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (qol) and functional outcomes. evidence for long-term qol and functional outcomes of transanal total mesorectal excision (tatme) is not provided in current literature. this study will compare short-term and long-term qol and functional outcomes after tatme compared to traditional abdominal tme (laparoscopic, robotic, and open approach)

quality of life and functional outcomes of patients undergoing tatme or abtme for stage i-iii rectal cancer will be analysed. a retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. the primary endpoint qol will be assessed by the european organization for research and treatment of cancer core questionnaire (eortc qlq-c30). secondary endpoints are the functional outcomes according to the eortc qlq-c30 questionnaire.

Eligibility criteria:
inclusion criteria: * elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer exclusion criteria: * diagnoses other than rectal cancer * recurrent rectal cancer * partial mesorectal excision * discontinuity resection (no anastomosis) * incomplete tnm staging information * metastatic cancer * 30-day mortality * lack of quality of life data * patient decline * age under 18 years

Keywords: transanal total mesorectal excision laparoscopic total mesorectal excision
a study to compare tivozanib hydrochloride to sorafenib in participants with refractory advanced renal cell carcinoma (rcc)

Conditions: Carcinoma, Renal Cell

Summary: this is a phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (rcc). participants will be randomized (1:1) to treatment with tivozanib or sorafenib. participants will be stratified by international metastatic renal cell carcinoma database consortium (imdc) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (vegfr tki); a prior checkpoint inhibitor \[programmed cell death -1 protein (pd-1) or pd-1 ligand (pd1-l) inhibitor\] plus a prior vegfr tki; a prior vegfr tki plus any other systemic agent). all participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. pharmacokinetic (pk) analyses are also included in study.


Eligibility criteria:
inclusion criteria: * 18 years or older * participants with metastatic rcc who have failed 2 or 3 prior systemic regimens, one of which includes a vegfr tki other than sorafenib or tivozanib. * histologically or cytologically confirmed rcc with a clear cell component (participants with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified rcc are excluded). * measurable disease per the response evaluation criteria in solid tumors (recist) criteria version 1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy ≥ 3 months. exclusion criteria: * prior treatment with sorafenib or tivozanib. * more than 3 prior regimens for metastatic rcc. * known central nervous system (cns) metastases other than stable, treated brain metastases. participants with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery). * significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders. * significant serum chemistry abnormalities * significant cardiovascular disease, including: active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications. * inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug. * currently active second primary malignancy.
pregnancy in guch patients

Conditions: Congenital Heart Disease; Pregnancy Related; Infant Development; IUGR; Fetal Growth Restriction

Summary: this study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns/children born from grown-up congenital heart (guch) mothers with follow-up at one year, extendable to two. the main question it aims to answer is: -does maternal congenital heart disease affects outcomes of newborn?

after being informed about the study and potential risks all patients giving written informed consent will undergo: * cardiological and obstetric evaluation in the first trimester of pregnancy; * cardiological and obstetric revaluation in the second trimester of pregnancy; * cardiological and obstetric revaluation in the third trimester of pregnancy; * cardiac and general neonatal evaluation at birth; * 2-year follow-up: maternal and neonatal cardiology evaluation, childhood neurodevelopment evaluation

Eligibility criteria:
inclusion criteria: * congenital heart disease in natural history or undergoing corrective and/or palliative cardiothoracic surgery. * chronological age \> 18 years. * single pregnancy progressing normally at a gestational age of 14 weeks + 0. * correct pregnancy dating based on crl as per isuog guidelines. (26) * normal results of non-invasive screening tests for foetal aneuploidies. * normal first-trimester ultrasound examination. * informed consent of the woman. exclusion criteria: * maternal chromosomal abnormalities. * maternal syndromic conditions. * spontaneous abortion. * vanishing twin. * high risk for chromosomal abnormalities on screening tests performed in the 1st trimester (combined test/nipt) or major foetal structural anomalies identified during first-trimester ultrasound evaluation.

Keywords: guch pregnancy
a randomized, crossover study to assess the effects of dietary fiber-containing bars on glucose and insulin responses

Conditions: Blood Glucose; Insulin Sensitivity; Dietary Fiber

Summary: this randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). the objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.


Eligibility criteria:
inclusion criteria: * male or female, 18-65 y of age, inclusive. * subject has a body mass index of 18.5 to 32.0 kg/m, inclusive. * subject is judged by the investigator to be in generally good health on the basis of medical history and screening measurements. * subject is willing to consume the study products as described in the protocol. * subject is willing to maintain usual diet and activity patterns throughout the study. * subject has no plans to change smoking or other nicotine use during the study period. * subject is willing and able to attend all clinic visits. * subject has a vein access scale score of 7-10. * subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator and is willing to complete study procedures. exclusion criteria: * individual has a clinically significant gastrointestinal, endocrine (including type 1 and type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder. * subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dl) at screening. one re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dl at screening (visit 1). * individual has uncontrolled hypertension (systolic blood pressure ≥160 mm hg or diastolic blood pressure ≥100 mm hg) at screening. * individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer. * individual has extreme dietary habits (e.g., atkins, vegan). * individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months. * individual has a known allergy, sensitivity, or intolerance to any ingredients in the study products. * individual is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. * individual has been exposed to any non-registered drug product within 30 days of screening. * individual has a condition the investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Keywords: postprandial glucose meal tolerance test
study evaluating 13 valent pneumococcal conjugate vaccine with trivalent inactivated influenza vaccine

Conditions: Influenza

Summary: this study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vpnc) and the trivalent inactivated flu vaccine (tiv) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vps), or when the vaccines are given 1 month apart. it will also evaluate the immune response to 13vpnc once per year for 4 years and then to a second dose of 13vpnc given 5 years after the first dose.


Eligibility criteria:
inclusion criteria: * male or female aged 50 to 59 years * determined by medical history, physical examination and clinical judgement to be eligible for the study * able to complete electronic diary * available for the 5 year 9 month duration of the study exclusion criteria: * previous vaccination with any licensed or experimental pneumococcal vaccine * allergic to egg proteins and chicken proteins * history of guillian-barre syndrome * vaccination with tiv within 6 months before study start * vaccination with diphtheria-containing vaccine within 6 months of study start * serious chronic disorders including immunodeficiency or metastatic malignancy * known or suspected hypersensitivity to any vaccine or vaccine component

Keywords: pneumococcal conjugate vaccine
medication exposure in older patients with constitutional hemorrhagic disease

Conditions: Hemophilia

Summary: the improvements observed in the care of patients with hemophilia or willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. this increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "franchini \& mannuccio", bjh, 2009). the care of these comorbidities represents a new challenge for the medical teams. toward multiple comorbidities, polypharmacy is often associated. many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or willebrand disease.


Eligibility criteria:
inclusion criteria: * community-dwelling patients over 65 years with hemophilia (a or b) * community-dwelling patients over 65 years with willebrand disease (type1, 2 and 3, rate \<30%) exclusion criteria: * patients without phone number * non french speaking patients

Keywords: willebrand disease