Kornimate/medical-research-clean huggingface dataset:
a study to assess resistance and durability of response to abt-493 and/or abt-530

Conditions: Hepatitis C

Summary: this was a long-term follow-up study to evaluate the durability of sustained virologic response (svr), persistence of direct-acting antiviral agent (daa) resistance, and clinical outcomes for participants who received glecaprevir (abt-493) and/or pibrentasvir (abt-530) in prior abbvie phase 2 or 3 clinical studies for the treatment of chronic hepatitis c virus (hcv) infection.

this was a phase 2/3, multicenter study offered to participants who received at least one dose of an abt-493- and/or abt-530-containing regimen at any dose level in an eligible prior abbvie phase 2 or 3 study for the treatment of chronic hcv and elected to enroll in this study. the participant must have completed the follow-up period of the prior eligible abbvie study. participants were followed for a total of approximately 3 years after their last dose of daa in the previous hcv clinical study. the 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.

Eligibility criteria:
inclusion criteria: 1. participant is male or female 18 years of age or older 2. participant has received at least one dose of an abt-493- and/or abt- 530 containing regimen in a prior abbvie hepatitis c virus (hcv) phase 2 or 3 study 3. the interval between the last dose of the abbvie direct-acting antiviral agent (daa) therapy from the previous clinical study and enrollment in study m13-576 must be no longer than 2 years for subjects who have not been retreated. participants who have been treated with a commercially available anti-hcv treatment may be enrolled greater than 2 years after the last dose of the abbvie daa therapy from the previous clinical study. 4. participant must voluntarily sign and date the informed consent form approved by an independent review board or ethics committee prior to the initiation of any study-specific procedures. 5. participant completed the post-treatment period of an eligible prior study. exclusion criteria: 1. the investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior abbvie clinical study). 2. receipt of any investigational hcv antiviral treatment after receiving abt-493 and/or abt-530 in the prior study. 3. participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of abt-493/abt-530. 4. participation in abbvie's study m15-942 protocol for re-treatment for virologic failure in the prior phase 2 or 3 study.

Keywords: chronic hepatitis c hepatitis c virus sustained virologic response hepatitis c direct acting antiviral
interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in turkish women

Conditions: Periodontitis

Summary: the investigators hypothesized that the il-1a (+4895), il-1b (+3954), and il-1rn gene polymorphisms may be associated with plbw. smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. therefore, the investigators only selected non-smoking individuals in this study as the smoking-related risk could obscure the polymorphism-related increase in risk for periodontitis and adverse pregnancy outcomes. this study aimed to determine the association between il-1a (+4895), il-1b (+3954), and il-1rn polymorphisms with adverse pregnancy outcomes and periodontitis in a non-smoking turkish population.

pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. subjects were divided into normal birth (nb) and plbw groups on the basis of their pregnancy outcome. women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the nb group. women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the plbw group. current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study. maternal, obstetric, and demographic factors such as maternal age, maternal education, regular prenatal care, genitourinary tract infections during pregnancy, total number of births, previous plbw, and antibiotic use during the pregnancy period were also recorded.

Eligibility criteria:
inclusion criteria: subjects were divided into normal birth (nb) and plbw groups on the basis of their pregnancy outcome. women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the nb group. exclusion criteria: current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study.

Keywords: periodontitis; adverse pregnancy outcomes; il-1 polymorphism
hemodynamic impact of hyperbaric versus isobaric for spinal anesthesia during cesarean delivery

Conditions: Hypotension

Summary: the purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.


Eligibility criteria:
inclusion criteria: * pregnant woman scheduled for elective cesarean delivery under spinal anesthesia exclusion criteria: * patients who refuse involved * patients who have pre-eclampsia * patients who have heart disease * patients who fetal distress is suspicious

Keywords: hypotension cesarean section
improving outcomes for hypertensive children

Conditions: Hypertension

Summary: approximately 200 children age 6 - \<18 years receiving medications for essential hypertension (htn) will be recruited from the pediatric hypertension clinic at the time of a routine clinic visit. participating subjects will be asked to wear the ambulatory blood pressure monitor (abpm) for 24 hours within 2 weeks of the qualifying visit. measurements obtained with the abpm will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. kappa statistic will be utilized to compare differences in documented bp control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the abpm readings. the overall goal is to confirm that abpm leads to an increased detection of uncontrolled htn along with a similar increase in adjustments increasing anti-hypertensive medication regimens.


Eligibility criteria:
inclusion criteria: 1. age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit 2. arm circumference measurement of 15-50 cm (limits of spacelabs abpm cuffs). exclusion criteria: 1. severe htn which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study. 2. secondary htn from all causes (excluding obesity-related htn). this includes but is not limited to renovascular htn, chronic kidney disease, coarctation of the aorta, and monogenic forms of htn. 3. physical limitations prohibiting placement of the abpm monitor. 4. significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect bp accurately.

Keywords: hypertension
treatment of atrophic post acne scars by fat grafting

Conditions: Atrophic Acne Scars

Summary: this single-center, clinical trial consists of a one autologous fat grafting treatment followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks.

this investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for the treatment of atrophic acne scarring on cheeks. overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural on the goodman-barron scale. the subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at the end of the follow-up period.

Eligibility criteria:
inclusion criteria: * patients with atrophic post acne scars on the cheeks, between 20 - 40 years old * not to apply other treatments a month before the procedure * informed consent to enter the study exclusion criteria: * first grade of goodman - barron scale. * a systemic or associated skin disease that may affect the results of the study * patients with chronic consumption of nonsteroidal anti-inflammatory drugs (nsaids) or other non-aggregating agents. * patients with acne in the acute stage * pregnancy and breastfeeding * tendency to form keloids

Keywords: acne- atrophic scars - autologous fat
a study of changes to prostate procedures

Conditions: Prostate Cancer

Summary: the purpose of this study is to look whether using local anesthesia during a transperineal prostate biopsy, while put to sleep by iv sedation, helps reduce the number of people who feel significant pain in the recovery room. the researchers will also look at how local anesthesia affects the amount of pain medication used, how quickly people can go home after the biopsy, and how well they recover after leaving the hospital.


Eligibility criteria:
inclusion criteria: local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under iv sedation: * patients scheduled for transperineal prostate biopsy at the jrsc. standardization of a periprocedural pathway versus usual care for focal gland ablation: * patients scheduled for a partial prostate gland ablation procedure at the jrsc. exclusion criteria: local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under iv sedation: * none standardization of a periprocedural pathway versus usual care for focal gland ablation: * none

Keywords: needle-based procedures iv sedation local anesthesia 25-085
detection of heterogeneity in central lung cancer - ebus-tbna and ctdna analysis vs. endobronchial forceps biopsy

Conditions: Lung Neoplasms

Summary: study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling. consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (ebus-tbna and conventional forceps sampling). the sequence of both sampling methods will be randomized in advance. the resulting tissue samples will be analyzed by a pathologist using multiplex pcr and fish. the corresponding analysis results will be compared between sampling methods. assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. medicinal products will be used according to current practice and marketing authorisation.


Eligibility criteria:
inclusion criteria: subjects eligible for enrolment in the study must meet all of the following criteria: 1. informed consent: a signed and dated written informed consent prior to study participation. 2. type of subject: inpatient 3. age: subjects of more than 18 years and less than 85 years. 4. central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy. 5. central lesion has to be accessible by the biopsy techniques under investigation exclusion criteria: subjects meeting any of the following criteria must not be enrolled in the study: 1. females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child 2. any contraindication for bronchoscopy and ebus-tbna (ibnlt: inr\>2, thrombocytopenia \<40/nl) 3. drug/alcohol abuse impairing cognitive knowledge which is needed for a gcp conform informed consent. 4. inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
low-dose ct for diagnosis of pneumonia in copd exacerbations and comparison of the inflammatory profile.

Conditions: COPD Exacerbation

Summary: \* hypothesis: there is an underdiagnosis of pneumonia in copd (chronic obstructive pulmonary disease) exacerbations which could be demonstrated by performing low-dose chest ct. differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen. \* objective: to assess the degree of underdiagnosis of pneumonia in copd exacerbations, using chest low-dose ct and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia. \*material and methods: prospective observational study including 75 patients with the diagnosis of copd at the time of an exacerbation and with criteria for a respiratory tract infection. at the time of inclusion clinical features, blood and sputum analysis, chest x-ray and chest low-dose ct are performed. the investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.


Eligibility criteria:
inclusion criteria * clinical and spirometric diagnosis of copd. * for study group: clinical symptoms of exacerbation and infection of low airway. * signed informed consent. exclusion criteria * no acceptance of informed consent. * the study group: treatment with antibiotic more tan 2 days before consultation. * another entity known pulmonology other than copd (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation). * chronic treatment with oral corticosteroids or immunosuppressive drug. * severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis. * severe alteration of nutritional status. * heart disease evolved. * limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).

Keywords: pneumonia in copd exacerbation
plasma homocysteine distribution in the united states

Conditions: Cardiovascular Diseases; Heart Diseases; Hyperhomocysteinemia

Summary: to describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. to determine the extent to which hyperhomocysteinemia is associated with status of folate and vitamin b12. finally, to describe the relationships between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and assess the importance of this risk factor as a cause of vascular disease among us adults. the study was renewed for one year to investigate normal homocysteine concentrations among children and to identify nutritional and non-nutritional determinants of total homocysteine concentrations in children.

background: hyperhomocysteinemia, a condition of elevated plasma homocysteine concentrations resulting from impaired sulfur amino acid metabolism, may be a powerful risk factor for occlusive vascular disease. however, little is known about the distribution of hyperhomocysteinemia in the general population. furthermore, inadequate nutritional status might be a strong determinant of hyperhomocysteinemia, but its importance at a population level (as measured by the prevalence of hyperhomocysteinemia associated with inadequate nutrition) has received little study. finally, levels of homocysteine associated with elevated risk of vascular disease have not been clearly established. design narrative: using previously collected plasma samples, studies were conducted on the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. investigations were undertaken on the extent of the relationship of hyperhomocysteinemia to folate and vitamin b12. finally, the relationships were described between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and the importance of this risk factor as a cause of vascular disease among us adults was assessed..

Eligibility criteria:
no eligibility criteria
attitudes toward human papillomavirus and influenza vaccination among mothers of early adolescents

Conditions: Human Papillomavirus Vaccines; Influenza Vaccines; Attitude to Health

Summary: the purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (hpv) or influenza.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * lives in united states * mother or female legal guardian of at least one child aged 9-13 * able to understand english * for hpv condition: target child must not have received any doses of hpv vaccine * for flu condition: target child must not have received the flu vaccine during the prior flu season exclusion criteria: * under 18 years of age * not mother or female legal guardian of at least one child ages 9-13 * not living in united states * not able to understand english and spanish * for hpv condition: target child had already received at least 1 dose of the hpv vaccine * for flu condition: target child received the influenza vaccine during the previous flu season
functional and clinical long-term outcome of ewing sarcoma treatment

Conditions: Sarcoma, Ewing's

Summary: the purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 long-term survivors of ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 ewing sarcoma patients with a follow-up of 3 decades.

trial objective: as survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. this study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of ewing sarcoma. the data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment. working plan: the working plan provides for the assessment of functional outcome and quality of life by means of validated tools (tess, sf36, pedqol) and objectively measuring daily activity patterns by using the step activity monitor (sam) in 600 long-term ewing sarcoma survivors and a control group of 300 matched healthy subjects. information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified. exploitation of results: the results will be presented at scientific meetings and will be published in international journals. guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. in the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.

Eligibility criteria:
inclusion criteria: * cess81/cess86/eicess92/euro-e.w.i.n.g.99 trials participants of the german society of pediatric hematology and oncology (gpoh) exclusion criteria: * no complete remission (cr) * any kind of paralysis * \<3y after diagnosis

Keywords: bone tumors long-term function daily activity late sequelae
safety and efficacy trial to treat open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: to investigate the safety and efficacy of de-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

this study will be conducted in two stages. stage one is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of de-112 ophthalmic solution enrolling a total of 24 subjects. stage two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of de-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Eligibility criteria:
inclusion criteria: * provide signed, written informed consent * 18 yeas of age and older * diagnosed with primary open-angle glaucoma or ocular hypertension * female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study * meet specific visit 2, day 0 (baseline)criteria at baseline exclusion criteria: * females who are pregnant, nursing or planning a pregnancy * presence of any abnormality or significant illness that could be expected to interfere with the study.