Kornimate/medical-research-clean huggingface dataset:
a study to diagnose lung cancer by sputum cytology (01-312)

Conditions: Lung Cancer

Summary: the primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of utp compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.


Eligibility criteria:
inclusion criteria: * be suspected of having primary lung cancer based upon chest radiograph(s), ct scan(s), or pet scan(s) and with symptom, risk profile, or history suggestive of malignancy * have fev1 greater than or equal to 40% predicted normal for age and height exclusion criteria: * have obtained a confirmed diagnosis for the current suspicious lung tumor * have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening * have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing
peng block vs fnb + onb in patients undergoing hip fracture surgery with contraindications to neuraxial anesthesia

Conditions: Hip Fractures; Pain, Postoperative; Coagulopathy; Comorbidities and Coexisting Conditions

Summary: the aim of the study is to demonstrate the efficacy of peng block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.


Eligibility criteria:
inclusion criteria: * patients undergo hip surgery * patients with contraindications at spinal anesthesia exclusion criteria: * allergy at local anesthetic * age under 18 or weight under 30
life-long monitoring of copd in veneto region

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with copd produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. in addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.

the study is designed to evaluate the impact of telemonitoring on the management of copd compared with outpatient usual care. from a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve copd patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and er visits) and the anxiety about health conditions. a cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. the evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * copd gold class 3-4 * life expectance \> 12 months exclusion criteria: • patient unable to use the equipment provided (alone or assisted).

Keywords: chronic obstructive pulmonary disease telemonitoring
enhanced prescription drug label to improve patient understanding and use

Conditions: Prescription Medication Understanding

Summary: the overall objective of this study is to test the efficacy of an evidence-based, enhanced rx container label design to improve patients' understanding of instructions for use. the investigators will conduct a randomized controlled trial (n=960) to evaluate the efficacy of the enhanced rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. patients with type ii diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (nova scripts central - nsc) receive their prescribed medicines from this location. recruited subjects in this study will be randomly assigned to either intervention (enhanced rx container label) or control (standard rx label). all pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ace inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. patients' ability to read and demonstrate rx label instructions, including auxiliary warnings, will be the primary outcomes. other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin a1c (hba1c) and blood pressure measurements. data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study.


Eligibility criteria:
inclusion criteria: * diagnosis of type ii diabetes or hypertension in their medical chart. * 30 years or older. * fluent in english. exclusion criteria: * uncorrectable hearing or visual impairment. * too ill to participate.

Keywords: prescription medication understanding among diabetic and hypertension patients. prescription medication use among diabetic and hypertension patients. hemoglobin a1c changes among diabetic patients. blood pressure changes among hypertension patients.
green laser photocoagulation study in proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: to demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

proliferative diabetic retinopathy is ocular pathology in poor glycaemic controlled diabetic patient characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue. in this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Eligibility criteria:
inclusion criteria: * patients more than 18 years of age * eyes with proliferative diabetic retinopathy requiring laser photocoagulation exclusion criteria: * eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation * patients requiring more than two sessions of laser photocoagulation * patients who had undergone previous laser photocoagulation * patients who had undergone any previous vitreo-retinal surgery

Keywords: retina retinal diseases retinal vessels laser coagulation
docetaxel plus imatinib mesylate in metastatic breast cancer

Conditions: Breast Cancer

Summary: this trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

all patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic breast cancer confirmed by biopsy * no more than one prior chemotherapy regimen for metastatic breast cancer * able to perform activities of daily living with minimal assistance * adequate bone marrow, liver and kidney function * age 18 years or older * give written informed consent exclusion criteria: you cannot participate in this study if any of the following apply to you: * moderate to severe peripheral neuropathy * uncontrolled blood pressure or uncontrolled heart beat irregularities * diabetes mellitus with fasting blood sugar greater than 200 mg % * significant heart disease within the prior 6 months * severe or uncontrolled medical disease * active uncontrolled infection * known chronic liver disease * known diagnosis of hiv infection * pregnant or breast feeding females please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: breast cancer
postoperative immobilization and physical therapy following volar locked plating for distal radius fractures

Conditions: Distal Radius Fracture

Summary: the purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). currently there is no consensus for post-operative protocol following fixation of distal radius fractures. the decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. the goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.

188 patients treated for distal radius fractures with open reduction internal fixation using volar locked plating will be split into two study groups: a group that is immobilized in a splint post operatively and given formal physical therapy and a group that does not receive either of these post operative interventions. the primary outcome will be loss of fixation. secondary outcomes will include pain, cost, quick dash, range of motion, and grip strength. data will be recorded at the pre-operative visit, as well as at post-operative visits at 2 weeks, 6 weeks, 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws. 1. \> 10 degrees of dorsal tilt 2. volar displacement (volar barton's type fracture) 3. shortening \> 3 mm 4. intra-articular displacement or step off \> 2mm. exclusion criteria: * ipsilateral upper limb concomitant fracture * fracture fixation other than volar locked plating and screws * dislocation or neurologic injury * gustilo-anderson grade iii open fractures
bioequivalence of losartan and hydrochlorothiazide (hctz) combination tablet and coadministration of its components (0954a-306)

Conditions: Hypertension

Summary: this study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (hctz) combination tablet and coadministration of losartan and hydrochlorothiazide.


Eligibility criteria:
inclusion criteria: * subject is a healthy male or female between the ages of 18 and 45 years of age * subject does not smoke exclusion criteria: * subject has a history of any illness that might pose additional risk to participation or confound the results of the study * subject has a history of hepatitis b or c or significant drug allergies
comparison of 3 versus 6-month use of cgms in non-insulin using t2dm patients

Conditions: T2DM (Type 2 Diabetes Mellitus); Continuous Glucose Monitoring

Summary: to determine whether 3-month versus 6-month professional cgm utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled t2dm not treated with insulin.

patients not receiving any insulin treatment with an hba1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional cgm for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). after removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. the 6-month data will be analyzed to determine if frequency of professional cgm wear positively affects time spent in target range.

Eligibility criteria:
inclusion criteria: 1. 18 years or older with a diagnosis of t2dm with a scheduled office visit with primary care provider within the next 4 weeks 2. last 2 hba1c values between 7.5 - 10% measured in the last 12 months 3. treated with non-insulin therapies or therapeutic lifestyle changes 4. never worn professional cgm or have not worn in last 12 months 5. willing to perform requirements needed for professional cgm exclusion criteria: 1. current or previous treatment with any insulin within 3 months at baseline
oct vibrography for biomechanical properties of tissues

Conditions: Cornea; Skin Diseases; Gingival Diseases

Summary: the overall goal of this study is to develop oct vibrography (aka oct elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.

the overall goal of this study is to develop oct vibrography (aka oct elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo. the investigators aim to establish baseline data in healthy subjects, compare elastic moduli in different tissue types, and measure differences in elastic moduli between keratoconus and normal eyes. if successful, this project will provide useful, previously inaccessible elastic parameters and advance the investigators' understanding of the relationship between the bulk mechanical properties and the microstructure of the human tissue in vivo. this information can ultimately be used to improve the diagnosis and treatment of keratoconus, inflammatory skin diseases, and inflammatory gingiva diseases. more broadly, the technologies developed in this project will have relevance to other potential applications beyond the tissues in this research study.

Eligibility criteria:
group 1: inclusion criteria: • subjects with healthy eyes (age 18 - 75, n = 50) exclusion criteria: * subjects with history of eye diseases, and previous eye surgeries. * subjects with diabetes, glaucoma family history * subjects allergic to anesthetic eyedrop, especially proparacaine * subjects with severe allergy * subjects who have difficulty biting * subjects who have recurrent corneal erosion group 2: inclusion criteria: • subjects with healthy skin (age 18 - 75, n = 10) exclusion criteria: • subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition group 3: inclusion criteria: • subjects with healthy gingiva (age 18 - 75, n = 10) exclusion criteria: • subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition group 4: inclusion criteria: • mild or moderate keratoconus subjects (age 18 - 40, n = 20) exclusion criteria: • subjects with k-max above 60 diopters (pentacam imaging) are excluded

Keywords: biomechanics cornea skin gingiva optical coherence tomography vibrography
iron deficiency and ttg normalization

Conditions: Celiac Disease in Children

Summary: the investigators conducted a retrospective, observational cohort study which enrolled cd subjects aged 2-18y, diagnosed between jan 2016 and dec 2020. demographic and laboratory data were collected at diagnosis and 1y after adherence to gfd. id was determined according to hemoglobin and ferritin levels. the investigators compared cd subjects with and without id at cd diagnosis in relation to ttg normalization at 1y.


Eligibility criteria:
inclusion criteria: * children (male and female) diagnosed with cd * age 2-18y exclusion criteria: * total iga deficiency * anemia due to other causes - anyone with anemia and normal or elevated ferritin levels (e.g. thalassemia, spherocytosis) * other chronic conditions increasing the risk of anemia or falsely elevated ferritin (e.g. inflammatory bowel disease, chronic kidney disease, infection)
neurovisual function in charge syndrome

Conditions: CHARGE Syndrome

Summary: the rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with charge syndrome in order to identify a pattern of specific indicators to enable better patient care

charge syndrome is a malformative condition characterized by coloboma in about 70-95% of patients. this anatomical abnormality results in severe visual impairment that strongly affects the characterization of the disability profile. although the ocular anatomical deficits associated with the syndrome have been extensively described in the literature, coloboma being a major criterion for diagnosis, little is reported about the characteristics of visual function, such as acuity, visual field ocular motility, and other features. patients with charge syndrome have multiple sensory deficif often accompanied by intellectual disability, which often makes the classical methods used in ophthalmologic evaluation inapplicable. according to the few studies in the literature, visual acuity in patients with charge syndrome is often severely impaired with mean values below 20/60 (mcmain et al 2008; nishina et al 2012; russell-eggitt et al. 1990; stromland et al. 2005; tellier et al. 1998) however in opposition to the recurrent pessimistic findings resulting from ophthalmologic assessment in clinical practice, such patients present with good visual and adaptive abilities in daily life. the rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with charge syndrome in order to identify a pattern of specific indicators to enable better patient care

Eligibility criteria:
inclusion criteria: patients with molecularly confirmed charge syndrome. exclusion criteria: patients with charge syndrome that has not been molecularly confirmed

Keywords: charge syndrome visual function
safety and efficacy of skin cleanser contained roselle extract in acne

Conditions: Acne

Summary: skin cleanser for daily used is essential and one of the most common questions asked by acne patients. there are studies reported beneficial effects of cleansers in acne treatment. extracts of plants as active ingredients in skin cleansers are increasingly popular worldwide. roselle is a common tropical shrub. usually, the calyces of the plant have been used to make beverages but it also used in thai traditional medicine for several purposes including as antiseptic and astringent. the extract of roselle showed antioxidant and keratolytic effects from previous studies which fit to the pathogenesis of acne. the aims of the study is to determine the safety and efficacy of skin cleanser contained roselle extract in acne.

acne is one of the most common skin problems in teenagers and adolescents. keys pathogenesis of the disease are 1.abnormal hypercornification of pilosebaceous duct,2.excess sebum production, 3.inflammation, 4.the present of propionibacterium acnes. treatments often include combination of topical and oral medications according to degree of acne severities. acne medications can lead to drying and irritation of skin. proper skin cleansing is important and can improve tolerability and efficacy of acne treatment. traditional medicine with longstanding used of herbal ingredients for skin problems and beauty is increasing more popular. hibiscus sabdariffa l.(roselle) is used as food, drink and topical formulation for skin infection in thai traditional medicine. the extract from calyces contained polyphenolic compounds and anthocyanins that showed antioxidant and keratolytic activities. there for skin cleanser with roselle extract might be benefit to acne by loosen comedone, reduce propionibacterium acne and prevent keratinocyte injury. the purposes of this study is to evaluate skin cleanser contained roselle extract in two aspects ; 1. safety for irritation and allergic effects, 2. efficacy in acne as cleanser alone and as supportive care with others acne therapies.

Eligibility criteria:
inclusion criteria: * age 12-45 yrs,both sex * clinical diagnosis of mild to moderately severe acne vulgaris(grade 1-3) * have at least 10 facial acne lesions * not changing any acne treatment during study period * able to follow up according to protocol * written informed consent exclusion criteria: * pregnant or breast feeding * severe acne(grade4 or nodulocystic acne) * treated with isotretinoin orally during the last 3 months * have other systemic disease or illness * have allergic history to roselle

Keywords: acne skin cleanser hibiscus sabdariffa roselle safety efficacy
hrd status reference standard based on wgs

Conditions: Ovarian Cancer

Summary: when evaluating the analytical performance of homologous recombination deficiency (hrd) status testing, there is currently no widely accepted reference standard. therefore, a collaborative project was initiated to establish a hrd status reference standard for the industry. although there is no genotyping strategy that is universally recognized as the most accurate for evaluating hrd status, whole-genome sequencing (wgs) is one of the best candidates.

* primary objective: to establish a hrd status reference standard based on wgs. * secondary objective: to validate the analytical performance of panel hrd status using wgs hrd status as reference standard. * exploratory objective 1: to explore how methylation of selective genes correlate with wgs hrd status and efficacy. * exploratory objective 2: to explore how hrr gene mutations correlate with wgs hrd status and efficacy. * exploratory objective 3: to set up a harmonized bioinformatic analysis workflow for wgs hrd status.

Eligibility criteria:
inclusion criteria: * at least 18 years of age at diagnosis * ovarian cancer, fallopian tube cancer, or primary peritoneal cancer * high-grade serous or high-grade endometroid histological type * figo stage ii, iii, or iv * complete response or partial response following completion of first-line adjuvant chemotherapy * parpi administered as first-line maintenance therapy exclusion criteria: * first-line surgery not conducted * total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5 * first-line parpi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy * genotyping quality-control failed
avoidance of hyperglycaemia in people with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this study aims to learn more about avoidance of hyperglycaemia in adults with type 1 diabetes. people who attend a type 1 diabetes clinic will be invited to complete a number of self-report questionnaires and a survey. a subsection of people who experience avoidance of hyperglycaemia will be invited to take part in an interview in order to gain a more in-depth understanding of this issue.


Eligibility criteria:
inclusion criteria: * type 1 diabetes of at least 6 months duration exclusion criteria: * inability to understand or write in the english language * pregnant women * unable to participate in the study due to other factors, as assessed by the chief investigators

Keywords: diabetes hyperglycaemia psychology