Kornimate/medical-research-clean huggingface dataset:
stratification of vulvar scc by hpv and p53 status to guide excision

Conditions: Vulvar Squamous Cell Carcinoma

Summary: this study is being done to answer the following question: are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?

this study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. the usual approach is defined as care most people get for early-stage vulvar cancer. the usual approach for patients who are not in a study is treatment with surgery. tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended. for patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. the laboratory assessments include a test to determine if the cancer is caused by the human papilloma virus (hpv) or not caused by hpv. if the laboratory test results show the vulvar cancer is caused by hpv, the study doctor will recommend the patient participate in sub-study a. in sub-study a, the patient will receive no additional surgery (observation). if the laboratory test results show the vulvar cancer is not caused by hpv, the study doctor will recommend the patient participate in sub-study b. in sub-study b, patients will receive either a second surgery or no additional surgery (observation).

Eligibility criteria:
inclusion criteria: * histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (vscc) * surgically staged figo i-ii vscc as per figo 2021 guidelines * vulvar resection according to standard of care guidelines * post-operative margin assessment of tumour clearance, dvin and p53 status. * participants' age must be ≥ 18 years old * participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either english or french * participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements exclusion criteria: * recurrent vulvar squamous cell carcinoma * non-squamous cell carcinoma histotypes * participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy * primary tumour hpv-i p53 wild-type vscc * surgical margins positive for invasive cancer. * participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years * lymph node positive vscc
botswana tdf/ftc oral hiv prophylaxis trial

Conditions: HIV Infections

Summary: this study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in botswana without hiv infection and whether it reduced their risk of getting an hiv infection.

twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without hiv infection were enrolled in francistown and gaborone, botswana. they were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. in addition, volunteers were randomized to receive either tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their hiv status. persons who become hiv infected during the trial received ongoing supportive counseling, cd4 and viral load monitoring, education about hiv infection/disease, and access to hiv care including free antiretrovirals when clinically indicated. volunteer safety was monitored by a local ethics committee, centers for disease control institutional review board (cdc irb) and an independent data safety and monitoring board

Eligibility criteria:
inclusion criteria: * citizen of botswana 18-39 years old * sexually active * hiv uninfected * hepatitis b and c uninfected * calculated creatinine clearance \>= 60 ml/min * hemoglobin \>= 8 gm/dl * alt and ast \<= 2x uln * total bilirubin \<= 1.5 mg/dl * total serum amylase \<= 1.5x uln * serum phosphorus \>= 2.2 mg/dl * willing to use hormonal contraception (females) * living within 1 hours travel of study clinic * pass comprehension test * willing and able to give informed consent exclusion criteria: * 18-20 without parent/guardian consent * history of significant renal or bone disease * any chronic illness requiring ongoing prescription medication * pregnant or breastfeeding * planning to move away from site in the next year * participating in another hiv prevention or vaccine safety trial * any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements

Keywords: hiv incidence hiv prevention tenofovir emtricitabine botswana hiv seronegativity
evaluate the efficacy and safety of id1201 for dose-finding in mild alzheimer's disease

Conditions: Alzheimer Disease

Summary: the objective of this study is to evaluate the safety and efficacy of id1201 in patients with mild alzheimer's disease

id1201 is a fruit extract of melia toosendan. id1201 alleviates alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to aβ reduction, rage inhibition, neuro-protection, and anti-inflammatory activities.

Eligibility criteria:
inclusion criteria: 1. patient diagnosed with dementia of alzheimer's type according to dsm-iv criteria and probable alzheimer's disease according to the nincds-adrda 2. modified hachinski ischemia scale score of less than or equal to 4 3. mini-mental state examination score 16 to 26 and clinical dementia rating-global scale score 0.5 to 1 4. amyloid postivie pet image (bapl score 2 or 3) 5. patients who have not received ache inhibitors or nmda antagonist at least for 3 months prior to the screening visit exclusion criteria: 1. patients diagnosed or accompanied with dementia due to other neurodegenerative disorders other than alzheimer's disease 2. chronic alcohol and/or drug abuse within the past 5 years 3. subjects who have medical history of significant renal disease (ccr\<30ml/min) or hepatic disease( 3\*uln \<= alt or ast) 4. has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, ginko biloba extract, vitamin e, hormone replacement therapy etc. in the previous 4 weeks
comparative efficacy of tacrolimus and clobetasol propionate in alopecia areata

Conditions: Alopecia Areata

Summary: methodology: the 70 patients of age 20 to 50 years presented to the out-patient department of cmh abbottabad suffering from alopecia areata were enrolled. the non-probability consecutive sampling technique was used. patient in group-a applied clobetasol propionate 0.05% twice daily, whereas group-b applied topical tacrolimus 0.1% twice daily for upto 3 months. the patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. hair loss was calculated from salt score at presentation and on follow-up after 3 months. the degree of response was assessed on the basis of hair re-growth as excellent (\>75% re-growth), marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). to determine statistical significance χ2-square test, taking p-value \<0.05 as significant, was used.


Eligibility criteria:
inclusion criteria: * patients age 20 to 50 years * both male and female * duration of illness less than 2 months * those who never received any treatment before exclusion criteria: * patients having duration of alopecia greater than 2 months * atypical alopecia areata i.e., alopecia universalis etc * hypersensitivity history to topical corticosteroids or tacrolimus * patients taking any systemic immune suppression * pregnancy/lactation
a new pathway with bronchoscopic or oesophageal ultrasound for lung cancer diagnosis and staging (boost)

Conditions: Bronchogenic Carcinoma

Summary: in the uk, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. the investigators wish to determine whether using the newer techniques of endobronchial ultrasound (ebus) and endoscopic ultrasound (eus) improves lung cancer staging. the investigators' hypothesis is that eus (endoscopic ultrasound) or ebus (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after ct scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.


Eligibility criteria:
inclusion criteria: * consecutive patients suspected of lung cancer on ct scan * written informed consent * able to tolerate bronchoscopy and thoracic surgery exclusion criteria: * evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial * any disorder making reliable informed consent impossible * patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Keywords: lung cancer staging endobronchial ultrasound endoscopic
copeptin registry (procore) biomarkers in cardiology (bic)-19

Conditions: Acute Myocardial Infarction

Summary: registry of an interventional study-proved strategy (bic-8) using copeptin and troponin for the early rule-out of acute myocardial infarction (ami) in patients with suspected acute coronary syndrome (acs) and a low-to intermediate risk profile.

registry of an interventional study-proved strategy (bic-8) using copeptin and troponin for the early rule-out of acute myocardial infarction (ami) in patients with suspected acute coronary syndrome (acs) and a low-to intermediate risk profile. primary objective: to monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of acs and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile url). secondary objectives: * to monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result * to monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission

Eligibility criteria:
inclusion criteria: * admission to the emergency department or cpu with signs and symptoms consistent with acute coronary syndrome * low-to intermediate risk profile (grace-score below 140 and a low- to intermediate likelihood of acs as judged by the treating physician) * patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision * full-aged patient exclusion criteria: * none

Keywords: copeptin rule out marker, emergency department, cheast pain unit emergency department chest pain unit
assessing e-cigarettes for tobacco harm reduction in the context of lung cancer screening

Conditions: Electronic Cigarette Use; Smoking, Cigarette; Nicotine Dependence

Summary: this study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ecs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. this open-label single-arm pilot clinical trial will test the impact of ec provision on: 1) study feasibility, 2) ec acceptability, 3) tobacco use behavior (e.g., cigarettes per day, ec use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). participants will be asked to switch from combustible cigarettes to the njoy ace 5% nicotine electronic cigarette (ec) for 4 weeks. they will be followed an additional 4 weeks after ec provision ends (to 8 weeks). the first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. the second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of ec provision, relative to their baseline values.


Eligibility criteria:
inclusion criteria: * participants who completed the screen assist study (nct03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (cc) to electronic cigarettes (ec). individuals who expressed interest in switching to ec on that survey were screened for eligibility for this pilot study * smoked ≥5 cigarettes/day in past month * smoking status at study entry confirmed by breath carbon monoxide (co) ≥ 6ppm * willing to try switching from cc to ec for 4 weeks * owns a mobile telephone * english speaking * willing to travel to the massachusetts general hospital campus for 3 in-person visits. exclusion criteria: * plans to quit smoking and has set a quit date in the next 30 days * used smoking cessation treatment in the past 30 days * used ec on \>2 days in the past 30 days * hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month * not willing to abstain from smoking marijuana in the 24h before each study visit

Keywords: tobacco use disorder
a direct-to-patient intervention to increase rates of osteoporosis care

Conditions: Osteoporosis

Summary: the purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. this novel content will use "story-telling" delivered via the internet and digital video discs (dvds). the content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. we will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms. we hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (h1) prescription osteoporosis therapies, (h2) non-prescription therapy with calcium and vitamin d, and (h3) bone mineral density (bmd) testing.


Eligibility criteria:
inclusion criteria: * self-reported history of fracture exclusion criteria: * self-reported current prescription osteoporosis treatment
hip fracture characterization with ultrasound exam

Conditions: Hip Fractures

Summary: hip fractures are usually classified according to their x-ray as subcapital, pertrochanteric. we examine hip fractures with ultrasound in order to characterize the fractures with several parameters.


Eligibility criteria:
inclusion criteria: * patients over 50 years with x rays showing a hip fracture exclusion criteria: * previous fracture or surgical intervention in the hip * fracture over 3 days old * pregnancy * flexion contracture of hip

Keywords: hip fracture ultrasound
endometrioma sclerotherapy and ovarian preservation

Conditions: Endometrioma

Summary: a randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma. secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.

participants with endometrioma(ta), identified on imaging, who are opting for surgical management of endometriosis will be randomly allocated to laparoscopic ethanol sclerotherapy of endometrioma or laparoscopic surgical excision of endometrioma(ta). any concurrent endometriosis identified at surgery will be excised as per routine care. ovarian reserve will be assessed by serum anti-mullarian hormone (amh) and antral follicle count (afc), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by ehp-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy. each participant will be followed up for a total of 24 months from surgery.

Eligibility criteria:
inclusion criteria: * female (xx genotype, assigned female at birth) * age 18-40 * finding of suspected uni- or bi-lateral ovarian endometrioma(ta) of ≥ 2cm on tvuss and/or pelvic mri scan (tvuss, a uni- or multi-locular ovarian cystic lesion with low level echoes and diffuse homogeneous ground glass appearance; mri any of, ovarian lesion hyperintense t1 without loss of signal on t1 fat-suppressed images, hypointense t2 exhibiting shading sign and/or t2 dark spot sign, variable restricted diffusion on dwi) * appropriate to be listed for laparoscopic excision of endometrioma (endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management is unsuccessful or unacceptable to the patient, to facilitate art) exclusion criteria: * postmenopausal status * suspicion of malignancy * unable to undergo tvuss * declines to take part in the study * unable to understand verbal or written information in english * lack of capacity to consent at the point of recruitment * known safeguarding issues

Keywords: endometrioma endometriosis sclerotherapy
study to investigate the long term survivorship of coflex

Conditions: Spinal Fractures

Summary: examine the long-term survivorship via ct scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the paradigm spine coflex ide study.

this is a prospective, multi-center, single-arm, radiographic evaluation of all coflex ide patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using x-ray or ct). all patients were enrolled and followed through 60 months under the ide and extended follow-up protocol. the specific objective of this ct study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a ct scan at post-60 months. a ct scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.

Eligibility criteria:
inclusion criteria: * participant in coflex ide study * willing and able to give informed consent * spinous process fracture identified by site and/or radiographic lab at 24 months exclusion criteria: * subjects who died, were withdrawn or withdrew consent to participate in the study * subjects who are pregnant, or planning to become pregnant, during the course of this study * subjects who have cancer, whether active or in remission
pancreatic enzyme supplementation for celiac disease

Conditions: Celiac Disease

Summary: the purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. this protocol specifically aims to: 1. evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet. 2. assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.


Eligibility criteria:
inclusion criteria: * biopsy proven celiac disease. * age 18-80. * ongoing symptoms defined as a ced-gsrs score of greater than 3 during the run in period. * subject must be following a gluten free diet. * ttg \< 40 units at screening. exclusion criteria: * taking prescription or over the counter enzyme supplements for 1 month prior to enrollment. * pregnant, breastfeeding or planning pregnancy. woman using acceptable methods of contraception will be included. acceptable methods of contraception include oral hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide, condoms, intra-uterine device, abstinence, and male partner vasectomy. * patients with a pork allergy or who are unwilling to consume pork products. * english proficiency unsuitable for completion of surveys. * known severe pancreatic disease. * known history of prior cancer (except squamous or basal cell skin cancer). * patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2 tablespoons) of whole milk per day. * clinically significant abnormality in safety lab values (i.e. cbc and bmp) at screening that may impact subject safety or the scientific integrity of the study. * other known active gi condition including but not limited to inflammatory bowel disease, small intestine bacterial overgrowth, and obvious fodmap intolerance. * history of all major gastrointestinal surgery other than appendectomy or cholecystectomy. * comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study.

Keywords: pancreatic enzyme supplementation
the effect of occupational therapy on sensory-based feeding problems

Conditions: Feeding Disorder; Autism Spectrum Disorder; Sensory Integration Disorder (Disorder)

Summary: feeding problems are common in individuals with autism spectrum disorder (asd).this study was planned to investigate the effect of occupational theraphy on sensory feeding problems in asd.

feeding problems are common in individuals with autism spectrum disorder (asd).this study was planned to investigate the effect of occupational theraphy on sensory feeding problems in asd.

Eligibility criteria:
inclusion criteria: * asd * feeding problems