Kornimate/medical-research-clean huggingface dataset:
varenicline for adolescent smoking cessation

Conditions: Nicotine Dependence

Summary: this is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. after assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

the objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. the guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. after assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. participants will provide smoking self-report (cigarettes per day) throughout the study. biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. after the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (week 13, week 18, and week 26).

Eligibility criteria:
inclusion criteria: * age 14-21 * daily smoker for ≥6 months * desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study * if under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status) * if female, agreement to use birth control (any form of hormonal contraception such as depo-provera, daily oral contraception, transdermal patch, or nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy exclusion criteria: * lifetime history of any dsm-iv-tr mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia) * lifetime history of suicidality, homicidality, or clinically significant hostility/aggression * current substance dependence, other than nicotine * current unstable major medical disorder * current pregnancy or breastfeeding * current use of medications with smoking cessation efficacy * known hypersensitivity to varenicline
hybryte (synthetic hypericin) versus valchlor (mechlorethamine) in the treatment of ctcl

Conditions: Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Summary: the objective of this clinical study is to compare the safety and effectiveness of valchlor versus hybryte following 12 weeks of treatment.

participants will be randomized to receive hybryte or valchlor in a 1:1 randomization. participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial. prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Eligibility criteria:
inclusion criteria: * minimum of 3 active treatment-accessible ctcl lesions * subjects must have a clinical diagnosis of cutaneous t-cell lymphoma (ctcl, mycosis fungoides), stage ia, ib, or stage iia * subjects willing to follow the clinical protocol and voluntarily give their written informed consent * female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation exclusion criteria: * history of severe allergic reaction to any of the components of hybryte or mechlorethamine (valchlor) * pregnancy or mothers who are breast-feeding * all women of childbearing potential (wocbp) and males with female partners who are wocbp not willing to use effective contraception * subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (sle), sjogren's syndrome, etc.) * subjects whose condition is spontaneously improving * subjects receiving valchlor (or any topical compound containing mechlorethamine) in the preceding 2 months * subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for ctcl within 2 weeks of enrollment * subjects receiving systemic steroids, psoralen ultraviolet a (uva) radiation therapy (puva), narrow band ultraviolet b (uvb) light therapy (nb-uvb) or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment * subjects who have received electron beam irradiation within 3 months of enrollment * subjects with a history of significant systemic immunosuppression * subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment * subject has any condition that, in the judgment of the investigator, is likely to interfere with participation in the study * subjects receiving drugs known to cause photosensitization within 2 weeks of starting hybryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks

Keywords: ctcl mf hypericin hybryte
efficacy of ultrasound-guided local anesthetic injection into or around the sciatic nerve for lower limb anesthesia

Conditions: Orthopedic Disorders; Foot Diseases; Injuries, Leg; Injuries, Foot; Injuries, Knee

Summary: this study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg. the investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. they will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery. the safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.

this will be a randomized, controlled, patient- and observer-blinded trial assessing block characteristics after intra- or perineural injection of ropivacaine for subgluteal sciatic nerve blocks performed for elective surgery of the lower limb.

Eligibility criteria:
inclusion criteria: * undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet * asa physical status class i-iii * consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block) exclusion criteria: * unable to understand or communicate for the purpose of the study * exhibiting any neurological disturbance of the ipsilateral lower extremity * inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist

Keywords: lower extremity sciatic nerve anesthetics, local ropivacaine ultrasonography
apoe in the predisposition to, protection from, and prevention of alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to track changes in the brain related to alzheimer's disease. the results from this study will be used to develop new approaches to prevent or delay the onset of memory and thinking problems associated with alzheimer's.

this study aims to establish, use, and extensively share a comprehensive longitudinal resource of genetic, non-genetic, and cognitive data, brain imaging and fluid biomarker measurements of amyloid-β, tau pathophysiology, neurodegeneration, and inflammation and biological samples to advance the study of cognitively unimpaired older adults at six levels of genetic risk for alzheimer's disease due to their apoe genotype including understudied apoe2 and apoe4 homozygotes (hms) at the lowest and highest risk and those apoe4 hms and heterozygotes (hts) who remain unimpaired at older ages due to unknown protective factors and spared pathophysiological effects despite their genetic risk. each participant will provide blood samples for clinical lab analysis, dna, rna, plasma, serum, and peripheral blood mononuclear cells (pbmcs) every 12 months; amyloid and tau pet scans, a nearly one hour battery of mris, a lumbar puncture (lp) for the collection of csf samples, and a comprehensive battery of cognitive, behavioral, risk factor, and other assessments every 24 months. extracted dna will be used to characterize the participant's apoe genotype, screen for rare apoe variants that might make them eligible for other studies, and perform whole genome sequencing (wgs) and genome-wide genotyping.

Eligibility criteria:
inclusion criteria: * male or female age 50 to 90 years old in good general health with no diseases expected to interfere with the study. * willing to undergo health and cognitive assessments, brain imaging sessions (mri and pet), and collection and banking of blood with venipuncture and csf by lumbar puncture for genetic research, biomarker research, and dna banking. * determined to be cognitively unimpaired by pi (mechanisms may include verbal interview, participant or study partner reports or specific scores on cognitive assessments) exclusion criteria: * participants with significant health issues or medical diseases that may interfere with participation, including infectious diseases that pose a risk to study personnel. * for pet or mri: female participant who is pregnant, lactating, or of childbearing potential without a negative pregnancy test or being two years postmenopausal or surgically sterile. * for mri: any contraindication for mri including, but not limited to, pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body. * for csf collection: medical or surgical contraindication for lumbar puncture (e.g. on anti-coagulant therapy or had prior lumbar spinal surgery).
breakthrough anxiety and sleep evaluation using linked devices and smartphone application onar (basel)

Conditions: Sleep Deprivation; Sleep Hygiene; Sleepiness; Sleep Driving; Depression, Anxiety; Anxiety Disorders; Depressive Symptoms

Summary: sleep is not simply the absence of wakefulness. sleep is an active procedure, normally happening every night, and is absolutely vital. good sleep is essential for our well-being. survival without food can be further than without sleep. work time and commuting time seem to affect total sleep time and night bedtime. social and work obligation can, therefore, suppress sleep time. sleep deprived individuals may be facing anxiety and depression symptoms. the aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application onar. onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. an established questionnaire (hospital anxiety depression scale/ hads) will be used to quantify and detect the presence of anxiety and depression in the study population.


Eligibility criteria:
inclusion criteria: * acceptance of terms of use of the application must be done prior to participation in the study. * male and female adults aged ≥18 years old and ≤60 years old. * subjects using the application on a daily basis for at least 1 week prior to participation. exclusion criteria: * history of alcohol or other substance abuse.

Keywords: smartphone wearables app sleep anxiety depression
culturally tailored decision aid for hispanic patients diagnosed with prostate cancer

Conditions: Prostate Cancer

Summary: a pilot study testing the effect of an in-visit english and spanish language decision aid for hispanic-latino men using best practices of cultural tailoring to be used in urology practice. subjects will be followed for approximately 1 year during standard care in-clinic office visits. study results and subject surveys will be analyzed to determine clinical utility of the tool.

the objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of hispanic-latino patients. the specific aims are: i. to develop and pilot test in an uncontrolled fashion an in-visit english and spanish language decision aid for hispanic-latino men using best practices of cultural tailoring to be used in urology practice ii. to pilot and test the impact of a culturally tailored, english and spanish language version of the prostate choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income hispanic/latino patients diagnosed with localized prostate cancer iii. to assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.

Eligibility criteria:
inclusion criteria: * subjects utilize english or spanish as their primary spoken or written language and identify with a latino ethnicity and/or culture * men with a new histologic diagnosis of localized prostate cancer * psa level of 0.1 - 50 ng/dl * gleason score of 6 - 10 * cancer stage: t1 - 4n x m0 exclusion criteria: * metastatic disease, including lymph nodes or distant metastasis * psa \> 50 ng/dl * individuals with a medical condition that necessitates a specific prostate cancer treatment plan * individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study

Keywords: decision aid focus group
early stockholm obesity prevention program

Conditions: Obesity; Overweight

Summary: to study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.

early stopp project wants to promote good health in children from early age by supporting good habits for the whole family. our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. normal weight parents will also be needed in this study. background life is in constant change and affects our habits. in many ways this is positive but it also contributes to less favorable health factors. for example, take the car instead of cycling, take the lift instead of the stairs. this makes us less active in everyday life. individuals also eat more unhealthy foods in larger portions. in combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children. good treatment methods for childhood obesity are lacking, making prevention very important. the earlier good habits are introduced to a child the better it is. in early stopp project we study food, physical activity and sleep habits in the families with a little child. the height, weight, waist circumference and blood pressure will be recorded in both child and parents. the parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. during the study, the child's physical activity will be measured.

Eligibility criteria:
inclusion criteria: * one obese or two overweight parents, 1 year old child exclusion criteria: * weight effecting diseases

Keywords: child overweight child obesity prevention targeted intervention development of overweight
a prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.

Conditions: Advanced Breast Cancer Brain Metastasis

Summary: a prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.


Eligibility criteria:
inclusion criteria: 1. males or females who are at least 18 years of age on the day of signing the informed consent form. 2. patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology. 3. patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (mdt) at the stage of brain metastasis. 4. patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. these drugs include: adc drugs (such as t-dxd, t-dm1, etc.), cdk4/6 inhibitors, tki drugs (such as pyrotinib, tucatinib, etc.), novel chemotherapy drugs (such as utidelone, irinotecan liposomes, etc.), bevacizumab, pd-1/pd-l1 inhibitors, etc. 5. patients with a traceable medical history during the treatment period. 6. patients who are able to sign the informed consent form to participate in the study. exclusion criteria: 1. the subject has leptomeningeal metastasis. 2. if the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy. 3. the subject has not signed the informed consent form. 4. pregnant or breastfeeding women. 5. other situations deemed by the investigator as unsuitable for inclusion in the study.
neutropenic sepsis in patients with non-small cell lung cancer treated with single-agent docetaxel and associated resource use in the uk

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (nsclc) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. the primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (ns) episode following initiation of treatment with single-agent docetaxel. data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.


Eligibility criteria:
inclusion criteria: * diagnosed with locally advanced or metastatic (stage ill or iv) non-small cell lung cancer (nsclc) * relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy * initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection * aged 18 years at date of first docetaxel dose * completed or stopped treatment with docetaxel at least 30 days prior to date of data collection exclusion criteria: * receiving docetaxel in an interventional clinical trial * for whom no details of absolute neutrophil count are recorded
prevalence of femoroacetabular impingement in asymptomatic patients

Conditions: Femoroacetabular Hip Impingement Syndrome

Summary: femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. in this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. the purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.

participants in this study will be asked to come to the hospital after regular work hours for an mri of the hip joints. prior to the mri, a physician will perform a range of motion check of the participants hips. the mri will take approximately 20 minutes during which the participant will have to lie still in a closed space. participants will receive a letter which can be forwarded to their family doctor if the mri has any abnormal findings including signs of hip impingement.

Eligibility criteria:
inclusion criteria: * no hip problems * no containdications to mri exclusion criteria: - patient does not meet above criteria

Keywords: femoroacetabular impingement
long-term follow-up study of rgx-314 administered in the suprachoroidal space for participants with diabetic retinopathy

Conditions: Diabetic Retinopathy, DR

Summary: this is a prospective, observational study designed to evaluate the long-term safety and efficacy of rgx-314. eligible participants are those who were previously enrolled in a clinical study of dr without center involved-diabetic macular edema (ci-dme) in which they received scs administration of rgx-314. enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. participants will be followed for a total of 5 years post-rgx-314 administration (inclusive of the parent study). as such, the total study duration for each participant may vary depending on when they enroll in the current study following rgx-314 administration in the parent study.


Eligibility criteria:
inclusion criteria: * must provide written, signed informed consent for this study * must have been enrolled in a previous clinical study of rgx-314 for the treatment of dr without ci-dme and must have received an scs injection of rgx-314 in that study * must be willing and able to comply with all study procedures exclusion criteria: * none

Keywords: diabetic retinopathy, dr
effect of anesthesia technique on outcome after hip fracture surgery in elderly adult patients

Conditions: Hip Fracture

Summary: despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. while many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. this study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based tiva and spinal anesthesia with bupivacaine.


Eligibility criteria:
inclusion criteria: 1. patients older than 65 years scheduled for elective or emergency hip fracture surgery. exclusion criteria: 1. patient refusal 2. inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis 3. allergies to propofol or its ingredients, soybeans or peanuts 4. patients with altered mental status 5. illiterate patients or foreigners