Kornimate/medical-research-clean huggingface dataset:
to determine the maximum tolerated dose level (mtd) of pep005 topical gel in patients with sbcc

Conditions: Superficial Basal Cell Carcinoma

Summary: the purpose of this study is to determine maximum tolerated dose level (mtd) of pep005 topical gel for the treatment of superficial basal cell carcinoma on the trunk

basal cell carcinomas (bccs) are a common skin problem largely caused by long term sun exposure. current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. non-invasive alternative therapy for treatment of bcc lesions is thus being researched. sap from the plant euphorbia peplus has been used for many years in australia as a "folk" remedy to treat a number of skin conditions. the active component of euphorbia peplus has been isolated and made into a gel applied directly to the skin by peplin opeation pty ltd. the proposed study follows a previously conducted 12 week study in sbcc, pep005-003. this was a two dose schedule evaluating doses up to 0.05%. histological clearance rate at the end of study was 71% for the 0.05% concentration on the day 1, day 2 schedule compared with 0% in the vehicle group. the proposed study aims to determine the maximum tolerated dose level (mtd) of pep005 topical gel, in patients, when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

Eligibility criteria:
1. male or female patients at least 18 years of age. 2. a primary clinically diagnosed and histologically confirmed sbcc lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass 3. ability to follow study instructions and likely to complete all study requirements. 4. written informed consent has been obtained. 5. agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

Keywords: sbcc topical dermatology
an immunologic study of treatment-naive hiv patients starting a darunavir/ritonavir- or efavirenz-based haart

Conditions: Human Immunodeficiency Virus; HIV

Summary: the purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (hiv) infection starting a darunavir/ritonavir- or efavirenz-based highly active antiretroviral therapy (haart) regimen.

this is an ex-vivo study (study which takes place outside the organism and records immune parameters from stored blood and cells of a defined population without any intervention by the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (hiv) infection starting a darunavir/ritonavir (drv/r)- or efavirenz (efv)-based highly active antiretroviral therapy (haart) regimen. in previously stored plasma blood samples, the role of drv/r compared with efv in reducing t-lymphocyte activation, drv/r compared with efv in recovering t-lymphocyte immune phenotype in peripheral blood and thymic production, and drv/r compared with efv in recovering t-lymphocyte function (functional immunity) will be studied. blood samples will be analyzed before (baseline) and up to 48 weeks after initiating haart. each patient will receive orally administered (given by mouth) regimens of either darunavir/ritonavir (drv/r) + tenofovir/emtricitabina or efavirenz (efv) + tenofovir/emtricitabina.

Eligibility criteria:
inclusion criteria: * documented human immunodeficiency (hiv)-1 infection * at baseline plasma blood sampling, has never received antiretroviral therapy * attending the clinic of infectious diseases of the university of milan at san paolo hospital * asymptomatic (demonstrating no acquired immunodeficiency syndrome \[aids\]-defining symptoms) at baseline, week 12, and week 24 * cd4 cell count \>50 to \<250/mm3 at baseline * receiving treatment with either darunavir/ritonavir + tenofovir/emtricitabina or efavirenz + tenofovir/emtricitabina highly active antiretroviral therapy (haart) regimens at week 12, week 24, and week 48 plasma blood sampling. exclusion criteria is not defined in protocol.

Keywords: human immunodeficiency virus; hiv; highly active antiretroviral therapy; haart; darunavir; ritonavir; efavirenz; kinetics; immunological recovery
looking at cognitive and brain changes in people with lymphoma receiving car-t therapy

Conditions: Lymphoma Receiving CAR-T Therapy

Summary: the purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving car-t therapy.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older * planned treatment with commercial cd19-specific car t cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma. * patients must have adequate end organ function for car t cell therapy * eastern cooperative group (ecog) performance status of 0 to 2 * meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for cart therapy as described in corresponding product package insert * no evidence of central nervous system disease at study entry * fluent and able to communicate well enough in english to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o patients who report that english is not their primary language will be asked the us census english proficiency question: "how well do you speak english," and the answer "very well" will be required exclusion criteria: * signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain mri, either at the time of enrollment or during the study period. * current diagnosis of major axis i psychiatric disorder (dsm-iv), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report * history of neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report * a history of epilepsy as per medical records or patient report * current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report * evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report * contraindications to mri examinations as per standard screening guidelines used in the department of radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)

Keywords: neurocognitive evaluations neuroimaging evaluations 19-268
blood flow restriction on functional mobility in pre-frail older adults

Conditions: Frailty

Summary: this study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. it is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

participants aged over 65 years old with less than two items positive of fried frailty phenotype assessment result will be recruited. the participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. both groups will receive the training 30 minutes/session, two sessions/week for six weeks. muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

Eligibility criteria:
inclusion criteria: * aged over 65 years old * fried frailty index fulfill 1-2 criteria * able to walk 6 meters independently * able to understand and follow ≥ 3 instructions exclusion criteria: * severe hypertension (\>180/110mmhg) * peripheral neuropathy * history of deep-vein thrombosis (dvt) * cardiovascular diseases (i.e. heart failure nyha classification iii or iv, myocardial infarction, pulmonary hypertension, coronary artery stenosis) * neuromuscular diseases (i.e. stroke, parkinsons' disease) * history of resisted exercise training program within the last 6 months before screening

Keywords: pre-frail, blood flow restriction, functional mobility
investigation of the effects of obesity surgery on appetitive behaviour

Conditions: Roux-en-Y Bariatric Surgery

Summary: among all the existing ways to treat obesity (lifestyle, pharmacological), roux-en-y gastric bypass (rygb) surgery is currently the most effective. it results in long term weight loss maintenance, significant remission of obesity-related comorbidities and decreased overall mortality. it also induces changes in gastrointestinal hormones responses, with an increase of anorexigenic hormones glp-1, and pyy. although successful, the mechanisms for rygb-induced weight loss are not completely understood. the rygb does result in increased satiation, decreased calorie intake and decreased preferences for sweet and fatty foods. previous work from our lab has shown using progressive ratio task (prt) that rygb specifically decreases the appetitive behaviour for sweet and fat stimuli but not for vegetables. the reasons for this change in appetitive behaviour after the surgery remain unknown. they may be triggered by changes in gut hormones, conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids levels. this study aims to assess whether rgyb-induced gut hormone changes contribute to the decrease in appetitive behaviour for sweet and fatty foods observed after the surgery. this is a double blind controlled study comparing the effect of blocking gut hormones with somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be carried out. appetitive behaviour will be measured using the progressive ratio task. the investigators hypothesize that blocking the gut hormones in obese patients with rygb will increase their appetitive behaviour for sweet-fat candies.


Eligibility criteria:
inclusion criteria: * gastric bypass surgery since at least 6 months exclusion criteria: * serious illness * pregnancy or breast feeding * more than three alcoholic drinks per day * substance abuse * psychiatric illness * significant longstanding heart disease or heart intervention (for example, patients who have had heart attacks, have pacemakers or have had heart surgery)

Keywords: rygb bariatric surgery taste reward food behaviour gut hormones
machine learning to predict lymph node metastasis in t1 esophageal squamous cell carcinoma

Conditions: Lymph Node Metastasis

Summary: existing models do poorly when it comes to quantifying the risk of lymph node metastases (lnm). this study generated elastic net regression (elr), random forest (rf), extreme gradient boosting (xgb), and a combined (ensemble) model of these for lnm in patients with t1 esophageal squamous cell carcinoma.

lymph node metastases (lnm) is a relatively uncommon but possible complication of t1 esophageal squamous cell carcinoma (escc). existing models do poorly when it comes to quantifying this risk. this study aimed to develop a machine learning model for lnm in patients with t1 esophageal squamous cell carcinoma. patients with t1 squamous cell carcinoma treated with surgery between january 2010 and september 2021 from 3 institutions were included in this study. machine-learning models were developed using data on patients' age and sex, depth of tumor invasion, tumor size, tumor location, macroscopic tumor type, lymphatic and vascular invasion, and histologic grade. elastic net regression (elr), random forest (rf), extreme gradient boosting (xgb), and a combined (ensemble) model of these was generated. use area under curve (auc) to evaluate the predictive ability of the model. the contribution to the model of each factor was calculated. in order to better meet clinical needs, the investigators have designed the model as a user-friendly website.

Eligibility criteria:
inclusion criteria: * (i) thoracic escc * (ii) no history of concomitant or prior malignancy * (iii) tumor with pt1 staging * (iv) 15 or more lymph nodes examined exclusion criteria: * underwent neoadjuvant treatment or endoscopic submucosal dissection before surgery
aquaporin-4 single nucleotide polymorphisms in patients with idiopathic and familial parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to understand the relationship between problems in sleep, genetic variations in the aquaporin-4 gene (aqp4), and the development of parkinson's disease.

parkinson's disease (pd) is a progressive neurodegenerative disease characterized by the abnormal deposition in the brain of aggregates called lewy bodies, packed with a protein called α-synuclein. the mechanisms why this protein accumulates in the brain of patients with pd, as well as its relationship with clinical symptoms, is unknown. recently, an internal mechanism of drainage of waste proteins called glymphatic system has been identified and characterized. this system is silent during wakefulness and works during sleep. when it is active, a virtual space between the blood capillaries and cells of the brain called astrocytes opens and lets out waste products from the brain. this process is mediated by a protein of the astrocytes called aquaporin-4 (aqp4). preclinical studies have shown that the function of this system could be critical for the clearance of β-amyloid, a protein linked with the development of alzheimer's disease. studies in humans have shown that genetic variations some parts of the aqp4 gene, defined as single nucleotide polymorphisms, may increase the likelihood to develop an aggressive form of alzheimer's disease. however, no studies in humans have ever been performed in parkinson's disease and α-synuclein. in this study, the investigators aim to elucidate whether genetic variations in the aqp4 gene contribute to variations in the clinical presentation and progression of sporadic and genetic forms of parkinson's disease. to do so, the genetic profile of patients will be determined through a small venous blood sample collection. this will be coupled with clinical and sleep assessment.

Eligibility criteria:
inclusion criteria: * 18-85 years of age * able to give informed consent * able to perform online neuropsychological examinations * diagnosis of pd according to brain bank criteria * no presence or personal or family history of other neurological or psychiatric disorders exclusion criteria: * presence of other neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions * inability to perform online neuropsychological assessment * inability to have access to informatics technology to perform the online assessment tests * inability to travel for the assessments * native language different from english

Keywords: parkinson's disease aqp4 glymphatic system genetics
study to evaluate the efficacy and safety of erenumab (amg 334) compared to placebo in migraine prevention

Conditions: Migraine

Summary: to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to \< 15 migraine days per month with \< 15 headache days per month will be randomized 1:1 to placebo or erenumab. double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.

Eligibility criteria:
inclusion criteria: * history of migraines (with or without aura) for ≥ 12 months * migraine frequency: ≥ 4 and \< 15 migraine days per month on average acrossthe 3 months prior to screening * headache (ie, migraine and non-migraine headache) frequency: \< 15 headache days per month on average across the 3 months prior to screening * demonstrated compliance with the ediary exclusion criteria: * older than 50 years of age at migraine onset. * history of cluster headache or hemiplegic migraine headache. * unable to differentiate migraine from other headaches * no therapeutic response with \> 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial. * concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. if only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study * used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase. * received botulinum toxin * anticipated to require any excluded medication, device, or procedure during the study. * active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain). * history of major psychiatric disorder. * history of seizure disorder or other significant neurological conditions other than migraine. * human immunodeficiency virus (hiv) infection by history. * myocardial infarction (mi), stroke, transient ischemic attack (tia), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening. * the subject is at risk of self-harm or harm to others. previously randomized into an amg 334 study. * unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.

Keywords: migraine headache episodic prevention prophylaxis
supervised three-month exercise program in men with prostate cancer receiving androgen-deprivation therapy

Conditions: Prostatic Neoplasms; Metastasis

Summary: the goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. the main question\[s\] it aims to answer are: * what is the impact of exercise on quality of life * what is the impact of exercise on physical fitness participants will have an individual training program with supervised training by physiotherapists. researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.


Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 years old * able to read and complete questionnaires in dutch * proven histologically and /or radiologically metastatic prostate cancer (txnxm1) exclusion criteria: * other cancers * clinicians' judgement * age \>80 years old or not able to walk 400m * structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months * musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising * spinal cord compression, history of pathological fractures
survey of optical values of the breast using radiation-free pressure-free optical scanning

Conditions: Breast Lesions; Breast Cyst; Early-Stage Breast Cancer; Benign Growth, Breast

Summary: the purposes of this study is to establish normal optical values of breast tissue in the general population. this will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.


Eligibility criteria:
inclusion criteria: * you must be female * you must be 21 to 50 years old * you must not have or have had breast cancer. * you must not have or have had breast implants or breast surgery * you must not have had a breast biopsy or injury, or a breast infection, in 90 days. exclusion criteria: * any one or more of the above conditions not met * lack of informed consent

Keywords: screening compositional analysis metabolism breast breast cyst breast infection breast inflammation lipoma benign growth women without a diagnosis for a region of interest in the breast
a controlled trial of a 4-month quinolone-containing regimen for the treatment of pulmonary tuberculosis

Conditions: Tuberculosis

Summary: tuberculosis is currently treated with a 6-month course regimen. during this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. a shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. the aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,

in order to evaluate the efficacy and safety of the 4-month test gatifloxacin-containing regimen, comparison will be made with a standard 6-month regimen, recommended by who. patients will be treated with one of the two regimens that will be randomly allocated. a total of 2070 patients will ne recruited in the trial and followed-up for a duration of 2 years. the trial is multicentre, and conducted in 5 countries in africa.

Eligibility criteria:
inclusion criteria: * male or female patients * aged 18 to 65 years * currently suffering from recently diagnosed microscopically proven pulmonary tuberculosis and providing informed consent for inclusion in the study. exclusion criteria: * patients with history of tuberculosis treatment within the last 3 years * history of diabetes mellitus or non insulin dependent diabetes mellitus requiring treatment * concomitant infection requiring additional anti-infective treatment (especially anti-retroviral therapy) * hiv infected patients with who stage 3 infection - except those presenting with only the "loss of weight\>10% body weight" criterion - and all hiv infected patients at who stage 4.

Keywords: tuberculosis treatment quinolone short course chemotherapy
clinical and biochemical evaluation of 1% metformin in non-surgical treatment of periodontitis

Conditions: Periodontitis

Summary: the aim of the study to evaluate the clinical and biochemical efficacy of 1% metformin gel in treatment of periodontitis patients


Eligibility criteria:
inclusion criteria: * patients with stage iii grade a periodontitis. * systemically free according to the modified burkitt's health history questionnaire, group i. (glick et al., 2021). * good compliance with the plaque control instructions following initial therapy. * availability for follow up and maintenance program. exclusion criteria: * smokers * pregnant and lactating females. * vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).