Kornimate/medical-research-clean huggingface dataset:
treatment of nodular basal cell carcinoma (bcc) with imiquimod 5% cream after curettage

Conditions: Basal Cell Carcinoma

Summary: to assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

the primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular bcc lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. the secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

Eligibility criteria:
inclusion criteria: 1. are willing and able to give informed consent; 2. are at least 18 years of age; 3. are willing to comply with all study requirements, evaluations, and procedures 4. have 1 clinically typical, visible nodular bcc lesion which meets the following criteria: * a primary lesion (not recurrent, not previously treated or biopsied) * non-infected * size between 0.25 and 1.5 cm2 * located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the h-zone of the face * clinically consistent with nodular bcc * histologically consistent with nodular bcc and have no histological evidence of a morpheaform or micronodular pattern * suitable for treatment with surgical excision * easily identifiable and treatable by subject or reliable subject representative 5. are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations. 6. are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits. exclusion criteria: 1. have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study. 2. have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination. 3. have a bcc lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline. 4. are pregnant at the screening or treatment initiation visit. 5. have known allergies to any excipient in the study cream 6. have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. in addition, skin in the potential application area must be healed.

Keywords: imiquimod cream nodular basal cell carcinoma curettage
open label trial to assess iressa in prostate cancer patients

Conditions: Prostate Cancer

Summary: a study to assess the activity of iressa in patients who's prostate cancer has recurred, and who have rising psa levels


Eligibility criteria:
inclusion criteria: * prostate cancer diagnosis * no evidence of metastasis * age 18 or older exclusion criteria: * prior chemotherapy for recurrent prostate cancer * radiotherapy completed within 28 days of starting the study * incomplete healing from prior cancer or other major surgery

Keywords: iressa gefitinib prostate cancer psa
a study combining folfox or folfiri with ag-013736 or bevacizumab (avastin) in patients with metastatic colorectal cancer after failure of one first line regimen

Conditions: Colorectal Neoplasms

Summary: the study is designed to demonstrate that the combination of ag-013736 with either folfiri or folfox is superior to folfiri or folfox in combination with bevacizumab (avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.


Eligibility criteria:
inclusion criteria: * histologically documented colorectal cancer plus one of the following: * failure of one prior irinotecan- or oxaliplatin-containing regimen, or * adjuvant refractory to irinotecan- or oxaliplatin-containing regimen. exclusion criteria: * prior treatment in first line metastatic setting with more than one regimen * prior irradiation of more than 25% of bone marrow.
apatinib and etoposide in patients with platinum resistant or refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients with platinum resistant or refractory ovarian cancer when combined with etoposide.

ovarian cancer is the leading cause of death for patients with gynecologic malignancies. in most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. however, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. therefore, it is important to seek alternative agent that can improve the outcome. apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor and it has been approved for the treatment of advanced gastric cancer. the preclinical studies suggest apatinib may be effective in other cancers such as ovarian cancer. therefore, the purpose of this study is to test the efficacy and safety of the study drug apatinib when combined with a standard treatment, etoposide, for patients with platinum resistant or refractory ovarian cancer.

Eligibility criteria:
inclusion criteria: * histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. * platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) or platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy) * at least treated with one line of platinum-based chemotherapy * female, age ≥18 years and ≤70 years, signed informed consent. * eastern cooperative oncology group (ecog) performance status 0-2 * measurable disease according to response evaluation criteria in solid tumors (recist) 1.1 version * patients must have a life expectancy of at least 3 months. * patients must have adequate organ function as defined by the following criteria: * white blood cell count ≥ 3 x 10\^9/l, absolute neutrophil count (anc) (≥ 1.5 x 10\^9/l), hemoglobin of ≥ 80 g/l, platelets ≥ 70 x 10\^9/l * total bilirubin ≤ 1 x upper limit of normal (uln), ast and alt ≤ 2 x uln * serum creatinine ≤ 1 x uln exclusion criteria: * had prior exposure to apatinib or has known allegies to any of the excipients. * history of myocardial infarction, or unstable angina, or new york heart association (nyha) grade iii-iv within 6 months prior to day 1. * patients with qt interval prolongation * serious, non-healing wound, active ulcer, bowel obstruction. * history of abdominal fistula or gastrointestinal perforation within 28 days prior to day 1 * evidence of bleeding diathesis or coagulopathy * inadequately controlled hypertension * major surgical procedure within 28 days prior to day 1 * symptomatic central nervous system (cns) metastasis

Keywords: ovarian cancer apatinib etoposide chemotherapy
mmp14(mt1-mmp) targeting bicyclic peptide probe for pet imaging in solid tumors

Conditions: Solid Tumor

Summary: the objective of the study is to construct a noninvasive approach using 68ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (mmp14, mt1-mmp) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from mmp14 targeting treatment.

analysis plan: 1. recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (fih), major organ distribution, and tumor uptake information via whole-body pet/ct imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. recruit all participants for a final summary.

Eligibility criteria:
inclusion criteria: 1. malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology; 2. age ≥18 and ≤75 years old, male or female; 3. ecog score 0 or 1; 4. expected survival time ≥6 months; 5. there was at least one measurable target lesion according to recist1.1 criteria, and biopsy could be performed within one month before and after pet scan, and the patient could provide 2-3 lesion tissue slides; 6. women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination; 7. patients recommended by clinicians to undergo pet/ct examination for tumor staging; 8. the subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent. exclusion criteria: 1. pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes. 2. individuals known or suspected to be allergic to the investigational drug or any of its components. 3. individuals with significantly abnormal liver or kidney function: serum total bilirubin (tbil) \> 1.5 × 20 µmol/l, or aspartate aminotransferase (ast) \> 2.5 × 45 µmol/l, or alanine aminotransferase (alt) \> 2.5 × 40 µmol/l, or serum creatinine \> 1.5 × 130 µmol/l. 4. unable to cooperate in completing the pet scan, or suffering from claustrophobia or other conditions that prevent cooperation during the pet scan. 5. other situations deemed inappropriate for participation in the trial by the investigator. female patients who are pregnant or breastfeeding.

Keywords: solid tumor mmp14 mt1-mmp pet imaging
vitaltraq for the detection of crs

Conditions: Hematologic Malignancy

Summary: the purpose of this study is to evaluate two vital sign monitoring devices, temptraq and vitaltraq, in patients with hematologic malignancies undergoing therapy with chimeric antigen receptor t-cell therapy (car-t) or bispecific t-cell engagers (bite) products. temptraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. vitaltraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (bp), heart rate (hr), heart rate variability (hrv), and respiratory rate. these remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (crs) and febrile neutropenia.


Eligibility criteria:
inclusion criteria: 1. adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (car) t-cell therapy or bispecific t-cell engagers (bite), as follows: * axicabtagene ciloleucel * lisocabtagene maraleucel * brexucabtagene autoleucel * idecabtagene vicleucel * ciltacabtagene autoleucel * obecabtagene autoleucel * tisagenlecleucel * blinatumomab * mosunetuzumab * talquetamab * elranatamab * teclistamab * glofitamab 2. owns a smart phone (e.g., iphone, android, samsung) that is compatible with the vitaltraq app and that can connect to wi-fi. this will be assessed at screening. 3. able to read and understand english 4. willing and able to provide informed consent to the study exclusion criteria: 1. receiving a non-fda approved car-t or bite product 2. receiving epcoritamab
sleep and pain interventions in women with fibromyalgia

Conditions: Fibromyalgia; Insomnia; Chronic Widespread Pain

Summary: insomnia affects 67-88% of chronic pain patients. spin ii is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. this trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

this mechanistic trial will assess sleep, pain, arousal, and neural imagining outcomes at baseline, post-8 week behavioral treatment (cbt-i or she), as well as at 6 and 12 month followups. this information will provide novel information about the neural structures and functional networks associated with chronic pain, and their manipulation through a cognitive behavioral intervention to improve insomnia. demonstration that a relatively brief intervention can reverse or resolve pain related maladaptive neural plasticity, and improve or resolve clinical pain symptoms would have immediate and far-reaching implications for millions of chronic pain sufferers as well as for the us healthcare system and economy.

Eligibility criteria:
inclusion criteria: * female * 18+ years of age * willing to be randomized * can read and understand english * diagnosed with fibromyalgia and insomnia * no prescript or over the counter pain or sleep medicaments for 1+ month exclusion criteria: * unable to provide informed consent * cognitive impairment * sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder * bipolar or seizure disorder * other major psychopathology (other than depression or anxiety) * psychotropic or other medications that alter pain or sleep * participation in non-pharmacological treatment (including cbt) for pain, sleep, or mood outside current trial * internal metal objects or electrical devices * pregnancy
a single ascending dose study assessing the safety, tolerability, pk and pd of myk-491

Conditions: Dilated Cardiomyopathy

Summary: up to 72 healthy volunteers will be given a single dose of myk-491 or placebo and be monitored for safety and tolerability over a 7 day period.

up to 72 healthy volunteers will be given a single dose of myk-491 or placebo and be monitored for safety and tolerability over a 7 day period. after the 28 day screening period, the eligible subject will be admitted to the clinical site and will receive a single dose of study drug or placebo. subjects will be confined to the clinical site for five days (day -1 to day 4) and will return to the clinic on day 7 for a safety follow-up.

Eligibility criteria:
inclusion criteria: * weight between 60 and 90 kg inclusive * resting heart rate of \< 80 beats per minute * documented lvef greater than or equal to 55% during screening * normal electrocardiogram (ecg) at screening * normal acoustic windows on transthoracic echocardiograms at screening * all safety laboratory parameters within normal limits at screening * history or evidence of another clinically significant disorder, in the opinion of the investigator. exclusion criteria: * active infection * history of coronary artery disease * history of malignancy with the exception of in situ cervical cancer more than 5 years prior to screening or surgically-excised non-melanomatous skin cancers more than 2 years prior to screening * positive serology tests at screening * current use of tobacco or nicotine-containing products exceeding 10 per day.
impact of tooth loss and denture on oral senses and food preferences

Conditions: Tooth-loss

Summary: tooth loss impacts taste abilities and food intake. present study aims at pertaining the impact of teeth loss and the replacement by means of complete denture on taste and trigeminal abilities, and on food preferences, and taste appetence.

two groups of participants will be included. participants wearing complete denture for at least one year (n=20) and their matched controls for age, sex, tobacco, and saliva secretion (n=20). their oral sensory abilities of participants will be assessed including taste (electrogustometric thresholds, chemical taste identification ability) and trigeminal quantitative sensory testing. food preferences and selectivity (maitre et al., 2014) and taste appetence (deglaire et al., 2012) will also be assessed.

Eligibility criteria:
inclusion criteria: study group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. controls: controls group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in angle's class i occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate. exclusion criteria: * aged under 18 or over 80 y, * not consenting to participate * suffering from dental * periodontal or gum pain for the last month.

Keywords: teeth loss edentulousness denture tast trigeminal senses oral sensory ability
"outwalk ms" - benefits of outdoor walking in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwms), furthermore having a negative influence on well-being. studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwms. this may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwms and (2) advantageous due to the health benefits offered through the interaction with nature itself. both these aspects are also relevant for well-being. few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwms. the purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwms.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * self-reported clinical ms diagnosis * pdds ≤ 4 (corresponding to preserved walking capacity without assistive devices of at least 10 m) * able to independently attend the testing exclusion criteria: * self-reported comorbidities excluding participation in the intervention * recent (6 months retrospective) fractures, amputation or other critical physical impairments that eliminates participation in the described training study * participation in structured exercise therapy (including walking) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)

Keywords: exercise walking
24-hour glycemia: rosiglitazone versus glimepiride in type 2 diabetes

Conditions: Non-Insulin-Dependent Diabetes Mellitus

Summary: a better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. the objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).


Eligibility criteria:
inclusion criteria: * males and females aged 40 to 80 years * diagnosis of type 2 diabetes mellitus for at least 6 months * body mass index (bmi) ≥25kg/m2 * 7%≥hba1c ≤ 9% at visit 2 * treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1 * female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures * written informed consent exclusion criteria: * use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening * significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure * subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis * subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1 * subjects with a history of severe hypoglycaemia * anemia defined by haemoglobin concentration \<11.0g/dl for males or \<10.0g/dl for females * renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/l in males and ≥110µmol/l in females * presence of clinically significant hepatic disease (i.e. alt, ast, total bilirubin or alkaline phosphatase \>2.5 times the upper limit of the normal reference range) * congestive heart failure (nyha class i to iv), unstable or severe angina, recent myocardial infarction * subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids * female who are lactating, pregnant, or planning to become pregnant * any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ecg, ...) * use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study * active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance * subjects not willing to comply with the procedures described in this protocol.

Keywords: type 2 diabetes rosiglitazone metformin glimepiride glycemia
linking cognitive functioning to multimodal imaging in multiple sclerosis (ms)

Conditions: Multiple Sclerosis; Cognition Disorders

Summary: multiple sclerosis (ms) is the most common progressive neurologic disorder to occur in adults of working-age. despite longstanding recognition of cognitive impairment as a symptom of ms, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. first is the absence of a sensitive and precise measure of cognitive impairment. second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. this project overcomes both obstacles to link cognitive impairment to ms disease biomarkers. the absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (ms). this project overcomes both obstacles to link cognitive function to ms disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (tecfidera) for preserving cognitive function.


Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. 2. male and female subjects between 18 and 45 years 3. wrat-4 reading \[127\] standard score \> 85 4. able to undergo neuroimaging data collection procedures. for ms participants 5. definite diagnosis of rrms \[128\] 6. edss of 0 to 6.0 7. adequate vision as as reported by the participant (with correction if applicable) 8. clinically prescribed tecfidera, tysabri or ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit 9. at baseline visit, concurrent medications to be kept constant over three months prior to data collection visits 10. no relapse or steroids in previous month exclusion criteria: 1. unable or unwilling to provide informed consent. 2. beck depression inventory-fast screen (bdi-fs) \[129, 130\] score of 4 or more 3. current alcohol or other substance use disorder 4. primary psychiatric disorder that would adversely influence ability to participate 5. other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury) 6. other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction) 7. learned english language after 12 years of age 8. for low absolute low lymphocyte count (alc), uspi guidance will be utilized. for ms participants: 9. lemtrada, cladribine, mitoxantrone