Kornimate/medical-research-clean huggingface dataset:
ccr2 pet for pancreatic cancer imaging and prediction of response to standard and ccr2-targeted therapy

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: currently there is no clinical biomarker that can be used to select patients for ccr2-targeted therapy and to monitor response to such therapy. considering the toxicity and the rate of response to ccr2-targeted therapy, it is crucial to be able to identify patients who may not response to this therapy in order to avoid the morbidity and expense associated with ineffective therapy. therefore, the combination of the novel ccr2 imaging agent with the novel ccr2-targeted therapy in this trial is of great importance to promote science while prolonging the life and its quality in patients with pdac. the investigators also believe that this combination will make substantial contributions to the fields of cancer immunotherapy and tumor monocyte/macrophage biology. moreover, this imaging agent has the potential to not only facilitate development and testing of future ccr2-targeted therapeutic agents but also serve as a prescreen tool to select appropriate patients for imaging guided treatment.


Eligibility criteria:
inclusion criteria: * adult patients 18 years of age or older with: * newly diagnosed early-staged localized pancreatic ductal adenocarcinoma (pdac) scheduled to undergo whipple procedure (cohort 1a) or down-staged after neoadjuvant chemotherapy now eligible to undergo resection or * borderline resectable, locally advanced, metastatic, or recurrent pdac (cohort 1b) scheduled to undergo chemotherapy or * borderline resectable, locally advanced pdac (cohort 2) who is eligible and / or signed consent to undergo ccr2-targeted therapy example:\[(phase 1/2 clinical trial combining an oral ccr2/5i (bms-813160) with chemotherapy (gemcitabine plus nab-paclitaxel) and anti-pd-1 (nivolumab), pi, dr. kian lim) hrpo #201806007 - closed to accrual march 2022\] and * at least one measurable \[defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with ct scan or mri\] a cohort 1b subject who has been previously treated for pdac with a diagnosis of recurrence and a lesion size of 1.5 cm or greater will be allowed to enroll before institution of therapy or within 20 days after starting a 2nd line or later (new therapy) for recurrent disease. * able to give informed consent * not currently pregnant or nursing: subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64cu-dota-ecl1i) is negative exclusion criteria: * patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years * unable to tolerate up to 90 min of pet/ct imaging per imaging session.
comparison of coagulation profiles between zoely and minidoz: rct

Conditions: Contraception; Hypercoagulability

Summary: the purpose of this study is to compare the effects of zoely® and minidoz® on hemostatic profiles

compare the effects of zoely® and minidoz® on hemostatic profiles : d-dimer, antithrombin and fibrinogen

Eligibility criteria:
inclusion criteria: * woman age 19-40 yr * normal uterus and both adnexae * bmi \< 28.5 kg/m2 * require contraception with cocs exclusion criteria: * pregnancy * postartum period within 6 wk * smoking * bp ≥ 140/90 mmhg * contraindication to cocs : vte, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, ca breast, dm with dn/dr * use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system * use contraceptive steroids within 3 months
zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy in patients with untreated metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective of this study is to compare the effect of zimberelimab (zim) and domvanalimab (dom) in combination with chemotherapy relative to pembrolizumab (pembro) in combination with chemotherapy on overall survival (os) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.


Eligibility criteria:
key inclusion criteria: * life expectancy ≥ 3 months. * pathologically documented nsclc that meets both of the criteria below: * have documented evidence of stage iv nsclc disease at the time of enrollment (based on american joint committee on cancer (ajcc), eighth edition). * have documented negative test results for epidermal growth factor receptor (egfr) and anaplastic lymphoma kinase (alk) mutations. * have no actionable genomic alterations such as ros proto-oncogene 1 (ros1), neurotrophic tyrosine receptor kinase (ntrk), proto-oncogene b-raf (braf), ret mutations, or other driver oncogenes with approved frontline therapies. * have not received prior systemic treatment for metastatic nsclc. * measurable disease per recist v1.1 criteria by investigator assessment. * eastern cooperative oncology group performance status (ecog ps) score of 0 or 1. * have adequate organ functions. key exclusion criteria: * have mixed small-cell lung cancer (sclc) and nsclc histology. * positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period. * received prior treatment with any anti-pd-1, anti-pd-l1, or any other antibody targeting an immune checkpoint. * known hypersensitivity to the study drug, its metabolites, or formulation excipient. * have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment. * have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). * are receiving chronic systemic steroids. * have significant third-space fluid retention. * have untreated central nervous system (cns) metastases and/or carcinomatous meningitis. * active chronic inflammatory bowel disease (ulcerative colitis, crohn's disease) or gastrointestinal perforation within 6 months of enrollment. * has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * has had an allogenic tissue/solid organ transplant. * have received a live-virus vaccination within 30 days of planned treatment start. seasonal flu and covid-19 vaccines that do not contain live virus are permitted. * have known active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. note: other protocol defined inclusion/exclusion criteria may apply.
conjoint analysis of patient preferences in joint interventions

Conditions: Arthritis; Femoroacetabular Impingement; Osteochondritis Dissecans; Hip Fractures; Ankle Fractures; Tibial Fractures

Summary: this study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (fai), osteochondritis dissecans, achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. this study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.


Eligibility criteria:
inclusion criteria: * patient age criteria for each condition is listed below: 1. hip arthritis: 50-80 years 2. knee arthritis: 50-80 years 3. hip labral tears and fai: 18-65 4. osteochondritis dissecans: parents with children between the ages of 8-18 5. achilles tendon rupture: 25-60 years 6. patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age 7. distal radius fracture: 18-80 years 8. hip fracture: 50-85 years 9. ankle fracture: 18-80 years 10. tibia fracture: 18-80 years 11. proximal humerus fracture: 18-80 years 12. ankle arthritis: 40-80 years exclusion criteria: * inability to read, understand and give effective english consent
midfoot fusion bolt (mfb) in the early stage of diabetic-neuropathic charcot feet

Conditions: Diabetes Mellitus 1 or 2; Midfoot Charcot Neuroarthropathy

Summary: randomized clinical trial (rct) to compare treatment failure rates of surgical arthrodesis with mfb against cast treatment in patients suffering from early stage charcot neuroarthropathy (cn) of the midfoot (sella and barrette stages 0, 1 or 2) within the first 2 years after initial treatment. treatment failure is defined as the occurrence of one or more of the following: 1. amputation, 2. occurrence of ulcer or worsening of existing ulcer, 3. surgical intervention for correction of deformity after initial treatment. the secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients with diabetes mellitus type i or ii * cn stages 0, 1 or 2 of the midfoot (sella and barrette classification) * willingness and ability to participate in the study follow-up according to the protocol * ability to understand and read local language at elementary level * signed informed consent exclusion criteria: * legal incompetence * previous charcot foot on the affected side * active osteomyelitis in the affected foot * above knee amputation on the contralateral side * patient health status not adequate for surgery * active malignacy * severe peripheral arterial disease (ankle-brachial index \<0.7 or absent digital waveforms on doppler) * ulcer grade 2 or more on the wagner classification system * alcohol or drug abuse * life-threatening co-morbidities

Keywords: sella and barrete stage 0 1 or 2
development and validation of a deep learning algorithm to evaluate endoscopic disease activity of ulcerative colitis.

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to develop an artificial intelligence(ai) assisted scoring system, which can evaluate the disease severity and mucosal healing stage in patients with ulcerative colitis. then testify whether this new scoring system can help physicians to enhance the accuracy of disease severity assessments in a multi-center clinical practice.

ulcerative colitis is a non-specific chronic inflammation of gut characterized by referral bloody stool, diarrhea and abdominal pain. endoscopic features of the disease severity and mucosal healing stage are strongly associated with treatment response and prognosis in the future. currently, the mayo endoscopic sub-score (mayo es) and ulcerative colitis endoscopic index of severity (uceis) are commonly recommended to guide therapeutic adjustments. however, the accuracy of these scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. recently, deep learning algorithm based on convolutional neural network (cnn) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. up to now, no randomized controlled trials have been conducted to evaluate the performance of deep learning algorithm for assessing disease activity in ulcerative colitis. this study aims to train a deep learnig algorithm to assess severity and mucosal healing stage of ulcerative colitis using the mayo es and uceis scale, then testify whether the engagement of ai can improve the evaluation accuracy of physicians in a multi-center clinical practice.

Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis undergoing colonoscopy exclusion criteria: * known or suspected bowel obstruction, stricture or perforation * compromised swallowing reflex or mental status * severe congestive heart failure (new york heart association class iii or iv) * uncontrolled hypertension (systolic blood pressure \> 170 mm hg, diastolic blood pressure \> 100 mm hg) * pregnancy or lactation * hemodynamically unstable * colonic surgery history * bad bowel preparation (segmental bbps\<2) * unable to give informed consent

Keywords: ulcerative colitis deep learning convolutional neural network
caffeine vs. ala in bms treatment. (bms: burning mouth syndrome. ala: alpha-lipoic acid.)

Conditions: Caffeine; Burning Mouth Syndrome

Summary: the aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

the etiology of bms is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. neurologically, bms has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like trpv1 and p2x3 in the pathogenesis of bms. hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition. caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. as a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. it affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. additionally, caffeine has mild anti-inflammatory properties. its stimulatory effects may also improve mood and cognitive function.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age * diagnosis of bms according to the 3rd edition of the international classification of headache disorders (ichd-3) * daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months * normal oral mucosa and sensory testing * condition not better accounted for by another ichd-3 diagnosis exclusion criteria: 1. secondary bms due to local or systemic disorders 2. prior treatment for bms 3. psychiatric or progressive neurological disorders 4. systemic disorders potentially associated with oral disease 5. long-term history of smoking, drinking, or medication use 6. consumption of caffeinated products 7. poor oral hygiene 8. abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin b12 levels) 9. incomplete medical records 10. unwillingness to participate
efficacy and safety of imotun capsule in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: efficacy and safety of imotun capsule in osteoarthritis of the knee

a six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of imotun capsule in osteoarthritis of the knee

Eligibility criteria:
inclusion criteria: * agreement with written informed consent and 40 years of age and older * patients with more than 63months history of oa of knee according to acr criteria * radiographic evidence of kellgren \& lawrence grade ii to iii oa of the knee * the 100mm pain vas is over 40mm * the lequensne's index is over 5 exclusion criteria: * treatment with sysadoa within 3 months * history of joint surgery within 5 years or arthroscopic surgery within 1year * intra-articular injections within 3 months * treatment with nasids within 7 days * any history of adverse reaction to the study drugs * clinically significant hepatic, renal, cardiovascular diseases * patients with gastrointestinal ulcers or bleeding disorders * pregnant women, nursing mothers or fertile women who not practice contraception with appropriate methods * history of drug abuse or alcoholism * patients on any other clinical trial or experimental treatment in the past 4 weeks * an impossible one who participates in clinical trial by investigator's decision

Keywords: osteoarthritis of the knee
reducing symptoms of depression, stress and anxiety and enhancing positive mental health: a randomized-controlled study of the positive emotions training

Conditions: Positive Emotions; Mental Health; Intervention (Training) Condition; Randomized Controlled Study; General Population (no Specific Condition or Disease)

Summary: based on the results of the previously published paper "positive emotions training (poet) as an online intervention to improve mental health: a feasibility study" (niemann et al., 2023) the goal of this study was to examine the effects of the "positive emotions training" on mental health in a randomized-controlled study. furthermore, possible predictors for the efficacy of poet are to be explored. hypotheses: 1. it was hypothesized that participants receiving poet would show a significant increase in positive mental health factors at the second assessment point (t2) at end of the second training day. 2. furthermore, participants receiving poet are to be expected to show a significant decrease in depression, anxiety and stress symptoms at t2. 3. it was hypothesized that the changes in mental health factors remain stable up to the last assessment point (t3) three month after the training. 4. lastly, it was hypothesized that there would be no significant changes in the positive or negative mental health factors in the control group at t2 and t3. 5. the possible predictors of the training's efficacy were not hypothesized, but examined in exploratory investigations. methods: the final sample was n = 207 with n = 90 in the poet group and n = 117 in the control. the control group did not receive any intervention in the experimental period, but was offered to participate in a later poet. the allocation was randomized. participants in the poet group completed two online training sessions (3 hours each) via zoom. group size was about 25-30 people. the sessions included the following positive psychology constructs: happiness, humour, optimism, loving kindness and gratitude on the first day, and hope, self-efficacy, meaningfulness, forgiveness and resilience on the second day. all participants completed a questionnaire at the beginning of the first training session, at the end of the second one as well as three months after the second session. participants were given an exercise booklet for all exercises (during the training sessions and at home). the one-week break between the two sessions was advertised as a "7-day-challenge" to improve the motivation in participants to exercise at home. data was collected pseudonymised via "qualtrics". data analyses were conducted with rstudio. for the possible effects of poet on mental health two-factorial repeated measures anovas were conducted. for the exploration of possible predictors for the efficacy of the training, a hierarchical regression was conducted.


Eligibility criteria:
inclusion criteria: * legal age (18), ability to use zoom and all associated technology exclusion criteria: * none

Keywords: positive emotions online intervention positive psychology randomized controlled study intervention general population
pharmacogenetic effect on the pharmacodynamics of glibenclamide

Conditions: Diabetes

Summary: glibenclamide is metabolized by the hepatic enzyme p450 cyp2c9 to less active form. polymorphism of this enzyme demonstrated clinical significance when examined on other drugs from the sulfonylurea drug family, to whom glibenclamide is included. the investigators assumption is that patients with less active alleles of the enzyme may show lower dose requirements of the drug for glycemic control, when compared to patients homozygotes to wild-type alleles.


Eligibility criteria:
inclusion criteria: * tx with metformin and glibenclamide exclusion criteria: * tx which affecting the p450 2c9 action * renal failure
ext. long-term safety study in cf patients: single arm tip

Conditions: Long-term Safety of TIP

Summary: the purpose of this extension study is to collect additional 48 weeks of safety data from patients taking tip who have completed the core study ctbm100c2401. the purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of tip.


Eligibility criteria:
inclusion criteria: * completion of the core study ctbm100c2401 and able to comply with all protocol requirements of the extension study exclusion criteria: * serum creatinine 2mg/dl, bun 40mg/dl or proteinuria 2+ or more at the time of entry into the extension * use of loop diuretics within 7 days prior to entry into the extension study * pregnant or nursing women * women of child bearing potential unless using highly effective method of contraception as indicated in the protoco

Keywords: cf, open-label, tip, phase iv, extension study
enhancing mhealth technology to activate chronic care patients

Conditions: Diabetes Mellitus, Type 2

Summary: multi-site feasibility study designed to assist type-2 diabetes patients in self-care activities. the study includes bluetooth-enabled medical devices (i.e. scales, blood pressure cuffs, glucometers, and activity monitors) for both intervention and control groups. those in the intervention group will have the devices linked too a mobile health care environment that provides key benefits that include: device data trending, reinforcing tailored behavioral messages, and enhanced communication with the clinic.

multi-site phased study, conducted within the military health system that includes a user-centered design phase and a patient centered medical home (pcmh)-based feasibility trial. in phase i the investigators will assess both patient and clinician preferences and usability regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic self-care management. the data from the experience will be coded and analyzed by the research team and the technology will be adapted accordingly before phase ii. phase ii research is a single-blinded 12-month feasibility study that seeks to include the enabling technology to support diabetes self-care management with tailored behavioral messaging aimed at reinforcing and encouraging self-care behavior based on patients' readiness. we have included safety thresholds that alert patients and clinical team under certain conditions.

Eligibility criteria:
inclusion criteria: * men and women age 18 years or older, * ability to understand and read english, * be empanelled to one of the target pcmh sites, and * diagnosed with type 2 diabetes. exclusion criteria: * pregnant women, * non-english speaking patients, * receiving hospice care, * active cancer and treatment with chemotherapy or radiation therapy, * taking coumadin, * recipient of gastric bypass or similar procedure, * diagnosis of uncontrolled hypothyroidism, * known cushing's syndrome, * being treated with oral steroids, * known liver disease, * current diagnosis of cognitive impairments which would interfere with use of technology, * congestive heart failure new york heart association class 3 or 4, * inability to use a mobile device due to cognitive or physical impairments, and * pam® score = 4 during initial screening.