Kornimate/medical-research-clean huggingface dataset:
targeted imaging of melanoma for alpha-particle radiotherapy

Conditions: Melanoma (Skin); Melanoma Stage IV; Melanoma, Uveal; Melanoma, Mucosal

Summary: the study hypothesis is that new imaging agents \[203pb\]vmt01 and \[68ga\]vmt02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor (mc1r) by spect/ct and pet/ct imaging modalities respectively.

this is a first-in-human study evaluating the suitability of \[203pb\]vmt01 for spect/ct imaging and \[68ga\]vmt02 for pet/ct imaging of mc1r-expressing metastatic melanoma. study results will provide foundational data to develop imaging and dosing for future therapeutic trials of \[212pb\]vmt01 for the treatment of metastatic melanoma. the study will be a cross-over study with the participants serving as their own comparator. participants with positive fdg-pet scans for stage iv (or inoperable stage iii) metastatic melanoma will undergo spect/ct scans utilizing \[203pb\]vmt01 followed a few weeks later by pet/ct scans utilizing \[68ga\]vmt02, or vice versa. the order of the imaging agents will be randomly assigned.

Eligibility criteria:
inclusion criteria: 1. diagnosed with stage iv metastatic melanoma, or inoperable stage iii equivalent 2. baseline fluorodeoxyglucose (fdg)-pet scan available from within 30 days prior to date of enrollment 3. blood counts and metabolic results within protocol limits within 14 days prior to enrollment 4. ability to lie flat and still for a minimum of two hours for imaging 5. male and female participants with reproductive potential must agree to use highly effective contraception in preparation of the study, during the study, and for 4 weeks following the last dose of an investigative imaging agent 6. documented life expectancy of at least 3 months exclusion criteria: 1. active secondary malignancy 2. prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable 3. pregnancy or breast feeding a child 4. uncontrolled infection 5. treatment with another investigational drug within 30 days prior to enrollment date 6. any treatment with braf inhibitors since the baseline fdg-pet scan or plans for such treatment during the study 7. kidney function not within protocol limits 8. bmi\>40 kg/m2 9. history of a condition resulting in anaphylaxis or angioedema

Keywords: melanoma theranostic radiopharmaceutical radiotherapy alpha-particle diagnostic metastatic single photon emission computed tomography (spect) positron emission tomography (pet) melanocortin receptor sub-type 1 (mc1r) vmt01 vmt02 pb-203 ga-68 cancer immunohistochemistry (ihc)
efficacy and safety of mt-3995 in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to evaluate the efficacy of mt-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (uacr) in the first morning void urine sample as an indicator.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * glycated hemoglobin(hba1c) values (national glycohemoglobin standardization program : ngsp) ≤10.5% * estimated glomerular filtration rate(egfr) of ≥30 ml/min/1.73 m2 * the median uacr of the first morning void urine samples is ≥50 mg/g cr and \<300 mg/g cr * stable blood pressure(diastolic blood pressure (dbp) \<100 mmhg and stable systolic blood pressure (sbp) \<160 mmhg) exclusion criteria: * type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. * a diagnosis of non-diabetic renal disease. * a following serum potassium level. * egfr of 30-59ml/min/1.73m2; serum potassium level of \ 4.7 mmol/l, * egfr of ≥60ml/min/1.73m2: serum potassium level of \ 5.0 mmol/l * symptomatic and clinically significant hypotension(diastolic blood pressure(dbp)\<50mmhg and systolic blood pressure(sbp)\<110mmhg) * qt prolongation or torsades de pointes, or, a history or family history of qt prolongation or torsades de pointes * new york heart association (nyha) class iii or iv heart failure

Keywords: diabetic nephropathy
prostate cancer patient management with 18f-dcfpyl pet/ct

Conditions: Prostate Cancer

Summary: this is a multi-center, single-arm, open-label, phase iii trial in patients with biopsy-proven prostate cancer. patients will receive regular standard of clinical care. the only study-specific procedures will the administration of 18f-dcfpyl followed by a pet/ct scan. differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18f-dcfpyl pet/ct imaging by a central panel of experts will be captured at study completion.

objectives: the primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18f-dcfpyl pet/ct in prostate cancer patients as proposed by a central panel of experts. primary endpoint: 1. differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18f-dcfpyl pet/ct imaging retrospectively by a central panel of experts. secondary endpoints: 1. 18f-dcfpyl pet/ct scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by psa. 2. immediate ae up to 90 minutes post-administration of 18f-dcfpyl.

Eligibility criteria:
inclusion criteria: * male sex * age 18 years or older * previously diagnosed with prostate cancer, under referring physician's care * ecog performance status 0 - 3, inclusive * able to understand and provide written informed consent * able to tolerate the physical/logistical requirements of a pet/ct scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection cohort a - high risk staging (hrs): staging of high risk not previously treated patients as defined by any one of the following: * gleason score \> 7 * serum psa \> 15 ng/ml * t stage of t3 or greater on tnm staging * equivocal/inconclusive conventional staging such as ct, mri or bone scan * clinical suspicion of advance stage disease (e.g. bone pain) cohort b - biochemical recurrence: restaging of biochemically recurrent prostate cancer patients as defined by increasing serum psa on serial measurements and current psa above 0.1 ng/ml following any treatment for prostate cancer. exclusion criteria: * patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * patients who exceed the safe weight limit of the pet/ct bed (usually approximately 400 lbs.) or who cannot fit through the pet/ct bore (usually approximately 70 cm diameter) * patients with unmanageable claustrophobia
a retrospective validations microsatellite instability (msi) testing v mismatch repair (mmr) in gastric adenocarcinoma

Conditions: Gastric Cancer

Summary: to compare the idylla microsatellite instability test versus mismatch repair immunohistochemistry (ihc) in gastric adenocarcinoma.

gastric adenocarcinoma is a common form of cancer which is associated with a poor prognosis. up to 22% of gastric adenocarcinomas arise via the microsatellite instability (msi) / mismatch repair (mmr) pathway. these cases can be detected either by mismatch repair immunohistochemistry (ihc) or microsatellite instability testing. detection of mismatch repair deficiency or microsatellite instability is important because patients with this type of gastric adenocarcinoma are shown to benefit from a different therapeutic approach. high concordance between mismatch repair immunohistochemistry and microsatellite instability testing has already been demonstrated. the implementation of either method is largely based on local availability. the idylla msi test presents a novel method of establishing msi status in comparison to pre-existing msi testing platforms. the idylla msi tests uses a fully automated, ultra-rapid system that can work on formalin-fixed, paraffin embedded tissue with no need for preceding dna extraction. implementation of the idylla msi test could reduce reporting turnaround times and requires less technical expertise to perform in comparison to other platforms. the investigators department does not currently have the facilities to perform msi testing on any platform, so the advantages of introducing the idylla msi test would also include the generic advantages of msi testing. these advantages include: the ability to quickly check cases shown to have possible mmr loss on ihc (i.e. equivocal cases) with msi testing; and providing an alternative to mmr ihc for screening of lynch syndrome, reducing the burden on reporting pathologists and reduce the inter-observer variability associated with ihc interpretation. the idylla msi test already demonstrates high concordance with other msi testing platforms but has yet to be compared to the department's accepted standard of mmr ihc. this project aims to compare the idylla msi test to in-house mmr ihc to establish whether the two methods are concordant in reporting mmr / msi status in gastric adenocarcinoma.

Eligibility criteria:
inclusion criteria: * patient consent * adequate tissue including adequate tumour burden * diagnosis of adenocarcinoma in this biopsy exclusion criteria: * no patient consent * inadequate tissue or block not present in archive * no adenocarcinoma in biopsy
carpal tunnel release with risk factors for amyloidosis

Conditions: Amyloidosis

Summary: bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. one study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. however, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. in our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. all patients with positive biopsy results would be referred to cardiology. outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.


Eligibility criteria:
inclusion criteria: positive screening is defined as two characteristics from tier 1 or one characteristic from tier 1 and one from tier 2 tier 1 * male \> 50 years old * female \> 60 years old * bilateral carpal tunnel symptoms or prior release surgery tier 2 * spinal stenosis * history of biceps tendon rupture * atrial fibrillation or flutter (active or previous history) * pacemaker * congestive heart failure * family history of transthyretin amyloidosis (attr) exclusion criteria: * unable or unwilling to follow up with cardiology. * previous diagnosis of cardiac amyloidosis.
prospective study of the impact of sleeve gastrectomy on gastro-esophageal junction function

Conditions: Morbid Obesity

Summary: improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. however, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (ger) requiring treatment. improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (ugi series) may not provide adequate preoperative assessment of esophago-gastric dynamics. current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. there is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (gej) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. a more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. as laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. this study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - ct scan- mri - hrm).

Eligibility criteria:
inclusion criteria: * patient, male or female over 18 years old * patient scheduled to undergo a sleeve gastrectomy for obesity * patient with surgical indication validated by the obesity multidisciplinary meeting (rcp) * patient able to understand the study and to provide written informed consent * patient registered with the french social security regime non-inclusion criteria: * patient unable to give written informed consent * patient presenting contra-indication to the conduct of an mri (claustrophobia, implantable medical devices) * patient presenting risks of allergic reaction to mri contrast agents (gadolinium) * patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures * patient pregnant or breast-feeding * patient within exclusion period from other clinical trial * patient having forfeited their freedom of an administrative or legal obligation * patient being under guardianship

Keywords: sleeve gastrectomy oesogastric junction - gej dynamic mri imaging
efficacy evaluation of pitaya ovule extract on skin

Conditions: Skin Condition

Summary: to assess the efficacy of pitaya ovule extract on skin


Eligibility criteria:
inclusion criteria: * 20 to 65-year-old males or females exclusion criteria: * received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial * outdoor workers (exposed to the sun more than 5 hours a day) * people who are breastfeeding, pregnant or planning to become pregnant during the test (self-report) * people with heart, liver, kidney, endocrine and other major organic diseases (self-reported) * people who have undergone major surgery (according to medical history) * people who take drugs for a long time * people with mental illness * students who are currently taking courses taught by the principal investigator of this trial
ceramide cream in treating women with cutaneous breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of ceramide cream in treating women who have cutaneous breast cancer.

objectives: i. determine the objective response rate in women with cutaneous breast cancer treated with topical ceramide cream. ii. determine the time to progression in patients treated with this regimen. iii. determine the toxicity of this regimen in these patients. iv. assess the quality of life of these patients treated with this regimen. outline: topical ceramide cream is applied to all cutaneous lesions twice daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline and then at 1 and 3 months. patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed cutaneous breast cancer for which no curative or significantly palliative therapy exists including chest wall radiotherapy measurable disease disease progression after at least 1 hormonal therapy for estrogen receptor positive disease and after radiotherapy if chest wall disease has been previously irradiated no infection at site of cutaneous metastatic disease hormone receptor status: estrogen receptor status known patient characteristics: age: 18 and over sex: female menopausal status: not specified performance status: ecog 0-3 life expectancy: at least 12 weeks hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: no concurrent biologic therapy during first 2 months of study chemotherapy: no other concurrent local antineoplastic therapy for cutaneous disease no concurrent systemic chemotherapy during first 2 months of study endocrine therapy: see disease characteristics radiotherapy: see disease characteristics at least 4 weeks since prior radiotherapy no concurrent radiotherapy during first 2 months of study except for cns disease surgery: not specified

Keywords: stage iv breast cancer recurrent breast cancer
feasibility study of an enhanced lithotripsy system in the treatment of urinary stone disease

Conditions: Urinary Stone

Summary: this is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the enhanced lithotripsy system, to treat urinary stones.

this is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the enhanced lithotripsy system, to treat urinary stones. subjects will be treated up to 2 times with the enhanced lithotripsy system and followed for 30 days after the last treatment session.

Eligibility criteria:
inclusion criteria: * individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days * males and females aged 18 or older * capable of giving informed consent, and willing to have the informed consent process videotaped * stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less. exclusion criteria: * individuals under 18 years of age * individuals with radiolucent stones * individuals with stones in the lower pole of kidney * individuals not following up in the treating hospital * individuals with history of cystinuria * individuals with urine ph below 5.5 * individuals with untreated urinary tract infection * individuals who are not willing to use adequate method of contraception during the study period * women who are pregnant, lactating or planning pregnancy during the study period * individuals with a coagulation abnormality or taking prescription anticoagulants. * individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side * individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.) * individuals with a body mass index greater than 35 * individuals with asa score of 3 or greater general anesthesia risk level * known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
a study of oral venetoclax tablets and oral azacitidine as maintenance therapy in adult participants with acute myeloid leukemia in first remission after conventional chemotherapy

Conditions: Acute Myeloid Leukemia (AML)

Summary: this study will be conducted in two parts. part 1 will be the dose confirmation portion to determine recommended phase 3 dose (rptd) of venetoclax in combination with azacitidine (aza). part 3 will be the dose finding portion to determine rptd of venetoclax in combination with aza. part 2 and part 3 randomization of the study were removed.


Eligibility criteria:
inclusion criteria: * diagnosis of newly diagnosed acute myeloid leukemia (aml). * participant meets the following disease activity criteria: * confirmation of aml by world health organization (who) criteria (2016) and have confirmed complete remission (cr) or complete remission with incomplete blood count recovery (cri) following completion of intensive induction and consolidation chemotherapies. * achieved first cr + cri within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies. * aml has intermediate or poor risk cytogenetics per national comprehensive cancer network (nccn) 2016 criteria. * eastern cooperative oncology group (ecog) performance status \<= 2. * participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol. exclusion criteria: * history of acute promyelocytic leukemia (apl). * history of active central nervous system involvement with acute myeloid leukemia (aml).

Keywords: acute myeloid leukemia (aml) venetoclax azacitidine (aza) maintenance therapy conventional chemotherapy best supportive care (bsc)
chemomechanical caries removal using papain gel

Conditions: Dental Caries

Summary: to evaluate the efficacy of a papain-based gel in caries removal.

twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. a total of 40 teeth were randomly divided into two treatment groups: group a, papain-based gel; and group b, conventional technique. data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Eligibility criteria:
inclusion criteria: * children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial. * the caries were located on the occlusal surface. exclusion criteria: * children with pathological process of the dental tissue, with pulpal involvement

Keywords: dental caries caries removal chemomechanical caries removal
the quality of life assessment of lung cancer patients in china

Conditions: Lung Cancer

Summary: the goal of this study is assess the quality of life of advanced non-small cell lung cancer (nsclc) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (qol). the method is to use the functional assessment of cancer therapy-lung (fact-l) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. after 3 time-points, investigators analyze all the subscales and constructs of fact-l. the assumption is the quality of life will be better after 2 cycle of chemotherapy.

1. lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (nsclc). the quality of life of nsclc patients become more and more important, because of most nsclc is incurable. 2. the recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Eligibility criteria:
inclusion criteria: * age: \>18 and \<75 years old * pathological or cytological diagnosis confirmed advanced non-small cell lung cancer * eastern cooperative oncology group performance status: 0-2 * have never receive any kind of anti-cancer chemotherapy * agree to regularly assessment of quality of life * sign the informed consent form exclusion criteria: * currently attending any antitumor drug clinical trials * pregnancy or breast-feeding women * currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously. * not suitable to participate in this test

Keywords: lung cancer quality of life fact-l