Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lobeglitazone versus sitagliptin

Conditions: Diabetes Mellitus, Type 2

Summary: efficacy and safety of lobeglitazone versus sitagliptin in inadequately controlled by metformin alone type 2 diabetes mellitus patients with metabolic syndrome.

efficacy and safety of lobeglitazone versus sitagliptin in inadequately controlled by metformin alone type 2 diabetes mellitus patients with metabolic syndrome: 24-week, multi-center, randomized, double-blind, phase 4 study.

Eligibility criteria:
inclusion criteria: * ≥19 years old * waist line: male ≥ 90cm, female ≥ 85cm * applied to 1 or more categories listed below (ncep-atp iii) 1. sbp ≥ 130mmhg and/or dbp ≥ 85mmhg and/or taking drug for bp control 2. hdl-c: male \< 40mg/dl, female \< 50mg/dl and/or taking drug for hdl-c increase 3. tg ≥ 150mg/dl and/or taking drug for tg control * at visit 1: applied to 1 or more categories listed below 1. type 2 dm patients who does not need stabilization period : 7% ≤ hba1c ≤ 10%, if treated with metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → visit 3(randomization) 2. type 2 dm patients who need stabilization period : 7% ≤ hba1c ≤ 10%, if not treated with metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (applied to 1 or more categories listed below) ① drug naïve ② taking metformin \< 1000mg monotherapy and/or taking metformin \< 12 weeks prior to this study ③ taking oha * at visit 2(after 12 weeks of stabilization period): 7% ≤ hba1c ≤ 10% * patients who signed informed consent form exclusion criteria: * type 1 dm patients or secondary dm * patients with ketoacidosis * patients with taking insulin \> 7 days within 12 weeks * hypersensitive to biguanide and/or glitazone and/or dpp4-inhibitor * patients with taking corticosteroid \> 7 days within 4 weeks * patients with lactic acidosis * patients with galactose intolerance and/or lapp lactase deficiency and/or glucose-galactose malabsorption * patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease * history of malignant tumor within 5 years * history of drug or alcohol abuse within 12 weeks * patients with congestive heart failure(nyha class iii\~iv) or uncontrolled arrythmia within 6 months * patients with acute cardiovasvular disaese with 12 weeks * applied to 1 or more categories listed below 1. ast and/or alt ≥ 3\*uln 2. serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl 3. hb \< 10.5g/dl * women with pregnant, breast-feeding * childbearing age who don't use adequate contraception * patients who have participated in other clinical trials * not eligible to participate for the study at the discretion of investigator
efficacy of an anorectal fistula plug with sealing of the internal opening as a treatment for perianal fistula

Conditions: Fistula in Ano

Summary: the investigators aim to assess the efficacy of the curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. healing of the fistula tract will be assessed both clinically and radiologically with mr imaging.

perianal fistula is a challenging condition for colorectal surgeons. achieving a favourable balance between healing and incontinence is the key to success. surgeons have adopted many methods to close off this abnormal tract, which include laying opening, use of setons, advancement flaps and permanent stoma. a more recent approach has been the use of devices or substances to block the tract in the hope that it will seal off. most of the devices that have been used to close the tract have not proved to be as effective in healing as a lay open with high rates of fistula persistence. a major failure of the devices has been their early expulsion and their inability to seal off the internal opening. the new curaseal plug may be able to overcome these shortcomings. this plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure. the investigators aim to assess the efficacy of the curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. healing of the fistula tract will be assessed both clinically and radiologically with mr imaging.

Eligibility criteria:
inclusion criteria: * patients who are psychologically stable and suitable for intervention and able to provide informed consent * patients who are willing and competent to fill in questionnaires and undergo investigations at various time points during the study * patients with an idiopathic extra and trans-sphincteric perianal fistula. exclusion criteria: * patients aged less than 18 or \>80 years. * patients unfit to undergo general or spinal anaesthesia. * patients with a supra-levator fistula. * patients with a rectovaginal fistula. * patients with inflammatory bowel disease (crohn's disease, ulcerative colitis). * patients with a fistula secondary to trauma, foreign body, developmental cyst or pelvic irradiation. * patients who are immunosuppressed.
microenvironment and immunity of digestive cancers - east paris multicentric cohort

Conditions: Colorectal Cancer; Pancreas Tumor; Biliary Tract Tumor; Immune System and Related Disorders

Summary: colorectal and pancreatobiliary cancers are the most common digestive cancers. their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. in addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies. tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. the links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored. objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers. method: retrospective and prospective monocentric cohort study


Eligibility criteria:
inclusion criteria: * colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma * cytologically or histologically proven adenocarcinoma, regardless of stage and treatment * age ≥ 18 years old * diagnosed from 2015 onwards * signed consent * affiliation to a social security scheme (including cmu (universal health coverage)) exclusion criteria: * patient under guardianship, curatorship or safeguarding of justice * pregnant or breastfeeding woman * any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment. * refusal to participate in the study * patient on ame (state medical assistance) * persons deprived of liberty by a judicial or administrative decision * persons under psychiatric care
single rotary file system versus conventional manual k-file in pulpectomy of primary molars.

Conditions: Endodontically Treated Teeth

Summary: the sample size will be divided between two groups, group a pulpectomy will be done using single rotary file in primary molars and group b pulpectomy will be done using manual k file system. follow up of the patients and clinical and radiographical success rates of cases will be seen.

each patient will have access in the primary molar and pulpectomy procedure will be done according to inclusion and exclusion criteria , the patients will be divided according to two groups group a using single file rotary and group b manual k file system. time will be recorded in each procedure and each patient will receive stainless steel crown. follow up for the patients will be done clinical and radiographical success will be seen, postoperative pain will be measured and all data will be collected and statistically analyzed.

Eligibility criteria:
inclusion criteria: 1. absence of external or internal root resorption 2. presence of two thirds of the root 3. primary molars with deep caries and irreversible pulpitis that require pulpectomy in a single visit. molars can be vital with a history of spontaneous pain or non-vital as indicated by absence of bleeding from the pulp. exclusion criteria: * children with physical, intellectual disability or medical conditions that may complicate treatment. * teeth with poor prognosis due to the presence of a sinus, excessive mobility or advanced bone resorption. * teeth with radiolucent areas in furcation regions.

Keywords: primary-molars pulpectomy rotary
a study of brepocitinib in adults with active non-infectious non-anterior uveitis

Conditions: Non-infectious Intermediate Uveitis; Non-infectious Posterior Uveitis; Non-infectious Pan Uveitis

Summary: this study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (niu).


Eligibility criteria:
inclusion criteria: 1. adult subjects (18-74 years old) 2. diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). 3. active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator: 1. active, inflammatory chorioretinal and/or retinal vascular lesion; or 2. ≥2+ vitreous haze grade (nei/sun criteria). 4. receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy 5. weight \> 40 kg with a body mass index \< 40 kg/m2. exclusion criteria: 1. has isolated anterior uveitis. 2. has confirmed or suspected current diagnosis of infectious uveitis 3. history of: * any lymphoproliferative disorder * active malignancy; * history of cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. at risk of thrombosis and cardiovascular disease 5. have a high risk for herpes zoster reactivation 6. have active or recent infections other protocol defined inclusion/exclusion criteria may apply

Keywords: brepocitinib pf-06700841 uveitis niu
a study of abt-652 in combination with a nonsteroidal anti-inflammatory drug (nsaid) in adults with osteoarthritis pain of the knee

Conditions: Osteoarthritis of the Knee

Summary: to evaluate the safety and efficacy of abt-652 in combination with a non-steroidal anti-inflammatory drug (nsaid) compared to nsaid alone in adults with osteoarthritis (oa) of the knee.

this is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. the total treatment period will be 10 weeks.

Eligibility criteria:
inclusion criteria: * history of osteoarthritis (oa) of the knee joint and meeting american college of rheumatology (acr) clinical and radiographic criteria, * currently taking nonsteroidal anti-inflammatory drugs (nsaids) and still experiencing pain as per the protocol requirements. * willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures. exclusion criteria: * diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint * any cardiac, respiratory, neurological, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment

Keywords: osteoarthritis of the knee
evaluation of t1rho magnetic resonance imaging for diagnosis of cartilage lesions in hips with developmental dysplasia

Conditions: Developmental Dysplasia of the Hip

Summary: one of the leading causes of hip arthritis is developmental dysplasia of the hip (ddh). ddh can lead to major damage in the hip joint and may result in hip arthritis later in life. patients recruited into this study will be undergoing corrective hip surgery within the next 6 months with a goal of preventing further hip problems down the road. this study is being done to see how well a newer type of magnetic resonance imaging (mri) detects hip cartilage damage compared to an older but well validated mri method.

the start of arthritis can first be detected in certain molecules in the joint. proteoglycan is a molecule that is important to cartilage structure, and is lost as arthritis develops. magnetic resonance imaging (mri) is one of the best ways to image cartilage, and an investigational mri technique that has shown great promise in detecting proteoglycan amounts is called t1-rho. in this study, patients with hip dysplasia will undergo this investigational mri in addition to a well validated mri method (called dgemric) to see if t1-rho is as good as dgemric at detecting cartilage damage. the dgemric mri requires an injection of a contrast agent, while the t1-rho mri does not. if the t1-rho is shown to be as useful as the dgemric method it can then be used to look at cartilage damage in the hip without having to have an injection.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of developmental dysplasia of the hip (ddh) exclusion criteria: * patients under the age of 18 * pregnancy and/or lactation * non-mri compatible implants (stents, electronic devices, cardiac pacers or wires) * severe claustrophobia * prior contrast allergic reaction * kidney impairment * previous hip surgery * osteoarthritis on conventional radiographs (tönnis grade\>0) * additional underlying hip diseases such as posttraumatic arthritis, legg-calvé-perthes-disease (lcpd), or slipped capital femoral epiphysis (scfe)

Keywords: t1-rho mri dgemric mri ddh developmental dysplasia of the hip
cabergoline combined hydroxychloroquine/chloroquine to treat resistant prolactinomas

Conditions: Resistance, Disease; Prolactinoma

Summary: the purpose of this study is to preliminarily evaluate the safety and efficacy of cabergoline combined hydroxychloroquine/chloroquine(hcq/cq) therapy for cabergoline-resistant prolactinomas

the dopamine agonist cabergoline (cab) has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients with prolactinoma. chloroquine (cq) is an old drug widely used to treat malaria. recent studies, including our own (j clin endocrinol metab, 2017; autophagy, 2017; oncotarget, 2015), have revealed that cab and cq are involved in induction of autophagy and activation of autophagic cell death. furthermore, cq enhanced suppression of cell proliferation by cab. we established a low-cab-dose condition in which cab was able to induce autophagy but failed to suppress cell growth. addition of cq to low-dose cab blocked normal autophagic cycles and induced apoptosis, evidenced by the further accumulation of p62/caspase-8/lc3-ii. the data suggest that combined use of cab and cq may increase clinical effectiveness in treatment of intolerance and/or resistant prolactinomas.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 70 years old, either sex; 2. karnofsky performance status ≥ 70; 3. patients who were suffered drug-resistant,which has taken cabergoline ≥2.0mg/week no less than 3 months, referring to failure to normalize prl levels and failure to decrease macroprolactinoma size by \>or=50%; 4. the patient has signed the informed consent. exclusion criteria: 1. patients concomitantly taking the psychotropic drugs or other drugs causing elevated prl ; 2. patients with parkinson disease and is taking dopaminergic agents; 3. patients with prolactinoma who received gamma knife treatment; 4. patients who use any dopamine receptor agonists other than cabergoline; 5. pregnant or lactating women, or women preparing pregnant; 6. patients with poor compliance, who cannot implement the program strictly. 7. history of allergic reactions attributed to compounds of similar chemical or biologic composition to hcq. 8. glucose-6-phosphate dehydrogenase (g6pd) deficiency, as hcq may cause hemolytic anemia in patients with g6pd deficiency.

Keywords: cabergoline prolactinomas resistant hydroxychloroquine chloroquine
copper cu 64 tp3805 pet in detecting cancer in patients with prostate cancer undergoing surgery

Conditions: Prostate Adenocarcinoma; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Summary: this pilot phase i trial studies copper cu 64 tp3805 (cu-64-tp3805) positron emission tomography (pet)/computed tomography (ct) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). many patients with benign lesions must undergo biopsy to test the lesion. cu-64-tp3805 is a radioactive substance that attaches to cancer cells but not normal cells. pet/ct uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. using cu-64-tp3805 pet/ct scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether cu-64-tp3805 pet/ct can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.

primary objectives: i. to assess the ability of cu-64-tp3805 to detect prostate cancer (pc) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy. outline: patients receive copper cu 64 tp3805 intravenously (iv) and undergo pet/computed tomography (ct) at 30 minutes and 2 hours post-injection. patients then undergo radical prostatectomy within 1 to 3 weeks after scans. after completion of study, patients are followed up at 24 hours.

Eligibility criteria:
inclusion criteria: 1. ability to provide signed informed consent and willingness to comply with protocol requirements 2. biopsy confirmed presence of adenocarcinoma of the prostate gland 3. have intermediate or high-risk pc as defined by \>= t2b disease, or gleason score \>= 7 or prostate-specific antigen (psa) \>= 10 ng/dl 4. scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic) 5. agree to use an acceptable form of birth control for a period of 7 days after the cu-64-tp3805 injection exclusion criteria: 1. participating would significantly delay the scheduled standard of care therapy 2. administered a radioisotope within 10 physical half-lives prior to study drug injection 3. have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
krt-232 compared to ruxolitinib in patients with phlebotomy-dependent polycythemia vera

Conditions: Polycythemia Vera

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, for the treatment of patients with phlebotomy-dependent polycythemia vera (pv). inhibition of mdm2 in pv is a new mechanism of action in pv. in part a, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. in part b, patients must be resistant or intolerant to hydroxyurea. this study is a global, open-label phase 2a/2b study to determine the efficacy and safety of krt-232. in part a of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of krt 232. in part b of the study, patients will be randomized either to treatment with krt-232 administered at the recommended dose and schedule from part a or to treatment with ruxolitinib.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pv (who 2016) * ecog ≤ 2 * part a: patients with and without splenomegaly are eligible * part a: patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon * part b: only patients with splenomegaly are eligible * part b: patients must be resistant or intolerant to hydroxyurea exclusion criteria: * diagnosis of post-pv myelofibrosis (iwg-mrt) * prior treatment with mdm2 inhibitors, p53-directed therapies, hdac, bcl 2 inhibitors * splenic irradiation within 3 months prior to the first dose of study treatment * clinically significant thrombosis within 3 months of screening * grade 2 or higher qtc prolongation * part b: prior treatment with a jak inhibitor
active surveillance of 2 groups of patients with localized prostate cancer

Conditions: Adenocarcinoma of the Prostate

Summary: active surveillance manages selected men with prostate cancer expectantly with curative intent. this means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress. the goal of this study is to validate the treatment option active surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. a number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.

objectives: primary - to evaluate the equivalence of the time on active surveillance before an active treatment between group epstein + and the expanded active surveillance group (epstein -) secondary * to evaluate the role of diffusion-weighted mri (dw-mri) in the initial diagnosis and the follow-up of patients under active surveillance * to evaluate the role of bcar-1 to predict the clinical outcome of localized prostate cancer * to evaluate the proportion of patients who discontinued active surveillance * to evaluate the mortality at 10, 15 and 20 years from the inclusion in the study * to evaluate the time to radical treatment * to evaluate the time to metastatic disease * to evaluate patients quality of life

Eligibility criteria:
inclusion criteria: * localized adenocarcinoma of the prostate with a gleason score of 3+3 (group i patients) or 3+4 (group ii patients) * percentage of tumor biopsy invasion \<50% and/or with a size of maximum 8 mm * with a number of positive tumor biopsies ≤3 (group i patients) or ≤ 5 (group ii patients) * tnm stage t1-2a n0 m0 (group i patients); tnm stage t1-2c n0 m0 (group ii patients) * psa level at diagnosis \< 10 ng/ml for group i patients; \< 15 ng/ml for group ii patients * tumor volume negative (group i patients); positive (group ii patients) * absence of extra-capsular extension * life expectancy \> 10 years * signed informed consent * patient has elected active surveillance as preferred management plan for the prostate cancer exclusion criteria: * previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy) * patients with hypogonadism