Kornimate/medical-research-clean huggingface dataset:
evaluation of patients with bulky gist using sunitinib

Conditions: Tumor

Summary: the primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (gist) results in tumor shrinkage allowing for successful surgery. therapy will be administered orally and the response of the tumor will be assessed using cts or mris.

gastrointestinal stromal tumor (gist) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. the most common site is the stomach followed by the duodenum and small intestine. surgery is the mainstay of therapy for gist patients whose primary tumor is felt to be resectable. prior to the introduction of gleevec, patients with inoperable gist had essentially no therapeutic options. however, sunitinib trials offer options to patients who are gleevec resistant or have intolerant gist. clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.

Eligibility criteria:
inclusion criteria: * patients more than 19 years old with pathologically proven gist which is bulky or marginally resectable * patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. bone lesions do not qualify. * patients must have an ecog performance of greater than or equal to 2, with projected survival of at least three months. * patients must have adequate laboratory parameters: hematologic: hb \>9.0; wbc \>3200 and platelets \>100,000/mm3; hepatic: bilirubin \<2.0 and ast within 4 times upper limit of normal; renal: creatinine of less than or equal to 1.6 or egfr greater than or equal to 50 ml/min * men and women who are of childbearing potential must practice strict birth control for the duration of the study. * women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration. * the patient, a witness, and attending physician will have signed an irb-approved informed consent prior to sunitinib administration. exclusion criteria: * known brain metastases or significant pleural effusion or ascites. * uncontrolled hypertension, diabetes, or other medical condition. * major surgery within 21 days of registration. * patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation. * history of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance. * prior therapy for gist. * a history of hiv or hepatitis virus infection. * any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation. * patients with impaired kidney function.

Keywords: gist gastrointestinal stromal tumor gastrointestinal stomach tumor sunitinib
embozene microspheres for uterine fibroid embolization (ufe)

Conditions: Uterine Fibroids

Summary: this is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. all subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.


Eligibility criteria:
inclusion criteria: * subject is able to provide informed consent and must sign the institutional review board approved informed consent form. * pre-menopausal women age 30-50 years at time of enrollment * have been selected foruterine fibroid embolization (ufe) prior to entry to the study. exclusion criteria: * patient has a history of pelvic malignancy * patient has an abnormal pap smear within 12 months of the planned uterine fibroid embolization procedure * patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts). * is at substantial risk for the need of organ transplantation, such as renal insufficiency. * patient has evidence of current or recent pelvic inflammatory disease or uterine infection. * patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents. * patients unable to comply with the follow-up requirements of the study.
long-term study in chronic kidney disease patients with hyperphosphatemia not on dialysis

Conditions: Chronic Kidney Disease; Renal Insufficiency; Hyperphosphatemia

Summary: this is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of asp1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.


Eligibility criteria:
inclusion criteria: * patients who completed study 1585-cl-0101 or new patients who meet following criteria * chronic kidney disease patients (egfr \< 60 ml/min/1.73 m2) * serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl * written informed consent exclusion criteria: * patients with gastrointestinal surgery or enterectomy * patients with severe cardiac diseases * patients with severe constipation or diarrhea * patients with a history or complication of malignant tumors * patients with uncontrolled hypertension * patients treated with parathyroid intervention

Keywords: ckd not on dialysis asp1585 bixalomer
to evaluate safety and tolerability of the fixed- dose combination of obeticholic acid and bezafibrate

Conditions: Primary Biliary Cholangitis

Summary: an open label long-term study to evaluate the safety and tolerability of the fixed-dose combination (fdc) of obeticholic acid (oca) and bezafibrate (bzf) tablet in subjects with primary biliary cholangitis (pbc).


Eligibility criteria:
inclusion criteria: * all subjects with pbc who participated and are actively taking investigational product in study 747-213 or study 747-214 are eligible to enroll in this study (977-311). exclusion criteria: * history or presence of other concomitant liver diseases * clinical complications of pbc * history or presence of hepatic decompensating events * current or history of gallbladder disease * if female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: primary biliary cholangitis obeticholic acid bezafibrate ursodeoxycholic acid
paired integrative exercise program for people with dementia and caregivers

Conditions: Dementia

Summary: preventing loss of independence through exercise (plié) is a unique, multimodal movement program for people with dementia (affected individuals) that is taught by trained instructors and combines physical, mental and social activities. the paired plié program is an adapted version designed for pairs of affected individuals and care partners. the goal of this study is to perform a randomized, controlled trial (rct) with a delayed start design to examine the effects of the paired plié program on function and quality of life in affected individuals and care partners.

study participants are 30 pairs of individuals with mild-to-moderate dementia and their primary care partners (n=60 total) who are randomly assigned to group 1 (immediate start) or group 2 (delayed start). pairs randomized to group 1 participate together in the paired plié program 2 days/week for 12 weeks (24 classes total) while pairs randomized to group 2 continue with their usual activities. then group 1 transitions into a maintenance phase, and group 2 participates in the paired plié program 2 days/week for 12 weeks. outcome data are collected in all study participants at baseline, mid-point and end-point so that we can examine the initial impact of the program as well as whether effects are maintained in group 1. outcome measures include cognitive function, physical performance, quality of life and caregiver well-being.

Eligibility criteria:
inclusion criteria: person with cognitive impairment * diagnosis of cognitive impairment or dementia * mild to moderate severity, defined as clinical dementia rating of 0.5, 1 or 2 * willing and able to engage in study procedures * english language fluency inclusion criteria: care partner * provide care for person with cognitive impairment * willing and able to engage in study procedures * english language fluency exclusion criteria: person with cognitive impairment * planning to miss more than 2 weeks during the study period * behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues) * unable to take 2 steps independently without cane or walker * terminal illness (life expectancy \< 1 year) * currently participating in another research study that could impact current study * changes to dementia medications 3 months prior to baseline or changes planned during the study period exclusion criteria: care partner * planning to miss more than 2 weeks during the study period * behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues) * unable to take 2 steps independently without cane or walker * terminal illness (life expectancy \< 1 year) * currently participating in another research study that could impact current study

Keywords: exercise function quality of life caregiver
role of microrna in the development of cutaneous squamous cell carcinoma

Conditions: Cancer of the Skin

Summary: the aim of this study is to analyze the differential expression of the mir transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (c-scc). in this aim the investigators plan to recruit a cohort of 20 patients suffering of c-scc and to collect from each of them, biopsies corresponding to i) non uv-exposed areas ii) uv-exposed areas, iii) actinic keratosis and iv) tumoral regions. total rnas will be prepared from each biopsy and the mirna profiles will be characterized using a dedicated mir array.


Eligibility criteria:
inclusion criteria: * patient older than 40th, suffering of a c-scc * letter of consent signed by the patient * to be registered to social security exclusion criteria: * pregnant women or breastfeeding. * small c-scc (size \< 6mm) * allergy to xylocaine * all vulnerable (minor, adult guardianship...)
a comparison of two triple-drug combinations in patients who have never been treated with anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (nlf) with that of zidovudine plus lamivudine plus nlf. this study also examines how long these drug combinations are effective in lowering viral load (level of hiv in the blood).


Eligibility criteria:
inclusion criteria patients must have: within 15 business days prior to randomization: * cd4 cell count greater than or equal to 100 cells/mm3. * hiv rna greater than or equal to 2,000 copies/ml by roche amplicor assay. exclusion criteria co-existing condition: patients with any of the following symptoms or conditions are excluded: * bilateral peripheral neuropathy. * intractable diarrhea. * proven or suspected acute hepatitis within 30 days prior to study entry. concurrent medication: excluded: - therapy for any co-existing disease that may interfere with patient ability to participate in this study. concurrent treatment: excluded: therapy for any co-existing disease that may interfere with patient ability to participate in this study. patients with the following prior conditions are excluded: history of acute or chronic pancreatitis. prior medication: excluded: * therapy for any previous disease that may interfere with patient ability to participate in this study. * excluded within 14 days prior to randomization: greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy. * excluded within 3 months of the start of this study or expected need at time of enrollment: * agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential. * inability to tolerate oral medication. prior treatment: excluded: therapy for any previous disease that may interfere with patient ability to participate in this study. risk behavior: excluded: active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.

Keywords: hiv-1 didanosine drug therapy, combination zidovudine stavudine lamivudine rna, viral nelfinavir anti-hiv agents viral load
cerebrovascular reactivity in hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: it has been observed that patients with cirrhosis present a generalized state of vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. on progression of the disease, vascular regulation is mismatched, causing altered systemic blood flow and lose in the cerebrovascular reactivity. the investigators hypothesize that the altered cerebrovascular reactivity induces neurological disturbances related to hepatic encephalopathy and, therefore, the existence of a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.

there is no bibliography that evidenciates a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy. there are however, papers that reveal generalized systemic vasoconstriction in patients with cirrhosis and others that affirm the presence of vascular disregulation and altered reactivity in the middle cerebral artery in cirrhotic patients. in the other hand, there is published data that correlates the neurological manifestations of diseases characterised by altered blood flow and cerebrovascular reactivity with the degree of the vascular disregulation itself, identified by us doppler. however, there are no studies correlating transcranial us doppler findings of cerebrovascular reactivity and hepatic encephalopathy in patients with cirrhosis. giving its importance to the chance of revealing a new way of pathophysiology and therefore, early therapeutic management.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of liver cirrhosis exclusion criteria: * personal history of surgery in the last 4 weeks * diagnosis of diabetes mellitus, hypertension, copd or liver metabolic diseases (wilson's disease and hemochromatosis) * personal history of stroke and/or cancer * use of neuropsychiatric drugs * neuropsychiatric disorders (schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder) * thyroid disorders without replacement therapy * hepatic or renal transplant * alcoholism with active ingest of alcohol in the last 6 months * pregnancy * labour turn-overs

Keywords: hepatic encephalopathy psychometric hepatic encephalopathy score critical flicker frequency cerebrovascular reactivity endotoxemia transcranial doppler liver cirrhosis
young stroke service deep phenotyping: exploring recovery in young adult survivors of stroke

Conditions: Stroke Patients; Stroke; Stroke; Sequelae; Young Adults

Summary: we are running a small, early-phase research study across several hospitals in melbourne, australia. the study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. our goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group. this process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. we'll look at how well this approach works in practice, including how easy it is to use, whether it's done consistently, and how acceptable it is to participants. at the same time, we'll also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. this pilot study will help us prepare for larger studies in the future.


Eligibility criteria:
inclusion criteria: 1. between 18 and 55 years. 2. within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis exclusion criteria: 1. severe, intercurrent or progressive illness likely to either 1. have a prognosis for survival under 24 months; or 2. in the opinion of the investigator will mask the importance to the individual participant data (e.g. severe ms, dementia, etc) 2. major psychiatric condition requiring medical intervention

Keywords: recovery young stroke ischemic stroke hemorrhagic stroke poststroke fatigue post-stroke cognitive impairment function mood
clinical study of ctdna and exosome combined detection to identify benign and malignant pulmonary nodules

Conditions: Pulmonary Nodules

Summary: this study through the detection of egfr、alk、ros1、kras、her2、barf、ntrg1 seven ctdna and exosome rna in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. if the results of ctdna test is positive, the target nodule is malignant; if the reaults of ctdna teste is negatie but exocome rna is positive, the target nodule is also malignant. if the results of both tests are negtive, the target nodule is recognized as benign. the purpose is study the sensitivity, specificity and diagnostic accuracy of ctdna and exosome combined detection in the identification of benign and malignant pulmonary nodules. besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

pulmonary nodules are round or irregular shape lesions with a diameter of less than or equal to 3cm. 10% lung nodules will become lung cancer, and lung cancer is evolved from small nodules. liquid biopsy is an effective and noninvasive means to assist in the early diagnosis of lung cancer, including circulating tumor cell、exosome and ctdna detection. ctdna is used to detect dna fragments relesased to plasma by cracking or apoptotic tumor cells. exosomes are derived from living cells, and researchers found that exosome nucleic acid detection of living cells may be closely related to the dynamic development of tumors. this study through the detection of egfr、alk、ros1、kras、her2、barf、ntrg1 seven ctdna and exosome rna in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. if the results of ctdna test is positive, the target nodule is malignant; if the reaults of ctdna teste is negatie but exocome rna is positive, the target nodule is also malignant. if the results of both tests are negtive, the target nodule is recognized as benign. the purpose is study the sensitivity, specificity and diagnostic accuracy of ctdna and exosome combined detection in the identification of benign and malignant pulmonary nodules. besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

Eligibility criteria:
inclusion criteria: age ≥18 years old; the diameter of pulmonary lesions is 0.5-3cm in chest ct within 3 months; healthy patients in normal control group had a smoking index ≥400; patients who are eligible and intend to bronchoscopy. exclusion criteria: the patient received blood transfusion within 1 month； patients suffer from autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, etc； patients with cardiopulmonary dysfunction or other taboos, not suitable for bronchoscopy; patients refused to participate in this clinical trial; the investigator considerates that the patient has other conditions that is unsuitable for this clinical trial.

Keywords: bronchoalveolar lavage fluid ctdna exosomes
a study to demonstrate the efficacy and safety of adapalene/benzoyl peroxide topical gel in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: this is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. efficacy and safety evaluations will be performed at screening (safety only), baseline and weeks 1, 2, 4, 8 and 12. all investigator's global assessment evaluators and lesion counters must be trained and approved by galderma. the evaluator of a subject should remain the same during the study. the primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of acne vulgaris with facial involvement. * a minimum of 20 but not more than 50 inflammatory lesions * a minimum of 30 but not more than 100 noninflammatory lesions * a score of 3 (moderate) on the investigator's global assessment scale. exclusion criteria: * more than one acne nodule or any acne cyst. * acne conglobata, acne fulminans, secondary acne, or severe acne. * known previous participation in an adapalene/benzoyl peroxide topical gel trial. * underlying diseases that require the use of interfering topical or systemic therapy. * use of prohibited medications prior to the study unless appropriate washout period is documented * use of hormonal contraceptives solely for control of acne

Keywords: acne vulgaris adapalene benzoyl peroxide
soft tissue augmentation using caf with either sctg and vitamin c versus sctg alone in management of rt1 gingival recession

Conditions: Gingival Thickness

Summary: compare gingival thickness following caf with sctg and vitamin c versus sctg alone in management of rt1 gingival recession.

control group (coronally advanced flap and subepithelial connective tissue graft alone) test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) same procedure will be executed but with the addition of vitamin c injection. intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of l-ascorbic acid will be done. it will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). the needle will be introduced parallel to the gingival tissues with the bevel facing upwards. vitamin c will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. vitamin c will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.

Eligibility criteria:
inclusion criteria: 1. patients 18 years or older. 2. periodontally and systemically healthy. 3. buccal recession defects classified as cairo rt1. 4. presence of identifiable cej (zucchelli et al., 2010). 5. clinical indication and/or patient request for recession coverage. 6. o'leary index less than 20% (o'leary, drake and naylor, 1972). exclusion criteria: 1. cairo rt2 or rt3 recession defects. 2. pregnant females. 3. smokers as smoking is a contraindication for any periodontal plastic surgery (khuller, 2009). 4. handicapped and mentally retarded patients. 5. patients undergoing radiotherapy. 6. teeth with cervical restorations, abrasion and malalignment. 7. presence of systemic disease that would affect wound healing.