Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of duvelisib in relapsed/refractory follicular lymphoma

Conditions: Follicular Lymphoma

Summary: this is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (fl) that is relapsed or refractory to either chemotherapy or radioimmunotherapy (rit).

this is an open-label, single arm, multi-center clinical trial to evaluate the efficacy and safety of duvelisib administered to subjects who have been diagnosed with follicular lymphoma that is relapsed or refractory to either chemotherapy or rit. subjects (n=57) will receive 25 mg duvelisib twice daily (bid) over the course of 28-day treatment cycles for up to 12 cycles. after completing 12 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. however, to receive additional cycles of duvelisib beyond 12 cycles, subjects must have evidence of response (cr, pr or sd) by the end of cycle 12.

Eligibility criteria:
inclusion criteria: 1. subjects must have been fully informed and signed informed consent form. 2. subjects must be adults (\>/=18 years), male or female. 3. subjects who have been defined as fl by histologic or cytologic diagnosis, and must have relapsed or been refractory (at least two prior regimens for fl). 4. measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by ct, pet/ct or mri according to lugano 2014 criteria. 5. eastern cooperative oncology group (ecog) performance status of 0-2. 6. adequate renal and hepatic function. 7. women of childbearing potential must have a negative serum or urine β human chorionic gonadotropin (βhcg) pregnancy test. 8. willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study, including 30 days after the last dose of duvelisib. exclusion criteria: 1. grade 3b fl and/or clinical evidence of transformation to a more aggressive subtype of lymphoma. 2. known hypersensitivity to the study drug duvelisib or excipients. 3. previous treatment with a pi3k inhibitor or btk inhibitor. 4. prior history of allogeneic hematopoietic stem cell transplant (hsct). 5. prior chemotherapy, cancer immunosuppressive therapy, radiotherapy or other investigational agents within 4 weeks before the first dose of study drug. 6. symptomatic central nervous system (cns) lymphoma. 7. ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment. 8. human immunodeficiency virus (hiv) infection. 9. active cytomegalovirus (cmv) or epstein-barr virus (ebv) infection. 10. hepatitis b or hepatitis c infection. 11. history of stroke, unstable angina, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug. 12. female subjects who are pregnant or breastfeeding.
a dose-titration study of gk activator (2) in patients with type 2 diabetes.

Conditions: Diabetes Mellitus Type 2

Summary: this study will assess the efficacy, safety and tolerability of increasing doses of gk activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. after a 2 week washout from their previous antidiabetic therapy, patients will receive gk activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (fpg) of \<100mg/dl. the anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening. exclusion criteria: * type 1 diabetes mellitus; * treatment with insulin, ppar agonists or systemic corticosteroids during the 3 months prior to screening; * women who are pregnant, breast-feeding or not using adequate contraceptive methods.
a study to investigate quality of recovery up to day 7 in females undergoing laparoscopic abdominal surgery provided apfel-score based ponv care and prophylaxis

Conditions: Quality of Recovery

Summary: synopsis title: an observational study to investigate quality of recovery and the incidence and impact of post-operative nausea and vomiting (ponv)/post-discharge nausea and vomiting (pdnv) and up to 7 days in females undergoing laparoscopic abdominal surgery provided apfel-score based ponv care and prophylaxis. study period: september 2018- september 2019 hypothesis: when a high risk patient, apfel-score 3 or 4, is given apfel-score based ponv care with strict adherence to ponv guidelines there should be no difference in quality of recovery between a high-risk patient and a low-risk patient. aim: the aim of the study is to investigate if it is possible to reach no difference in quality of recovery (qor) between a high-risk patient and a low risk patient using apfel-score based ponv care. primary objective: assessing quality of recovery, using qor15 at 24h, 48h, 72h and after 7 days. secondary objectives: assessing the incidence and severity of ponv and pdnv in females undergoing laparoscopic surgery up to 72h. assessing ponv and pdnv severity and duration. nicotine habits and impact on ponv. study outline: females scheduled for elective abdominal laparoscopic surgery will be provided ponv care based on apfel risk-score. all patients will fill in the qor15 form before surgery (base line). ponv and pdnv will be assessed in the pacu postoperatively, after 24h, 48h and 72h. quality of recovery will be assessed up to 7 days after surgery. treatment: the females will be given ordinary care after local routines, with strict adherence to ponv guidelines. study population: 100 females aged 18-65, asa 1-2, undergoing laparoscopic abdominal surgery in danderyds hospital. primary outcome variables and examinations: when the qor 15 reaches base line or better after surgery. number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the qor.


Eligibility criteria:
inclusion criteria: * asa class 1-2 exclusion criteria: * asa 4, obese

Keywords: quality of recovery ponv pdnv
intrathecal chemoprophylaxis to prevent neurotoxicity associated with blinatumomab therapy for acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.


Eligibility criteria:
inclusion criteria: * adults receiving first cycle of blinatumomab for relapse/refractory or mrd-positive b-cell acute lymphoblastic leukemia * adequate renal and hepatic function * negative for hiv * negative serum pregnancy test, if applicable * ecog 0-2 exclusion criteria: * active cns involvement by all * relative cns disorders (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, parkinson's, cerebellar disease, psychosis, coordination or movement disorder) * contraindication to receive intrathecal methotrexate * prior treatment with blinatumomab * active malignancy other than all * active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
evaluating safety of andiabet on diabetes mellitus type ii patients, phase i ct.

Conditions: Diabetes Mellitus, Type 2

Summary: this phase i clinical trial is used to evaluate the safety of andiabet, a herbal-derived medicinal product that assists in the treatment of type 2 diabetes (t2d). thereby, determine efficacy of the drug on stabilizing blood glucose in t2d patients.

this is a 28-day phase i, open-label clinical trial to evaluate safety of andiabet on . the general purpose is the evaluate safety via adverse events and tolerability of andiabet on t2d patients, and evaluate effect of andiabet on clinical and laboratory parameters. the study conducted on volunteering t2d patients, whose hba1c level is =\< 7.5% and are not pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. the main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which evaluated based on adverse events. ensuring quality of the data: sponsor and cro are supervisors. supervision will be conducted periodically, ensuring the compliance with the research proposal, following gcp. hanoi medical university-clinical center of pharmacology is responsible for managing the data. completed cfr are sent to the center of clinical pharmacology, entered by microsoft excel and analysed using spss 16.0 before analysing, these data will be checked randomly, avoiding errors in data entry.

Eligibility criteria:
inclusion criteria: participants must meet all the following criteria: * type 2 diabetes (t2d) patients with hba1c lower than or equal to 7.5% * bmi range: 18-40 kg/m2 * diagnosed with t2d or currently treating t2d (prescribed by physicians) with one or more of the following drugs: metformin, sulfonyl urea, dipeptidyl peptidase-4 inhibitors, or a-glucosidase inhibitors * be able to stop using t2d drugs in 4 weeks, while maintaining diets and exercising routine. * willing to take part in the study. exclusion criteria: participants that have one of the following: * diagnosed with type 1 diabetes. * history of complications due to diabetes mellitus. * history of cardiovascular diseases: hypertension, heart failure, unstable agina, stroke or transient ischemic attack, myocardial infarction, arrhythmias, coronary artery interventions. * history of drugs, alcohol addiction. * uncontrolled high blood pressure * pre-study screening blood test with abnormal results in total blood compositions, urea, ast, alt, creatinine, albumin, total bilirubin, total urine analysis. * test positive for hiv or hbsag * abnormal ecg results that are clinically significant. * history of hypersensitivity to any of the ingredients in the testing product. * female participants that are pregnant or having pregnancy intention
intraosseous catheter confirmation study

Conditions: Critical Illness

Summary: this is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (io) catheter. intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (iv) access is not present or difficult to achieve. it is standard of care to confirm the correct placement of an io catheter prior to using it to administer medications or fluids. three io placement confirmatory tests will be performed on all research subjects using a standardized protocol. there will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the io catheter is attached to a pressure transducer). primary outcome measures of the study will be the determination of correct or incorrect io catheter placement from the confirmation methods. this data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. secondary outcomes include complications from the io catheter. the goal of this study is to see if a more sensitive and specific method of io catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. additional subgroup analyses will be performed in regards to the research subjects bmi and the anatomic site selected for io catheter use (proximal tibia or humeral head).


Eligibility criteria:
inclusion criteria: * patients greater than 18 years of age * full code * require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access * capable of undergoing all three intraosseous placement confirmatory methods exclusion criteria: * age less than 18 years old * pregnant patients * prisoner/incarcerated * patients unable to undergo all three intraosseous placement confirmatory methods

Keywords: intraosseous catheter intraosseous access resuscitation diagnostic accuracy
artificial intelligence analysis of initial scan evolution of traumatic brain injured patient to predict neurological outcome

Conditions: Trauma, Brain

Summary: we assume that an early iterative automatic ct scan analysis (d0, d1 and d3) by different ai approaches will allow an early differentiation of the tissues evolution after tbi. our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.

traumatic brain injury is a common and serious pathology, responsible of an important morbi-mortality. the tbi can be consider as a complex set of nosological entities of different evolution with difficult early identification whereas the main issue of this pathology depends on prevention and management of the lesions caused by the initial cerebral aggression. different evolutionary profiles seems to exist and sometimes coexists: edema evolution, hemorrhagic transformation and/or cerebrospinal fluid (csf) resorption issues with hydrocephalus apparition. currently, there is no imaging methods that can be used in every day clinical management that allows a visualization, quantification and prediction of these different lesional evolutions ct scan is the reference imaging method for tbi patient monitoring. it allows a lesion description, a therapeutic adaptation and an evaluation of the prognostic. even if it is used as a routine examination, the analysis of cerebral scanners remains manual and a non-quantitative one, which make a little informative analysis as far as lesions evolution is concerned. recently it has been established the automatic mri analysis with ai approach allows: 1. - to show aspects of images that can't be seen to the naked eye 2. - to automatically segment and quantify the different tissues (edema, hemorrhage...). first tests on this kind of analysis on ct scans shows that this technology can be transferred from mri to ct scans and more importantly it brings out new quantitative informations on cerebral lesions evolution.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * closed tbi * primary admission in grenoble university hospital * initial ct scan with visible cerebral lesion rated at least 3 on abbreviated injury score (ais) * in icu for an expected length of 48 hours * social security system affiliation exclusion criteria: * life expectation \<48 hours * in icu for more than 24h * transferred from another hospital * patients corresponding to articles l1121-5, l1121-6, l1121-7, l1121-8 (under legal protection) of french public health code * patient in exclusion time of another study
a study investigating the efficacy and safety of lampalizumab intravitreal injections in participants with geographic atrophy secondary to age-related macular degeneration

Conditions: Geographic Atrophy

Summary: this study is a phase iii, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * well demarcated area(s) of geographic atrophy (ga) secondary to age-related macular degeneration (amd) with no evidence of prior or active choroidal neovascularization (cnv) in both eyes exclusion criteria: ocular exclusion criteria: study eye * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd * previous laser photocoagulation for cnv, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy * previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) ocular exclusion criteria: both eyes * ga in either eye due to causes other than amd * previous treatment with eculizumab, lampalizumab and/or fenretinide
clinical study of the inqb8 ttvr system

Conditions: Tricuspid Valve Regurgitation

Summary: prospective, multi-center study to assess safety and performance of the inqb8 monarq tricuspid valve replacement system.

the study is a multi-center, prospective, single-arm study to assess safety and performance of the inqb8 medical technologies monarq tricuspid valve replacement system.

Eligibility criteria:
inclusion criteria: * anatomically suitable for the monarq ttvr system * symptomatic, tricuspid regurgitation (tr) that is severe or greater * adequately treated for heart failure based upon medical standards * hemodynamically stable exclusion criteria: * need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * refractory heart failure (hf) that requires or required advanced intervention * any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up. * currently participating in another investigational biologic, drug or device study
hemoclin gel for the treatment of hemorrhoids

Conditions: Hemorrhoids Grade I and II

Summary: post market, single arm, clinical investigation to assess safety and performance of the product.


Eligibility criteria:
inclusion criteria: 1. healthy subjects. 2. sex: male or female. 3. age: more than 18 years old. 4. symptomatic haemorrhoids stage 1 and 2 (goligher classification). 5. episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study. 6. able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day). 7. able and willing to provide informed consent and comply with study procedures exclusion criteria: 1. pregnant or nursing woman or planning a pregnancy during the study. 2. subject not able or not willing to provide informed consent and comply with study procedures 3. subject who had been deprived of their freedom by administrative or legal decision. 4. major subject who is under guardianship or who is not able to express his consent. 5. subject in a social or sanitary establishment. 6. subject suspected to be non-compliant according to the investigator's judgment. in terms of associated pathology 7. grade iii or iv haemorrhoids (goligher classification). 8. other pre-existing anal disorders and diseases including crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections. 9. any anal surgery (including surgical or instrumental procedures in the last 60 days). relating to previous or ongoing treatment 10. any anal topical medication applied in last 7 days. 11. known or suspected sensitivity or allergy to ingredients of the investigational product. in terms of covid pandemic 12. subject who was abroad in a country with higher incidence rate of covid-19 than poland within 14 days before the beginning of the study. 13. subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°c. 14. subject who had contact with any person infected with covid-19 within 10 days before the beginning of the study. 15. subject who is currently during home quarantine recommended by the sanitary inspection
multicenter study of the safety and efficacy of dermal filler, belotero® soft

Conditions: Facial Wrinkles

Summary: this study is to determine the safety and effectiveness of belotero® soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

the purpose of the study is to see if belotero® soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. the second objective of the study is to see if belotero® soft works better than the active comparator. subjects will receive belotero® soft injection to one side of the face and the active comparator to the other side of the face.

Eligibility criteria:
inclusion criteria: * subjects must have bilateral facial wrinkles, such as nasolabial folds exclusion criteria: * other nasolabial fold correction within 6 months prior to study entry.

Keywords: facial wrinkles nasolabial folds
comparison of healthy diets on breast cancer markers

Conditions: Breast Neoplasms

Summary: women post breast mass biopsy with er+or er- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. the initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (ki-67) and apoptosis (tunel).

a healthy diet has been defined in various ways. the investigators wish to compare the effects of two diets on er positive breast cancer tissues. the diets will be administered between the time of diagnosis and the time of surgical removal. both diets have been proposed as healthy, but differ in their composition. one constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Eligibility criteria:
inclusion criteria: women with biopsy proven breast cancer. exclusion criteria: -

Keywords: diet dietary intervention carbohydrate restriction low carbohydrate fat restriction low fat cancer breast cancer pre-surgical window biomarker