Kornimate/medical-research-clean huggingface dataset:
a phase i study of oral lgx818 in adult patients with advanced or metastatic braf mutant melanoma

Conditions: Melanoma and Metastatic Colorectal Cancer

Summary: clgx818x2101 is a first-time in-human, phase i study to establish the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) of daily administered lgx818 (daily, twice daily and/or every-other-day), a raf kinase inhibitor. patients with locally advanced or metastatic melanoma harboring the braf v600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the braf v600 mutation (during the expansion phase) will be enrolled. the study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of lgx818, followed by a safety dose expansion part were patients will be treated with oral dose of lgx818 given at the mtd or rp2d.


Eligibility criteria:
inclusion criteria: for the dose escalation phase: 1. histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage iiib to iv per american joint committee on cancer \[ajcc\]). for the dose expansion phase: (i) histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage iiib to iv per american joint committee on cancer \[ajcc\]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mcrc) for which no further effective standard therapy exists. 2. written documentation of braf v600e mutation, or any other braf v600 mutation. 3. evidence of measurable disease exclusion criteria: 1. previous therapy with a mek inhibitor. 2. symptomatic or untreated leptomeningeal disease. 3. symptomatic or untreated brain metastasis.patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. brain metastasis must be stable with verification by imaging. 4. known acute or chronic pancreatitis. 5. clinically significant cardiac disease 6. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral lgx818 7. previous or concurrent malignancy. exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry. 8. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\> 5 miu/ml). 9. history of thromboembolic or cerebrovascular events within the last 6 months other protocol-defined inclusion/exclusion criteria may apply

Keywords: braf mutant, braf mutated, melanoma, metastatic, advanced, raf kinase inhibitor braf v600 mutation
prediction of fluid responsiveness by nicom (non-invasive cardiac output monitoring) in children with congenital heart disease after cardiac surgery

Conditions: Fluid Responsiveness

Summary: the purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of nicom(noninvasive cardiac output monitor)system during congenital cardiac surgery.


Eligibility criteria:
inclusion criteria: * congenital cardiac surgery * \< 6 years old * who were required the evaluation by transesophageal echocardiography exclusion criteria: * right heart failure * supported by more than 2 inotropic agents * reduced kidney function * any valvar stenosis * moderate or severe tricuspid regurgitation * single ventricle

Keywords: stroke volume variation, cardiac output, fluid responsiveness, noninvasive cardiac output monitor
evaluation of the use of the genxpert to detect hepatitis c rna

Conditions: Drug Use; Hepatitis C

Summary: the results of the gx device are equivalent to standard venous blood sampling. with this study we are going to determine the prevalence in drug users with difficult venous access. on the other hand, we want to look at the place this device can have in primary care.


Eligibility criteria:
inclusion criteria: * have recently or ever used drugs * older than 18 years * written informed consent exclusion criteria: * not being able to speak the dutch language
a study on the use of cormatrix® ecm® for femoral arterial reconstruction

Conditions: Peripheral Vascular Disease

Summary: to gather information on the use of cormatrix ecm for vascular repair in the reconstruction of the femoral artery.

objective the objective of the study is to actively gather additional information on the use of cormatrix ecm for vascular repair in the reconstruction of the femoral artery. the cormatrix ecm for vascular repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Eligibility criteria:
inclusion criteria: 1. subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure 2. surgeon intends to use cormatrix ecm per fda cleared indications for use 3. subject possesses ability to provide informed consent 4. subject expresses understanding and willingness to fulfill all expected requirements of protocol exclusion criteria: 1. known sensitivity to porcine material
splinted and unsplinted ot bridge systems in screw retained implant restoration

Conditions: Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System

Summary: evaluation of bone level changes around dental implants in all on 4 cases with immediate loading using conversion denture and ot bridge system either splinted or not


Eligibility criteria:
inclusion criteria: * any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration. * patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial. * implant sites must allow the placement of four implants. * non- heavy smokers will be included (smoking up to 10 cigarettes/day) * in case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study. * patients with no systemic condition that may interfere with implant placement (e.g., immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates) exclusion criteria: * - patients with poor oral hygiene and motivation. * pregnancy or nursing. * drug abusers. * psychiatric problems or unrealistic expectations. * patients with infection and or inflammation in the area intended for implant placement. * patients participating in other studies, if the present protocol cannot be properly adhered to. * patients with signs of hyperactive muscles.
evaluate the safety and efficacy of sinocare cgm system regarding real time glucose level monitoring

Conditions: Type 1 or Type 2 Diabetes

Summary: from jan 2022 to june 2022, 120 subjects (22-75 years of age, mean ±standard deviation \[sd\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in p.r. china. subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/h3 cgm app). subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long ysi frequent sampling test (fst) periods, where intravenous (iv) blood samples were drawn every 15 min and analyzed using the ysi 2300 stat plus glucose \& lactate analyzer (yellow springs instrument, ysi life sciences, yellow springs, oh).


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years, male or female; 2. clinically diagnosed with diabetes; 3. being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring; 4. consent to participate in this clinical study, and sign the informed consent form (icf). exclusion criteria: 1. disagree to wear the investigational device continuously according to the requirements of the trial; 2. refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial; 3. plan to undergo magnetic resonance imaging (mri) during the clinical trial; 4. with diffuse subcutaneous nodules at the wearing site of the investigational device; 5. have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening; 6. with mental disorders, lack of self-control and inability to express clearly; 7. have participated in any other clinical trial within the past 1 month; 8. where the investigator thinks not suitable for being enrolled.
effect of salmeterol on fluid clearance from alveolar-capillary membrane in copd patients

Conditions: Salmeterol Effect Against an Acute Alveolar Fluid Clearance Challenge Secondary to Lung Fluid Overload in COPD Patients; Chronic Obstructive Pulmonary Disease; Bronchodilator Agents; Salmeterol

Summary: the cardiovascular component associated with copd plays a major role in prognosis of the disease, being responsible of 25% of the deaths. experimental and initial clinical data suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar airspace, with potential positive effect on cardiogenic pulmonary edema. the aim of this study was to investigate the effects of a long-acting beta-2 agonist, salmeterol, on alveolar fluid clearance in copd patients by evaluating the diffusive and mechanical lung properties. our experimental model to test alveolar fluid clearance was rapid saline intravenous infusion. ten copd and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin of the study were evaluated, in four non consecutive days, just before and after a saline infusion or a similar period without infusion. both in copd and healthy subjects rapid saline infusion, with placebo or salmeterol premedication, lead to a significant decrease of dlco and fev1. nonetheless, salmeterol pretreatment lead to a significant reduction of the impairment of gas exchange due to saline infusion (-64% of dlco reduction in comparison with placebo), whilst it did not affect the changes in fev1. in the control setting, with no infusion, we did not find any significant change of both dlco and mechanical properties of the lung. in conclusions, in copd patients salmeterol appears to provide a protective effect against an acute alveolar fluid clereance challenge secondary to lung fluid overload providing an intriguing mechanistic explanation for the benefits observed in larger trials.


Eligibility criteria:
inclusion criteria: * copd diagnosis (consistent with the diagnostic standards of the european respiratory society, ers, for the management of copd) * stable condition for ≥4 weeks and had a prebronchodilator forced expiratory volume in one second (fev1) of \<60% of the predicted value exclusion criteria: * known allergies to the study medication * long-term oxygen therapy * history of asthma, allergic rhinitis, atopy, or a total blood eosinophil count greater than 400/mm3 * chronic heart failure, untreated arterial hypertension, myocardial infarction within the last 6 months, diabetes mellitus * increased serum potassium levels.

Keywords: copd laba salmeterol
genderspecific differences in hormone levels after trauma

Conditions: Polytrauma

Summary: the goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. the main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma. this is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status. hormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. furthermore a detailed questionnaire aims to answer any hormone-related health questions.


Eligibility criteria:
inclusion criteria: * polytrauma with iss≥16, * severe traumatic brain injury (ais ≥3) * over the age of 18 * must reach emergency room alive exclusion criteria: * pregnant patients * dead on arrival to the hospital * incarcerated patients * secondarily transferred patients
efficacy and safety of liraglutide versus sulphonylurea both in combination with metformin during ramadan in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa and asia. the aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (su) both in combination with metformin during ramadan in subjects with type 2 diabetes (t2dm).


Eligibility criteria:
inclusion criteria: * - subjects diagnosed with t2dm and treated with metformin equal to or above 1000 mg/day and su (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose * - hba1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive) * - body mass index (bmi) equal to or above 20 kg/m\^2 * - subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during ramadan after receiving medical counselling regarding the risk of fasting exclusion criteria: * - any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour) * - any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol * - history of chronic pancreatitis or idiopathic acute pancreatitis * - screening calcitonin value equal to or above 50 ng/l * - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) * - impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl) * - impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula) * - any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening * - diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
influence of mango intake of skin health in postmenopausal women

Conditions: Wrinkle; Skin Red

Summary: this study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.

mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted. we hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.

Eligibility criteria:
inclusion criteria: * postmenopausal * fitzpatrick skin type i and ii * bmi 18.5 - 35.0 kg/m2 * normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician exclusion criteria: * allergic to mangoes * fruit consumption of 2 or more cups per day * vegetable consumption of 3 or more cups per day for females * fruit juice consumption of more than 1 cup per day * self-reported malabsorption * currently taking regular prescription drugs i.e. statins, thyroid, anti-inflammatory drugs * had any medical or cosmetic procedures such as laser resurfacing or plastic surgery to the face within the last 6 months, including botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure * autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as ehler-danlos) * smoking (current smoker, smoked within the past year, former smokers with greater than a 20 pack-year history of smoking within the past 20 years. * indications of substance or alcohol abuse * unwillingness to discontinue high antioxidant supplements during washout and interventions

Keywords: skin health skin wrinkle skin redness carotenoid mango
"variable-psv" study

Conditions: Acute Respiratory Failure; Critical Illness; Ventilation Weaning

Summary: variable psv is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set psv level.this study aimed to compare the ventilatory behavior, sleep quality and gas exchange between variable (or noisy)-psv and "standard" (or fixed)-psv during the weaning phase of critically ill patients who required mechanical ventilation.

twenty patients will be enrolled. they will be ventilated withvariable-psv and standard-psv: for 24 h each in a randomized crossover order. the ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. before randomisation, a sequence of variable-psv will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of variable-psv.

Eligibility criteria:
inclusion criteria: * ventilation planned for more than 48 h * patient alert and calm corresponding to a richmond agitation-sedation scale (rass) between -2 and 0 * age \> or equal 18 * surrogate decision maker's consent exclusion criteria: * clinical instability for any reason. * life support withdrawal code * patient under tutelage * pregnancy * no french health insurance

Keywords: acute respiratory failure critical illness mechanical ventilation ventilation weaning intensive care unit variable (noisy) psv psv
chemotherapy and avastin followed by maintenance treatment with avastin +/- tarceva

Conditions: Metastatic Colorectal Cancer

Summary: chemotherapy and bevacizumab is given for 4 months. patients who have not progressed will continue with maintenance treatment with either bevacizumab (avastin) alone, or bevacizumab and erlotinib (tarceva).

patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. in addition to chemotherapy, avastin (bevacizumab) will be given during the treatment period. after the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with avastin alone or avastin in combination with tarceva (erlotinib). patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Eligibility criteria:
inclusion criteria: 1. adenocarcinoma of the colon or rectum. 2. age \> 18. 3. measurable disease according to recist criteria. 4. expected survival more than three months. 5. adequate bone marrow, liver and kidney function. 6. inr \< 1.5 times upper limit. 7. adequate contraception for fertile patients. 8. signed written informed consent. exclusion criteria: 1. earlier chemotherapy for metastatic colorectal cancer. 2. adjuvant treatment within 6 months. 3. surgery or significant trauma within 28 days prior to study entry. 4. planned radiotherapy against target lesions. 5. cns metastases. 6. prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma. 7. bleeding diathesis 8. uncontrolled hypertension. 9. significant cardiovascular disease. 10. treatment with anticoagulant drugs. 11. participation in other clinical trial. 12. pregnant or lactating.
a clinical study of t3011 in subjects with advanced melanoma

Conditions: Advanced Melanoma

Summary: this clinical study evaluated the tolerability, safety and preliminary efficacy of t3011 in subjects with advanced melanoma.


Eligibility criteria:
inclusion criteria: 1. subjects with advanced melanoma; 2. at least one measurable lesion; 3. eastern cooperative oncology group (ecog) performance status 0 or 1; 4. expected survival \> 12 weeks; 5. laboratory inspection meets the requirements; 6. for women of childbearing potential, the serum pregnancy test results must be negative within 7 days prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (icf) until at least 6 months after the last dose; 7. male subjects of childbearing potential agree to use effective contraception from signing the icf until at least 6 months after the last dose; in addition, male subjects must agree not to donate sperm during this period; 8. understand and voluntarily sign the icf，willing and able to comply with all experimental requirements. exclusion criteria: 1. subjects who have received other antitumor therapy within the prescribed time prior to the first dose; 2. subjects with a history of other malignancies within the prescribed time prior to the start of study treatment. 3. at screening, subjects with a history or evidence of high risk cardiovascular disease; 4. subjects with persistent or active infection requiring intravenous anti-infective therapy; 5. subjects with autoimmune diseases or a history of autoimmune diseases; 6. subjects with known psychiatric disorders that may affect trial compliance; 7. subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment; 8. subjects requiring systemic treatment with anti-hsv drugs during the study period; 9. subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; subjects who have received any tumor vaccine in the past; 10. subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period; 11. subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the icf; 12. female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period; 13. the investigator considers it inappropriate to participate in this study.