Kornimate/medical-research-clean huggingface dataset:
dose escalation study of auy922 in advanced solid malignancies in japan

Conditions: Advanced Solid Tumors

Summary: this study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of auy922 in adult patients with advanced solid malignancies in japan.


Eligibility criteria:
inclusion criteria: * patients with advanced malignant solid tumors * ecog performance status of ≤ 2 * patients must have the following laboratory values: * absolute neutrophil count (anc) ≥ 1.5 x 109/l, hemoglobin (hgb) ≥ 8.5 g/dl, platelets (plt) ≥ 100 x 109/l * potassium, calcium, magnesium, phosphorus within normal limits or correctable with supplements * ast/sgot and alt/sgpt ≤ 2.5 x upper limit of normal (uln) * serum bilirubin ≤ 1.5 x uln, serum albumin \> 2.5g/dl, serum creatinine≤ 1.5 x uln or 24-hour clearance ≥ 50 ml/min * able to sign informed consent and to comply with the protocol exclusion criteria: * patients with brain metastasis. * prior treatment with any hsp90 or hdac inhibitor compound. * treatment with therapeutic doses of coumarin anticoagulants. * pregnant and lactating women. * severe and/or uncontrolled acute or chronic liver disease * severe and/or uncontrolled acute or chronic renal disease * chronically significant heart disease * history (or family history) of long qt syndrome. qtc ≥ 450 msec on screening ecg, ischemic heart disease, heart fail, ecg abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or torsades de pointes. * patients who are currently receiving treatment with any medication which has a relative risk or prolonging the qtcf interval or inducing torsades de pointes * patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g gilbert's syndrome). other protocol-defined inclusion/exclusion criteria may apply

Keywords: hsp90 molecular chaperone advanced solid tumors japan
free study: efficacy and toxicity of trizivir

Conditions: HIV Infections

Summary: antiretroviral naïve patients with \ 30.000 cop/ml are started on combivir ® and kaletra ®. when patients have reached an undetectable viral load of\< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with combivir/kaletra or switch to trizivir ® twice daily one pill during 96 weeks. all patients randomised in the combivir/kaletra arm are eligible to switch to trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.

the primary objective is to compare the antiviral efficacy of an early switch from a boosted pi/2nrti regimen to trizivir (after undetectability of hiv-rna has been achieved on 2 consecutive occasions) with uninterrupted use of the pi/2nrti regimen for 96 weeks.

Eligibility criteria:
inclusion criteria: * adults \>18 years of age, confirmed hiv-1 infection, never received antiretrovirals before, plasma-hiv-rna \>30.000 cop/ml, cd4 \< 350 e6/l. exclusion criteria: * pregnancy, women using proven barrier methods of contraception, defined uncontrolled active aids defining complication, being on treatment for diabetes, other serious illnesses, expected non-compliance, defined laboratory abnormalities

Keywords: aids treatment naive
descriptive study of the evolution in proportion of regulatory b lymphocytes in patients hospitalized in intensive care for severe sepsis

Conditions: Severe Sepsis

Summary: severe sepsis and septic shock are the most severe forms of sepsis (which associates a systemic inflammatory response with infection). these are serious pathologies with a lethality estimated at almost 40% at 28 days (after the onset of sepsis). after a first pro-inflammatory phase, a second compensatory phase called compensatory anti-inflammatory response syndrome (cars) takes place quickly. patients then show signs of immunosuppression and profound alterations in immune functions. it is during this phase that the vast majority of deaths occur, far from the onset of the shock, which is related to the inability of the immune system to eliminate the initial infectious agent and / or a greater susceptibility important to develop secondary infections (nosocomial infection, latent virus reactivation ...). the cars phase has been the subject of studies focusing on measuring the plasma concentration of anti-inflammatory cytokines (such as interleukin (il) -10), the percentage of regulatory t lymphocytes (treg), or the percentage of monocytic expression of hla-dr in septic patients. the investigator proposes to carry out the first study on a newly described regulatory lymphocytic subpopulation: regulatory b lymphocytes (breg) from a quantitative and functional point of view in severe septic states.


Eligibility criteria:
inclusion criteria: * adult patients with severe sepsis or septic shock diagnosed less than 24 hours (defined as d0) and hospitalized in the medical resuscitation department of the amiens-picardie university hospital. * the definitions of severe sepsis and septic shock are the result of the consensus of the société de réanimation de langue française dating from 2005: * sepsis refers to a systemic inflammatory response syndrome (sirs) in the presence of suspected or identified infection. sepsis is said to be severe when lactate\> 4 mmol / l or arterial hypotension prior to filling or organ dysfunction is present (one is sufficient): hypoxemia with a pao2 / fio2 \ 4 or bilirubin\> 78 μmol / l, thrombocytopenia (platelets \ 176 μmol / l, coagulation disorders with inr\> 1.5 disorders of higher functions with a glasgow coma score \<13. * finally, septic shock is defined as a severe sepsis condition with persistent hypotension despite a well-conducted vascular filling (20-40 ml / kg isotonic saline). exclusion criteria: * patient with active neoplasia, immune deficiency, autoimmune disease or autoimmune disease. * patient under tutorship or curatorship * taking an immunomodulatory or immunosuppressive treatment at the time of the study or the year prior to hospitalization for sepsis. * antecedent or haematopoietic graft in progress. * pregnancy in progress. * known history of infection with human immunodeficiency virus (hiv) type 1 or 2 or with hepatitis b or c virus * patient with agranulocytosis (defined as neutrophils \<0.5 g / l).

Keywords: b lymphocyte
optimizing mental health management with ai-guided (genais tm) dietary supplementation

Conditions: Mental Disorder

Summary: the study "optimizing mental health management with ai-guided (genais tm) dietary supplementation" aimed to compare the effectiveness of ai-guided dietary supplement (ds) prescriptions versus standard physician-guided prescriptions in managing mental health disorders, specifically depression and anxiety. this 6-month randomized controlled trial included 160 participants diagnosed with major depressive disorder or generalized anxiety disorder. participants were divided into two groups: one received ds based on physician judgment, and the other based on genais ai system analysis. primary outcomes focused on changes in mental health scores, while secondary outcomes included quality of life, metabolic markers, and ds adherence. data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * diagnosed with major depressive disorder (mdd) or generalized anxiety disorder (gad) according to dsm-5 criteria. * moderate to severe symptoms as indicated by scores on ham-d (≥17) for depression or gad-7 (≥10) for anxiety. * stable on psychiatric medication for at least 3 months prior to the study. * willingness to provide genetic and metabolic data. * written informed consent. exclusion criteria: * current or past history of severe psychiatric conditions such as schizophrenia, bipolar disorder, or other psychotic disorders. * current substance abuse or dependence within the last 6 months. * significant medical conditions like severe renal, hepatic, or cardiovascular diseases. * pregnancy or breastfeeding. * recent changes in psychiatric medication within the last 3 months. * participation in another clinical trial within the last 30 days.

Keywords: ai-guided dietary supplementation genetic profiling metabolic profiling depression management anxiety management
capsulorhexis size and capsular outcome

Conditions: Congenital Cataract

Summary: different capsulorhexis size results in different capsular outcome when treating pediatric cataract, and there should be an appropriate capsulorhexis size for the best capsular outcome.

numerous studies have reported that ideal anterior capsulorhexis size is 4.5-5.0 mm with the capsulorhexis edges covering iol optic surface because it can inhibit the proliferation and migration of remnant lens epithelial cells (lec). but there are no reports investigating the relationship between the capsulorhexis size and the capsular outcome after pediatric cataract surgery. therefore, the aim of the current study is to prospective evaluate the capsular outcomes of three controlled groups receiving different anterior capsulorhexis sizes (3.0-3.9, 4.0-5.0, 5.1-6.0 mm in diameter).

Eligibility criteria:
inclusion criteria: * age\< 2 years * performed cataract surgery without iol implantation * without capsular fibrosis, glaucoma, ocular trauma, corneal disorders before surgery * no other corneal and systemic abnormalities * written informed consents provided exclusion criteria: * patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, lowe syndrome, capsular fibrosis * cases with surgical complications * those who can't dilute pupil normally postoperation or can't complete the follow-up
evaluate the safety and efficacy of 48-hour infusions of hno (nitroxyl) donor in hospitalized patients with heart failure

Conditions: Heart Failure

Summary: a study to evaluate safety and efficacy of continuous 48-hour intravenous infusions of hno donor in hospitalized patients with heart failure and impaired systolic function


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * actively being hospitalized for acute decompensated heart failure * at least 1 administration of iv diuretic for the current episode * be randomized within 18 hours of first dose of iv diuretic for current episode for part 1 cohort 1, or 48 hours for first dose for part ii cohort ii * have shortness of breath at rest or with minimal exertion after administration of 1 dose of iv diuretic * have history of heart failure and a left ventricular ejection fraction (lvef) ≤ 40% exclusion criteria: * systolic blood pressure \ 160mm hg or heart rate \ 130 bpm * have an active infection requiring iv anti-microbial treatment * be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening * have a history of a cerebral vascular accident (cva or stroke) or of a transient ischemic attack (tia) during the previous 90 days prior to screening * suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis) other protocol defined inclusion/exclusion criteria could apply
stroke counseling for risk reduction

Conditions: Stroke

Summary: the purpose of this study is to test the efficacy of the stroke counseling for risk reduction (scorre) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle behavior change to reduce stroke risk in young adult african americans.


Eligibility criteria:
inclusion criteria: * self-identify as african american/black * age 20-35 years * able to complete two study visits lasing 1 1/2- 2 hours and a brief daily diary for 8 weeks * has a cell phone or email address to receive weekly reminders and tips * has at least one modifiable risk factor for stroke identified during study visit one screening

Keywords: primary stroke prevention, risk factors for stroke
rtms in aphasic patients with neuroimage assessments

Conditions: Stroke; Aphasia

Summary: the refinement of repetitive transcranial magnetic stimulation (rtms) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. nevertheless, the efficacy of synchronous rtms protocol integrated with computer-integrated speech training is not well understood. it is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. the aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. advanced mr neuroimaging techniques, such as fmri and dti, are powerful tools to evaluate the concomitant nervous changes after rtms treatment on aphasic patients. the knowledge from fmri and dti microstructural evolution provides insight into underlined mechanism operating the language improvement.

the efficacy of synchronous rtms protocol integrated with computer-integrated speech training is not well understood. it is also not clear regarding the efficacy of inhibitory or excitatory stimulation protocol. the aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. advanced mr neuroimaging techniques, such as fmri and dti, are powerful tools to evaluate the concomitant nervous changes after rtms treatment on aphasic patients. the knowledge from fmri and dti microstructural evolution provides insight into underlined mechanism operating the language improvement

Eligibility criteria:
inclusion criteria: * aphasic stroke in chronic stage (over 3 months) exclusion criteria: * no seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Keywords: stroke aphasia rtms functional mri speech training
combining antidepressant medication and psychotherapy for insomnia to improve depression outcome

Conditions: Major Depressive Disorder; Insomnia

Summary: this study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

difficulties falling and/or staying asleep are common in people who suffer from depression. persistent insomnia can hinder response to treatment. in addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. this study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression. participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. all participants will also receive escitalopram oxalate, an antidepressant medication. the study will last 12 weeks. the severity of participants' depression and insomnia will be assessed. study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder * hrsd(17) score of at least 14 * presence and complaint of insomnia for at least 1 month * fluent in english * use of an effective form of contraception throughout the study exclusion criteria: * other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder) * psychotic symptoms * serious, unstable, or terminal medical condition * axis ii diagnosis of antisocial, schizotypal, or severe borderline personality disorder * substance abuse * not willing to end other psychiatric treatment * previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year * sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study) * other sleep disorders * currently pregnant or breastfeeding * history of seizure disorder * disease or condition that produces altered metabolism or hemodynamic responses * liver or kidney dysfunction * current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, st. john's wort, same)

Keywords: major depressive disorder insomnia sleep mental health
raman spectroscopy in the diagnosis of extrahepatic cholangiocarcinoma - a pilot study

Conditions: Cholangiocarcinoma, Extrahepatic; Cholangiocarcinoma of the Extrahepatic Bile Duct; Cholangiocarcinoma, Perihilar; Diagnosis; Raman Spectroscopy; Klatskin Tumor; Endoscopy; Biliary Stricture; Malignant Biliary Stricture

Summary: diagnosis of extrahepatic cholangiocarcinoma is challenging because the yield of imaging and tissue sampling is limited. raman spectroscopy is an optical method based on the analysis of scattered monochromatic light. raman spectroscopy is able to provide a molecular 'fingerprint' of the tissue to determine its type. the aim of this pilot study was to develop a methodology for in vivo raman spectroscopy in bile ducts to improve the current diagnostic capabilities of extrahepatic cholangiocarcinoma.

during ercp, a fibre raman probe (endoscopic fiber-optic raman probe bundle fiber, uni-export instruments, usa) is introduced transpapillary into the known extrahepatic cholangiocarcinoma. the raman probe is placed in an adequate position under fluoroscopy control. raman spectroscopy measurements are performed (without fluoroscopy) 20 times for each patient (laser wavelength 785 nm), 10 times for extrahepatic cholangiocarcinoma and 10 times for healthy bile duct. the attained data are saved and analysed by a specialised biophysicist. all patients provided informed consent.

Eligibility criteria:
inclusion criteria: * person older than 18 years, who has known extrahepatic cholangiocarcinoma and is indicated for ercp exclusion criteria: * disagreement with the study
understanding hiv susceptibility in the female genital tract

Conditions: HIV Infections

Summary: there is great variability in susceptibility from one person to another, and less than one in a hundred sexual exposures to hiv results in infection. in addition, some recent trial of methods to prevent hiv - including vaccines and microbicides - have actually increased hiv acquisition among trial participants for reasons that we do not fully understand. while we know that immune differences in the genital lining are an important determinant of whether a person is infected after a sexual hiv exposure, we don't know enough about these differences to be able to accurately assess a person's individual hiv risk. therefore, the development of safe and non-invasive laboratory tests to estimate a person's susceptibility in the genital tract would be useful in clinical studies of new hiv prevention tools.

heterosexual intercourse is the most common mode of transmission of hiv, but the risk of hiv acquisition after exposure is so low that studies to assess hiv risk must have a huge sample size. the goal of this study is to assess the suitability of a prototype pseudovirus assay to identify early hiv target cells in the female genital tract, using cervical cytobrush samples collected from healthy women, and to optimize assay sensitivity. this novel hiv entry assay may overcome the need for a large sample size by directly measuring how susceptible a person is by using a sample similar to a pap test. the assay is performed on immune cells obtained from a cervical cytobrush and enables assessment of hiv cell entry within 24 hours. if the assay works, this technique may have the potential to assess the impact of clinical parameters such as stage of menstrual cycle, or sexually transmitted infections and their treatment on hiv susceptibility in the female genital tract. therefore, the assay may serve as an important monitoring tool in clinical trials of hiv prevention, serving as an invaluable intermediate endpoint to assess hiv acquisition risk, rather than relying on actual participant hiv seroconversion/infection.

Eligibility criteria:
inclusion criteria: * women over the age of 18 years exclusion criteria: 1. pregnant 2. actively menstruating 3. known hiv infection 4. genital ulceration or discharge on history or physical examination
carpentier-edwards perimount magna ease pericardial bioprosthesis, model 3300tfx

Conditions: Coronary Artery Disease; Aortic Valve Disorder; Heart Failure; Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: the purpose of the study is to demonstrate the long term safety and effectiveness of the carpentier-edwards perimount magna ease valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

this is a prospective, single-arm, multi-center, interventional study to be conducted in the us and outside the us (ous). this study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. the study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.

Eligibility criteria:
inclusion criteria: 1. the patient requires, as indicated in the preoperative evaluation, a replacement aortic valve. 2. the patient is an average or better operative risk. 3. the patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years. 4. the patient is 18 years or older. 5. the patient has signed and dated the subject informed consent form prior to surgery. exclusion criteria: 1. the patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year. 2. the patient presents with active endocarditis within the last 3 months. 3. the patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). 4. the patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, marfan's syndrome). 5. the patient is pregnant or lactating. 6. the patient is an intravenous drug abuser. 7. the patient is currently a prison inmate. 8. the patient is currently participating in a study of an investigational drug or device. 9. the patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve. 10. the patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device. 11. the patient was previously enrolled in the study. 12. the patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.

Keywords: perimount, aortic valve replacement/regurgitation