Kornimate/medical-research-clean huggingface dataset:
evaluation of dasatinib monotherapy efficacy in acute myeloid leukemia patients refractory to venetoclax-azacitidine

Conditions: Acute Myeloid Leukemia

Summary: the goal of this clinical trial is to learn about the efficacy of dasatinib monotherapy in acute myeloid leukemia patients refractory to venetoclax-azacitidine. the main question it aims to answer is to assess the tumor response after 2 cycles of dasatinib monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to venetoclax-azacitidine therapy. participants will be given dasatinib treatment up to 3 months. response will be assessed by a myelogram and a complete blood count at the end of every cycle. follow up will last 6 months.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aml except philadelphia chromosome-positive aml (ph+) and acute promyelocytic leukemia (aml m3) * age ≥ 18 years * ecog ≤3 * ven-aza refractory defined as no response after two cycles of ven-aza whatever the dose and the treatment duration * signed informed consent form * affiliation to a social security system, or beneficiary of such a system exclusion criteria: * patient eligible to a targeted therapy having a market authorization * central nervous system involvement * heart failure * liver failure * kidney failure * contraindication to dasatinib * positive for hiv (detectable viral load), hepatitis b or c * pregnant or breastfeeding woman * no efficient contraception for the women of childbearing age * emergency situation person or not able to express his/her informed consent * patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice) * inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
a phase ii study to assess the efficacy and safety of olokizumab in patients with crohn's disease

Conditions: Crohn's Disease

Summary: the primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe cohn's disease (cd) following treatment with different doses and dose regimens of olokizumab, relative to placebo.


Eligibility criteria:
inclusion criteria: * subject is male or female, 18 to 65 years of age at screening * diagnosis of cd (colonic localization) confirmed (at least 12 weeks prior to screening) by either radiological or endoscopic evidence and/or histological examination * colonoscopy performed prior to first study medication administration (week 0) with evidence of active cd and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other screening assessments have been completed) * moderately to severely active cd (cdai score: 220 to 450, inclusive) at baseline * female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/ parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide) exclusion criteria: * subject has a diagnosis of ulcerative colitis or indeterminant colitis as determined by the investigator * subject has obstructive strictures with clinical evidence of partial or complete obstruction * subject has an active fistula (fistula secreting spontaneously or by gentle pressure) * subject has a history of diverticulitis or symptomatic diverticulosis * subject has any prior exposure to anti-il-6 agents (eg, tocilizumab) * female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the study drug * subject has a high risk of infection (eg, subjects with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound) * subject has a concurrent malignancy or a history of malignancy. subjects who have been successfully treated and who have remained malignancy-free for at least 5 years prior to screening may be included

Keywords: olokizumab okz cdp6038 crohn's disease cdai ibdq
transcranial direct current stimulation as treatment for auditory hallucinations

Conditions: Psychotic Disorders; Mood Disorders; Personality Disorders; Stress Disorders, Post-Traumatic; Hearing Disorders

Summary: the present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.

rationale: auditory hallucinations (ah) are a symptom of several psychiatric disorders, such as schizophrenia. in the majority of patients, these ah respond well to antipsychotic medication. yet, a significant minority continues to experience frequent ah despite optimal pharmacotherapy and ah severely decrease quality of life in these patients. the number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. transcranial direct current stimulation (tdcs), in contrast, is a safe, non-invasive technique that is able to directly influence cortical excitability through the application of very low electric currents. this technique has only a few transient side-effects and is cheap and portable. to date, only one randomized controlled trial has been published, suggesting high efficacy of tdcs for the treatment of medication-resistant ah in a relatively small sample. we aim to replicate and extend these findings by investigating the efficacy of this technique in a larger sample.

Eligibility criteria:
inclusion criteria: * age over 18. * frequent auditory hallucinations (at least 5 times a week). * patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks * mentally competent for informed consent. * provided informed consent. exclusion criteria: * metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing) * history of seizures, or a history of seizures in first-degree relatives. * history of eye trauma with a metal object or professional metal workers * history of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker. * skin disease on the scalp on the position of the tdcs electrodes * coercive treatment based on a judicial ruling * pregnancy in female patients
poziotinib in stage iv lung adenocarcinoma with her2 mutation (kastt001)

Conditions: HER2 Gene Mutation; Adenocarcinoma Lung Stage IV

Summary: in this trial, treatment efficacy and safety of poziotinib will be assessed in patients with stage iv lung adenocarcinoma harboring her2 mutation.

this study is designed to be multi-center, open-label, single-arm, prospective, phase ii trial of patient with stage iv lung adenocarcinoma with her2 mutation who have not received prior egfr-tki. approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from irb and korea: mfds approval date. the study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. the initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. a cycle of study treatment is defined as 28 days.

Eligibility criteria:
inclusion criteria: 1. lung adenocarcinoma, stage iv 2. patients with her2 mutation by sequencing - confirmed triple-negative patients with remnant tumor dna 3. patients who have histories of previous exposure to at least one more systemic chemotherapies (not egfr-tki) 4. ecog performance status 0\~2 5. patient with at least one measurable lesions according to recist 6. patients who have proper organ functions as follows * neutrophil count: \> 1,500/ul * platelet count: \> 100,000/ul * hb: \> 9.0g/dl * ast/alt : \< 2.0 x upper normal limit * bilirubin: \< 1.25 x upper normal limit * serum creatinine : \< upper normal limit exclusion criteria: 1. expected lie expectancy \< 3 months 2. cns metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study) 3. patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 4. patients who have histories of previous exposure to egfr-tki

Keywords: pan-her inhibitor
a study of the effect of aldurazyme® (laronidase) treatment on lactation in female patients with mucopolysaccharidosis i (mps i) and their breastfed infants

Conditions: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie

Summary: the purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving aldurazyme® (laronidase) and the effects of aldurazyme (laronidase) on the growth, development, and immunologic response of their breastfed infants.

recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient.

Eligibility criteria:
inclusion criteria (mothers): * the patient must have a documented laronidase deficiency with a fibroblast, plasma, serum, leukocyte, or dried blood spot laronidase enzyme activity assay. * be pregnant, planning to breastfeed post-partum, and receiving aldurazyme (laronidase) therapy while breastfeeding. * provide signed, written informed consent prior to any protocol-related procedures. consent of a legally authorized guardian(s) is (are) required for mothers younger than 18 years of age. if a mother is under 18 years old and can understand the consent, written informed consent is required from both the mother and the authorized guardian(s). * provide signed, written informed consent for their infants to participate as study patients. if a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian. exclusion criteria (mothers and infants): * have a medical condition, serious intercurrent illness, or other extenuating circumstance that may interfere with study compliance, including all prescribed evaluations and follow-up activities. * have received an investigational drug within 30 days prior to study enrollment.
genomic opioid optimization of dosing and selections (goods) study

Conditions: Perioperative/Postoperative Complications

Summary: the researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.

participants, undergoing total knee replacements, will be randomized into two groups. both groups will receive pharmacogenomics (pgx) testing preoperatively. the pgx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. the control group results will be sealed until completion of treatment and clinicians will not have access to this information. these participants will undergo standard treatment dosing and medication selection.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total knee arthroplasty * patients must understand and provide written informed consent and hipaa authorization prior to initiation of any study-specific procedures. exclusion criteria: * patients with a current diagnosis of chronic pain * patients requiring narcotics for greater than one week prior to surgery * patients with chronic kidney disease with a pre-op creatinine greater than 1.5 * patient preference or need for spinal anesthesia rather than general anesthesia * patient planned for robotic surgical approach

Keywords: pharmacogenomics preoperative evaluation perioperative opioid use
chronic schizophrenia with obsessive-compulsive symptoms: comorbidity or a subtype?

Conditions: Schizophrenia; Obsessive Compulsive Disorder

Summary: evaluating the prevalence and characteristics of obsessive-compulsive (oc) symptoms in patients with chronic schizophrenia


Eligibility criteria:
inclusion criteria: * schizophrenic patients * schizophrenic patients with ocd exclusion criteria: * organic problems
microburst vagus nerve stimulator (vns) therapy feasibility study

Conditions: Epilepsies, Partial; Epilepsy, Tonic-Clonic

Summary: evaluate the initial safety and effectiveness of microburst vns stimulation in subjects with refractory epilepsy.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of medically refractory epilepsy with primary generalized tonic-clonic seizures (limited to 20 subjects) or partial onset seizures including complex partial seizures with or without secondary generalization (limited to 20 subjects). 2. must be on adjunctive antiepileptic medications. 3. willing and capable to undergo multiple evaluations with functional magnetic resonance imaging (fmri), electroencephalogram (eeg) and electrocardiogram (ecg). 4(a) for subjects with partial onset seizures: an average of ≥ 3 countable seizures per month based on seizure diary during the 3 month baseline period and no seizure-free interval greater than 30 days during those 3 months. 4(b) for subjects with pgtcs: have at least ≥ 3 countable seizures during the 3 month baseline period. note: each seizure within a cluster may be counted as separate seizures. 5. 12 years of age or older. 6. subject is a male or non-pregnant female adequately protected from conception. females of childbearing potential must use an acceptable method of birth control. 7. provide written informed consent-assent/health insurance portability and accountability act (hipaa) authorization and self-reported measures with minimal assistance as determined by the investigator. exclusion criteria: 1. currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. 2. a vns therapy system implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject. 3. a planned procedure that is contraindicated for vns therapy. 4. history of implantation of the vns therapy system. 5. currently receiving treatment from an active implantable medical device. 6. presence of contraindications to mri per the mri subject screening record. 7. known clinically meaningful cardiovascular arrhythmias currently being managed by devices or treatments that interfere with normal intrinsic heart rate responses (e.g., pacemaker dependency, implantable defibrillator, beta adrenergic blocker medications). 8. history of chronotropic incompetence (commonly seen in subjects with sustained bradycardia \[heart rate \< 50 bpm\]). 9. cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments. 10. history of status epilepticus within 1 year of study enrollment. 11. dependent on alcohol or narcotic drugs as defined by dsm iv-tr within the past 2 years, based on history. tests for drug or alcohol use will not be administered. 12. currently being treated with prescribed medication that contains cannabis or cannabis related substance including recreational use. 13. any history of psychogenic non-epileptic seizures. 14. currently participating in another clinical study without livanova written approval.
international multicentric study aron-1

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Summary: the aron-1 study is designed as an international multicentric retrospective study to collect global experiences with the use of immuno-combinations in patients with metastatic rcc. two supplementary studies (aron-1α and aron-1β) have been designed. the aron-1α supplementary study has been designed to investigate for the presence of genomic signatures from tumor samples of patients treated with first-line immuno-combinations for advanced rcc. the aron-1β supplementary study has been designed to charaterize the immune cell populations and assess their relationship with the clinical outcome of mrcc patients treated with first-line immuno-combinations


Eligibility criteria:
inclusion criteria: * patients aged \>18y * cytological or histologically confirmed diagnosis of clear cell or non-clear cell rcc * histologically or radiologically confirmed diagnosis of metastatic disease * first-line treatment with nivolumab plus ipilimumab or nivolumab plus cabozantinib or pembrolizumab plus axitinib or pembrolizumab plus lenvatinib or avelumab plus axitinib or atezolizumab plus bevacizumab exclusion criteria: * patients without histologically confirmed diagnosis of rcc * patients without histologically or radiologically confirmed metastatic disease * patients treated with immuno-combinations not included in the list reported in the inclusion criteria section

Keywords: immunotherapy mrcc immuno-combinations artificial intelligence technology real-world data
air as a placebo: increasing the respiratory performance of people with copd through simple expectations of improvement

Conditions: Chronic Obstructive Pulmonary Disease

Summary: copd (chronic obstructive pulmonary disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. the disease (known as copd, chronic obstructive pulmonary disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow. among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis. the differences found between different types of placebos (e.g. oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act. this is also the context for the studies by lacasse et al. (for the international nocturnal oxygen (inox) research group et al., 2017) and jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia. however, in the literature, there are no studies investigating the role of oxygen (o2) during the performance of a test such as the walking test, otherwise known as the 6 minute walking test (6mwt) compared with a placebo in patients with chronic obstructive pulmonary disease (copd), nor whether the use of the latter would lead to comparable results.


Eligibility criteria:
inclusion criteria: * subjects who voluntarily agree to participate in the study; * subjects with moderate-grade chronic obstructive pulmonary disease (copd) (gold 2-50% ≤ fev1 \<80% of predicted) according to gold criteria; * subjects undergoing treatment with oxygen therapy and non-smokers; * ex-smokers * outpatients and inpatients exclusion criteria: * refusal of informed consent * severe cognitive impairment, detected by administration of the mini mental status examination test (mmse) * pregnancy * patients with oncological or psychiatric pathologies * main immunodepression

Keywords: chronic obstructive pulmonary disease copd placebo oxygen therapy
laparoscopic ultrasound guided tissue sampling in patients with cancer of the upper gastrointestinal tract

Conditions: Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer

Summary: laparoscopic ultrasound (lus) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). when a suspect lesion is visualized during lus a biopsy should be provided in order to differentiate between benign and malignant lesions. a new system for lus guided biopsy has been developed, but how often these biopsies are clinically relevant (i.e. changing patient management)and how reliable are these biopsies are unknown. the study hypothesis is that lus guided biopsies are accurate and clinically relevant in the pre-treatment evaluation of patients with upper gastrointestinal tract cancer.


Eligibility criteria:
inclusion criteria: * biopsy proven upper gi tract cancer * laparoscopic ultrasound indicated during pre-treatment evaluation exclusion criteria: * patients unfit for surgery

Keywords: laparoscopy ultrasound cancer biopsy
long study - longitudinal thrombosis in end stage renal disease

Conditions: End Stage Renal Disease; Thrombosis; Bleeding; Cardiovascular Disease

Summary: the primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events.

hemodialysis patients have a very high rate of heart attacks, strokes and amputation. these problems are caused by a blood vessel problem called atherosclerosis (hardening of the arteries), and by clotting. clotting is also a problem in the access, which is their lifeline for hemodialysis. we have early results which show that some risk factors for clotting in the general population are common in dialysis patients. bleeding is another significant problem within this population. in this pilot study we will measure bleeding/clotting factors in the blood of consenting patients who are just starting dialysis. we will also do special tests to show how much calcium build up and atherosclerotic build up has happened in the arteries and whether the arteries are becoming stiff. we will then follow patients for up to four years and record any health problems that might reflect bleeding, clotting or a blood vessel problem. at the end of the study, we will compare people who have had bleeding, clotting or blood vessel problem with those who have not, and learn which of the measurements predicted problems. we will go on to study potential treatments, such as anti-clotting drugs, which might prevent or delay the occurrence of such problems. this would improve the health of dialysis patients.

Eligibility criteria:
inclusion criteria: * adult patient (aged \> 18 years) * patient on hemodialysis between 30 and 90 days exclusion criteria: * anticipated recovery of renal function (on dialysis \< 90 days) * critical illness at time of recruitment (patients who are critically ill \[icu\] when first screened, who survive to 80 days, will be rescreened and will be able to participate at that point if no longer critically ill) * planned live-donor renal transplant within 6 months * patient cannot consent due to language barrier * patient cannot consent due to cognitive difficulties * patient cannot consent due to hearing impairment * patient cannot consent due to speech impairment * patient or decision maker declines consent * patient is unable to give consent and no substitute decision maker is available * patient on dialysis longer than 90 days