Kornimate/medical-research-clean huggingface dataset:
an intermediate expanded use trial of dfmo

Conditions: Neuroblastoma; Medulloblastoma; Typical Teratoid Rhabdoid Tumor; Embryonal Tumor With Abundant Neuropil and True Rosettes; Ependymoblastoma; Medulloepithelioma

Summary: to provide dfmo in an expanded use setting to subjects with relapsed rare tumors with increased lin28 expression or mycn amplification or up regulation of ornithine decarboxylase.


Eligibility criteria:
inclusion criteria: * age: 0-30 years at the time of initial diagnosis. * diagnosis: histologic verification at either the time of original diagnosis or a previous relapse of high risk neuroblastoma, medulloblastoma, atypical teratoid rhabdoid tumor, embryonal tumor with abundant neuropil and true rosettes, ependymoblastoma, medulloepithelioma and other rare pediatric myc, odc or lin28/let7 driven tumors (each type will form a new subset). * disease status: subjects must be in one of the following disease categories: 1. high risk neuroblastoma patients that have completed standard of care upfront therapy and are not eligible for nmtrc014. 2. medulloblastoma patients who have completed standard of care therapies. 3. relapsed/refractory neuroblastoma patients who have completed standard of care therapies. 4. rare tumors with increased lin28 expression or mycn amplification or up regulation of ornithine decarboxylase who have completed standard of care therapies. * subjects are not eligible to enroll on dfmo studies nmtrc002, nmtrc003, nmtrc010, or nmtrc014. * a negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age). * both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. these methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (iud), levonorgestrol implants (norplant), or medroxyprogesterone acetate injections (depo-provera shots). if one of these cannot be used, contraceptive foam with a condom is recommended. * informed consent: all subjects and/or legal guardians must sign informed written consent. assent, when appropriate, will be obtained according to institutional guidelines exclusion criteria: * bsa (m2) of \<0.25 * investigational drugs: subjects who are currently receiving another investigational drug are excluded from participation.
efficacy of omega-3/omega-6 fatty acids in pre-school children at risk for adhd

Conditions: Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study

Summary: the efficacy of pufas (as nutritional supplement) in/for pre-school children with adhs symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.

the study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical adhd symptoms. the 3-6 years old children will be identified by a combined parent and teacher rating adhd-symptoms questionnaire (fbb-adhs-v). children with adhd symptoms \>90th percentile will participate in a following diagnostic process. the children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - epa (372mg), dha (116mg), gla (40mg) and vitamin e (7.2 mg) ) or placebo group. the study is divided into two phases with four months each. after unblinding after the first phase pre-school children taking placebo receive omega-3/omega-6 fatty acids. children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. in this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). clinical examination (questionnaires, intelligence test, medical examination) and evaluation of adhd symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. in addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. additionally regular phone calls will be implemented. medical examinations and meetings will taken place if required. if symptoms increase, children will be treated medical and/ or psychotherapeutically.

Eligibility criteria:
inclusion criteria: * age: 3 - 6 years * visit of a preschool (kindergarten) * parents have a command of the german language * screening score \>90th percentile in a combined parent and teacher screening questionnaire exclusion criteria: * hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine) * consumption of omega fatty acids preparation * consumption of fish oil-capsules

Keywords: omega-3/omega-6 fatty acids pre-school children with adhd symptoms randomized controlled trial
everflex™ self-expanding peripheral stent with entrust™ delivery system clinical study

Conditions: Peripheral Arterial Diseases

Summary: the purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the everflex™ self-expanding peripheral stent with entrust™ delivery system.


Eligibility criteria:
inclusion criteria: * has stenotic, restenotic (from pta or adjunct therapy, not including stents or stent grafts), * or occluded lesion(s) located in the superficial femoral artery (sfa) and/or proximal popliteal artery (ppa) suitable for primary stenting. exclusion criteria: * has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

Keywords: superficial femoral artery proximal popliteal artery everflex entrust stent
treatment use of 3,4-diaminopyridine

Conditions: Myasthenic Syndromes, Congenital

Summary: this protocol provided 3,4 diaminopyridine (dap) under a treatment-use ind to patients with congenital myasthenic syndrome (cms). it is now closed.

cms diagnoses were made based on clinical, electrophysiologic and molecular genetic findings. all patients were referred to the pi for dap treatment. this study enrolled minors and adults. cms patients under age 18 years were included if their parent or guardian gave written permission. minors who turned 18 while in the program were re-consented as adults. the dose of dap was determined individually for each patient. adults were started with a dose of 10 mg 3-4 times daily, increased over several weeks to the dose that produced the maximum symptomatic response, not to exceed 100 mg daily. pyridostigmine bromide (pb) was often added at low doses and increased to the dose that produced the best response, not to exceed 360 mg daily. in children, equivalent doses of these medications were calculated on a surface area basis. the doses of dap and pb were periodically adjusted to assure that the smallest effective doses are used.

Eligibility criteria:
inclusion criteria: * diagnosis of congenital myasthenic syndrome (cms) * women of childbearing potential must have negative pregnancy test and agree to practice adequate contraception while taking dap * must be competent to give consent exclusion criteria: * known seizure disorder * pregnancy * known cardiac arrhythmia or evidence of significant arrhythmia on screening ecg * known hepatic, renal or hematologic disease

Keywords: 3,4 diaminopyridine (dap)
open-label multicenter phase 1 study of tbi 302 as second-line therapy in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is one of the most common cancers worldwide. tbi 302 is being developed for the treatment of inoperable hcc by intravenous infusion. the objective is to determine the safety and tolerability of tbi 3002.

this is an open-label, phase 1 study to evaluate the safety, tolerability, pk, and mtd of tbi 302 in patients with non-resectable, non-transplantable hcc. tumor response will be assessed at week 9 (5 weeks following cessation of treatment) according to recist (ver 1.1) and aasld criteria.

Eligibility criteria:
inclusion criteria: * patients histologically or cytologically confirmed, unresectable, or metastatic hcc * child-pugh category a or b (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites * male or female patients 18 years of age or older * patients must be willing and able to read, understand and sign a written informed consent form * male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment * life expectancy of greater than 3 months * plasma haptoglobin ≥ lln (lower limit of normal) exclusion criteria: * patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels * patients who have received a blood transfusion within 4 weeks of enrolment * patients with infiltrating diffuse hepatocellular carcinoma, type 1 or 2 diabetes mellitus, hepatitis b or hepatitis c infection * systemic chemotherapy-naive patients * patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months * patient with a history of tumor rupture * patients with serious non-healing wound , ulcer or bone fracture * known positive human immunodeficiency virus (hiv) test

Keywords: hepatocellular carcinoma liver cancer
premedication with intranasal dexmedetomidine or midazolam for prevention of emergence agitation in children

Conditions: Emergence Delirium

Summary: study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. the hypothesis is that dexmedetomidine is superior but previous studies lack quality.

children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. emergence agitation will be assessed by paed scale.

Eligibility criteria:
inclusion criteria: * scheduled for amygdalectomy * american society of anesthesiologists physical status pi or pii * absence of congenital neuropathy * absence of cardiac pathology (any) * intolerance to one of the studied drugs. exclusion criteria: * protocol violation * need to transfer for icu intubated

Keywords: emergence delirium emergence agitation premedication dexmedetomidine midazolam
transcranial alternating current stimulation (tacs) on serotonin-1a receptor in depression

Conditions: Major Depressive Disorder

Summary: this study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18f-mppf pet/mr, neuropsychological tests, and polysomnography (psg) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tacs) for depressive disorders, mainly focusing on the serotonergic system revealed by serotonin-1a (5-ht1a) receptor.

5-ht1a receptor appears to be significantly involved in the effectiveness of electroconvulsive therapy (ect). like alternating current in ect, tacs also applies alternating current to intervene in neuropsychiatric disorders. we previously found that tacs with large current, such as 15 ma, via the forehead and bilateral mastoids can improve depressive symptoms. however, the underlying mechanism of 15 ma tacs in depression remains unclear. we propose a scientific hypothesis that 15 ma tacs may increase hippocampal 5- ht1a receptors, then to reduce depression in depressive patients. meanwhile, 15 ma tacs may increase the whole-brain functional connectivity with the hippocampus as the seed point. this study will utilize a multimodal data through 18f-mppf pet/mr, including mppf metabolism, resting-state fmri, dti, and 3d-t1 structural images. by observing the alterations of 5-ht1a receptor and the functional network between mdd patients and healthy controls, and between the pre- and post-tacs intervention in mdd patients, our aims to explore the effect of tacs on the serotonergic system in depression.

Eligibility criteria:
inclusive criteria: 1. 18 to 65 years old, chinese, male or female. 2. non-psychotic major depressive disorder according to dsm-iv. 3. hamd-17 total score ≥ 17 at the baseline. 4. currently experiencing an acute episode. 5. no history of prior treatment with psychotropic medications. 6. understanding of all aspects of the research protocol and the ability to provide informed consent. exclusion criteria for patients: 1. unable to do pet/mr examinations. 2. have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses. 3. severe or unstable organic diseases. 4. pregnant or lactating women or those planning a pregnancy in the near future. 5. alcohol or substance dependence or abuse within the past year. 6. received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment. 7. skin damage at the electrode placement site or those allergic to electrode gel or adhesives. 8. participated in any other clinical trials within the month before baseline. 9. any inappropriate conditions considered by the study group. inclusion criteria for healthy volunteers 1. to undergo pet/mr examinations. 2. be matched with the patient group regarding age, sex, and educational level. exclusion criteria for healthy volunteers: 1. those who are enrolled in other clinical studies. 2. the inappropriate conditions considered by the study group.

Keywords: major depressive disorder depression tacs 5-ht
safety and efficacy of easycool catheter

Conditions: Cardiac Arrhythmia

Summary: the goal of this observational study is to learn about risks and benefit of easycool catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias. the main question\[s\] it aims to answer are: * will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure * what are the adverse events at procedure, after 3 and 6 months all participants will receive cardiac ablation with easycool catheter.


Eligibility criteria:
inclusion criteria: * patients requiring intracardial rf- ablation with irrigated catheter exclusion criteria: * absence of patient´s consent; * age \<12 years; * pregnancy or breast-feeding women; * acute local infection; * acute systemic infection; * atrial thrombosis or myxoma - the transseptal approach is contraindicated in patients with left atrial thrombus; * existence of active implants (pacemaker, defibrillator etc.); * hemodynamic instability; * hypercoagulability; * inadequate tissue damaged e.g. by radiation or suppuration; * obstruction of the artery or vein selected for insertion; * patients with artificial heart valve: the use of intracardial catheters is not advised; * physiologic or anatomic abnormalities that could cause postoperative complications e.g. aneurysms in the application area, bleeding diathesis, decreased resistance to infections; * previously diagnosed spasms of the coronary arteries; * recurrent metastasizing cancer; * sepsis; * severe concomitant illness for which an increase or surgery time is associated with a significant increased risk; * thrombosis of the leg veins and the deep pelvic vein.

Keywords: easycool catheter cardiac ablation
spi-2012 vs pegfilgrastim in management of neutropenia in breast cancer participants with docetaxel and cyclophosphamide

Conditions: Neutropenia; Breast Cancer

Summary: the purpose of this study is to compare the efficacy of spi-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (tc) as measured by the duration of severe neutropenia (dsn).

this is a phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of spi-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with tc chemotherapy as measured by the duration of severe neutropenia (dsn). each cycle was 21 days. four cycles were evaluated for this study. on day 1 of each cycle, participants received tc chemotherapy. on day 2 of each cycle, participants received study drug (spi-2012 or pegfilgrastim). after cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.

Eligibility criteria:
key inclusion criteria: * new diagnosis of histologically confirmed early-stage breast cancer (esbc), defined as operable stage i to stage iiia breast cancer * candidate for adjuvant or neo-adjuvant tc chemotherapy * eastern cooperative oncology group (ecog) performance status \<= 2 * absolute neutrophil count (anc) \>=1.5×10\^9/l * platelet count \>=100×10\^9/l * hemoglobin \>9 g/dl * calculated creatinine clearance \> 50 ml/min * total bilirubin \<=1.5 mg/dl * aspartate aminotransferase (ast) / serum glutamic oxaloacetic transaminase (sgot) and alanine aminotransferase (alt)/serum glutamic pyruvic transaminase (sgpt) \<=2.5×uln (upper limit of normal) * alkaline phosphatase \<=2.0×uln key exclusion criteria: * active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease * locally recurrent/metastatic breast cancer * known sensitivity to e. coli-derived products * concurrent adjuvant cancer therapy * previous exposure to filgrastim, pegfilgrastim, or other g-csf products in clinical development within 12 months prior to the administration of study drug * active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment * prior bone marrow or stem cell transplant * used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• radiation therapy within 30 days prior to enrollment * major surgery within 30 days prior to enrollment

Keywords: neutropenia breast cancer long-acting granulocyte colony stimulating factor early stage breast cancer docetaxel + cyclophosphamide (tc) chemotherapy
assessment of the social cost of crohn's disease: economic and quality of life aspects (study p04560)

Conditions: Inflammatory Bowel Disease; Crohn's Disease

Summary: this observational study will evaluate the social cost and quality of life of participants who have had crohn's disease for at least 6 months and have active disease despite drug therapy. participants are followed for a total of 18 months.

participants for this study will be enrolled from 25 gastroenterology sites, even spread across italy. each center will enroll between 10 and 40 participants each.

Eligibility criteria:
inclusion criteria: * participant must: * be between 18 and 70 years of age, * have active crohn's disease (cd) with cdai score \>= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease, * be diagnosed with cd for at least 6 months, * sign the informed consent, * be capable of understanding the study and replying to the questionnaires. exclusion criteria: * participants who are unreliable in filling out questionnaires, * participants with diseases which may interfere with the cost's of cd or its complications, * participants who are participating in a clinical trial

Keywords: euroqol (eq-5d)
changes in faecal calprotectin levels and participation-related scores following three weeks of inpatient rehabilitation

Conditions: Crohn Disease; Ulcerative Colitis

Summary: for many people affected by inflammatory bowel disease (ibd), their quality of life and their ability to participate in their professional and social lives are severely restricted. rehabilitation measures based on the biopsychosocial icf model aim to support the restoration of these abilities. physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (pros) can be used to assess the success of icf-based rehabilitation measures and to optimize them. a suitable biomarker to monitor inflammation in ibd patients is faecal calprotectin. in addition, pros that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. the aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected pros after a three-week inpatient phase ii rehabilitation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn's disease or ulcerative colitis * participation in an inpatient phase ii rehabilitation exclusion criteria: -
a clinical trial to evaluate the effects of a herbal tincture on energy levels, weight management, and markers of metabolic health

Conditions: Stress; Fatigue

Summary: this study will evaluate the effects of the blue burn tincture on energy levels, weight management, and markers of metabolic health. it is a single-arm, hybrid trial involving 40 participants over a 12-week period. participants will use the product daily, complete scheduled questionnaires, attend blood tests at labcorp (baseline and week 12), and provide body mass measurements. primary outcomes include changes in cortisol levels, energy levels, and body mass.


Eligibility criteria:
inclusion criteria: * be male or female. * be aged 30 or over. * anyone who owns a body weight scale. * anyone currently experiencing issues regarding all of the following: 1. self-reported feelings of stress. 2. self-reported issues with maintaining their current body weight or losing weight. * exercises at least once per week. * if taking prescription medications, are willing to discuss this study with their physician before starting the study. * willing to maintain the study protocol for the study duration. * willing to refrain from taking any products, new medication, or supplements that target cortisol levels, stress, energy levels, or weight management during the study duration. * if taking oral over-the-counter supplements or herbal remedies targeted at improving cortisol levels, stress, energy levels, or weight management, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration. * willing to maintain their current diet, sleep schedule, and activity level for the study duration. * anyone who is generally healthy - does not live with any uncontrolled chronic disease. * resides in the united states. * not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration. exclusion criteria: * anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * anyone who is planning to undergo any surgeries or invasive treatments for the study duration. * anyone diagnosed with a condition related to the thyroid. * anyone diagnosed with type i or type ii diabetes. * anyone who has had any major illness in the last three months. * anyone who drinks heavily (i.e., eight or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men). * anyone with an allergy to nightshade vegetables. * anyone with known severe allergic reactions to any of the study product ingredients. * any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period). * anyone with a history of substance abuse. * anyone who is currently a smoker or has been a smoker in the past 3 months.

Keywords: weight management energy levels