Kornimate/medical-research-clean huggingface dataset:
effects of vitamin b12 on the body's internal clock

Conditions: Sleep Disorders, Circadian Rhythm

Summary: circadian rhythms are 24-hour cycles that influence natural functions in the body such as heart rate, blood pressure, and body temperature. circadian rhythms provide the body with an internal clock and affect sleep patterns. the purpose of this study is to determine the effects of vitamin b12 supplements on circadian rhythms and sleep-wake regulation.

individuals with circadian rhythm sleep disorder suffer from recurrent patterns of disrupted sleep that can significantly affect their daily functioning. evidence suggests that vitamin b12 supplements may have a beneficial effect on sleep patterns. however, research on the effects of vitamin b12 supplements on sleep is limited. this study will determine the effects of vitamin b12 supplements on circadian rhythms and sleep-wake regulation. this study will last 47 days. participants will undergo a 3-week medical and psychological screening prior to study entry. eligible participants will be admitted to the general clinical research center where they will live in a private study room for the duration of the study. the room will be a time-free environment with no windows, clocks, television, or radio. participants will not be able to make or receive telephone calls, and their bedtimes, wake times, and mealtimes will be determined by study researchers. participants will be randomly assigned to receive three capsules of either vitamin b12 or placebo daily. blood and saliva collection will occur daily to determine core body temperature and hormone levels. performance tests to determine participants' cognitive abilities will be administered at regular intervals throughout each day. participants' sleep will be recorded every night with polysomnography, which will monitor brain and muscle activity and breathing patterns during sleep.

Eligibility criteria:
inclusion criteria: * diagnosis of delayed sleep phase syndrome or self-described as a "night owl" exclusion criteria: * history of medical illness * history of psychiatric illness in participant or his or her family members * current medication or vitamin use * follow a vegan diet * significant visual problem * recent travel across time zones * history of rotating shiftwork

Keywords: circadian rhythm biological clock complementary and alternative medicine
the influence of a natural anti-inflammatory product on levels of inflammatory markers in cases with osteoarthritis of knee

Conditions: Osteoarthritis

Summary: this is a randomized, placebo controlled study. the first subject is expected to be enrolled in july 2014, and the last subject is expected to complete the study by july 2015. each subject will be provided with the prn joint comfort formula, placebo or prn flex omega benefits® combination depending on randomization (1:1:1 at each site) during the course of the study. instructions and frequency of use will be determined by the labelling.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 90 at the time of informed consent. * subjects with symptomatic moderate arthritis of the knee defined as per * kellgren-lawrence grade ii or iii (appendix b). subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study. * ability to walk 50 feet unassisted. * lequesne's functional index score greater than 7 points exclusion criteria: * subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others * subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis. * subjects taking hormone replacement therapy * intra-articular corticosteroid injections 3 weeks prior to enrollment. * hypersensitivity to fish oil. * hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, hypertension (bp\>140/90), cancer and hyperkalemia. * major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders. * high alcohol intake (\>2 standard drinks per day). pregnant, breastfeeding or planning to become pregnant during the study * subjects awaiting surgery on the affected knee within three months. * consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. also, the regimen should not contain the same active compounds tested in the prn joint health formula product. * vitamins/supplements cannot be introduced during a subject's participation in the study.
a study on the relationship between gastric xanthoma and gastric cancer and precancerous lesions

Conditions: Gastric Xanthoma; Helicobacter Pylori Infection; Gastric Cancer; Intestinal Metaplasia; Precancerous Lesions

Summary: to explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

this is a large-scale single center case-control study. patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.record the location and quantity of gastric xanthoma and situation of helicobacter pylori infection in each patient.

Eligibility criteria:
inclusion criteria: 1. age range from 18 to 75 years old, regardless of gender; 2. endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia hyperplasia/gastric cancer 3. voluntarily sign an informed consent form. exclusion criteria: 1. previously underwent upper gastrointestinal surgery 2. previous diagnosis of malignant tumors 3. individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons 4. those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons

Keywords: gastric cancer helicobacter pylori precancerous lesion gastric xanthoma
cd7 car-t cell treatment of relapsed/refractory cd7+ t -acute lymphoblastic leukemia/ lymphoma

Conditions: Relapsed/Refractory, High Risk Hematologic Malignancies; T-ALL/Lymphoma

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of cd7 car-t cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

t-acute lymphoblast leukemia (t-all) accounts for 15-20% of all all cases. it is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor t cells. t-all is a highly aggressive tumor. adults need intensive chemotherapy, and the cure rate is \<50%, even with stem cell transplantation. the prognosis is also very poor. the combined chemotherapy has significantly improved the prognosis of t-acute lymphoblast leukemia/lymphoma. however, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. therefore, exploring safe and effective treatments is a critical unmet medical need. since 95% of t-alls express cd7, this might provide an effective targeting approach for the vast majority of t-all cases.

Eligibility criteria:
inclusion criteria: * 1. signed written informed consent; patients volunteer to participate in the clinical trial; 2. diagnosis is mainly based on the world health organization (who) 2008; 3. complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%; 4. leukemic blast cells express cd7 (cd7 positive by flow cytometry or immunohistochemistry ≥70%); 5. the expected survival period is greater than 12 weeks; 6. ecog score ≤2; 7. age 2-60 years old; 8. hgb≥70g/l (can be transfused); 9. total bilirubin does not exceed 3 times the upper limit of normal value, and ast and alt do not exceed 5 times the upper limit of normal value. exclusion criteria: * 1. patients declining to consent for treatment 2. prior solid organ transplantation 3. one of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged qt syndrome or secondary qt prolongation; clinically significant pericardial effusion; cardiac insufficiency nyha (new york heart association) iii or iv; 4. history of severe pulmonary dysfunction diseases; 5. severe infection or persistent infection cannot be effectively controlled; 6. severe autoimmune disease or congenital immunodeficiency; 7. active hepatitis; 8. human immunodeficiency virus (hiv) infection; 9. clinically significant viral infections, or uncontrollable viral reactivation, including ebv (epstein-barr virus).

Keywords: cd7 cd7car leukemia acute lymphoblastic leukemia/lymphoma hematologic malignancies
baclofen for children with rumination syndrome

Conditions: Rumination Syndrome

Summary: the goal of this clinical trial is to learn about baclofen in pediatric patients with rumination syndrome. the main question it aims to answer is whether baclofen is effective in treating children with rumination syndrome. participants will be asked to take baclofen or placebo for 4 weeks and fill out surveys regarding symptoms.

rumination syndrome is a functional gastrointestinal disorder characterized by effortless, repetitive regurgitation of recently ingested meal. the objective of this study is to evaluate the efficacy of baclofen, a gaba-b agonist, in children with rumination syndrome. the investigators hypothesize that children with rumination syndrome who are treated with baclofen in addition to standard behavioral treatment will have greater clinical improvement compared to those who receive placebo. after enrollment into the study, participants will be randomized into one of two parallel groups in a 1:1 ratio: (a) baclofen or (b) placebo control. the research team will be blinded to randomization. participants will subsequently meet with investigational pharmacist and receive four-week supply of either baclofen 0.5 mg/kg/day up to 15 mg divided three times a day or matching placebo three times a day in liquid formulation. at baseline, the research team will collect information on demographics, medical, and surgical history, relevant diagnostic testing, and relevant past treatments (including working with a psychologist). patients/families will complete a baseline questionnaire (rumination severity questions, pedsql, route of nutrition, medications) and then the patient will start taking study drug or placebo in addition to their usual care as determined by the patient's primary gastroenterologist. participants/families will complete follow-up questionnaires at week 1, week 2, week 4, and then week 8. the questionnaires will be filled out by the patient or guardian electronically via redcap. the research team will closely monitor for side effects. in addition to asking about any side effects at follow-up timepoints, the research team will also emphasize that families should contact the team using the research team phone number with any instances of suspected side effects even before the next follow-up timepoint. after the 4-week drug or placebo period, participants are free to start or continue baclofen, or use other treatment modalities, as determined by their primary gi team.

Eligibility criteria:
inclusion criteria: * children 4-18 years of age who meets rome iv diagnostic criteria for rumination syndrome and are see at nch gi clinic exclusion criteria: * patients who have contraindications to baclofen due to medical history and/or current medications * patients who are non- english speaking * patients who are pregnant
nv psr inspire-a pipeline™ vantage post approval study

Conditions: Intracranial Aneurysm

Summary: the purpose of the pipeline™ vantage embolization device with shield technology™ post approval study (pas) ("pipeline™ vantage pas") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (ia) using the pipeline™ vantage embolization device with shield technology™ ("pipeline™ vantage device") in a post approval setting.

the inspire pipeline™ vantage post approval study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the pipeline™ vantage embolization device with shield technology™. this study is a sub-study to the neurovascular product surveillance registry (nct02988128).

Eligibility criteria:
inclusion criteria: 1. patient or legally authorized representative (lar) has provided written informed consent using the ethics board and medtronic approved informed consent form and agrees to comply with the protocol requirements. hipaa/data protection authorization has been provided and signed by the patient (or patient's lar) as applicable per local law. 2. patient has an intracranial aneurysm intended to be treated with the pipeline™ vantage embolization device with shield technology™. 3. patient is an adult per local law at time of consent. exclusion criteria: 1. patient with any contraindications for the device or procedure per the pipeline™ vantage device local geography ifu. 2. patient who may be unable to complete the study follow-up. 3. the investigator determined that the health of the patient may be compromised by the patient's enrollment. 4. female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
universal familial hypercholesterolemia screening in children

Conditions: Familial Hypercholesterolemia; Polygenic Hypercholesterolaemia

Summary: 30 million individuals globally with undiagnosed familial hypercholesterolemia (fh) are at a substantial cardiovascular disease (cvd) risk, which could be normalized by early diagnosis and treatment. effective screening strategies are urgently needed, but the data on universal fh screening (ufhs) is scarce. the investigators aim to assess the overall performance of the ufhs program in slovenia and to compare the common elements to the pilot ufhs program in lower saxony (ls; germany).

the study will include pediatric patients (or their siblings and parents in slovenian cohort) undergoing the universal hypercholesterolemia screening; those with elevated cholesterol at universal cholesterol screening at primary care level are referred to the lipidology specialist at the umc ljubljana (slovenia) or kinderkrankenhaus auf der bult (lower saxony, germany). for those with elevated cholesterol levels, the familial hypercholesterolemia genetic diagnostics is done centrally in umc ljubljana. only those will be included from whom a signed informed consent by themselves or by their parents/guardians will be obtained prior to the genetic diagnosis of familial hypercholesterolemia.

Eligibility criteria:
inclusion criteria: * elevated total cholesterol (cohort 1) or ldl-cholesterol (cohort 2) at universal screening program in children. * completed fh genetic analysis (cohort 3). * parent or sibling of child with confirmed familial hypercholesterolemia (cohort 4). exclusion criteria: * children with hypercholesterolemia not referred through the screening program. * fh genetic analysis not completed.

Keywords: familial hypercholesterolemia fh screening universal cascade pediatric
adding appetite stimulants to an ons in older adults

Conditions: Malnutrition

Summary: study to determine whether adding specific nutrients to a high-protein oral nutritional support (ons), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years. this contributes to research into a new type of nutritional nutrition for people with disease related malnutrition (drm)


Eligibility criteria:
inclusion criteria: 1. 65 years of age or older 2. able to consume high energy and/or high protein ons at discretion of the investigator 3. written informed consent 4. willing and able to refrain from smoking during the visits 5. able to speak and read in dutch to communicate with the site staff and comply with the instructions and requirements of the study. exclusion criteria: 1. any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, parkinson disease). 2. any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder) 3. known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon. 4. any known chronic/continuous use, and/or within 24-48h before the visit, of medication that strongly affects with gastric emptying or gastric acid secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers, beta-adrenergic receptor agonists, h2 receptor antagonists, proton pump inhibitors; tricyclic antidepressants such as amitriptyline, imipramine, systemic steroids) 5. known active cancer treatment 4 weeks prior the study start 6. body mass index \>= 30.0 kg/m² 7. presence of diabetes mellitus (self-reported or the use of diabetes medication: i.e., insulin, biguanides, dpp-4 inhibitors, glp-1 receptor agonists) 8. investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or alzheimer's disease 9. known renal dysfunction with protein restriction diet 10. known allergy to cow's milk protein 11. known allergy to soy 12. known galactosaemia 13. known lactose intolerance 14. excessive alcohol consumption (use of \> 14 units per week for women or \> 21 units per week for men, on average during the past 6 months). 15. drug abuse based on investigator's judgement. 16. any contraindication to oral feeding per se being: any degree of dysphagia, gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis. 17. enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline 18. employees, family members or other relatives of employees of the participating centre or of danone global research \& innovation center.
neuroimaging predictors of improvement to pivotal response treatment (prt) in young children with autism

Conditions: Autism Spectrum Disorder; Autism

Summary: autism spectrum disorder (asd) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. the goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with asd who are receiving pivotal response treatment (prt), an evidence-based behavioral intervention. specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a prt program (prt-p) targeting language deficits in young children with asd who will be randomized to either prt-p or to a delayed treatment group (dtg).


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum spectrum disorder (asd) based on clinical interview and diagnostic and statistical manual, 5th edition (dsm-5) and confirmed using the autism diagnostic interview revised (adi-r) and the autism diagnostic observation schedule (ados) and/or brief observation of symptoms of autism (bosa) and/or childhood autism rating scale- second edition (cars-2). * outpatients between 2.0 and 4.11 years of age of either gender, * children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained * language delay as measured by the preschool language scale, 5th edition (pls-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\], * stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation, * stable treatment \[applied behavior analysis (aba), floortime, or other interventions\], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation, * no more than 60 minutes of 1:1 speech therapy per week, * the child's exposure to the english language must be sufficient that administration of standardized tests in english is appropriate for measuring progress, * the availability of at least one parent who can consistently participate in the training sessions and related activities, and * successful completion of baseline brain scan. exclusion criteria: * current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder), * genetic abnormality (e.g., fragile x) * presence of active medical problem (e.g., unstable seizure disorder), * receiving more than 15 hours of in home 1:1 applied behavior analysis (aba) per week * magnetic resonance (mr) contraindication (e.g., the presence of ferrous metal), or * previous adequate pivotal response treatment (prt) trial.

Keywords: pivotal response treatment imaging