Kornimate/medical-research-clean huggingface dataset:
metabolic effects of choline and docosahexaenoic acid supplementation in preterm infants

Conditions: Infant, Premature

Summary: to explore the effects of enteral choline and dha supplementation on plasma choline and dha-pc concentrations and metabolism, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, dha supplementation, and choline and dha supplementation. after 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized dha-pc determined to assess plasma levels, uptake and distribution of choline and dha. this study is designed to inform larger studies evaluating this approach of enteral co-application of choline and dha on clinical important outcomes.

in utero, there is a constant high supply of choline to the fetus. preterm delivery disrupts this maternal-fetal choline-transfer. we have shown that choline plasma levels rapidly half after preterm delivery. we also demonstrated that plasma dha-pc rapidly falls after preterm delivery. dha supplementation has been evaluated and found safe, however the clinical benefits have been smaller than expected. we speculate that choline deficiency may have contributed to the smaller than expected benefit of dha supplementation in the past. this study verifies the hypothesis that concomitant supply of choline and dha will improve dha-pc availability and turn-over. this is important because dha-pc is the transport molecule for the dha transport to the brain and the retina. to explore the effects of enteral choline and dha supplementation on plasma choline and dha-pc concentrations, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, dha supplementation, and choline and dha supplementation. after 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized dha-pc determined to assess plasma levels, uptake and distribution of choline and dha. this study is designed to inform future larger studies evaluating this approach of enteral co-application of choline and dha on important clinical outcomes.

Eligibility criteria:
inclusion criteria: * preterm infants with a gestational age at birth between 24 and 32 weeks * on almost complete enteral feeding (\>75% of total fluid intake) exclusion criteria: * insufficient enteral intake, * gastrointestinal disease, * missing parental consent

Keywords: choline docosahexaenoic acid
study of inv-102 ophthalmic solution in adults with acute infectious keratoconjunctivitis

Conditions: Acute Infectious Keratoconjunctivitis

Summary: phase 2, randomized study to assess topically administered eyedrops of inv-102 compared to vehicle during 1-week dosing in participants with acute infectious keratoconjunctivitis (aik). participants will return for a follow up visit 1 week after end of treatment.


Eligibility criteria:
inclusion criteria: * male or female patient ≥ 18 years of age * a clinical diagnosis of aik with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye exclusion criteria: * untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit * infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (note: if the blepharitis is secondary to the conjunctivitis, the patient can be included) * suspected allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the investigator * suspected corneal ulcer * ocular topical steroid use within two weeks prior to baseline visit * ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to baseline visit (this does not exclude naïve patients or patients that have not taken topical antibiotics) * ocular topical povidone iodine use within 1 week prior to baseline visit * systemic antibiotic use within 2 weeks prior to baseline visit * ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit * ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit * corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any immunosuppressant use within 30 days prior to baseline visit * on current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included) * known or suspected ocular fungal infection or ocular microsporidia infection

Keywords: pink eye conjunctivitis
a study comparing maintenance subcutaneous rituximab with observation only in participants with relapsed or refractory indolent non-hodgkin's lymphoma who had responded to rituximab-based immunochemotherapy induction and 2-year maintenance with subcutaneous rituximab

Conditions: Non-Hodgkin's Lymphoma

Summary: this multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent non-hodgkin's lymphoma (nhl). all participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[iv\] in cycle 1, then 1400 mg subcutaneous \[sc\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance i period with rituximab (1400 mg sc every 8 weeks). participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg sc every 8 weeks) or observation with no treatment during maintenance ii period and will be followed for at least 15 months. anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.


Eligibility criteria:
inclusion criteria: * histologically confirmed cluster of differentiation 20-positive (cd20+) follicular nhl grade 1, 2 or 3a, or other cd20+ indolent nhl (waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to world health organization (who) classification system * participants must have received and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrollment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy * eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 2 exclusion criteria: * transformation to high-grade lymphoma * aggressive lymphoma (for example, mantle cell lymphoma \[mcl\]) * presence or history of central nervous system (cns) lymphomatous disease * other malignancy within 5 years prior to enrollment, except for curatively treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell skin cancer, or cervical carcinoma stage 1b or less, breast cancer in situ or localized prostate cancer stage t1c if treated with curative intent and relapse- and metastasis-free for at least 2 years prior to enrollment * inadequate hematological, hepatic or renal function * known human immunodeficiency virus (hiv) infection * active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis b or c) * pregnant or breastfeeding women
a study of pharmacodynamic and genetic parameters of abira-des study participants (nct02217566) - participants with metastatic castration-resistant prostate cancer treated with abiraterone acetate following unresponsive treatment with diethylstilbestrol

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the primary purpose of this study is to evaluate the influence of hsd3b1 (1245c) germline variant and potential pharmacodynamic markers on abiraterone activity in participants with metastatic castration-resistant prostate cancer after unresponsive use of diethylstilbestrol.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of prostate adenocarcinoma without neuroendocrine or small cell differentiation and was a participant in the abira-des study (nct0221756), which includes: diethylstilbestrol pretreatment for castration-resistant prostate cancer with evidence of disease progression or grade 3/4 toxicity with diethylstilbestrol; metastatic disease confirmed by bone examination or metastatic lesions by computed tomography or magnetic resonance * abiraterone acetate therapy during the abira-des study (nct0221756), and peripheral blood samples have been collected from at least of the three proposed study timepoints * must sign, and/or his/her legally acceptable representatives, where applicable, must sign the icf allowing the use of clinical data and biological samples in accordance with local requirements. for deceased participants who did not provide consent prior to death, permission to research their information must meet local requirements exclusion criteria: - having withdrawn the consent to use the samples collected during their participation in the abira-des study (nct02217566)
vaccine therapy in treating patients with recurrent soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: phase ii trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.

objectives: i. determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. ii. determine the safety and tolerability of this treatment regimen in this patient population. iii. determine the anti-tumor response to this treatment regimen in these patients. outline: at approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. patients with improving or stable disease or without recurrence continue on therapy for up to 1 year. projected accrual: a total of 35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent soft tissue sarcoma incompletely or completely resected metastatic or locally recurrent disease (surgery must be performed with intent of complete resection) no active brain metastases patient characteristics: age: over 18 performance status: karnofsky 70-100% life expectancy: at least 16 weeks hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,000/mm3 platelet count at least 80,000/mm3 hepatic: not specified renal: creatinine no greater than 2.5 mg/dl cardiovascular: no new york heart association class iii or iv heart disease other: no active infections requiring antibiotics within 2 weeks of study no other serious medical illness requiring hospitalization no history of primary or secondary immunodeficiency or autoimmune disease no contraindications to mri (e.g., aneurysm clips or cardiac pacemakers) not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 6 weeks since prior immunotherapy and recovered chemotherapy: at least 6 weeks since prior chemotherapy and recovered endocrine therapy: no concurrent systemic corticosteroids radiotherapy: at least 6 weeks since prior radiotherapy and recovered surgery: see disease characteristics no prior splenectomy other: at least 6 weeks since other prior experimental anticancer therapy and recovered no concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs no other concurrent participation in a clinical trial

Keywords: recurrent adult soft tissue sarcoma stage iv adult soft tissue sarcoma
safety and immunogenicity study of qivc in healthy pediatric subjects

Conditions: Influenza; Human; Virus Diseases

Summary: this phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of qivc versus a us-licensed comparator qiv in children 6 months through 47 months of age. the purpose of this study is to demonstrate that vaccination with qivc elicits an immune response that is noninferior to that of a us-licensed comparator qiv containing the same virus strains, in children 6 months through 47 months of age.


Eligibility criteria:
inclusion criteria: * individuals of 6 through 47 months of age on the day of informed consent. * individuals whose parent(s)/legally acceptable representative (lar) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. * individuals who can comply with study procedures including follow-up * individual is in generally good health as per the investigator's medical judgement exclusion criteria: * acute (severe) febrile illness * history of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study * a known history of guillain-barre syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis * any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study * received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.

Keywords: influenza rna virus who strains
infections of the central nervous system

Conditions: Adult Patients With Suspected Meningitis and/or Encephalitis

Summary: this study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection.

the specific aims of the study include: 1. to assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed me. 2. to examine clinical differences between patients with initially suspected and confirmed infectious meningitis (me) versus those with suspected but not confirmed infectious me. 3. to evaluate potentially prognostic factors for pathological ct findings (especially expanding cerebral mass lesions) in patients with suspected infectious me. 4. to identify a specific group of patients that benefit from cranial ct prior to lp. 5. to examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, ...) of lumbal punction (lp) and their correlations to pathologic signs on cranial ct. 6. to compare the outcome between patients with suspected infectious me and cranial ct prior to lp versus patients without prior cranial ct.

Eligibility criteria:
inclusion criteria: * all patients aged ≥18 years admitted to the university hospital basel with confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from january 2006 to december 2021 with or without cranial ct prior to lp * all patients aged ≥18 years admitted to the university hospital basel over the same time period with suspected infectious meningitis and/or encephalitis as principal and/or secondary diagnosis with or without cranial ct exclusion criteria: * patients without suspected infectious meningitis and/or encephalitis. * patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission * patients who have refused "general consent" (i.e., written agreement of patients which allows the further use of their collected medical data for research purposes in encoded form).

Keywords: meningitis encephalitis
the roles of peers and functional tasks in enhancing exercise training for adults with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study aims to evaluate the effects of an online exercise and peer support intervention for people living with copd. in the framework of a randomized control trial, 24 adults with copd will be recruited to participate in the study and will be randomly assigned to either the control or intervention group. the control group will participate in an 8-week virtual program based on the exercise component of a standard home-based pulmonary rehabilitation program (one online consultation and 7 phone calls with a kinesiologist). the intervention group will participate in a twice a week online intervention that includes an exercise component based on individuals' activities of daily living and a peer support component where individuals will be taught and encouraged to discuss behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise. the goal of this study is to determine the efficacy of the novel online exercise intervention and whether the benefits are above other intervention options.


Eligibility criteria:
inclusion criteria: * individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a copd diagnosis, be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, speak english or french, and have the intention to become physically active in the next 2 months or have been minimally active (\<150 minutes per week) in the past 2 months exclusion criteria: * less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with copd by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.

Keywords: exercise peer support behavior change
clinical outcome after anterior cervical decompression and fusion and cervical total disc replacement

Conditions: Cervical Disc Disorders

Summary: the aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be preferred.

the study population consists of patients who are suffering from neck and cervicobrachial pain because of degenerative diseases of the cervical spine. in that population conservative treatment such as analgesia and physiotherapy is no more sufficient, so that surgery is necessary. for surgical treatment are chosen either total disc replacement with an cervical disc prostheses or anterior cervical decompression and fusion. in the context of this work the clinical success of these surgical methods should be analasied by means of the neck disability index (ndi), the visual analogue scale (vas) in centimeter, clinical examinations, the satisfaction of patients with the surgery and the occurrence of adverse events. the included patients are examined and seen before and after the surgery. furthermore the two different methods are compared to each other in order to detect a possible advantage of one type of surgery.

Eligibility criteria:
inclusion criteria: * all patients who have to undergo surgery such as spondylodesis or disc prosthesis of the cervical spine because of degenerative diseases and who have been operated in the university hospital of bonn between 2011 and 2015. exclusion criteria: * patients under the age of 18 years * pregnant women * patients who are not willing to participate in the study * patients unable to take part in the study because of any other known restriction or incompatibility

Keywords: cervical fusion cervical arthroplasty cervicobrachial pain
ism1 versus embryogen media for embryo culture in previous pregnancy loss cases

Conditions: Infertility; Miscarriage

Summary: recently, it has been suggested that culture of embryos in embryogen medium can increase the live birth rate in ivf patients with a previous history of pregnancy loss. couples requiring ivf treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study. controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant fsh. fertilization will be achieved by standard ivf or intracytoplasmic sperm injection. fertilized eggs will be cultured in 6% co2, 5% o2, 89% n2 atmosphere in microdrops. in the treatment group embryogen culture medium (eg, origio, måløv, denmark) will be adopted throughout the culture period. in the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. ims1 medium (ism1, origio, måløv, denmark), maintaining unchanged all other culture conditions. procedures of embryo transfer, will be carried out on day 2 using embryogen or ism1 respectively. the endometrial support will be the same in the two groups. the investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with embryogen medium. as secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with embryogen medium.


Eligibility criteria:
inclusion criteria: - at least one (maximum 3) miscarriage and/or biochemical pregnancy after art treatment exclusion criteria: * frozen spermatozoa * frozen oocytes * women with pco and pcos * women with more than 4 art treatments

Keywords: ivf embryo culture ongoing pregnancy rate ongoing implantation rate miscarriage
thoracic manipulation in patients with cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: hypothesis: the group of cervical radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.


Eligibility criteria:
inclusion criteria: * 18-65 yrs * 3 out 4 items positive of clinical prediction rule for cervical radiculopathy exclusion criteria: * history of previous cervical or thoracic spine surgery * bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease, * medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).

Keywords: cervical radiculopathy neck pain manipulation