Kornimate/medical-research-clean huggingface dataset:
biomarkers, neurodevelopment and preterm infants

Conditions: Preterm; Neurodevelopmental Disorder; Epigenetic Changes

Summary: approximately 2% of neonates in the us are born very preterm. preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. the investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. the overarching hypothesis of this proposal is that dna methylation profiles of cd34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.


Eligibility criteria:
inclusion criteria: * \<32 weeks" gestation * born at weiler division of montefiore exclusion criteria: * intraventricular hemorrhage * chromosomal abnormalities * congenital viral conditions
harnessing placebo effects: non-deceptive use of placebo in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

seventy patients with irritable bowel syndrome (ibs) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. the study will involve three visits: baseline, midpoint and end point. at baseline all patients will physical examination, be evaluated for ibs and be administered standardized ibs questionnaires including: "ibs adequate relief" questionnaire, ibs global symptom improvement scale, ibs quality of life and ibs symptom severity scale. at midpoint and endpoint the same questionnaires will be administered. patients on no treatment will be offered education on managing ibs at the end of the study.

Eligibility criteria:
inclusion criteria: * irritable bowel syndrome. exclusion criteria: * any signs of organic bowel disease such as rectal bleeding. * no other major illnesses.

Keywords: irritable bowel syndrome no organic digestive disease
safety study of meningococcal acyw135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 months

Conditions: Meningitis, Meningococcal

Summary: the purpose of this study is to evaluate safety of meningococcal acyw135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 months


Eligibility criteria:
inclusion criteria: * 3-11 months health infants who haven't immuned with meningococcal a and c conjugate vaccine and population above 1 year old who have't given boost immunity. * subject or legal representative who consent and has signed written informed consent. * subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. * subject and parent/guardian who is able to comply with all study procedures. * axillary temperature ≤37.0 ℃. exclusion criteria: * history of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease. * allergic history after vaccination. * history of meningitis infection disease. * acute febrile illness and infectious diseases. * febrile illness (temperature ≥ 38°c) in the 3 days. * immunodeficiency diseases patients who administered with immunosuppressive agents. * children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease. * liver and kidney or cardiopulmonary disease，acute hypertension and diabetes. * in pregnancy or lactation or pregnant women. * subject who plan to participate in or is in any other drug clinical trial. * meningococcal vaccine contraindication. * any condition that, in the judgment of investigator, may affect trial assessment.
splint users' satisfaction and functional status with custom finger splints

Conditions: Hypermobility of Interphalangeal Joints; Swan-Neck Deformity

Summary: this feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3d-printing in a clinical setting and looks at splint users' experiences with customizable 3d-printed finger splints compared to conventionally made splints. fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3d-printed finger splint) or a control group (conventional thermoplastic finger splint). participants will wear assigned splint for 1 month. functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. the findings will contribute to evidence that customizable 3d-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. it will further justify the need for the application of 3d-printing in a clinical setting.


Eligibility criteria:
inclusion criteria: * fluent in english * 18 years or older * finger proximal interphalangeal joint (pip) joint hyperextension (with or without swan-neck deformity) * pregnant or not pregnant women * able to tolerate a finger orthosis over the course of 1 month * not decisionally impaired * have or have not previously worn a finger orthosis for symptoms exclusion criteria: * non-fluent in english * decisionally impaired * younger than 18 years old * no proximal interphalangeal joint (pip) joint finger hyperextension * unable to tolerate a finger orthosis over the course of 1 month

Keywords: 3d-printing technology finger splints hypermobile joints
a safety & efficacy clinical study to evaluate the narrowing of the renal arteries while using gadodiamide

Conditions: Renal Artery Stenosis

Summary: magnetic resonance angiography (mra) is an examination similar to magnetic resonance imaging (mri) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using mr. the study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. intra-arterial digital subtraction angiography will be used as the standard of truth.

gehc has decided not to provide this detail.

Eligibility criteria:
inclusion criteria: * study subjects must be adults with confirmed or suspected renal artery stenosis. * the subject must have been referred for digital subtraction angiography. exclusion criteria: * the subject has a known hypersensitivity to either conventional x-ray or gadolinium-based mr contrast media including, but not restricted to, the investigational product. * the subject is lactating. * the subject is pregnant as defined by a serum or urine β-hcg pregnancy test obtained within 24 hours before investigational product administration. * the subject has received or is scheduled to receive mri contrast medium within 24 h prior to or less than 24 hours after the investigational product administration. * the subject has received or is scheduled to receive x-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product. * the subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration. * the subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months. * the subject has had a percutaneous transluminal angioplasty (pta) in the renal region performed within 4 weeks prior to investigational product administration. * the subject has a stent in the renal arteries. * the subject has had a kidney transplantation. * the subject has a serum creatinine value of \>3.5 mg/dl (309.4 µmol/l). * the subject has previously been included in this study. * the subject has a contra-indication for mri according to accepted clinical guidelines.

Keywords: renal artery stenosis occlusion diagnostic imaging omniscan magnetic resonance angiography contrast media
preoperative strength-resistance training in valvular heart disease patients

Conditions: Exercise Based Prehabilitation in Valvular Surgery

Summary: cardiovascular diseases (cvd) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. cvd is the leading cause of mortality worldwide, representing 31% of deaths. in spain, cvd caused 24% of all deaths in 2020. major surgery is often chosen as the treatment of choice for cvd. the concept of fast-track rehabilitation after surgery appeared in the 1970s. participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay. the purpose of the present study is to evaluate whether the implementation of an additional resistance training (rt) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce icu length of stay, postoperative complications, and hospital length of stay (los). additionally, the secondary objective is to determine whether a program that includes rt in addition to respiratory and aerobic training can have better effects on ventilatory variables. this study follows the protocol of a prospective, parallel, non-randomized clinical trial. ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. the control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. the experimental group, in addition, will receive rt targeting peripheral muscles. variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. quantitative variables will be analyzed using a t-test or anova, or mann-whitney test if the distribution is non-parametric.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with valvular pathology who have been admitted as candidates for cardiac surgery for the first time, and who have been scheduled for surgery exclusion criteria: * stage 4 or 5 renal failure, low ejection fraction, euroscore greater than 15 (nashef et al., 2012) , non-st-segment elevation acute coronary syndrome (nsteacs), coronary artery disease, or need for urgent intervention

Keywords: physiotherapy muscular strengthening quality of life hospital stay
neonatal evaluation of norepinephrine infusion in spinal anesthesia for cesarean section

Conditions: Caesarean Section;Stillbirth

Summary: this retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. the main objective is to compare the initial apgar score. the records of patients who received norepinephrine are compared to those without norepinephrine. to limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, asa score, comorbidity, urgency. the patients analysed correspond to the period 2016-2017.


Eligibility criteria:
inclusion criteria: * age \> 18 * spinal anesthesia for cesarean section exclusion criteria: * sub epidural cesarean section * contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
an exploratory study of herombopag for thrombocytopenia induced by chemotherapy combined with immunotherapy in nsclc

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer

to observe and evaluate the safety and efficacy of the tpo receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: 1. the patients signed the informed consent and voluntarily joined the study; 2. age 18-75 years old, male or female; 3. patients with stage iiib-iv non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( icis) treatment; 4. the investigator determined that the patient could receive hetrombopag administration; 5. thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (plt) ≤ 75×109/l; 6. the values of laboratory tests performed for screening shall meet the following criteria: 1) blood routine examination: a) hemoglobin (hb) ≥ 90 g/l; b) absolute neutrophil count (anc) ≥ 1.5×109/l; c) platelet count (plt) ≥ 80×109/l; 2) biochemical tests: a) ast and alt ≤ 3 times uln (if there is tumor liver metastasis, ≤ 5 times uln); b) tbil ≤ 2 times uln; c) cr ≤ 2 times uln, or creatinine clearance (crcl) ≥60 ml/min (cockcroft-gault formula); 7. life expectancy at screening ≥12 weeks; 8. ecog: 0-1; 9. the main organ functions are normal, and there are no serious complications; exclusion criteria: 1. pregnant or breastfeeding women; 2. inability to understand the research nature of the research or to obtain informed consent; 3. the investigator judges other circumstances that are not suitable for inclusion in the study; 4. thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.); 5. have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction; 6. those with a history of blood disease or tumor bone marrow infiltration; 7. those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past; 8. arterial or venous thrombotic events within the past 6 months; 9. there are currently uncontrollable infections.
an extension study of duloxetine in fibromyalgia (extension of f1j-je-hmgz, nct01552057)

Conditions: Fibromyalgia

Summary: the purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.


Eligibility criteria:
inclusion criteria: * participants who have completed the 15-week treatment in the preceding study hmgz * participants who wish continuous treatment with duloxetine after the preceding study * participants are able to give their own written consent exclusion criteria: * participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators * participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units/liter (iu/l) or total bilirubin of not less than 1.6 milligrams/deciliter (mg/dl) at week 0 (visit 8 of the preceding study) * participants with serum creatinine level of not less than 2.0 mg/dl, participant who has undergone kidney transplantation or hemodialysis at week 0 (visit 8 of the preceding study) * participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment * participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by three-month or longer drug therapy * participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency * participants with uncontrolled angle closure glaucoma * participants who received monoamine oxidase (mao) inhibitors within 14 days before week 0 (visit 8 of the preceding study) or need to receive a mao inhibitor within 5 days after study discontinuation * participants who have experienced suicidal ideation or suicide attempt during the preceding study * participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring in the preceding study (columbia suicide severity rating scale, suicide ideation section - questions 4 and 5; suicidal behavior section) * female participants who are pregnant, lactating, or who want to get pregnant during the study period. male participants who want his partner to get pregnant * females of child-bearing potential who cannot agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study * participants assessed ineligible by the investigator (sub-investigator) for other reasons
hiv risk and prevention in women

Conditions: HIV

Summary: this study gathers information about hiv testing utilization and influences on hiv testing decisions among young, general population russian women at-risk of hiv exposure. the study compares hiv testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. the overarching goal is to gain knowledge that can be used to increase utilization of hiv testing among at-risk young women and offer gender-specific strategies for improving prevention.

the study uses an adaptive design. that is, the procedures and phases of the study experienced by a participant depend to some extent on their responses to earlier phases. ultimately, this design yields a number of practice relevant pathways and endpoints, each of which has a testing rate associated with it. phase-i is initial screening for risk status, collecting background data, and ascertaining whether there has been recent independent hiv testing. if there has been independent testing, information about the independent testing is collected and the participant's involvement is complete. those who are not independent testers enter phase-ii. phase ii will include: randomization to opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or non-acceptance; participating in a focus group in which participants who have not accepted hiv testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to hiv prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized. the design was selected in order simultaneously answer a number of questions that we believe will be important for engineering a testing and prevention strategy suitable for testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey); (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data about reasons for decisions in the women's own words (focus group); and (4) identify any incremental benefit related to peer discussion.

Eligibility criteria:
inclusion criteria: * the participant's sexual risk behaviors (i.e., a) two or more partners in the last 12 months, or her partner's hiv risk (e.g., hiv positive, no hiv testing and a diagnosis of sexually transmitted diseases in last 12 months, multiple partners, blood transmission, male partners, served in prison, or drug use) and no or inconsistent condom use in the last 3 months, and no hiv testing in the last 12 months, or b) any sexually-transmitted disease and no hiv testing in the last 12 months). exclusion criteria: * does not speak russian, are currently pregnant, have a condition that might preclude a finger-stick procedure, or have tested hiv positive in the past.

Keywords: transmission prevention women childbearing age hiv testing testing strategy
choline and iron deficiency

Conditions: Pediatric Iron Deficiency; Anemia

Summary: background: iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. but iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations. gap supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with fetal alcohol spectrum disorders. choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development. hypothesis: infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo. methods: this randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at mulago hospital, kampala, uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months. results: pending impact: if our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. this intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. this simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.


Eligibility criteria:
inclusion criteria: * age 6 months +/- 28 days * hb \< 11.0 g/dl * zpp \> = 80 * t\<37.5°c * malaria-negative based on rapid diagnostic test (rdt) * mother is hiv-negative. exclusion criteria: * developmental disorder * severe malnutrition (severe wasting or bipedal edema) * known sickle cell disease * neurologic disorder, brain injury, or other condition affecting brain development * not currently breastfeeding * birthweight \< 2000 g

Keywords: iron deficiency choline anemia