Kornimate/medical-research-clean huggingface dataset:
tandem: skin-to-skin transfer from the delivery room to the neonatal unit

Conditions: Preterm Birth; Neonatal Respiratory Distress; Mother-Infant Interaction

Summary: immediate skin-to-skin contact (ssc) is already standard care for healthy term newborns, but its use for term or preterm newborns requiring admission to neonatal unit (nicu) with or without respiratory support is challenging. this study aimed to assess the safety and feasibility of ssc during the transfer of newborn infants, using a new purpose-built mobile shuttle care-station, called "tandem". a monocentric prospective observational study was conducted at the tertiary referral center of the université libre de bruxelles in brussels, belgium infants born with a birth weight above 1500g were eligible. following initial stabilization, infants were placed in ssc with one of their parents and transferred to the nicu using the tandem.

prior to delivery, the trained neonatal team prepares both the tandem and a transport incubator as a backup. delayed umbilical cord clamping will be performed for at least one minute unless prompt resuscitation required. then, infants will be stabilized on a resuscitation table following european resuscitation council guidelines, with applying electrodes for continous monitoring of heart rate, saturation and temperature. after initial stabilization respiratory support will be continued if needed using the tandem's gas supply. in cases when, antibiotics or continuous iv glucose infusion are necessary, peripheral venous catheters will be placed before departure. in case of respiratory support, nasogastric tube will be insterted. infants will be then transferred to the nicu under the supervision of a pediatric nurse and/or pediatrician with the tandem in skin-to-skin position with either the mother or the father. whenever possible, ssc will be continued for at least 120 minutes before placing the infant in an incubator. blood glucose measurement will take place at least once during the procedure.

Eligibility criteria:
inclusion criterias: * neonates with an estimated foetal weight above1500 grams * neonates requiring admission to the neonatal intensive care unit * neonates requiring or not non-invasive respiratory support * neonates with at least one parent who has a good understanding of the method of transfer exclusion criteria: * neonates presenting a malformation incompatible with this type of transfer * neonates with invasive ventilation
supporting baby behavior through pediatric offices

Conditions: Infant Behavior; Feeding Behavior; Breastfeeding; Pediatric Obesity

Summary: the primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing baby behavior education of wic participants.

the primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing baby behavior education of wic participants. the intervention, currently used in all california wic agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying. this project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff. it is expected that trained staff will be prepared to share baby behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.

Eligibility criteria:
inclusion criteria: * will attend a participating pediatric clinic for her well-baby visits * primiparous, singleton pregnancy * currently enrolled in wic * at least 18 years of age * speaks and reads english or spanish * has a telephone and access to the internet * plans to stay in the area for 6 months after birth of infant * abstained from smoking during pregnancy exclusion criteria: * gave birth before 37 weeks gestation * she and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding * she and/or her infant has health condition(s) or known health risks that impact infant growth and development
the safety & efficacy of imatinib for the treatment of sars-cov-2 induced pneumonia

Conditions: COVID-19

Summary: a randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe sars-cov-2 induced pneumonia.

as the coronavirus disease (covid-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. a highly elevated levels of cytokines in covid-19 patients requiring icu admission, has suggested that a "cytokine storm" was associated with disease severity. data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. this data is especially derived from imatinib, the most studied abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with sars-cov-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.

Eligibility criteria:
inclusion criteria: * patients with pcr positive for sars-cov-2 * hospitalized with moderate to severe respiratory symptoms as assessed by the egyptian ministry of health national guidelines * informed consent explained \& signed by patient or his 1st degree relatives or legally authorized representative. exclusion criteria: * pregnant women (or) breast feeding women * patients younger than 18 years of age * patients with known allergy to imatinib * total bilirubin, aspartate aminotransferase (ast), or alanine aminotransferase (alt) \> 5x upper limit of normal (uln). * creatinine clearance (crcl) \< 30 ml/minute. * patient already on mechanical ventilation at time of screening.

Keywords: sars-cov-2 pneumonia ards cytokine storm
assessment of interactions between intravenous methamphetamine and modafinil - 1

Conditions: Amphetamine-Related Disorders

Summary: the purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral modafinil.

the primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (hr), blood pressure (bp), and electrocardiogram (ecg) and stroke distance (icg).

Eligibility criteria:
inclusion criteria: * normotensive * good physical and mental health * body mass index between 18 and 30 * if female, using an acceptable method of contraception and are not pregnant * able to give voluntary informed consent exclusion criteria: * please contact site for further details
effect of vitamin d on the size of fibroids in women with vitamin d deficiency

Conditions: Size of the Uterine Fibroids

Summary: vitamin d supplementation in patients with uterine fibroids who present hypovitaminosis d to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of vitamin d on the myoma cells.


Eligibility criteria:
inclusion criteria: * diagnosed with at least one fibroid \> 3 cm * with hypovitaminosis d (25(oh)d \< 30 ng/ml) * bmi \< 30 * no hormonal treatment in the 3 months prior to the ultrasound study exclusion criteria: * black race * symptomatic fibroids subsidiary to hormonal or surgical treatment * desire of gestation in the next 6 months * presence of degenerating adenomyosis or fibroids * treatment with sexual hormones: mifepristone, agnrh or any other medication that may interfere with fibroids. * history of neoplasia of gynecological origin and/or existence of uterine malformations. * hypercalcemia or abnormal liver or kidney function is present
comparison of autogenous dentin matrix versus bovine-derived xenograft for socket preservation

Conditions: Alveolar Bone Resorption

Summary: the present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(ddm) versus bovine derived xenograft(dbm) for socket preservation procedure.

* after local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest. * tooth extraction will be performed using atraumatic extraction methods using periotome. * after extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution. * the socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group. * intra surgical measurements will be recorded. * socket preservation will be performed with either demineralized dentin matrix ddm(test) or bovine derived xenograft dbm (control). bone graft will be extended to the height of intra proximal bone. * collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest. * flaps will be approximated with sutures.

Eligibility criteria:
inclusion criteria: * teeth indicated for extraction and subsequent implant placement * age group of 18 to 55 years * single rooted tooth indicated for extraction due to endodontic failure, caries or fracture * presence of \>2 mm keratinized tissue to allow flap management * extraction site should have adjacent tooth on either side * systemically healthy patients * class ii or iii extraction socket defects according to hammerele and jung(2008) * full mouth plaque score(fmps)\<25% at baseline.(pi) * full mouth bleeding score(fmbs)\<25% at baseline. (bi) exclusion criteria: * .presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls * medical conditions contraindicating surgical interventions * known smokers and alcoholics * subjects with known bone metabolic disorders.(pagets disease,fibrous dysplasia etc.) * acute infections at the site of extraction. eg , abscess * history of malignancy * patients who have undergone radiotherapy or chemotherapy * periapical pathology such as granulomas, cyst, hypercementosis, ankylosis. * pregnant and lactating women * maxillary and mandibular 3rd molars.
study of vitamin d supplementation to male hiv sero-positive patients

Conditions: HIV Seropositive

Summary: the investigators want to investigate if hiv sero-positive males benefit from vitamin d supplementation. the study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets): 1. calcium 2. calcium and 25-hydroxy-vitamin d 3. calcium and 25-hydroxy-vitamin d and 1,25-dihydroxyvitamin d the endpoints are: * serum vitamin d * parathyroid hormone * ionized calcium * t-lymphocyte fractions (naïve, mature, tregs) * osteocalcin (bone metabolism)


Eligibility criteria:
inclusion criteria: * male * hiv-positive * at least 18 years old * receiving higlyactiveantiretroviral therapy (haart) exclusion criteria: * hypercalcemia * tuberculosis * osteoporosis or other bone disease * cancer with bone metastasis

Keywords: hiv-1 humans vitamin d 1-hydroxy-vitamin d rocaltrol calcium complementary therapies
the validity and reliability of fit-hansa in breast cancer patients

Conditions: Breast Cancer; FIT-HaNSA; Upper Extremity Dysfunction

Summary: breast cancer is the most common type of cancer among women and covers 25% of all cancers. after mastectomy and reconstruction, many patients develop various upper extremity complications such as joint movement limitation, pain, lymphedema, and axillary cord. because of such upper extremity problems, evaluation and treatment of upper extremity functions are important. upper extremity functions are generally evaluated with questionnaires filled out by the patients themselves and which reflect their own perspectives subjectively. however, these questionnaires cannot reflect the observations and evaluations of the clinicians. performance tests are important for clinicians to make decisions. with this study, we want to examine the usability of the fit-hansa test in the evaluation of upper extremity functions in patients with breast cancer. our hypothesis; the fıthansa test is successful in evaluating the upper extremity function in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * those whose treatments for breast cancer have been completed 18 years and over exclusion criteria: * have a history of upper extremity surgery, excluding breast cancer surgery have a history of upper extremity trauma those who have orthopedic, neurological, rheumatological or cognitive impairments that may interfere with the application of the test.

Keywords: breast cancer fit-hansa upper extremity dysfunction
pilot trial of resistant starch in stage i-iii colorectal cancer survivors

Conditions: Colon Cancer; Rectal Cancer; Cancer Survivor; Colorectal Adenocarcinoma; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8

Summary: this phase ii, randomized pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage i-iii colorectal cancer survivors. foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.

participants are randomized to 1 of 2 groups. group i (intervention group): participants eat a diet consisting of resistant starch foods daily for 8 weeks. study provided foods are in addition to their own usual daily diet. group ii (control group): participants eat a diet consisting of regular corn starch foods daily for 8 weeks. study provided foods are in addition to their own usual daily diet.

Eligibility criteria:
inclusion criteria: * history of diagnosed american joint committee on cancer (ajcc) stage i-iii colorectal adenocarcinoma. * completed all treatment of colorectal adenocarcinoma within past 4-36 months. * current eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 (per physician). * ability to consent and follow study protocol. exclusion criteria: * active cancer. * prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin \[hgb\] a1c \> 8.0). * active inflammatory bowel disease (i.e., patients who are symptomatic despite medical therapy). this includes irritable bowel syndrome, crohn's disease, or any other inflammatory bowel disorder. * known food allergy/intolerances to wheat, gluten, dairy or eggs. * use of antibiotic(s) within the last 3 months prior to enrollment. * women who are pregnant and/or breastfeeding. * current body mass index (bmi) \< 18.5 kg/m\^2. * uncontrolled constipation. * inability to speak and fully understand english.

Keywords: resistant starch colorectal cancer
icosapent ethyl to slow down aortic valve stenosis progression

Conditions: Aortic Valve Stenosis

Summary: this study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.


Eligibility criteria:
inclusion criteria: 1. age \> 50 years 2. mild to moderate avs exclusion criteria: 1. bicuspid aortic valve 2. history of chest radiotherapy 3. history of rheumatic fever 4. moderate to severe renal failure, defined as egfr \< 30 ml/min 5. hyperparathyroidism 6. paget's disease 7. diagnosis of (active) malignancy in last 5 years 8. anticipated or planned aortic valve surgery in the next 6 months 9. life expectancy \<2 years 10. chronic atrial fibrillation 11. use of anticoagulant medication or dual antiplatelet therapy 12. known hypersensitivity to fish and/or shellfish 13. known hypersensitivity to soya 14. malabsorption syndrome and/or chronic diarrhea 15. women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\] to avoid pregnancy for the entire study. 16. women who are pregnant or breastfeeding 17. any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator 18. inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
use of patiromer to transition chronic kidney disease patients with hyperkalemia to a plant-rich diet.

Conditions: Chronic Kidney Diseases; Hyperkalemia

Summary: the purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (veltassa®, relypsa, inc., redwood city, ca) can be used to maintain normal serum potassium concentrations in chronic kidney disease (ckd) patients who are transitioned to a plant-rich diet.


Eligibility criteria:
inclusion criteria: * stages 3b-4 ckd (estimated glomerular filtration rate (egfr) of 15-44 ml/min/1.73m2, not treated with dialysis) * no prior treatment with patiromer * mild hyperkalemia (potassium 5.1 to \<6.5 meq/l) on one of the last two blood tests * no prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 meq/l) in the past 6 months * deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., dialysis) exclusion criteria: * change in medications that alter potassium homeostasis (e.g., raas inhibitors, diuretics, β-blockers) in the last month * diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major gi surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea) * dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods) * pregnant (females) or planning to become pregnant (males and females) during the study

Keywords: chronic kidney disease, stages 3b-4
multi-center study on ccell-in vivo's clinical efficacy for intraoperative brain tumor diagnosis.

Conditions: Frozen Sections; Indocyanine Green; Brain Tumor

Summary: the primary objective of this study is to demonstrate the non-inferiority of ccell compared to frozen section analysis. the investigational device is intended for use with indocyanine green (icg) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovascular before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, which is then read and analyzed by trained-professional for intraoperative diagnosis. the comparison will be held by the device with the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years or older * patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection * patients who understand and have signed the informed consent form the specimens used in this study must meet all of the following criteria: * specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria * normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients exclusion criteria: * patients undergoing multiple surgeries * patients with bacterial or viral infections * patients who develop allergic reactions to the investigational medical device * patients with a history of allergy to indocyanine green (icg) * patients with iodine hypersensitivity * patients taking choleretic agents or rifampicin specimens meeting any of the following criteria will be excluded from this clinical trial: - specimens with unclear tumor presence or carcinoma diagnosis results based on the reference standard permanent section analysis

Keywords: diagnostic imaging intraoperative confocal laser endomicroscopy
a study in cancer patients with hepatic impairment to evaluate the pharmacokinetics and safety of nktr-102 (etirinotecan pegol)

Conditions: Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

Summary: the purpose of this study is to investigate the pk and safety of nktr-102 in patients with mild, moderate, or severe hepatic impairment.

safety and pk data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.

Eligibility criteria:
inclusion criteria: * relapsed or progressive advanced solid tumor malignancies * measurable or non-measurable disease * eastern cooperative oncology group (ecog) performance status of 0-2 * life expectancy greater than 3 months * resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments * adequate bone morrow and kidney function * no signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis * agree to use adequate contraception exclusion criteria: * previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1 * cytochrome p450 cyp3a4 inducers and inhibitors within 4 weeks prior to day 1 * intake of grapefruit, grapefruit juice, seville oranges, or other products containing grapefruit or seville oranges within 14 days prior to day 1 * ugt1a1 genotype of ta 7 in both alleles (homozygous ugt1a1\*28) or ta 8 in either one or both alleles (hetero- or homozygous for ugt1a1\*37) * major surgery within 4 weeks prior to day 1 * undergone a liver or other organ transplant * concurrent treatment with other anti-cancer therapy * untreated central nervous system metastases * ongoing or active infection * chronic or acute gi disorders resulting in diarrhea * pregnancy or lactation