Kornimate/medical-research-clean huggingface dataset:
the effects of lactobacillus reuteri dsm 17938 on immunomodulation and gastric motility in preterm newborns

Conditions: Preterm Birth

Summary: the investigators propose a phase ii interventional trial to investigate the role of lactobacillus reuteri dsm 17938 on the intestinal motility and immune response of premature infants and further evaluate safety of the use of this probiotic in a population of premature infants.

hypothesis administration of lactobacillus reuteri to premature infants will improve their intestinal motility when compared with infants receiving placebo. primary objective evaluate the effects of l. reuteri in the intestinal motility by measuring the gastric emptying rate in infants before and after 21 consecutive days of administration of l. reuteri. secondary objectives 1. mechanisms of action of l. reuteri - l.reuteri impact in the host immune response by determining fecal cytokines, siga and calprotectin before and after 21 days of administration - l.reuteri rate of colonization after its administration. 2. efficacy and safety of l. reuteri to premature infants - clinical beneficial effects secondary to the administration of l. reuteri to premature infants. the following clinical outcomes will be identified and compared between groups: * number of gastrointestinal symptoms (regurgitation, vomiting, stasis) * days to full feeds. number of days to reach full feeds defined as \> 120cc/kg/day) x2 days or more. * days on parenteral nutrition * weight gain defined as the number of days needed to reach 150% of birth weight * length of hospital stay * any possible side effects and adverse events secondary to the administration of l. reuteri to premature infants. * incidence of late onset sepsis. * incidence and severity of necrotizing enterocolitis categorized by bell's classification * use of antibiotics (number of days on antibiotics during the hospital stay) * mortality (at 28 days after birth and at hospital discharge).

Eligibility criteria:
inclusion criteria: * gestational age 30 - 32 weeks. gestational age will be defined by the best estimate based on prenatal ultrasound in the first trimester, dlm and/or balard score after birth. exclusion criteria: * cardiovascular or (respiratory) instability after 48 hours of age - chromosomal anomalies. * major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia) * congenital (e.g. jejunal atresia) and acquired (e.g. gi perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention * parental refusal * prior enrollment into a conflicting clinical trial. conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies that could alter the intestinal motility or the immune response of the premature infants.

Keywords: preterm newborns gastric motility mucosal immunity
phase ii trial assessing efficacy and toxicity of capecitabine and oxaliplatin in the treatment of colorectal cancer

Conditions: Colorectal Cancer

Summary: to assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the 1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the neo-adjuvant and adjuvant setting of resectable metastases. primary endpoint: objective response rates secondary endpoints: treatment related toxicity progression free survival (if not resected) disease free survival (from metastastectomy, if resected) overall survival 60 day all cause mortality number undergoing liver resections/curative resection (ro) rate


Eligibility criteria:
inclusion criteria: * age \>18 * histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups * no previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix. * unidimensional measurable disease as assessed by ct. (unless adjuvant therapy only) * adequate bone marrow function; hb \>10g/dl, platelets \>100 x109/l, wbc \>3x109/l, neut \>1.5x109/l. * adequate liver function: serum bilirubin \<1.5 x upper limit of institutional normal * adequate renal function, calculated creatinine clearance \>50mls/min * no concurrent uncontrolled medical conditions * who performance status 0,1 or 2 * adequate contraceptive precautions, if appropriate * informed written consent * negative pregnancy test in women of child bearing age * life expectancy \> 3 months exclusion criteria: * medical or psychiatric condition that comprise the patient's ability to take informed consent. * clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months. * patients with any significant symptoms or history of peripheral neuropathy.
using machine learning to adapt visual aids for patients with low vision

Conditions: Ophthalmology; Artificial Intelligence; Low Vision Aids

Summary: according to the who's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. although china is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting. traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. at present, there are almost no intelligent fitting models of assisting devices in the world. therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in fujian province, china in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility criteria:
inclusion criteria: * low vision * aged 3 to 105 exclusion criteria: * severe systemic disease * failure to sign informed consent or unwilling to participate

Keywords: artificial intelligence low vision
drug-drug interaction study between henagliflozin proline and hydrochlorothiazide

Conditions: Diabetes in Adults

Summary: a single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy chinese volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male; 2. age 18-40 (including threshold); 3. weight ≥ 50 kg, body mass index (bmi): 19.0\~26.0 kg/m2 (including critical value); 4. volunteers (and their spouses) must not plan for childbearing or sperm donation within one month prior to signing the informed consent form and from the period of taking the research drug until three months after stopping it; 5. be able to communicate well with the investigators and understand and comply with the requirements in this study. exclusion criteria: 1. those have allergic constitution, or those with a known history of allergies to study drug or their excipients 2. physical examination, vital signs, blood-routine examination, blood biochemistry, infectious disease screening, coagulation function, urine-routine examination, chest x-ray, b ultrasound and other examination results are abnormal and judged by the research doctor as clinically significant. 3. hepatitis b surface antigen positive, hepatitis c antibody positive, hiv antibody positive, syphilis antibody positive; 4. previous history of urinary tract infection or genital infection; 5. previous history of hypoglycemia and other important diseases; 6. those who have used other experimental drugs or medical devices within 3 months before screening; 7. those who seek medical within 3 months prior to screening, which are judged by the research doctor to be unfit for participants;those who have undergone any surgery within 6 months prior to screening; 8. those who donate blood or other reasons of bleeding cause the total loss of blood more than 400ml or receive blood transfusions within 3 months before screening; 9. have used any drugs in two weeks prior to taking the study drug; 10. can not comply with the unified dietary arrangement; 11. alcohol abuse, or those who smoke more 5 cigarettes per day in the 6 months prior to screening; 12. positive alcohol breath test,or positive drug screening; 13. from 3 days before taking the study drug, subjects have xanthine-rich beverages or food, or grapefruit and other fruits or juices that may affect metabolism; 14. subjects who are judged by researchers to be unsuitable for participating in this test.
managing the nutritional needs of older filipino with due attention to protein nutrition and functional health study

Conditions: Sarcopenia

Summary: the study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of filipino older adults.

the objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.

Eligibility criteria:
inclusion criteria: * pre-sarcopenia/pre-frail * aged 60 years old and above, male or female * free-living in the community, ambulatory * able to respond to food recall/interview as self-declared * normal cardiac function as measured by resting ecg exclusion criteria: * bed ridden, unable to perform exercise independently * presence of serious medical condition (i.e. cancer, existing fracture) * presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician * renal problem * under controlled or medically-supervised diet not flexible to include the intervention agent * allergic to any ingredients in the nutrition supplementation

Keywords: sarcopenia body composition protein exercise functional status
mri in women with newly diagnosed breast cancer prior to breast conserving surgery

Conditions: Breast Cancer

Summary: to see if performing breast mri before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. the study will also measure how well mri can find unsuspected cancers in the same breast as the known cancer; how well mri will find unsuspected cancers in the opposite breast; how often mri will generate false positive mri findings; whether routinely incorporating breast mri delays care or adds unnecessary cost; and, whether breast mri is able to reduce the frequency of cancer recurrence in the treated breast or elsewhere in the body.


Eligibility criteria:
inclusion criteria: * dcis less than 5 cm. t1/t2 invasive breast cancer. patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach * no breast mri within the past year. prior core biopsy, but no prior excision allowed. patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast mri. * women with age \>= 18. no ethnic restrictions. * no life expectancy restrictions. * performance status not a factor. * no requirements for organ or marrow function. * ability to understand and the willingness to sign a written informed consent document.\&#xa; exclusion criteria: * patient is unable to complete a breast mri due to such factors as hardware and claustrophobia. * no limitations as to other investigational agents. patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of mri interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast mri in comparison with untreated patients. * there are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast mri scanning. * there are fewer reactions to mri contrast media, but if there is such a history, the patient will be excluded from consideration. * there are no exclusion criteria based on concomitant medications. * there are no other agent specific exclusion criteria. * pregnancy is considered a contraindication given the uncertain effects of breast mri on the fetus. * cancer survivors are candidates for the study unless the patient has a prior ipsilateral breast tumor.
prospective evaluation of the use of intralesional cryotherapy for treatment of keloid and hypertrophic scars

Conditions: Keloid; Cicatrix, Hypertrophic

Summary: this prospective evaluation studies the effectiveness of il cryotherapy in treating keloids and hypertrophic scars in a large population of mixed fitzpatrick skin types.

intralesional (il) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. published results are promising, however only caucasian patient populations have been studied. this prospective evaluation studies the effectiveness of il cryotherapy in treating keloids and hypertrophic scars in a large population of mixed fitzpatrick skin types. all patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called cryoshape scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. in addition, scars are evaluated using the patient and observer scar assessment scale.

Eligibility criteria:
inclusion criteria: * keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion * hypertrophic scars1 older than 12 months and insensitive to other treatments. keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (\>1yr) * a period between previous treatment and il cryotherapy covered a minimum of 12 weeks * patients with all fitzpatrick17 skin types * patients older than 10 years of age exclusion criteria: * pregnancy * diabetes mellitus

Keywords: keloid, hypertrophic scar
electromagnetic stimulation (frems) in patients with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: we postulate that frequency-modulated electromagnetic stimulation (frems) may decrease pain in patients with painful diabetic neuropathy.

the stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. each patient received two series of ten treatments of either frems or placebo in random sequence, with each series lasting no more than three weeks. primary outcomes (daytime and night-time pain scores) an secondary outcomes (motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after frems/placebo series and after 4 months follow-up.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes (american diabetes association criteria) * painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., \<40 m/sec in at least one nerve trunk of the lower limbs) * vibration perception at the big toe \>25 v exclusion criteria: * presence of any concomitant severe disease * pregnancy * renal disease (serum creatinine \>2.0 mg/dl) * history or current foot ulcer * lower limb arterial disease (ankle-brachial index \<0.9) or transcutaneous partial pressure of oxygen \<50 mmhg)

Keywords: diabetic neuropathy complications of diabetes neuropathies electromagnetic stimulation neuropathic pain
there is a value of luteinizing hormone predictive of in vitro fertilization treatment outcome in antagonist protocols?

Conditions: Female Infertility

Summary: this study, prospective randomized controlled trial, tried to identify a cut off value of luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible gonadotropin-releasing hormone antagonist protocols. 202 norma-ovulatory women \< 39 years were randomized to fixed or flexible group in gnrh antagonist protocols the follicular phase profile of luteinizing hormone, estradiol and progesterone in the two study groups was measured. total number of retrieved oocytes, implantation and pregnancy rate were recorded. .


Eligibility criteria:
inclusion criteria: * 1) age \<39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels \< 12 iu/ml; (4) body mass index (bmi) between 18-30 kg/m2; (5) no oral contraceptive pills taken in the last year exclusion criteria: * polycystic ovaries, age \>39 years
the safety and efficacy of "3-hole" subxiphorid approach in the treatment of anterior mediastinal tumor

Conditions: Thymectomy; Myasthenia Gravis

Summary: surgery plays an important role in the treatment of anterior mediastinum disease. the major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. the cervical approach is rarely adopted because of its restricted visual field. the cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. but the trauma of this approach is much larger, and the postoperative complication is also a serious problem. the video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. in clinical practice, the investigators designed a new method named "3-hole" subxiphoid approach. this study is designed to compare the safety and validity between this new method and others.


Eligibility criteria:
inclusion criteria: * mg with thymic hyperplasia, thymoma or other anterior mediastinum disease * masaoka stagingⅰ-ⅱ * thymoma without mg * mass diameter \<10cm * inform consent form is signed exclusion criteria: * unable to tolerate surgery * myasthenic crisis * masaoka staging ⅲ-ⅳ * patients who have undergone previous surgery or radiotherapy * pregnancy , breastfeeding or younger than 18 years old

Keywords: 3-hole approach extended thymectomy myasthenia gravis safety effectiveness
assessment of tear film-based proteins associated with care solution induced corneal staining

Conditions: Corneal Staining

Summary: the purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.


Eligibility criteria:
inclusion criteria: for non-lens wearers: * normal eyes. * currently not wearing contact lenses and has not worn contact lenses for the previous 6 months. * free of dry eye using the ocular surface disease index (schiffman et al). * other protocol-defined inclusion criteria may apply. for contact lens wearers: * currently wearing soft contact lenses. * free of dry eye during lens wear using the contact lens dry eye questionnaire short-form (nichols et al, cornea, 2002). * reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear). * reports only occasional use of contact lens rewetting drops or artificial tears. * other protocol-defined inclusion criteria may apply. exclusion criteria: for non-lens wearers and contact lens wearers: * pregnant. * participating in another research study. * exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions). * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses contact lens solution corneal staining
construction of a recurrence risk prediction model for liver resection based on drug sensitivity of patient-derived hepatocellular carcinoma organoid

Conditions: Hepatocellular Carcinoma

Summary: liver cancer is the sixth most common malignant tumor worldwide and the third leading cause of cancer-related deaths. china is a high-risk area for liver cancer, accounting for approximately 55% of primary liver cancer worldwide. liver cancer is highly malignant and easy to recur, which seriously endangers the life and health of our people. hepatectomy is the preferred treatment for liver cancer, but the 5-year recurrence rate remains as high as 70%, severely limiting the effectiveness of the surgery. therefore, exploring the risk factors and predictive methods for early tumor recurrence after liver resection in patients has high clinical value. clinical practice has found that primary liver cancer patients can be treated with postoperative adjuvant transarterial chemoembolization (tace) to prevent recurrence. however, the effectiveness of tace varies among patients and may be related to tumor heterogeneity. however, many studies have reported that drug sensitivity testing based on patient derived organoids can indicate the clinical efficacy of drugs, but there is currently no relevant research indicating that organoids can reflect the therapeutic response of tace. therefore, the aim of this study is to explore the correlation between patient derived organoid drug sensitivity testing results and tace treatment responsiveness and tumor recurrence, and further construct a column chart model to predict tumor recurrence after adjuvant tace.


Eligibility criteria:
the inclusion criteria were as follows: (1) age between 18 and 80 years; (2) postoperative pathological diagnosis of hcc; (3) adjuvant tace performed 4-8 weeks after radical surgical resection; and (4) successful culture of pdto, with sufficient quantity for drug testing. the exclusion criteria were as follows: (1) patients with an american society of anesthesiologists (asa) score greater than 3; (2) failure or contamination of pdto culture; (3) failure to complete standardized adjuvant tace treatment postoperatively; and (4) patients who received neoadjuvant or other adjuvant therapies, including radiotherapy and systemic treatments.