Kornimate/medical-research-clean huggingface dataset:
helen keller international's enhanced-homestead food production program in burkina faso

Conditions: Growth; Anemia

Summary: helen keller international (hki) has been implementing homestead food production (hfp) programs in asia for the past 20 years and has recently begun implementing hfp programs in africa as well. in general, these programs target women and are designed to improve maternal and child health and nutrition outcomes through three primary pathways: 1. increasing the availability of micronutrient-rich foods through increased household production of these foods; 2. raising income through the sale of surplus production; and 3. increasing knowledge and adoption of optimal nutrition practices, including the consumption of micronutrient-rich foods. evaluations of hfp programs have consistently demonstrated significant increases in household production and consumption of micronutrient-rich foods. this increased consumption, along with improvements in health and nutrition related knowledge, and increased income, could all contribute to improvements in maternal and child health and nutrition outcomes. however, to date there has been limited understanding as to how these types of programs can be optimized to maximize impacts on these outcomes. in order to better understand the potential of these types of programs to improve maternal and child health and nutrition outcomes and how this impact may be achieved ifpri has been collaborating with hki to evaluate one of their e-hfp programs in burkina faso. the evaluation considers impact of the program through the three pathways above, and assesses anthropometric and clinical measures of nutrition, as well as looking at how the programs might be improved.


Eligibility criteria:
inclusion criteria: * mother of child between the ages of 3 and 12 months and her child exclusion criteria: * n/a
descartes-08 consolidation treatment in patients with high-risk multiple myeloma high-risk multiple myeloma who have residual disease after induction therapy

Conditions: Myeloma Multiple

Summary: to assess minimal residual disease (mrd)-negative complete response (scr) rate after consolidation treatment with descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older at the time of enrollment * high-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs). exclusion criteria: * patients who are pregnant or lactating. * patients who have any active and uncontrolled infection. no blood cultures are necessary unless clinically indicated.
single vs double epidural catheter analgesia for scoliosis surgery

Conditions: Adolescent Idiopathic Scoliosis

Summary: this is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone pca, for analgesia following surgery for correction of scoliosis.


Eligibility criteria:
inclusion criteria: 1. patients undergoing surgery via a posterior approach for ais 2. children ages 11-18 3. asa physical status 1-2 4. informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age) 5. planned correction of at least 8 vertebral levels exclusion criteria: 1. patient refusal to participate 2. patients on chronic narcotic medication 3. allergy to standard of care drugs used in the study (omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam) 4. coagulopathy 5. pre-existing neurological deficit 6. inability to use a numerical rating scale (nrs: 0-10 patient self-reported score) for pain assessment
influence of beverage choice on hydration status cognition and learning in children

Conditions: Dehydration in Children; Thirst; Beverage Hydration Index

Summary: the main aim of this clinical trial is to compare the beverage hydration index of three different beverages in primary school-aged children.the beverage hydration index (bhi), compares the hydration value of beverages against plain water. this study will explore the fluid retention capabilities of semi-skimmed milk, milk permeate, and water. this study will also investigate: * identify the most effective beverage for hydration and the potential cognitive and mood benefits. * to test if these beverages have any effect on gastric emptying * to test if these beverages have any effect on appetite. * to test the acceptability and palpability of semi-skimmed milk, milk permeate, and water in primary school-aged children. participants will: * take part in three study days (one for each beverage) * study day will take part between 9:00am-12:30pm * participants will also record their food and fluid consumption the day before and consume a standardised breakfast before each trial. * the beverage hydration index will be calculated as the mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment. * blood and urine samples will be taken to measure hydration * breath samples will be taken for gastric emptying rate * compass (computerised mental performance assessment system), fnirs (functional near infrared spectroscopy) and visual analogue scales (vas) measures will be obtained to assess cognition/mood * an ad libitum pasta meal will be consumed after the trial to measure appetite, along with blood glucose and glp-1 and further vas to measure self reported hunger and fullness. * a focus group will be held following completion of all three beverage trials, to gather participants opinion of each drink.


Eligibility criteria:
inclusion criteria: * aged between 9-11 * healthy exclusion criteria: * psychiatric, neurological or mental disorder. * children with any morbidity that might influence hydration status (i.e., renal/cardiovascular/metabolic disease), blood-borne illness, or if they were taking any medications that may impact fluid balance. * children that are lactose intolerant * children that have any food allergies

Keywords: appetite cognition gastric emptying
evaluation of the effect on glucose control of ac2993 in patients with type 2 diabetes mellitus treated with a sulfonylurea

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: this is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of ac2993 as compared to placebo in patients with type 2 diabetes. patients will be randomized into one of two ac2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * treated with a sulfonylurea at defined doses for at least 3 months prior to screening * bmi= 27-45 kg/m2 * hba1c value between 7.5% and 11% exclusion criteria: * treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening * patients treated previously with ac2993 * patients presently treated with insulin

Keywords: type 2 diabetes mellitis
pure single incision laparoscopic distal gastrectomy (sidg) versus totally laparoscopic distal gastrectomy (tldg)

Conditions: Early Gastric Cancer

Summary: 1. compare the immune response and postoperative complications between pure sidg (single-incision laparoscopic distal gastrectomy) and tldg (totally laparoscopic distal gastrectomy) for early gastric cancer (egc) 2. validate the safety, usefulness, minimal invasiveness and feasibility of sidg (egc)

there are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery. recently, beyond laparoscopy-assisted distal gastrectomy (ladg), which has the mini-laparotomy, tldg, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. furthermore, the report on early experience of sidg, which has no incision except umbilicus port, is going to be published. however, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. in this study, i would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications. this study is planned as a phase ii study. there are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.

Eligibility criteria:
inclusion criteria: * clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds) * 20\< age \< 80 exclusion criteria * history of other malignancy * received preoperative chemotherapy

Keywords: stomach neoplasm tldg sidg single-port inflammatory response
effect of amino acids on hepatic fat content in adolescents (aminos study)

Conditions: Hepatic Steatosis; NAFLD; Adolescent Obesity

Summary: participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. after the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

the goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. the main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done they will have an mri to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement. after the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

Eligibility criteria:
inclusion criteria * ages 13-18, tanner stage 4-5 * suspected or diagnosed with nafld per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. their mri liver fat \>5.5% * diagnosis of non-alcoholic fatty liver disease (nafld) per hepatologist * sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week * bmi equal or greater than the 85th percentile for age and gender, this is overweight and obese categories exclusion criteria * use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, hiv medications. * currently pregnant or breastfeeding women. development of pregnancy during the study period will necessitate withdrawal from the study * severe illness requiring hospitalization within 60 days * diabetes, defined as hemoglobin a1c \> 6.4% * bmi percentile less than the 85th percentile for age and sex. waist circumference \>200 cm * anemia, defined as hemoglobin \< 11 mg/dl * diagnosed major psychiatric or developmental disorder limiting informed consent * implanted metal devices that are not compatible with mri * use of blood pressure medications * known liver disease other than nafld or ast or alt \>150 iu/l

Keywords: amino acid supplement
endostapler gastric bypass study

Conditions: Obesity

Summary: the goal of this prospective, post-market study is to evaluate safety and efficacy of the aeon™ endostapler when used in laparoscopic roux-en-y gastric bypass surgery.

stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. the study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic roux-en-y gastric bypass (gb). the gb procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Eligibility criteria:
inclusion criteria: * patients undergoing planned laparoscopic roux-en-y gastric bypass * informed consent for study obtained and signed from each subject exclusion criteria: * planned open surgical approach * use of staple line reinforcement material (buttress) * revision or other bariatric procedure * patients with a bleeding disorder: known coagulopathy, or platelets \ 45sec, or pt\> 15sec, or inr\>1.5 * patients with active hiv or hepatitis b * patients under the age of 18 on the date of the surgery * patients who are pregnant * patients using tobacco products within the last 2 weeks prior to surgery date * patients using cortisone or related products within the last 2 weeks prior to surgery date
a trial of eptinezumab in participants with migraine and insufficient response to anti-cgrp medications

Conditions: Migraine

Summary: the main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (cgrp).


Eligibility criteria:
key inclusion criteria: * the participant has a diagnosis of migraine as defined by international headache society (ihs) international classification of headache disorders 3rd edition (ichd-3) guidelines with a history of migraine of at least 12 months prior to the screening visit. * the participant has ≥8 migraine days per month for each month within the past 3 months prior to the screening visit. * the participant has documented evidence of recent inadequate response to either one anti-cgrp monoclonal antibody (mab) (other than eptinezumab) or one gepant, indicated and used for migraine prevention. key exclusion criteria: * the participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period. * the participant has previously had an inadequate response to more than one cgrp-targeting therapy (anti-cgrp mab or gepants), indicated for migraine prevention. * the participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of eptinezumab. male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. participants under surveillance for a low and stable level of m-component are allowed. * the participant has previously been treated with eptinezumab. other protocol-defined inclusion and exclusion criteria apply.

Keywords: eptinezumab cgrp-targeting therapies anti-cgrp monoclonal antibodies (mabs) gepants
safety and pharmacokinetics of jin fu kang in comb w/docetaxel for patients w/non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: researchers from memorial sloan-kettering cancer center are conducting a research study on a chinese herbal medicine known as "jin fu kang". we want to see if this can help patients with advanced lung cancer. jin fu kang might reduce the growth of cancer or improve quality of life. you are eligible for this trial because your cancer has progressed after prior chemotherapy and your doctor has recommended further chemotherapy treatment. lung cancer that has been confirmed and that has spread is called advanced cancer. there is no known permanent cure for advanced lung cancer, but chemotherapy may temporarily shrink the cancer and improve the quality of patients' lives.

jin fu kang is a herbal medicine specially developed in china for the treatment of lung cancer. it is based on a traditional medicine that is widely used and appears to be safe. although clinical trials in china suggest that jin fu kang may be of benefit, it has never been researched in patients with lung cancer in the united states. as such, its risks and benefits are not fully understood. the scientific aims are to determine the toxicity of jin fu kang/docetaxel combination treatment in patients with non-small cell lung cancer, to determine whether jin fu kang alters the pharmacokinetics of docetaxel and to provide preliminary efficacy and survival data for jin fu kang/docetaxel combination treatment in patients with non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: -patients must meet all of the following inclusion criteria: * pathologic confirmation of stage iii or iv nsclc. * docetaxel therapy for cancer is clinically indicated. * kps\>=60% \*anc\<1,000/mcl and platelets\<100/mcl exclusion criteria: -patients must meet none of the following exclusion criteria: * wbc\ uln, ast \>1.5 x uln, alkaline phosphatase \> 2.5 x uln, creatinine \> 1.5 mg/dl or creatinine clearance \ 10,000/µl) * prior docetaxel * patient must have recovered from all previous treatment-related toxicity * concurrent use of any botanicals for anticancer intent * use of jin fu kang or any of its constituent botanicals in the previous three weeks. * history of allergy to any of the constituent botanicals in jin fu kang. * pregnant or lactating women or women of childbearing potential not using effective contraception. a negative pregnancy test must be documented during the screening period for women of childbearing potential. * concurrent active cancer. * concurrent use of immunosuppressives: as an immunostimulant, astragalus-containing products are contraindicated for patients on immunosuppressive therapy.

Keywords: lung cancer
alcoholism and schizophrenia: effects of clozapine

Conditions: Schizophrenia; Dual Diagnosis; Schizoaffective Disorder; Psychotic Disorder; Substance Abuse; Alcohol Abuse

Summary: the purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. the hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * current diagnosis of an alcohol use disorder with active use in the last 30 days. * the participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent. * ages 19-65. * taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization * if taking depot medication, at least 3 injection cycles since the last injection prior to study randomization. exclusion criteria: * contraindication to clozapine * women who are currently pregnant or who desire to become pregnant during the course of the study. * current and past treatment with clozapine * current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium). * meets dsm-iv criteria for current dependence of substances other than alcohol.

Keywords: clozapine atypical antipsychotic conventional antipsychotic schizophrenia dual diagnosis substance abuse alcohol abuse
antimicrobial pk in infants with suspected or confirmed infection

Conditions: Infection

Summary: the purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.

greater than 90% of infants born \<32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their nicu hospitalization. most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. dosing is based largely on pharmacokinetic data from older children or in some cases, adults. this study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. the sites of the nih-sponsored pediatric pharmacology research network (ppru) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will 1. guide dosing of commonly used antimicrobial agents, and 2. provide preliminary data for future industry and government trials in the nursery.

Eligibility criteria:
inclusion criteria: * infants ≤32 weeks and 6 days ega with high probability of receiving one of the antimicrobial agents listed are eligible for study. * age younger than 120 days * written informed consent from parent or legal guardian * infants likely to survive beyond 48 hours after enrollment exclusion criteria: * failure to consent

Keywords: infection anti-infective agents antifungal agents proteomics
evaluation of desarda technique in management of complicated inguinal hernia

Conditions: Desarda; Complicated; Inguinal Hernia

Summary: this study aims to evaluate the desarda technique in management of complicated inguinal hernia.

desarda technique is one of the best surgical methods suitable for emergency hernia surgery repair, but there is still limited consensus. the purpose of this study is to assess the long-term outcome of the pure tissue desarda technique for the treatment of emergency inguinal hernias repair (incarcerated, irreducible, and obstructed patients) regarding postoperative complications, groin pain, and recurrence rate. surgical techniques for emergency inguinal hernia surgery remain an important less documented area. emergency inguinal hernia can have different presentations. incarceration is characterized by the irreducibility of contents and strangulation by the compromise of the blood supply of the contents (e.g., bowel, omentum).

Eligibility criteria:
inclusion criteria: * age above 14 years old. * irreducible, incarcerated \& obstructed inguinal or inguinoscrotal hernia; unilateral or bilateral exclusion criteria: * recurrent hernias. * intra-operative finding of separated thin and/or weak external oblique aponeurosis.