Kornimate/medical-research-clean huggingface dataset:
nutributter programming to prevent undernutrition: an evaluation

Conditions: Undernutrition

Summary: this randomized, controlled effectiveness study examines nutributter programming within an integrated package of maternal and child health services offered by haiti's ministry of health (mspp) to prevent undernutrition among young children in haiti. the aim of the process evaluation is to better understand the uptake of nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of mspp's package of services. this project is being carried out at a public hospital in fort san michel, an impoverished community outside of cap haitien, haiti.


Eligibility criteria:
inclusion criteria: * infants 6 to 12 months old * lives in fort san michel exclusion criteria: * moderately or severely malnourished * peanut allergy

Keywords: stunting hidden hunger diarrhea vitamin a deficiency
the expanded access use of viltolarsen in duchenne muscular dystrophy with confirmed exon 53 amenable mutation

Conditions: Muscular Dystrophy, Duchenne; DMD

Summary: this is an open label expanded access program for boys, 3 to 12 years old, for the treatment of duchenne muscular dystrophy (dmd) with confirmed mutation(s) in the dystrophin gene that is amenable to skipping of exon 53.

this expanded access program is designed to provide access to viltolarsen in patients with dmd with confirmed mutation(s) in the dystrophin gene amenable to skipping of exon 53, who in the opinion and clinical judgement of the treating physician, would benefit from treatment with viltolarsen.

Eligibility criteria:
inclusion criteria: * male ≥ 3 and ≤ 12 years of age * clinical signs compatible with dmd * confirmed dmd mutation(s) in the dystrophin gene that is amenable to skipping of exon 53 to restore the dystrophin messenger ribonucleic acid (mrna) reading frame * able to walk independently without assistive device * not able to participate in a phase 3 trial exclusion criteria: * chronic systemic fungal or viral infections * an acute illness within 4 weeks prior to the first dose of viltolarsen * symptomatic cardiomyopathy * patient has a previous or ongoing medical condition, medical history, physical findings, or laboratory abnormality that could affect participant safety in the opinion of the treating physician * surgery within the 3 months prior to the first anticipated administration of viltolarsen and in the opinion of the treating physician would impact weekly treatment schedule * positive test results for hepatitis b antigen, hepatitis c antibody, or human immunodeficiency virus (hiv) antibody at screening * currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of viltolarsen * previously enrollment in any viltolarsen study. * currently taking any other exon skipping agent or has taken any other exon skipping agent within 2 weeks prior to the first dose of viltolarsen (would need to be discontinued in order to be eligible) * any gene therapy for dmd * inadequate renal function as defined by a serum cystatin c \> 1.5 x upper limit of normal (uln). if the value is \> 1.5 x uln then the measurement can be repeated once. if repeat measurement is still \> 1.5 x uln then the patient should be excluded.

Keywords: muscular dystrophies muscular dystrophy, duchenne muscular disorders, atrophic muscular diseases musculoskeletal diseases neuromuscular diseases nervous system diseases genetic diseases, inborn genetic diseases, x-linked
oligo-metastases npc patients received radiation for primary tumors and treatments for metastatic lesions

Conditions: Nasopharyngeal Cancer; Neoplasm Metastasis

Summary: oligo-metastases npc patients received radiation for primary tumors and treatments for metastatic lesions.

the patients enrolled will received 4-6 cycles chemotherapy at first.then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. the efficacy and side-effect will be evaluated and analyzed.

Eligibility criteria:
inclusion criteria: 1. histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx. 2. clinical stages,t1-4n0-3m1，ivc(ajcc 2010). 3. the metastatic lesions ≤5 and metastatic organs ≤2 4. karnofsky scores \>70 5. normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/l, neutrophil count\>1.5×109/l, platelet count \>100×109/l, hemoglobin≥90g/l, normal liver/kidney function). 6. informed consent signed. exclusion criteria: 1. histologically conformed initial keratinizing carcinoma or others. 2. the metastatic lesions \>5 or metastatic organs \>2. 3. any severe complications contraindicated chemotherapy or radiotherapy. 4. history of malignant tumors. 5. pregnant or nursing women. 6. history of radiotherapy or chemotherpy in head and neck regions. 7. patients refused the informed consent.
tumor relapsed study of serum trxr activity in advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer; First Line Treatment; Thioredoxin Reductase Activity; Carcinoembryonic Antigen; Progression

Summary: in pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity could be a warning marker for early progression of first-line treatment for advanced non-small cell lung cancer

this is a cooperative research project involving patients in medical oncology department of affiliated cancer hospital of xiangya school of medicine central south university, and the state key laboratory for natural medicine and biomimetic drugs perking university. the primary objective is to measure the thioredoxin reductase activity using blood in subjects received platinum based chemotherapy, to study the warning progression ability of thioredoxin reductase in blood. the secondary objective is to compare the warning progression activity of blood thioredoxin reductase reductase activity with carcinoembryonic antigen in subjects received platinum based first-line chemotherapy. blood will be collected before chemotherapy, after every 2 cycles of chemotherapy, every 3 months after all first-line chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor progression, evaluation ct results every time collecting blood samples.

Eligibility criteria:
inclusion criteria: * pathologically proven non-small cell lung cancer, stage ⅳ patients or unsuitable for local treatment of ⅲb stage patients * malignant tumor treatment naive including surgery（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before, except for lung cancer patients who received surgery and adjuvant chemotherapy after 12 month then diagnosed with stage ⅲb or ⅳ） * signed informed consent would like to provide blood for research exclusion criteria: * patients received antitumor treatment before * patients with contraindication of chemotherapy * pregnant or breast feeding women

Keywords: non-small cell lung cancer thioredoxin reductase
quality of life in traumatic brain injury patients

Conditions: All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma

Summary: the aim of this study is to describe the quality of life of ct patients in our study, at least 6 months after the occurrence of the trauma. this assessment is related to the patient's degree of sequelae, using the gose scale.

the assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. thus, we should no longer simply assess how patients "should feel", based on objective biomedical criteria, but how they actually "perceive" themselves, based on subjective criteria. this is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . while research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors. the aim of this study is to describe the quality of life of ct patients at least 6 months after the trauma. this assessment is related to the patient's degree of sequelae, using the glasgow outcome scale extended gose.

Eligibility criteria:
inclusion criteria: all adult patients (age 18 or over) admitted to the hmpit intensive care unit for management of head trauma (isolated or as part of a polytrauma). exclusion criteria: patients lost to follow-up after discharge. incomplete icu medical records. patients or their families who refused to participate in the study.
dual-wave boluses in children with type 1 diabetes insulin boluses in children with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: to analyze with the aid of cgm the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

primary objective to analyze with the aid of cgm the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner. primary endpoint to compare time in range (tir) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. trial design this is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase. trial population a total of 30 subjects with type 1 diabetes.

Eligibility criteria:
inclusion criteria: 1. children aged 7-18 years treated at the children's clinic of tartu university hospital for type1 diabetes. 2. insulin pump and cgm initiated at least 3 months prior to the recruitment. 3. estimated hba1c based on the 14-days cgm report above 8.5%. 4. daily insulin dose of more than 0.5 international units per kilogram. exclusion criteria: 1. subjects with known diabetes complications. 2. elevated tissue transglutaminase iga antibodies in the last two years. 3. children who developed an acute viral infections during the week preceding the recruitment. exclusion criteria after the run-in period 1. basal insulin proportion \> 55% of daily insulin dose. 2. children with any symptoms of an infectious disease or acutely sick during the last two weeks. 3. estimated hba1c \> 8.5% based on the 14-days cgm report.
alterations in serotonergic functions in cocaine addicts - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate alterations in the serotonergic system in cocaine addicts and attempt to dissociate changes secondary to cocaine use from those associated with premorbid characteristics.


Eligibility criteria:
please contact site for information.
a study of fluoxetine in major depressive disorder (mdd) short-term dosing

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the short-term efficacy and safety of fluoxetine in japanese adult participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * outpatient japanese participants diagnosed with mdd * diagnosis of moderate or greater severity of mdd * agree to abstain from sexual activity or to use a reliable method of birth control * judged to be reliable (agree to keep appointments for clinic visits and to undergo all tests and examinations required by the protocol) exclusion criteria: * have previously been exposed to fluoxetine (ly110140) for any indication in the past * significant suicidal risk * have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder * have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine * have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks * have a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms), or vagus nerve stimulation (vns) within 1 year * have had treatment with a monoamine oxidase inhibitor (maoi) within 14 days * need to use thioridazine or pimozide during the study * have previously enrolled, completed, or withdrawn from this study * have a positive urine drug screen for drugs with abuse potential * female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant * have a history of seizure disorder * have frequent or severe allergic reactions to multiple medications * have a serious or unstable medical illness or condition, or psychological condition * participants deemed ineligible by the investigator or sub-investigator for other reasons
identification and evaluation of circulating tumor cells and tumor related rare cells in immunotherapy

Conditions: CTC and Tumor Related Rare Cell

Summary: the primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. the secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.


Eligibility criteria:
inclusion criteria: 1. evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. over 20 years of age. 3. cancer patients on immune checkpoint inhibitors. exclusion criteria: 1. subjects who have other cancer history 2. pregnant females 3. subjects with active, known or suspected autoimmune disease. 4. known history of human immunodeficiency virus (hiv)
virtual reality cognitive training for older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Older Adults

Summary: this study aims to (1) develop and assess the feasibility of a fi-vrct program based on iadl for older adults with mci, (2) implement and evaluate the effectiveness of the fi-vrct program based on iadl in older adults with mci, and (3) investigate the potential mechanism of the fi-vrct program based on iadl for older adults with mci and refine this intervention accordingly.

as research on cognitive training methods for older adults with mild cognitive impairment (mci) progresses, fully immersive virtual reality cognitive training (fi-vrct) has emerged as a promising approach. while the benefits of fi-vrct for enhancing cognitive function have been recognized, its potential to improve instrumental activities of daily living (iadl) and promote independence remains uncertain. this study addresses these questions by developing and validating a fi-vrct program based on iadl to enhance cognitive and iadl performance among older adults with mci.

Eligibility criteria:
inclusion criteria: 1. aged 65 or above. 2. moca score between 18 and 25. 3. capability to follow directions and do tasks. exclusion criteria: 1. history of dementia. 2. previous neurodegenerative illness diagnosis. 3. severe medical or surgical problems. 4. major psychological disorders. 5. inability to use vr system
procrit versus placebo to determine efficacy in pre-operative major surgical oncology operations

Conditions: Cancer

Summary: the purpose of this study is to evaluate the effectiveness of a two-dose regimen of procrit prior to a major surgical oncology operation.


Eligibility criteria:
inclusion criteria: * undergoing a major surgical oncology procedure as defined below: * pancreatectomy * hepatectomy * esophagectomy * gastrectomy * retroperitoneal sarcoma resection * 18 years of age and older * hemoglobin level of ≥ 10g/dl to \< 13g/dl, within 10 days of enrollment * if female of child-bearing potential, negative pregnancy test within 14 days prior to surgery * if subject is a sexually active male or a sexually active female of child- bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits * irb-approved informed consent, signed by the subject or the subject's legally authorized representative ≥ 18 years of age exclusion criteria: * pre-operative hemoglobin level ≥ 13g/dl or \< 10g/dl * uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110) * history of allergy to procrit® * known hypersensitivity to mammalian cell-derived products or human albumin * history of spontaneous venous thrombotic vascular events * anemia due to factors other than cancer,(e.g. iron deficiency, b12 deficiency) * history of (within 12 months) deep venous thrombosis (dvt), pulmonary embolus (pe), or other venous thrombotic events. prior superficial thrombophlebitis is not an exclusion criterion * history of (within 6 months) uncontrolled cardiac arrhythmias, cerebrovascular accident (cva), transient ischemic attack (tia), acute coronary syndrome (acs), or other arterial thrombosis. acs includes unstable angina, q wave myocardial infarction (qwmi), and non-q wave myocardial infarction (nqmi) * currently receiving therapeutic or prophylactic anticoagulants for conditions other than planned surgery. the only exceptions are low dose aspirin (≤ 325 mg/day) or low dose anticoagulant to maintain patency of intravenous (iv) lines * patient is a candidate for autologous blood transfusion

Keywords: procrit erythropoietin patients undergoing major surgical oncology operations
effect of l-prf and a-prf in ridge preservation

Conditions: Atrophic Maxilla; Ridge Preservation

Summary: a split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: l-prf vs a-prf vs control. patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. the use of each platelet concentrate or control will be randomized by means of a computer program. the results will be analysed clinical and radiographically (cbct). when the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. the region will be localized with a customized stent, fabricated with the position of the extracted teeth. vas scales will be provided to evaluate the post-operative discomfort.


Eligibility criteria:
inclusion criteria: * 3 single-rooted teeth needed to be extracted in the upper jaw * patient in good general health as documented by self-assessment * patients must be committed to the study and must be willing to sing the informed consent. exclusion criteria: * any systemic medical condition that could interfere with the surgical procedure or planned treatment. * current pregnancy or breast feeding * radiotherapy or chemotherapy in head and neck area * intravenous and oral bisphosphonate * patients smoking \>20 cig/day * unwillingness to return for the follow-up examination

Keywords: leucocyte- and platelet rich fibrin ridge preservation growth factors platelet concentrates
epidemiological study of dry eye disease in stavanger: dry eye disease in patients treated with intravitreal injections

Conditions: Dry Eye

Summary: to investigate prevalence of dry eye disease in norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of ded in this population.

questionaires (osdi, mcmonnies) and clinical investigation using the oculus 5 keratograph for objective ocular surface evaluation. tear fluid samples will be collected for later biochemical analysis.

Eligibility criteria:
inclusion criteria: * amd diagnosis * treated with intravitreal injection agents exclusion criteria: * not able to cooperate
mmf after pediatric liver transplantation

Conditions: Liver Transplantation; Chronic Kidney Disease

Summary: the use of cnis (csa or fk) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term. the study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (csa or fk plus steroids) to a triple immunosuppression (mmf plus csa (reduced dosage) plus steroids.


Eligibility criteria:
inclusion criteria: * patients after pediatric liver transplantation * no acute rejections for the last half year exclusion criteria: * concomitant malign disease (e.g. ptld) * neutropenia (granulocytes \<1000/µl) * systemic infection * thrombopenia (\<80/nl)

Keywords: liver transplantation children immunosuppression mycophenolatmofetil calcineurin inhibitor kidney disease
breast mri for newly diagnosed breast cancer:impact on re-excision lumpectomy

Conditions: Breast Cancer

Summary: this study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. the investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.

this is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to mri versus no breast mri. data analyzed will include medical record information abstracted from the clinical records. date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results. the primary aim of this study is to assess if the use of pre-operative mri can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

Eligibility criteria:
inclusion criteria: * must undergo definitive local therapy with either breast conserving therapy or mastectomy * clinical stage 0, i or ii breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. tumors must be less than 5 cm in size and the patient clinically node negative * able to undergo breast mri exclusion criteria: * not pregnant or breastfeeding * no prior breast mri for the newly diagnosed carcinoma at the outside hospital * no prior mantle radiation * no locally advanced breast cancer * no diffuse malignant appearing microcalcifications requiring mastectomy * no known collagen vascular disease * no previous ipsilateral radiation * no participants who undergo surgery at an outside institution * no prior history of breast carcinoma

Keywords: newly diagnosed early stage