Kornimate/medical-research-clean huggingface dataset:
impact of one versus two amino acid chelated iron capsules on prevention of iron deficiency anemia in non-anemic women with twin gestations

Conditions: Anemia

Summary: anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. during pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass. iron deficiency anemia is the commonest type of anemia during pregnancy. the pregnant woman needs about 1000 mg of iron during pregnancy. diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the centers for disease control and prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. as most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further iron deficiency anemia. oral iron is a cheap, effective and relatively safe line to prevent iron deficiency anemia during pregnancy. the common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting. iron amino acid chelates have been emerged to be used as agents for prevention and treatment of iron deficiency anemia. these agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects. twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. the iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of iron deficiency anemia.


Eligibility criteria:
inclusion criteria: * twin gestations * ±12 weeks) * normal hemoglobin level (hb ≥ 120 g/l). * women were living in nearby area to make up follow up quit possible * willing to participate in our study exclusion criteria: * a recent blood transfusion * threatened miscarriage * pathological blood loss * vegetarian diet * intolerant to oral iron form * history of haematologic disorder * chronic diseases * unwillingness to co-operate.
zileuton for the treatment of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. subjects will be monitored off treatment for three months for changes in symptoms and physiology. subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. the primary endpoint of this trial is change in ltb4 levels in bronchoalveolar lavage fluid following six months of treatment. secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis * taking \< 15 mg prednisone for at least 30 days prior to screening * age 35-80, inclusive * able to understand a written informed consent and comply with the study protocol exclusion criteria: * significant environmental exposure * diagnosis of collagen vascular disease * evidence of active infection * clinically significant cardiac disease myocardial infarction, coronary artery bypass or angioplasty within 6mo unstable angina pectoris congestive heart failure requiring hospitalization within 6 months uncontrolled arrhythmia * poorly controlled or severe diabetes mellitus * pregnancy or lactation * women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, norplant) * current enrollment in another experimental protocol physiologic criteria: * fev1/fvc \< 0.60 laboratory criteria: * total bilirubin \> 1.5 x upper limit normal * ast or alt \> 3x upper limit normal * alkaline phosphatase \> 3x upper limit normal * white blood cell count \< 2,500/mm3 * hematocrit \< 30% * platelets \< 100,000/mm3 * prothrombin time inr \> 1.5
molecular signature from tumor to lymph nodes

Conditions: Lung Cancer; Stage IIIA-cN2; Operated With Curative Intent; Primary Tumor Tissue Available; Node Tumor Tissue Available

Summary: mediastinal lymph node (ln) involvement (n2) in non-small cell lung cancer (nsclc) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. the n2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. regarding anatomy, the mountain and dresler's regional ln classification for lung cancer staging remains the reference. different studies classified iiia-n2 disease into 4 groups, in addition to the skip-n2 phenomenon: minimal-n2, n2 single station, n2 multiple stations, and bulky-n2. other subgroups were recently proposed for the 8th edition of the tnm: n2a1 - single station skip, n2a2 - single station non-skip, n2b - multiple stations. the french national cancer institute (inca) proposed guidelines, but in case of cn2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation. thus, optimal management of ciiia-n2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery \[1\]. in this situation, the identification of markers that will help select iiia-n2 patients who will benefit from surgical resection is mandatory.

we planned a comprehensive molecular characterization of tumors and lymph nodes to evaluate the impact of molecular signatures and molecular heterogeneity on disease-free survival after surgery in iiia-n2 nsclc patients. identification of specific molecular profiles in primary tumors and evolution profiles in nodes might provide clues to the potential risk of metastatic evolution and trigger specific management. for patients included prospectively, we planned to analyze cell free circulating tumor dna (ctdna) as prognostic marker. because multiple biopsies are not always available in care settings, ctdna could also be analyzed as a surrogate marker of molecular heterogeneity. next generation sequencing (ngs) that was validated in our lab to screen ctdna using a specific bio-informatics workflow allows accurate and cost effective ctdna screening

Eligibility criteria:
inclusion criteria: * adult patient, men and women age \>18 years * patients operated with a curative intent for an iiia-cn2 nsclc * social security affiliation * written informed consent for patient included in part 2 (prospective) or not opposing the use of this data for patient included in part 1 (retrospective) exclusion criteria: * patient with t4, r1 or r2 surgical resection, sublobar resection, no radical lymphadenectomy * patient under protectives measures * pregnancy or breast-feeding

Keywords: nsclc n2 molecular profile prognosis
action against malnutrition through agriculture (aama) plus mnp study

Conditions: Anemia

Summary: helen keller international (hki), the ministry of health and population, and ministry of agriculture and cooperatives, of nepal and local non-governmental organizations (ngo) partners are currently implementing a usaid funded action against malnutrition through agriculture (aama) project in baitadi district located in far western development region of nepal. hki is undertaking this study within the aama project to test whether providing micro-nutrient powders (mnps) in a programmatic context along with homestead food production (hfp) and an intensive community level infant and young child feeding behavior change communication (iycf-bcc) intervention will have a greater impact on reducing anemia and improving growth in young children than only providing the hfp and iycf-bcc intervention without mnps or a control with no intervention.

the aama project uses the homestead food production (hfp) model that focuses on increasing households year round access to nutritious food as a platform to deliver a proven essential nutrition actions (ena) related messages to household with children less than 2 years old. the aama project seeks to examine the effects of household level hfp on malnutrition. so the recipient and other partners wishes to undertake a study to explore a plausible delivery mechanism for mnps along with hfp and intensive community level iycf-bcc and their impact on infant/child growth and anemia. the study is a cluster randomized controlled trial with a three arm factorial design. the trial involve 330 randomly selected children aged 6-9 months at the time of enrollment (n=110 per each of the three study arms). mnps distributed through fchvs to 110 children selected from communities that already have the hfp and iycf-bcc intervention. this group of children will be compared on outcome parameters for anemia, growth (stunting, underweight and wasting) and infections (diarrhea, fever and cough) to a similar sub-set of children (n=110) who receive only the hfp and iycf-bcc intervention and to a third sub-set of control children of similar age (n=110) who are not receiving either of these interventions. children aged 6-9 months were chosen for the study because this age range captures the recommended age for introduction of complementary foods to children and our chosen age group also falls within the 0-24 month age range which is considered the period of rapid growth and development and therefore period of highest nutrient requirements in children.

Eligibility criteria:
inclusion criteria: * children 6-9 months of age during enrollment time * mothers who want to enroll their children in study exclusion criteria: * severe anemia * children age below six months and age over 23 months during study time

Keywords: mnp aama program nepal hfp iycf bcc
registry for automated mechanical ventilation in adults

Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation

Summary: the aim of the here proposed study is to assess safety, performance and provide real world evidence (rwe) of the hamilton medical ag automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.

the harmful effect of invasive mechanical ventilation can be prevented by intensive training of icu physicians, respiratory therapists, and icu nurses on the one hand, and by improvement of the technology installed in ventilators on the other hand. advanced mechanical ventilation modes use new technologies to assist physiology, optimize gas exchange and minimize ventilator induced lung injury. modes such as proportional assist ventilation and neuronally adjusted ventilatory assist deliver assisted ventilation proportional to the patient's effort, improving ventilator patient synchrony. the adaptive support ventilation (asv) mode automatically adjust tidal volume and respiratory rate based on patient's respiratory mechanics to protect from mechanical ventilator induced lung injury, hence deliver safe mechanical ventilation. the implementation of advanced closed-loop systems automates medical reasoning and has potential to improve patient ventilator interactions, the time spent on mechanical ventilation, staff workload and potentially outcome.

Eligibility criteria:
inclusion criteria: age ≥ 18 years. any patient in need of hfno, niv and imv at some time during its icu stay. exclusion criteria: expected to be weaned from hfno, niv within 2 hours. expected to be weaned and extubated from imv without subsequent need of hfno or niv support within 2 hours. expected to be transferred to another non-participating icu within 2 hours. moribund subject: death expected within 2 hours.

Keywords: real world data, acute respiratory failure, respiratory support, invasive mechanical ventilation, niv, high-flow nasal oxygen
assessment of long-term safety in patients with non-cancer-related pain and opioid-induced constipation

Conditions: Opioid-Induced Constipation (OIC)

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of nktr-118 treatment of opioid-induced constipation (oic) in patients with non-cancer-related pain.


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study-specific procedures. * new patients only: self-reported active symptoms of oic at screening (\ 1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the bms over the previous 4 weeks); and documented confirmed oic (\<3 sbms/week on average over the 2-week oic confirmation period. * patients enrolling from other nktr-118 studies: receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies. * for patients randomized to receive nktr-118: willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if bm has not occurred within at least 72 hours of the last recorded bm. exclusion criteria: * patients receiving opioid regimen for treatment of pain related to cancer. * history of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer. * medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation. * other issues related to the gastrointestinal tract that could impose a risk to the patient. * pregnancy or lactation.

Keywords: non-cancer-related pain opioid-induced constipation
adipose derived stem cells transplantation for chronic obstructive pulmonary disease

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. people with copd have difficulties breathing, primarily due to the narrowing of their airways, this is called airflow obstruction. some preclinical evaluations showed that copd is closely related to chronic inflammation; therefore, this study aimed to use adipose-derived stem cells (adscs) in the form of non-expanded culture - that usually names as a stromal vascular fraction (svf) in combination with activated platelet rich plasma (prp) to treat this disease. both svf and prp are autologous sources that obtained from adipose tissue and peripheral blood, respectively. this mixture is intravenously transfused into the patients.


Eligibility criteria:
inclusion criteria: * age 40 to 80, inclusive * a prior diagnosis of moderate to severe copd * gold iia, iii, iv exclusion criteria: * pregnant or lactating * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * any illness which, in the investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results * subjects on chronic immunosuppressive or chemotherapeutic therapy * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * subjects with alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease). * unwilling and/or not able to give written consent * patient is positive for hepatitis (past history of hepatitis a is allowed) * any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient * cerebral aneurysm clips

Keywords: safety and efficacy adipose stem cells stem cell therapy
fractional ablative laser treatment for skin grafts

Conditions: Burn Scar; Skin Graft Scar

Summary: doctors and patients refer to all areas of skin changes from burn injury as burn scars. however, different areas of scars from burns can be treated differently. the burn scars that come from skin grafting surgery might be improved with laser treatment. the purpose of this study is to see if treating burn skin graft scars with a laser could make it better. fractional ablative laser has been approved by the us food and drug administration (fda), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.

this pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. the study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the fractional carbon dioxide (fxco2) laser and have significantly less secondary contracture than control sites. the great majority of laser studies have addressed treatment of established scars. ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. the current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. preliminary work completed by our team has confirmed that the red duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the fxco2 on split-thickness skin grafts decreased secondary contracture. further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. the study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. in these patients who had larger burn returning to the or for additional procedures, the study team was able to offer fxco2 treatment as a "salvage" therapy. with this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. the study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) fxco2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.

Eligibility criteria:
inclusion criteria: * patients who are to undergo skin grafting procedures for acute treatment of thermal burns. * patients with grafts placed over at least 100cm\^2 exclusion criteria: * patients who have are not scheduled to undergo skin grafting procedures * patients who have grafts placed under 100cm\^2

Keywords: fractional laser ablative laser carbon dioxide laser
effect of different frequencies of umbilical cord-mesenchymal stem cells through peripheral vein in patients with esld

Conditions: End-Stage Liver DIsease

Summary: stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating esld. it seems that the multiple infusion is better than single infusion.

ninety-two participants with end-stage liver disease admitted to the department of gastroenterology of the general hospital of northern theater command are expected to be enrolled over a period of 1 year. the participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. the investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and child-pugh score in patients at weeks 24 post-infusion.

Eligibility criteria:
inclusion criteria: * 1. 18-80 years old * 2. end-stage liver disease * 3. signed informed consent exclusion criteria: * 1. tumours of the liver or other organs * 2. liver transplantation recipients * 3. acute myocardial infarction, acute heart failure, type i and type ii respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases * 4. other diseases that may seriously affect the survival * 5. human immunodeficiency syndrome * 6. interferon or glucocorticoid therapy within 1 year * 7. treated for mental illness * 8. participation in other clinical trials within 30 days * 9. pregnant or breastfeeding subjects * 10. allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies * 11. other circumstances that are unsuitable for participation in this study

Keywords: cirrhosis end-stage liver diseases umbilical cord-mesenchymal stem cells randomized controlled trial
testing the effect of zinc supplementation to improve the treatment effect of botulinum toxin for oculofacial spasm

Conditions: Blepharospasm; Hemifacial Spasm

Summary: the purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

botulinum toxin (botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. it has also gained widespread use for cosmetic purposes. the efficacy and duration of its effect is not constant amongst all patients. some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. zinc is known to be an important co-factor in the molecular effects of botox. the investigators hypothesize that one of the many factors that may contribute to the variability in the response to botox may be the level of zinc available within the neuromuscular junction of those patients. the investigators plan to to test whether or not giving patients supplemental zinc with their botox injections would help improve the magnitude and duration of the intended clinical effect.

Eligibility criteria:
inclusion criteria: * greater than the age 18 years old * patient with hemifacial spasm * patient with benign essential blepharospasm. exclusion criteria: * patients who have received botox within 3 months time, * patients prone to malabsorption (i.e. those with celiac disease, inflammatory bowel disease, liver disease, laxative use) * patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.

Keywords: blepharospasm hemifacial spasm botox zinc