Kornimate/medical-research-clean huggingface dataset:
evaluation of a comprehensive school health programme in zambia

Conditions: Helminth Infection; Malaria; Schistosomiasis; Anemia; UTI; Diarrhea; Skin Rash; Cough

Summary: in zambia, the health and well-being of children aged 5 to 14 has often been overlooked, leading to various health challenges affecting their development and education. the healthy learners (hl) program, in collaboration with the zambian government, aims to address this gap by implementing a comprehensive school health program. trained teachers, known as school health workers (shws), play a key role by delivering health education, coordinating preventative care with local clinics, and overseeing a 'school health room' for sick students. this study is a large cluster-randomized control trial in 225 schools. the goal of this trial is to compare the effects of the comprehensive school health programme (shp) developed by hl against two alternatives: the current level of school health provision and the current school health activities enhanced with deworming and vitamin a coordination by hl, with their technical and financial support ensuring the reliable delivery of all health activities currently planned by the government. 1. what is the impact of the program on health-seeking, health, and education outcomes? 2. what are the indirect effects of the program on teachers and clinics? 3. what is the added value of such a comprehensive shp, compared to (i) optimized (ii) or imperfect (status-quo) delivery of a limited range of school health activities (e.g., deworming and vitamin a supplements)? 4. how costly is the comprehensive shp, and what factors affect its implementation? 5. what are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?


Eligibility criteria:
* schools: eligible for shp (not inaccessible in the rainy season, within 10km of health centre) * school administrator: has at least one year experience in school and is the primary or deputy school manager (e.g., headteacher, deputy headteacher, senior teacher acting as financial officer) * learners: registered and in attendance in school during baseline, in grade 1, grade 3, or grade 5 * parents, primary caregivers or guardians of selected learners. guardians are eligible if they stay with the child and make schooling and health decisions for the child in the absence of parents/primary caregivers. * teachers: any teacher employed by study eligible schools (not volunteers) * health facilities: designated facilities in the catchment area of study schools * health facility staff: any staff doing opd consultation present during facility data collection days

Keywords: school health services
prevention of disease progression in early stage indolent b cell malignancies. (smm)

Conditions: Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma; Chronic Lymphocytic Leukemia

Summary: escalating doses of omega 3 fatty acids are being used in patients who have early stage chronic lymphocytic leukemia (es-cll), monoclonal gammopathy of undetermined significance (mgus), or smoldering multiple myeloma (smm), whose disease does not currently require treatment. the primary aim of the study is to determine if the omega 3 supplementation will help prevent or delay progression of the disease to a stage that requires treatment.


Eligibility criteria:
inclusion criteria: * must be over 18 years of age. * must be free of other medical conditions that would decrease life expectancy to less that 12 months. * must be free of omega 3 supplements or other fish oil containing nutritional supplements for a minimum of two months prior to enrollment. * must have a ecog performance status of 0,1 or 2. exclusion criteria: * any life-threatening condition such as (but not limited to) advanced heart disease, kidney or liver failure with an expected survival of less than 12 months. * any other active malignancy. * women who are pregnant or lactating. * individuals unable to give informed consent. * individuals with known allergy or intolerance to fish oil supplements. * any patient with an active bleeding diatheses or disorder. * ecog performance status of 3 or 4.

Keywords: es-cll mgus smm early stage - chronic lymphocytic leukemia
comparing patient-adjusted versus physician-adjusted titration of biasp 30 combined with metformin in type 2 diabetes patients

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa and asia. the aim of the trial is to compare patient-adjusted versus physician-adjusted titration of biasp 30 combined with metformin in type 2 diabetes patients uncontrolled on nph insulin.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for a minimum of 12 months prior to screening * currently treated with a nph insulin for at least 3 months prior to screening * stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment. the metformin treatment must have been stable for at least 2 months prior to screening * hba1c between 7.0% and 10.0% (both inclusive). (one re-test within one week of screening visit is allowed. the last sample will be conclusive.) * body mass index (bmi) below or equal to 40.0 kg/m\^2 * able and willing to eat at least 2 main meals each day during the trial * able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol * experience in performing self-measured plasma glucose (smpg) exclusion criteria: * treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to screening * impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.) * impaired kidney function with serum creatinine above or equal to 133 µmol/l (1.5 mg/dl) for males and above or equal to 124 µmol/l (1.4 mg/dl) for females. (one re-test within one week of screening visit is allowed. the last sample will be conclusive.) * cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg) * previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * known proliferative retinopathy or maculopathy requiring treatment
efficacy of vitamin d2 to treat chronic kidney disease mineral and bone disorder

Conditions: Vitamin D Deficiency

Summary: it is hypothesised that the efficacy and safety of vitamin d2 soft capsule to treat the chronic kidney disease mineral and bone disease (ckd-mbd) are equal to 1,25(oh)2 vitamin d3 (rocaltrol) in the patients with ckd stage 3-5.

this study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (ckd-mbd)as defined by kidney disease improvement global outcome (kdigo) guidelines. patients in one center will be randomized to receive oral vitamin d2 soft capsule or rocaltrol. a total of 200 patients will be enrolled, 100 in the vitamin d2 group and 100 in the 1,25(oh)2 vitamin d3 group. outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin d. other outcomes will also be assessed, which include secondary hyperparathyroidism (shpt), vascular calcification, and cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * patients with age between 18-75 years. * patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder. exclusion criteria: * renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system. * new fracture in last 3 months. * active system immunity diseases. * history of liver failure * history of intestinal malabsorption or chronic diarrhea * treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin d metabolism * primary hyperparathyroidism * treatment with cinacalcet or other calcimimetic within the past 6 months * anticipated dialysis within 6 months after randomization * have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator * subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s). * current treatment with vitamin d 50,000 iu * using glucocorticoid or immunosuppressive agents. * acute renal dysfunction. * the expected live time is less than 2 years. * pregnant or lactating woman. * suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months. * patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Keywords: chronic kidney disease mineral and bone disorder vitamin d2 parathyroid hormone
survey on patient satisfaction rate for mirena use in heavy menstrual bleeding

Conditions: Menorrhagia

Summary: the purposes of this study are: * to evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by mirena. * to collect italian data for mirena in clinical routine.


Eligibility criteria:
inclusion criteria: * women diagnosed with idiopathic menorrhagia and mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. these women should also accept to be on contraception during the time period that they have mirena in situ * body mass index = 18-30 exclusion criteria: * one or more of the following disorders: current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product * nulliparity * consumption of iron, antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study. * history of diabetes mellitus, cardiovascular disease and thyroid abnormalities * anticoagulation therapy * cancer history including breast cancer
regional anesthesia for lower extremity surgery

Conditions: Erector Spinae Plane Block; Lower Extremity Surgery; Sciatic Nerve Block

Summary: in this study, patients who underwent osteosynthesis with plate via standard anterolateral incision due to proximal tibia fracture in the orthopedic clinic within the last year; those who underwent perioperative anesthesia with spinal block, those who underwent postoperative analgesia with ultrasound-guided popliteal sciatic nerve block, lumbar-sacral erector spine plane block combinations in the recovery unit will be identified and their files will be scanned retrospectively. gender, surgical duration, postoperative block, pre-post block pain levels will be reviewed via visual analog scale scoring, postoperative analgesics consumed and their amounts, bromage scale, mobilization times, block-related complications, satisfaction levels will be determined and these two groups of patients who underwent block will be compared in terms of analgesia, complications, and satisfaction.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 * patients undergoing spinal anesthesia * patients undergoing postoperative erector spinae plane block * patients undergoing postoperative sciatic nerve block exclusion criteria: * pregnant patients * patients who cannot be contacted * patients who have undergone perioperative general anesthesia * patients with a history of cerebrovascular disease * patients with data loss * patients who did not receive consent

Keywords: sacral erector spinae plane block lower extremity surgery lumbar erector spinae plane block sciatic nerve block
vaginal cleansing before cesarean delivery to reduce infection

Conditions: Complications; Cesarean Section

Summary: the purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

cesarean delivery is the most common surgical procedure performed on women in the us; nearly 1.3 million are performed each year. postoperative infectious morbidity is the most common complication of cesarean delivery. post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. thus, reducing vaginal microbial load may reduce post-cesarean infection. however, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed. the investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Eligibility criteria:
inclusion criteria: * women undergoing cesarean delivery after labor at barnes-jewish hospital. exclusion criteria: * inability to obtain consent * known or suspected allergy to iodine or shellfish * women with active herpes simplex virus infection

Keywords: cesarean section wound infection vaginal cleansing endometritis
radiotherapy of tongue cancer using an intraoral stent

Conditions: Tongue Cancer

Summary: radiotherapy of tongue cancer is associated with acute and late morbidity. use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. the aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.

radiotherapy of tongue cancer is associated with acute and late morbidity. use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. the main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. a secondary objective is to measure the reduction in acute mucositis in the palate. the intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. the intervention group and control group will consist of approximately five patients each. target coverage will be measured by the minimum dose covering 98% of the clinical target volume (d98ctv). dose to the organs at risk (hard and soft palate) will be measured by the mean dose. data will be collected from the planning computed tomography (ct) and daily cone-beam ct (cbct). acute mucositis will be scored by common terminology criteria for adverse events (ctcae) v3.0.

Eligibility criteria:
inclusion criteria: * patients with tongue cancer * curatively intended radiotherapy requiring a total dose of 50-70 gy * age \>18 years * performance status, eastern cooperative oncology group (ecog) 0-2 exclusion criteria: none

Keywords: radiotherapy head and neck cancer intraoral stent
effectiveness study of nivolumab compared to placebo in prevention of recurrent melanoma after complete resection of stage iib/c melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of stage iib/c melanoma with no evidence of disease (ned) who are at high risk for recurrence.


Eligibility criteria:
inclusion criteria: * had a negative sentinel lymph node biopsy * participant has not been previously treated for melanoma * ecog 0 or 1 * participants must have been diagnosed with histologically confirmed, resected, stage iib/c cutaneous melanoma exclusion criteria: * history of ocular or mucosal melanoma. * pregnant or nursing women * participants with active known or suspected autoimmune disease * known history of allergy or hypersensitivity to study drug components * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, anti-ctla-4 antibody, or agents that target il-2 pathways, t-cell stimulators, or checkpoint pathways other protocol defined inclusion/exclusion criteria apply.
what is the optimal follow-up for patients with systemic sclerosis?

Conditions: Systemic Sclerosis

Summary: systemic sclerosis (ssc) is a complex multisystem rheumatic autoimmune disease. currently, evidence based guidelines for frequency and intensity of follow-up of ssc patients are not available. based on expert consensus annual extensive evaluation is recommended. to provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the "leiden combined care in ssc (cciss) pathway" was started in 2009. data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. therefore there is a need for tailor made care in ssc patients in accordance to disease activity. to enable this, a prediction model was developed that can identify patients with low risk for disease progression.

objectives: to evaluate in ssc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the care pathway. outcome parameters we will evaluate include 1) health care utilization, 2) patients' perception of the disease and delivery of care, 3) health-related quality of life and 4) disease progression. health care utilization as primary outcome is defined as number of contacts with heath care providers during 12 months. study population: patients with a clinical diagnosis of ssc that participated in the combined care in systemic sclerosis cohort from leiden university medical center (lumc), or in the comparable care pathway of the haga hospital and haaglanden medical center (hmc), and that have had at least two care pathway evaluations are eligible to participate in this study.

Eligibility criteria:
inclusion criteria: 1. participation in the prospective haga, hmc or lumc cohort 2. clinical diagnosis of ssc 3. age of ≥18 years 4. \>= two evaluations in the care pathway 5. low or intermediate risk for disease progression according to the prediction model 6. written informed consent exclusion criteria: 1. patients with ssc who are part of ongoing (randomized) trials 2. patients who have had an autologous stem cell transplantation in the past five years 3. patients with ssc who were categorized as high risk for disease progression according to the prediction model.

Keywords: prediction model systemic sclerosis value based health care
effects zulresso on postpartum psychosis

Conditions: Postpartum Psychosis

Summary: this is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. this study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression.

this is a single site, open label study design to evaluate the efficacy, safety and tolerability of zulresso in female subjects diagnosed with postpartum psychosis. participants will be consented, and if possible, participation will be discussed with available family members. participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an ekg to determine eligibility. if eligible, participants will be admitted in-patient to unc hospitals and administered a continuous 60-hour infusion of zulresso using the approved fda rems protocol for postpartum depression. a target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. monitoring will occur for an additional 12 hours after the infusion. the subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90.

Eligibility criteria:
inclusion criteria: * all participating subjects sign an informed consent form; * age 18-45 years old; * onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning; * clinician diagnosis of affective psychosis or mania; * ≤12 months postpartum at screening exclusion criteria: * positive pregnancy test at screening or day 1; * recent pregnancy did not result in a live birth; * subject is in renal failure; * subject is in hepatic failure; * subject is anemic (hemoglobin ≤10 g/dl); * untreated or inadequately treated hypothyroidism or hyperthyroidism; * history of schizophrenia, and/or schizoaffective disorder; * current/active alcohol or drug abuse
comparison of cilostazol-based triple antiplatelet therapy versus dual antiplatelet therapy for outcomes of below-the knee endovascular intervention in patients with critical limb ischemia (tap cli study)

Conditions: Critical Limb Ischemia

Summary: * prospective, randomized, controlled, multi-center study * a total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria. * patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (tap: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (dap: aspirin, clopidogrel) a group, or dap (aspirin, cilostazol) b group. * all patients will be treated with angioplasty for critical limb ischemia. * patients will be followed clinically for 1 year after the procedure. * ankle-brachial index and image study follow-up (duplex us or ct angiography) will be performed at 1 year.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * patients with critical limb ischemia (rutherford 4 \& 5) * successful below-the knee endovascular intervention. exclusion criteria: * major bleeding event within recent 3 months or high risk of major bleeding * patients requiring anticoagulation * allergic reactions to antiplatelet drugs * acute limb ischemia * severe hepatic dysfunction (3 times normal reference values) * pregnant women or women with potential childbearing * life expectancy \< 1 year due to comorbidity * previous amputations in the target limb

Keywords: peripheral artery disease critical limb ischemia angioplasty antiplatelet therapy