Kornimate/medical-research-clean huggingface dataset:
triple artemisinin-based combination therapy for delaying drug resistance development - a randomized clinical trial

Conditions: Uncomplicated Plasmodium Falciparum Malaria

Summary: background: artemisinin resistance has emerged in parts of southeast asia, and there are reports in africa of reduced susceptibility of plasmodium falciparum parasites against artemisinin-based combination therapy (act). no new drugs are available in the pipeline to replace acts in case they fail. this study aims to assess whether a sequential administration of triple acts with different partner-drugs can improve the efficacy of act for treatment of uncomplicated malaria. methods: a health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (al+asaq) or artemether-lumefantrine with by amodiaquine (al+aq) compared to artemether-lumefantrine plus placebo (al+pbo). eligible children aged 6 - 120 months and with microscopy confirmed uncomplicated p. falciparum malaria will be enrolled, administered with trial medicines and followed-up at 0 (just prior to first drug intake) and 8 hours on day 0, 12 hourly on days 1, 2, 3, 4, 5, followed by once daily on days 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28, 35, 42 and 56 for clinical and laboratory evaluations. clinical evaluation will involve assessment of signs and symptoms related to the disease and or trial medicine during follow-up. laboratory evaluation will include microscopic determination of presence of malaria parasites and species, hemoglobin level, molecular analysis for markers of drug resistance and to differentiate recrudescence from new infection. the primary outcome will be polymerase chain reaction (pcr)-adjusted adequate clinical and parasitological cure rate on days 28 and 42. expected outcomes: the findings will give an insight on whether 3 acts are more efficacious than the use of first-line regimen alone, and are tolerable for treatment of uncomplicated falciparum malaria.


Eligibility criteria:
patients presenting at the health facility with suspected acute uncomplicated malaria will be screened for eligibility. inclusion criteria: * age from 6 - 120 months * weight ≥ 5 kg * body temperature ≥37.5°c or history of fever in the last 24 hours * microscopy confirmed p. falciparum mono-infection * parasitemia level of 1000-200000/μl * ability to swallow oral medication * ability and willingness to abide by the study protocol and the stipulated follow-up visits * a written proxy informed consent from a parent/guardian exclusion criteria: * children aged below 6 months will not be included in the study because acts are contraindicated in this group. * evidence of severe malaria or danger signs * known allergy to trial medicines * reported antimalarial intake ≤2 weeks * haemoglobin \<5 g/dl * blood transfusion within last 90 days * febrile condition other than malaria * known underlying chronic or severe disease (including severe malnutrition).

Keywords: artemisinin-based combination therapy plasmodium falciparum uncomplicated malaria
single autologous stem cell transplantation followed by maintenance therapy as front-line treatment for myeloma

Conditions: Multiple Myeloma

Summary: the clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (vad) or thalidomide/dexamethasone between 18 to 65 years.

this is an open label clinical trial to evaluate the efficacy of single autologous hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. all patients will receive 4-6 cycles of induction therapy which includes vad chemotherapy (vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. after peripheral hematopoietic stem cell mobilization and apheresis, patients will receive a standard conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at 100-200mg orally daily starting from d+60 till disease progression or untolerable toxicity.

Eligibility criteria:
inclusion criteria: * man or woman between age 18-65 with newly diagnosed multiple myeloma for whom stem cell transplantation is considered appropriate * measurable serum and/or urinary paraprotein * european cooperative oncology group performance status 0-3 * serum bilirubin \< 1.5x the upper limit of normal (uln) * serum alanine transaminase (alt)/aspartate transaminase values \< 2.5 x uln * subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * woman of child bearing potential * non-secretory mm * serum creatinine \> 400 micromol/l after initial resuscitation * patients with previous grade 2-4 peripheral neuropathy * uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug * uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or iii-iv heart failure

Keywords: autologous hematopoietic stem cell transplantation maintenance
effect of the "sitting out of bed in an arm-chair position" in icu on functional recovery among ventilated patients

Conditions: ICU Acquired Weakness

Summary: chair positioning is one of a series of early mobilization techniques. at present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. it does not constitute a rehabilitative act as such, but it is considered in common paradigms as a technique to improve "the patient's breathing and strength". however, recommendations issued in 2013 by the society of intensive care physiotherapy and the society "société de réanimation de langue française (srlf)", reveal that this chair position cannot be recommended with a high grade. the aim of the investigators is therefore to break down this early mobilization process in intensive care, to find out whether the armchair is an indispensable tool for improving functional and muscular processes. the research hypothesis is therefore as follows: "early armchairing of the resuscitation patient, improves functional recovery compared to a conservative positioning strategy (sitting in bed)."


Eligibility criteria:
inclusion criteria: 1. patient \> 18 years old 2. patient on invasive mechanical ventilation for more than 24 hours 3. patient in recovery phase with a rass score greater than "-3" for more than 12 hours 4. stay expected to last 72 hours 5. patient has never been placed in a chair during this hospitalization in intensive care. 6. fragility score \< 6, during the month preceding admission to intensive care 7. patient (or support person/relative if patient is unable to participate) who has agreed to take part in the study. exclusion criteria: 1. patient with an absolute and non-resolving contraindication to chair positioning 1. fracture or orthopedic disorder contraindicating mobilization out of bed 2. obesity with body mass index greater than 45 kg/cm2 3. sacral eschar stage greater than 2 2. patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology). 3. patient treated with veno-venous or veno-arterial ecmo at the time of screening. 4. moribund patient 5. encephalic death 6. acute polyradiculoneuritis (guillain-barré syndrome) 7. myasthenia 8. patient treated by continuous hemodialysis or hemofiltration for more than 72 hours following the onset of awakening. 9. complete transmetatarsal or higher amputation of one or both lower limbs. 10. protected person (under guardianship or curatorship) 11. person under court protection 12. person not affiliated to a social security scheme 13. pregnant or breast-feeding woman 14. patient already included in the study 15. patient taking part in an interventional clinical study, the aim of which is to show an improvement in functional level on discharge from the intensive care unit or which focuses on the theme of early rehabilitation in the intensive care unit.

Keywords: mechanical ventilation icu acquired weakness arm chair sitting early mobility
treatment of corneal wounds emergencies during the covid-19 shutdown: absorbable 10-0 vicryl sutures as a valuable strategy.

Conditions: Eye Trauma

Summary: vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a covid-19 pandemic. this has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. the aim of this study is to evaluate the vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.


Eligibility criteria:
inclusion criteria: * corneal penetrating injury and/or lamellar laceration exclusion criteria: * corneal penetrating injury trauma requiring necessarily only nylon 10-0 * traumatism requiring necessarily a cryopreserved human amniotic membrane (for example) * traumatism eligible for biological glue (long-axis wound \< 2 mm)

Keywords: corneal penetrating injury lamellar laceration covid polyglactin vicryl
district-based mainstreaming nutrition project in rural pakistan

Conditions: Malnutrition

Summary: this study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the national program for family planning and primary health care (lhw program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.

this project aims to do the following: * to evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the national program for fp/phc (lhw program) * impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district

Eligibility criteria:
inclusion criteria: * live born infants and young children from all registered pregnancies within participating villages and catchment population * pregnant women * consent given by at least one of the parents exclusion criteria: * children born with congenital malformations or serious birth injury * suspected non-compliance (mobile and poorly motivated parents). * failure to give consent

Keywords: malnutrition growth
evaluation of hydration status when consuming alkaline water compared to reverse osmosis purified water.

Conditions: Hydration

Summary: to conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.

a randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. the study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.

Eligibility criteria:
inclusion criteria: * adult people of either gender; * age 18 - 65 years (inclusive); * bmi between 18.0 and 34.9 (inclusive); * screening results showing at least one of the following: * hematocrit: women: 45.0 or higher; men: 48.7 or higher; * bun/creatinine ratio 20 or higher; * sodium levels 146 mmol/l or higher; * potassium levels 5.3 mmol/l or higher; * chloride levels 108 mmol/l or higher. * willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study; * willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour prior to a clinic visit; * willing to abstain from alcohol for at least 12 hours prior to a clinic visit; * willing to maintain a consistent habit of abstaining from exercising and nutritional supplements on the morning of a study visit. exclusion criteria: * cancer during past 12 months; * chemotherapy during past 12 months; * significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). * previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\]; * implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (icd); * currently experiencing peripheral edema in legs and /or feet; * diagnosed with any blood clotting disorder or taking clotting factor concentrates; * diagnosis of peripheral artery disease; * diagnosis of varicose veins; * currently taking blood pressure medication; * currently taking blood thinning medication (81mg aspirin allowed); * currently taking diuretic medication; * currently taking nutritional supplements and other substances judged by the study coordinator to negate or camouflage the effects of the test product; * women who are pregnant, nursing, or trying to become pregnant.
protein supplementation in infants with brain injury

Conditions: Perinatal Stroke; Hypoxic-ischemic Encephalopathy; White Matter Injury

Summary: to date, few studies have been done regarding nutrition supplementation in infants with brain injury. therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. the investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the cincinnati children's hospital neonatal intensive care unit (nicu) into the study. upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation. protein supplementation will continue for the first 12 months of age. growth parameters, such as weight, length, and head circumference, will be measured while the infant is the nicu. head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. at 18-22 months, the infants will be tested for neurodevelopmental outcomes using the bayley scales of infant development. the investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.


Eligibility criteria:
inclusion criteria: * infants admitted to the nicu at cchmc * known or suspected brain injury * parental consent obtained * at least 48 hours of age at the time of randomization exclusion criteria: * congenital or posthemorrhagic hydrocephalus * major congenital brain malformations * congenital gastrointestinal malformations or bell stage iii nec * inborn errors of metabolism * chromosomal abnormalities * significant cardiac disease
role of bladder training during post-operative hospital stay after radical hysterectomy in patients

Conditions: Uterine Cervical Neoplasms

Summary: the objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.


Eligibility criteria:
inclusion criteria: - women who underwent querleu-morrow class b2 and class c1 rh were enrolled in this randomized prospective study. exclusion criteria: -all the patients with preoperative urinary dysfunctions were excluded by study. other exclusion criteria were surgery of lower urinary tract and psychiatric disease.

Keywords: bladder training, radical hysterectomy,gynaecologic cancer
comparison of the effect of two anaesthesia methods in preventing perioperative myocardial infarcation in patients with cardiac risk undergoing total knee arthroplasty

Conditions: Myocardial Ischaemia

Summary: comparison of the effect of two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty

we enrolled 50 patients of both sex of american society of anesthesiologists (asa) physical status ii where the presence and/or risk for coronary artery disease (cad) as well as planned lower extremity surgery was considered. presence of cad was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ecg finding. risk for cad included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dl), and diabetes. who met the selection criteria were randomly allocated to 1 of the 2 groups (25 patients) each: * group (g): received general anaesthesia followed by iv patient-controlled analgesia (iv pca). * group (f): received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved. we aimed to compare the effect of the two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty. the primary outcome included perioperative levels of brain natriuretic peptide \& cardiac troponins. secondary outcomes included postoperative operative pain assessment using visual analogue scale, total amount of analgesic consumption, patient satisfaction \& cardiovascular complications (myocardial infarction, arrhythmias , heart failure, hypotension, hypertension \& the need for inotropic agents).

Eligibility criteria:
inclusion criteria: * presence and/or risk for coronary artery disease (cad) as well as planned lower extremity surgery was considered. presence of cad was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ecg finding. risk for cad included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dl), and diabetes. exclusion criteria: * 1) severe impairment of left ventricular function (ejection fraction \< 40 %). 2) renal failure requiring hemodialysis. 3) known allergies to the drugs used in the present study. 4) contraindications to regional blocks (localized infection, and use of an antiplatelet drug within 3 days before the surgery). 5) unusual blood coagulation tests.
cardiovascular effects of metformin on obesity

Conditions: Insulin Resistance

Summary: it has been shown that asymptomatic obese adolescents can demonstrate abnormal regional myocardial contraction, with preserved global cardiac function. metformin has been shown to decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance, but the mechanism of cardiovascular protection is unknown. the purpose of this study is to evaluate the reversibility of subclinical cardiovascular abnormalities in obese adolescents with insulin resistance after a six-month course of metformin. the investigators hypothesized that the beneficial effects of metformin will be progressive and sustained after six months of therapy.


Eligibility criteria:
inclusion criteria: * adolescents 12 to 17 years old under clinical care at the ucsf watch clinic * body mass index\> 95th percentile for age and gender according to the centers for disease control and prevention 2000 growth charts for the united states * insulin resistant after 6 months of healthy diet and exercise * able to understand the assent form exclusion criteria: * patients with known cardiac disease * patients with contraindications to metformin as listed below: * renal disease or renal (serum creatinine levels ≥1.5 mg/dl for males, and ≥1.4 mg/dl for females; * known hypersensitivity to metformin; * acute or chronic metabolic acidosis; * patients with contraindications to mri including: * cardiac pacemaker; * claustrophobia; * metallic foreign body in the eye, * aneurysm clip in the brain * pregnancy; * patients who could not stay still for 30 minutes within the mri scanner due to other reasons besides claustrophobia

Keywords: metformin insulin resistance cardiac function
parenting concerns in patients with cystic fibrosis (mucopar)

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to explore and collect the perceptions, expectations and needs of cf patients about parenting. this will be done in the context of several small groups of patients led by a psychologist who will ensure that all the participants express themselves; he will encourage them to develop their points of view, their divergences and their common points about what constitutes to be a parent. the collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations

life expectancy has improved significantly in cystic fibrosis in recent years. from paediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. parent patients still face the risk of complications and death while their child is still young. however, there is very little data in the literature on parenting in cystic fibrosis. therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of cf patients and their spouses about parenting. all patients with children, followed in 2 large adult cf centers, and their spouses will be invited to participate in a 6 to 10-person discussion group (focus group) led by a psychologist. he will ensure that all the participants express themselves and are encouraged to develop their points of view, their divergences and their common points about what constitutes to be a parent. the discussions will be recorded and transcribed. patients who cannot participate in groups (e.g. patients colonized with burkholderia cepacia complex) but wish to be included in the study will benefit from an individual interview with the psychologist, also registered and transcribed. a thematic analysis will be carried out from the transcriptions of group contents. for individual interviews, phenomenological interpretative analysis (ipa) will be used. a synthesis of the two analyses will then be done. the collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Eligibility criteria:
inclusion criteria: for patients * have cystic fibrosis * be a parent and raise or have raised at least one child * being followed in one of the two adult cf centers participating in the study for cf patients' spouses - live with the cf patient participating in the study for both cf patients and spouses * being an adult (at least 18 y.o.) * have a good level of french and good speaking skills exclusion criteria: * for both cf patients and spouses * psychiatric pathology (borderline state, bipolarity and other psychotic disorders) * serious somatic disease not related to cystic fibrosis

Keywords: cystic fibrosis parenthood psycho-social qualitative study