Kornimate/medical-research-clean huggingface dataset:
evaluation of fosmidomycin and piperaquine in the treatment of acute falciparum malaria

Conditions: Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria

Summary: the objective of this study is to explore the role of fosmidomycin and piperaquine as non-artemisinin-based combination therapy for acute uncomplicated plasmodium falciparum when administered over three days. together, fosmidomycin and piperaquine fulfil the who criteria for combination therapy by meeting the three key parameters of having different modes of action and different biochemical targets while exhibiting independent blood schizonticidal activity. like the artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active against existing drug-resistant parasites. piperaquine has a long half life protecting fosmidomycin as a much shorter lived molecule against selection of resistant parasites and will provide post-treatment prophylaxis.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 1 to 60 years inclusive * body weight between 5kg and 90kg inclusive * acute manifestations of a mono-infection with plasmodium falciparum as determined by either a rapid diagnostic test for adults or microscopically confirmed by an asexual parasitaemia of 1,000 to 150,000/ul and fever with an axillary temperature of \> 37.5 degress c or oral/rectal/tympanic temperature of \> 38.0 degrees c or history of fever during the previous 72 hours * compliance with contraceptive measures throughout the study period of 63 days in females of child bearing potential exclusion criteria: to be eligible for inclusion in the study, subjects must not meet any of the following criteria: * signs of severe/complicated malaria according to who criteria * pregnancy as excluded by negative serum human chorionic gonadotrophin (hcg) test * lactation * mixed plasmodium infection * severe vomiting on three or more occasions in the previous 24 hours * severe diarrhoea on four or more occasions in the previous 24 hours * concomitant disease masking assessment of response including * abnormal liver function tests with bilirubin \> 40 µmol/l, aspartate aminotransferase (asat) and alanine aminotransferase (alat) levels \> x 2 upper limit of normal * impaired renal function with creatinine level \> x 2 upper limit of normal * haemoglobin level \< 7.5g/dl * white cell count \> 12000/µl * history of cardiovascular disease including arrhythmia with qtc interval ≥ 450msec, respiratory disease including active tuberculosis, hepatic disease including jaundice, renal failure, malignancy, neurological disorders including convulsions and psychiatric disturbances * history of immunological disease including hepatitis a, b and c and hiv-aids * severe malnutrition * history of hypersensitivity or adverse reactions to fosmidomycin, piperaquine, artesunate and mefloquine * treatment with antimalarial and antibacterial agents within the previous 28 days
rosuvastatin/amlodipine vs atorvastatin/amlodipine in hypertension patient with dyslipidemia

Conditions: Dyslipidemias; Hypertension

Summary: this study is to compare the efficacy and safety of rosuvastatin/amlodipine combination therapy versus atorvastatin/amlodipine combination therapy in hypertension patient with dyslipidemia


Eligibility criteria:
inclusion criteria: * both man and woman who is over 19 years old * patient with dyslipidemia and hypertension * written informed consent exclusion criteria: * triglyceride ≥ 400 mg/dl at screening * hypertensive patients who need antihypertensive medication except amlodipine, β-blockers, ras inhibitors * ssbp difference is ≥20 mmhg or sdbp difference is ≥10 mmhg * a history of rhabdomyolysis, myopathy * patient with hypersensitivity to statin or amlodipine * patients undergoing egfr \<30 ml/min/1.73 m2 (mdrd) at screening * ast(aspartate aminotransferase) or alt(alanine aminotransferase) level ≥ 3x uln (upper limit of normal range) or active liver disease * creatine kinase (ck) level ≥ 5x uln (upper limit of normal range) * contraindications stated in the label of rosuampin or caduet * those participating in other clinical trials for investigational products at screening * patients deemed to be ineligible to participate in the trial by investigator
somatosensory evoked potential (ssep) monitoring for detection of intraoperative positional neuropraxia

Conditions: Peripheral Nerve Injuries; Thoracic Surgery

Summary: pni (peripheral nerve injury) occurs in 5-15% of patients in cardiac surgery. so far, the mechanism of injury has never been researched. in this study, we will compare minimally invasive cardiac surgery with conventional cardiac surgery using a novel portable ssep device to pinpoint the mechanism and timing of pni during cardiac surgery.

general objectives the general objective of this study is to identify the causative insults during various kinds of cardiac surgeries. to attain this objective, we have three specific aims. firstly, surgical insults such as excessive or asymmetric sternal retraction have long been regarded as the main causes of pni. therefore, we will investigate this by comparing cardiac surgeries with sternotomy to the ones without sternotomy. secondly, more and more cardiac surgeons utilize minimally invasive techniques these days. in the current study, we will investigate the incidence, mechanisms and patterns of pni in minimally invasive cardiac surgeries by comparing conventional surgeries to minimally invasive surgeries. thirdly, recent studies have suggested systematic insults such as ischemia, inflammation, and underlying neuropathy might play more prominent roles in the mechanism of pni. in this study, we will analyze various factors such as intraoperative hemodynamics and baseline patient characteristics to pinpoint the most responsible factors. background the studies regarding mechanisms of pni in cardiac surgeries have not been done over the past few decades. with respect to minimally invasive cardiac surgeries, no studies have been done to investigate the mechanism of pni. regarding the device used in this study the conventional ssep device is large in size, invasive, and requires expertise to interpret. these characteristics have prevented its use in the operating room. this new portable ssep device is devoid of these properties. significance identification of causative insults will help clinicians to recognize and possibly prevent pni during cardiac surgeries.

Eligibility criteria:
inclusion criteria: ●all adult (age\>18, \<95 years of age) cardiac surgical patients who are undergoing the four following procedures, open avr, tavi, conventional cabg, robotic cabg exclusion criteria: * any patients with contraindication to ssep monitoring, which include skin burns or trauma at ssep electrode sites * lack of written consent * emergency surgery * language barrier * fluctuating neurological signs/symptoms * regional anesthesia (spinal, epidural, nerve block) * cabg with radial artery harvest, combined cardiac surgeries

Keywords: peripheral nerve injuries thoracic surgery minimally invasive cardiac surgery
a study to evaluate aln-agt01 in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) effects of subcutaneous (sc) aln-agt01 (zilebesiran) in participants with hypertension. the study will be conducted in 4 parts: part a will be a single ascending dose (sad) phase in hypertensive participants, part b will be a single dose (sd) phase in hypertensive participants with controlled salt intake, part d will be a md phase in hypertensive participants who are obese, and part e will be an open-label sd phase with co-administration of irbesartan in hypertensive patients.


Eligibility criteria:
inclusion criteria: * has mild to moderate hypertension with mean sitting systolic blood pressure (sbp) of \>130 and ≤165 mmhg without hypertensive medication for parts a, b and d, and \>135 and ≤165 mmhg without hypertensive medication for part e * parts a and b: has body mass index (bmi) ≥18 and ≤35 kg/m\^2; part d: has bmi \>35 and ≤50 kg/m\^2; part e: has bmi ≥18 kg/m\^2 and ≤50 kg/m\^2 * has a normal 12-lead electrocardiogram (ecg) * is a nonsmoker exclusion criteria: * has secondary hypertension * has orthostatic hypotension * has estimated glomerular filtration rate (egfr) of \<60 ml/min/1.73m\^2 * recently received an investigational agent * has diabetes mellitus * has history of any cardiovascular event * has history of intolerance to sc injection(s)
percutaneous kirschner wires with mutual linking technique in the management of proximal humeral fracture

Conditions: Proximal Humeral Fractures

Summary: this is study evaluates a novel technique to improve the stability of k-wires used in the fixation of proximal humeral fractures


Eligibility criteria:
inclusion criteria: * both sexes * age from 60 to80 years * 2 or 3 parts fracture * recent injury less than 3 weeks exclusion criteria: * 4 parts fracture * old injury more than 3 weeks * previous surgeries or pathologies affecting shoulder range of motion

Keywords: proximal humeral fractures mutual linking
a study of al101in patients with adenoid cystic carcinoma (acc) bearing activating notch mutations

Conditions: Adenoid Cystic Carcinoma

Summary: this is a phase 2, non comparative, open label, multicenter study of al101 in patients with recurrent or metastatic acc who harbor notch 1,2,3,4 activating mutations.

this is a phase 2, non-comparative, open-label, multicenter study of al101 in patients with recurrent or metastatic acc who harbor notch 1,2,3,4 activating mutations. the study includes 2 cohorts, ran in a sequential fashion: cohort 1 - al101 4 mg once weekly (qw) intravenously (iv) cohort 2 - al101 6 mg qw iv

Eligibility criteria:
inclusion criteria: 1. confirmed adenoid cystic carcinoma with known notch 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy. 2. evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed. 3. patients must have formalin-fixed, paraffin-embedded tissue available . 4. must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis. exclusion criteria: 1. diagnosed with a malignancy other than acc in the past 2 years. 2. uncontrolled, active infection 3. gastrointestinal (gi) disease with increased risk of diarrhea \[e.g. inflammatory bowel disease (ibd)\] 4. symptomatic central nervous system (cns) metastases. 5. unstable or severe uncontrolled medical condition 6. eastern cooperative oncology group (ecog) performance status ≥2. 7. abnormal organ and marrow function
fluid challenge impact in the portal vein pulsatility depending on the fluid responsivness status

Conditions: Cardiovascular Insufficiency; Venous Congestion

Summary: portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. it is associated with acute kidney injury, especially in critically ill patients. it may be considered as a dynamic marker. the investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.


Eligibility criteria:
inclusion criteria: * vasopressor requirement to maintain mean arterial pressure \>65mmhg and * at least one of the following criteria: * arterial lactate \>2mmol/l; * capillary refill time \>3s; * mottling score \>1; * diuresis \<0,5ml/h for more than 6hours. exclusion criteria: * diameter of vena cava \<20mm * cirrhosis * pregnancy * severe acute pulmonary edema * phototype 4 or 5 * patient opposition to participate

Keywords: point of care ultrasound portal vein pulsatility index venous congestion preload dependence
sitosterolemia extension study (0653-003)(completed)

Conditions: Lipid Metabolism, Inborn Errors; Heart Disease

Summary: this is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. this study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

the duration of treatment is 52 weeks.

Eligibility criteria:
inclusion criteria: * patients with elevated sitosterol levels while taking current medication exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Keywords: homozygous sitosterolemia
energy specific far infrared radiation treatment for sciatica

Conditions: Sciatica

Summary: a preliminary study to determine the use of far infrared radiation for the treatment of back pain

sciatica is created by joint misalignment, muscle spasm and inflammation. generally, sciatica is a combination of lower back pain, pain radiating into the buttock and possibly down the leg. far infrared radiation of the sciatic nerve, coupled with the stretching of the spinal cord, is a promising non-invasive method for treating sciatica.

Eligibility criteria:
inclusion criteria: * persons with lower back pain exclusion criteria: * none

Keywords: neuralgia, sciatic sciatic neuralgia sciatica, bilateral lower back pain
effect of fluoride varnish and cpp-acp on oral and salivary symptoms during chemotherapy

Conditions: Mucositis; Dry Mouth; Infection

Summary: the purpose of this study was to investigate the effect of fluoride varnish and casein phospho-peptide amorphous calcium phosphate (cpp-acp) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy.

chemotherapy as a treatment method of cancers, affects different parts of the oral cavity such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during chemotherapy.oral status of patients under chemotherapy will be affected by consumption of the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity, changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues, xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. no effective preventive protocol has been presented for oral care during chemotherapy. patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic lesion in their oral cavity, were not treated by radiotherapy and did not have specific systemic diseases or head and neck cancer) were selected for the study. the participants were evaluated according to oral and salivary symptoms.

Eligibility criteria:
inclusion criteria: * to have cancer (in the first stage of their treatments) * to have at least 20 teeth, * age over 12 exclusion criteria: * to have pathologic lesion in the oral cavity * being under radiotherapy * to have specific systemic diseases * to have head and neck cancer

Keywords: fluoride varnish cpp-acp paste dry mouth burning sensation chemotherapy
safety study of igan, ln, mn, & c3 glomerulopathy including dense deposit disease treated with oms721

Conditions: IgAN; Lupus Nephritis; MN; C3 Glomerulopathy

Summary: the purpose of this study is to evaluate the safety and tolerability of oms721 (narsoplimab) in subjects with immunoglobulin a nephropathy (igan), lupus nephritis (ln), membranous nephropathy (mn), and complement component 3 (c3) glomerulopathy including dense deposit disease. the study will also evaluate pharmacokinetics (pk), pharmacodynamics (pd), anti-drug antibody response (ada), and neutralizing antibodies (nab) of oms721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of asian descent with iga nephropathy.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at screening and competent to provide informed consent; for cohort 4 only, participants are of asian descent * have a diagnosis of one of the following: 1. igan on kidney biopsy 2. ln, mn and c3 glomerulopathy including dense deposit disease on kidney biopsy and 24-hour urine protein excretion (upe) \> 1000 mg/24 hours (for cohort 1 only) 3. igan diagnosis is confirmed by biopsy within 8 years of screening for asian descent (for cohort 4 only) * for cohort 4 only: subjects with igan of asian descent, documented history of 24-hour upe \> 1 g within 6 months prior to screening or urine protein-creatinine ratio (upcr) \> 0.75 by spot urine at screening * screening estimated glomerular filtration rate (egfr) \>= 30 ml/min/1.73 m\^2 * are on physician-directed, stable, optimized treatment with angiotensin converting enzyme inhibitors (acei) and/or angiotensin receptor blockers (arb) and have a systolic blood pressure of \< 150 mmhg and a diastolic blood pressure of \< 90 mmhg at rest exclusion criteria: * have a hemoglobin less than 9.0 g/dl * have a platelet count =less than 100,000/mm\^3 * have an absolute neutrophil count \<500 cells/mm\^3 * have an alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 5.0 x the upper limit of normal (uln) * have systemic manifestations of henoch-schonlein purpura within 2 years prior to screening * have used: belimumab, eculizumab, or rituximab within 6 months prior to screening * have a history of renal transplant * history of human immunodeficiency virus (hiv), evidence of immune suppression, active hepatitis c virus (hcv) infection (subjects with positive anti-hcv antibody * have a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for 5 years or more

Keywords: igan lupus nephritis mn c3 glomerulopathy
surgical treatment for trapeziometacarpal osteoarthritis eaton & glickel stage 2-3

Conditions: Trapeziometacarpal Osteoarthritis; Thumb Carpometacarpal Osteoarthritis

Summary: trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. a relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate. we hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.


Eligibility criteria:
inclusion criteria: * women. * 40 years of age or more. * symptomatic trapeziometacarpal osteoarthritis. * eaton \& glickel stage 2 and 3. exclusion criteria: * an operation for trapeziometacarpal osteoarthritis on the same hand in the past. * participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand. * secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout. * symptomatic carpal tunnel syndrome in same hand. * symptomatic quervain's tenosynovitis in same hand. * neurological or other disorders of the affected side that can influence postoperative rehabilitation. * insufficient knowledge of dutch language.

Keywords: osteoarthritis thumb total joint arthroplasty trapeziectomy
exogenous sodium lactate infusion in traumatic brain injury (eli-tbi)

Conditions: Brain Injuries, Traumatic

Summary: metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (lpr). we have performed preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof of concept that exogenous fuels alter brain metabolism. we will conduct a multicenter, adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels in patients with severe traumatic brain injury to determine safety and efficacy.

metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (lpr). we have performed safety analysis of exogenous sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. animal tbi studies have demonstrated proof of concept for exogenous lactate and pyruvate. we will conduct a multicenter, adaptive design-based, proof of concept biomarker mechanistic safety study of exogenous sodium lactate. the preliminary goal is to determine if exogenous lactate infusion is safe and has a demonstrated effect on selected biomarkers.

Eligibility criteria:
inclusion criteria: * adult patients seen in the medical center emergency department * adult patients transferred to the neurocritical intensive care unit with a physician's diagnosis of brain injury. * gcs 3-12 exclusion criteria: * pregnancy at time of injury * history of diabetes mellitus * history of hemodynamic instability * known terminal illness which alters brain functioning * diagnosed aids progressed to aids dementia * known history of chronic severe neurological disturbance * severe retardation * previous severe diminished mental capacity * no command of either english or spanish * arrest for a felony * active neurologic condition such as stroke, recent tbi * metabolic disorder * preexisting hyperlactatemia * instability precluding experimental intervention

Keywords: brain trauma, metabolic therapy