Kornimate/medical-research-clean huggingface dataset:
intermittent preventive treatment for malaria in infants in navrongo ghana

Conditions: Anaemia; Malaria

Summary: evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through expanded programme on immunisation vaccination clinics.

anaemia is one of the main disease burdens of children in developing countries. severe anaemia is often fatal, while moderate anaemia leads to growth and cognitive disorders. the incidence of anaemia in children is extremely high in malaria endemic areas since episodes of clinical malaria and asymptomatic parasitaemia result in red cell destruction. it has been shown in tanzania that the incidence of severe anaemia in infants can be reduced by 30% by regular administration of iron supplements, and by 60% if regular malaria chemoprophylaxis is given in addition. one way to operationalise this research finding, with minimal additional cost to governments and communities, is to link the distribution of iron and antimalarial drugs to the epi programme. we propose a community-randomised trial to study the effectiveness of intermittent iron supplements and malaria chemotherapy in reducing the incidence of anaemia and clinical malaria, and to investigate any possible interactions of iron and antimalarial drugs with epi vaccines. the study will have two arms: children in both arms will receive monthly supplies of twice weekly iron supplements when they attend epi and growth monitoring clinics. in addition, children in arm 1 will receive a placebo when they receive polio/dpt 2, polio/dpt 3 and measles vaccines, while those in arm 2 will receive sulfadoxine-pyrimethamine (sp). the baseline incidence of anaemia and malaria, and immune response to epi vaccines, will be estimated in a sample of children from a non-intervention area adjacent to the study area. the immune response to epi vaccines, drug side-effects, and the incidence of anaemia and malaria will be compared between the two arms of the study and with the non-intervention area. any possible 'rebound' in malaria incidence due to impairment of immunity will be monitored and treated during the six months after stopping the chemotherapy and supplementation.

Eligibility criteria:
inclusion criteria: * all infants living in study clusters without a history of allergy to sulfadoxine-pyrimethamine were eligible for enrollment in the study. exclusion criteria: * history of allergy to sulfadoxine-pyrimethamine.

Keywords: incidence of anaemia
non-invasive characterization of systemic microvascular reactivity by near-infrared diffuse optical spectroscopy in covid-19 patients

Conditions: COVID-19; Endothelial Function

Summary: the purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill covid-19 patients, and to correlate its alterations with 28-day mortality in icu covid-19 patients.

after giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (sto2) measured non-invasively on the forearm by means of near-infrared spectroscopy (nirs). once a baseline stable sto2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. the test will allow the obtention of a local metabolic rate, and a sto2 recovery rate after the ischemic stimulus. this sto2 recovery rate will be considered as a reflection of the endothelial health of the patient. patients will be studied as soon as possible after admission to the icu, and followed-up until icu discharge or death.

Eligibility criteria:
inclusion criteria: * recent diagnosis of sars-cov2 infection * arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload. exclusion criteria: * severe peripheral vasculopathy * raynaud's syndrome * skin lesions or trauma in upper limbs interfering the placement of nirs probe and/or the occlusion tourniquet * deep venous thrombosis in the upper limbs

Keywords: covid-19
vibrotactile coordinated reset in parkinson's disease - proof of concept study

Conditions: Parkinson Disease

Summary: the purpose of our study is to evaluate vibrotactile coordinated reset stimulation (vcr) and its effects on parkinson's symptoms. vcr will be administered with a device called the stanford glove. vcr is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and/or deep brain stimulation. patients will be followed for 14 months.

the purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.

Eligibility criteria:
inclusion criteria: ages 18 or older * diagnosed with idiopathic parkinson's disease * fluent in english * off-state updrs iii motor score at least 30, as assessed within the past 6 months before study consent or at screening visit. * demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures. exclusion criteria: * participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. any other trial participation should be approved by the principal investigators. * pregnancy, breast-feeding or wanting to become pregnant * physical limitations unrelated to pd that would affect motor ratings * has implantation of a medical device * sensory abnormalities of the fingertips
the effect of dopamine on diabetic retinopathy

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the use of electroretinogram (erg) using a novel handheld system, reteval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device. investigators also seek to assess if a medication called sinemet™ cr can improve the electrical functions of the eye in participants with diabetes mellitus. this study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. participants with diabetes mellitus and electroretinogram (erg) delays will be randomized to a low or high dose sinemet cr group.

the purpose of this study is to evaluate the use of electroretinogram (erg) using a novel handheld system, reteval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device. investigators also seek to assess if a medication called sinemet™ cr can improve the electrical functions of the eye in participants with diabetes mellitus. this study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. participants with diabetes mellitus and electroretinogram (erg) delays will be randomized to a low or high dose sinemet™ ct group. age-matched controls will not receive sinemet ct drug treatment. the study involves four visits over the course of 4 weeks, each visit consisting of 2-3 hours. visual testing will be performed at 1 day and 2 weeks following treatment. the drug treatment will be halted and testing repeated again after a 2 week wash-out period.

Eligibility criteria:
inclusion criteria participants with diabetes mellitus: * diagnosis of diabetes mellitus type-2 * hba1c between 8 and 12% age-matched controls: * non-diabetic exclusion criteria participants with diabetes mellitus: * currently taking dopamine-enhancing drugs (l-dopa, bromocriptine) * currently taking nonselective monoamine oxidase (mao) inhibitors * diagnosis of psychosis, parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa) * pregnancy age-matched controls: * diabetes diagnosis * currently taking dopamine-enhancing drugs (l-dopa, bromocriptine) * currently taking nonselective monoamine oxidase (mao) inhibitors * diagnosis of psychosis, parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa) * pregnancy

Keywords: ophthalmology
cardiometabolic risk factors registry

Conditions: Atherosclerosis; Metabolic Syndrome; Diabetes; Cardiovascular Risk Factor; Cardiovascular Diseases; Obesity

Summary: carfare (cardiometabolic risk factors registry) is a registry done in the context of a cardiovascular primary prevention program of the cardiometabolic unit officia of the cardiology department of the austral university hospital. the structured and sequential evaluation include measurement of anthropometric parameters (body mass index, bmi), laboratory with metabolic profile, baseline electrocardiogram, blood pressure (bp) measurement, arterial stiffness, subclinical atherosclerosis screening in the carotid and ileo-femoral territories using echo-doppler, echocardiogram, and ergometry test.


Eligibility criteria:
inclusion criteria: * age \>18 years old. exclusion criteria: * previous cardiovascular and/or cerebrovascular event * stable chronic angina * advanced chronic kidney disease (stage iv or v) * cancer

Keywords: subclinical atherosclerosis metabolic syndrome primary prevention
evaluation of 18f-dcfpyl psma- versus 18f-naf-pet imaging for detection of metastatic prostate cancer.

Conditions: Metastatic Prostate Cancer

Summary: the objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (psma), \[18f\]dcfpyl (dcfpyl) pet/ct (or pet/mri imaging if available) for detection of metastatic prostate cancer. psma is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, dcfbc, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. investigators propose to assess the ability of dcfpyl pet to detect metastatic prostate cancer by visual qualitative and quantitative suv analysis. correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific \[18f\]sodium fluoride (naf)-pet/ct imaging for prostate cancer.


Eligibility criteria:
inclusion criteria: 1. histological confirmation of prostate cancer 2. radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (ct, mri, or ultrasound), bone scintigraphy, \[18f\]sodium fluoride pet, and/or \[18f\]fdg pet 3. rising psa on two observations taken at least 1 week apart 4. adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration 5. patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease 6. patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging 7. patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits 8. patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures exclusion criteria: 1. patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration 2. prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest) 3. initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. 4. serum creatinine \> 3 times the upper limit of normal 5. total bilirubin \> 3 times the upper limit of normal 6. liver transaminases \> 5times the upper limit of normal 7. unable to lie flat during or tolerate pet/ct (or pet/mri imaging if available) 8. prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.
cpk levels after lc and association with analgesic modalities

Conditions: Myotoxicity

Summary: regional anesthesia and analgesia technics are widely and securely used during general surgery procedures. interfascial plane blocks are the latest used ones for analgesia. there are studies in literature indicating that bupivacaine cause myotoxicity. the investigators aimed to examine plasma creatine phosphokinase (cpk) levels to see whether myotoxicity occurs or not after fascial plane blocks are applied to patients undergoing laparoscopic cholecystectomy.

during 3 months period all elligible patients undergoing laparoscopic cholecystectomy surgery will be included in the study. different postoperative analgesic modalities will be used according to the anesthesists experience. during routine blood sample tests plasma creatin phosphokinase (cpk) levels will be tested 3 times of all patients(preoperative, postoperative 6th hour, postoperative 24th hour). data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility criteria:
inclusion criteria: * asa 1-3 * laparoscopic cholecystectomy * under general anesthesia exclusion criteria: * morbidly obesity or cachexia * local anesthetic allergies * myopathies * coagulopathies * obstructive sleep apne syndrome * hearth diseases * liver diseases * kidney diseases * thyroid-parathyriod dieseas * hiperlipidemias using statins(hmg-coa reductase inhibitors) * pregnancy

Keywords: creatine phosphokinase cholecystectomy interfascial plane blocks
vent flow study of prototype nasal cpap mask

Conditions: Obstructive Sleep Apnea (OSA)

Summary: as continuous positive airway pressure is the treatment choice for osa, a mask is vital in ensuring the effectiveness of therapy delivery. the study will evaluate the performance of a new mask system with diffuse vent technology. this is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. the study will also subjectively assess breathing comfort and performance of the mask system.


Eligibility criteria:
inclusion criteria: * participants willing to give written informed consent * participants who can read and comprehend english * participants using apap for \>6 months * participants who are willing to use the mask system for the 3 month duration of the trial. * participants who are over 18 years of age * participants who currently use a nasal mask system exclusion criteria: * participants not willing to give written informed consent * participants who cannot read and comprehend english * participants using an inappropriate mask system * participants on a bilevel or asv therapy * participants who are pregnant * participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer lung injury; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection * participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (non-ferrous implants may be acceptable) * participants that weight \<30 kg * participants who are unsuitable to participate in the study in the opinion of the researcher
biobanking and new biomolecular metrics

Conditions: Melanoma (Skin); Liquid Biopsy

Summary: the goal of this interventional study aims to apply, in our institutes, a 4p oncological model i.e. predictive, personalized, of precision and participated (regina elena and san gallicano).

patients will be recruited with an innovative and systematic scheme: collection and biobanking of biological materials (tissue biopsy, re-biopsy and liquid biopsy) followed by a molecular monitoring thanks to genomic and epigenomic methods. it's an open-ended study. in particular we will try to identify new "actionable" signatures and we will try to insert the patients to innovative clinical trials, thanks to the evaluation of all cases with a molecular tumor board. the main objectives are: * introduce a new methodology to improve and integrate the already existent institutional pdta * evaluate and measure the applicative value * establish a biostatistical platform

Eligibility criteria:
inclusion criteria: * melanoma affected patients exclusion criteria: * no patiens affected by other pathology
clinical and virological efficacy of pegylated interferon alpha in the treatment of rhinovirus infection in patients with primary hypogammaglobulinemia: randomized controlled trial

Conditions: Rhinovirus Infection

Summary: the study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to eradicate rhinovirus in patients with primary hypogammaglobulinemia. patients with hypogammaglobulinemia have persistent rhinovirus infections. rhinovirus may worsen pulmonary complications. pegylated interferon alpha with ribavirin appear to effectively clear persistent rhinovirus infections in hypogammaglobulinemia patients. patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will be randomly assigned in a double-blind fashion to receive either * group 1: subcutaneous pifnα2a * group 2: subcutaneous placebo subjects will have scheduled study visits at 1-week and at 2-month after entry to study. in addition, possible bacterial infections will be treated with antibiotics. each patient will be followed with weekly nasal surveillance samples for 2 months and a symptom diary. blood draws take place at study entry, 1-week and 2-month time-points.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years), * primary hypogammaglobulinemia with regular immunoglobulin replacement therapy, * rhinovirus positive from nasal swab, * thrombocytes over 90 x109/l, * neutrophiles \> 1,5 x109/l * written informed consent. exclusion criteria: * participation to another study, * need for intensive care unit treatment, * difficulties to understand national language, pregnancy and breastfeeding, * any somatic, psychiatric or social disease or issue which in the opinion of the investigator makes participation in the trial not being in the best interest of the subject.
simplified treatment of anti-retrovirus in china (c-star)

Conditions: HIV/AIDS

Summary: to observe the efficacy and safety of simplified therapy regimen for treating with hiv-1 infected patients in chinese real word.

this is an phase iv open-label, multicenter, single-arm clinical trial in. a total of 600 cases were planned to be recruited. these cases were given simplified therapy regimen of lopinavir (200mg) and ritonavir (50mg) (500mg, oral, bid ) combined with lamivudine (300mg, oral, qd. the observation duration is thirty-sixth months. patients will be followed up before and 12, 24 and 36 months after receiving the simplified regimen, observing the viral inhibition rate and the change of cd4 cell count, the safety and patients'compliance.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infection confirmed 2. agree to use simplified therapy regimen. 3. agree to detect cd4 count at least once per half a year exclusion criteria: 1. have participated in hiv vaccine clinical trial or other drug trials in the past three months. 2. patients who could not complete the scheduled follow-up (such as weakness and poor compliance). 3. patients who have the history of resistance or allergy to lpv/r or 3tc.

Keywords: simplified therapy regimen real world study hiv-1-infected patients
the effect of mannitol on the serum potassium during craniotomy

Conditions: Mannitol Adverse Reaction; Hyperkalemia

Summary: this is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.

patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.the serum potassium was measured by arterial blood gas analysis before infusion (t0), infusion finished (t1), 15min (t2), 30min (t3), 60min (t4) and 120min (t5) after infusion.

Eligibility criteria:
inclusion criteria: * age 18 to 70 * american society of anesthesiologists physical status i to ii * liver and kidney function is normal * preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/l exclusion criteria: * history or presence of congestive heart failure (new york heart association class iii to iv) * history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion) * intraoperative blood transfusion
non-invasive imaging technique for the study of lordosis in pregnant women and its relationship to birth outcome

Conditions: Pregnancy Outcome; Biomechanics; Back Disorder; Diagnostic Imaging; Biomedical Technology

Summary: the study consists of collecting measurement data of the rachis in pregnant women and the subsequent outcome of her delivery. this will make it possible to validate a non-invasive imaging technique through software that can be used to study this anatomical curve proposing a new measurement method for the angle of lordosis. finally, with the research data, the investigators will try to find a correlation between these variables (angle of lordosis and delivery outcome.


Eligibility criteria:
inclusion criteria: * pregnant women between 20 and 40 years old with a low-risk pregnancy exclusion criteria: * pregnant women under 20 years and over 40 years of age or with a significant lumbar pathology or with a very high-risk pregnancy or with imc \>35
metoclopramide in upper gastrointestinal bleed

Conditions: Upper GI Bleeding; Bleeds Gastric; Bleed Ulcer; Hemorrhage Gastric; Hemorrhage; Ulcer

Summary: the goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (gi) bleeds. the main questions the investigators hope to answer is does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper gi bleed? does metoclopramide improve visibility of the gi walls in cases of upper gi bleed?

the purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper gi bleed can decrease the need for repeat endoscopy due to poor visibility. metoclopramide stimulates stomach and intestine activity. it is used to treat nausea, vomiting and slow gut movement. the investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper gi bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.

Eligibility criteria:
inclusion criteria: * age 18 and above * admitted to er or inpatient services at javon bea hospital mercyhealth riverside * present with upper gi bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena * plan to undergo egd within 24 hours since admission or since first symptoms * calculated glasgow-blatchford score ≥ 2 exclusion criteria: * failure to obtain informed consent * known allergy to metoclopramide * concurrent use of medications known to cause tardive dyskinesia (td)/extrapyramidal symptoms/neuroleptic malignant syndrome * history of td or dystonic reaction to metoclopramide * pheochromocytoma, catecholamine-releasing paragangliomas * parkinson's disease * epilepsy * pregnancy or lactation * previous gastrectomy

Keywords: metoclopramide prokinetic upper endoscopy egd endoscopic gastroduodenoscopy esophagogastroduodenoscopy