Kornimate/medical-research-clean huggingface dataset:
efficacy of artesunate + amodiaquine four years after its introduction in zanzibar

Conditions: Malaria

Summary: the purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in zanzibar. the hypothesis is that the treatment has a polymerase chain reaction (pcr)adjusted parasitological cure rate of at least 85% 42 days after treatment.


Eligibility criteria:
inclusion criteria: * age below 60 months * weight ≥5kg * no general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2) * history of fever within 24 hours or axillary temperature ≥ 37.5cº * no other cause of fever is detectable * no severe malnutrition * presence of p. falciparum asexual parasite density between 2000- 200,000/ul * guardian/patient has understood the procedures of the study and is willing to participate * patient able to come for stipulated follow up visits and has easy access to the study site exclusion criteria: * not able to drink or breastfeed * persistent vomiting * recent history of convulsions * lethargic or unconscious * unable to sit or stand (as appropriate for age) * history of allergy to test drugs * history of intake of any drugs other than paracetamol and aspirin within 3 days
evusheld assessment real world effectiveness in the va health system

Conditions: SARS-CoV-2, COVID-19

Summary: an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population in the department of veterans affairs (va) health system.

this a phase iv observational, secondary data study to assess the effectiveness of evusheld in preventing covid-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system. the study is designed as an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population in the va health system.

Eligibility criteria:
inclusion criteria: 1. receipt of evusheld under the fda eua for evusheld 2. eligibility to access evusheld use under the eua. exclusion criteria: * none

Keywords: evusheld tixagevimab and cilgavimab pre-exposure prophylaxis covid-19 sars-cov-2 effectiveness
behavioral effects of drugs inpatient 44 neurobehavioral mechanisms of opioid choice

Conditions: Opioid Use Disorder

Summary: the objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fmri to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.


Eligibility criteria:
inclusion criteria: * individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening. * history of intravenous opioid use. * baseline o2 saturation of 95% or greater. * between the ages of 18-50 years. * female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, iud, cervical cap with a spermicide, or abstinence). urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant. * able to speak and read english. * otherwise healthy. exclusion criteria: * history of, or current, clinically significant physical disease (e.g., respiratory disease \[asthma, copd, sleep apnea\], impaired cardiovascular functioning, seizure disorder or cns tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder. * meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (oud subjects only) or nicotine/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening. * contraindications for mri scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device). * vision or hearing problems that would preclude completion of experimental tasks. * poor venous access. * regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions. * at risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed. * seeking treatment for sud or currently taking buprenorphine or methadone as the primary opioid of use.
crohn disease exclusion diet after single medication de-escalation

Conditions: Crohn Disease

Summary: the primary objective of this study is to determine whether pediatric crohn disease (cd) patients in long-standing remission remain in remission longer after stopping medications if they follow the crohn's disease exclusion diet (cded). the hypothesis is that subjects on the cded will have longer time-to-relapse as opposed to those on an unrestricted diet.

crohn disease (cd) is an idiopathic, chronic, relapsing and remitting inflammatory condition of the gastrointestinal tract with a high risk for complications and need for surgical interventions, particularly in children. immunomodulators and biologic therapies are effective at inducing and maintaining remission in pediatric cd, yet there is no proven strategy for reducing exposure to medications once sustained remission has been achieved. diet has been proven to impact disease activity in cd and may allow for sustained drug-free remission. the primary objective of this study is to determine whether pediatric cd patients in long-standing remission remain in remission longer after stopping medications if they follow the crohn's disease exclusion diet (cded). the hypothesis is that subjects on the cded will have longer time-to-relapse as opposed to those on an unrestricted diet.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of crohn disease using the revised porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care. * normal growth velocity, or tanner 5 * steroid-free remission (pediatric crohn disease activity index score \<10 without the height component) for at least 12 months prior to enrollment * colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment * stool calprotectin \<250µg/g during the preceding 3 months * parental/guardian permission (informed consent) and, if appropriate, child assent. exclusion criteria: * discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist. * those subjects who in the judgment of the investigative team are unable to complete the study endpoints.
pilot study of anti-cd20-car-engineered t cells in patients with chemotherapy resistant or refractory cd20+ lymphoma

Conditions: Lymphoma, B-Cell

Summary: chimeric antigen receptor (car) t cells targeting cd20 will be evaluated for safety and efficacy in patients with cd20+ b cell lymphoma. the car consists of a cd20 targeting antibody scfv with two intracellular signaling domains derived from cd3 zeta and cd28. autologous t cells will be gene-engineered with the car gene using a retrovirus vector. prior to t cell infusion, the patients will be subjected to preconditioning treatment. after t cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of car t cells and efficacy.


Eligibility criteria:
inclusion criteria: 1. relapsed or refractory cd20+ b-cell lymphoma. 2. measurable disease. 3. performance status ecog 0-2. 4. age:18-65. 5. fertile females/males must consent to use contraceptives during participation of the trial. 6. signed informed consent exclusion criteria: 1. any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. patients with primary cns lymphoma. 3. known human immunodeficiency virus (hiv) infection. 4. active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection). 5. other serious underlying medical conditions, which, in the investigator's judgment, could impair the ability of the patient. 6. treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. 7. patients that do not consent to that tissue and blood samples are stored in a biobank. 8. pregnancy. -
crystalloid fluids and cardiac surgery

Conditions: Surgery-Complications

Summary: all cardiac patients admitted to the intensive care unit after surgery received crystalloid fluids as standard care procedure. 3 crystalloid fluids can be used during their stay: normal saline, plasmalyte or ringer's lactate. they differ in their respective composition, mainly in chloride and sodium concentrations. inflammatory consequences of the crystalloid fluids used in this population are unknown. the investigators plan to evaluate which one of the three fluids mentioned above is advantageous in cardiac surgery patients with regards to reduced rate of infection and renal failure.

inflamed patients admitted to the intensive care unit after cardiac surgery received large volumes of crystalloid fluids as standard care procedure. the goal is to control the balance between the initial pro-inflammatory phase and the subsequent/compensatory anti-inflammatory phase, the later being associated to immune fatigue and the apparition or re-activation of infections. infectious complications are responsible for the increased rate of morbidity and mortality in this cardiac surgery population. the inflammatory impacts of each of the crystalloid fluids administered to the patient are still ill-defined and represent an opportunity to better control the hyperinflammation and/or immunosuppression often observed following cardiac surgery. hence, the investigators will evaluate the activation of the immune system following crystalloid fluid (either normal saline (ns), plasmalyte (pl) or ringer's lactate (rl)) administration in this population with regard to one recurrent clinical issue, i.e renal failure. the hypothesis is that lr is less ''immuno-activator'' on monocytes than ns and pl. the objectives are: 1-evaluate the inflammatory profiles of each of the crystalloid fluids in consent cardiac surgery patients during their stay in the intensive care unit by studying white blood cell phenotypes and inflammatory cytokines present in plasma and 2-evaluate the impacts of crystalloid fluids in vitro using white blood cell from cardiac surgery patients obtained before surgery.

Eligibility criteria:
inclusion criteria: * patient for coronary artery bypass surgery with cpb (cardiopulmonary bypass) exclusion criteria: * use of immunomodulating medication 6 months before surgery * chemiotherapy/radiotherapy 6 months before surgery * history of neoplasia * auto-immune disorders * pregnancy * severe infection 1 month before surgery * renal/hepatic failure * left ventricular ejection fraction \<40% * hepatitis c or hiv * symptomatic peripheral vascular diseases * chronic obstructive pulmonary disease * cerebrovascular accident * hemoglobin \<90g/l * leukocytes \ 12x10e6/l

Keywords: cardiac surgery renal failure
pain neuroscience education and motor imagery-based exercise protocol for patients with fibromyalgia

Conditions: Fibromyalgia; Pain; Psychology Regression

Summary: the main aim of this study is to find out whether applying both pain neuroscience education (pne) and motor imagery-based exercise protocol (miep) will primarily reduce the pain of fibromyalgia. these therapies could show an evidence of improvement in fibromyalgia patients. however, there are no studies evaluating their effectiveness in combination. secondary outcomes: to assess motor imagery ability of pne in fibromyalgia patients to assess motor imagery ability of miep in fibromyalgia patients to evaluate the motor imagery ability of pne+miep combined in fibromyalgia patients to evaluate pain beliefs of pne in fibromyalgia patients to assess the pain beliefs of miep in fibromyalgia patients combined pne+miep to assess pain beliefs in fibromyalgia patients. to assess fear of movement in fibromyalgia patients of pne to assess fear of movement in fibromyalgia patients of miep combined pne+miep to assess fear of movement in patients with fibromyalgia pne to assess anxiety, depression, cognitive and mood in patients with fibromyalgia. to assess anxiety, depression, cognitive and mood in patients with fibromyalgia miep to evaluate anxiety, depression, cognitive and mood in patients with fibromyalgia together with pne+miep pne to assess self-esteem and body awareness in fibromyalgia patients. to assess self-esteem and body awareness in fibromyalgia patients of miep combined pne+miep to assess self-esteem and body awareness in fibromyalgia patients.


Eligibility criteria:
inclusion criteria: * experiencing widespread chronic pain for more than 12 months * pain in at least 12 or more of 18 tender points with a pressure of 5 kg/cm2 * 18 to 60 years old * not using pharmacological therapeutics * not having participated in any pain program. * not having participated in any physical exercise programs in the last twelve exclusion criteria: * pregnancy * not being able to do a physical activity program * currently receiving treatment with any alternative medical methods (eg.hyperbaric). * cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease * other causes of chronic pain * receiving any treatment support related to pain * mental disability status
randomized control trial on seprafilm and guardix in preventing ileus

Conditions: Patient Under Going Colorectal and Stomach Cancer Surgery

Summary: the purpose of the study is to evaluate the efficacy of seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (saes) associated with the use of seprafilm and guardix occurring within 30 days postoperatively.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gi cancer * operable exclusion criteria: * withdrew consent * pregnant * ascites * distant metastasis * liver dysfunction (serum total bilirubin \>2.0 mg/dl) * renal failure (serum creatinine \>1.5 mg/dl) * a past history of small bowel obstruction.
monitored anesthesia care: dexmedetomidine-ketamine versus dexmedetomidine- propofol for chronic subdural hematoma

Conditions: Conscious Sedation

Summary: inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate mac during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients. dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.

* null hypothesis (h0): there are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation. * alternative hypothesis (h1): there are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.

Eligibility criteria:
inclusion criteria: * patient acceptance. * both sex. * age (50-80) years old. * patient with body mass index (bmi) (25-30kg/m²). * american society of anesthesiologist (asa) ii / iii * patient scheduled to burr-hole surgery for chronic subdural hematoma evacuation under mac. exclusion criteria: * patient with difficult airway (mallapati iii,iv). * altered mental status (psychiatric and anexity disorder). * post-traumatic stress disorders. * history of allergy to study drugs. * patient on sedative or hypnotic medication. * patients with on painkiller. * patients with any degree of heart block. * sever liver, respiratory or renal impairment.
a study of two approved drugs in the treatment of postoperative dental pain (0966-183)

Conditions: Postoperative Pain

Summary: the purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

the duration of treatment is 24 hours.

Eligibility criteria:
inclusion criteria: * impaction of a molar tooth requiring removal exclusion criteria: * any known allergy to the study drugs

Keywords: dental surgery molar removal
safety and effectiveness of 3 anti-hiv treatments in patients who have failed previous treatments containing nelfinavir

Conditions: HIV Infections

Summary: the purpose of this study is to see if 3 anti-hiv drug combinations are safe and effective in patients who have failed previous anti-hiv treatments using nelfinavir (nfv).

patients receive 1 of 3 salvage regimens. treatments a and b include delavirdine, 1 of 2 doses of indinavir, and 2 nucleoside reverse transcriptase inhibitors (nrtis) to which the patient has not been exposed. treatment c includes ritonavir, indinavir, and 2 nrtis to which the patient has not been exposed. when virologic failure is first observed, the patient must return in 2 weeks for confirmation of failure and start the salvage regimen within 1 month of the first assay in which failure was observed. patients who have less than 400 copies/ml hiv rna after 16 weeks of therapy are considered responders and continue on the study. those who have more than 400 copies/ml after 16 weeks of therapy are considered nonresponders and should be discontinued from the study. in addition, patients who respond and subsequently rebound with a viral load 0.5 log above the nadir and greater than 400 copies/ml on 2 consecutive assays at least 2 weeks apart are considered treatment failures and should be discontinued from the study. patients have regular physical exams, as well as virologic, immunologic, and pharmacokinetic assessments.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * had a viral load of less than 400 copies/ml, followed by an increase in viral load while taking an anti-hiv drug combination including nfv (treatment failure). * can start the study treatment within 1 month of treatment failure. * have a viral load of less than 30,000 copies/ml when they enter the study. * have not taken nonnucleoside reverse transcriptase inhibitors (nnrtis) or protease inhibitors (pis) other than nfv.

Keywords: drug therapy, combination hiv protease inhibitors ritonavir indinavir delavirdine reverse transcriptase inhibitors salvage therapy anti-hiv agents viral load nelfinavir
intravascular lithotripsy and/or mechanical debulking for severely calcified coronary artery lesions

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: to evaluate intra-procedural and long-term effects of intravascular lithotripsy with the shockwave system and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.

at present age, there are few real-world data published about the use of intravascular lithotripsy. its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. finally, there are few data about long-term outcomes in the real-life setting. subject population: subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable cad or acute coronary syndromes, that are suitable for percutaneous coronary intervention (pci). approximately 400 subjects at 20 sites will be enrolled. subjects will be followed through discharge, 30 days, 6 and 12 months

Eligibility criteria:
inclusion criteria: general inclusion criteria: 1. ≥18 years of age; 2. native coronary artery disease suitable for pci; 3. patients with stable ischemic heart disease or unstable ischemic heart disease (unstable angina, non-st elevation myocardial infarction, st-elevation myocardial infarction), patients with concomitant cardiogenic shock. 4. patient or legally authorized representative, signs a written informed consent form to participate in the study, prior to any study-mandated procedures; angiographic inclusion criteria: 1. the target vessel reference diameter must be ≥2.5 mm. 2. de novo coronary lesions or calcific in-stent restenosis or suboptimal stent expansion in a severely calcified coronary segment: unprotected or protected left main, lad, lcfx, ramus, rca. 3. angiographic stenosis \> 70% or stenosis \> 50% and \< 70% with ffr \< 0.80 or ifr \< 0.90 or ivus or oct minimum lumen area ≤4.0 mm²; 4. evidence of calcification at the lesion site: angiographic calcifications (mintz el al classification) are described as : none/mild, moderate (radio-opacities noted only during cardiac cycle prior to contrast injection) severe calcification: radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen. exclusion criteria: 1. patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint; 2. patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment); 3. patient has an allergy to imaging contrast media which cannot be adequately pre-medicated; 4. patient has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics;