Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of the novel selective nicotinic receptor partial agonist, chantix (varenicline) in patients with acute coronary syndrome

Conditions: Smoking; Acute Coronary Syndrome

Summary: assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.


Eligibility criteria:
inclusion criteria: * active smokers presenting to hospital with an acute coronary syndrome exclusion criteria: * patients with an acute coronary syndrome who are not active smokers

Keywords: smoking tobacco abuse
treatment of acute myeloid leukemia (aml) in adults 50 to 70 years, study of two anthracyclines and the interest of maintenance treatment with interleukin 2

Conditions: Acute Myeloid Leukemia

Summary: randomized comparison of standard induction treatment with daunorubicin for 3 days and idarubicin for 3 or 4 days in adult aml patients between 50 and 70 years. study of maintenance treatment with il2

patients from 50 to 70 years with de novo aml were randomized to receive arac 200 mg / m² / d iv x 7 d with either dnr 80 mg/m²/dx3d (arm 1) or ida 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). the pts received a failing course of remedial mitoxantrone involving x 2 and j arac 1g / m 2 x / d x 4 days the pts in cr then received 2 courses of consolidation with, according to initial randomization either dnr 80 mg / m² ida 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and arac 1 gsm 2/jx x 4 days the pts in cr were then randomized persistent il2 (5 million iu / m² x 5 d / month in sc for 12 months) or no treatment.

Eligibility criteria:
inclusion criteria: * patient from 50 to 70 years * aml de novo * no prior therapy for aml * absence of severe infection (who grade greater than 2), independent of the aml * cardiac function determined by radionucleotide or echography within normal limits. * total bilirubin less than or equal 2n and serum creatinin less than or equal 2n * ecog performance status 0 to 3 * signed informed consent. exclusion criteria: * m3-aml * history of neoplasia treated by radiotherapy or chemotherapy * myelodysplasia diagnosed more than 6 months before the diagnosis of aml * prior treatment for aml * uncontrolled infection * other active malignancy * patient unable to undergo regular surveillance

Keywords: acute myeloid leukemia in adults newly-diagnosed untreated aml patient aged 50 to 70 years
phase 2 study of velusetrag in diabetic or idiopathic gastroparesis

Conditions: Gastroparesis

Summary: this is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. the study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis. study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.


Eligibility criteria:
inclusion criteria: * symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to screening * body mass index (bmi) between 18 and 35 kg/m2, inclusive * gastroparesis cardinal symptom index (gcsi-2w) composite score ≥2 and ≤4 at screening * delayed gastric emptying, defined as a gastric emptying half-time (ge t1/2) \> 160 minutes as determined by \[13c\]-octanoate breath test, at screening * upper gastrointestinal (ugi) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis exclusion criteria: * acute severe gastroenteritis within 2 weeks prior to screening * history of gastric outlet obstruction * prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication * recurrent vomiting, defined as vomiting more than 2 days per week * hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to screening * presence of thyroid dysfunction not controlled by treatment. subjects with abnormal thyroid stimulating hormone (tsh), hypothyroidism, or hyperthyroidism at screening * if type 1 or type 2 diabetic, a glycosylated hemoglobin (hba1c) level \>10% or a glucose \> 250 mg/dl at screening

Keywords: gastroparesis diabetic idiopathic delayed gastric emptying
pregnancy/implantation rates using a day 3 score versus graduated embryo score plus a biochemical marker (shla-g)

Conditions: Infertility

Summary: objective: to compare pregnancy rates and implantation rates when embryos are selected based on a single day 3 (d.3) score vs. a ges score plus shla-g expression.

comparing pregnancy rates and implantation rates when embryos are selected using the most common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated over 72 hours and the expression of shla-g at 44-46 hours post fertilization.

Eligibility criteria:
inclusion criteria: * self paying art patients exclusion criteria: * abnormal uterus * specific immunologic factors

Keywords: pregnancy implantation miscarriage shla-g
antiviral activity of and resistance to lamivudine in combination with zidovudine, stavudine, or didanosine

Conditions: HIV Infections

Summary: to evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3tc) combined with zidovudine (azt), stavudine (d4t), or didanosine (ddi) in comparison with d4t or ddi monotherapy in hiv-infected patients with no prior nucleoside therapy. 3tc may be uniquely effective in combination with azt due to the interaction of azt and 3tc resistance mutations. one explanation is that the m184v mutation, which confers resistance to 3tc, suppresses azt resistance. this benefit of 3tc may not extend to combination therapy with other nucleoside analogs.

3tc may be uniquely effective in combination with azt due to the interaction of azt and 3tc resistance mutations. one explanation is that the m184v mutation, which confers resistance to 3tc, suppresses azt resistance. this benefit of 3tc may not extend to combination therapy with other nucleoside analogs. patients are randomized to either a ddi limb or d4t limb, then randomized a second time to one of six treatment arms, as follows: ddi alone, d4t alone, 3tc/azt (on both ddi and d4t limbs), 3tc/ddi, and 3tc/d4t. treatment is given for 48 weeks. at study week 24, patients on monotherapy will have 3tc added to their regimen (in a blinded fashion). per amendment 10/18/96: a treatment extension phase has been added to the study design in order to allow subjects who complete 48 weeks of therapy to remain on their same blinded treatment until approximately 2 months after the last enrolled subject completes 48 weeks on the study.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * pcp prophylaxis. patients must have: * hiv infection. * cd4 count 200 - 600 cells/mm3. * life expectancy of at least 24 weeks. * consent of parent or guardian if less than 18 years old. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * unexplained temperature \>= 38.5 c for 7 consecutive days within 30 days prior to study entry. per amendment 1/25/96: * a malignancy that requires systemic chemotherapies other than kaposi's sarcoma. concurrent medication: excluded: * concurrent other antiretroviral or immunologic agents. * other experimental therapies. * systemic corticosteroids (except as adjuvant therapy for acute pcp) and other immunosuppressive drugs. * systemic cytotoxic chemotherapy. * induction or maintenance with foscarnet or ganciclovir (oral or iv). patients with the following prior conditions are excluded: * history of acute or chronic pancreatitis. * history of grade 2 or higher peripheral neuropathy. prior medication: excluded: * antiretrovirals within 90 days prior to study entry. * more than 7 days total lifetime use of any antiretroviral nucleoside.

Keywords: didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents zidovudine stavudine lamivudine
inhalation low dose radionuclide therapy in treatment covid-19

Conditions: Covid19; Pneumonia, Viral

Summary: coronavirus disease (covid-19) is a pandemic of unprecedented proportions with an exponential increase in incidence. airway epithelium infection caused by coronavirus (sars-cov-2) triggers a cascade of difficult-to-control reactions, a so-called "cytokine storm". in contrast to the previously used method of external beam radiation therapy for patients at high risk of a cytokine storm, in present study a different dose delivery mechanism through inhalation of 99mtc-labeled carbon ultrafine aerosol obtained from a technegasplus generator is used. by utilizing anthropometric phantoms the dosimetric characteristics of the applied technique and obtained the coefficients of the transition from the count rate over the area of interest to the activity contained in this area (in kbq) were studied. by observing a group of healthy volunteers after inhalation of 99mtc-labeled carbon ultrafine aerosol, the accumulated dose in the human lungs under internal irradiation of 99mtc was determined. a novel technique has been developed and the possibility of using inhaled low-dose radionuclide therapy in the complex treatment of patients with covid-19 - associated pneumonia has been studied. as a result, a significant improvement of hematological parameters in the group of patients after inhalation of 99mtc-labeled carbon ultrafine aerosol as compared to the control group is expected.


Eligibility criteria:
inclusion criteria: 1. positive sars-cov-2 polymerase chain reaction (pcr) 2. ct confirmed pneumonia 3. men and non-pregnant women ≥ 18 y/o with early laboratory signs of cytokine storm 4. men and non-pregnant women \<65 y/o and/or with early laboratory signs of cytokine storm 5. informed consent obtained for participation exclusion criteria: 1. age ≤ 18 2. severe course of covid-19 3. pregnant or breast-feeding females 4. severe concomitant pathology 5. previous and/or present treatment of oncology disease (e.g. immunotherapy) 6. autoimmune diseases, severe cardiac disease, bone marrow and/or visceral transplantation 7. surgical treatment and/or radiotherapy of chest pathology 8. treatment with specific antiviral and anticytokine agents a day before inhalation procedure 9. absence of informed consent obtained for participation

Keywords: covid-19 viral pneumonia radionuclide therapy
the effectiveness of osteopathic manipulative medicine in the management of headaches associated with post concussion syndrome

Conditions: Headache; Post-Concussion Syndrome

Summary: pilot study looking at the osteopathic manipulative treatment (omt) for various headache types in patients with post-concussion syndrome (pcs). twenty-six subjects with symptoms lasting \>3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).

evidence shows the effectiveness of osteopathic manipulative treatment (omt) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (mtbi). no studies were found regarding omt for headaches in patients with post-concussion syndrome (pcs), defined as symptom persistence \>3 months after mtbi. objective: to evaluate omt for headaches in patients with pcs. methods: a controlled pilot study was conducted of patients with pcs who presented to an outpatient interdisciplinary rehabilitation clinic. twenty-six subjects with symptoms lasting \>3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13). primary outcome measures were 1) immediate change in headache scores with a visual analog scale (vas) and 2) change in the 6-item headache impact test (hit-6) between baseline and follow-up visits. 10 control participants completed hit-6 between baseline and follow-up visits but did not receive omt and did not complete vas. after omt, immediate vas changes in treatment group and the improvements in hit-6 scores for both groups between baseline and follow-up were analyzed for statistical significance.

Eligibility criteria:
inclusion criteria: * diagnosis of mild traumatic brain injury (mtbi), * age 18 years or older * injury occurring \>3 months prior, and * headache as a primary symptomatic concern. exclusion criteria: * history of moderate to severe traumatic brain injury (tbi), * documented intracranial injury, * chronic headache or migraine headache before the injury, * treatment with a headache specialist at the time of injury, or receipt of iv infusion for medication for headache at the time of treatment.
intravascular ultrasound-guided pci in patients with chronic kidney disease

Conditions: Coronary Artery Disease; Chronic Kidney Diseases

Summary: the ivus-ckd study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (ivus)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (ckd) patients with respect to target vessel failure (tvf) at 12 months after randomization.


Eligibility criteria:
inclusion criteria: * ckd patients with egfr\<60 ml/min/1.73 m\^2 * de novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and ivus imaging * signed written informed consent exclusion criteria: * onset of stemi within 24 hours or emergent angiography * pregnant or childbearing women * co-morbidity with an estimated life expectancy of \< 1 year * lvef ≤ 30% * cardiogenic shock or hemodynamic instability * severe hepatic dysfunction, defined as alt or ast more than 5 times the uln * pci within the previous 12 months * target lesion of stent thrombosis or in-stent restenosis * any planned non-cardiac surgery within 12 months * inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk * current enrolment in other clinical trials * contraindication to anti-platelet agents * history of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid) * chronic total occlusion lesion with unsuccessful guidewire crossing * current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin b, polymyxin, platinum complexes) * immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, iga nephropathy) * planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days * intake of anticoagulants * hemoglobin \<60 g/l * severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial * patients allergic to metals or contrast

Keywords: coronary artery disease chronic kidney disease percutaneous coronary intervention intravascular ultrasound randomized trial
the pharmacokinetics of double boosted protease inhibitors in antiretroviral-naive hiv-1 infected patients

Conditions: HIV Infections

Summary: treatment with only protease inhibitors might benefit hiv patients. laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. this study will explore this idea.

treatment with only protease inhibitors might benefit hiv patients, who experience problems with the other antiretrovirals drugs classes. another reason to only use protease inhibitors is that the remaining classes are spared. this leaves the option to use these classes in the future, for instance in cases of drug resistance. laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. this study will explore this idea.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. arv-naïve 3. hiv-1 infected thai male or female \> 18 years old 4. documented positive test for hiv-1 infection exclusion criteria: 1. inability to understand the nature and extent of the study and the procedures required. 2. pregnancy or lactating 3. active opportunistic infection 4. alt/ ast more than 2x upper limit 5. creatinine more than 1.5 time the upper limit 6. smoke cigarettes more than 10 cigarettes a day. 7. drink alcohol more than 2 units a day 8. relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. 9. use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir

Keywords: hiv-1 infection pharmacokinetics protease inhibitor double boosted protease inhibitors pis treatment naive
effect of influenza vaccination of healthcare workers (hcw) on the risk of influenza in patients hospitalized in short stays units

Conditions: Patient With Influenza Like Illness

Summary: hospital acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. vaccination of hcw is recommended to prevent influenza transmission in healthcare setting. outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in patients (higher than 85%). it is necessary to underline that an adequate vaccine cover in the elderly population will not necessarily result in a total control of the incidence. consequently, the prevention of influenza outbreaks in this vulnerable population must also include the reduction of the exposure to the influenza viruses, in particular thanks to the vaccination of hcw. a pilote case-control study, implemented in edouard herriot hospital (at lyon university hospitals), indicates that a shielding effect of more than 35% of vaccinated hcw on hospital acquired influenza among patients (bénet et al.; bmc infectious diseases 2012). the results suggest a protective effect but investigations, carried out on a more important sample are needed to validate the benefit of hcw vaccination. the aim of this prospective multicentric cohort study is to estimate incidence of influenza among hospitalized patients according to % of influenza vaccination of hcw in short stay units.


Eligibility criteria:
inclusion criteria: * all adults patients and healthcare workers of the participating units * with influenza like illness exclusion criteria: * patients aged \< 18 years

Keywords: influenza vaccination rate hospital acquired infection
immunologic aspects of the pathogenesis of chronic sinusitis in children

Conditions: Sinusitis

Summary: chronic sinusitis is a common pediatric disease; it ranks among the top five infectious diseases of the upper respiratory tract. its treatment is limited and may be due largely in part to a lack of understanding of its cause. the investigators have preliminary data to support the notion that pediatric chronic sinusitis is a distinct disease, different from acute sinusitis and adult chronic sinusitis. we are proposing to perform pathogenesis studies in children with chronic sinusitis. specifically, we wish to elucidate the microbiologic features and immunologic factors involved in the formation of this disease. the study plan calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing and mucosal biopsies. four populations will be studied and they are: 10 children with chronic sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis (negative control) and 5 adults with chronic sinusitis (positive secondary control).


Eligibility criteria:
inclusion criteria: * chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy

Keywords: chronic sinusitis
mechanical versus manual cardiopulmonary resuscitation

Conditions: Cardiac Arrest; Resuscitation

Summary: in this study, the investigators compared mechanical and manual chest compressions in in-hospital cardiac arrest cases.

in this study, the investigators analyzed cardiopulmonary resuscitations performed over a 2-year period in an emergency department of a training and research hospital and compared success of manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge. investigators present the study as an in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases included in the study were performed in the emergency department.

Eligibility criteria:
inclusion criteria: over 18 age cardiac arrest cases in-hospital cardiac arrest cases resuscitations performed in emergency department exclusion criteria: \<18 age

Keywords: cardiopulmonary resuscitation chest compression in-hospital mechanical manuel
comparison of cardiovascular risk stratification in young people with type 1 diabetes by coronary calcium score to esc/esa2019 recommendations

Conditions: Type 1 Diabetes; Coronary Artery Calcification

Summary: the aim of the study is to compare esc recommendations on cardiovascular (cv) risk stratification with the achievement of a cac (coronary artery calcification). the development of a cac, currently not systematically offered to these patients to refine cv risk, could make it possible to offer more intensive management of cv risk facors for patients who objectively have a high cv risk as evidenced by a high coronary calcium score. ldl target recommandations have become more aggressive with a very high level of evidence in type 2 diabetic patients but low in type 1 diabetic patients because there is no specific cv intervention study for t1d patients. these recommendations have far-reaching consequences because they would justify introducing in young type 1 diabetic patients, considered from the outset to be at moderate cardiovascular risk (young t1dm \ 10 years) or very high cardiovascular risk (duration of diabetes \> 20 years), treatment with statins or even aspirin, based only on the length of time they have had diabetes. the realization of a cac, currently not systematically offered to these patients to refine cv risk, could make it possible to propose a more intensive management of cv risk factors for patients with objectively high cv risk attested by a high coronary calcium score. in this case the introduction of treatment with statins would be indicated.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years and ≤ 35 years; type 1 diabetic patient (defined by t1dm antibody positivity or onset in pediatric age); in primary cardiovascular prevention (with no cv events); patient not treated by statins; duration of diabetes \> 5 years; equipped with a continuous interstitial glucose measurement system for at least 14 days; no previous cac performed patient with social security or with third party coverage. free subject, without guardianship or curatorship or subordination; informed consent signed by the patient after clear and fair information about the study. exclusion criteria: * cardiovascular secondary prevention patients (with a previous cv event); ecg abnormality suggestive of coronary ischemia; intolerance or contraindication to statins person benefiting from reinforced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations; pregnant and/or breastfeeding woman.