Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of interferon to treat patients hospitalized for influenza

Conditions: Influenza

Summary: a pilot study to evaluate the safety and efficacy of interferon-alfacon1 (infergen) in the treatment of patients hospitalized with influenza-like illness caused by a novel swine origin influenza virus and other circulating influenza viruses. the use of interferon-alfacon1 as a co-treatment along with the standard of care antiviral is hypothesized to be safe. clinical improvement of patients is hypothesized to be quicker.

the purpose of this study is to see if using a medication called infergen, can help get rid of the virus and/or can help the immune response to prevent the illness from getting worse in the lungs. we hope that infergen will either prevent patients from getting worse and requiring intensive care or will decrease the time for which they will need intensive care. the interferon-alpha (also called interferon-alphacon1 or ifn-alphacon1 or infergen) is an immune molecule, which has been shown to work against different viruses (anti-viral). interferon is the standard of treatment for patients with chronic (infection that has been there for a long time) hepatitis c (a virus which affects the liver over many years) by giving it for 6-12 months. it has also been used for a shorter time of up to 14 days, in a small study for patients with respiratory disease caused by sars and seemed to help these patients get better more rapidly. it also has been shown to stop different influenza viruses from growing in test tubes and in lung tissue. it has also been shown to decrease the immune response to prevent it from over-reacting to viruses.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * aged \>=18 and \< 70 * hospitalized * suspect, probable, confirmed influenza a * symptom onset \<8 days * able to attend all scheduled visits exclusion criteria: * known hypersensitivity to interferon preparation * pregnancy * chronic liver disease * moderate to severe congestive heart failure, grade iii or iv left ventricular function * previous history of serious psychiatric illness * history of severe or active autoimmune disease

Keywords: influenza a, h1n1
safety, tolerability, pharmacokinetics and antiviral activity of gs-9669 in subjects with chronic hepatitis c virus infection

Conditions: Hepatitis C

Summary: this is a research study to evaluate the safety, tolerability and anti-viral activity of gs-9669 in patients with hepatitis c infection.


Eligibility criteria:
inclusion criteria: * adult subjects 18-65 years of old, inclusive * documented chronic hcv infection to be of at least 6 months duration and plasma hcv rna ≥ 5 log10 iu/ml at screening. * hcv treatment naïve or peg-ifn, ifn, and/or rbv experienced (treatment must have ceased at least 3 months prior to screening). treatment experienced subjects should not exceed 40% of the subjects enrolled in each cohort * mono-infection with hcv genotype 1a for cohorts 1, 2, 3, 4, and 5 and mono-infection with hcv genotype 1b for cohort 6 and 7. * estimated creatinine clearance ≥ 70 ml/min, * qtcf interval ≤ 450 msec for males and ≤ 470 msec for females, qrs duration \< 120 msec, pr interval \< 220 msec, * body mass index (bmi) of 19.0 to 34.0 kg/m\^2, inclusive. exclusion criteria: * urine drug screen positive for illicit/illegal drugs * alt and ast levels \> 5 times the upper limit of the normal range (uln) * direct bilirubin \> uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets \< 90,000/mm\^3, prothrombin time ≥ 1.5 × uln and albumin \< 3.5 g/dl) are not eligible for study participation. * subjects with an absolute neutrophil count (anc) \< 1,000 cells/mm\^3 (\< 750 cells/mm\^3 for black or african-american subjects), hemoglobin (hb) \< 11 g/dl, * coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype other than genotype 1a/b are not eligible for study participation. * evidence of hepatocellular carcinoma (e.g., a-fetoprotein \> 50 ng/ml or as indicated by recent ultrasound or other standard of care measure) * history of significant cardiac disease. the following ecg abnormalities at screening are exclusionary: qtcf (qt corrected using fridericia's formula=qt/rr\^0.333) \> 450 msec for males and \> 470 for females; qrs \> 120 msec (left or right hemiblock is not exclusionary); pr interval \> 220 msec; bradycardia (\< 45 beats per minute); second or third degree heart block. * history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility

Keywords: hcv rna polymerase inhibitor treatment naïve and treatment experienced gs-9669 hepatitis c hcv
a 2-part single dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of e2006

Conditions: Insomnia

Summary: part a: the purpose of this study is to evaluate the safety and tolerability of single oral doses of e2006 administered in the morning to healthy male and female subjects. part b: the purpose of this study is to evaluate selected pharmacodynamic (pd) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of e2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.


Eligibility criteria:
key inclusion criteria: healthy subjects: * with habitual time in bed \> 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800 * who report typical sleep latency of \</= 30 minutes * with typical total sleep time (tst) \>/= 420 minutes primary insomnia subjects: * otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the diagnostic and statistical manual of mental disorders-iv-text revision \[dsm-iv-tr\]) present at the time of screening for at least 3 months * with a score of \> 15 on the insomnia severity index (isi) at screening * who report taking \>/= 30 minutes to fall asleep on at least 3 nights per week for the past month * who report 6.5 hours sleep or less on at least 3 nights per week for the past month * with mean latency to persistent sleep (lps) on both baseline nights of \>/= 20 minutes with neither night \< 15 minutes * with mean wake after sleep onset (waso) \>/= 20 minutes on both baseline nights, with neither night \ 420 minutes key exclusion criteria: * with a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome \[rls\], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for part b) * subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ecg finding, or laboratory test results which require medical treatment * all females must be of non-childbearing potential * with a known history of significant neurological or serious psychiatric illness
pre-approval access single patient request for teclistamab (jnj-64007957)

Conditions: Multiple Myeloma

Summary: teclistamab pre-approval access in relapsed or refractory multiple myeloma.


Eligibility criteria:
must have relapsed/refractory multiple myeloma (rrmm) and have evidence of disease progression after last therapy. must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors \[pis\], immunomodulatory imide drugs \[imids\], anti cd38 monoclonal antibodies \[mabs\] and therapies targeting exportin 1 \[xpo1\] and b cell maturation antigen \[bcma\]). must not be eligible for a clinical trial with teclistamab or other medicines in this setting
thyroid dysfunction in patients with type 2 diabetes with early diabetic nephropathy.

Conditions: Evaluation Thyroid Functions in Diabetic Patient

Summary: diabetes mellitus is the most common disorder seen. the impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (usa) on diabetes . so, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . the association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. with insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other . diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis. as hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so severe diabetic complications where noted in patients with sub- clinical hypothyroidism . sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.

recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. it results from interactions between hemodynamic and metabolic factors.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus and with diabetic nephropathy. exclusion criteria: * 1) insulin dependent diabetes 2) patients with: * gestational diabetes mellitus. * steroid induced diabetes. 3) thyroid disease

Keywords: evaluation of thyroid function in diabetes patients
high flow nasal cannula to prevent deoxygenation during induction of general anesthesia in cesarean section

Conditions: Hypoxic Brain Injury; Maternal Death

Summary: transnasal humidified rapid-insufflation ventilatory exchange (thrive) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results

eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (spo2) decreases by 2%.

Eligibility criteria:
inclusion criteria: * pregnant females * of american society of anesthesiologists (asa) physical status i and ii * for elective cesarean section under general anesthesia exclusion criteria: * with room air saturation of \<98% * anticipated difficult airway * anticipated obstetric risk factor or precious baby * chronic obstructive pulmonary disease * thyrotoxicosis * pheochromocytoma * hyperkalaemia * significant cardiac illness
outcome following endodontic treatment using traditional access versus conservative access

Conditions: Pulpitis - Irreversible

Summary: this study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis

after thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be obtained after explaining the procedure and its associated risks and benefits. clinical diagnosis of symptomatic irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. once included, study subjects will be randomly allocated to either traditional access or conservative access group. subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary niti file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. teeth will be restored using composite resin in the same appointment. pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. all the subjects will be followed up for evaluation of success at 6 and 12 months from baseline.

Eligibility criteria:
inclusion criteria: * the patient should be ≥18 years of age. * restorable mandibular molars with extremely deep caries involving occlusal surface only * clinical diagnosis of symptomatic irreversible pulpitis with pai score ≤2. * tooth should give positive response to pulp sensibility testing. * tooth with probing pocket depth and mobility are within normal limits. * non-contributory medical history. exclusion criteria: * teeth with immature roots. * no pulp exposure even after caries excavation. * teeth with signs of pulpal necrosis including sinus tract or swelling. * teeth with percussion sensitivity * positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis * had taken analgesic in past 3 days * teeth with pathologic changes such as internal or external resorption * teeth with morphological variation * teeth with root canal calcification * teeth with fixed full coverage prosthesis

Keywords: irreversible pulpitis endodontic treatment traditional access conservative access contracted endodontic cavities
development and evaluation of computerized olfactory training program for cognitive decline in early alzheimer's disease

Conditions: Mild Cognitive Impairment; Early Alzheimer's Disease; Memory Impairment

Summary: the purpose of this study is to determine whether daily treatment with this new treatment approach, called cot would be effective in protecting the memory and brain regions of people who are already showing signs of memory loss.

alzheimer's disease process starts in parts of the brain used for perceiving and interpreting smell many years before people begin to lose their memory and other cognitive functions. these parts of the brain are called the "olfactory regions." from these olfactory regions, alzheimer's disease spread to involve other parts of the brain. scientists have shown that stimulating the olfactory regions through exposure to multiple naturally occurring essential or plant oils help to reduce the brain changes of alzheimer's disease in animals. also, many components from these plant oils have been shown to protect nerve cells from various kinds of stress and injuries; and we say they are 'neuroprotective'. a novel home-based olfactory chemosensory stimulation program that uses a portable, programmed, device known as the computerized olfactory training (cot) program, administers olfactory psychophysical tasks while patients are being stimulated repeatedly with neuroprotective olfactory stimulants, using neuroscience-guided stimulation parameters to ensure sustained activation of all primary and secondary olfactory structures.

Eligibility criteria:
inclusion criteria: 1. age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years 2. probable mild ad according to the core clinical criteria outlined in the national institute on aging/alzheimer's association (nia-aa) guidelines 3. mmse score between the range of 21 to 27; cdr score of 1.0 (mild ad); scores on logical memory ii subscale (delayed recall) from the wechsler memory scale-revised (wms) within the recommended education-adjusted ranges 4. have either cerebrospinal fluid (csf) aβ42 levels that are consistent with alzheimer's disease as measured via mass spectrometry by c2n, or document elevated amyloid burden consistent with alzheimer's disease from positron emission tomography (pet) imaging 5. screening mri without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease. 6. all participants must have a study partner with normal cognitive function. exclusion criteria: 1. any significant neurologic disease 2. major psychiatric disorder within the past 2 years 3. substance use disorder within the past 2 years 4. any unstable medical condition 5. contraindications to mri 6. any alzheimer's disease modifying therapy (dmt) in the past 6 months 7. antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.

Keywords: cognition memory alzheimer's disease computerized olfactory training device
extension study of pimecrolimus cream in pediatric patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. in this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in japanese pediatric patients with atopic dermatitis. this study is a 6-month extension study following core study. this study is not enrolling patients in the united states


Eligibility criteria:
inclusion criteria: * - patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator * patients whose guardians have given written informed consent to participation in this study exclusion criteria: * - patients who failed in treatment compliance in the core study * patients who had a major violation of the protocol in the core study

Keywords: atopic dermatitis, asm981, pimecrolimus
evaluation of tomosynthesis for characterization and the management of breast lesions

Conditions: Breast Neoplasms; Tomosynthesis; BRCA1 Protein; BRCA2 Protein

Summary: tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis. the objective of this study is to evaluate if the bi-rads classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.


Eligibility criteria:
inclusion criteria: * patient having clinical or breast imaging abnormalities classified as birads 3, 4, 5 (table 1). (5) * patient over 18 years old * signed informed consent exclusion criteria: * patients at high risk of breast cancer, mutations brca 1 (breast cancer gene 1) or brca 2 (breast cancer gene 2) carriers, li fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation. * patient unable to give informed consent for physical, mental, or legal reasons. * patient not affiliated with french social security insurance. * patient under treatment for breast cancer. * when mammography is not recommended according to good practice by the french health authority (has). * pregnant patient.
validation of a new technique for the evaluation of the patello-femoral joint kinematics

Conditions: Knee Osteoarthritis

Summary: the objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

in total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. after surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. in this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking. the possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint. the goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

Eligibility criteria:
inclusion criteria: * patients with unilateral primary knee arthrosis indicated for total knee replacement. * patients able to understand the protocol and to sign the informed consent. exclusion criteria: * patients with indications for revision surgery. * patients with patellectomy. * child-bearing female.

Keywords: total knee arthroplasty patellar resurfacing patellar tracking patello-femoral joint kinematics surgical navigation computer-aided surgery