Kornimate/medical-research-clean huggingface dataset:
study to assess adverse events, change in disease activity and how oral abbv-552 capsules moves through the body of participants aged 50 to 90 years with mild alzheimer's disease

Conditions: Alzheimer's Disease (AD)

Summary: alzheimer's disease (ad) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. this study will assess how safe and effective abbv-552 is in treating symptoms of early ad. adverse events, change in disease activity, how abbv-552 moves through body of participants and the body response to abbv-552 will be assessed. abbv-552 is an investigational drug being developed for the treatment of alzheimer's disease (ad). study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. each group receives a different treatment. there is a 1 in 4 chance that participants will be assigned to placebo. approximately 240 participants aged 50-90 years with mild ad will be enrolled in approximately 60 sites across the world. participants will receive oral abbv-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease according to the national institute of aging-alzheimer's association (nia-aa) (2011) criteria. * mini-mental state examination (mmse) score of 20 to 26, a clinical dementia rating (cdr) global score of 0.5 or 1.0, with a cdr memory score of 0.5 or higher, and at least 1 cdr functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at screening visit 1. exclusion criteria: - clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive abbv-552.

Keywords: alzheimer's disease (ad) dementia abbv-552
to demonstrate the relative bioavailability study of ondansetron hcl 24 mg tablets under non-fasting conditions

Conditions: Nausea; Vomiting

Summary: to demonstrate the relative bioavailability study of ondansetron hcl 24 mg tablets under non-fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antiemetic
preventive exacyl® on perioperative bleeding during orthognathism of maxillary surgery

Conditions: Peri-operative Hemorrhage or Hematoma; Surgery; Retrognathism

Summary: prospective, randomized, double-blind, placebo-controlled, mono center, phase iii trial to compare exacyl in preventive with placebo on perioperatory bleeding in orthognathism surgery.

the aim of our study was to evaluate the clinical value of preventive treatment exacyl® on bleeding during surgery to orthognathism. our hypothesis is that this preventive treatment is not enough reduces bleeding to cause a change in patient management (count additional blood count, extra padding, transfusion). prospective equivalence trial type controlled by two parallel group, randomized, triple-blind (patient, surgical team, anesthesia team). * exacyl® group: 1 syringe 1g exacyl® on one hour + 1 syringe 1g exacyl® on 8 hours * control group: 1 syringe 30 ml of saline on one hour + 1 syringe 30 ml saline on 8 hours main criteria is amount of blood during the entire hospitalization: bleeding during surgery completed in the amount of blood present in the suction drains and nasogastric tube until ablation thereof.

Eligibility criteria:
inclusion criteria: * patients to be operated on an osteotomy of the maxilla through a orthognathism surgery in the department of surgical specialties salengro hospital * senior surgeon * hb ≥ 12 g / dl in the preoperative * patient asa 1 or 2 exclusion criteria: * patient with coagulation disorders * patients treated with anticoagulant or antiplatelet * patients who require anticoagulation postoperatively * patient with against-indication to exacyl® ( severe renal failure , convulsions history, history of thromboembolism venous or arterial ) * surgery recognized preoperatively as particularly complicated by surgeons

Keywords: bleeding perioperative exacyl oorthognathism surgery hematoma
venous congestion and organ dysfunction.

Conditions: Venous Congestion; Organ Dysfunction Syndrome

Summary: venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality. indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. clinical and ultrasound indications have been described to diagnose this condition. to date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. however, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. the presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes. it is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.


Eligibility criteria:
inclusion criteria: * adult * patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information) * patient admitted to intensive care for less than 24 hours. exclusion criteria: * person not affiliated to the national health insurance * minor, protected major * pregnant or breastfeeding women * anechogenicity confirmed by the operator * chronic atrial fibrillation * mechanical cardiac assistance * uncontrolled blood pressure (map \< 65 mmhg)
wristart total wrist arthroplasty implant first in human study

Conditions: Wrist Osteoarthritis

Summary: the wristart implant will be implanted for the first time in humans' wrists


Eligibility criteria:
inclusion criteria: 1. subjects suffering from one the following conditions: 1. osteoarthritis (oa) of the wrist joint due to various causes (age, trauma, avascular necrosis) 2. rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint 3. unrepairable previous intraarticular fractures of the distal radius, scaphoid or lunate bones of the wrist joint (i.e., historical fractures that were failed to fuse surgically) 4. symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of madelung's deformities etc. 5. patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion 2. patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery 3. patient rated wrist evaluation score (prwe) at baseline is above 70 points out of 100 4. visual analog pain score (vas) at baseline is above 70 points out of 100 exclusion criteria: 1. patients younger than 18 years old 2. patients for whom bone growth did not complete yet 3. paralytic hand patients 4. patients with sensitivity to titanium (add/change materials as needed) 5. cerebral palsy patients with wrist joint contracture and loss of sensation in the hand 6. low quality of capitate bone and/or excessively short capitate bone (≥50% destruction) due to various causes (avn, comminuted fracture, lytic lesions, congenital etc.)
integrated functional evaluation of the cerebellum

Conditions: Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 7

Summary: one of the main objectives of this project is to validate potential biological, clinical and/or imaging biomarkers in sca patients through a multimodal assessment, for future asos trials.

spinocerebellar ataxias (scas) are autosomal dominantly inherited neurological disorders, characterized by a predominant atrophy of the cerebellum and the brainstem. the most common forms are caused by abnormal cag repeat expansions, encoding elongated polyglutamine (polyq). nowadays, no preventive or curative treatments are available but different therapeutic approaches are ongoing. antisense oligonucleotides (asos) therapy showed promising results in huntington disease (hd), a disease that shares with the scas the same mutational mechanism. asos are currently under development for scas. however, in scas, clinical scales as an only criteria to monitor a treatment are not appropriate because of the lack of sensitivity of change and the small number of patients available. the importance to dispose of outcome measures to inform about the efficacy of a treatment is fundamental as well as of new alternative designs to conduct a clinical trial in rare diseases with small sample sizes. a comprehensive, multimodal approach is hence needed to provide a translational and integrated overview of cerebellar dysfunction in polyq scas over a year.

Eligibility criteria:
common inclusion criteria for all participants: * ability to walk independently 30 foot without an assistive device * able to stand unassisted for 30 seconds * affiliated with the french social security, or a social security equivalent, if they are not french. * capacity to consent * signed informed consent by the subject * ability to undergo mri scanning inclusion criteria for sca patients: * genetic diagnosis of sca 2 or 7 (available cag repeat length) * sara score ≤15 inclusion criteria for control participants: * negative genetic diagnosis of sca2/sca7 available * no significant neurological symptoms * sara score \< 5 common inclusion criteria for elective participant for csf sampling: • ability to undergo a lumbar puncture exclusion criteria * subjects currently receiving, or having received within 2 months prior to enrolment into this study, any investigational drug * pregnancy or breastfeeding * genotype consistent with other inherited ataxias * changes in coordinative physical and occupational therapy for ataxia 2 months prior to study participation * concomitant disorder(s) or condition(s) that affects assessment of ataxia or severity of ataxia during this study * contra-indications to mri examination * person deprived of their liberty by judicial or administrative decision

Keywords: spinocerebellar ataxia multimodal approach biomarker antisense oligonucleotides (asos) therapy
predictive power of share wave fibro scan in hcc after hcv infection

Conditions: Hepatocellular Carcinoma

Summary: shear wave electrography score allows stratification of hcc risk in a noninvasive and reliable way and can guide the surveillance strategy for hcc in patients with cld

liver fibrosis is common to all chronic liver disease (cld) , with time, this progressive disruption of hepatic architecture can develop into cirrhosis, characterized by "diffuse conversion of normal liver architecture into structurally abnormal nodules", about1% to 4% of patients with hcv-induced liver cirrhosis are diagnosed with hcc each year . the historical gold standard for quantifying fibrosis is liver biopsy, but its invasive nature and potential for complications make it unpopular among patients and impractical for serial assessments of cld. furthermore, since histological lesions are not uniformly distributed across the liver parenchyma, this allows for large sampling error. the need for credible alternatives to biopsy has stimulated research into non-invasive methods of fibrosis assessment, including serum biomarkers , axial imaging and transient elastography. fibroscan™ (echosens, paris, france) allows a non-invasive liver stiffness measurement (lsm), it is a relatively simple, highly reproducible and operator independent technique which examines an area 100 times that of a biopsy, reducing sampling bias , shear wave elastography (swe) measures ls by quantifying the velocity of shear waves produced in the liver tissue and uses a normal b-mode ultrasound probe for measuring ls in real time. in addition, swe imaging using the aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis .

Eligibility criteria:
inclusion criteria: * post hepatitis c with hcc exclusion criteria: * hepatic encephalopathy, ascites or pregnancy, hepatorenal syndrome or hepato-pulmonary syndrome, right side heart failure (liver congestion), extra hepatic tumors, history of liver transplantation, cholestasis, and hepatitis b patient
tpap for comfort in osa

Conditions: Obstructive Sleep Apnea

Summary: therapap is a prototype device (with full documented electrical and isolation safety) being developed by sleepres for the treatment of obstructive sleep apnea (osa) that can deliver either standard cpap at a set pressure or what is called tpap . tpap is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. the present study, therapap comfort, aims at assessing whether tpap improves patient comfort vs. cpap during supine wakefulness.

the therapap comfort study is an in-office study to assess comfort of tpap vs. cpap in cpap-naïve patients with osa during supine wakefulness. patients will be recruited after routine outpatient visits. they will be asked to breath normally for approximately 1 minute in supine wakefulness while being administered background cpap (at 9 or 13 cmh2o) or tpap at various pressure drops. tpap drops will be administered in a paired comparison before or/and after each corresponding cpap level, according to a randomized design. eventually, 6 one-to-one comparisons (tpap vs. corresponding background cpap or tpap vs. tpap) will be made, 3 per each randomized order. as an example, cpap 9 will be compared to tpap 1/1 cmh2o drops; cpap 9 will be compared to tpap 2/2 cmh2o drops; and tpap 1/1 cmh2o drops will be compared to tpap 2/2 cmh2o drops in a random sequence.

Eligibility criteria:
inclusion criteria: * 18 - 70 age range * ahi (apnea/hypopnea index) \> 10 on a previous hst (home sleep test) * cpap-naive participants * bmi (body mass index) \>= 18 kg/m\^2 exclusion criteria: 1. current clinically significant sleep disorder other than osa (obstructive sleep apnea) of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central ahi \> 5 events/h). 2. any chronic lung diseases. 3. chronic oxygen therapy. 4. a serious illness or infection in the past 30 days as determined by investigator. 5. patients with hypoglossal nerve stimulation implant. 6. any non-previously mentioned vulnerable population. 7. any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.

Keywords: cpap comfort
deflazacort in dysferlinopathies

Conditions: LGMD2B; Miyoshi Myopathy; Dysferlinopathy

Summary: the present study is designed to assess the natural history in a one year pre-phase of the trial and evaluate therapeutic efficacy and side effects of deflazacort in lgmd2b/mm patients in a placebo-controlled trial. furthermore, long-term development of the disease under naturalistic conditions will be documented in a 2-year follow-up after the end of the double-blind treatment phase.

limb girdle muscular dystrophies (lgmds) are a genetically heterogeneous group of disorders encompassing various genetically defined subtypes (lgmd 2a-2h). therapeutic trials should address each disease entity separately to assess effectiveness of medical treatments. a placebo-controlled trial in patients with dysferlinopathy may reveal insights in the natural course of the disease and show therapeutic options in a homogeneous group of patients. so far, steroids are the only drugs showing efficacy in muscular dystrophies, mainly in duchenne muscular dystrophy (dmd). both dystrophin and dysferlin are attached to the sarcolemma and deficiency of both proteins cause sarcolemmal defects; therefore, any membrane-stabilizing steroid effect may be beneficial in both dmd and lgmd2b/ myoshi myopathy (mm). furthermore, there is marked inflammation in muscle biopsies of many lgmd2b patients. therefore, the anti-inflammatory effect of steroids may improve muscle function in lgmd2b/mm. in our trial, effects of deflazacort in patients with dysferlinopathy (lgmd2b/mm) on strength and daily-life activities are addressed. the present study is designed to assess the natural history and evaluate therapeutic efficacy and side effects of deflazacort / placebo in lgmd2b/mm patients. although no major therapeutic breakthrough has been achieved and curative treatment modalities are not yet applicable, life expectancy and quality of life of dysferlinopathy patients could be remarkably improved by establishing a drug therapy, capable of delaying the dystrophic process and improving muscle strength and function. therefore, the results of this study are warranted and may influence further guidelines for steroid treatment in dysferlinopathies. furthermore, the assessment of the natural history of the disease will provide new insights in the clinical understanding of dysferlinopathies.

Eligibility criteria:
inclusion criteria: * clinically, histologically, immunohistochemically and genetically defined muscular dystrophy with dysferlin-deficiency (lgmd2b/mm). * patients should fulfill clinical, morphological, immunohistochemical and immunoblot criteria of lgmd 2b and definite mutation in dysferlin gene. * there is no limitation on age for study inclusion. exclusion criteria: * patients confined to bed or wheelchair. * patients with other neurologic or internistic diseases and patients with former or current steroid treatment will not be included. * exclusion criteria during the trial are withdrawal of informed consent or lack of compliance.

Keywords: muscular dystrophy therapy steroids deflazacort dysferlinopathy lgmd mm
clinical pathways for the management of acute coronary syndromes - phase 3,cpacs-3

Conditions: Acute Coronary Syndromes

Summary: the burden of chronic, non-communicable disease, of which cardiovascular disease comprises a significant component, has increased rapidly and substantially in china over recent years. over the coming decades china is predicted to experience a 69% increase in acute coronary disease(acs), amounting to nearly 8 million additional events. a recent randomized trial of more than 15,000 patients with acute coronary syndromes, the second phase of clinical pathway for acute coronary syndromes in china (cpacs-2) study, showed that a quality improvement initiative could improve aspects of hospital care, including the proportion of patients discharged on appropriate medication. the study also identified a number of barriers to improved care including out of pocket costs and administration systems. however, the study was not able to determine the impact on clinical outcomes or the cost-effectiveness of the intervention. the aim of the third phase of the clinical pathway for acute coronary syndromes in china (cpacs-3) study is to determine whether a complex intervention comprising a clinical pathway for acs management in combination with a number of physician and patient-oriented education tools can improve the quality of care and health outcomes among acs patient admitted to resource-limited (provincial) hospitals. the effectiveness of the intervention will be evaluated using a cluster randomized trial (stepped wedge design) of acs patients admitted to 104 hospitals in china. the study will incorporate two additional components (1) a qualitative substudy to identify the barriers and enablers to improved care and (2) a study comparing the cost-effectiveness of the intervention compared to usual care, from the perspective of the health care provider. the study will be conducted in conjunction with the chinese ministry of health and the chinese society of cardiology. the findings from cpacs3 will be able to inform health policy-makers about the extent to which quality improvement initiatives can reduce the risk of death and disability among the millions of acs patients admitted to hospitals in china each year.


Eligibility criteria:
inclusion criteria: * admitted to participating hospitals * diagnosed as acute coronary syndromes(acs) at the time of death or discharge * aged 18 years or older exclusion criteria: * death happened within 10 mins after arriving hospital * acs happened during hospitalization due to other health problem * patients already registered in the database

Keywords: quality of care acute coronary syndromes (acs)
a dose ranging study to compare the safety and efficacy of aliskiren 150mg, 300mg, and 600mg to placebo in patients with high blood pressure.

Conditions: Hypertension

Summary: evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined exclusion criteria may apply.

Keywords: hypertension, aliskiren, blood pressure, placebo
cutaneous and systemic reactions to metal implants

Conditions: Dermatitis, Allergic Contact

Summary: the purpose of this study is to evaluate if metal patch testing in metal allergic patients is useful for predicting the development of allergic skin disease or systemic symptoms in patients who recieve a metal orthopedic implant.

this prospective cohort study will enroll patients with a history of metal allergy who require implantation of a metal orthopedic device. patients will be followed for one year after surgery to determine if any symptoms including rash, itch, joint pain, joint swelling, and/or joint failure develop post implantation. patients will be recruited from two sites: (1) divisions of orthopedics and allergy \& immunology, winthrop university hospital, and (2) division of immunology, and allergy section, university of cincinnati medical center.

Eligibility criteria:
inclusion criteria 1. age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder) 2. able to undergo patch testing exclusion criteria 1. patients on oral immunosuppressant medications within 4 weeks of patch testing or topical corticosteroids to the back within 1 week of patch testing 2. patients who are pregnant or breastfeeding

Keywords: metal allergy