Kornimate/medical-research-clean huggingface dataset:
risk markers of arterial aging. the paris prospective study iii-2

Conditions: Arterial Stiffness

Summary: the main objectives of pps3-2 are (i) to describe the dynamics of vascular aging and baroreflex sensitivity 12 to 16 years a part, (ii) to identify their determinants, and (iii) to quantify the subsequent risk of cardiovascular diseases.

since may 2008, pps3 is being following the cvd morbidity of 10157 healthy volunteers aged 50-75 years at baseline. in pps3-2, we plan to re-invite survivors and volunteers of pps3 to undergo a second physical examination. in particular, they will undergo a second high-precision carotid echotracking to measure vascular aging parameters and baroreflex sensitivity, permitting to study their respective dynamics. they will also underwent for the first time ultra fast echo of the radial artery to measure vascular aging parameters of the medium-sized arteries. according to fundings, blood samples will be taken and stored at -80°c in the whole population or in a subsample.

Eligibility criteria:
inclusion criteria: * being enrolled in pps3 and having signed an informed consent for pps3-2 exclusion criteria: * institutionalized participants * participants under guardianship * participants under judicial safeguard measure

Keywords: risk factors cohort cardiovascular diseases
a post-market clinical study to collect safety and performance data on johnson & johnson surgical vision products

Conditions: Refractive Error; Glaucoma; Cataracts; Clear Lens Exchange

Summary: retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility criteria:
inclusion criteria: 1. patients who have been implanted with and/or undergone ophthalmic surgery using targeted jjsv products 2. status post ophthalmic surgery between 1 day and 24 months for year 1. subsequent years after year 1 will be between 1 day and 18 months. exclusion criteria: 1. concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial 2. use of surgical devices not in accordance with the product labeling or indications for use 3. degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logmar (0.63 decimal, 6/9.5 or 20/32 snellen) during the retrospective data collection period 4. use of systemic or ocular medications that may affect vision during the retrospective data collection period 5. known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period 6. pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.
mentor wellness program

Conditions: Traumatic Brain Injury

Summary: this randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (tbi). participants will be randomized at enrollment into two groups: immediate treatment (it) and delayed treatment (dt) group. this study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (sdoh).


Eligibility criteria:
inclusion criteria: * have a medically-documented (e.g., ems report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe tbi requiring admission to an acute inpatient rehabilitation unit * be at least 12 months post-tbi * have access to the internet on a computer, tablet, and/or smartphone. * speak and understand english or spanish * agree to participate * are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study exclusion criteria: * no history of complicated-mild, moderate, or severe tbi * less than 12 months post-tbi * in minimally conscious or vegetative state * beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible) * in the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection * in the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection

Keywords: traumatic brain injury tbi brain injury wellness physical activity nutrition chronic mindfulness
avalglucosidase alfa extension study

Conditions: Glycogen Storage Disease Type II Pompe Disease

Summary: primary objective: long-term safety and pharmacokinetics (pk) of avalglucosidase alfa secondary objective: long-term effect of avalglucosidase alfa on pharmacodynamic variables

the planned duration of the study for each participant was initially 6 years. each participant continued with the study until the participant withdrew, the investigator withdrew the participant, or the sponsor terminated the study. an additional follow-up phase began after the participant has completed the 6-year study period, and lasted until avalglucosidase alfa was approved in the participant's country, except in the united kingdom (uk), germany and denmark, where the duration of the additional follow-up phase was up to the approval in the country or limited to a maximum of 2 years, whichever occurred first (ie, for participants in the uk, germany and denmark, the total study duration per participant was 8 years at the maximum including the initial 6-year period and the additional 2-year follow-up).

Eligibility criteria:
inclusion criteria: participants with pompe disease who previously completed an avalglucosidase study. the participant and/or their parent/legal guardian is willing and able to provide signed informed consent, and the participant, if \<18 years of age, was willing to provide assent if deemed able to do so. the participant (and participant's legal guardian if participant is \<18 years of age) must have had the ability to comply with the clinical protocol. the participant, if female and of childbearing potential, had to have a negative pregnancy test \[urine beta-human chorionic gonadotropin\] at baseline. exclusion criteria: the participant was concurrently participating in another clinical study using investigational treatment. the participant, in the opinion of the investigator, was unable to adhere to the requirements of the study. the participant had clinically significant organic disease (with the exception of symptoms relating to pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, precluded participation in the study or potentially decreases survival. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
self-managing hiv and chronic disease

Conditions: HIV/AIDS

Summary: the purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with hiv/aids and other chronic conditions.

450 adult hiv+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book living well with hiv \& aids. letters will be sent by aids service organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. posters and brochures will also be posted in public areas of the asos. the individualized intervention combines problem-solving, with motivation and self-management. this trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific hiv behavioral outcomes and non-disease-specific outcomes.

Eligibility criteria:
inclusion criteria: * age 50 years or older * hiv-positive serostatus * currently prescribed antiretroviral medication * antiretroviral nonadherence reported in past 30 days * provision of oral informed consent exclusion criteria: * hearing problems that preclude participation in a telephone study * presence of probable dementia or acute psychosis detectable by screening interview

Keywords: complementary therapies
efficacy and safety of paclitaxel-eluting balloons for below the knee peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: comparing the efficacy and safety of drug-eluting balloons (deb) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (ba).

over the past decade, percutaneous transluminal angioplasty (pta) has established its position in the treatment of below the knee arterial occlusive disease with intermittent claudication and/or critical limb ischemia. however, the efficacy of percutaneous transluminal angioplasty (pta) with conventional balloons, is limited by the high 12-month restenosis and target lesion revascularization (tlr) rates. local delivery of newer anti-proliferative drug via drug-eluting balloons (debs) has recently shown promising results in the treatment of femoropopliteal disease, and in the btk area, a reduction in 3-month binary restenosis has been observed compared with historical controls treated with pta. drug eluting balloon has three potential advantages: (1) homogenous drug transfer to the vessel wall; (2) highest drug concentrations at the vessel wall at the time of injury; and (3) absence of a stent or delivery polymer. this study sought to investigate the long-term efficacy and safety of new drug (paclitaxel)-eluting balloons (deb) for the treatment of below the knee peripheral arterial disease.

Eligibility criteria:
inclusion criteria: 1. patients with peripheral vascular disease with or without diabetes. 2. rutherford class 2-6. 3. target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention. 4. target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length. 5. written informed consent signed by the patients or representatives exclusion criteria: 1. previous bypass surgery or stent placement at the ipsilateral lower limb 2. history of intolerance to antiplatelet therapy, heparin, or contrast media. 3. bleeding diathesis; 4. active systemic bacterial infection; 5. severely impaired renal function (serum creatinine level \> 2.5 mg/dl. 6. expected survival time of less than 24 months
effect of tamsulosin on stone expulsion and pain resolution in ed patients with ureterolithiasis

Conditions: Kidney Stone

Summary: tamsulosin (flowmax)is approved by the fda for the treatment for enlarged prostate. several studies regarding the use of tamsulosin for the treatment of lower kidney stones have been carried out in the non-emergency department setting. this study will compare tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. the purpose of this study is to compare the usefulness of tamsulosin versus placebo on time to stone passage and pain relief in emergency department patients with kidney stones.


Eligibility criteria:
inclusion criteria: * 18 y.o. or older * diagnosed with a kidney stone less than or equal to 10 mm determined by ct scan * physician has made the decision that you will be discharged to home * must be able to take study medication for up to 10 days and strain your urine * must be able to keep a record of pain medication taken and complete a pain scale rating exclusion criteria: * patients currently taking: tamsulosin (flowmax), calcium channel blockers, beta blockers, alpha blockers, sildenaphil (viagara), tadalaphil (cilias), warfarin (coumadin, jantoven), cimetidine (tagamet, tagamet hb) * patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever * patient known to have hypersensitivity to tamsulosin * patient history of cataract surgery * inability of patient to perform visual pain scale * allergy or intolerance to acetaminophen/oxycodone * patient is unable to understand informed consent * prisoners

Keywords: kidney stone ureterolithiasis tamsulosin flowmax emergency department
effect of intravenous metochlopramide prophylaxis on gastric volume

Conditions: Aspiration Prophylaxis

Summary: gastric fluid volume and ph in patients undergoing cesarean section are essential considerations for general anesthesia (ga). increased gastric volume and low ph of gastric contents could predispose the risk of aspiration pneumonitis. the present study explored the research question "whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under ga

since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). the administration of intravenous anaesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. moreover, a high level of sedation also reduces the tone of the les (lower oesophageal sphincter). both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anaesthesia. the risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml and its ph falls below 2.5. however, the risk of aspiration significantly decreases in "fasted" outpatients. since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis is not recommended anymore. the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the ph of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p\ 25 ml) and low ph (\<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p\<0.05) .

Eligibility criteria:
inclusion criteria: * pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate. exclusion criteria: * a neurological and psychological disorders * renal or hepatic diseases * chronic gastroesophageal reflux diseases * refusal to consent

Keywords: metoclopramide cesarean section ultrasound gastric volume
hip fracture study of gsk576428 (fondaparinux sodium)

Conditions: Thromboembolism

Summary: this study is requested by pmda to confirm the efficacy and the safety for hfs.


Eligibility criteria:
inclusion criteria: * patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma). exclusion criteria: * active, clinically significant bleeding (excluding drainage).

Keywords: xa factor vte mosll pentasaccharide
prospective observation of wound healing with prevena incision management system

Conditions: Scarring

Summary: this study aims to assess the quality of wound healing in abdominal scars with and without the prevena incision management system. the hypothesis is that prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

the quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. this study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. the technology may provide benefits even in lower risk patients.

Eligibility criteria:
inclusion criteria: * abdominal procedure with incision \>20cm * must be \>18 years of age exclusion criteria: * \<18 years of age * history of allergy or reaction to adhesives * pregnant or anticipated pregnancy within 6 months

Keywords: prevena negative pressure wound therapy incisional wound vac
a study of ly900014 in elderly and younger adult participants with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to compare ly900014 with insulin lispro (humalog) in elderly and younger adults with type 1 diabetes mellitus. screening is required within 28 days prior to the start of the study. for each participant, the total duration of the clinical trial will be between 3 to 8 weeks.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 1 diabetes mellitus (t1dm) * have a body mass index (bmi) of 18.5 to 30.0 kilogram per meter square (kg/m²) * have a glycated hemoglobin (hba1c) less than (\<)9.0 percent (%) * have had no episodes of severe hypoglycaemia in the last 6 months exclusion criteria: * have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from t1dm), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data * have a history of renal impairment * have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives * have proliferative retinopathy or maculopathy and/or severe neuropathy
safety and immunogenicity of inactivated influenza virus vaccine among healthy children 6-12 weeks of age

Conditions: Inactivated Influenza Vaccine

Summary: study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. this study is double-blind, randomized, and placebo-controlled.

methods: a double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy us infants 6-12 weeks of age. subjects received either 2 doses of trivalent inactivated influenza vaccine (tiv, fluzone®, sanofi pasteur 2005-6 pediatric formulation) (n=915) or placebo (n=460) 1 month apart, along with indicated concomitant vaccines. solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second tiv/placebo dose. results: no significant differences were seen between tiv and placebo groups for any safety outcomes. fever ≥38oc rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of tiv vs placebo recipients. serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of tiv and 1.5% of placebo recipients; only one (hypersensitivity reaction in a tiv recipient) was considered vaccine-related. significantly increased antibody responses (p\<0.001) were seen against all 3 strains in tiv recipients by titer ≥ 1:40 or geometric mean titer (gmt) (p\<0.001). altogether, 50% of infants had antibody titers ≥ 1:40 for h1n1, 86% for h3n2, and 11% for b compared with 7%, 10%, and 0.3% in the placebo group. the reciprocal gmt for influenza recipients was 33, 95, and 11 for h1n1, h3n2, and b vs. 7, 9, and 5 for placebo recipients. over 90% of infants who received tiv had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group. conclusions: tiv administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.

Eligibility criteria:
inclusion criteria: * age 42 to 84 days on the day of inclusion * full term (born at \>=36 weeks with birth weight \>=2.5 kg * considered to be in good health * parental consent obtained and available * available for the study duration (6 months) exclusion criteria: * reported allergy to egg proteins, chicken proteins * previous history of influenza vaccination or disease * receipt of any vaccine other than hepatitis b prior to enrollment * acute illness with rectal temperature \>= 38.0 (defer enrollment) * known bleeding disorder * participation in other interventional clinical trial within 30 days prior to enrollment

Keywords: influenza vaccine infants safety immunogenicity