Kornimate/medical-research-clean huggingface dataset:
a comparative trial of valacyclovir hydrochloride ( 256u87 ) and acyclovir for the suppression of anogenital herpes infections in hiv-infected patients

Conditions: Herpes Simplex; HIV Infections

Summary: to determine the safety and efficacy of oral valacyclovir hydrochloride ( 256u87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in hiv-infected patients with cd4 counts = or \> 100 cells/mm3.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection with cd4 counts = or \> 100 cells/mm3. * documented culture of anogenital herpes simplex virus (hsv) within the last 5 years. * history of recurrent anogenital hsv infection, with a recurrence (with or without culture) within 1 year prior to study. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy. concurrent medication: excluded: * systemic antiherpes medication. * interferon. patients with the following prior conditions are excluded: history of hypersensitivity to acyclovir.

Keywords: acyclovir acquired immunodeficiency syndrome aids-related complex antiviral agents anus diseases herpes genitalis
comparison of vasodilator response of inhaled epoprostenol and inhaled nitric oxide

Conditions: Pulmonary Hypertension

Summary: the overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in ph, and to further characterize the relationship of vasoreactivity to disease severity and ph phenotype.


Eligibility criteria:
inclusion criteria: * mpap ≥ 21mmhg, pawp ≤ 25mmhg, and pvr ≥3 wu * classified as who group i-iii pulmonary hypertension exclusion criteria: * who group iv and v pulmonary hypertension * patients who are on baseline pulmonary vasodilator medications * severe aortic or mitral valve disease * patients who are pregnant * left ventricular ejection fraction of \<35% * patients who are hospitalized as inpatients at the time of rhc * patients with systolic blood pressure \<90mmhg or mean arterial pressure of \< 60mmhg
a study to evaluate satisfaction of the personal health record platform for chronic patients in emergency department

Conditions: Emergencies, Chronic Disease

Summary: the investigators developed the service showing patient health record altogether which is managed by each hospital separately and recording the patient health information based on mobile application. this study is a multi-centered study involving two hospitals, providing services to patients, care givers and medical staffs. after the participants use this service, the investigators evaluate the effectiveness and satisfaction of this service through questionnaires and in-depth interviews.

\ emergency situations for chronic patients are increasing due to aging, eating habits and lifestyle changes. for chronic patients, comprehensive health records and utilization are important for health care and emergency situations. in particular, in the event of an emergency, information on the patient's personal health records, such as recent surgery records, disease history, prescription and dosage history is needed immediately, but it is difficult to check separately for each hospital. in addition, in emergencies, it may take more time for proper treatment to take place if patients themselves cannot directly talk about their medication or past surgical history, or if they are unable to communicate with patients. recently, conditions have been prepared for the collection and utilization of personal health record information due to changes in policy and technology environment, making it possible to provide services for emergency patients with chronic diseases. \ to establish a service for collection and utilization of medical records (care, examination, surgery, prescription records) and pghd for chronic patients and to evaluate its effectiveness. \ mixed methods study (questionnaires and interview) \ at the samsung medical center and the dong-a medical center. \ 400 patients(care givers) \ 1. 400 patients(care givers) are enrolled and use the personal health wallet service. (personal health record service) 2. the participants fill out questionnaire to evaluate the service 3. some of them are invited for an in-depth interview.

Eligibility criteria:
\ * a chronic patient (or his or her care giver) who visits the emergency department and has a plan to visit outpatient or other hospitals in one month of the visiting emergency department. * adults over 19 years old. * those who voluntarily agreed to participate in the research \ * anyone who disagrees with this study * patients who are not conscious when leaving the emergency room, patients who are not aware of or are not aware of their orientation, patients who are not aware of their level of awareness, or people who are in shock or in deep shutdown situations) (even in the above cases, caregivers can be included in the clinical trial target if they are present. )
obesity, sleep apnea, and insulin resistance

Conditions: Insulin Sensitivity; Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) and type 2 diabetes confer increasing economic, social, and public health burdens in the united states. that these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with osa. among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving osa, insulin resistance, and/or insulin secretion. in a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (cpap) for 12 weeks in patients with osa. investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.


Eligibility criteria:
inclusion criteria: * healthy individuals * age 30-70 years old * bmi- 25-40 kg/m2 * must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography exclusion criteria: * any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer. * must not have previously received treatment for osa, including cpap. * must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity. * pregnancy/lactation is also an exclusion.

Keywords: obstructive sleep apnea insulin sensitivity cardiovascular risk positive airway pressure therapy
siesta (sleep of inpatients: empower staff to act) for acute stroke rehabilitation

Conditions: Sleep; Sleep Disordered Breathing; Stroke

Summary: given the critical role of sleep in enhancing neural recovery, motor learning, neuroprotection, and neuroplasticity, interventions to enhance sleep that target sleep could improve recovery and rehabilitation outcomes for stroke patients. in this proposal, a multidisciplinary group of researchers with expertise in rehabilitation medicine, sleep medicine, nursing, physical therapy, wearable technologies, and implementation science will adapt, implement and evaluate a state-of-the-art intervention to promote sleep for stroke patients undergoing acute rehabilitation. siesta-rehab, adapted from a previous unit-based intervention, bundles two sleep-promoting interventions to address the unique sleep challenges stroke patients face during acute rehabilitation: (1) nursing education and empowerment to reduce unnecessary disruptions; (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing if present during acute stroke rehabilitation.


Eligibility criteria:
inclusion criteria * individuals diagnosed with stroke admitted to the shirley ryan abilitylab (inpatient) * age 18 or older * able and willing to give written consent and comply with study procedures . medical clearance from physician exclusion criteria * serious cardiac conditions or neurological degenerative pathologies as co-morbidities (such as multiple sclerosis, alzheimer's disease, parkinson's disease, etc.) * pregnant or nursing * skin allergies or irritation; open wounds * utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or lvad)
emergency curative resection of colorectal cancer

Conditions: Colorectal Cancer; Oncologic Complications and Emergencies

Summary: the feasibility and efficacy of emergency curative resection of complicated colorectal cancer is still controversial. this prospective study aim is to assess surgical and oncologic outcomes after emergency compared to elective curative resection of colorectal cancer

60 consecutive patients presented with complicated colorectal cancer managed by emergency surgery were included and compared to another 155 consecutive patients admitted during the same period with uncomplicated colorectal cancer managed by elective surgery. both groups were compared regarding curative resection rate, early postoperative mortality and morbidity, 3-years tumor recurrence and survival rates.

Eligibility criteria:
inclusion criteria: * all patients presented with potentially operable colorectal cancer * no clinical or radiological evidence of metastatic disease exclusion criteria: * patients received preoperative chemoradiation * patients with clinical or radiological evidence of metastatic disease * patients with intraoperative evidence of metastatic disease * patients with intraoperative evidence of irresectable disease * patients with incomplete follow up

Keywords: complicated colorectal cancer curative resection surgical and oncologic outcomes
assessment of bronchial obstruction in adolescents with hiv

Conditions: HIV

Summary: in children, data from the literature find a higher prevalence of asthma in the population treated for hiv. bronchial hyperreactivity, indicative of chronic inflammation and bronchial obstruction, is also present. screening for early peripheral obstruction could therefore make it possible to initiate appropriate anti-inflammatory treatment, if necessary, and early preventive management.

in adults chronically infected with hiv, there is an increased prevalence impaired respiratory function, with a greater occurrence of copd than in the uninfected population. in children, data from the literature find a prevalence of greater atopy in the hiv-infected pediatric population. furthermore, a bronchial hyperreactivity or even peripheral bronchial obstruction, indicative of a local chronic inflammation has been found in young adolescents treated since the birth for hiv infection in utero. screening for early peripheral obstruction in hiv-infected adolescents could therefore make it possible to initiate, if necessary, a anti-inflammatory treatment, and early management to prevent the occurrence of impaired respiratory function in adulthood for this this single-center prospective study chose to perform respiratory function explorations with forced oscillometry with the endpoint main factor of the peripheral obstruction the r5hz parameter expressed in % predicted. patients from 11 to 25 years to whom it was proposed added to that to answer a questionnaire of respiratory quality of life

Eligibility criteria:
inclusion criteria: * children over 11 and under 25-year-old infected with hiv and on antiretrovirals and followed up at robert debré hospital for this pathology * consent of the holders of parental authority and patients informed and not objecting to participate in research exclusion criteria : • * age ≤ 11 years old * not treated for hiv * patients under guardianship / curatorship

Keywords: antiretrovirals
multifactorial intervention on diabetes (midiab study)

Conditions: Diabetes Mellitus, Type 2

Summary: the prevalence of diabetes mellitus has been increasing in recent decades in china, and vascular complication is the major burden in patients with type 2 diabetes. previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the chinese diabetes society and other national guidelines recommend an integrated multifactorial treatment approach. in this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. 35-75 years old; 2. diagnosed as type 2 diabetes according to the criteria of the world health organization in 1999. exclusion criteria: 1. type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes; 2. acute cardiovascular or cerebrovascular accidents within past 3 months; 3. severe hepatic or renal dysfunction; 4. malignant tumor; 5. allergic history or contraindication for any drugs in trials; 6. taking part in other clinical trials; 7. obviously poor compliance.

Keywords: type 2 diabetes mellitus diabetic vascular complications multifactorial intervention digital and network management
a study of v503 given concomitantly with menactra™ and adacel™ in 11 to 15 year olds (v503-005)

Conditions: Human Papillomavirus Infection

Summary: this study will evaluate the tolerability and immunogenicity of administration of the first dose of v503 at the same time as menactra™ and adacel™ versus administration of v503 one month prior to administration of menactra™ and adacel™.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject's parent/legal guardian can read, understand, and complete the vaccine report card * subject is not sexually active and does not plan on becoming sexually active during the study * subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years) exclusion criteria: * subject has a known allergy to any vaccine component of v503, menactra™, or adacel™ * subject has a condition that is a contraindication to vaccination with menactra™ or adacel™ * subject has any coagulation disorder * female subject is pregnant * subject is immunocompromised or immunodeficient * subject has had a splenectomy * subject has received immunosuppressive therapies in the prior year * subject has received any immune globulin product or blood-derived product in the last 3 months * subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination * subject has received a marketed hpv vaccine or has participation in an hpv vaccine trial * subject has received a meningococcal vaccine * subject has a fever \>= 100f within 24 hours of vaccination * subject has a history of hpv
olfactory odour stimulation for metabolism control

Conditions: Obesity

Summary: in this preliminary short-term study it is investigated, whether a short olfactory stimulation with d-limonene leads to an acute improvement of glucose metabolism in patients with obesity.


Eligibility criteria:
inclusion criteria: * age 18-70 years * obesity (bmi ≥35 kg/m2) * written informed consent * normosmia (defined by sniffin sticks test) exclusion criteria: * known allergy to d-limonene, citrus fruits, citrus flavours, slvo * regular smoking * current illicit drug abuse including daily marijuana and cannabidiol (cbd) consumption (alcohol ≤2 drinks per day allowed) * diabetes mellitus * pre-treatment with insulin sensitizing drugs including glp-1 analogues * history of neurodegenerative diseases, severe head trauma * severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2) * known liver cirrhosis or other severe liver impairment * acute upper respiratory tract infection * uncontrolled dysthyroidism * uncontrolled hypertension * regular use of psychopharmaceutic drugs * patient aims to start a new diet or exercise program during the study * bariatric surgery * pregnancy/lactation * symptoms of menopause * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * participation in an interventional study within the last 3 months

Keywords: d-limonene lavender oil (slvo) olfactory stimulation obesity glucose metabolism
to assess the efficacy of the investigational products compared to placebo in participants with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis


Eligibility criteria:
inclusion criteria: * male and female participants at least 40 years of age * ipf diagnosed based on ats/ers/jrs/alat ipf 2018 modified guidelines * fvc ≥45% predicted * dlco, corrected for hemoglobin, ≥25% predicted (inclusive) * unlikely to undergo lung transplantation during this trial in the opinion of the investigator * if a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization exclusion criteria: * airway obstruction (i.e. prebronchodilator fev1/ fvc \< 0.7) or evidence of a bronchodilator response at screening * emphysema \>20% on screening hrct * fibrosis \<10% on screening hrct * clinical diagnosis of any connective tissue disease * clinically diagnosed acute exacerbation of ipf (ae-ipf) or other significant clinical worsening within 3 months of randomization additional protocol-defined inclusion / exclusion criteria may apply.
validation of tearlab osmometer - human factor usability report

Conditions: Dry Eye Syndromes

Summary: the objective of this study is to validate the performance of the ocusense tearlab™ osmolarity test when performed in physician office laboratories (pol) by health care professionals using human tear fluid collected from volunteer subjects and contrived tear samples.

to validate the performance and usability of the tearlab osmometer, specifically human factor usability, when used in the hands of intended users, i.e. ophthalmology and optometry clinics. this testing is required to insure that the osmolarity system meets the product requirements and for completion of the technical file, design history file and fda 510(k) submission.

Eligibility criteria:
inclusion criteria: * healthy volunteers representing the general population (a minimum of 120 subjects representing 50% of the total study population, * otherwise healthy volunteers previously-diagnosed with moderate or severe chronic dry eye and/or sjogrens syndrome and/or designated as dry eye disease subjects by the osdi questionnaire (a minimum of 40 subjects representing 50% of the total study population), * men or women, * adult 18 years or older, * contact lens wearers may participate, * patients having undergone refractive surgery may participate, * patients having undergone cataract surgery may participate exclusion criteria: * eye pathology other than previously-diagnosed moderate or severe chronic dry eye and/or sjogrens syndrome, use of topical medication within the last 24 hours, * eye drop usage within the last 2 hours, * ocular surface staining within the last 2 hours, * other invasive ocular diagnostic testing within the last 2 hours, * crying within the last 30 minutes, * eye makeup present on the eye lid within 10 minutes of tear collection, * examination by slit lamp within 10 minutes of tear collection.

Keywords: dry eye disease tear osmolarity tear osmolality
a study to assess long-term safety of the cypass micro-stent in patients completing the compass trial

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: the purpose of this study is to evaluate the long-term safety of the cypass micro-stent in subjects who completed study protocol tmi-09-01, compass trial.

the compass trial (tmi-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the cypass micro-stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. in the study, 505 subjects were randomized to either the cypass group, who underwent cataract surgery and received the cypass micro-stent, or the control group, who underwent cataract surgery alone. all subjects randomized were to be followed for 2 years postoperatively. four hundred eighty (480) subjects completed this study. the compass-xt (tmi-09-01-e) trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the compass trial. in compass-xt, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.

Eligibility criteria:
inclusion criteria: 1. completed the compass trial 2. understands study requirements and is willing to follow study instructions and return for study visits exclusion criteria: 1. systemic disease that would put subject health at risk and/or prevent completion of required study visits. 2. early termination from the compass trial.
post marketing surveillance (pms) study for velaglucerase alfa (vpriv) in india

Conditions: Gaucher Disease

Summary: the main aim of this study is to measure the safety and to find out the effects of vpriv in participants with gaucher disease using both retrospective and prospective data when used in the post-marketing setting and to collect genetic mutation data from participants with gaucher disease. this study is about collecting data available in the participant's medical record as well as data from each participant's ongoing treatment. no study medicines will be provided to participants in this study. when the participants start the study, they will visit the study clinic close to approximately 12 months.


Eligibility criteria:
inclusion criteria: * participants with type 1 gaucher disease prescribed vpriv according to the investigator's judgment and current indian prescribing information (pi) are eligible for this study. * participants or legally authorized representative must provide written informed consent to participate. exclusion criteria: - participants will be excluded from this study if the participant met any of the contraindications included in the current indian pi for vpriv.