Kornimate/medical-research-clean huggingface dataset:
trial to assess the ocular safety of vorapaxar (sch 530348) in participants with atherosclerosis (study p05183)

Conditions: Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident

Summary: this study is designed to evaluate the long-term ocular safety of sch 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the tra 2°p - timi 50 study (p04737) (nct00526474).


Eligibility criteria:
inclusion criteria: * evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems exclusion criteria: * the study will include participants who meet none of the exclusion criteria for the parent protocol (p04737) and also the following: * history or evidence of age-related macular degeneration on baseline evaluation * history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation * history or evidence of other retinal diseases, including retinal injury, on baseline evaluation * history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation * history or evidence of glaucoma on baseline evaluation * history or evidence of high intraocular pressure of \>22 mm hg on baseline evaluation * evidence of center foveal thickness of \>190 µm on baseline oct examination * presence of vacuoles in the retina on baseline oct
prevention of worsening renal function of intravenus albumin in heart failure patients

Conditions: Diuretics Drug Reactions; Heart Failure; With Decompensation; Albumin; Double

Summary: patients hospitalized for acute decompensation of chf are usually complicated by worsening renal function (wrf) which leads to diuretic resistance and inadequate decongestion as well as poor prognosis. wrf has been attributed to a reflex renal vasoconstriction elicited by intravascular volume depletion during brisk diuresis. the investigators hypothesize that chf patients with hepatic dysfunction are more prone to wrf due to poor albumin production. this sub-group of chf patients may benefit more (increased diuretic efficacy and protected against worsening renal function) by the use of iv loop diuretics in combination with an intravascular volume expander such as iv human albumin.

acute decompensation of chronic heart failure (chf) warranting hospital admission, defined as diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, weight gain, worsening functional class or edema) and one sign (rales, peripheral edema, ascites, increased jugular vein pressure, hepatomegaly, third heart sound gallop or pulmonary vascular congestion on chest radiography) of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization

Eligibility criteria:
inclusion criteria: 1. age over 18 yrs 2. acute decompensation of chf 3. evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography) 4. history of chf with previous use of an oral loop diuretic 5. anticipated need for iv diuretic therapy for at least 72 hours there is no pre-specified inclusion criterion with respect to ejection fraction exclusion criteria: 1. hemodynamic collapse (at least one of the following: systolic blood pressure (bp) \ = 40 mmhg for \>= 15 min, with end-organ hypoperfusion; need for inotropes (except of digoxin); need for cardiopulmonary resuscitation). 2. hepatic dysfunction of other than cardiac etiology 3. severe anemia (hb\<8 g/dl) 4. uncontrolled hypertension or hypertensive emergency/urgency 5. pulmonary edema or pulmonary congestion necessitating use of iv vasodilators 6. serum creatinine \> 3 mg/dl or glomerular filtration rate (gfr) \< 30 ml/min

Keywords: human albumin furosemide heart failure
evaluate the efficacy and safety of andrographolide sulfonate in patients with acute bronchitis

Conditions: Acute Bronchitis

Summary: a multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute bronchitis

the patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. experimental group: xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: xiyanping injection simulation(0.9% sodium chloride injection) 10-20ml/d, the treatment method is the same as the experimental group. treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped treatment).

Eligibility criteria:
inclusion criteria: * 1.18-65 years, males or females; * 2.patients met the acute bronchitis diagnosis; * 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial; * 4.patients compliance is good, written informed consent was obtained from all participants before the study. exclusion criteria: * 1.patients had a history of andrographolide sulfonate or andrographolide allergy. * 2.pregnancy, lactation, and absence of contraception in women of fertile age. * 3.judging by the researchers, past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases. * 4.after checking, patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases * 5.patients using systemic steroids or other immunosuppressive therapy * 6.patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases. * 7.patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year. * 8.patients were participated in any study of drug trials in the last 30 days. * 9.according to the researchers' judgment, anyone who are not suitable for the study.
different oral colonization of gram-negative bacteria in icu patients when using chlorhexidine at 0.12% versus chlorhexidine at 2.0%

Conditions: Chlorhexidine; Ventilator Associated Pneumonia

Summary: this study will assess the utility of different chlorhexidine mouthwash concentrations on icu patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. one group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.


Eligibility criteria:
inclusion criteria: * patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation. exclusion criteria: * patients who wish to withdraw consent and leave the study.

Keywords: chlorhexidine gram-negative colonization
longitudinal assessment of cardiovascular and metabolic parameters in obese and lean children

Conditions: Obesity

Summary: the investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age. to identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years. in addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.


Eligibility criteria:
inclusion criteria: * height -2 to +2 sds * pubertal stage adequate for age * no medications * written consent of guardians and children≥12y * weight ≥ -2 sds exclusion criteria: * secondary/syndromal obesity * known existing hypertension * chronic disease (eg. errors of metabolism) * acute illness (eg. respiratory tract infection) * previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment

Keywords: endothelial function children obesity cardiovascular dysfunction carotid intima media thickness blood pressure oral glucose tolerance test
role of sugammadex as reversal agent in patients extubated immediately after isolated coronary artery bypass grafting surgery

Conditions: Surgery; Coronary Artery Disease

Summary: the purpose of this study is to examine whether the use of sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in coronary artery bypass grafting patients. this study is a prospective, clinical interventional, randomized single blinded single-center design. the nurses in the cardiac intensive care unit will be blinded to treatment allocation (group 1 or 2).

enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures . to facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. it also expedites de-escalation of acuity of care. several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.

Eligibility criteria:
inclusion criteria: * age 18 - 70 years * american society of anesthesiology physical status i-4 * isolated coronary artery bypass graft surgery (cabg) * ability to give written informed consent exclusion criteria: * any other surgical procedure concomitant to cabg surgery * known or suspected neuromuscular disease/pre-existing weakness * creatinine clearance less than 30 ml/min * bradycardia of less than 40 beats/min * pregnancy, breastfeeding women * known or suspected allergy to bridion® (sugammadex),neostigmine, or rocuronium * patients with contraindications towards sugammadex, neostigmine, or rocuronium * patients included in another trial within the last 30 days * patients with legal guardians or surrogate decision-making * female patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex. * patients undergoing emergency surgery * patient refusal * patients with ejection fraction \<30% * patients with restrictive and obstructive lung disease * patients with obstructive sleep apnea * patients with body mass index greater than 40

Keywords: coronary artery bypass grafting surgery sugammadex
is there is a role of prophylactic therapy with tamsulosin before extracorporeal shock wave lithotripsy to avoid development of steinstrasse ?

Conditions: Kidney Stones

Summary: the purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 persons that will go to extracorporeal shock wave lithotripsy will randomize to 2 groups. group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy . group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the eswl all 2 group will take abdominal radiograph to evaluate the presence of steinstrasse.


Eligibility criteria:
inclusion criteria: * size of stone 1-2 cm exclusion criteria: * ureteral stricture presence of internal stent prior use of alfa bloker prior eswl

Keywords: size of stone 1-2 cm pt. with no use of alfa bloker prior eswl pt. without internal stent
walking program with pedometer on quality of life in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with copd. method: patients with copd were randomly assigned to pedometer group (pg) or control group (con). subjects in pg walked to target steps daily with pedometer for 6 weeks. before and after the program, the following measurements were performed: pulmonary function test (pft), daily steps, six-minute walk test (6mwt), copd assessment test (cat), and quality of life questionnaire (sf-12).

patients with chronic obstructive pulmonary disease (copd) are suffered from impaired pulmonary function and dyspnea which result to limited level of physical activity, and impaired quality of life. exercise and regular physical activity have been proven to break the vicious circle. the aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with copd. method: patients with copd were randomly assigned to pedometer group (pg) or control group (con). subjects in pg walked to target steps daily with pedometer for 6 weeks. before and after the program, the pulmonary function was assessed by spiromtery test. the exercise capacity were assessed by six-minute walking test, the physical activity level was assessed by daily steps, the quality of life was assessed by copd assessment test (cat), and quality of life questionnaire (sf-12). .

Eligibility criteria:
inclusion criteria: 1. diagnosed with copd 2. in a medically stable condition 3. able to walk unassisted 4. ≥ 40 years of age exclusion criteria: 1. oxygen therapy, 2. hemodynamic instability, 3. signs/symptoms of acute infection 4. severe neurological, musculoskeletal, or cardiovascular conditions that affect walking

Keywords: copd pedometer physical activity quality of life
safety study of dipg treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines

Conditions: Diffuse Intrinsic Pontine Glioma

Summary: the purpose of this study is to asses safety of diffuse intrinsic pontine glioma (dipg) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines evaluate the nonspecific immune response generated in peripheral blood and cerebral spinal fluid (csf) by proposed treatment evaluate the specific antitumor immunity response generated in peripheral blood and csf assess overall survival and progression free survival correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and csf quality of life evaluation


Eligibility criteria:
inclusion criteria: * newly diagnosed dipg patients without progressive disease * aged between 3 and 18 yo lansky scale \>50 (karnofsky for patients aged more than 16 yr) * life expectancy \> 8 weeks * preserved bone marrow function normal hepatic and renal function exclusion criteria: * impossibility to perform aphaeresis * patient participation of other experimental study within the last 3 months * patient under antitumor treatment in the last 4 weeks * co-morbidity that does not allow the study treatment * patients requiring \> 2mg/day of dexamethasone treatment corticoid-dependent patients * patients under uncontrolled infection * positive serologies of hiv, hepatitis c virus (hcv) or hepatitis b virus (hbv)
mantram repetition meditation for veterans with ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: the aim of this study was to determine the usefulness of a portable, meditation-based intervention called the mantram repetition program (mrp) for veterans with military-related posttraumatic stress disorder (ptsd). this study compared the individual delivery of the mrp to individual delivery of present-centered therapy (pct) at two sites in san diego, california, and bedford, massachusetts.

the investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the mantram repetition program (mrp) by offering it as a stand-alone intervention, compared to an attention control condition of present centered therapy (pct) in a diverse sample of veterans with post-traumatic stress disorder (ptsd). primary outcomes included clinician-assessed and self-reported ptsd symptom severity. secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the department of veterans affairs healthcare system.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * read and write english fluently * traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma * transportation to attend meetings and available to complete study protocols * stable dose and type of ptsd medications for at least 6 weeks (per chart review) * willing to track medication changes during study exclusion criteria: * inability to give informed, voluntary consent * cognitive impairment sufficient to cause inability to complete the protocol * psychotic symptoms * dementia or other organic mental disorders that may cause inability to complete the protocol * significant documented alcohol/substance abuse * presence of severe suicidal urges or intent * residence in a geographical area outside of san diego county or bedford, massachusetts area * current daily practice of any skills of any meditation-based program - including, but not limited to: * transcendental meditation (tm) * yoga * tai chi * qi-gong * vipassana or insight meditation * loving-kindness or compassion meditation * mindfulness-based stress reduction (mbsr) or other mindfulness program * guided imagery * mantram repetition * passage meditation * walking meditation * zen or buddhist meditation * self-hypnosis, bio-feedback, etc. * other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.

Keywords: complementary therapy stress disorders, post-traumatic veterans health clinical trials, randomized mindfulness spirituality meditation mind-body therapy
the effects of isoflavone and estrogen in sex response in climacteric women

Conditions: Postmenopausal Symptoms

Summary: climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. additionally, these symptoms impair sexual life and life quality. these effects can be counteracted by administration of estrogen therapy. however, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. the aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified mccoy's sexual questionnaire.


Eligibility criteria:
inclusion criteria: * women aged 45-65 years old * presenting climacteric symptoms * sexual complaints exclusion criteria: * hormonal therapy * counter indication to hormonal therapy * uncontrolled comorbidities

Keywords: climacterium sexual life isoflavone estrogen mccoy's sexual questionnaire kupperman index
pulmonary embolism and stroke in patient with patent foramen ovale

Conditions: Recent Stroke; Pulmonary Embolism; Patent Foramen Ovale

Summary: the cause of ischemic stroke remains frequently unknown. in patients with patent foramen ovale (pfo), the link between pfo and stroke is unclear. the investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

inclusion criteria : * age \> 18 years old * confirmed pulmonary embolism * informed consent * social ensured exclusion criteria : * pregnancy * age \< 18 years old * protected major person (in sense of public health) * consent refused * mri contraindications

Eligibility criteria:
inclusion criteria: * age \> 18 years old * confirmed pulmonary embolism * informed consent * social ensured exclusion criteria: * pregnancy * age \< 18 years old * protected major person (in sense of public health) * consent refused * mri contraindications

Keywords: patent foramen ovale pulmonary embolism stroke
a detailed look at what patients experience in medullary thyroid cancer clinical study

Conditions: Medullary Thyroid Cancer

Summary: clinical studies, with a distinct emphasis on medullary thyroid cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition. these trials serve as essential tools to determine whether new medications surpass conventional therapies, providing substantial evidence to endorse their broader adoption. the primary objective is to meticulously examine trial completion rates and voluntary withdrawals within this specific patient group. by actively participating in this observational study plays a critical role in pushing medical knowledge forward and advancing care for individuals suffering from the medullary thyroid cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of medullary thyroid cancer * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * no serious medical or psychiatric illness likely to interfere with participation in this clinical study. exclusion criteria: * is pregnant, breastfeeding or expecting to conceive within the projected duration of the study * any serious and/or unstable pre-existing medical disorders * patients who are currently receiving any other investigational drug.

Keywords: medullary thyroid cancer
multimodal pain management following primary tka

Conditions: Pain

Summary: the investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cfnb) vs. liposomal bupivacaine (lb) vs. periarticular infusion cocktails (pic) following primary total knee arthroplasty (tka). in addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.


Eligibility criteria:
inclusion criteria: * ≥ 40 years old * scheduled for primary total knee arthroplasty exclusion criteria: * opiate tolerant (≥60mg/day oral morphine/equivalent for ≥1 week) * neuromuscular deficit affecting the lower limbs * peripheral neuropathy * radiculopathy/sciatica * known allergy or intolerance to bupivacaine or ropivacaine * hepatic disease * renal disease/patients needing dialysis * planned unicompartmental knee replacement * less than 90 degree of knee flexion preoperatively. * patients who lack the capacity to consent or are unwilling to do so * at the discretion of the pi, patients who may have difficulty complying with standard of care (soc) followup may also be excluded

Keywords: primary total knee arthroplasty