Kornimate/medical-research-clean huggingface dataset:
study of the vascular effects of serelaxin

Conditions: Coronary Artery Disease

Summary: this was a mechanistic study in patients with coronary artery disease on the effects of serelaxin on micro- and macrovascular function.

double blind, randomized, parallel group, placebo controlled study

Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years of age, with body weight \<160 kg. * patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, pet or spect myocardial perfusion), or invasive coronary angiography or by ct coronary angiography at any point in time in patients with or without mild left ventricular systolic dysfunction (lvsd) exclusion criteria: * previous treatment with serelaxin (also known as: rlx030, relaxin) * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. * current or planned dialysis. * impaired renal function during screening defined as an estimated glomerular filtration rate (egfr) at screening and prior to treatment of \<30 ml/min/1.73 m2, calculated using the simplified modification of diet in renal disease (smdrd) equation due to potential issue with administration of gddtpa used as the mri contrast agent. * sick-sinus-syndrome * current or history of pulmonary edema, including suspected sepsis. * restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function) * known significant valvular disease (including any of the following: severe aortic stenosis \[ava \ 50 on prior or current echocardiogram\], severe aortic regurgitation, or severe mitral stenosis). * clinical diagnosis of acute coronary syndrome (acs) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria * troponin elevation and dynamics indicative of acs at any time between screening and randomization. * previous myocardial infarction within 3 months of screening * history of coronary artery bypass graft (cabg) surgery * heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate \ 120 beats per minute) * any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease) * acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function).

Keywords: coronary artery disease
targeting hyaluronan accumulation through exercise in t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: a pilot longitudinal study to examine hyaluronan (ha) accumulation in muscles of individuals with type 2 diabetes mellitus (t2dm), and the effects of exercise on ha accumulation, muscle stiffness, strength, ankle joint mobility, and physical function. ha accumulation will be assessed non- invasively using magnetic resonance imaging.

this single-center, longitudinal design study uses mri to evaluate the mechanistic effects of exercise on skeletal muscle function. twenty-five t2dm patients will be enrolled and be prescribed a 10-week exercise program. the exercise program will comprise aerobic and resistance components; a moderate level of intensity will be calculated based on results from a maximal graded exercise test (vo2r) conducted prior to the intervention. mri data will be acquired at baseline and before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function.

Eligibility criteria:
inclusion criteria: * be between the ages of 40 and 75 * clinical diagnosis of type 2 diabetes * have a bmi less than 40 kg/m2 (due to magnet bore restrictions) * able to walk unassisted exclusion criteria: * serious cardiac pathology or musculoskeletal problems that would limit exercise ability * current open wound or history of plantar ulcer for the last 3 months * partial foot amputations * inability to ambulate without assistive device * stroke or other central nervous system pathology * stage 2 hypertension (resting blood pressure \>160 systolic or \>100 diastolic) * contraindications to 3t whole body mri scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems). * subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment * pregnant women and children
calcium electroporation for the treatment of keloids

Conditions: Keloid

Summary: the purpose of this study is to evaluate the effect of calcium electroporation on keloids.

the keloids wil be treated with intratumoral injection of calcium followed by electroporation. it is a once only treatment and the patients will be followed up for 24 months.

Eligibility criteria:
inclusion criteria: * at least 1 keloid available to electroporation. * patient should have been offered standard treatment. * at least 8 weeks since other keloid treatment. * performance status \<2 (ecog). * platelet count \>50 mia/l * international normalized ratio (inr) \<1,2. * age \>18. * patient should be able to understand participants information. * signed, informed consent. exclusion criteria: * clinically significant coagulopathy. * pregnancy or lactation. * participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Keywords: calcium electroporation calcium electroporation electrotransfer keloid
clinical trial of quantitative detection kit for hsp90α in colorectal cancer

Conditions: Colorectal Cancer

Summary: detect plasma hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

detect plasma hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of hsp90α kit.

Eligibility criteria:
inclusion criteria: * colorectal cancer patients, healthy volunteers, benign colorectal diseases patients exclusion criteria: * patients who previously accepted radiotherapy

Keywords: cancer
dihydroartemisinin-piperaquine and primaquine for uncomplicated plasmodium falciparum cases

Conditions: Malaria

Summary: artemisinin-based combination therapy (act) has been known to be controversial for stopping malaria transmission.the addition of primaquine (pq) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. a study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (dhp) regimens with or without pq on the sexual and asexual stages of p. falciparum in sumatra, indonesia.

the study was conducted in hanura primary health center, padang cermin district, lampung province (105°45'-103°48'e and 3°45'-6°45's) located at the southern end of sumatra island. the study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight. patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa-stained thick blood films to detect p. falciparum infection. all subjects were allocated by open-label randomization to receive dhp alone (on day 0 to day 2) or dhp plus a single dose of pq (day 3). the procedures of drug administration in the study were as follows:

Eligibility criteria:
inclusion criteria: * age ≥ 4 years old * parasite count ≥ 1,000 asexual parasites/µl * normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (trinity biotech® no 203, usa) * hemoglobin level ≥ 8 gr/dl as measured by hemoque® apparatus; * have the ability to return for 42-day-follow up and * willingness to sign the informed-consent form. exclusion criteria: * are infected with other r plasmodium species * have only gametocytes of p. falciparum; * are pregnant - measured by positive result on hcg urine test and/or breastfeeding women * present signs of pitting edema on both legs as a sign of malnutrition * have complicated or severe malaria, other chronic diseases or history of drug allergies.

Keywords: malaria dhp pq gametocytes
comparing the effects of conivaptan and diuretics on plasma neurohormones and renal blood flow in patients with chronic congestive heart failure

Conditions: Heart Failure

Summary: the purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones.

1. to define the hemodynamic, neurohormonal and renal responses to intravenous conivaptan in patients with chronic stable heart failure (hf), and compare these responses to those after intravenous furosemide. 2. to define the hemodynamic, neurohormonal and renal responses to the combination of the two drugs (conivaptan and furosemide).

Eligibility criteria:
inclusion criteria: * have a diagnosis of chronic congestive heart failure of any etiology * be between 18-80 years of age * able to provide consent * have a documented left ventricular ejection fraction within the last year of \< 40% * on a stable dose (no changes within 2 weeks) of 40 mg or greater daily dose of furosemide or its equivalent * on standard hf therapy medications (acei or arb and beta-blocker unless contraindicated) * have an estimated glomerular filtration rate (gfr) of 30 ml/minute or greater (based on the cockcroft gault calculation) * have a hemoglobin of \> 10 grams/dl * have a negative urine pregnancy for women of childbearing years only exclusion criteria: * acute coronary syndrome within 1 month * systolic blood pressure less than or equal to 90 mmhg at time of enrollment * poor peripheral venous access * severe concomitant disease which deemed by the investigator would render them unsuitable for this trial * allergy or contraindication to the use of iothalamate, pah - specifically any allergies to iodine or iodine containing products, history of asthma and hay fever which deemed by the investigator would render them unsuitable for this trial

Keywords: heart failure
a study to evaluate usability of subcutaneous auto-injector of ct-p17 in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: clinical trial to evaluate usability of subcutaneous auto-injector of ct-p17 in patients with active rheumatoid arthritis

ct-p17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to humira. the purpose of this study is to evaluate usability of subcutaneous auto-injector of ct-p17 in patients with moderate to severe rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: * male or female patient aged 18 to 70 years, inclusive. * patient must be able and willing to self-administer subcutaneous (sc) injections via auto injector (ai). exclusion criteria: * patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (tnf) α inhibitor for any purposes. * patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
noninvasive hemoglobin monitoring for maintaining hemoglobin concentration within the target range

Conditions: Hemoglobins; Blood Transfusion; Hemorrhage

Summary: the primary aim of this study is to evaluate whether pulse oximetry based noninvasive hemoglobin (sphb) monitoring can reduce the incidence of hemoglobin (hb) level out of the target range in adult patients undergoing major surgery with the potential risk of bleeding.


Eligibility criteria:
inclusion criteria: * adult patients with asa physical status class i, ii, iii, who scheduled to undergo elective non-cardiac major surgery with more than moderate risk of bleeding under general anesthesia or spinal anesthesia. * eligible surgery include: spine surgery, bone tumor surgery, total hip replacement, ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open retroperitoneal mass excision, radical retropubic prostatectomy, explorative laparotomy for abdominal mass excision, abdominal aortic aneurysm repair * patients who are requiring an arterial catheter as a part of their standard care. exclusion criteria: * patients with preexisting deformity or skin condition that would impede sensor placement * patients with allergies to the adhesive sensor material * patients with uncorrected preoperative anemia (preoperative hemoglobin \< 7 g/dl) * patients who were not suitable for participation in the opinion of the study investigator.
study to evaluate the safety & efficacy of flx-787-odt to treat fasciculations in tongue and upper or lower extremity muscles most affected in subjects with als

Conditions: Amyotrophic Lateral Sclerosis; Fasciculation

Summary: the flx-787-106 study will determine how well flx-787-odt works to reduce fasciculations in patients with amyotrophic lateral sclerosis (als). the study will measure how often fasciculations occur, and monitor any side effects that might develop while taking the investigational product. participants will be assessed before and after taking a single dose of flx-787-odt. approximately 15 people will take part in this study at one center in the united states. participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.


Eligibility criteria:
inclusion criteria: * documented diagnosis of als diagnosis of less than 3 years. * expected survival \> 6 months * frequent fasciculations noted during clinical examination of any single muscle (\>6 visible fasciculations per minute) observed in part i * normal oral cavity exam at screening * proficient in english * male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study * male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study exclusion criteria: * presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results * tremor or other movement disorder that would interfere with recording * inability to lie flat * presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers * presence of laryngospasm or significant swallowing problems * presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or g-tube * inability to tolerate a spicy sensation in the mouth or stomach * actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol * participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening * pregnant, breastfeeding, or planning to become pregnant * blood pressure of ≥160 mmhg systolic and/or ≥100 mmhg diastolic * clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).

Keywords: als amyotrophic lateral sclerosis fasciculation flx-787
effects of il-1β and its receptor antagonists in the treatment of severe infection and inflammatory storm in children

Conditions: Critical Illness; Sepsis, Severe

Summary: in severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. however, the role of il-1β and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. to date, the efficacy and safety of il-1β and its receptor antagonists in children with severe infection is not fully evaluated.

the investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of children's hospital of fudan university from january 2022 to december 2023. children with a picu length of day less than 48h will be excluded. patients who met the inclusion criteria will be divided into trial group and control group. clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

Eligibility criteria:
inclusion criteria: * children between 29 days and 18 years old. * severe pneumonia and/or sepsis. * patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in children (2019) issued by the national health commission of the people's republic of china and/or who meet the international guide to the 2020 campaign to save sepsis: management of septic shock and sepsis-related organ dysfunction in children. exclusion criteria: * notifiable infectious diseases. * the researcher believes that he is not suitable to participate in other situations in this study. * participants in other clinical trials in the same period. * discharge within 48 hours

Keywords: critical illness sepsis anakinra canakinumab children
epidemiology, identification rate and treatment penetration of osteoporotic vertebral fractures in switzerland

Conditions: Postmenopausal Osteoporosis; Spinal Fractures

Summary: in switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the swiss hospitals statistics represent only the tip of the iceberg. in addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin d production) and/ or in physical activity and/ or dietary habits. clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). whether a combination of both would improve sensitivity and specificity is unknown. the gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral x-rays of the thoracic and lumbar spine. despite standardization of x-ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. in a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients. the recent availability of software for vertebral fracture assessment (vfa) coupled to dxa measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. recently published results show that vfa allows the diagnosis of a vertebral fracture. the sensitivity of vfa for detection of vertebral fractures compared to expert radiologist reading of x-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.

examinations * community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers) * aged 65-79 yrs * written informed consent

Eligibility criteria:
inclusion criteria: * community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers) * aged 65-79 yrs * written informed consent exclusion criteria: * patients who underwent spine surgery * not willing or not able to sign informed consent * in patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.

Keywords: vertebral fracture assessment (vfa) vitamin d
estetrol for the treatment of female sexual arousal disorder in postmenopausal women

Conditions: Sexual Dysfunction, Physiological

Summary: the goal of this clinical trial is investigating estetrol (e4) in women after menopause, suffering from sexual arousal disorder. the main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. placebo is a pill that looks the same as estetrol but has no active ingredient. researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants.


Eligibility criteria:
main inclusion criteria: - hysterectomized postmenopausal women, ≥40 up to ≤65 years, diagnosed with female sexual arousal disorder main exclusion criteria: * not willing to stop any hormonal products during their participation in the study * history of unresolved sexual trauma or abuse that is contributing to any sexual dysfunction problem * have experienced a recent major life stress or relationship discord that could interfere with sexual activity * clinically significant abnormal gynecological findings * history of malignancy, with the exception of basal cell or squamous cell carcinoma of the skin * systolic bp higher than 140 mmhg, diastolic bp higher than 90 mmhg * is judged by the investigator to be unsuitable for any reason

Keywords: female sexual arousal disorder fsad
effect of different colistin doses on clinical outcome of pediatric cancer patients with gram negative infections

Conditions: Gram-Negative Bacterial Infections; Pediatric Cancer; Colistin; Colistin Adverse Reaction; MIC

Summary: prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with mdr gram-negative infection or sepsis

the aim of this study is to: 1. evaluate the clinical outcome of two different dosing regimen of iv colistin in the treatment of children with multidrug resistant gram-negative infections or sepsis. 2. to estimate the frequency of colistin associated adverse effects. 3. to correlate the serum colistin concentration and mic to microbiological clearance and clinical outcome

Eligibility criteria:
inclusion criteria: 1. age between one year and 18 years 2. all paediatric cancer patients who are prescribed intravenous colistin due to: * sepsis due to mdr or minimally susceptible gram-negative bacteria * history of mdr gram-negative infection or sepsis due to organisms sensitive to colistin. * culture result consistent with mdr gram negative for this febrile neutropenic episode. * patient in sepsis and colistin was administered empirically to increase antibiotic coverage. exclusion criteria: 1. age less than one year or over 18 years 2. patients with renal impairment 3. colistin use less than 72 hours