Kornimate/medical-research-clean huggingface dataset:
prospective study assessing blood pressure and other outcomes post-treatment in patients with primary aldosteronism

Conditions: Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Summary: majority of patients with hypertension have primary hypertension (without an underlying cause). secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. primary aldosteronism (pa) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. pa is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands). distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication. it has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. this is supported by studies showing reversal of these effects after treatment for pa. in addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results. hence, the investigators aim to accurately subtype patients with pa into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.


Eligibility criteria:
inclusion criteria: i. legally capacitated ii. 21-80 years iii. diagnosed with primary aldosteronism iv. patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease) exclusion criteria: i. unable to give consent ii. \ 80 years iii. glucocorticoid remediable aldosteronism iv. adrenal carcinoma v. severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. female patients who are pregnant, intending to become pregnant or breastfeeding

Keywords: primary aldosteronism blood pressure adrenalectomy mineralocorticoid-receptor antagonists cardiovascular endothelial renal
regional adipose tissue characteristics in type ii diabetes

Conditions: Obesity and Type 2 Diabetes; Bariatric Patients Undergoing Bariatric Surgery; Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery; Adipose Tissue Inflammation

Summary: fat tissue in different parts of the body has different characteristics. several studies have associated abdominal fat to an increased risk for multiple metabolic diseases, such as type 2 diabetes and cardiovascular disease, compared with fat located under the skin at the hips and thighs. however, the investigators do not know how the abdominal fat causes or contributes to the development of these diseases or how the development of these disease may in turn cause or contribute to changes in the fat tissue. the general objective of this study is to understand these mechanisms. to investigate these questions, the study will recruit 140 participants, both men and women aged 18-65 years. the participants will be divided into three groups: 40 people with obesity, 40 with diabetes, and 60 lean individuals. participants will be recruited from patients at the ciusss du nord-de-l'île-de montréal - hôpital du sacré-coeur de montréal who are awaiting bariatric or general abdominal surgery, as well as from the general population in the montreal area.


Eligibility criteria:
inclusion criteria: * men, premenopausal and postmenopausal females between 18-65 years * anticipating having bariatric surgery (participants with obesity) or general surgery in the abdominal area (normal weight participants) with a duration of less than 1.5 hours. * bmi 30 kg / m2 (participants with obesity) * weight stable for a minimum of two months prior to the first pre-op visit exclusion criteria: * smoking * renal impairment defined by creatinine clearance; 60 ml/minute * uncontrolled hypothyroidism * no comorbidity other than diabetes type ii exceptions: controlled hypertension, hypothyroidism controlled, controlled dyslipidemia * use prescribed medication that affect our outcomes e.g. exceptions include metformin, dpp-4 inhibitors, inhibitors of the α-glucosidase, hypotensive with a stable dose for 3 months lipid lowering with a stable dose for 3 months.

Keywords: obesity type 2 diabetes bariatric surgery adipose tissue characterization adipose tissue inflammation
the effects of kinesio taping in women with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.


Eligibility criteria:
inclusion criteria: * 18 to 35 years of age, * having primary dysmenorrhea * being volunteer women exclusion criteria: * having give birth, * having a serious psychiatric disorder * having used oral contraceptive or depression drug in the last 6 month * having secondary dysmenorrhea * having irregular menstrual cycle * having allergy to taping
safety and efficacy of srd441 ointment in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. ad is characterised by an itchy skin eruption and may cover large parts of the body. the exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. the objective of this study is to determine whether srd441 ointment is a safe and effective therapy for mild to moderate atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 18 or over * subjects with a history of ad * written and dated informed consent * satisfactory medical assessment with no clinical relevant abnormalities. exclusion criteria: * subjects with current or recurrent disease (except ad) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. * subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. * subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive uv exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study. * subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x ast uln (upper limit of normal) respectively.
the nutritionist's educational intervention on the protein intake in hospitalized elderly people

Conditions: Old Age; Cachexia; Dietary Habits; Sarcopenia; Protein Malnutrition; Patient Participation

Summary: the food intake is often compromised in the elderly, and during hospitalization, dietary restrictions may be imposed, making them more susceptible to the risk of malnutrition and sarcopenia. it is essential to make an early identification of the elderly with low intake and involve them in their self-care. the aims will be assess the influence of the nutritionist's educational action to increase protein intake in elderly patients, to analyze the knowledge on its importance in the prevention of sarcopenia and to identify the prevalence of nutritional risk. this is a field, prospective, correlational, comparative and randomized study. the elderly patients will be randomized into a control group and intervention group.

the control group will follow the flow of nutritional assessment and monitoring while the intervention group will receive daily visits to monitor food intake, leaflet and educational video on the importance of protein and its source foods. in both groups, a questionnaire on knowledge of protein sources and its importance will be applied, and we will calculated the 24-hour recall of a regular day and for three days of hospitalization. patients will be assessment by mini nutritional assessment-short form and sarc-f and will be the measurements of calf circumference and hand grip strength.

Eligibility criteria:
inclusion criteria: * elderly patients aged 60 years or older, * with a prescription of oral feeding, exclusively, * minimum period of three days. exclusion criteria: * palliative care, * treatment for chronic renal failure, * patients with neurological deficit and dysphagia, * readmissions during the study, * receiving enteral and/or parenteral nutritional therapy, * patients in isolation.

Keywords: malnutrition sarcopenia hospitalized patients elderly patient-centered care food intake protein nutritional supplements
a phase i multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of hiv-1 recombinant envelope glycoprotein gp160

Conditions: HIV Infections

Summary: to determine the reactivity and safety of hiv-1 recombinant envelope glycoprotein gp160. to determine the immunogenicity of gp160. although recent advances have been made in antiviral therapy against aids, there is currently no cure. it is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against hiv.

although recent advances have been made in antiviral therapy against aids, there is currently no cure. it is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against hiv. healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis b vaccine, and placebo. the hepatitis b vaccine group will serve as an additional control for immunological evaluations. an optional fourth injection may be given 15-21 months following the initial inoculation.

Eligibility criteria:
inclusion criteria subjects must have: * normal history and physical exam. * negative for hiv infection by elisa and western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). * t4 count \>= 800 cells/mm3. * normal chest x-ray and urinalysis. * negative surface antibody and core antibody for hepatitis b. * negative hepatitis b surface antigen. * negative hiv p24 antigen test. * normal skin reactivity by merieux test. exclusion criteria co-existing condition: subjects with the following symptoms or conditions are excluded: * positive ppd. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, or use of immunosuppressive medications. * prior hepatitis b vaccination. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. prior medication: excluded: * prior hepatitis b vaccine. prior treatment: excluded: * prior blood transfusions or cryoprecipitates within the past 6 months. identifiable high-risk behavior for hiv infection (as determined by prescreening questions designed to identify risk factors for hiv infection), including: * any history of iv drug use. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. * more than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Keywords: vaccines, synthetic vaccinia virus viral vaccines hiv-1 hiv envelope protein gp160 aids vaccines hiv seronegativity hiv preventive vaccine
menstrual health and genital hygiene status in cerebral palsy

Conditions: Menstrual Problem; Cerebral Palsy; Women's Health

Summary: there is little information about the menstrual health and genital hygiene behaviors of young women with cp. the most important reason for this is that women with cp did not meet the inclusion criteria and were excluded from the study. this may lead to a knowledge gap that limits the design of approaches that can help women and families with cp. therefore, this study was planned to determine menstrual health and genital hygiene behaviors in women with cp.


Eligibility criteria:
inclusion criteria: for women with cerebral palsy (cp) 1. participating in the research voluntarily, 2. being diagnosed with cp 3. to be gmfcs level i-ii-ii 4. to be 10-30 years old, 5. being able to read and write turkish, 6. not having any mental problems that prevent cooperation and understanding, 7. being a woman 8. to have menstruated at least once. for healthy women 1. participating in the research voluntarily, 2. to be 10-30 years old, 3. being able to read and write turkish, 4. not having any mental problems that prevent cooperation and understanding, 5. being a woman 6. to have menstruated at least once. exclusion criteria: 1. having a history of pregnancy 2. having an acute genital infection 3. to have undergone gynecological surgery.
safety, tolerability, pk & efficacy of v81444 in volunteers with attention deficit/ hyperactivity disorder (adhd)

Conditions: ADHD

Summary: the purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (pk) of twice daily oral doses of v81444 in adults with adhd. pharmacokinetics (pk) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. pharmacokinetics is what the body does to the drug. blood samples will be taken throughout the study for pk analysis.


Eligibility criteria:
inclusion criteria: * subjects must: 1. be male or female subjects aged 18 to 50 years inclusive 2. meet dsm-iv-tr criteria for a primary diagnosis of adhd combined, hyperactive-impulsive or predominantly inattentive type; confirmed by a minimum score of 24 on the adhd-rs with adult prompts: 3. have a body mass index (bmi) between 19 and 32 kg/m2 inclusive 4. be willing and able to comply with the requirements of the entire study 5. be able to read and understand english 6. give written informed consent exclusion criteria: 1. have a significant medical condition or a history of such a condition that the investigator considers should exclude the subject from the study 2. have any other significant psychiatric disorder, as determined by the structured clinical interview for dsm-iv-tr axis i disorders (scid-i) 3. have known mental impairment defined as an intelligence quotient (iq) less than 75, or clinical evidence of mental impairment based on the opinion of the investigator 4. have a history or evidence of clinically significant gi disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis 5. have had any previous gastric surgery and/or bariatric procedure 6. have any known malformations that would make egd difficult or unsafe 7. have taken any prohibited concomitant medication 8. have multiple drug allergies or be allergic to any of the components of v81444 study medication or its matching placebo (see section 7.1) or lidocaine 9. have abused drugs in the 12 months before study drug administration 10. in the 90 days before study drug administration, on average * have smoked more than 5 cigarettes per day * have consumed more than 28 units of alcohol per week * have consumed more than 500 mg of caffeine per day 11. in the 2 calendar months before study drug administration * have donated blood or plasma in excess of 500 ml * been exposed to any new investigational agent 12. in the calendar month prior to screening * used non-steroidal anti-inflammatory drugs regularly * had a new tattoo or body piercing 13. have any clinically relevant abnormal findings at screening and/or admission 14. plan to undergo elective procedures/surgery at any time during the study 15. have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the investigator.

Keywords: adhd attention deficit/ hyperactivity disorder
a study to evaluate androderm®'s effect on blood pressure in adult hypogonodal male participants

Conditions: Hypogonadism

Summary: this study will evaluate the effect of a once daily androderm® dose on blood pressure (bp) in adult hypogonadal men as measured by 24-hour abpm.


Eligibility criteria:
inclusion criteria: * naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (dhea), including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months * male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period * participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent * body mass index (bmi) \< 35 kilograms per metre square (kg/m\^2) * male exclusion criteria: * uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to androderm® * history of prostate (current or in the past) or breast cancer * had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event * history of alcohol or other substance abuse within the previous 2 years * known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications * participant who works night shifts or who will need to perform strenuous manual labor while wearing the abpm monitor
non-cirrhotic hyperammonemia versus hyperlactatemia in septic patients and impact of treatment

Conditions: Sepsis

Summary: objectives: this study aims to determine the validity of hyperammonemia in predicting true sepsis compared to hyperlactemia in critically ill septic patients. background: sepsis is associated with amino acid flux towards the liver, which increases the ammonia load. the combination of decreased clearance and increased load is thought to be the major cause of increased ammonia in sepsis. methodology: 60 septic patients were classified into 2 equal groups, group i: septic patients with positive microbial cultures. group ii: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days. the primary outcome was to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. the secondary outcomes were need for mechanical ventilation, mortality, and length of stay (lhs) within the intensive care unit.

objectives: the study compares between non-cirrhotic hyperammonemia and hyperlactemia in predicting sepsis in critically ill septic patients. the septic patients were classified into 2 equal groups, group i: septic patients with positive microbial cultures. group ii: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days, to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. also, need for mechanical ventilation, mortality, and length of stay (lhs) within the intensive care unit were reported.

Eligibility criteria:
inclusion criteria: * adult patients aged 19-75 years old * both sexes with severe sepsis and septic shock * within the first 48 hours of icu admission exclusion criteria: * hepatic patients (cirrhotic, hepatitis), * renal failure, ureterosigmoidostomy, * malignancy or on chemotherapy, * pregnancy, * parenteral nutrition, * autoimmune diseases or immunosuppressive illness, and * trauma

Keywords: sepsis hyperammonemia hyperlactemia prediction
renal safety evaluation after dotarem®-enhanced mri

Conditions: Renal Insufficiency

Summary: although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. the aim of this study was to evaluate the safety profile of gadoterate meglumine (dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced mri or unenhanced mri examination to specify a diagnosis, were selected for inclusion. two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a dotarem®-enhanced mri and those undergoing an unenhanced mri. a clinically significant increase in serum creatinine levels after the contrast-enhanced mri exam was used as an indication of contrast induced nephrotoxicity. a blood test was performed 24h before the mri in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. an increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. the primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced mri exams.

Eligibility criteria:
inclusion criteria: * male or female, \> or equal 18 years ; * patient with a known stable renal insufficiency ; * patient scheduled to undergo an mri examination to specify a diagnosis ; * patient able to understand and provide written informed consent to participate in the trial ; exclusion criteria: * patient with a contra-indication to mri ; * patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ; * patient who needs hemodialysis ; * patient with known allergy to gadolinium chelates ; * patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ; * patients planned to either undergo surgery or receive chemotherapy ; * any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ; * patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ; * patient with newly discovered unstable diabetes.

Keywords: contrast-induced nephropathy, creatinemia