Kornimate/medical-research-clean huggingface dataset:
protein requirements in children with phenylketonuria (pku)

Conditions: Phenylketonuria

Summary: phenylketonuria (pku) is an inherited inborn error of an amino acid phenylalanine (phe) metabolism affecting 1:15,000 births. it is caused by a decreased activity of an enzyme in the liver called phenylalanine hydroxylase (pah) which is important to convert phe into tyrosine, another amino acid. consequently, phe accumulates in the blood leading to mental and developmental delays. nutritional management is the primary choice of treatment that includes providing sufficient protein in the diet and at the same time restricting phe. however the amount of protein to be given is unknown. a new technique called indicator amino acid oxidation (iaao) will be used to determine the protein requirements in children with pku (5-18y). the study will help treat and manage these children with sufficient protein to ensure proper growth and development. current dietary recommendations range from 35-65 g/day and is based on factorial calculations. the investigators hypothesize that the protein requirement in children with pku will be higher than the current mathematically calculated recommended intake of 35-65 g/day for the 5-18y children.


Eligibility criteria:
inclusion criteria: * children (5-18y) who are diagnosed with phenylketonuria (pku), and clinically stable with no acute illness exclusion criteria: * children less than 5y of age and who are diagnosed with pku, as it may be difficult to take breath samples and perform indirect calorimetry in very young children. * children diagnosed with pku, but are currently ill, with a fever, cold, vomiting or diarrhea.

Keywords: phenylketonuria pku phenylalanine metabolism protein requirements indicator amino acid oxidation stable isotopes
effect of lixisenatide on postprandial plasma glucose compared to sitagliptin in combination with insulin glargine

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate significant reduction in postprandial plasma glucose (δauc0:30-4:30h) after a standardized breakfast from baseline to day 29. secondary objectives: to demonstrate: * changes from baseline to day 29 in maximum postprandial plasma glucose excursion, c-peptide and glucagon levels after a standardized breakfast * delaying gastric emptying (13c-acetic acid breath test) * safety and tolerability

the duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances. 13c-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, treated with lantus±su; ≥5-year after diagnosis * aged 20-75 years * hemoglobin a1c ≥7.0%-≤10.0% * fasting plasma glucose ≤180 mg/dl at screening * stable treatment (±20%) with lantus for 3 months or more prior to screening. * sulfonylurea dose stable for 3 months or more prior to screening exclusion criteria: * type 1 diabetes mellitus * pregnancy or lactation * hypersensitivity to lixisenatide * severely uncontrolled glycemic situation * history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease * history of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening * history within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse * uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure \>180 mmhg or diastolic blood pressure \>95 mmhg * amylase and/or lipase \>3 times or aspartate aminotransferase (ast), alanine aminotransferase (alt) or alkaline phosphatase (alp) \>2 times the upper limit of the normal laboratory range * end-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
cardiovascular mri and cardiopulmonary exercise capacity after neonatal aso) in young adults

Conditions: Transposition of the Great Arteries; Artery Switch Operation

Summary: magnetic resonance imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries.

after aso obstruction of the transposed coronary arteries with resulting reduced perfusion of the heart at stress or abnormities of the right ventricular blood flow resulting in increasing heart rate as well as abnormities in pulmonary flow can appear. in this single centre trial a large homogeneous group of young adults after surgery for transposition of the great arteries (tga), the so called artery switch operation (aso), will undergo magnetic resonance imaging (mri) of the heart at rest and under drug- induced stress to receive data of the functional status of the heart and its perfusion as well as data of the pulmonary arterial perfusion. also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary exercise capacity. therefore the mri data will be compared to cardiopulmonary exercise capacity data determined by cardio pulmonary stress test (cpx) concerning the feasibility of a correlation of the data and possible generalisation of the results leading to long term assessment of coronary perfusion and myocardial status after aso for recommendations of physical activity of the young adults.

Eligibility criteria:
inclusion criteria: * former emah (adults with congenital heart defects) patients \> 18 years old * after neonatal aso for tga at the department of pediatric cardiac surgery * also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy exclusion criteria: * contraindications of mri as metallic implants, claustrophobia * contraindications of mri contrast agents * severe chronic kidney disease (estimated glomerular filtration rate \< 30 ml/min) * contraindications of exercise stress test with dobutamine or cardiopulmonary exercise stress test (e.g. instable angina pectoris, complex arrhythmia) * disabled persons not able to perform cardiopulmonary exercise stress test * pregnancy and breast feeding

Keywords: tga aso magnetic resonance imaging (mri) young adulthood
integrating enhanced hiv prep into a sti clinic in lilongwe

Conditions: HIV Infections; Sexually Transmitted Diseases; Blood-Borne Infections; Communicable Disease; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases, Viral; RNA Virus Infections; Virus Disease; Syphilis; Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection

Summary: this is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating hiv pre-exposure prophylaxis (prep) into a sexually transmitted infection (sti) clinic alongside assisted partner notification and etiologic sti testing in lilongwe, malawi.


Eligibility criteria:
patient participant inclusion criteria: * ≥15 years of age. * eligible for prep according to malawi prep guidelines (see below) * presenting for care at sti clinic (primary presentation or referral from partner based on sti or hiv exposure) * able to consent for study participation and willing to provide locator information for follow-up tracing \*malawi prep eligibility criteria: * age ≥15 years * hiv seronegative iii. at substantial risk for hiv, with prioritization of persons who: * buy or sell sex; key population (female sex worker, men who have sex with other men, transgendered persons; vulnerable population included adolescent girls and young women aged 15-24; sti clients; serodiscordant couples including hiv-negative women who are pregnant or breast feeding or hiv-negative men or women for whom their hiv-infected partner is: not on art, on art \<6 months, has an unsuppressed or high viral load, or is non-adherent to art, iv. have ruled out acute hiv infection, or defer prep initiation for anyone with signs or symptoms consistent with acute hiv infection, v. willingness to attend scheduled prep visits, vi. no contraindication to use of tdf and 3tc, vii. bodyweight ≥30 kg, viii. estimated glomerular filtration rate (egfr) ≥60ml/min, ix. no known renal diseases, x. no diabetes mellitus. exclusion criteria: * current imprisonment or incarceration in a medical or psychiatric facility provider participant: inclusion criteria: * ≥18 years of age. * duties relevant to integration or provision of prep and/or apn at sti clinic exclusion criteria: - unable or unwilling to provide informed consent

Keywords: tenofovir pre-exposure prophylaxis emtricitabine assisted partner notification
comprehensive behavioral intervention for tics

Conditions: Tic Disorders

Summary: the purpose of this protocol is to examine treatment outcomes of youth receiving the comprehensive behavioral intervention for tics (cbit) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.


Eligibility criteria:
inclusion criteria * a current diagnosis of a diagnostic and statistical manual of mental disorders (dsm)-5 tic disorder (e.g., tourette's disorder/syndrome, persistent (chronic) motor or vocal tic disorder, or provisional tic disorder) or caregiver/youth report of clinically impairing tic symptoms * ability for youth to speak/read english sufficiently * at least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in english. exclusion criteria * a current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder. * youth currently receiving psychotherapy elsewhere and/or have previously received cbit. * currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded * youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay treatment).
pain in diagnostic hysteroscopy

Conditions: Pain in Diagnostic Hysteroscopy

Summary: the objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.


Eligibility criteria:
inclusion criteria: * female gender * diagnostic hysteroscopy indication * italian-speaking patients exclusion criteria: * patients who had previously undergone a diagnostic hysteroscopy * patients who had been previously undergone to cervical surgery * ongoing pregnancy * cervical carcinoma * pelvic inflammatory disease * excessive uterine bleeding * performance of an endometrial biopsy during the procedure

Keywords: diagnostic hysteroscopy pain vas multivariate analysis normal saline carbon dioxide
study of pirtobrutinib (loxo-305) in participants with impaired liver function and healthy participants

Conditions: Healthy; Hepatic Insufficiency

Summary: the main purpose of this study is to measure how much of pirtobrutinib (loxo-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants. the side effects and tolerability of pirtobrutinib will also be evaluated. participation could last about 46 days.


Eligibility criteria:
inclusion criteria: * participants with mild, moderate or severe hepatic impairment and healthy participants with normal hepatic function * males and females of non-childbearing potential. * within body mass index (bmi) range 18.5 to 40.0 kilograms per square meter (kg/m²). * participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ecg), and clinical laboratory tests, as determined by the investigator (or designee). * able to comply with all study procedures, including the 8-night stay at the clinical research unit and follow-up phone call. exclusion criteria: * history or presence of any of the following, deemed clinically significant by the investigator (or designee), and/or sponsor: 1. pancreatitis 2. peptic ulcer disease 3. intestinal malabsorption 4. gastric reduction surgery 5. history or presence of clinically significant cardiovascular disease. * participants with out-of-range, at-rest vital signs. * abnormal laboratory values determined to be clinically significant by the investigator (or designee). * clinically significant abnormality, as determined by the investigator (or designee), from physical examination. * participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (day 1). * use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (day 1) and through end of trial. * history or presence, upon clinical evaluation, of any illness that, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk. * donation of blood from 56 days prior to screening, plasma or platelets from 4 weeks prior to screening. * receipt of blood products within 2 months prior to check-in (day -1). * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (gi), neurological, or psychiatric disorder (as determined by the investigator).
investigation of the potential pharmacokinetic interaction between nevirapine (viramune) and ethinyl estradiol/norethindrone in hiv-1 infected women

Conditions: HIV Infections

Summary: study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (ee)/norethindrone (net).


Eligibility criteria:
inclusion criteria: * female patients between the ages of 18 and 65 years * plasma hiv-1 rna \<= 400 copies/ml, documenting hiv-1 infection, within 28 days prior to study day 0 * lymphocytes expressing cd4+ surface marker (cd4+ cell count) \>= 100 cells/mm³ within 28 days prior to study day 0 * patients who meet the following laboratory parameter: * lymphocyte count \>= 1000 cells/mm³ * hemoglobin \>= 9.0 g/dl (men and women) * platelet count \>= 75000 cells/mm3 * alkaline phosphatase \<= 3.0 times the upper limit of normal * serum glutamic-oxaloacetic transaminase (sgot) and serum glutamic-pyruvic transaminase (sgpt) \<= 3.0 times the upper limit of normal * total bilirubin \<= 1.5 times the upper limit of normal * creatinine \<= 2mg/dl * female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam) * patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines * patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation exclusion criteria: * female patients who are pregnant or breast-feeding * patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (study day 0). such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin * patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication * patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake * patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the investigator and boehringer ingelheim pharmaceutical incorporated (bipi) medical monitor to be a significant impairment to health and compliance * patients undergoing treatment for an active infection * patients with hepatic insufficiency due to cirrhosis * patients with renal insufficiency * patients who are heavy smokers (e.g. \> 20 cigarettes per day) * patients currently taking norvir® (ritonavir) or rescriptor® (delavirdine)
peripheral artery tonometry in children with type 1 diabetes and obese children

Conditions: Peripheral Artery Tonometry; Diabetes; Children; Obesity

Summary: background: the reactive hyperemia-peripheral artery tonometry (rh-pat) is a newly developed method for noninvasive endothelial function assessment. objective: the goal of this study is to determine whether a significant difference in rh-pat score is present between adolescents with type 1 diabetes (t1d) in comparison with controls. we will also compare rh-pat scores in obese adolescents versus controls.


Eligibility criteria:
inclusion criteria: * 12-19 years of age exclusion criteria: * type 2 diabetes; obesity in group of type 1 diabetes
analyzing genes that may increase the risk of developing high blood pressure

Conditions: Hypertension

Summary: high blood pressure is one of the most common health problems in the united states. genetic variations may cause some people to be more susceptible to developing high blood pressure. this study will identify variations in genes known to play a part in the development of high blood pressure.

high blood pressure affects nearly one third of all individuals in the united states. it is especially common in african americans, with more than 40% of african americans diagnosed with this condition. high blood pressure usually develops earlier in life and is more severe in african americans than in other racial or ethnic groups. many factors can cause high blood pressure, including stress, diet, diabetes, kidney disease, or obesity. previous studies have also shown that genetic variations on two regions of chromosomes 6 and 21 may predispose some people to develop high blood pressure. admixture mapping is a type of genetic analysis that aims to identify disease-causing genetic variations across different populations of people. using admixture mapping, this study will examine previously collected genetic samples from african american participants in the family blood pressure program (fbpp) study and from african american, mexican american, nigerian, and jamaican participants enrolled in other clinical studies. study researchers will analyze the samples to identify and characterize genetic variations that are associated with an increased risk of high blood pressure in the african american population, as well as other racial and ethnic groups.

Eligibility criteria:
inclusion criteria: * participated in the fbpp study (african american \[800 people with high blood pressure and 800 control group participants\] and mexican american participants) * participated in the american family study (african american participants) * participated in the phenotyping study (african american, nigerian, and jamaican participants)

Keywords: high blood pressure
cost of using fluorescence to green of indocyanine for the detection of breast cancer.

Conditions: Sentinel Lymph Node

Summary: the purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (indocyanine green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

the main objective is to evaluate the overall cost at 1 month of the sentinel lymph node detection technique using indocyanine green compared to the technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital. the chosen time horizon is up to 1 month post-intervention. the choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications. this is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (indocyanine green and isotope) from a dual perspective (health insurance and hospital).

Eligibility criteria:
inclusion criteria: * patient aged 18 or over, having given her oral non-objection ; * patient with histologically proven breast cancer ; * patient eligible for the sentinel lymph node technique by indocyanine green or isotopes. exclusion criteria: * patient who has expressed her opposition to the use of her medical data ; * patient under legal protection, guardianship or curatorship ; * pregnant patient ; * patient not affiliated to a social security scheme.