Kornimate/medical-research-clean huggingface dataset:
safety study of th9507 in subjects with stable, type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study was to determine whether th9507, a stabilized analogue of growth hormone-releasing factor (grf), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or postmenopausal or surgically sterilized female subjects, 50 years of age or older; * documented diagnosis of type 2 diabetes as defined by the american diabetes association; * diagnosis of type 2 diabetes for at least 3 months before screening; * subjects on stable diabetes treatment regimens (receiving oral hypoglycemics with or without insulin) for at least 2 months before screening; * screening and pre-randomization glycosylated hemoglobin (hba1c) \<10.0%, according to central laboratory; * body mass index (bmi) between 25 and 38 kg/m2 * subjects willing to perform specified home blood glucose monitoring and comply with all study protocol requirements; * signed informed consent. exclusion criteria: * serum creatinine \>2 mg/dl; * fasting triglycerides \>1000 mg/dl; * albuminuria \>200 mg/24 hours; * positive mammography (if female) or prostate-specific antigen (psa) or prostate examination for cancer (if male); * use of oral or parenteral glucocorticoids in the 30 days before screening; * use of any experimental or marketed growth hormone, growth hormone secretagogues, insulin-like growth factor-1 (igf-1), or insulin-like growth factor binding protein-3 (igfbp-3) during the previous 6 months; * subjects with two or more severe hypoglycemia episodes within the past 6 months, or any hospitalization or emergency room visit due to poor glycemic control within the past 6 months. similarly, during the lead-in period, any subject with more than one severe hypoglycemic episode or any hospitalization or emergency room visit due to poor glycemic control will be excluded from randomization; * history of or presence of active concomitant conditions or diseases (e.g., myocardial infarction, poorly controlled hypertension, thyroid disease, rheumatoid arthritis, seizure disorder, diabetic neuropathy, diabetic retinopathy \[except subjects with only microaneurysms on fundus examination\]) that would interfere with the protocol conduct and endpoint measurements; * subjects with a major surgical operation during the 30 days before screening; * subjects with known hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma; * current cancer or history of cancer, except non-melanomatous skin cancer; * subjects with active infection at any body site or a history of severe infection (requiring oral or parenteral treatment) during the 30 days before screening; * subjects with clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor); * subjects with allergy to synthetic growth hormone products or their excipients; * subjects who had previously received growth hormones in any clinical trial; * participation in a trial of an experimental drug or device within 90 days before screening.
pilot study to evaluate the effect of aromatase inhibitor therapy on pain threshold in breast cancer patients

Conditions: Breast Cancer; Pain; Arthralgia

Summary: postmenopausal women who have hormone receptor positive breast cancer are typically treated with aromatase inhibitor medications, which substantially decrease the amount of estrogen produced by their bodies. these medications are fairly well tolerated, but can cause aches and pains which can be quite severe in some cases. people experience pain differently. estrogen appears to play a role in how we experience pain. therefore, decreasing estrogen levels may lead to more pain in some women than others. the goal of this study is to evaluate perception of pain in women with breast cancer, and to determine if differences in pain perception lead to more aches and pains in some women treated with aromatase inhibitors. in this study, we plan to enroll 55 women with breast cancer who are starting treatment with an aromatase inhibitor. participants will undergo testing to evaluate their perception of pain, and will also complete a set of questionnaires. testing will be conducted before starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. we will investigate whether pre-existing differences in pain perception lead to different amounts of pain during aromatase inhibitor therapy.


Eligibility criteria:
inclusion criteria: * female gender * postmenopausal, age 21 or greater * stage 0-iii estrogen receptor and/or progesterone receptor positive breast cancer who will be receiving a standard dose of letrozole, anastrozole, or exemestane * performance status 0-2 * willing to sign the consent form exclusion criteria: * average pain \>=8/10 over the past 24 hours * peripheral sensory neuropathy grade 2 or higher * personal history of schizophrenia, or suicidal ideation or attempt within the past 2 years * thumbnail abnormalities on either hand that are likely to alter pain perception during testing

Keywords: aromatase inhibitor pain threshold
characterizing perceived physical fatigability in nusinersen-treated sma

Conditions: Spinal Muscular Atrophy

Summary: the purpose of this project is to investigate the utility of the sma effort, an sma-specific patient-reported outcome measure, to assess perceived physical fatigability that is anchored to intensity and duration of activities. we aim to characterize perceived physical fatigability (ppf) in a diverse cohort of people with sma (pwsma) and evaluate the change of ppf before and after nusinersen dosing.

fatigue and fatigability are symptoms often experienced by people living with spinal muscular atrophy (pwsma). nusinersen is shown to extend survival and improve motor function, but fatigue and fatigability persist. treated patients report changes in their ability to complete repetitive physical activities but a way for measuring this has not been created. while tests completed in the clinic by individuals with sma highlight that fatigability is an important part of the sma experience,we do not fully understand how pwsma experience fatigability with everyday tasks. anecdotal reports of pwsma suggest a waning effect in endurance toward the end of their treatment window, however this change has not been measured.the sma effort is specifically designed for pwsma and aims to better understand how they feel when completing daily physical activities.

Eligibility criteria:
inclusion criteria: 1. all types of 5qsma (homozygous deletion or point mutation of the smn1 gene and any number of smn2 copies) 2. receiving a stable dosing regimen of 12mg nusinersen for at least 6 months exclusion criteria: 1. an injury or surgery within the previous 3 months that would impact their ability to perform in-clinic function and/or fatigability assessments 2. enrolled in an ongoing clinical trial, or extension study, expanded access program, or long-term registry of an investigational or recently approved medication 3. receiving adjuvant and/or dual therapy (e.g., muscle-targeted, nmj, or symptomatic treatments)

Keywords: spinal muscular atrophy neuromuscular disease nusinersen fatigability exercise sma fatigue
ddi hv (atv - merck)

Conditions: HIV Infections

Summary: the purpose of this study is to to assess the effect of atv 300 mg bid on the pk of raltegravir 400 mg bid, to assess the effect of raltegravir 400 mg bid on the pk of atv 300 mg bid, and to assess the ecg effects of atv 300 mg bid over 21 days, given with or without raltegravir 400 mg bid.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (bmi) of 18 to 32 kg/m² * prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (wocbp) must have a negative pregnancy test exclusion criteria: * any significant acute or chronic medical illness * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations. * use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration * use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Keywords: antivirals / hiv
video-assisted anal fistula treatment versus seton in the management of high peri anal fistula

Conditions: Post Operative Pain; Recurrence

Summary: anal fistula is the most common peri anal disease. it's a disease with an incidence of 9 in 100,000. anal fistula is classified on the basis of its location into high and low anal fistula, above or below dentate line respectively. multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases. there are typically 8-10 anal crypt glands at the level of the dentate line in the anal canal arranged circumstantially. these glands afford a path for infecting organisms to reach the intramuscular spaces. the cryptoglandular hypothesis states that an infection begins in the anal canal glands and progresses into the muscular wall of the anal sphincters to cause an anorectal abscess. according to internal opening many author proposed certain classification but the standardized in all of them is park's classification, so this study categorized the patient through this classification. there are four types of fistula-in-ano in park's classification intersphincteric (between internal and external sphincters is 70%), transsphincteric (across external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above and through levator ani).high anal fistula is considered to be difficult to treat because of its location.this study diagnosed the internal opening of high perianal with the help of endoluminal ultrasound and mri. classic method of its treatment are fistulotomy, fistulectomy and setone placement but these are associated with lots of complication like fecal incontinence,recurrence,pain.therefore many method have been recently devised including ligation of intersphincteric fistula tract (lift), glue repair and flap advancement.another recently introduced method for its treatment is video-assisted anal fistula treatment (vaaft) proposed by p. meinero which has been associated with less complications.


Eligibility criteria:
inclusion criteria: 1. patients of either gender with age ranging from 15 to 60 years. 2. all patients with high anal fistula exclusion criteria: 1. patients with suspected malignancy determined by the presence of a mass on digital rectal examination, 2. history of previous perianal surgery, 3. history of irritable bowel disease determined by medical record 4. uncontrolled diabetes
an study to determine the bioavailability of e2609 tablets compared to capsules and the effect of food on absorption

Conditions: Alzheimer's Disease

Summary: this study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an api-capsule formulation of e2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.


Eligibility criteria:
inclusion criteria 1. caucasian males defined as persons of a european or latin american descent 2. healthy male 30 to 55 years inclusive at the time of informed consent 3. body mass index (bmi) of 18 to 32 kg/m2 at screening 4. subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. no sperm donation is allowed during the study period and for 30 days after study drug discontinuation. exclusion criteria 1. any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures 2. any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at screening or within past 5 years 3. any history of cerebrovascular disease (stroke or transient ischemic attack) 4. a history of prolonged qt/qtc interval or prolonged period from the beginning of the qrs complex to the end of the t wave on an ecg (qt)/ qt corrected for heart rate using fridericia?s formula (qtcf) interval (qtcf \&gt; 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ecgs) (recorded at least 1 min apart) at screening or baseline period 5. any other clinically significant ecg abnormalities at screening or baseline periods, e.g. component of the ecg cycle from onset of atrial depolarization to onset of ventricular depolarization (pr)\&gt;220 ms, component of ecg wave representing ventricular depolarization (qrs)\&gt;110 ms 6. hypersensitivity to the study drugs or any of their excipients
preterm donor human milk supplementation of mother's own milk in vlbw infants

Conditions: Prematurity

Summary: this prospective randomized controlled trial aims to investigate whether feeding very low birth weight (vlbw) infants with mother's own milk (mom) supplemented with either preterm (pdm) or term donor milk (tdm), when mom is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

mother's own milk (mom) is the optimal nutrition for preterm infants. when mom is not sufficient, pasteurized donor milk (dm) is the best alternative according to current recommendations. donor milk is primarily derived from mothers of term-born infants for the first six months of lactation. however, this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy. the investigators hypothesized that feeding vlbw infants with preterm donor milk (pdm) in combination with mom may positively influence the protein intake and, consequently, the infants' growth. the aim of the current study is to assess whether mom supplementation with pdm has any beneficial effects on the nutrition, growth and morbidity in vlbw infants.

Eligibility criteria:
inclusion criteria: • vlbw infants with birth weight \<1500g born to mothers who agree to provide donor milk for the first three weeks of life (donor milk period) if their own milk quantity is insufficient exclusion criteria: * congenital anomalies * chromosomal disorders * metabolic diseases * feeding with formula at any point during the first 3 weeks of life (donor milk period)

Keywords: preterm infants nutrition donor milk breast milk
multimodal monitoring of fetal risk of inflammation in preterm premature rupture of membranes

Conditions: Preterm Premature Rupture of Membranes; Fetal Inflammatory Response Syndrome; Early Onset Neonatal Sepsis; Infection of Amniotic Cavity

Summary: the purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ecg analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (firs) or a neonatal early onset sepsis (eos) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by pprom.

preterm premature rupture of membranes (pprom) is one of the leading causes for preterm birth and adverse neonatal outcome. between 24 0/7 and 34 0/7 weeks of gestation the prolongation of pregnancy is the recommended course of action to reduce the risks of prematurity in most countries. an intra-amniotic infection resulting in fetal inflammatory response syndrome (firs) or early onset neonatal sepsis (eos) is often associated with high morbidity and mortality. standard monitoring includes the maternal response to inflammation (i.e. maternal serum parameters) as well as fetal signs of acute firs (i.e. fetal tachycardia, high cytokine level in amniotic fluid obtained by amniocentesis). changes of fetal ecg-parameters are also a sign of an acute firs. currently, there is no adequate parameter for the surveillance of a possible ongoing intra-amniotic infection. other studies have reported a correlation between vaginal fluid interleukine 6 (il6) collected noninvasively and the risk of firs and eos. information obtained by computerized fetal ecg analysis might be suitable to detect early signs of fetal infection before the manifestation of firs. with the implementation of a vaginal fluid collector it is possible to detect the vaginal fluid cytokine in clinical everyday routine. with the improvement of fetal ecg monitoring it is possible to record the fetal ecg daily. this study examines the correlation between these new parameters and the onset of fetal infection before the manifestation of a severe systemic fetal inflammation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of preterm rupture of the fetal membranes * pregnancy between 24 0/7 and 34 0/7 weeks of gestation * ability to give informed consent in german or english exclusion criteria: * sign of acute amniotic infection syndrome * independent indication for urgent delivery * active labor * missing informed consent

Keywords: preterm premature rupture of the membranes pprom prom fetal membranes premature rupture neonatal early onset sepsis amniotic fluid amniotic infection fetal inflammatory response syndrome adverse neonatal outcome firs
mitral insufficiency reduction with biventricular pacing

Conditions: Mitral Regurgitation

Summary: the purpose of this study is to show that crt(cardiac resynchronization therapy) pacing in patients with severe functional mr (mitral regurgitation) who are not currently indicated for crt will demonstrate chronic benefit of mr reduction( via echo measured mr/la area and ero per american society of echo guidelines) and to show that crt pacing is safe in these patients.

approximately 50 patients will be randomized, followed and analyzed in this prospective study. patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a crt system. baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. the baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patients with moderate-to-severe or severe functional mr. * eroa \> 40 mm2 and an mr/la \> 40% (severe) * 30 ≤ eroa ≤ 40 mm2 and 30 ≤ mr/la ≤ 40% (moderate-to-severe) * baseline rates of 50-90 beats per minute (patients with sinus rhythm) or af * qrs \< 120 ms * lvef \< 35% * willing to sign informed consent * on standard stable heart failure medical regimen (beta blockers and ace-i or arbs) for at least 1 month before randomization, if tolerated * patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information * patient has the ability to comply with study procedures and protocol, including required study visits exclusion criteria: * candidate for crt or has a previously implanted crt device * previously implanted implantable pulse generators (ipg) or implantable cardioverter defibrillator (icd) with at least 10 % pacing in the right ventricle * patient has life expectancy \<6 months * patient is pregnant * significant aortic stenosis * uncontrolled hypertension * mitral valve stenosis * severe mitral valve calcification * ruptured chordae tendinae or papillary muscle * mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease) * chronic mitral leaflet degeneration (ie. marfans) * previous valve replacement or surgery * iv inotropes or iv vasodilators * candidate for mitral valve repair or replacement surgery within the next 6 months * patient has in-hospital acute coronary syndrome (acs) (nstemi/stemi) prior to randomization * patient has planned or elective percutaneous coronary intervention (pci) or other non-cardiac surgery prior to randomization * patient is currently enrolled in an investigational drug or device study * patient is clinically unstable per pi assessment
insight-ahp: a study to characterize the prevalence of acute hepatic porphyria (ahp) in patients with clinical presentation and history consistent with ahp

Conditions: Acute Hepatic Porphyria; Hepatic Porphyrias; Acute Intermittent Porphyria (AIP); Hereditary Coproporphyria (HCP); Variegate Porphyria (VP); ALA Dehydratase Deficient Porphyria (ADP); Porphyria Acute

Summary: this study will use specific diagnostic tests on a group of patients who are experiencing symptoms typical of acute hepatic porphyria (ahp) to determine how many have the condition, and to potentially help improve the diagnostic process for patients in the future.


Eligibility criteria:
inclusion criteria: * ≥ 16 years of age * recurrent and severe episodes of abdominal pain that last for at least 24 hours * at least 1 episode of severe abdominal pain that required an urgent healthcare visit in the past 12 months * other symptoms related to ahp that your doctor will discuss with you * willing and able to comply with protocol required assessments and provide written informed consent exclusion criteria: * known diagnosis of ahp * alternative explanation for abdominal pain with clinical response to treatment specific for alternative diagnosis

Keywords: acute hepatic porphyria hepatic porphyrias acute intermittent porphyria (aip) hereditary coproporphyria (hcp) variegate porphyria (vp) ala dehydratase deficient porphyria (adp) porphyria acute
effect of growth hormone on insulin signaling in muscle tissue

Conditions: Insulin Resistance

Summary: the purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.


Eligibility criteria:
inclusion criteria: * male * healthy * age between 18 and 30 years * bmi ≤ 26 exclusion criteria: * known present disease including diabetes mellitus * bmi \> 26 * uses any medication * consumes \> 21 units of alcohol per week

Keywords: growth hormone insulin signaling gh signaling