Kornimate/medical-research-clean huggingface dataset:
glp-1-mediated gluco-metabolic effects of bile acid sequestration

Conditions: Type 2 Diabetes Mellitus

Summary: the objective of this study is to investigate the potential glp-1-mediated contribution to the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration . exendin9-39 has been demonstrated to act as a potent and specific glp-1 receptor antagonist with no partial agonistic potential and is considered a useful tool in the assessment of glp-1 physiology. the aim is to evaluate any contribution of sevelamer-induced glp-1 secretion to the reduced plasma glucose concentrations observed after treatment with sevelamer. a randomised placebo-controlled cross-over study involving two 17-day treatment periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2 diabetes, will be conducted. the impact of bile acid sequestration on glp-1 secretion and effect will be examined during two randomised experimental days after 15 and 17 days of treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. during each of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo will be performed (for evaluation of any glp-1-mediated effects). postprandial plasma glucose excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum excursions of insulin, c-peptide, glp-1, glucagon, glucose-dependent insulinotropic polypeptide (gip), glucagon-like peptide-2 (glp-2), peptide yy (pyy), oxyntomodulin, ghrelin, fibroblast growth factor (fgf)-19, fgf-21, c4 (an intermediate in the de novo synthesis of bile acids), cholecystokinin (cck), bile acids and plasma lipids. furthermore, gastric emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will be examined.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 3 months (diagnosed according to the criteria of the world health organization (who)) * men and postmenopausal women * metformin applied as the only glucose-lowering drug * caucasian ethnicity * normal haemoglobin * age above 40 years and below 75 years * bmi \>23 kg/m2 and \<35 kg/m2 * informed and written consent exclusion criteria: * liver disease (alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary disorder * gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * nephropathy (serum creatinine \>150 µm and/or albuminuria) * hypo- or hyperthyroidism * hypo- or hypercalcaemia * hypo- or hyperphosphataemia * active or recent malignant disease * treatment with medicine that cannot be paused for 12 hours * treatment with oral anticoagulants * any treatment or condition requiring acute or sub-acute medical or surgical intervention * any condition considered incompatible with participation by the investigators

Keywords: bile acid
personalized training for people with rare neuromuscular disorders

Conditions: Neuromuscular Diseases (NMD); Charcot Marie Tooth Disease (CMT); Facioscapulohumeral Muscular Dystrophy; Myotonic Dystrophy Type 1 (DM1)

Summary: the goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: charcot-marie-tooth (cmt), facioscapulohumeral muscular dystrophy (fshd), and myotonic dystrophy type 1 (dm1). the key objectives are: 1. to investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group 2. to investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up 3. to investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life. this is a national study and will involve 120 individuals with rare-neuromuscular disorders from norway's four health regions.


Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of either fshd, dm1 or cmt * 18-70 years of age at the time of signing the informed consent. * any gender * ability to stand, rise from a chair and walk at least 10 meters with or without any need of assistive devices * indication for rehabilitation as confirmed by the treating neurologist or physiotherapist * ability to understand and follow instructions in norwegian * capable of giving signed informed consent exclusion criteria: * pregnancy or planning to become pregnant * any other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart-failure/cardiomyopathy, on-going cancer treatment * alcohol or drug abuse as per their medical chart * history of non-compliance to medical advice/follow-up

Keywords: personalized training rehabilitation rare-neuromuscular disorders motor unit number estimation neuromuscular ultrasound dual-energy x-ray absorptiometry activity tracking metabolomics dynamic balance
microvascular endothelial function in a cohort of patients with the cardiac form of chronic chagas disease.

Conditions: Chagas Cardiomyopathy

Summary: the present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of chagas disease, and to search for associations with clinical and laboratory variables.

chagas disease is an endemic anthropozoonosis in south america, caused by the protozoatrypamosoma cruzi. between 15 and 17 million people are estimated to be infected by the parasite in south america. during the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. the myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. the first type is characterized by heart failure symptoms. the second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias. microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. the identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure. the effects of t. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. there are no studies evaluating the microcirculation of patients with the cardiac form of chagas disease.

Eligibility criteria:
inclusion criteria: * patients presenting with chagas cardiomyopathy exclusion criteria: * diabetes

Keywords: endothelial function, microvascular laser speckle contrast imaging capillaroscopy, skin
melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients

Conditions: Multiple Myeloma; Diagnosis

Summary: in this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (mel200) or two courses of melphalan 100 mg/m2 (mel100). informed consent will be obtained upon enrolment. inclusion criteria included: diagnosis of untreated durie e salmon stage iia-iiib measurable multiple myeloma; age \ 2.5 times normal and alat and/or asat \> 2 times normal; seropositivity for hiv, hcv or hbv, active non-hematologic malignancies. induction therapy, pbsc mobilization, and autografting initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (pbsc) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and g-csf, 10 ug/kg given i.v. or subcutaneously. after at least one month from pbsc collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved pbsc infusion on day 0. patients received g-csf, 5 ug/kg, from days +3 until neutrophil count \> 1000/ul were achieved. supportive care and toxicity grading following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and pneumocystis carinii. cytomegalovirus cmv reactivation was monitored through levels of cmv antigenemia and/or serum cmv dna levels and treated with ganciclovir or foscarnet as clinically indicated. standard criteria (common toxicity criteria version 3.0) were used for grading hematological and non-hematological toxicity.


Eligibility criteria:
inclusion criteria included: * diagnosis of untreated durie \& salmon stage iia-iiib measurable multiple myeloma; * age \< 65 years. exclusion criteria included: * prior treatment for myeloma; * abnormal cardiac function, defined as systolic ejection fraction \<50%; * abnormal pulmonary spirometry test; * serum bilirubins \> 2.5 times normal and alat and/or asat \> 2 times normal; * seropositivity for hiv, hcv or hbv, active non-hematologic malignancies.

Keywords: myeloma melphalan autologous transplantation
open-label study to evaluate metreleptin in patients with partial lipodystrophy

Conditions: Partial Lipodystrophy

Summary: this is an open label, phase iv, post authorisation study to evaluate the efficacy, safety and immunogenicity of daily subcutaneous metreleptin treatment in people with partial lipodystrophy


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of familial or acquired partial lipodystrophy exclusion criteria: * treatment with any investigational medicinal product (imp) within 6 months or 5 times the terminal half-life of the corresponding imp, whichever is longer, before the screening visit. other protocol defined inclusion/exclusion criteria apply

Keywords: metreleptin
ribociclib (lee011) rollover study for continued access

Conditions: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

Summary: this study is to allow continued use of ribociclib (lee011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible novartis-sponsored ribociclib (lee011) study that has reached its primary objective(s) or has been halted for other reasons.


Eligibility criteria:
inclusion criteria: 1. patient is currently enrolled in an eligible novartis-sponsored study and receiving ribociclib (lee011) as single agent or in combination with other investigational treatment. 2. patient is currently deriving clinical benefit from the study treatment, as determined by the investigator. exclusion criteria: 1. patient has been permanently discontinued from ribociclib (lee011) in the parent protocol for any reason. 2. patients who do not meet parent protocol criteria to continue study treatment.

Keywords: ribociclib lee011
open-label, bridging study of telaprevir in treatment-naïve and treatment-experienced russian patients with genotype 1 chronic hepatitis c

Conditions: Genotype 1 Chronic Hepatitis C

Summary: the purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (peg-ifn)-alfa-2a and ribavirin (rbv) in treatment-naïve and treatment-experienced russian participants with genotype 1 chronic hepatitis c.

this is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis c) and treatment-experienced (participant did receive previous treatment for hepatitis c) russian participants with genotype 1 chronic hepatitis c. after a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with peg-ifn-alfa-2a and rbv followed by 12 or 36 weeks of treatment with peg-ifn-alfa-2a and rbv alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. after the treatment period, there is a follow-up phase of at least 12 weeks.

Eligibility criteria:
inclusion criteria: * participant has genotype 1 chronic hepatitis c with hcv rna level \>1000 iu/ml * participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c, or participant is treatment-experienced who did not achieve sustained virologic response (svr) 24 weeks after at least 1 prior course of peg-ifn/rbv therapy (null-responder, partial-responder or viral relapse) * participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan \> 2 years ago prior to screening * a female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of rbv exclusion criteria: * prior non-responder that is classified as a viral breakthrough participant * participant is infected or co-infected with hcv of another genotype than genotype 1 * participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c * participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection * participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma

Keywords: genotype 1 chronic hepatitis c vx-950hpc3007 vx-950 hepatitis c telaprevir hcv
myo-inositol during pregnancy to prevent gestational diabetes

Conditions: Pregnancy Related

Summary: myoinositol is an insulin-like compound that is present in both plant and animal cells. humans synthesize it naturally, but it is also obtained in our diet. it works through an intracellular signaling pathway to increase insulin sensitivity. myoinositol has been used as an over-the-counter (otc) supplement in the management of polycystic ovarian syndrome due to this effect. myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (gdm). this is a double blind rct offering myo-inositol or placebo to those who are eligible and enrolled.


Eligibility criteria:
inclusion criteria: singleton gestations women aged \> 18 years and \< 45 years recruited before 16 weeks gestation obese (pre-pregnancy bmi ≥ 30) receiving prenatal care at tufts medical center planning to give birth at tufts medical center can tolerate glucose tolerance test willing and able to wear cgm willing and able to sign informed consent exclusion criteria: multiple gestation preexisting diabetes taking medications that impact body weight or metabolism (eg metformin) inability to tolerate glucose tolerance test adults unable to consent (cognitively impaired adults) wards of the state non-viable neonates neonates of uncertain viability
"natural history" study of choroideremia

Conditions: Choroideremia

Summary: the purpose of this study is to understand the rate of progression of all stages of choroideremia using a variety of assessments performed in the clinic including visual field measures, specialized photography of the eye and participant-reported visual problems


Eligibility criteria:
inclusion criteria (primary cohort): * healthy individuals (at least 14 years) with choroideremia (20/200 or better vision) willing to participate in an observational study and meeting the eligibility criteria. inclusion criteria (expansion cohort): * healthy individuals (at least 18 years) with choroideremia (20/200 or better vision in both eyes) willing to participate in an observational study and meeting the eligibility criteria. exclusion criteria (primary and expansion cohort): 1. prior therapy with an aav vector-based treatment 2. pre-existing eye conditions that would: (1) preclude future planned treatment in a therapeutic intent clinical trial (i.e. intravitreal injection), (2) interfere with the interpretation of study endpoints, and/ or put patient at risk for surgical complications 3. complicating systemic diseases that would preclude future enrollment in a therapeutic intent clinical trial 4. any other condition that would not allow the potential subject to complete follow-up examinations during the course of the study and, in the opinion of the investigator, makes the potential subject unsuitable for the study.

Keywords: retinal degeneration eye rep-1 gene
reduction of right ventricular pacing using the feature ventricular intrinsic preference (vip)

Conditions: Bradycardia

Summary: the purpose of this study is to evaluate the efficacy of the vip™ feature (available in dual chamber victory® devices) to reduce unnecessary rv pacing, and to determine if patients with implanted sjm pacemakers will benefit by using vip™ rather than only a programmed av/pv delay.


Eligibility criteria:
inclusion criteria: * patient has been implanted with dual chamber sjm victory® device with vip™ for 1 month (± 2 weeks). * at the time of pacemaker implant, vip™ is programmed "off". * at the time of enrollment, patient is paced in the rv ≤ 60% of the time. * patient is medically stable. exclusion criteria: * patient has evidence of complete av block, such that ventricular pacing would be required as part of the patient's routine management. * patient is indicated for af suppression. * patient has persistent or chronic atrial fibrillation. * patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons. * patient is currently participating in another device research study. * patient is younger than 18 years of age. * patient is pregnant. * patients life expectancy is less than 12 months.
association between resuscitation orders and mortality in icu patients

Conditions: Critical Illness

Summary: the hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. by incorporating conventional variables associated with death such as age, sex, and simplified acute physiological score, as well as including the new clinical frailty scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.


Eligibility criteria:
inclusion criteria: * admitted to icu exclusion criteria: * second or subsequent admission to icu during the study period.

Keywords: resuscitation orders
plantar cutaneous sensory stimulation in patients with diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: to determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * age ranged between 45-67 years. * both male and female genders are included. * dm for the past 7 years. * scored \> 2/13 on the michigan neuropathy screening instrument (mnsi) questionnaire including at least two dpn symptoms. * scored \>1/10 on mnsi physical assessment including impaired vibration perception exclusion criteria: * loss of protective foot sensation (defined as a lack of response to the monofilament of the sensory evaluation instrument). * comorbidities include visual impairment, cerebrovascular accident, orthopedic trauma, labyrinthitis, peripheral vascular disease, and heart failure. * foot ulcers, orthopedic or surgical problems in a lower limb, other neurological impairment. * use of assistive devices for ambulation. * inability to walk independently with or without an assistive device. * receiving any structured supervised physiotherapy intervention

Keywords: diabetic neuropathy gait parameters plantar cutaneous stimulation postural instability
cnep for the treatment of obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to determine whether cnep (continuous positive external pressure) is effective in treating obstructive sleep apnea


Eligibility criteria:
key inclusion criteria: * psg performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying psg") * on that psg, ahi must be 10 - 50/hr and \>80% of the apneas and hypopneas must be obstructive * no significant changes in health, medications, or lifestyle since the qualifying psg key exclusion criteria: * previous major surgery, injury or radiation to the neck * beard or excessive hair on the area of the neck where the collar will be applied * carotid artery disease * serious medical conditions * pregnancy * use of home oxygen * silicone allergy * sleep disturbance other than obstructive sleep apnea

Keywords: obstructive sleep apnea sleep apnea osa cnep continuous negative external pressure
return to work after a workplace-oriented intervention for patients on sick leave due to burnout

Conditions: Professional Burnout

Summary: the study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. the intervention intends to reduce job-person mismatch through patient-supervisor communication.the hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.

participants are consecutively recruited in co-operation with regional social insurance offices (rsios) in the two southern counties of sweden. persons accepting participation are clinically examined and interviewed of the course of events leading up to the burnout and the patient's expectations of changes necessary to facilitate return to work are recorded. the patient´s supervisor is then interviewed at the workplace, responding to the same questions on perceived main causes of the subordinate's sick leave and changes necessary to facilitate return to work. finally, the core intervention takes place, namely a dialogue being initiated between the patient and the supervisor to find solutions to facilitate return to work. out of those who do not want to participate, without giving any specific reason for that, a control group is matched by length and degree of sick leave at the time of the intervention.

Eligibility criteria:
inclusion criteria: * employment * sick leave at lest half time 2-6 months due to work related burnout * previously healthy exclusion criteria: * other somatic or psychiatric disease explaining the symptoms

Keywords: burnout sick leave intervention study prospective study work