Kornimate/medical-research-clean huggingface dataset:
observational study to assess glycosylated hemoglobin changes after 6 months of treatment with pioglitazone.

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (qd), treatment.

the metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. a low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. type 2 diabetes is a disease with a profound genetic component. peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue. pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. these include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle. this is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.

Eligibility criteria:
inclusion criteria: * fulfills all requirements for treatment with pioglitazone. * willing to start treatment with pioglitazone. exclusion criteria: * has previously participated in this study. * is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.

Keywords: glucose metabolism disorder dysmetabolic syndrome type ii diabetes diabetes mellitus, lipoatrophic dyslipidemia drug therapy
single-dose pharmacokinetics of bms-790052 in participants with hepatic impairment

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of bms-790052.


Eligibility criteria:
key inclusion criteria: * male and female subjects aged 18 to 70 years, with hepatic impairment conforming to child-pugh class a, b or c * healthy subjects to the extent possible matched to the first four hepatically impaired subject in each child-pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender key exclusion criteria: * history of esophageal and gastric variceal bleeding within past 6 months * primarily cholestatic liver diseases * active alcoholic hepatitis * stable encephalopathy of \>= stage 2 * presence of severe ascites or edema * presence of hepatopulmonary or hepatorenal syndrome * positive for hcv, unless hcv rna is undetectable
loteprednol etabonate in an ophthalmic base vs vehicle for the treatment of inflammation following cataract surgery

Conditions: Ocular Inflammation

Summary: evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects at least 18 years of age * subjects who have the ability to understand and sign an informed consent form and provide health insurance portability and accountability act (hipaa) authorization. * subjects who are candidate for routine, uncomplicated cataract surgery. * subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening. * subjects must be willing and able to comply with all treatment and follow- up procedures. exclusion criteria: * subjects who have known hypersensitivity or contraindication to the study drug or its components. * subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study. * subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the investigator's opinion, may preclude study treatment or follow-up. * subjects with elevated intraocular pressure (\>/= 21 mm hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. * subjects who are monocular or have pinholed snellen va 20/200 or worse in the non-study eye. * subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit. * women who are pregnant or breast feeding. * subjects who have participated in an investigational drug or device study within the last 30 days. * subjects previously randomized in this study.
proof of activity study of ur-63325 in allergic rhinitis induced by nasal challenge

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to explore the activity of ur-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.


Eligibility criteria:
inclusion criteria: * provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule * subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and history of symptoms of allergic rhinitis) within the previous two years * positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening * subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score \[tnss\]) within one hour after last nasal allergen challenge * screening and baseline fev1 \>80% predicted and fev1/fvc \> 70% predicted exclusion criteria: * symptoms of allergic rhinitis within 2 weeks prior to screening * upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods * structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery * history of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or fev1\<80% of predicted at screening or baseline
risk-guided disease management plan to prevent cad in patients treated with previous cancer

Conditions: Coronary Artery Disease

Summary: redeem-cad is a prospective multi-centre study of cad risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago.

redeem-cad is a prospective multi-centre study in which a process of evaluating the risk of coronary artery disease is studied in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago. the efficacy of this cad risk evaluation will be compared with the broad community in two existing studies - caught-cad and edcad. this unique screening/management plan (smp) has 2 components; 1) a novel clinical and imaging-based screening algorithm to select those most likely to develop coronary artery disease, 2) a clinical review to ensure optimal risk factor control and cardio protection. follow-up of treated patients will continue for an average of 36 months, with clinic reviews at 12, 24 and 36 months. the results will define the prevalence of subclinical coronary artery disease, and the feasibility and the efficacy of the smp.

Eligibility criteria:
inclusion criteria: a history of cancer \>5 y ago associated with potential cardiotoxicity from chemotherapy and/or radiotherapy (chiefly survivors of breast cancer, hodgkin's lymphoma and prostate cancer). exclusion criteria: * unable to provide written informed consent to participate in this study * known coronary artery disease at recruitment * history of previous coronary artery disease * inability to acquire interpretable ct images * contraindications/intolerance to or already taking statin therapy * oncologic (or other) life expectancy \<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the chief investigators) that it is not appropriate for the patient to participate in this trial
a phase i study of br790 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of the study was to evaluate the safety and tolerability of br790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (dlt), maximum tolerated dose (mtd) and/or recommended phase ii clinical trial dose (rp2d) .the study is divided into two phases: dose escalation phase and dose expansion phase.


Eligibility criteria:
inclusion criteria: * sign informed consent voluntarily. * age ≥18 and ≤75 years old. * subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment. * had at least one measurable lesion. * ecog≤1. * expected survival period ≥ 3 months. exclusion criteria: * any previous treatment with shp-2 inhibitor. * symptomatic brain metastases. * subjects with thoracic/ascites fluid that need drainage or intervention. * subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： anc\ 1.5×uln alt, ast\>2.5×uln (without liver metastases) or alt, ast\>5×uln (with liver metastases), cr \>1.5×uln. * with uncontrolled severe disease.
a study to assess efficacy and safety of hl036 in subjects with dry eyes

Conditions: Dry Eye

Summary: the objective of this study was to compare the safety and efficacy of 0.25% hl036 ophthalmic solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * have a patient-reported history of dry eye for at least 6 months prior to visit 1 * be willing and able to comply with all study procedures * have a schirmer's test score of ≤ 10 mm and ≥ 1 mm at visits 1 and 2 exclusion criteria: * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1 * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months * have any previous experience using hl036
safety and efficacy of telaprevir in combination with peginterferon alfa-2a and ribavirin in subjects co-infected with hepatitis c virus (hcv) and hiv

Conditions: Hepatitis C; HIV Infections

Summary: the purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis c virus (hcv) infection in subjects who are infected with both hcv and human immunodeficiency virus (hiv).


Eligibility criteria:
inclusion criteria: * chronic, genotype 1, hepatitis c with detectable hcv rna * hiv-1 infection for \>6 months * documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis) exclusion criteria: * previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c * previous treatment with interferon or ribavirin * evidence of hepatic decompensation in cirrhotic subjects * subjects who have participated in a clinical study involving administration of an investigational drug within 2 months * part a only: subjects who have been on a haart regimen within 12 weeks before study start

Keywords: vx-950 incivek incivo
a new diagnostic paradigm for retinitis pigmentosa secondary to ush2a pathogenic variants

Conditions: USH2A Variant Retinitis Pigmentosa

Summary: aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by ush2a retinitis pigmentosa (ush2a-rp), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. all the procedures will be performed according to normal clinical practice. in addition, a novel quantitative profiling of serum micrornas will be carried out in order to analyze the clinical importance of microrna biomarkers in the clinical setting of the disease.


Eligibility criteria:
inclusion criteria: * age \>18 years * genetically confirmed diagnosis of ush2a-rp * availability of genetic tests to assess the pathogenic variants exclusion criteria: * inability to understand and sign the written informed consent form * any inflammatory, infectious or degenerative eye disease * media opacities resulting incompatible with good imaging quality * uncontrolled systemic, metabolic, autoimmune neuroinflammatory and neurodegenerative disease * ophthalmologic surgery within the previous six months
phase 1 study to assess the safety and tolerability of tat4 gel in healthy volunteers

Conditions: Nasolabial Folds; Lipoatrophy; Lipodystrophy

Summary: this phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of tat4 gel administered once daily to 50 cm2 of skin for 14 days.


Eligibility criteria:
inclusion criteria: * men and women 40-70 years old * healthy volunteers * provision of informed consent exclusion criteria: * history of skin hypersensitivity * abnormality on screening assessments
neuromuscular study to assess foot intrinsic muscles

Conditions: Flexible Flatfoot

Summary: the purposes of these studies are to investigate: differences in abductor hallucis muscles'emg activities during different postural tasks between individuals with normal foot alignment and functional flat foot. differences in abductor hallucis muscles'h-reflex amplitudes between individuals with normal foot alignment and functional flat foot. changes in abductor hallucis muscles'emg activities during different postural tasks after a 3-week short foot exercises training regimen in individuals with functional flat foot. changes in abductor hallucis muscles'h-reflex amplitudes after a 3-week short foot exercises training regimen in individuals with functional flat foot. hypotheses: peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. h-reflex amplitudes of abductor hallucis muscles were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. changes of peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen. changes of h-reflex amplitudes of abductor hallucis muscles were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen


Eligibility criteria:
: inclusion criteria: * age between 20 and 45 years * no ankle injury within the previous 6 months * no diagnosed lower extremity injuries * no ankle pain at the time of the study * foot posture index score: 0 to +5 for the normal foot (nf) group; +6 to +12 for the functional flat foot (fff) group * navicular drop: 5-9 mm for the nf group; \> 10 mm for the fff group exclusion criteria: * foot posture index score: \<0 * navicular drop\< 5 mm * leg length discrepancy \> 1.5 cm * diagnosed severe scoliosis * neurological injuries over lower extremities

Keywords: electromyography,excessive foot pronation,exercise,neurology,physical therapy
efficacy and safety of mometasone furoate plus azelastine hcl combination versus mometasone furoate alone or azelastine alone in patients with perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine hcl in patients with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * patients over 12 years of age * medical history of perennial allergic rhinitis for at least two years * moderate ro severe nasal symptom (during placebo run-in period am rtnss or pm rtnss≥8) * positive skin prick test result within the previous 12 months exclusion criteria: * patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist * patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane * patients with herpes zoster, glaucoma or cataract * patients with history of operation or damage on nasal cavity or ocular region * patients with drug-induced rhinitis * patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days * patients with lung disease including copd * patients with history of immunotherapy or ongoing immunotherapy * patients administered with super potent or potent corticosteroid * patients administered with intra-muscular or intra-articular steroid within the previous 3 months * patients administered with subcutaneous omalizumab within the previous 5 months

Keywords: mometasone furoate azelastine hcl perennial allergic rhinitis
screening of pulmonary veino occlusive disease in heterozygous eif2ak4 mutation carriers

Conditions: Mutation; Genetic Syndrome

Summary: pulmonary veino occlusive disease (pvod) is a rare form of pulmonary arterial hypertension, characterised by a poor prognosis. recent studies demonstrated that heritable form of pulmonary veino occlusive diseaseis due to bi-allelic mutations in eif2ak4 gene. heritable pulmonary veino occlusive disease is an autosomal recessive disease. in the french referal center of severe ph, ulmonary veino occlusive disease patients carriers of bi-allelic mutations in eif2ak4 gene were identified. genetic counselling in these families allowed to identified herozygous carriers of a single mutation in eif2ak4 gene. however, to date, nothing is known about the risk of these persons of developping pulmonary diseases. it appears essential to determine the clinical, functional, echocardiographic and radiologics characteristics of these persons, and their risk of developping pulmonary veino occlusive disease

the investigators will evaluate the subjects at inclusion after informed by a clinical evaluation (dyspnea assessed by new york heart association functional class (i-iv), signs of right heart failure), a 6min walk test, a computerized tomography scan of the chest, an electrocardiogram, an echocardiography , an abdomina ulstrasound, a cardiopulmonary exercise testing, a lung function tests , arterial blood gases. at one and two years, a phone call will be made to to participants evaluate dyspnea and intercurrent events in all subjects. in the presence of pulmonary veino occlusive diseaseis symptoms, a new evaluation will be proposed in order to confirm of not pulmonary veino occlusive diseaseis.

Eligibility criteria:
inclusion criteria: * male or female adult (age ≥18 years of age at the date of inclusion), * with an identification of the presence of a mutation of the eif2ak4 gene in the heterozygous state, * having given free and informed consent. exclusion criteria: * minor (age \<18 years), * patient with known pulmonary veino occlusive disease or pulmonary arterial hypertension * woman having started a pregnancy or breastfeeding * protected adult persons, * persons deprived of their liberty, * people in emergency, * those who refused or were unable to give informed consent, * contraindication to the exercise test (acute coronary syndrome, syncope, tight stenotic valve disease ...) see the list of relative and absolute contraindications to the exercise test (chapter 6.2). * no affiliation to a social security scheme (beneficiary or beneficiary).

Keywords: pulmonary veino occlusive disease, pulmonary hypertension
study to evaluate the pharmacokinetics and pharmacodynamics of dabigatran etexilate in patients with stable severe renal disease.

Conditions: Renal Insufficiency, Chronic

Summary: the study to be conducted is a prospective, open label trial. it is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.


Eligibility criteria:
inclusion criteria: 1. male and female patients aged 18 years and older 2. impaired renal function defined as a stable cockcroft-gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation. 3. the single use of either aspirin or vitamin k antagonists 4. provision of informed consent. exclusion criteria: 1. unstable renal function and creatinin clearance \<15ml/min 2. patients treated with two or more platelet aggregation inhibitors 3. use of or indication for therapeutic heparin 4. patients with prosthetic heart valves 5. haemorrhagic disorder or bleeding diathesis 6. platelet count \<100 109/l) at screening or during the last 30 days before screening. 7. participation in another drug trial in the last 30 days before screening.
smoking cessation study

Conditions: Smoking Cessation; Arthropathy

Summary: the primary outcome of this study is to determine the true incidence of smokers among patients undergoing joint replacement and secondly, what percent are able to quit smoking before surgery under a structured cessation program with carbon monoxide breath testing. the investigators hypothesize that self-reported smoking status is underreported and that routine carbon monoxide breath testing will improve abstinence rates at the time of surgery.

this study looks at patients who have been referred to our clinic for a potential hip and knee joint replacement surgery. once it has been determined that the patient requires surgical replacement of either their hip or knee and is placed on our surgical waitlist, the patient will be asked if he or she would like to participate in the study. the investigators would ask all patients, both self-declared smokers and non-smokers, to participate. this study would include completing a smoking history questionnaire and a noninvasive carbon monoxide breath test. while smoking status is already assessed in the mcgill university health centre preoperative questionnaire, the investigators intend on expanding these questions in study participants to better quantify their nicotine exposure.

Eligibility criteria:
inclusion criteria: * adults ages 18-85 who require a primary total hip or knee replacement * any gender * smokers and non-smokers * osteoarthritis, rheumatoid arthritis, avascular necrosis exclusion criteria: * patients who require revision surgery * previous fracture to affected area * emergency surgery * patients who do not understand, read or communicate in either french or english
pregnant women vaccinated against covid-19.

Conditions: Pregnant Women Vaccinated Against Covid-19

Summary: establish a cohort of pregnant women exposed to a covid19 vaccine, whether or not they have experienced an adverse event, to assess the potential effects of vaccines on the course of pregnancy, on the fetus or newborn and on the mother.


Eligibility criteria:
inclusion criteria: * patient aged 18 years and over, * pregnant, * vaccinated against covid-19, * not having expressed any objection to inclusion in the cohort exclusion criteria: * no agreement at inclusion, * age under 18 years