Kornimate/medical-research-clean huggingface dataset:
a trial investigating the possible difference in development of type 2 diabetes between caucasian and japanese subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and japan. the aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a japanese and a caucasian population. healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. the development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and b-cell capacity.


Eligibility criteria:
inclusion criteria: * danish (northern european) or japanese (according to country allocation) background for at least 3 generations * bmi above or equal to 18 kg/m2 exclusion criteria: * treatment of diabetes mellitus with any insulin product * fasting plasma/serum glucose above 12 mm * therapy with tzd (thiazolidinedione) drugs within the past 3 months * therapy with more than 2 oads (oral anti-diabetics drugs)
continuous glucose monitoring evaluation of exenatide twice daily versus insulin glargine

Conditions: Type 2 Diabetes

Summary: the primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, hba1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

the primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (glp-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management. an ancillary study was approved as part of this study. the purpose of the ancillary study was to use cgm to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥18 and ≤75 years of age * clinical diagnosis of type 2 diabetes * diabetes duration ≥ 1 year * hba1c ≥7.0% * currently treated with metformin (hba1c ≤9%) or metformin/sulfonylurea (su) (hba1c ≤8%)or su alone (hba1c ≤8%) exclusion criteria: * previously treated with insulin or incretin-based therapy * treated with a thiazolidinedione within past 6 weeks * taken oral or injected prednisone or cortisone medications in the previous 30 days * any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease) * serum creatinine \>1.4mg/dl (women) or \>1.5 mg/dl (men) * egfr (estimated glomerular filtration rate) \<30 ml/min (using mdrd/ modification of diet in renal disease equation) * alt(alanine transaminase) \> 2x upper limit of normal (uln) * presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise he subject's safety or successful participation in the study * currently pregnant or planning pregnancy during the study period * unable to follow the study protocol * unable to speak, read and write in english * uncontrolled hyperglycemia with hba1c \> 9% on metformin or \>8% on su or metformin/su combination or ketonuria requiring immediate insulin therapy * at the investigator's discretion for other medical or psychological reasons

Keywords: diabetes continuous glucose monitoring exenatide insulin glargine
transcranial direct current electrical stimulation (tdcs) in drug-resistant epilepsy

Conditions: Epilepsy

Summary: this project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (seeg). seeg is used as part of the pre-surgical assessment. it consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions. in order to study the neuromodulatory and therapeutic effects of tdcs on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (meg) and high-resolution electroencephalography (hr eeg) will be used. finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tdcs on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.


Eligibility criteria:
inclusion criteria: * - age: older than 12 years old * patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure or refusing surgery. * seeg previously performed before inclusion with an adequate definition of the epileptogenic zone * a clinical or research mri scan that is suitable for navigated brain stimulation (nbs) and definition of target area. * number of seizures \>3/month during the baseline (before the first session of tdcs treatment), for at least 3 months * have stable medications for the whole study duration and few weeks before * total iq\>65 * be able to understand, speak and write in french * patient, parents or legally representative who have given written informed consent to allow the study data collection procedures, * be a beneficiary of affiliated to a health insurance plan exclusion criteria: * - generalized epilepsy * presenting contraindication to mri, a serious intercurrent pathology, a progressive brain tumor * skin conditions (e.g., eczema, lesion) * any cranial metal implants (excluding \<1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). * previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. * metal inside the head (outside the mouth) such as shrapnel, surgical clips * patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion. * any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study. * person protected by articles l1121-5, l1121-6 and l1121-8 of public health code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent).

Keywords: pharmaco-resistant epilepsy transcranial stimulation seeg
etrasimod versus placebo as induction therapy in moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * diagnosed with ulcerative colitis (uc) ≥ 3 months prior to screening * active uc confirmed by endoscopy exclusion criteria: * severe extensive colitis * diagnosis of crohn's disease (cd) or indeterminate colitis or the presence or history of a fistula consistent with cd * diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Keywords: ulcerative colitis etrasimod apd334
a study of topical arnica & ledum on bruise reduction in hnv

Conditions: Bruise, Contusion

Summary: subjects will have a bruise induced. a pad containing either a placebo or active will be applied to the bruise. photographs will be taken over the following days to record bruise healing.

this is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. the trial will be conducted at 5-8 sites with up to 150 subjects. each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. subjects and study investigators will be blinded to the order of treatment assignment. subjects will be asked to come to the clinic for photographic assessments of the bruise. each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on day 1. the pad will be applied by study staff immediately after bruise induction (within 5 minutes). the pad will cover the bruised area completely, and then sealed with tegaderm. all procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. all photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.

Eligibility criteria:
inclusion criteria: * fitzpatrick skin type 1-3 * bmi 25 kg/m2 * self described bruisers * intact skin in the target area, free of markings, blemishes and hair exclusion criteria: * use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy * known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing * inability to forego application of topical products in the target area * hair removal by laser, wax or chemicals within one week prior to day 1 * avoid tanning beds * history of allergy to topical gels, arnica or ledum * active wound or infection in the target area * history of keloids or hypertrophic scarring * history of collagen or vascular disease * history of organ transplant
a study for participants previously treated with century therapeutics cellular therapy product

Conditions: Hematological Malignancy; Solid Tumor Malignancy

Summary: this study is designed to collect long-term safety and survival data from participants previously treated in an eligible century-sponsored index trial. this is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (aes) that may appear after treatment with such cellular products. additionally, collection of persistence data from participants will support the identification of any long-term risks or late aes that may be causally related to treatment with such cellular products.


Eligibility criteria:
inclusion criteria: * participant has provided written informed consent prior to any long-term follow-up (ltfu) study-specific procedures. * participants received at least one treatment with a cellular therapy product in an eligible index trial. * participant was withdrawn, early discontinued or completed an eligible index trial. * participant is willing and able to comply with scheduled visits, study plan, and other study procedures. exclusion criteria: -this study has no exclusion criteria.

Keywords: century therapeutics cellular therapy cell therapy malignancy
differentiated service delivery for antiretroviral therapy

Conditions: HIV Infections

Summary: this study is a prospective observational cohort. the target study population is plhiv who receive art at hospitals and community-based organizations (cbos) in chiang mai, ubon ratchathani, chonburi, and songkhla. participants will receive art service in the same standard as in the hospital setting. secondary data will be collected from the medical records already existed in the hospital and cbo systems.

dsd-art service at the hospital * medical examination: all clients who receive art service at the hospital and agree to participate in the research project will be interviewed to collect personal information and receive physical and laboratory examination in order to assess eligibility in research participation. if ineligible, the clients will be referred to the standard of care. * preparation and dsd-art service offer: plhiv who are eligible to participate in the research will receive counselling to assess the supports the clients need and will be offered various models of dsd-art service. the clients may choose the model that is most suitable to their lifestyle.

Eligibility criteria:
inclusion criteria: 1. thai citizenship 2. age ≥ 18 3. hiv positive 4. received art for at least 6 months at a participating hospital (except for after hour art clinic model that will allow participants who receive art less than 6 months into service) exclusion criteria: n/a
a study to evaluate the safety of rituximab retreatment in subjects with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: this is a phase ii/iii, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (sle). the primary efficacy endpoint of the trial will be evaluated at 52 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle). * active disease at screening. * stable use of one immunosuppressive drug. * use of an antimalarial drug. * for subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation. exclusion criteria: * unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions. * active moderate to severe glomerulonephritis. * retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from sle. * lack of peripheral venous access. * pregnant women or nursing (breast feeding) mothers. * history of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies. * significant, uncontrolled medical disease in any organ system not related to sle that in the investigator's opinion would preclude subject participation. * concomitant conditions that require oral or systemic corticosteroid use. * known human immunodeficiency virus (hiv) infection. * known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics. * history of deep space infection. * history of serious recurrent or chronic infection. * history of cancer, including solid tumors, hematological malignancies, and carcinoma in situ. * active alcohol or drug abuse, or history of alcohol or drug abuse. * major surgery. * previous treatment with campath-1h antibody. * previous treatment with any b cell-targeted therapy. * treatment with any investigational agent within 28 days of screening (day -7) or 5 half-lives of the investigational drug (whichever is longer). * receipt of a live vaccine within 28 days prior to screening. * intolerance or contraindication to oral or iv corticosteroids. * use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening. * prednisone dose of ≥ 1 mg/kg/day prior to screening. * treatment with cyclophosphamide or a calcineurin inhibitor. * treatment with a second immunosuppressive or immunomodulatory drug. * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.5 x the upper limit of normal.

Keywords: rituxan sle lupus
chest wall muscle stretching and acute effects in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with chronic obstructive pulmonary disease.

randomized controlled trial involving patients with chronic obstructive pulmonary disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.

Eligibility criteria:
inclusion criteria: * clinical and functional diagnosis of chronic obstructive pulmonary disease according to the global initiative for chronic obstructive lung disease (gold, 2009), * forced expiratory volume in one second (fev1) less than 80% predicted post-bronchodilator; * clinical stability during the study, * both sexes, * age above 40 years, * body mass index (bmi) between 18.5 and 29.9 kg / m²; * smoking history, * symptoms of cough, * dyspnea or hypersecretion, * ex-smokers for at least three months. exclusion criteria: * disease exacerbation for at least eight weeks, * patients with other respiratory diseases, * cardiovascular or osteoarticular and * participants in pulmonary rehabilitation programs.
a phase iii trial of zd4054 (zibotentan) (endothelin a antagonist) and docetaxel in metastatic hormone resistant prostate cancer

Conditions: Prostate Cancer

Summary: enthuse m1c is a large phase iii clinical trial studying the safety and efficacy of zd4054 (zibotentan) in combination with docetaxel (taxotere) in patients with metastatic hormone resistant prostate cancer (hrpc). this clinical trial will test if the endothelin a receptor antagonist zd4054 (zibotentan) can further improve survival compared with docetaxel alone. zd4054 (zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking endothelin a receptor activity. this trial will look at the effects of zd4054 (zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. all patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. half the patients will receive zd4054 (zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. by participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. no patients will be deprived of standard prostate cancer therapy.


Eligibility criteria:
inclusion criteria: patients who answer true to the following criteria may be eligible to participate in this trial. * confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis) * increasing prostate specific antigen (psa), collected within one year of enrollment * currently receiving treatment with surgical or medical castration exclusion criteria: patients who answer true to the following are not eligible to participate in this trial. * previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). prior targeted cancer therapies are permitted if received during a previous clinical trial. * suffering from heart failure or had a myocardial infarction within last 6 months * a history of epilepsy or seizures

Keywords: hormone resistant prostate cancer endothelin a receptor antagonist endothelin a endothelin a antagonist
water drinking test study and disc hemorrhages in normal tension glaucoma

Conditions: Normal Tension Glaucoma

Summary: disc hemorrhages are a known risk factor for progression of glaucoma. a positive water drinking test is also associated with progression of primary open glaucoma. the purpose of this study is to determine if patients with normal tension glaucoma and disc hemorrhages have a positive water drinking test. patients with normal tension glaucoma and a disc hemorrhage will be recruited to undergo a water drinking test prior to any change in their treatment.

patient with normal tension glaucoma under the care of a fellowship trained glaucoma specialist and noted to have a disc hemorrhage in one or both eyes when examined in the office will be recruited to undergo a water drinking test (wdt). after an informed consent is obtained, arrangements will be made to undergo the wdt either at the ophthalmologist's office or the local hospital clinic(misericordia). the test will be administered in the following way: upon arrival the patients baseline intraocular pressure (iop) will be measured, then shortly afterwards the patient will drink 800 ml of water in a period of 5 minutes. immediately after the water ingestion has finished a second iop will be measured, followed by iop measurements every 15 minutes for 60 minutes with a goldman applanation tonometer by the same examiner. all of these measurements will be collected in a data sheet for the wtd. a total of 60 minutes would be the duration of the activity.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of normal tension glaucoma by a fellowship trained glaucoma specialist, * clinical diagnosis of a disc hemorrhage diagnosed by a fellowship trained glaucoma specialist, * must be able to swallow water * must be able to be positioned to allow accurate measurement of the intraocular pressure with a slit lamp mounted goldmann applanation tonometer * must have a smooth corneal surface to allow for accurate goldmann application tonometry measurement * outpatient * a sufficient level of education to understand study procedures and be able to communicate with site personnel exclusion criteria: * history of refractive surgery, * active ocular infection, * pregnancy, * cardiac or renal diseases, history of urinary retention, * corneal abnormalities preventing reliable iop measurements, * previous trabeculectomy or glaucoma shunt surgery, * previous laser iridotomy, * cognitive impairment or language barrier preventing ability to provide an informed consent.

Keywords: normal tension glaucoma disc hemorrhages water drinking test