Kornimate/medical-research-clean huggingface dataset:
a phase 1/2, open-label, dose escalation, safety and tolerability study of incb050465 and itacitinib in subjects with previously treated b-cell malignancies (citadel-101)

Conditions: B-Cell Malignancies

Summary: open-label, dose-escalation study in subjects with previously treated b-cell malignancies to find maximum tolerated dose (mtd) or pharmacologic active dose of a pi3kδ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (incb039110), a jak1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. parsaclisib inhibits pi3kδ, a protein involved in growth and survival of b-cell cancer cells.


Eligibility criteria:
inclusion criteria: * aged 18 years or older, with lymphoid malignancies of b-cell origin including: 1. indolent / aggressive b-cell non-hodgkin's lymphoma (nhl) * excluding: burkitt's lymphoma and precursor b lymphoblastic leukemia/lymphoma * including: any non-hodgkin's b cell malignancy such as chronic lymphocytic leukemia (cll) and rare non-hodgkin's b- cell subtypes such as hairy cell leukemia, waldenström macroglobulinemia (wm), mantle cell leukemia (mcl), and transformed nhl histologies 2. hodgkin's lymphoma (hl) * life expectancy of 12 weeks or longer * subject must have received ≥ 1 prior treatment regimen(s) * the subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice exclusion criteria: * has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (cns) * has an eastern cooperative oncology group (ecog) performance status of ≥ 3 (≥ 2 during dose escalation) * received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (gvhd) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant * received autologous hematopoietic stem cell transplant within the last 3 months * inadequate marrow reserve assessed by hematologic laboratory parameters * inadequate renal or liver function * known hiv infection, or hepatitis b virus (hbv) or hepatitis c virus (hcv) viremia or at risk for hbv reactivation
a trial comparing two therapies: basal insulin/glargine, exenatide and metformin therapy (bet) or basal insulin/glargine, bolus insulin lispro and metformin therapy (bbt) in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the study will compare two combination therapies: 1) combined basal insulin glargine (once a day), exenatide (twice a day), and metformin therapy; or 2) combined basal insulin glargine (once a day), bolus insulin lispro (three times a day), and metformin therapy, in subjects with type 2 diabetes mellitus who have inadequate glycemic control.


Eligibility criteria:
inclusion criteria: * have been taking a basal insulin glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start. * have been taking basal insulin glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (oam) regimens, for at least 3 months prior to study start: * metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or * metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start. * have an hba1c \> 7.0% and ≤ 10.0%. * have a body mass index (bmi) between ≥ 25 and ≤ 45 kg/m2. exclusion criteria: * are currently taking oam that is not described above and not allowed with concurrent use of insulin per local product label. * have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications). * have taken any insulin other than glargine within the 3 months prior to study start for more than 1 week. * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start. * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * have previously completed or been withdrawn from this study after enrollment.

Keywords: diabetes exenatide byetta insulin lispro humalog insulin glargine lantus amylin lilly
study to evaluate the safety and efficacy of jaktinib in adults with alopecia areata

Conditions: Alopecia Areata

Summary: this is a multi-center phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called jaktinib) in adults (≥18 years and \<65 years) who have 50% or greater scalp hair loss. the study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). it is double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


Eligibility criteria:
inclusion criteria: * participants voluntarily sign the informed consent form (icf); * age ≥ 18 years and \<65 years, either male or female; * clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years. * at least 50% scalp hair loss. * willing to comply with the study visits and requirements of the study protocol. exclusion criteria: * participants has taken a jak inhibitor prior to randomization; * participants who are unsuitable to the trial, as identified by the investigator.
interest of the t2 * sequence in mri for the diagnosis of migraine aura in the acute phase.

Conditions: Migraine Aura

Summary: investigators hypothesize that t2 \* vein abnormalities are frequent and are specific to the migraine aura.

the diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. the possibility of making the positive diagnosis of migraine aura on a routine mri sequence, t2 \*, would be an important advance for the management of these patients

Eligibility criteria:
inclusion criteria: * patients aged 18 to 55 years * admitted to the neuro-vascular intensive care unit for acute focused neurological symptoms and mri * less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission * less than two hours after the disappearance of symptoms if the patient arrives asymptomatic * affiliated to a social protection scheme. * having given their informed consent exclusion criteria: * patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness * presence of recent explanatory abnormalities on the mri to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations). * potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation. * pregnant women - patients with a contraindication for mri. * patients benefiting from a system of legal protection (tutelage,

Keywords: migraine aura
apart advanced profiling of anti-rheumatic therapies

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the utility of an electronic data capture system (edcs) in a rheumatology clinical practice setting and to assess the impact of this system on patient satisfaction with patient-physician interaction.

this is a randomized, multicenter observational study to assess the impact of the edcs in a rheumatology clinical practice setting on patient satisfaction with patient-physician communication using the health tracker electronic data capture system . patients will be randomly assigned in a 2:1 ratio to the health tracker-user or non-user groups, respectively. the primary outcomes of this study will be the impact that information gathered and analyzed by an electronic data capture system has on patient satisfaction with arthritis care and patient physician interactions in clinical practice. patient satisfaction will be assessed using a questionnaire developed specifically for this study. this study does not involve the use of any investigational drugs, and the protocol does not mandate the treatment regimen patients will receive. physicians will prescribe antirheumatic medications in accordance with usual clinical practice. the planned duration of subject participation is 12 months

Eligibility criteria:
inclusion criteria: * patients diagnosed with active rheumatoid arthritis according to the revised criteria of the acr (1987) * have rheumatoid arthritis that requires regularly scheduled visits with their rheumatologist at least every 3 months * willing and able to adhere to protocol requirements and participate in a study, lasting 12 months exclusion criteria: * patients currently receiving investigational drugs * currently participating in other clinical trials or safety registries for rheumatoid arthritis or rheumatoid arthritis -related therapies

Keywords: rheumatoid arthritis
48 weeks combination therapy for patients with hbeag-negative chronic hepatitis b virus (hbv) infection

Conditions: Hepatitis B

Summary: the purpose of this study is to investigate whether in patients with chronic hbeag-negative hepatitis b, peg-ifn-ribavirin combination therapy for 1 year leads to enhanced response (hbv dna \<10e4 copies/ml and normal alt 24 weeks after treatment discontinuation) in comparison with pegylated interferon (peg-ifn) monotherapy.

despite the introduction of newer drugs for the treatment of chronic hepatitis b, there is still no optimal treatment. pegylated interferon alfa has proven sustained efficacy in approximately 30-40% of patients with hbeag-positive or hbeag-negative chronic hepatitis b. it is likely that combination therapy of pegylated interferon alfa with ribavirin in chronic hepatitis b is more effective than pegylated interferon alfa monotherapy. in chronic hepatitis c, adding ribavirin to pegylated interferon therapy doubled the sustained response rate (29% vs. 56%) and has become the standard option of treatment. to investigate the effect of the treatment with pegylated interferon and ribavirin on the amount of inflammation and fibrosis in the liver, a liver biopsy will be performed within one year prior to screening and at the end of follow-up. when patients with chronic hepatitis b are treated outside any study with pegylated interferon, they visit the outpatient clinic approximately every month for blood samples. so in this study the amount of blood samples taken from every patient is not increased as compared with treatment outside a study.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b * biopsy performed within one year prior to screening or during screening * alt \> 1.5 x uln * hbeag negative, anti-hbeag positive * hbv dna \> 10e5 copies/ml * age 18-70 years * written informed consent * hepatic imaging without evidence of hcc * all fertile males and females must be using two forms of effective contraception exclusion criteria: * antiviral therapy against hbv within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol * severe hepatitis activity as documented by alt \> 10 x uln * advanced liver disease * pre-existent leucopenia or thrombopenia * co-infection with hcv,hdv or hiv * other acquired or inherited causes of liver disease * alpha fetoprotein \> 50 ng/ml. * evidence of severe renal disease * hyper- or hypothyroidism * significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes * immune suppressive treatment within the previous 6 months * contra-indications for alpha-interferon therapy * pregnancy, breast-feeding * any medical condition requiring chronic systemic administration of steroids * substance alcohol or drug abuse * subjects with clinically significant retinal abnormalities * subjects with clinically significant hearing abnormalities * hemoglobinopathies * subjects with known hypersensitivity to ribavirin

Keywords: hbeag-negative chronic hepatitis b viral
smarttarget therapy

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to assess how accurately smarttarget can direct high intensity focused ultrasound (hifu) to a pre-defined area (cancer) in the prostate. the current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. an alternative method is focal therapy. this is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue. prior to surgery prostate cancer can often be localised using mri imaging and detailed prostate biopsy techniques. the difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. this may cause higher rates of side-effects. smarttarget is an mri to ultrasound fusion device that maps the pre-treatment mri onto the live ultrasound during surgery. it then provides a target for the surgeons to treat during the operation. the results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment mri with a 1 week post treatment scan


Eligibility criteria:
inclusion criteria: 1. histological diagnosis of prostate cancer (psa \</=15ng/ml, gleason score \</=4+3, and radiological stage \</=t3anomo) 2. prostate biopsy concordant with mpmri lesion (template transperineal or mri-targeted biopsy only) 3. discrete lesion on mpmri scoring 3, 4 or 5 on radiological scale of suspicion 4. mpmri carried out according to european society of uro-radiology guidelines at 1.5t or 3t 5. an understanding of the english language sufficient to understand written and verbal information about the trial and consent process 6. signed informed consent exclusion criteria: 1. no lesion on mpmri 2. bilateral lesions on mpmri 3. mpmri undertaken over 6 months prior to visit 1 4. contralateral gleason \>/=3+4 and/or maximum cancer core length involvement \>/=6mm 5. men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months 6. prior immunosuppression or predefined immunosuppressed state 7. an irreversible coagulopathy predisposing to bleeding 8. unable to undergo transrectal ultrasonography 9. previous radiation therapy to the pelvis 10. previous hifu, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate. 11. men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging 12. men not fit for major surgery as assessed by a consultant anaesthetist 13. men who are unable to give informed consent

Keywords: prostatic neoplasms therapeutics magnetic resonance imaging ultrasonography high intensity focused ultrasound image fusion
evaluate the utility of 18fdg-pet as a tool to quantify atherosclerotic plaque (mk-0000-081 am3)(completed)

Conditions: Atherosclerotic Vascular Disease

Summary: the purpose of this study is to evaluate the utility of 18fluorine fluorodeoxyglucose positron emission tomography (18fdg-pet) as a tool to quantify atherosclerotic plaque.


Eligibility criteria:
inclusion criteria: * male or female ages 30 to 80 * participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening exclusion criteria: * participant has human immunodeficiency virus (hiv), hepatitis b or c * participant uses illegal drugs * participant has type i diabetes * participant has a history of claustrophobia
sustained effects of a non-glucidic nutrient preload on glucose tolerance in type 2 diabetes

Conditions: Diabetes

Summary: the investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, c-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.

as supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. the ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. the size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. the effect on 5 h glucose excursions of a combination of protein and fat given before carbohydrate is still unknown.

Eligibility criteria:
inclusion criteria: * diet-controlled type 2 diabetic patients * subjects ≥ 18 and ≤65 years of age * lean, overweight or obese (bmi: 18 to 35 kg/m2) * normal liver and kidney function * normal thyroid function * read and understood the informed consent form and signed it voluntarily exclusion criteria: * liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases. * type 1 or insulin treated diabetes. * pregnancy or lactation * illicit drug abuse or alcoholism * subjects taking anoretic drugs * subjects on steroid treatment * subjects after bariatric surgery.
elastography as gouty arthropathy outcome (ego)

Conditions: Gout

Summary: elastography as gouty arthropathy outcome (ego), a pilot study.

pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Eligibility criteria:
inclusion criteria: 1. subjects who are at least 18 years of age but younger than or equal to 99 years of age. 2. subjects with gouty arthritis as determined by the acr 1977 classification criteria for gouty arthritis. 3. subjects with one palpable tophus detectable by one of the three clinical parameters described. - exclusion criteria: 1. subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds. 2. subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial. 3. subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated. -
a prospective study to assess the screening value of n-terminal pro-b-type natriuretic peptide (nt-probnp) for the identification of patients that benefit from additional cardiac testing prior to vascular surgery

Conditions: Peripheral Vascular Disease

Summary: the purpose of this study is to validate the screening potential of nt-probnp for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. all patients will have nt-probnp concentrations measured pre-operatively. for low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.


Eligibility criteria:
inclusion criteria: * adult patients, \&#8805;18 years of age * patients with peripheral vascular atherosclerosis, scheduled for vascular surgery exclusion criteria: * n/a
impact of sophrology on the pain felt during a bone marrow aspiration and biopsy

Conditions: Hematologic Diseases; Diagnoses Disease; Pain

Summary: the bone marrow aspiration and biopsy (bmab) is an essential and indispensable examination for the diagnosis and the follow-up of the hematological diseases but which remains painful and dread by the patients. until then it was performed manually using a trocar. it is now practiced most often using a tool (like a small drill), device that pierces through the external iliac bone to extract a bone cylinder that will be analyzed if the gesture is faster than with the manual method, it remains overall painful and the noise generated by the drill that passes through the periosteum of the iliac bone is impressive for the patient. prevention measures to limit pain and anxiety are put in place during the examination: local anesthesia, with or without a lidocaine patch, as well as inhalation of a mixture of nitrous oxide and oxygen (meopa®). these, recommended by the "standards, options, recommendation" (sor) often remain insufficient and are not devoid of undesirable effects. despite these precautions, several studies show that the action remains painful and anxiety-provoking. an exploratory survey carried out in the hematology department of the françois baclesse center in 2013 confirms these results and specifies that the pain remains present for another 30 minutes after the examination. the investigators believe that associating a psycho-corporeal technique, as is sophrology, with the usual care, could contribute to the decrease of the threshold of pain and anxiety during the bmab and avoid the use of a premedication. the effectiveness of sophrology as a complementary technique in the field of pain prevention in invasive procedures is recognized by observations and clinical results. this complementary therapy, among others, has its place in the hospital. to date, to investigator's knowledge, there is no published, randomized study evaluating the effectiveness of sophrology on pain in invasive procedures. the investigators propose a study whose main objective is to evaluate the effectiveness of a session of sophrology on the pain felt during the realization of the bmab, in patients with hematological malignancy. this session will be provided by a sophrologist nurse this study should include 90 patients undergoing a bmab over a 24-month period.


Eligibility criteria:
inclusion criteria: * patient over 18 years old who has been informed of the study and has signed the consent form of the study * patient with a malignant hemopathy requiring a bmab as part of a diagnostic assessment * patient who has never had a bmab before * patient affiliated to a social security scheme exclusion criteria: * patient requiring oral premedication * patient with contraindications or intolerance to meopa® * patient with a history of allergy to local anesthetics * patient not understanding french * patient with deafness * patient with severe cognitive impairment * patient under legal protection