Kornimate/medical-research-clean huggingface dataset:
study to evaluate the pharmacokinetics & food effect of mk-0941 in adults with type 2 diabetes (mk-0941-009)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to compare the pharmacokinetics (pk) of the dry filled capsule (dfc) \& oral compressed tablet (oct) formulations of mk-0941-009 \& to assess the effect of food on the oct formulation.


Eligibility criteria:
inclusion criteria: * males or females (of non-childbearing potential) between the ages of 18 to 70 * participants have been diagnosed with type 2 diabetes * participants are nonsmokers for at least 6 months exclusion criteria: * participant should not be diagnosed with type 1 diabetes * participant should not be receiving insulin or ppar gamma agonists for 12 weeks prior to study start * participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start * participant has been diagnosed with glaucoma or is blind * participant has had trauma to one or both eyes * participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks * participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
a multicenter open-label study investigating the pharmacokinetics and safety of aripiprazole im depot formulation (opc-14597 imd) during repeated administration by injection into the deltoid muscle in patients with schizophrenia

Conditions: Schizophrenia

Summary: to assess the pharmacokinetics and safety of aripiprazole intra-muscular (im) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of schizophrenia as defined by diagnostic and statistical manual (dsm)-iv-text revision (tr) (295.30, 295.10, 295.20, 295.90, 295.60) * patients who have provided written informed consent by themselves (if the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.) * patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent * patients with a body mass index of 18.5 or higher and lower than 35.0 * patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent * patients who have received aripiprazole in the past exclusion criteria: * patients diagnosed as having a mental disorder other than schizophrenia, as defined by dsm-iv-tr criteria. * patients with a history or complication of diabetes. * patients with hepatic, renal, cardiac, or hematopoietic disorders. * female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant. * patients who have a drug allergy or drug hypersensitivity * patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine. * patients with a complication of parkinson's disease (excluding drug-induced parkinsonism). * patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication. * patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc). * patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent. * patients with a history of or a complication of convulsive disorder such as epilepsy. * patients with a history of or a complication of organic brain disorder including cerebrovascular disease. * patients with a history or a complication of granulocytopenia or agranulocytosis. * patients who have received electro-convulsive therapy (ect) within 12 weeks prior to obtaining informed consent.

Keywords: aripiprazole deltoid
axone-acute ii: acute assessment of a micro multipolar lead for enhanced cardiac resynchronisation therapy

Conditions: Cardiac Resynchronisation Therapy

Summary: pilot study to evaluate the performance of a lead below 2 french with specific distal shape to deliver efficient lv pacing


Eligibility criteria:
inclusion criteria: * male or female patient aged ≥18 years old. * patient presenting a crt-p or crt-d indication according to the latest esc guidelines1. * primary implant of a crt device (including upgrade from a single or dual-chamber pacemaker or icd). * signed and dated informed consent. exclusion criteria: * class iv of nyha (ambulatory or not). * allergy to contrast media used for imaging during cardiac catheterization. * severe renal failure (clearance of creatinine according to modification of diet in renal disease formula (mdrd) \< 30ml/mn/m²). * previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation. * already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks. * vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision). * known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate \< 1%.-

Keywords: quadripolar lv leads
insulin delivery using microneedles in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * ≥ 8 years of age * \<19 years of age * type 1 diabetes for at least 2 years * uses a conventional, fda-approved insulin pump for the past year * uses lispro insulin * mean hemoglobin a1c ≤ 8.5 % for the past year * body mass index ≤ 85th percentile for age * understand and be willing to adhere to the study protocol exclusion criteria: * type 2 diabetes * acanthosis nigricans * clinically significant major organ system disease * on glucocorticoid therapy * insulin requirement ≥ 150 u/day * illness on the day of the study * cognitive impairment (iq \ 2 grades behind age-appropriate grade) * pregnant or breast-feeding (if female).

Keywords: microneedle continuous subcutaneous insulin infusion
utility of bladder epicheck for detection of recurrent urothelial carcinoma

Conditions: Bladder Cancer

Summary: clinical trial to determine the performance characteristics (sensitivity and specificity) of the bladder epicheck test compared to the gold standard cystoscopy and pathology.

clinical trial to determine the performance characteristics (sensitivity and specificity) of the bladder epicheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Eligibility criteria:
inclusion criteria: * patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma * has all urothelial cell carcinoma tumor resected within the past 12 months * has a plan for cystoscopic surveillance exclusion criteria: * planning to undergo radical cystectomy or chemotherapy-radiation for ucc

Keywords: bladder cancer urine methylation
alkali therapy in chronic kidney disease

Conditions: Chronic Kidney Disease; Metabolic Acidosis

Summary: kidney disease is a common medical condition. individuals with kidney disease develop a build-up of acid in their blood. this acid can affect their muscles, bones, glucose metabolism and kidneys. the investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.


Eligibility criteria:
inclusion criteria: * estimate gfr \ 15 ml/min/1.73m2 * age \>18 exclusion criteria: * previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * bicarbonate level \ 25 meq/l * new york heart association class iii or iv heart failure * systolic blood pressure \>180 mmhg * initiation of esrd treatment planned within 6 months * kidney transplantation * treatment with immunosuppressives within the last 3 months

Keywords: alkali sodium bicarbonate kidney disease acidosis
a study to compare quality of life and compliance in patients receiving high-dose interferon versus pegylated interferon in patients with surgically resected melanoma

Conditions: Melanoma

Summary: to evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (hrqol) in surgically resected melanoma patients undergoing hdi or peg ifn therapy.

the primary objective of this study is: • to evaluate compliance with the administration of standard hdi versus peg ifn for patients with melanoma in need of adjuvant therapy the secondary objectives of this study are: * to compare the convenience and satisfaction with chemotherapy for patients on standard hdi versus peg ifn using a chemotherapy convenience and satisfaction questionnaire (ccsq) and to evaluate the treatment-related side effects that may impact the patient's hrqol using the functional assessment of cancer therapy of biologic response modifier (fact brm) * to assess the frequency of grade 3 and 4 toxicities, according to the national cancer institute (nci) common toxicity criteria for adverse events (ctcae) for patients on standard hdi versus peg ifn * to examine reasons for patients' choice of treatment with hdi versus peg ifn, for those cases in which patients are presented with a choice of either treatment option * to assess health resource utilization on both arms of the study

Eligibility criteria:
inclusion criteria: * patient is male or female at least 18 years of age * patient has had surgically resected melanoma and plans to receive adjuvant therapy with hdi or peg ifn * patient is willing and able to give written informed consent * patient is willing to comply with all study requirements exclusion criteria: * patient is unable or unwilling to complete qol questionaire or compliance diary * patient has a history of anaphylaxis due to any interferon alpha product * patient has autoimmune hepatitis * patient has decompensated liver disease (child-pugh score\>6 ( class b and c) * patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements

Keywords: melanoma, stage iii, adjuvant, quality of life
efficacy of spinal cord stimulation in burst mode in the treatment of complex regional pain syndromes type 1 of the upper limbs

Conditions: Complex Regional Pain Syndrome Type I

Summary: in this study, it is the procedure of spinal cord stimulation in burst mode, its results and the experience of the patients that are evaluated.

there is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. it is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting. there are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "burst" stimulation which uses stimulation trains repeated 40 times per second. the burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. this result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes. in addition, the burst mode consumes little energy, theoretically less than conventional stimulation. it is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.

Eligibility criteria:
inclusion criteria: * patients between 18 and 75 years of age * patient with crps of at least one upper limb * patient affiliated to a social security plan * patient who has signed and dated the no-objection form * patient with the cognitive ability to understand the treatment and complete the questionnaires * patient who can be followed for a minimum of 1 year exclusion criteria: * patient with an uncontrolled infection * pregnant or breastfeeding patient * patient who has already undergone treatment by spinal cord stimulation * patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...) * patient who cannot be followed regularly for psychological, social, family or geographical reasons * protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
once daily antiretroviral therapy in hiv infected adults treated with haart

Conditions: HIV Infections

Summary: the combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (haart) in hiv infected adults. in those with an undetectable viral load, a once daily combination of ftc, ddi, efavirenz would be easier to take, with less side effects and the same efficacy. the aim of the study was to evaluate if the once daily combination presents the same efficacy than the haart therapy with less side effects and a better adherence.

the combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (haart) in hiv infected adults, but side effects an the great number of pills induces less adherence to the therapy. once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the haart therapy versus changing for a once daily combination of ftc, ddi, efavirenz, during 48 weeks. the primary end-point is the viral success maintained until 48 weeks. secondary end-point is the safety and adherence. the trial is prolonged for a total of 48 weeks.

Eligibility criteria:
inclusion criteria: * hiv infected adults * antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors * cd4 cell count over 100/mm3 * hiv rna below 400 copies/ml since 6 months * signed written informed consent exclusion criteria: * previous treatment with non nucleoside analogue, ddi alone * pregnancy * alcool abuse * acute infection, past neurological or pancreatic disease, biological abnormalities * chemotherapy or immunotherapy

Keywords: hiv infections reverse transcriptase inhibitors treatment simplification
study of cemivil® (imatinib) in chronic myeloid leukemia patients in jordan

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Summary: this study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (cml) in jordan. it was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of ph+ cml, treated with cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed

primary objectives measure the proportion of philadelphia chromosome positive (ph+) cml patients in cp treated with cemivil who achieve optimal response : * complete hematologic response (chr) at 3 months; * minor cytogenetic response (mcyr) at 3 months (ph+ ≤65%); partial cytogenetic response (pcyr) at 6 months (ph+ ≤35%), and complete cytogenetic response (ccyr) at 12 months (no ph+ metaphases); * major molecular response (mmr) at 12 months of cemivil therapy \[a ratio of bcr-abl1 to abl1 ≤0.1% on the international scale\]; assess the safety and tolerability of cemivil after one year of treatment, based on: * incidence, severity, and relationship of adverse events (aes) to the study medication; * serious aes; * aes leading to permanent treatment discontinuation; * clinically relevant changes in laboratory tests (according to laboratory reference ranges). number of subjects evaluated: 91 (n=33 received generic imatinib as first-line therapy "first-line patients". n=58 switched from patented imatinib to generic imatinib "switched patients")

Eligibility criteria:
inclusion criteria: * age ≥18 years * newly diagnosed patients with ph+ cml in cp; or cml patients who started with cemivil treatment since its registration in jordan and who confirmed chr * written informed consent exclusion criteria: * age \<18 years * cml in accelerated phase * cml in blast crisis * cml with mutation(s) in the bcr-abl gene * contraindications to the administration of the study drug according to the approved summary of product characteristics (spc)
immediate loading of implants in the partially or completely edentulous jaw

Conditions: Jaw, Edentulous, Partially; Jaw, Edentulous

Summary: the investigators aim to evaluate the biological and mechanical short- and long-term outcome of il in partially or completely edentulous patients. moreover, the investigators aim to detect potential influencing risk factors predicting undesirable prosthetic outcome.

since its introduction in the late 1990s, immediate implant loading concepts (il) have become a frequent alternative for delayed implant procedures. il concepts reduce chair time, the number of surgical interventions and pain, and offer instant comfort to the patient. its reduced treatment time results in obvious socioeconomic advantages. although there is at present abundant evidence that supports il, evaluation of long-term biological and mechanical stability outcomes of large patient populations could allow quality improvement and more accurate patient selection. the departments of oral and maxillofacial surgery and the department of dentistry of the general hospital saint-john bruges act as one of the pioneers of il in belgium, routinely performing the concept since 2001. the investigators aim to evaluate the biological and mechanical short- and long-term outcome of il in partially or completely edentulous patients. moreover, the investigators aim to detect potential influencing risk factors predicting undesirable prosthetic outcome.

Eligibility criteria:
inclusion criteria: * patients of all ages * patients of all genders * patients with partially or complete edentulous jaw * patients treated at the department between 01/01/2001 and 31/12/2015 exclusion criteria: * patients not eligible according to abovementioned criteria * patients who required horizontal bone augmentation procedures of the complete alveolar bone * patients who required a jaw reconstruction after tumor resection, osteoradionecrosis or medication-related osteonecrosis of the jaw

Keywords: immediate loading biological stability mechanical stability long-term marginal bone level maxilla immediate placement dental implant fibre-reinforced provisional fixed prosthesis
positron emission tomography using [18f]-labeled substance p antagonist receptor quantifier in finding disease in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography (pet) using \[18f\]-labeled substance p antagonist receptor quantifier, may be effective in finding disease in patients with pancreatic cancer. purpose: this phase i trial is studying how well a pet scan using \[18f\]-labeled substance p antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.

objectives: * determine whether \[18f\]-labeled substance p antagonist receptor quantifier positron emission tomography can identify pancreatic cancer evident on multiphase ct scan. outline: patients undergo multiphase ct scan of the chest, abdomen, and pelvis. no more than 15 days later, patients receive \[18f\]-labeled substance p antagonist receptor quantifier iv and undergo positron emission tomography over 6 hours. blood is collected periodically to measure the metabolism of the radiotracer by high performance liquid chromatography with radioactive detectors.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the pancreas * primary or metastatic disease * at least one site of measurable disease * enrolled in an nci protocol (either a treatment or screening protocol) such as nci-05-c-0044 or nci-05-c-0141 patient characteristics: inclusion criteria: * ecog performance status 0-2 * wbc ≥ 1,200/mm³ * creatinine \< 2.0 mg/dl * negative pregnancy test * fertile patients must agree to use effective contraception * not pregnant or nursing exclusion criteria: * allergy to iv contrast * claustrophobia that would preclude completion of a scan or unable to lie on one's back for positron emission tomography scan prior concurrent therapy: inclusion criteria: * more than 4 weeks since prior abdominal surgery exclusion criteria: * prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits * aprepitant within 72 hours of \[18f\]-labeled substance p antagonist receptor quantifier positron emission tomography

Keywords: adenocarcinoma of the pancreas stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent pancreatic cancer
study to describe real world drug retention rate of the tocilizumab at one year

Conditions: Rheumatoid Arthritis

Summary: this multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of tocilizumab (tcz) subcutaneously (sc) under real-world conditions in participants with moderate to severe rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * participants at least 18 years old * participants with moderate to severe ra not previously treated with tcz (intravenous \[iv\] or sc) for whom the rheumatologists have decided to initiate tcz sc treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csdmard) exclusion criteria: * participants taking part in a clinical trial on ra at the time of inclusion * participants with a contra-indication to tcz sc therapy