Kornimate/medical-research-clean huggingface dataset:
arfi imaging for targeted prostate biopsy

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate a new ultrasound technique. this technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. the investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (mr) ultrasound fusion biopsy procedure. above the time required for the mr ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.


Eligibility criteria:
inclusion criteria: * men who are scheduled to undergo ultrasound fusion-mr prostate biopsy; * men who are willing to participate in the study; * subjects must freely sign informed consent to enroll in the study; * assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation. * 18 years or older exclusion criteria: * men who have had previous treatment for pca including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (hifu), laser therapy or hormone therapy; * men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (bph) (i.e., turp, tumpt, wit, tuna, etc); * standard pharmacological treatment of bph is allowable * men who are mentally impaired and cannot give written consent; * men with anomalies of the rectum.

Keywords: transrectal ultrasound prostate biopsy
early phase clinical trial to test the feasibility of an act-based physical activity promotion program for adults with depressive symptoms

Conditions: Physical Inactivity

Summary: the goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (act; activity) to a time- and attention-matched standard pa intervention (i.e., pa education, goal-setting, and self-monitoring) plus relaxation training comparison condition (relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month ymca membership to equate access to pa facilities.


Eligibility criteria:
inclusion criteria: * elevated depressive symptoms (ces-d score of greater than or equal to 10) * low-active (less than 60 minutes per week of moderate intensity pa) * willing and able to attend weekly virtual video sessions via zoom exclusion criteria: * regular mindfulness meditation practice (more than once per week) * body mass index (bmi) less than 18.5 or greater than 40 * history or presence of any condition that may limit or substantially increase the risks of physical activity * active suicidal thoughts or behaviors * currently participating in any exercise or weight-loss research studies * household member is participating in this study * does not have a rhode island mailing address or if only rhode island mailing address is a po box * unable to receive materials in the mail at residential mailing address * does not plan to live in rhode island for the next 6 months * unable to speak, read, and/or write fluently in english
suicide gene therapy for donor lymphocytes infusion after allogeneic hematopoietic stem cell transplantation

Conditions: Hematological Malignancy

Summary: the main complications of allogeneic hematopoietic stem cell transplantation (hsct) include graft-versus-host disease (gvhd) and poor immune reconstitution leading to severe infections and leukemia relapse. mature donor t-cells present in the transplant facilitate t-cell reconstitution but also induce gvhd, which itself impairs immune reconstitution. we have developed a strategy of alloreactive t-cell depletion, using t-cells expressing the herpes simplex thymidine kinase (tk) suicide gene combined with a ganciclovir (gcv) treatment. this system permits the selective elimination of dividing tk+ t-cells in vivo. to test this hypothesis in preclinical settings, we have previously developed several experimental models of gvhd using tk+ t-cells in mice. the demonstration that a preventive treatment with gcv administered close to the time of hsct could control gvhd brought the proof of concept. we now propose a clinical trial to test whether donor lymphocytes infusion (dli) using tk-transduced cells permits to induce a graft-versus-tumor (gvt) effect for treatment of relapse after hsct, while gvhd can be controlled by gcv treatment.

dli-tk is administered either after failure of 1 or several previous standard (std-) dli of, defined after a minimal follow-up of 2 months after the last injection. to prepare dli-tk, donor t-cells are transduced with a retroviral vector encoding tk. transduced cells are selected using a clinimacs device (myltenyi). in case of previous std-dli received, the dli-tk cell dose is adjusted to be below or equal to the maximal cell dose previously received in std-dli. no comparison is planned in the analysis.

Eligibility criteria:
inclusion criteria: * hematological malignancy. * previous allogeneic hematopoietic stem cell transplantation. * relapse diagnosed at the molecular, cytogenetic, or cytological level. * failure of a previous stdild or inclusion in first intention without previous stddli. * age \> 18 years and \< 70 years at the time of inclusion. for patients between 15 and 18 years of age, a case-per case inclusion will be studied. * performance status considered on the score eastern cooperative oncology group (ecog) \< 2. * life expectation 1-month-old superior. * signed written informed consent. * negative human chorionic gonadotropin (hcg) in the 7 days preceding the inclusion for women in age of procreation. * membership of the french national insurance. exclusion criteria: * grade \>ii acute gvhd or chronic extensive gvhd at the time of inclusion. * patient receiving an immunosuppressive treatment for gvhd treatment at the time of inclusion. * dysfunction of liver (alanine aminotransferase / aspartate transaminase (alat/asat) \> 5 n, or bilirubin \> 50 µm), or of the renal function (creatinine clearance \< 30 ml / min).

Keywords: hematological malignancy allogeneic hematopoietic stem cell transplantation donor lymphocyte infusion antitumor immunotherapy graft-versus-tumor effect gene therapy relapse adult
a multicenter study to evaluate the cholesterol lowering effects of two marketed products in patients with type 2 diabetes mellitus and hypercholesterolemia (mk-0653a-077)

Conditions: Type 2 Diabetes Mellitus; Hypercholesterolemia

Summary: the purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs. exclusion criteria: * type 1 diabetes mellitus * type 2 diabetes mellitus that is poorly controlled
mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse in primary care

Conditions: Chronic Pain; Opioid Use Disorders

Summary: the central aim of this study is to test the efficacy of mindfulness-oriented recovery enhancement (more), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. the investigators plan to conduct a full scale clinical trial to determine whether more (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.


Eligibility criteria:
inclusion criteria: * age 18-60+ * current back pain diagnosis as determined from icd-9 codes in claims data (including but not limited to icd-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to icd-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4) * current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days, and evidence of opioid misuse as indicated by the current opioid misuse measure * willingness to participate in study interventions and assessments exclusion criteria: * prior experience with mindfulness-based stress reduction, mindfulness-based cognitive therapy, or mindfulness-based relapse prevention * active suicidality, schizophrenia, psychotic disorder, and/or substance dependence (other than opioid dependence) * presence of clinically unstable systemic illness judged to interfere with treatment
a multi-center study on the clinical advantages of personalized total knee arthroplasty system

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (tka) in comparison with conventional tka. the study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.

this study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (tka) prostheses . the clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized tka system. this is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. they will be followed for one year post-surgery to assess clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. patients aged 50-80 years. 2. diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty. 3. willing and able to provide informed consent. exclusion criteria: 1. history of prior knee surgery or knee replacement. 2. severe knee deformity (valgus \>20° or varus \>15°) or instability. 3. severe contracture (\>25° flexion contracture). 4. undergoing total knee revision surgery. 5. rheumatoid arthritis diagnosis. 6. bmi \>35. 7. neuromuscular disorders affecting knee stability or gait. 8. pregnancy or lactation. 9. presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions. 10. active or recent severe infections or malignancy. 11. history of drug or alcohol abuse in the past six months.
non-interventional multi-center study on patients under routine treatment of pulmonary arterial hypertension (pah) with inhaled iloprost using i-neb as a device for inhalation

Conditions: Pulmonary Hypertension

Summary: this pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of pulmonary arterial hypertension (pah) with inhaled iloprost (using i-neb device for the inhalation). the planned study recruitment time is 18 months. the maximum follow up period in this study will be 12 months. the data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using i-neb device) since february 1st, 2013. frequency of visits and procedures will be performed under routine conditions. the primary objective of this study is to assess the compliance of patients with who/nyha (world health organization/new york heart association) functional class iii pulmonary arterial hypertension treated with inhaled iloprost in clinical practice, using the i-neb insight tool.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18years old), male or female * diagnosis of pulmonary arterial hypertension, group i of the dana point pulmonary hypertension classification (diagnosis made at the discretion of the attending investigator, including mpap ≥ 25 mmhg at rest, as measured by right heart catheterization.) * the treating physician has chosen to initiate the treatment with inhaled iloprost with i-neb device for the application, as described in the summary of product characteristics (smpc). * who/nyha functional class iii * willing to participate in the study (informed consent sign) * patients who received the first inhaled iloprost treatment with i-neb from february 1st, 2013. exclusion criteria: * any contraindication for the treatment with ventavis as described in the summary of product characteristics (smpc) * patients are not to be enrolled if they were treated with inhaled iloprost with i-neb or any other device for the application in the past, before the start of the observation period (february 1st, 2013)

Keywords: pulmonary hypertension ventavis patient compliance
interest of molecular analysis of cerebral thrombi in determining the prognosis and etiology of cerebral infarction

Conditions: Ischemic Stroke

Summary: the matisse (molecular analysis of thrombus for ischemic stroke prognosis and etiology) project evaluates the hypothesis that the molecular composition of cerebral thrombus in metabolites, lipids, and proteins conditions the clinical prognosis at 3 months of the infarction and informs on its etiological subtype


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older; * patient with a cerebral infarction documented by brain imaging who received endovascular treatment by mechanical thrombectomy; * patient for whom it was possible to collect cerebral thrombus for lc-ms analysis during mechanical thrombectomy: * patient who was informed of the study and formulated a non-opposition to participation. if not, patient for whom a relative was informed and formulated a non-opposition. exclusion criteria: * patient with a cerebral infarction documented by cerebral imaging, having benefited from an endovascular treatment with mechanical thrombectomy that did not allow the extraction of a cerebral thrombus. * protected persons (articles l1121-5, l1121-6 and l121-8 of the public health code): pregnant or breast-feeding women, persons deprived of liberty, under guardianship or curatorship

Keywords: ischemic stroke thrombi metabolites
assessment of orality disorders in children with food allergies

Conditions: Food Allergy in Children; 6 Years Old Maximum

Summary: orality disorders are frequent in child. there are complications like growth and psychomotor development disorders. the aim is to estimate the prevalence of orality disorder for child with one or several food allergy.


Eligibility criteria:
inclusion criteria: * every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of university hospital of angers * obtention of informed consent exclusion criteria: * child with allergy other than food * poor understanding of french
mri biomarkers in diabetic kidney disease

Conditions: Diabetic Nephropathies

Summary: diabetic kidney disease is one of the most severe and frequent complications of diabetes. few preclinical markers are available apart from plasma creatinine and microalbuminuria. these markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. therefor there is an uncovered need to identify complementary biomarkers. magnetic resonance spectroscopy (mrs) is a magnetic resonance imaging (mri) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.


Eligibility criteria:
inclusion criteria: common to all 3 category * male or female, * age≥ 35 years, * subject free, with legal protection guardianship or curatorship; * enrollment in the french social security system; * informed consent signed by the patient obese patients * bmi \>30 kgm² ; * with no known diabetes; * estimated glomerular filtration rate (egfr) \> 60 ml/min/1.73m² and urine albumin-creatinin ratio (acr) \< 3 mg/g type 2 diabetic patients without kidney disease - egfr \> 60 ml/min/1.73m² and acr \< 3 mg/g, type 2 diabetic patients with diabetic kidney disease defined as egfr 30 to 60 ml/min/1.73m² or acr \> 30 mg/mmol. exclusion criteria: age \< 35 years history of kidney transplant any contraindication to an mri examination legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations pregnant or lactating women, women of childbearing age who do not have effective contraception

Keywords: obesity diabetic nephropathies biomarkers metabolites
clinical performance of incremental and bulk fill composites in class ii restorations

Conditions: Dental Caries

Summary: this study will examine the clinical performance of class ii restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

specific aim: to place three commercially available resin composites in class ii cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by international dental federation (fdi).

Eligibility criteria:
inclusion criteria: * must have given written informed consent to participate in the trial * must need at least three posterior dental fillings * replacement restorations due to caries or an esthetic replacement with or without caries are acceptable. * must be available for the required post-operative follow-up visits * restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure * class ii restorations must have at least one proximal contact * restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips * all restorations must class ii with a proximal contact with a natural or artificial tooth exclusion criteria: * have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene * have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or sjogren's syndrome patients * have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored * are unavailable for long term recall * cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration. * do not meet all inclusion criteria * present with any systemic or local disorders that contra-indicate the dental procedures included in this study * have an unstable occlusion * have severe bruxing or clenching or in need of tmj related therapy * have teeth with periapical pathology or expected pulp exposures * have teeth that are non-vital or that exhibit signs of pulpal pathology * are pregnant.

Keywords: class ii molar and premolar resin composite adult restoration
music therapy on cognition in neurorehabilitation

Conditions: Dementia; Stroke; Traumatic Brain Injury

Summary: music therapy has received more attention with its surging application in neuro-rehabilitation overseas. given the dearth of music therapy and cognitive rehabilitation research conducted in malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

music therapy has received more attention with its surging application in neuro-rehabilitation overseas. given the dearth of music therapy and cognitive rehabilitation research conducted in malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs. thirty subjects participated in this study. each participant received one session of each of the following: active music therapy intervention, passive music therapy intervention, and standard card. mini-cog tests were conducted before and after each session and the scores were collected for data analysis. throughout the study, observations ensured the troubleshooting of any potential flaws for future recommendations.

Eligibility criteria:
inclusion criteria: * neurorehabilitation needs exclusion criteria: * obtain a score of above 22 or below 10 on the mmse * have documented current/active episodes of hallucinations and/or delusions * have documented hearing impairments with or without hearing aid(s) * have language barrier, i.e. do not speak or understand english, mandarin or malay

Keywords: music therapy active passive neurorehabilitation needs cognition
safety & efficacy of dual therapy with raltegravir/lamivudine

Conditions: AIDS

Summary: a pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with raltegravir/lamivudine combination when replacing standard combination therapy in hiv-infected patients with prolonged virological suppression


Eligibility criteria:
inclusion criteria: 1. eligible patients will be males or females at least 18 years of age. women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study. 2. patients seropositive for hiv-1 using standard diagnostic criteria. 3. patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/ml). 4. patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study. 5. patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). 6. patients who have signed informed consent to participate in the study. exclusion criteria: 1. pregnancy, lactation, or planned pregnancy during the study period. 2. previous failure to an integrase inhibitor-containing regimen. 3. previous failure to a 3tc or ftc-containing regimen. 4. resistance mutations to 3tc or integrase inhibitor if any resistance test had been previously performed. 5. any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. 6. chronic hepatitis b.