Kornimate/medical-research-clean huggingface dataset:
alk33bup-201: safety and tolerability study of alks 33-bup (alks 5461) administration in subjects with mdd

Conditions: Major Depressive Disorder

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of alks 33 with buprenorphine (alks 5461) in subjects with major depressive disorder (mdd) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri).


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 65 years of age, inclusive. * meet diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria for mdd. * current episode lasting ≥8 weeks prior to screening with an inadequate/partial response to an adequate trial (defined as at least 8 weeks) of a stable dose of an ssri or snri. inadequate/partial response is defined as: 1. a hamilton depression rating scale total score (ham-d17) ≥14, and 2. less than 50% reduction in depressive symptom severity on the massachusetts general hospital antidepressant treatment response questionnaire (atrq), and 3. clinical global impression - severity (cgi-s) score of ≥3. exclusion criteria: * axis i diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar i or ii disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder. * a clinically significant current axis ii diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder. * experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode. * the use of inducers or inhibitors of cytochrome p450 (cyp) 3a4 (prescription medications, over-the-counter \[otc\] medications, or dietary supplements) within 30 days before dosing. * have received electroconvulsive therapy during the current mdd episode. * pose current suicide risk as confirmed by the columbia suicide severity rating scale (c ssrs). * history of intolerance or hypersensitivity to buprenorphine. * history of allergy or hypersensitivity to opioid antagonists (eg, naltrexone, naloxone) or quinine.
survival thermal blanket versus draping fabric to prevent hypothermia in geriatric surgical patients

Conditions: Hypothermia; Anesthesia

Summary: this study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

study design was randomized single blinded. total of 126 geriatric subjects from march-april 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). preinduction temperature was measured using timpanic membrane termometer. intraoperatively, temperature is measured using nasopharynx.study design was randomized single blinded. total of 126 geriatric subjects from march-april 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). preinduction temperature was measured using timpanic membrane termometer. intraoperatively, temperature is measured using nasopharynx.

Eligibility criteria:
inclusion criteria: * age \> 60 years old * physical status asa 1-3 * undergo elective surgery under general anesthesia with or without regional anesthesia exclusion criteria: * thermoregulation disturbance * abnormal thyroid function * fever caused by infectious disease in 7 days prior to surgery * pre-induction hypothermia with temperature below 36 degree * on routine antipiretic * unstable hemodynamic preoperative and intraoperative

Keywords: perioperative hypothermia geriatric survival thermal blanket draping fabric
"elastography" and "tissue harmonic imaging" for characterisation of hilar and mediastinal lymph nodes

Conditions: Lymphadenopathy

Summary: several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "tissue harmonic imaging (thi)" might be useful for the differentiation of benign and malignant lymph nodes.

patient enrolment and data acquisition is to be carried out on a prospective basis. patients with hilar and/or mediastinal lymphadenopathy and indication for ebus-tbna are enroled. it is planned to evaluate 100 lymph nodes by elastography and thi. all patients will undergo diagnostic bronchoscopy at one study centre in heidelberg.

Eligibility criteria:
inclusion criteria: * indication for ebus-tbna * patient has provided written informed consent
a study of qls4131 in patients with recurrent or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to characterize the safety of qls4131 injection and to determine the recommended phase 2 dose (rp2d) and to further evaluate the efficacy and safety of qls4131 injection in participants with relapsed or refractory multiple myeloma at the recommended phase 2 dose.

multiple myeloma (mm) is a malignant disease with abnormal proliferation of clonal plasma cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia, and kidney damage. qls4131 is a novel tri-specific humanized antibody. the study consists 3 periods: screening phase, treatment phase and a post-treatment follow-up phase. the study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of qls4131 administered to participants with relapsed or refractory multiple myeloma. total duration of study is up to 2 years.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, regardless of gender. 2. subjects should be willing and able to comply with the study schedule and protocols. 3. documented initial diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria. 4. must have measurable disease as defined by the following: serum m-protein greater than or equal to 1 g/dl; or urine m-protein greater than or equal to 200 mg/24 hours; or serum free light chain (flc) assay; involved flc level greater than or equal to 10 mg/dl provided the serum flc ratio is abnormal. exclusion criteria: 1. known hypersensitivity to any of the ingredients of this product. 2. known active central nervous system (cns) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 3. has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
low dose vasopressin in traumatic shock

Conditions: Injuries; Shock, Traumatic

Summary: hypothesis: we hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.


Eligibility criteria:
inclusion criteria: to be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment: * patient is a male or female patient presumed to be at least 18 years of age; * patient has a systolic blood pressure \< 90 mmhg; * patient has clinical evidence of acute traumatic injury; * infusion of study drug must start within one hour following sbp (systolic blood pressure) \< 90 mmhg exclusion criteria: a patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment: * patient is admitted to one of the study hospitals' emergency department greater than six hours after injury; * patient has received greater than 4 liters fluid since time of injury; * patient is enrolled in another shock trial; * patient is asystolic or requires cpr (cardiopulmonary resucitation) prior to randomization; * female patient is pregnant by report or suspicion; * patient has known "do not resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);
decrease the frequency of inappropriate intravenous lines in internal medicine

Conditions: Acute Medical Patients Hospitalized in Internal Medicine

Summary: aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine

nationwide multicentre randomized prospective controlled trial enrolling 59 french internal medicine departments. during the first study visit, we collected data of patients with intravenous infusions from each participating centre in order to determine the number and frequency of inappropriate intravenous lines. using a computerized randomization process (on a 1:1 basis), the participating centres were randomized; half centres (interventional group) received an educational program consisting of educational material and two educational sessions; the other half did not receive the educational program (control group). the educational program provided medical doctors with posters and slides containing information on valid indications for the prescription and use of intravenous infusions (inability to drink or eat, malabsorption, medication only available intravenously with no oral equivalent). based on a previous pilot study, we assumed that the the frequency of inappropriate intravenous lines with be approximately 20% at baseline and hypothesize that the nationwide teaching program will decrease this frequency by 50%.

Eligibility criteria:
inclusion criteria: * internal medicine department

Keywords: education intravenous infusion
private medicine retailer-based trial of malaria tests and conditional treatment subsidies among patients with fever

Conditions: Malaria Falciparum

Summary: the goal of this study observational study is to test the effect of conditional subsidies for rapid diagnostic tests (rdt) and artemisinin combination therapies (act) on improving the management of malaria fevers that seek care in the retail sector. the main question it aims to answer is: • would a conditional subsidy scheme increase the proportion of clients with malaria receiving an act? researchers will compare the proportion of patients with malaria receiving an act in the intervention arms to the control arm. retail providers in the intervention arm have access to free rdts and subsidized acts distributed by the research team and are asked to use a recommended retail price for the rdt and act. in addition, the providers in the intervention arm are trained in the use of rdts and a mobile app that will prompt them to take and upload a picture of the rdt result. retail providers in the control arm are trained in the use of rdts but do not receive free rdts or subsidized acts.

the ultimate goal of the conditional subsidy scheme is to increase the proportion of patients with malaria that receives an artemisinin combination therapy (act) at the point of sale. the objective of this study is to test the effect of providing low-cost malaria rapid diagnostic tests (rdt) and artemisinin combination therapies (acts) to patients on improving the management of malaria fevers that receive care in private medicine retailers (pmr). during the study, malaria rdts are provided free of charge to the private provider to conduct malaria-rdt testing at a low cost (at a set recommended retail price) for patients with a malaria-like illness. subsidized acts are provided to the provider, conditional on the provider conducting the malaria rdt and selling the act at a low cost to patients testing positive for malaria. outcomes will be measured by exit interviews on random days each month at participating pmrs.

Eligibility criteria:
inclusion criteria: * participants who tested in the private medicine retailer and/or purchased antimalarial (s) for themselves. * individuals with malaria-like illness must be present at recruitment. * older than one year of age. exclusion criteria: * any individual with signs of severe illness requiring immediate referral. * individuals who have taken an antimalarial in the last seven days, including for the current illness. * patients \<18 years without a parent or legal guardian present. * adults who are unable to consent for themselves

Keywords: malaria private sector private medicine retailers drug shops subsidies case management rdt act nigeria
tacrolimus for the treatment of systemic lupus erythematosus with membranous nephritis

Conditions: Lupus Nephritis; Lupus Erythematosus, Systemic

Summary: the investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (sle). the treatment of membranous (type v) lupus nephritis, a subset that carries a high morbidity, remains unsatisfactory. recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of t-helper cells, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. the investigators plan to conduct an open-label single-arm study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy secondary to sle. twenty patients with biopsy-proven membranous nephropathy secondary to sle will be recruited. they will be treated with oral prednisolone and tacrolimus for 6 months, followed by 6 months of maintenance steroids alone. proteinuria, renal function, clinical and serologic lupus activity will be monitored. complete remission is defined as 24-hour urinary protein excretion to less than 0.5 gm/day. this study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis, which is usually resistant to conventional therapy.

Eligibility criteria:
inclusion criteria: * fulfill the revised american college of rheumatology criteria for sle * have biopsy-proven membranous nephropathy secondary to sle * nephrotic syndrome with proteinuria (\> 3 g/day) and serum albumin \< 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents) * age over 18 with informed consent * female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study exclusion criteria: * patient with abnormal liver function tests * patient with hepatitis b surface antigen or who is hepatitis c antibody positive * patient who is diabetic * patient who is receiving non-steroidal anti-inflammatory drugs (nsaids) or other agents known to influence urinary protein excretion * patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Keywords: sle glomerulonephritis immunosuppressive therapy type v (membranous) lupus nephritis
intestinal organoids

Conditions: Digestive System Diseases; Inflammatory Bowel Disease, Ulcerative Colitis Type; Crohn Disease

Summary: over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). they also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. the use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

the project aims to generate a biocollection of 3d intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

Eligibility criteria:
inclusion criteria: * subjects aged 18 to 75 years * subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples * subject having signed a free and informed consent in writing exclusion criteria: * subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty. * anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)

Keywords: biobank organoids digestive disease inflammatory bowel disease
comparison of standard neuronavigation with intraoperative magnetic resonance imaging (mri) for the neurosurgical treatment of malignant brain tumors

Conditions: Glioblastoma Multiforme

Summary: the treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. increased extent of tumor resection is associated with prolonged survival. the standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. however, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". this is caused by edema, loss of cerebrospinal fluid and tumor resection. a new form of neuronavigation uses intraoperative mri to compensate for brain shift, and to check for the presence of residual tumor that can be removed. this study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative mri.


Eligibility criteria:
inclusion criteria: * supratentorial brain tumor, on contrast enhanced dmri suspected to be gbm * indication for gross total resection (gtr) of the tumor * age ≥18 years * who performance scale ≤ 2 * asa class ≤ 3 * adequate knowledge of the dutch or french language * informed consent exclusion criteria: * recurrent brain tumor * multiple brain tumor localizations * earlier skull radiotherapy * earlier chemotherapy for gbm * chronic kidney disease or other renal function disorder * known mr-contrast allergy
prematurity related risks of cognitive impairment at school age

Conditions: Complications of Prematurity

Summary: the main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care. the study will be divided into 3 parts: 1. children born prematurely in our level iii referral center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. the relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term. 2. the quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth. 3. an anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment. thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources. the study will be divided into 3 parts: 1. children born prematurely in our level iii referral center will undergo psychometric evaluation at 8 to 11 years of age by routine test (wisc iv). the relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term. 2. the quality of parent and child relationship will be evaluated by standardized questionnaire (perinatal ptsd questionnaire). this questionnaire allows evaluating persistent perinatal stress trauma related to prematurity. 3. an anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. this part will use semi-directive interviews of caregivers involved in the follow-up network. this study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.

Eligibility criteria:
inclusion criteria: * former premature infants aged 8-11 years * school grade appropriate for their age * schoolmate control children born at term aged 8-11 years exclusion criteria: * any neurological sequelae

Keywords: children cognitive outcome prematurity care network outpatient follow-up of cognitive development care resources
study of the clinical management of bipolar disease

Conditions: Bipolar Disorders

Summary: this study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder i or ii (dsm-iv tr) in any phase of the disorder * patients who had at least one mood event (depression, mania, hypomania or mixed) according to dsm-iv tr definition during the 12 months prior to the beginning of the study exclusion criteria: * patients who had the index mood event during the 3 months before the beginning of the study (time 0).

Keywords: bipolar disorders everyday setting treatment adherence global