Kornimate/medical-research-clean huggingface dataset:
analysis of early neurodevelopmental alterations in bipolar disorder based on cortical organoid models

Conditions: Bipolar Disorder (BD); Organoids; Neurodevelopmental Conditions

Summary: demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder (bd) with a neurodevelopmental (nd) component, compared with patients with bipolar disorder (bd) without an nd component.


Eligibility criteria:
inclusion criteria: * presence of bipolar disorder according to dsm-5 criteria * able to freely give and sign consent * affiliated or beneficiary of a health insurance plan * previous participants in the nemo study (2022-a00353-40) for the "neurodevelopmental bipolar" (nd-bp) group: presence of a neurodevelopmental burden score in the top 5, as assessed in the nemo project (nct05674019). for the "non-neurodevelopmental bipolar" group (tb): presence of a neurodevelopmental load score of 0, or in the lowest 5, as assessed in the nemo project. exclusion criteria: * - presence of a severe symptomatic or unstable physiological or medical condition (including pregnancy) * history of psychiatric illness (stable or not), schizophrenia or any other pathology likely to interfere with bipolar disorder * history of severe head trauma (gcs\<8 at time of trauma) * presence of a neurological disorder affecting central nervous system function * presence of moderate to severe substance use disorders (\>=4/11 as defined in dsm-5), with the exception of tobacco use disorders. * the volunteer is under court protection or guardianship * it proves impossible to give the volunteer informed information, or the volunteer refuses to sign the consent form. * insufficient command of the french language to complete evaluations

Keywords: organoid neurodevelopmental alterations
the effects of home-based rehabilitation treatments among persons with symptomatic knee osteoarthritis

Conditions: Osteoarthritis

Summary: knee osteoarthritis (oa) is one of the most frequent causes of physical disability and pain among adults. recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (kba) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. kba techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. to determine the independent effects of kba training on functional abilities, it is necessary to test it as a training program unto itself. the proposed clinical trial is designed to do this by using three training groups: kba only; lower extremity strength training only; and a combination of the two. the total exercise time and intensity of each condition will be approximately equal. a non-exercise group will control for any effects related to the testing procedures and the passage of time. community volunteer men and women age 50 and over with physician diagnosed symptomatic knee oa will participate.


Eligibility criteria:
inclusion criteria: * aged 50 years or over of either gender * self-reported knee pain * physician diagnosed tibiofemoral oa, unilateral or bilateral, per acr guidelines * demonstrated minimal knee oa related dysfunction per womac score * not engaged in a regular leg exercise program for minimum of 6 months exclusion criteria: * high risk health status per (e.g.) acsm guidelines * inability to obtain physician release for exercise * unresolved balance disorder * unresolved neurological disorder * history of knee surgery or major knee trauma injury * hip or ankle instability, excessive weakness, surgery or major trauma injury * hip or knee replacement * intra-articular joint injection within 4 weeks of the study

Keywords: knee osteoarthritis arthritis
biomarkers in exhaled breath of glucose fluctuation in type 1 diabetes

Conditions: Volatile Organic Compounds; Hypoglycemia; Type 1 Diabetes Mellitus

Summary: the investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes.

the investigators aim through the use of proton-transfer-reaction mass spectrometry to perform comprehensive breath analysis to identify compounds of interest associated with glucose fluctuations. more than 500 different volatile organic compounds can be detected in human breath. compounds such as ethane, pentane and isoprene (hydrocarbons), as well as acetone, acetaldehyde, methanol, ethanol, 2-propanol (oxygen-containing compounds), are most likely to be relevant and measurable in our study population. hydrocarbons are stable end-products of lipid peroxidation and show only low solubility in blood and therefor are excreted into breath within minutes of their formation in tissues. there is evidence for increased hydrocarbon production in states of oxidative stress. oxygen-containing compounds such as acetone/acetaldehyde (ketones) are also clinically relevant in the measurement of insulin deficient states of catabolism in patients with diabetes. a previous study of exhaled isoprene was found to be elevated during hypoglycemia. this study aims to expand on this to characterize the full range of changes in concentrations of volatile organic compounds in human breath during glucose fluctuations. characterizing this "biochemical fingerprint" of hypoglycemia may provide clues about what so-called diabetes alert dogs are detecting as well as improve our understanding of hypoglycemia, the physiology behind hypoglycemia unawareness, and potentially identify a novel non-invasive measure of blood glucose.

Eligibility criteria:
inclusion criteria: * have a diagnosis of type 1 diabetes * no current or planned tobacco/nicotine use including vaping during the study * are not pregnant or planning to become pregnant during the study timeframe exclusion criteria: -
determining the effectiveness of early intensive versus escalation approaches for rrms

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the deliver-ms study seeks to answer the question: does early treatment with highly effective dmt improve the prognosis for people with ms? this is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. the study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18 to 60 years. 2. established diagnosis of ms, as defined by the 2017 revision of mcdonald diagnostic criteria (99). 3. rrms disease course as defined by the 2013 revisions of the ms clinical course definition (4). 4. participants must have evidence of active disease based on: one or more ms relapses within the last 18 months prior to screening visit or radiological evidence of ms activity (≥2 new t2 lesions within the last 12 months from screening \[compared to a previous recent mri within 18 months of screening\] or ≥1 gde demonstrated on brain or spinal cord mri performed within the last 12 months of screening). 5. participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no ms dmt at any time in the past). 6. participants must be eligible to receive at least one form of dmt within each treatment arm. 7. edss at baseline visit ≤ 6.5 exclusion criteria: 1. participants with contraindications to all forms of dmt in either of the treatment arms. 2. participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod. 3. participants must have not received any of the following medications, for reasons other than ms, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies. 4. participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study 5. participants unable to provide informed consent. 6. contraindication or inability to undergo mri with gd due to metal or metal implants, allergy to gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor. 7. unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the pi, is likely to affect the participant's ability to comply with the study protocol.
yaz post-marketing surveillance in japan

Conditions: Dysmenorrhea

Summary: this study is a regulatory post marketing surveillance in japan, and it is a local prospective and observational study of patients who have received yaz for dysmenorrhea. the objective of this study is to assess safety and efficacy of using yaz in clinical practice. a total 3,000 patients will be recruited and followed 3 years since starting yaz administration.


Eligibility criteria:
inclusion criteria: * patients who received yaz for dysmenorrhea additional criteria for qol questionnaire * patient informed consent exclusion criteria: * patients who are contraindicated based on the product label additional criteria for qol questionnaire * six months or less after treatment of estrogen or estrogen combination drug

Keywords: yaz dysmenorrhea
efficacy of the addition of a power interdental device to an electric toothbrush on gingival health.

Conditions: Gingivitis

Summary: the study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. additionally plaque removal will be evaluated after a single use and over 4 weeks.

data will be analyzed and reported as mean. the target population is approximately 70 healthy adult volunteers. there will be two groups with a total of 35 subjects per group. subjects will be randomized using a simple random sample. a computer-generated randomization schedule will be prepared by the study statistician. based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either: with 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with bop of 25%. the primary outcome will be the reduction in the percentage of sites with bleeding on probing (bop) after 4 weeks. reduction in the percentage of sites with bop after 2 weeks (+/- 2 days). reduction in the mgi after 2 (+/- 2 days) and 4 weeks. reduction in rmnpi pre \& post, 2 weeks and 4 weeks (=/- 2 days) data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. intraoral examination will be performed and any adverse events will be reported and followed up. subjects will complete a questionnaire at the completion of the study.

Eligibility criteria:
inclusion criteria: * be between 20 and 70 years of age * be able to provide written informed consent prior to participation * agree to not participate in any other oral/dental products clinical study for the study duration * be in good general health and be a non-smoker * have 50% bleeding on probing sites (moderate gingivitis) * have no probing depths greater than 4 mm * have a minimum of 20 teeth (not including 3rd molars) * no partial dentures, orthodontic brackets, wires or other appliances * agree to refrain from the use of any non-study dental device or oral care product for the study duration * agree to return for the scheduled visits and follow study procedures * agree to delay dental prophylaxis until study completion * have a minimum pre-brushing plaque score of 0.6 * have a minimum of 1.75 gingivitis score exclusion criteria: * have probing depth greater than 4 mm * have a systemic disease (ex. diabetes, autoimmune disease) * have advanced periodontitis * taking medication that can influence gingival health (ex. dilantin, procardia (calcium channel blockers), cyclosporine, anticoagulants) * have orthodontic appliances or removable partial dentures * pregnant at time of study * use of antibiotics within 6 months of study
immune-modulatory effect of probiotic strain on grass pollen allergic individuals

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of the current study is to evaluate the effect of administering a probiotic strain on allergic symptoms and immune parameters (th-2 cytokines, effector cells) in seasonal allergic rhinitis subjects.

to identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure

Eligibility criteria:
inclusion criteria: * confirmed allergy (allergic rhinitis) to grass pollen \> 1 year and positive spt \> 3mm wheal diameter to grass pollen. * age 20-65 years adults * body mass index 19- 29 (people in the normal and overweight range) * having obtained his/her informed consent. exclusion criteria: * anemia * family history of congenital immunodeficiency * regular consumption of immunosuppressive or anti-inflammatory treatment * under medication against allergy (e.g. anti histaminic) * avoid regular consumption of probiotic and other dietary nutritional interventions * have a high alcohol consumption (more than 1 drink/day) * consumption of illicit drugs * pregnancy * subject who cannot be expected to comply with the study procedures, including consuming the test products * currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
remote training in rural schools

Conditions: Behavior Disorders

Summary: rural areas have fewer, and less well trained, health care providers than non-rural areas. schools have become more involved in the delivery of mental health services and hold great potential for increasing access to children and adolescents. innovations in training and service delivery are needed to improve mental health care quality and availability in rural schools. evidence-based practices (ebps) can be incorporated into school-wide multi-tiered systems that are currently used to improve school climate and safety. school-wide positive behavioral interventions and supports (pbis), a service-delivery strategy based on the public health model is one example. investigators will use an iterative process (rapid prototyping) to develop and evaluate the appropriateness, feasibility, acceptability, and preliminary efficacy of a remote training strategy that provides resources to support use of tier 2 ebps and effective support for care coordination practices in rural schools.


Eligibility criteria:
inclusion criteria: any bhs (e.g., school counselor, school social worker or teacher who is under employment from a school district) based at a school implementing pbis and who may be nominated by the principal as a potential participant is eligible to be included in the study. additionally, the research staff will reach out to school behavioral health staff concurrently with the school principal. bhs staff will provide consent to participate. exclusion criteria: staff from schools not implementing pbis.

Keywords: positive-behavior interventions and supports evidence-based practices tier 2 mental health rural schools
validity of biological material sampling in patients with hospital-acquired pneumonia

Conditions: Hospital Acquired Pneumonia

Summary: the main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (hap) in critically ill patients to bronchoscopy-assisted protected brush method. evaluation of the present clinical praxis using bronchial secretion sampling in hap diagnostics and detection of the most common etiological agents in patients with hap are other priorities of the project. aiming to confirm or exclude the diagnosis of hap, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. finally, percentage of hap etiological agents resistant to initial empiric antibiotic therapy will be observed.

the main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (hap) in critically ill patients to bronchoscopy-assisted protected brush method. obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. evaluation of the present clinical praxis using bronchial secretion sampling in hap diagnostics and detection of the most common etiological agents in patients with hap will be other priorities of the project. the role of atypical and fungal pathogens in hap initiation will be discovered as well. aiming to confirm or exclude the diagnosis of hap, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. finally, percentage of hap etiological agents resistant to initial empiric antibiotic therapy will be observed. project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. it will make contribution to faster and more precise hap diagnosis and adequate antibiotic therapy.

Eligibility criteria:
inclusion criteria: * clinical signs of hap * need for intubation and mechanical ventilation exclusion criteria: * inability to obtain samples in 24 hours after clinical diagnosis of hap
evening primrose oil to misoprostol during induction of second-trimester missed miscarriage

Conditions: Missed Abortion

Summary: termination of pregnancy is an important subject that has complex and emotional controversies. the most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. there are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy


Eligibility criteria:
inclusion criteria: * nullipara or previous vaginal delivery only * bishop score was ≤ 5 * women who will accept to participate in the study exclusion criteria: * multiple gestations * rupture of fetal membranes * previous cesarean sections * women with heavy bleeding * evidence of low implanted placenta by us * evidence of intra-uterine infection (either clinical or laboratory)
acute cholecystitis: early versus delayed laparoscopic cholecystectomy; randomized prospective study

Conditions: Acute Cholecystitis

Summary: the best management of the acute cholecystitis is to do laparoscopic cholecystectomy. the hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.

Eligibility criteria:
inclusion criteria: * proved acute cholecystitis clinical, radiologic exclusion criteria: * evidence of peritonitis * asa iii or iv * previous upper abdominal surgery * pregnancy

Keywords: laparoscopic cholecystectomy acute cholecystitis early delayed
demonstration of the medical interest of the visiocyt® artificial intelligence test

Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)

Summary: european, multicenter clinical trial with visiocyt®, an in vitro diagnostic medical device. visiocyt® is an innovative solution for the early diagnosis of bladder cancer.

visiocyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted . the main objective of the study is to demonstrate the medical superiority of the visiocyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression

Eligibility criteria:
inclusion criteria: * age ≥18 years old and autonomous * patient understanding national language well and able to understand the protocol. * patient information and informed consent signature before the start of the study * patients under surveillance of non-muscle invasive bladder cancer (nmibc) at high and very high risk of progression, whatever the stage on the basis of a histological result. the diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account). exclusion criteria: * patients who have had total bladder resection or bladder reconstruction * age \<18 years old * person deprived of liberty or under guardianship (including curatorship) * bladder cancer outside of urothelial carcinoma * associated high urinary tract carcinoma * kidney transplant patient (bk virus) * pelvic radiotherapy patient (prostate cancer) * patients with or under surveillance of a muscle-infiltrating bladder tumor

Keywords: nmibc recurrence