Kornimate/medical-research-clean huggingface dataset:
mindfulness based cognitive therapy and antidepressant medication in recurrent depression

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (mbct) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.

in the netherlands, treatment as usual for patients with (recurrent) major depressive disorder consists of maintenance antidepressant medication. mindfulness-based cognitive therapy (mbct) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. it consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities. in this study, the (cost)effectiveness of a) mbct on its own, b) antidepressant medication on its own and c) the combination of mbct and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

Eligibility criteria:
inclusion criteria: * recurrent major depressive episode (at least 3 previous episodes) * treatment with therapeutic dose of antidepressant medication during past six months * currently in full or partial remission exclusion criteria: * bipolar disorder (current and previous (hypo)manic episodes) * psychotic disorder (current and previous) * neurological or somatic illness affecting depression or outcome measures * current alcohol or drugs dependency * use of high dosage benzodiazepines (\> 2 mg lorazepam equivalents daily) * recent electro convulsive therapy (\< 3 months ago)

Keywords: recurrent major depressive disorder mindfulness based cognitive therapy cost-effectiveness antidepressant medication randomized controlled trial
direct observation study of kratom product effects among regular consumers

Conditions: Kratom Pharmacokinetics; Kratom Pharmacodynamics; Kratom

Summary: the goal of this observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly. the main questions it aims to answer are: 1. what are the acute physiological, subjective, and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose? 2. what are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly? 3. what are the pharmacokinetics of kratom products consumed by adults who use regularly? on the first study day: under direct observation, participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical dose/serving. following this, serial blood draws and urine collection will occur along with administration of validated questionnaires, tests, and continual monitoring. after this first study day, participants will no longer be permitted to use any of the participants kratom product during the study. on study nights/days 2-3: participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome.


Eligibility criteria:
inclusion criteria: 1. \>21 years 2. reporting kratom use \>5 times per week for \>3 months prior to study screening 3. english language proficiency 4. willingness to provide requested samples of the kratom product being currently taken exclusion criteria: 1. reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening 2. having ever sought medical attention for an acute adverse health event as a result of taking any kratom product. 3. cannot or will not provide kratom product samples in the form of an unopened package of kratom that is clearly labeled with at least the product and vendor name. 4. self-reports using kratom products by any other route than orally swallowing. 5. current physical dependence on alcohol, benzodiazepines, or opioids 6. reports use of fentanyl within the past month and/or has a fentanyl positive drug screen. 7. discordance between self-reported substance use and drug screen results obtained during screening. 8. lifetime or current psychotic disorder 9. current untreated major depressive or bipolar disorder 10. pregnancy or nursing 11. physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high bmi, etc.).

Keywords: kratom
glutathione, brain metabolism and inflammation in alzheimer's disease

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is associated with significant, progressive cognitive decline. key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to ad. this trial will investigate the effects of supplementing glycine and n-acetylcysteine vs. alanine as placebo on these defects in ad, and examine the effects on cognition.

glutathione (gsh) deficiency, oxidative stress, mitochondrial dysfunction, insulin resistance and inflammation are linked to alzheimer's disease (ad). in prior studies, investigators have shown that gsh deficiency contributes to mitochondrial impairment and oxidative stress, and that gsh deficiency can be corrected by supplementing its precursors glycine and cysteine (provided as n-acetylcysteine, nac), with the combination termed glynac. this randomized clinical trial will evaluate the effect of glynac vs. alanine placebo supplementation provided for 24-weeks to patients with ad, and measure changes in cognition, gsh concentrations, oxidative stress, brain glucose uptake, brain inflammation and insulin resistance. participants who are positive for a beta-amyloid pet scan and meeting cognitive screening criteria will be recruited, and enrolled only after meeting eligibility criteria. before beginning study supplementation they will undergo imaging studies (mri, fdg-pet and tspo-pet scans), and only the fdg- and tspo-pet scans will be repeated after completing 24-weeks of nutrient supplementation. cognitive measurements, metabolic and mitochondrial measurements (as described below) will be done before supplementation, and after 12-weeks and 24-weeks of completing supplementation.

Eligibility criteria:
inclusion criteria: * age 55-85 years; * gradual and progressive memory loss for more than 1 year, with a montreal cognitive assessment score of 10-20; * amyloid positivity on pet scan; * availability of a study partner. exclusion criteria: * hospitalization in past 3 months; * use of insulin medications; * untreated thyroid disease; * creatinine levels \>1.5 mg/dl; * hemoglobin concentration \<11.0 g/dl; * known liver disease, or ast/alt level \>2x uln; * history of stroke, brain tumor, active heart failure or active cancer (removable basal cell cancers will not be an exclusion criteria); * untreated depression or other severe psychiatric disorders; * pregnancy or nursing (unlikely in this population)
biomarkers to predict the outcomes of sepsis

Conditions: Sepsis

Summary: sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. however, sepsis remains the main threat to global health. due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. the purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. there are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. according to lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. the world health organization (who) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. with the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. however, sepsis remains the main threat to global health. due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. the purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

Eligibility criteria:
inclusion criteria: - the clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the international consensus on sepsis and sepsis shock (sepsis-3.0) are: 1. sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a sequential organ failure score (sofa score) ≥ 2 points; 2. sepsis-3.0 diagnostic criteria for septic shock: sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmhg, and serum lactate level\>2mmol/l (18mg/dl). 3. age 18 to 85 years old exclusion criteria: 1. patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (\<0.5 × 109/l), malignant tumors or other serious chronic diseases (heart failure, liver failure, end-stage renal disease, etc.); 2. receiving glucocorticoid treatment; 3. pregnancy; 4. refuse enrollment or give up active treatment. -

Keywords: sepsis biomarker
meal stimulating after roux-en y gastric bypass

Conditions: Gastric Bypass; Obesity

Summary: in many studies, gastric bypass surgery led to total remission of type 2 diabetes (t2dm) as early as 1 - 2 days after surgery before any real weight loss has occurred. this suggests that the remission of the t2dm is due to the direct effect of the operation, more than the secondary effect of the weight loss. the reasons for the major effect on the glucose metabolism after gastric bypass surgery are still unaccounted for. the aim of this project will be to unveil some of the mechanisms that explain the effect of gastric bypass surgery on the glucose metabolism. further more to find a better way of testing patients that have just undergone gastric bypass surgery. it is not possible to test patients who have just undergone gastric bypass surgery with normal oral glucose tolerance test (ogtt) and a normal meal, because patients can only take in fluid and a normal ogtt will often lead to dumping. instead we will try to modify these tests - ogtt with lower glucose level and meal-testing with a protein drink. the hypothesis of the study is that the investigators can see changes in different hormones and adipokines before and after surgery, even with modified ogtt and meal testing. the project will consist of clinical trials on patients without t2dm that will undergo gastric bypass surgery. the studies will take place before and within the first week after surgery. the investigators will measure different hormones and adipokines after ogtt and a meal with a protein drink. the investigators expect to see significant changes in some of the analyses after the operation in patients undergoing gastric bypass.


Eligibility criteria:
inclusion criteria: * obese with bmi\> 40 undergoing gastric bypass surgery or * obese with bmi \> 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery * age between 20-60 years exclusion criteria: * age \> 60 * diabetes * psychiatric illness * mentally challenged * addiction * serious cardiac or lung diseases * diseases in the abdomen * other serious illness

Keywords: meal-test reduced ogtt gastric bypass surgery and glucose metabolism glucose metabolism before and after gastric bypass different ogtt new meal- test
intensive neurorehabilitation for cerebral palsy

Conditions: Cerebral Palsy

Summary: evaluation of effects of intensive neurophysiological rehabilitation system in children with cerebral palsy in a single-blinded randomized controlled trial with two groups.

intensive neurophysiologic rehabilitation system (inrs) is an intensive multimodal rehabilitation system, whereby versatile and multi-faceted methods are combined with the aim of improvement of functioning and quality of life of children with cp. treatment components are addressing different functional goals in the body functions domain of the international classification of functioning (joint mobility, muscle tone, voluntary movement, pain, intellectual functions) and activities and participation domains (fine hand use, walking, moving around, interpersonal interactions and family relationships. the intensive correction course includes up to four hours of daily training. the treatment program is tailored individually according to the patient's condition and incorporates some of the following component according to individual indications and contraindications: physical therapy, occupational therapy, full body massage, spinal manipulative therapy, joint mobilization techniques, paraffin and wax applications, reflexotherapy, strength training, computer game therapy, suit therapy, vibration therapy, treadmill training, group session of "rhythmic gymnastics". the influence of one technique complements and potentiates other rehabilitation components. the aim of the study is to evaluate effects of intensive neurophysiological rehabilitation system in children with cerebral palsy in a randomized controlled trial. a single-blinded randomized controlled trial with two groups will be conducted. the experimental group will undergo treatment course according to inrs, control group will continue receive usual home activity and care while staying on the waiting list. to avoid possible information leak about patient group allocation, the study should be performed in two independent centers: evaluation center and treatment center. assessments will be conducted three times: at the baseline, in 3 weeks, and 7 weeks after the baseline.

Eligibility criteria:
inclusion criteria: * cerebral palsy bilateral spastic forms, * age 4-12 years, * gross motor function classification system - levels i-iv, * manual ability classification system - levels i-iv. exclusion criteria: * uncontrolled epileptic syndrome, * severe intellectual disability, * uncooperative behavior, * surgery during ongoing year.

Keywords: rehabilitation motor skills activities of daily living
effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-pd-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the goal of this observational study is to learn about the effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-pd-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study


Eligibility criteria:
inclusion criteria: * 1: the patient was diagnosed with head and neck squamous cell carcinoma (stage i-iva), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy. 2: can speak chinese and have certain reading and writing skills 3: healthy group: dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors exclusion criteria: * 1: brain tumor, brain injury, or stroke at baseline or during follow-up 2: a history of stroke or a medical condition that puts you at high risk for future dementia or recurrence 3: active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week 4: neurocognitive diseases that affect cognitive function, such as parkinson's disease or alzheimer's disease 5: history of drug-associated encephalopathy or brain infection 6: patients who change their treatment plan during treatment 7: patients who are currently taking or have taken antidepressants
3 fixation devices in laparoscopic ventral herniotomy

Conditions: Ventral Hernia

Summary: clinical, controlled, randomized, prospective study. ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh. three randomization groups of 25 patients giving a total of 75 patients. mesh is fixated with either protack, securestrap or glubran ii. primary outcome: postoperative pain on the 2nd postoperative day. secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.

see brief summary

Eligibility criteria:
inclusion criteria: * ventral hernia 2(1,5) \ 7 cm * danish speaking * of sound mind * bmi \< 35 * asa 3 or less, no contra indication against laparoscopy exclusion criteria: * other size hernias, * no danish, * bmi \> 35
cow's milk allergy and functional gastrointestinal disorders

Conditions: Cow's Milk Allergy; Functional Gastrointestinal Disorders

Summary: cow's milk allergy (cma) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. it has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. intestinal microflora has been indicated as potential target for the management of cma and fgdis through the use of probiotics. lactobacillus rhamnosus gg (lgg) is the most studied probiotic. recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of lgg, satisfying both the american academy of pediatrics guidelines. lactobacillus gg exerts several benefits when added to an extensively hydrolyzed casein formula (nutramigen lgg), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with cma-induced allergic colitis, and faster induction of tolerance in infants with cma. the mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. studies and meta-analyses showed that lgg increases treatment success in children with functional gastrointestinal disorders.


Eligibility criteria:
inclusion criteria: * children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula exclusion criteria: * age higher than 12 months, * concomitant chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal tract, * suspected eosinophilic esophagitis or eosinophilic enterocolitis, * suspected food-protein-induced enterocolitis syndrome, * suspected cow's milk proteins-induced anaphylaxis.
dose-finding safety study of biib014 in early-stage parkinson's disease

Conditions: Parkinson's Disease

Summary: the main purpose of this study is to determine the safety of biib014 and how well biib014 is tolerated when given at different doses to patients with early-stage parkinson's disease. this study will also explore: * how biib014 is affected when given to patients with early-stage parkinson's disease (this will be done by measuring the levels of biib014 in the blood at several different times during the study), and * the activity of biib014 when given to early parkinson's patients (this will be done by performing different parkinson's disease assessments and other tests during the study). patients who enter this study will be randomly assigned to receive either biib014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.


Eligibility criteria:
inclusion criteria: * must give written informed consent and any authorizations required by local law. * must carry a diagnosis of idiopathic parkinson's disease(pd), without any other known or suspected cause of parkinsonism, according to the uk parkinson's disease society brain bank clinical diagnostic criteria. initial diagnosis of pd must have been made within the 5 years prior to screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability. * must be modified hoehn \& yahr stage 1 to 2.5 (inclusive). * must have a baseline updrs (part iii) motor score of at least 10. * subjects may be receiving an anticholinergic agent and/or mao-b inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other pd medication. exclusion criteria: * a mini mental state examination (mmse) score \<26. * history or clinical features consistent with an atypical parkinsonian syndrome. * any significant non-pd central nervous system disorder. * any significant axis i psychiatric disease as defined by the diagnostic and statistical manual of mental disorders. * history of cognitive or neuropsychiatric conditions. * history of surgical intervention for pd. * history of l-dopa-induced motor or non-motor complication. * history of malignancy. * history of severe allergic or anaphylactic reactions to any drug. * clinically significant renal dysfunction. * hba1c \>7.0%. * clinically significant baseline ecg. * orthostatic hypotension. * treatment with l-dopa/carbidopa or l-dopa/benserazide for more than 6 cumulative months at anytime since subject's initial pd diagnosis.

Keywords: early parkinson's disease mobile biib014
evaluation of oxiris membrane as a treatment for ischemia-reperfusion syndrome in cardiogenic shock treated with extracorporeal life support (ecmo/ecls): a randomized pilot study ecmorix

Conditions: Cardiogenic Shock

Summary: the oxiris membrane is an an-69 membrane whose surface is treated with polyethyleneimine (pei) grafted with heparin. this property allows the removal of lipopolysaccharide and cytokines from the blood. during septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). moreover, the literature suggests that the use of the oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. to our knowledge (pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ecls. the research hypothesis is that the early addition of an oxiris membrane to the ecls circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.


Eligibility criteria:
inclusion criteria: * trusted person or relative who has given oral consent or emergency consent * person of legal age * patient receiving ecls for refractory cardiogenic shock requiring continuous renal replacement therapy * included within 12 hours of ecls initiation exclusion criteria: * person not affiliated to national health insurance * person under legal protection (curatorship, guardianship) * person under court order * pregnant or breastfeeding woman * minor * severe hemorrhage under ecls