Kornimate/medical-research-clean huggingface dataset:
neuroregen scaffold™ with stem cells for chronic spinal cord injury repair

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to assess the safety and efficacy of neuroregen scaffold with bone marrow mononuclear cells (bmmcs) or mesenchymal stem cells (mscs) in patients with chronic spinal cord injury.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-65 years old. 2. completely spinal cord injury at the cervical and thoracic level (c5-t12). 3. classification asia a with no significant further improvement. 4. patients signed informed consent. 5. ability and willingness to regular visit to hospital and follow up during the protocol procedures. exclusion criteria: 1. a current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, huntington's disease, parkinson's disease). 2. serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans). 3. history of life threatening allergic or immune-mediated reaction. 4. clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis). 5. history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 6. severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree ii or above conduction abnormalities displayed via 12-lead ecg. 7. lactating and pregnant woman. 8. alcohol drug abuse /dependence. 9. participated in any other clinical trials within 3 months before the enrollment. 10. a drug or treatment known to cause effect on the central nervous system during the past four weeks. 11. a drug or treatment known to cause major organ system toxicity during the past four weeks. 12. poor compliance, difficult to complete the study. 13. any other conditions that might increase the risk of subjects or interfere with the clinical trial.
rumination-focused cbt training for the prevention of depression and anxiety

Conditions: Depression; Anxiety Disorders

Summary: depression and anxiety disorders are highly prevalent and associated with reduced quality of life for patients and enormous economic costs for society. although effective treatments are available, a substantial number of patients fail to respond, and the time between disorder onset and treatment is typically long. the development of prevention programs therefore appears promising. the current project aims to prevent depression and anxiety by targeting excessive levels of worry and rumination, two important risk factors for emotional disorders. participants will be selected on the basis of a high score on two validated questionnaires on worry and rumination. they will be randomly assigned to a rumination-focused cognitive-behavioral training delivered in a group format, a rumination-focused cognitive-behavioral training delivered via internet, or a no-training control condition. it is expected that both versions of the rumination-focused training will reduce symptoms of depression and anxiety, will reduce the incidence of major depressive episodes and generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.

see above

Eligibility criteria:
inclusion criteria: * a score above the 75% and 66.7% percentile on two validated self-report measures of rumination and worry, the ruminative response scale of the response style questionnaire (rsq; nolen-hoeksema \& morrow, 1991), and the penn state worry questionnaire (pswq; meyer et al. 1990). exclusion criteria: * a score indicating fulfillment of dsm-iv criteria for depression or generalized anxiety disorder according to the patient health questionnaire-9 (phq-9; kroenke, spitzer, \& williams, 2001) or the generalized anxiety disorder questionnaire-iv (gadq-iv; newman et al., 2002)
gut microbiome dysbiosis in sepsis-induced coagulopathy

Conditions: Sepsis

Summary: in the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. this project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.


Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤85 years * sign the informed consent form * expected icu hospital stay\> 24 hours * △sofa score ≥2 and confirmed or suspected infection exclusion criteria: * pregnant or breastfeeding women * estimated survival time \<24 hours * diagnosis of sepsis time\> 24 hours * the length of icu stay before diagnosis of sepsis\> 7 days * sepsis from which the source of infection cannot be determined * congenital coagulopathy
a study to evaluate a potassium normalization treatment regimen including sodium zirconium cyclosilicate (zs) among patients with s-k ≥5.8

Conditions: Hyperkalemia

Summary: the study is designed to determine if zs 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. patients will receive zs or placebo on top of standard of care treatment with insulin and glucose.


Eligibility criteria:
inclusion criteria: ≥ 18 years of age potassium ≥5.8 mmol/l exclusion criteria: possible pseudohyperkalaemia hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose. dialysis session expected within 4h after randomization treated with any therapy intended to lower s-k between arriving at the hospital and randomization during visit 1.
opus school meal study - cross sectional analyses from baseline investigations

Conditions: Metabolic Syndrome X

Summary: the present study is based on cross-sectional data from the baseline investigations carried out in opus school meal study - a randomized crossover study carried out in 9 primary schools in denmark 2011-2012. approximately 800 danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of cardiovascular disease (cvd), type ii diabetes and osteoporosis.


Eligibility criteria:
inclusion criteria: * pupils in 3rd and 4th grades * primary schools in the zealand region and capital region of denmark schools with an available school kitchen, that can be approved by the food authorities * schools where at least 60 % of the pupils in three or more classes signs up to participate in the study exclusion criteria: * the children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. this, however depends on the character of the other study. * the children must not suffer from serious food allergies or food intolerance. * the children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders * the schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis

Keywords: metabolic syndrome x fatty acids, omega-3 learning attention nutritional status nutrition assessments body weight physical activity sleep child nutrition sciences
eclaxir:search for an association between cx3cr1 v249i polymorphism, preeclampsia and endothelial injury

Conditions: Preeclampsia

Summary: the study hypothesis is the involvement of the couple cx3cr1/cx3cl1 in occurrence of endothelial injury in preeclampsia. according to this hypothesis, carriers of the i249 allele who express less cx3cr1 shoud be protected against this risk. the main objective of the study is the search of an association between cx3cr1 v249i polymorphism and preeclampsia. the secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

it is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included. the frequency of the v249i polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls). the v249i polymorphism will be identified by pcr followed by enzyme digestion. endothelial injury will be identified using three assays : von willebrand factor, soluble vcam-1 and thrombomodulin plasma levels. cx3cr1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.

Eligibility criteria:
inclusion criteria: * cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study exclusion criteria: * cases: multiple pregnancy, proteinuria \> 300 mg/24h before 21th gestation week.
a study of lc542019 in healthy subjects and subjects with t2dm

Conditions: Healthy; Diabetes Mellitus, Type 2

Summary: to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy subjects and subjects with type 2 diabetes (t2dm).

the study will be conducted in 2 parts: part 1 (single ascending dose) this part will include 6 sequential dose cohorts (s1-s6). part 2 (multiple ascending dose) this part will include 5 sequential dose cohorts (m1-m5). cohorts m1-m4 will enroll healthy subjects. cohort m5 will enroll subjects with t2dm.

Eligibility criteria:
for healthy subjects: inclusion criteria * adults ≥ 18 to ≤ 55 years. * body mass index (bmi) ≥18.5 to ≤ 30.0 kg/m2 * female subjects must be non-pregnant and non-lactating. females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening. * ability to provide written informed consent. exclusion criteria * history of or current diagnosis of diabetes mellitus type 1 or diabetes mellitus type 2 * history of or current significant diagnosis of cardiovascular, respiratory, hepatic, renal, gastrointestinal endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease * history of or presence of clinically significant ecg findings * history of or acute significant gastrointestinal disorder for t2dm subjects: inclusion criteria * adults ≥ 18 to ≤ 70 years. * body mass index (bmi) ≥18.5 to ≤ 35.0 kg/m2 with stable body weight by history for 3 months * subjects with t2dm \> 6 months, on stable therapy with metformin monotherapy. * female subjects must be non-pregnant and non-lactating. females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening. * ability to provide written informed consent. exclusion criteria * history of or current diagnosis of diabetes mellitus type 1 * a subject who has acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy * recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis * current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods)
topical insulin for glaucoma

Conditions: Glaucoma

Summary: the purpose of this phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).


Eligibility criteria:
inclusion criteria: * capable to provide informed consent * diagnosis of optic neuropathy either glaucoma or naion or optic disc drusen. * only one eye per patient will be selected as the study eye - if both eyes meet the inclusion criteria, the eye with the worse acuity and /or visual field will be selected. the contralateral eye will be left untouched. exclusion criteria: * pregnant or breastfeeding woman * presence of any ocular pathologies other than glaucoma that contributes to the severe vision loss (retinopathy / maculopathy, severe uveitis, keratopathy, etc.) * diagnosis of glucose intolerance, type 1 or 2 diabetes mellitus * inability to perform reliable visual field * unable to provide informed consent * unable to complete the tests and follow-ups required by the study
behavioral intervention for physical activity and sexual dysfunction in multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction

Summary: the prevalence of sexual dysfunction is higher among women with multiple sclerosis (ms) than women in the general population. the presence of sexual dysfunction is associated with decreased well-being and quality of life. there is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in ms. physical activity has beneﬁcial eﬀects on many of the consequences of ms, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in ms. the proposed research examines the eﬀect of an internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with ms. the research proposed, if successful, will provide evidence for the eﬃcacy of physical activity as a translatable approach for managing sexual dysfunction among women with ms.


Eligibility criteria:
inclusion criteria: 1. female 2. diagnosed of relapsing remmiting multiple sclerosis 3. relapse free in the past 30 days 4. initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in dsm-5) 5. currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction 6. internet and email access 7. willingness to complete the questionnaires, wear the pedometer, and undergo randomization 8. insufficient physical activity \[not meeting current physical activity guidelines based on a health contribution score of less than 14 units from the godin leisure-time exercise questionnaire (glteq)\] 9. ability to ambulate without assistance \[self-report and patient-determined disease steps (pdds) score between 0 and 2 (mild ambulatory disability)\] 10. age between 18 and 45 years 11. english as primary language - exclusion criteria: 1. moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise -

Keywords: physical activity sexual behaviour
periodontal regeneration using dental pulp stem cells (dpscs)

Conditions: Periodontal Diseases

Summary: the goal of this study is to evaluate if dental pulp stem cells (dpscs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.

in this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. the dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous dpscs. test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced chronic periodontitis * fmps\<20% * fmbs\<20% * infrabony defect \>2mm * probing depth \>5mm * presence of 1 vital and intact tooth requiring an extraction as autologous source of dpscs exclusion criteria: * smoking * controindicazion for periodontal surgery * systemic diseases affecting periodontal healing * pregnancy an lactation * fixed orthodontic appliance * history of periodontal surgery at the experimental teeth * prostethic restorations at the experimental teeth * furcation defects
asthma implementation research trial

Conditions: Asthma; Asthma in Children

Summary: asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (lmics), such as peru. while evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country (hic) and lmic settings alike. there a clear need for effective, locally-tailored solutions to address the asthma treatment gap in low-income communities in lmics, such as peru. this study aims to develop and test a locally-adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in lima. there is a paucity of research regarding the development and testing of interventions to improve asthma self-management in lmic settings, which experience unique or exacerbated barriers to receiving evidence-based care. to the investigators' knowledge, no studies have systematically developed and evaluated an asthma management program in peru. therefore, the long-term goal of this study is to disseminate locally appropriate asthma management strategies to reduce asthma-related emergency department visits and improve service utilization in lmic settings. for the current study, the investigators will carry out a randomized controlled trial to test the effectiveness of the intervention package in a group of 110 children with asthma who will be randomized to the intervention (55 children) or no intervention (55 children) arm. participants in the intervention group will receive case management from a designated nurse manager, who will provide ongoing educational, social, and self-management support during monthly follow-up home visits and text-message based communication. participants will be followed up every month for data collection over a six-month period. throughout the follow-up period, the investigators will collect data on asthma control, healthcare utilization, medication adherence, quality of life of children with asthma and the children's caregivers, caregiver mental health, fidelity to the intervention, and acceptability and feasibility. ultimately, this study will inform the scientific community about effective strategies and treatment programs for asthma in low-income settings.


Eligibility criteria:
inclusion criteria: * currently living in lima, peru * 5-17 years of age * has a physician diagnosis of asthma * has attended the emergency room or urgent care for asthma, or has been hospitalized for asthma at least once in the previous 12 months exclusion criteria: * family plans to move out of the study community within the next 12 months * co-occurring chronic respiratory or cardiovascular disorders other than asthma * active tuberculosis or are currently taking tuberculosis medications * diagnosis of hiv/aids

Keywords: implementation science global health peru
study comparing plate stabilization to conservative treatment in midshaft clavicle fractures

Conditions: Clavicle; Fracture

Summary: the purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. by tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. the goal of treatment is to restore painless function of the upper extremity. there have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. recently, increasing interest has emerged in the surgical treatment.

Eligibility criteria:
inclusion criteria: * a completely displaced middle third clavicle fracture, no cortical contact between main fragments * fresh fracture, treatment within seven days after injury * age between 18 and 70 years * provided informed consent exclusion criteria: * fracture was not dislocated * multiple injured patient * associated neurovascular injury, or suspicion of it * reduced cooperation * cancer or any severe illness impairing health * pathological fracture * treatment seven days after injury * open fracture * corticosteroid or immunosuppressive medication * upper extremity fracture at same time * an earlier clavicle or shoulder region fracture * pregnancy * lack of consent

Keywords: clavicle fractures midshaft dislocated operative treatment conservative treatment non-operative treatment randomized controlled trial bone plates
tapering heart failure medication in patients with heart failure with recovered ejection fraction; open label prospective random trial

Conditions: Heart Failure; Ejection Fraction; Recovery of Function

Summary: study start date is on nov 27th 2024. a patient with an initial ejection fraction (ef) of less than 40%, whose follow-up shows an improvement to an ef of 50% or higher, along with the left ventricular end-diastolic diameter returning to the normal range and taking 3 more heart failure medication randomed to drug tapering group ( ras blocker or beta blocker) or continuing medication group.

patients described above randomly assigned to drug tapering group and drug maintaining group. drug tapering group is 2 groups, which one is ras blocker tapering group and others is beta blocker tapering group. drug tapering group is monitored ejection fraction, lv dimension and lv gls by 1-3 month.

Eligibility criteria:
inclusion criteria: * initial echocardiogram ejection fraction less than 40% * follow up echocardiogram ejection fraction over 50% and lvedd index normal range * ntprobnp criteria 1. egfr ≥60 ; less 440 2. egfr 45-59: less 980 3. egfr 30-44; less 1220 4. egfr \< 30 : less 5300 5. in hd; no criteria for ntprobnp * on more than 3 heart failure medication ( ras blocker, beta blocker, mineral corticoid receptor antagonist, sglt 2 inhibitor) exclusion criteria: 1. under age 18 year 2. uncontrolled bp ( over 150/90) 3. coronary revascularization within 6 months 4. significant valve disease 5. arrhythmia requiring rate control 6. ckd with albuminuria ( over 30mg/g) 7. pregnancy

Keywords: heart failure with recovered ejection fraction tapering
complete clinical responders to definite chemoradiation in esophageal cancer : a survival analysis

Conditions: Esophageal Cancer

Summary: the aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer


Eligibility criteria:
inclusion criteria: * localized or locally advanced esophageal cancer * patient who underwent definite chemoradiation or radiation * patient with complete clinical response exclusion criteria: * metastatic disease

Keywords: esophageal cancer radiochemotherapy prognosis