Kornimate/medical-research-clean huggingface dataset:
the effect of non-surgical periodontal therapy on inflammatory bowel disease

Conditions: Periodontitis; Inflammatory Bowel Diseases

Summary: inflammatory bowel disease (ibd) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. it has two main forms, crohn's disease (cd) and ulcerative colitis (uc). the main mechanism of ibd pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. although the relationship between ibd and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. from this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (tim-3, tnf-α, il-6 and il-17) in patients with ibd and to evaluate the relationship between these values and periodontal clinical parameters. this is the first study to examine tim-3 levels in saliva, serum and gingival samples in patients with ibd and periodontitis with ibd.


Eligibility criteria:
inclusion criteria: * to be between the ages of 18-65, * having at least 8 teeth excluding wisdom teeth, * no periodontal treatment in the last 3 months, * not having used antibiotics in the last 3 months, * not being pregnant or breastfeeding, * the individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except ibd. exclusion criteria: * under 18 years of age and over 65 years of age, * having less than 8 teeth, * having undergone periodontal treatment in the last 3 months, * having used antibiotics in the last 3 months, * being pregnant or breastfeeding, * individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except ibd.

Keywords: periodontitis inflammatory bowel disease cytokine
incontinence ring on stress urinary incontinence

Conditions: Stress Urinary Incontinence; Urinary Incontinence

Summary: this study aims as defining success rate of the incontinence ring in women with test proven stress urinary incontinence and determining factors associated with successful use.

the primary objective of this study is to determine if the incontinence ring is effective in decreasing the incontinence episode frequency per week. other objectives include the determination of the cure rate (objective and subjective) with the ring, the effects to bladder function as noted on urodynamic testing, the impact on quality of life and the acceptability to this device in the treatment of stress urinary incontinence. in this cross-over study, 40 women will undergo a two-period treatment. in one of the periods, she will spend 4 weeks wearing continuously the ring and in the other (also 4 weeks duration), she will not be using any treatment for her incontinence. between periods, she will spend 2 weeks in "wash out" to eliminate the risk of continuous effect from the treatment in the preceding period. each woman will be randomly assigned to the treatment sequence. stress urinary incontinence is a common problem affecting at almost 20% of women. treatments currently advocated include pelvic floor exercises and surgery. pelvic floor exercises require great motivation and usually 3 months of training to show an impact. surgery is very effective, but costly and carries a number of complications. the use of the incontinence ring may allow women to control their symptoms with immediate result at minimal risk. this device has never been properly evaluated before its introduction into the market.

Eligibility criteria:
inclusion criteria: * symptoms of urinary stress urinary incontinence (i.e. urinary leakage associated with increased intra-abdominal pressure/cough) (if mixed incontinence the urinary stress urinary incontinence symptoms must predominate) * urodynamic stress urinary incontinence confirmed by urodynamic studies (i.e. urinary leakage associated with increased intra-abdominal pressure/cough in the absence of detrusor overactivity) * ability to understand spoken and written english exclusion criteria: * severe pelvic organ prolapse (\> or = stage 3 on the pelvic organ prolapse quantification system - pop-q) * contraindications to pessary use (including acute vaginal/urinary or pelvic infections, vaginal or cervical lesions or unexplained vaginal bleeding) * inability to properly fit the incontinence ring

Keywords: incontinence ring pessary urinary incontinence urodynamic study quality of life crossover trial randomised trial
mngie allogeneic hematopoietic stem cell transplant safety study

Conditions: Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE)

Summary: the purpose of this study is to find out if a stem cell transplant is safe for patients with a very rare disease. the stem cell transplant is called ahsct (for "allogeneic hematopoetic stem cell transplantation"). the rare disease is called mngie (for "mitochondrial neurogastrointestinal encephalomyopathy"). patients with mngie will be transplanted with stem cells from an individual who is human leukocyte antigen (hla) 10/10 matched. the purpose of the transplant is the production of thymidine phosphorylase.

patients who have been identified as having mngie by genetic testing and/or reduced thymidine phosphorylase levels will be considered for this study. the study team physician will evaluate the condition of the patient and determine if they are eligible. an hla matched donor is necessary for transplantation. if a suitable donor is found the transplant process can proceed. the patient receives immunosuppressive therapy ( 1 week in the hospital) with subsequent iv transfer of stem cells from the donor. the patient remains in the hospital for approximately 1 month to monitor the transplant. the patient is required to attend research visits at days 0, 100, 6m, 18m and 24 m.

Eligibility criteria:
inclusion criteria: * homozygous or compound heterozygous mutations in the tymp gene * plasma thymidine level \>3micromole/l * plasma deoxyuridine \>7.5 micromole/l * 5 to 55 years of age * appropriate stem cell donor (hla 10/10 matched) * karnofsky performance of at least 55 exclusion criteria: * severe cognitive impairment * severe psychiatric illness * moderate to severe lung disease * prior episode of peritonitis due to perforated diverticula * prior episode of intestinal pseudo-obstruction * moderate to severe hepatopathy * moderate to severe diabetes mellitus * moderate to severe cardiomyopathy * moderate to severe nephropathy * pregnancy or planning to become pregnant during study * hypersensitivity to e.coli derived products * hiv disease * positive to anti-donor hla dp

Keywords: allogeneic hematopoietic stem cell transplantation mngie stem cell transplant
a study of hrxg-k-1939 and adebrelimab in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1, open-label study evaluating the efficacy and safety of hrxg-k-1939 in combination with adebrelimab (anti-programmed death-ligand 1 \[anti-pd-l1\] antibody) in patients with advanced solid tumors. hrxg-k-1939 will be administered to patients in a dose escalation regimen to determine a recommended dose for expansion.


Eligibility criteria:
inclusion criteria: 1. voluntarily signed the informed consent form and complied with protocols requirements; 2. patients with advanced solid tumors that are suitable for immunotherapy; 3. ecog performance status of 0 or 1; 4. life expectancy ≥ 12 weeks; 5. at least one measurable disease per recist v1.1; 6. tumor specimen availability; 7. adequate marrow and organ function; 8. have resolution of toxic effects from prior therapy to grade 1 or less (except for grade ≤2 alopecia or neuropathy) per ctcae v5.0; 9. patients with fertility are willing to use an adequate method of contraception. exclusion criteria: 1. previously detected positive driver genes (egfr, alk, ros1, etc.); 2. have leptomeningeal, or actively progressing cns metastases (patients with stable brain metastases can be enrolled); 3. uncontrolled pleural effusion, pericardial effusion, or ascites; 4. major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study; 5. prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 21 days prior to initiation of study treatment; 6. live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study; 7. systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment; 8. any history of an immune-mediated grade 4 adverse event or grade 3 adverse event that resulted in permanent discontinuation; 9. active or history of autoimmune disease; 10. active tuberculosis or infection requiring treatment; 11. history of interstitial lung disease; 12. allergic to research drug ingredients; 13. prior malignancy within 5 years prior to study entry; 14. solid organ or allogeneic bone marrow transplant; 15. hiv positive, hcv positive, hbv dna copies ≥ 10\^3; 16. significant cardiovascular disease; 17. other situations that are not suitable for inclusion in this study judged by investigator
cystic fibrosis related diabetes

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a chronic disease characterized by recurrent pulmonary infections and exocrine pancreatic insufficiency. the vast majority of patients with cf will develop pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. the presence of overt diabetes in patients with cf is associated with adverse clinical outcomes. the underlying pathophysiology of cystic fibrosis related diabetes (cfrd) is still a matter of investigation. in addition to localized tissue damage developing similar to that of the exocrine pancreas, additional mechanisms may be involved. the investigators have recently shown that insulin secretion in patients with cf is significantly altered prior to the development of diabetes. this phenomenon is associated with reduced secretion of gut derived incretins (specifically gip). the blunting of incretin induced insulin secretion (whether due to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced secretion or due to rapid clearance of such peptides) may be a major underlying driver of altered glucose metabolism in such patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years * no diabetes based on screening ogtt * no c/i for use of the medications * normal kidney function * willing and able to participate exclusion criteria: * use of anti-hyperglycemic medications * acute illness or infection at enrollment
risk prediction model for severe autoimmune encephalitis

Conditions: Severe Autoimmune Encephalitis

Summary: a prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (ae). the study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. it seeks to identify clinical indicators for the early recognition of severe ae patients, develop and validate a predictive model for severe ae, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe ae.

to develop and validate a predictive model for severe autoimmune encephalitis (ae), a prospective multicenter study will be conducted. clinical data of hospitalized ae patients will be collected consecutively, and a multicenter integrated database will be established. this database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. the study will analyze the clinical and immunological characteristics of ae patients, identify clinical indicators for early recognition of severe ae, and develop and validate a predictive model for severe ae. additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on ae outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe ae.

Eligibility criteria:
inclusion criteria: * age 14-80 years * no restriction on gender * meets the diagnostic criteria for confirmed ae, with a clearly identified pathogenic antibody * within 3 months of ae * patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf exclusion criteria: * no lumbar puncture performed for csf antibody testing * did not receive immunotherapy * pre-onset modified rankin scale (mrs) score ≥3

Keywords: severe autoimmune encephalitis prediction model plasma exchange therapy plasma adsorption therapy targeted immunotherapy
clinical features and outcome of wilson's disease with generalized epilepsy in chinese patients

Conditions: Wilson Disease; Generalized Epilepsy

Summary: generalized epilepsy is rarely reported in patients with wilson disease (wd) and lacks experience in clinical practice. we aim to provide better experience for the diagnosis and treatment for wd patients with epilepsy in the future.

a retrospective study was performed in 13 chinese wd patients with generalized epilepsy. each patient was diagnosed with wd by clinical evaluation and genetic screening. patients were given small doses of antiepileptic drugs (aeds), followed by copper-chelation therapy when the seizures stabilized. clinical manifestations, brain imaging changes, and treatment and outcome after a long-term follow-up were analyzed.

Eligibility criteria:
inclusion criteria: * each patient was diagnosed with wd by clinical evaluation and genetic screening and had ever experienced generalized epilepsy exclusion criteria: * not wd \& without generalized epilepsy

Keywords: chinese clinical features generalized epilepsy outcome wilson's disease
memesto wearable repetitive message and music therapy device music therapy device that senses and reduces agitation in people with ad,

Conditions: Alzheimer's Disease

Summary: this is a 12-week proof-of-concept study to evaluate the efficacy of memesto in reducing agitation in persons with alzheimer's disease and alzheimer's disease related dementias (ad/adrd) currently living in a residential care facility. it is hypothesized that memesto use will result in a reduction in agitation.

after informed consent is obtained and preliminary eligibility established, participants will be trained and issued the memesto device for use over a 2-week screening/training phase. participants successfully completing this phase will proceed into a 10-week open label treatment phase (via telephone and/or in-person data collection).

Eligibility criteria:
inclusion criteria: given that people living with adrd can be of any adult age, people meeting criteria for adrd diagnosis will be regardless of age. younger-onset people living with adrd, which may be smaller, will be considered for participation along with adults older than age 65 that make up the largest portion of persons living with adrd. the family and professional caregivers can be any age greater than eighteen. we anticipate that 5% of the people living with adrd will be less than age 65 with 70% being greater than age 75 and 25% being between ages 65 and 74. for family caregivers, we envision most will be spouses with the same age distributions as the parents with a skew to a slightly younger age group for caregivers who are children of the person living with adrd and/or the spouses of children. for professional caregivers, we anticipate they will be between the residential care workforce ages of 20 and 65 with a skew toward persons over age 40. inclusion/exclusion criteria: eligible participants will be adults with a dementia diagnosis who have clinically significant agitation, defined as a state of poorly organized and purposeless psychomotor activity characterized by at least one of the following: aggressive verbal (screaming, cursing), aggressive physical (destroying objects, grabbing, fighting), or non-aggressive physical (restlessness, pacing) behaviors. the behavioral symptoms must be severe enough to warrant pharmacological treatment. a family caregiver must be willing to participate along with a professional caregiver from the resident living facility. -

Keywords: dementia alzheimer's disease
cholesterol lowering via bempedoic acid/ezetimibe, an acl-inhibiting regimen in acute coronary syndrome study

Conditions: Cardiovascular Diseases; NSTEMI; STEMI

Summary: the overall objective of the cholesterol lowering via bempedoic acid/ezetimibe, an acl-inhibiting regimen in acute coronary syndrome acs (clear acs) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (ba/e) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (acs) event independent of use of statin therapy before the acs event.

the clear acs study is a prospective, virtual, electronic health record (ehr)-based, randomized, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial (pct) embedded within kaiser permanente northern california's fully integrated and learning health care delivery system. the ehr will be screened in real-time for potentially eligible participants across all kaiser permanente northern california hospitals using validated diagnostic and procedural codes, disease registries, laboratory values, pharmacy dispensing information, and sociodemographic data sources. eligible patients that provide informed consent will be randomized in a 1:1 allocation ratio to an initial 12 weeks of blinded bempedoic acid/ezetimibe (ba/e) vs. matching placebo followed by a 12-week open-label extension phase where all patients will receive open-label, unblinded bempedoic acid/ezetimibe.

Eligibility criteria:
inclusion criteria: * men and women age \>18 years * able to provide informed consent * a documented recent acs event (i.e., defined as up to 14 days post-discharge from an index hospitalization for a non-st-elevation mi \[nstemi\] or st-elevation mi \[stemi\] necessitating urgent and/or emergent percutaneous coronary intervention \[pci\] and/or coronary after bypass graft \[cabg\]) * at least 6 months of continuous health plan membership and prescription drug benefit prior to enrollment * a registered e-mail address with kaiser permanente in order to obtain electronic consent (econsent) for study participation exclusion criteria: * receipt of ba/e on or within 3 months before the day of enrollment * a history of hypersensitivity to ba/e * women who are pregnant or planning to become pregnant and/or breastfeeding mothers * a diagnosis of gout and/or previously known laboratory-confirmed hyperuricemia (serum uric acid \>8.0 mg/dl) * a history of tendon disorders or tendon rupture * current and/or planned treatment with simvastatin/pravastatin, cyclosporine, fibrates, and/or bile acid sequestrants (to avoid drug-drug interactions) * a known life-limiting diagnosis (e.g., stage d heart failure, severe liver disease, end-stage kidney disease \[eskd\] requiring chronic dialysis or an estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2, metastatic cancer and/or actively receiving systemic chemotherapy) * institutionalized and/or receiving palliative care * non-english speaking
the effect of kinesio taping on q angle and pes planus in children with cerebral palsy

Conditions: Cerebral Palsy; Pes Planus

Summary: the aim of our study is to examine the effect of using kinesiology tape and using it for 8 weeks on q angle and pes planus on children with cerebral palsy.

at the beginning of the study, the pes planus level of the children will be determined. then randomization will be made and divided into 3 groups with equal number of participants. the groups will be called control, experiment, and placebo. only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group. the study will be followed for 8 weeks, and pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * being diagnosed with cerebral palsy * gross motor function classification system level 1,2 and 3 * 2-18 years exclusion criteria: * having gross motor function classification system levels 4 and 5 * those with genetic and metabolic diagnosis

Keywords: cerebral palsy kinesio tape pes planus q angle exercise
pilot study of raltegravir switch to resolve tenofovir induced proteinuria

Conditions: HIV Infections; Proteinuria

Summary: the study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. common hiv treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated. hypothesis: proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

as described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from tenofovir

Eligibility criteria:
inclusion criteria: * documented hiv infection * ability to comply to protocol requirements * on stable haart for minimum of 12 weeks * evidence of tdf induced proteinuria * no evidence of prior protease inhibitor failure * treatment-naïve to integrase inhibitors * vl\<200 x 12 weeks (minimum of 2 viral load measurements) exclusion criteria: * active hepatitis b infection * proteinuria predating tenofovir use * prams on historic gt or pt * life expectancy less than 6 months * subjects with any ongoing aids defining illness * any condition which could compromise the safety of study subject * grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)

Keywords: hiv human immunodeficiency virus tenofovir viread truvada proteinuria