Kornimate/medical-research-clean huggingface dataset:
comparison between apdt and systemic doxycycline on non-surgical periodontal therapy in type 2 diabetics

Conditions: Periodontal Disease; Type 2 Diabetes

Summary: the objective of this study is to evaluate photodynamic therapy (pdt) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. a total of 40 individuals will be selected and divided in two groups. on the treatment stage, the control group (group c) will receive standard non surgical periodontal treatment. the test group (group t) will be treated with pdt as an adjunct to non surgical periodontal treatment. the treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. the follow-up will be done for 6 months. the clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. in addition, the evaluation of crevicular fluid volume and the levels of il-1, tnf-α, subgingival microbiota by the hybridization dna-dna checkerboard technique. the investigators expect to find identical or better results for the test group.


Eligibility criteria:
inclusion criteria: * poorly controlled type 2 diabetes (hba1c \> 7%) * advanced chronic periodontitis * presence of 15 teeth exclusion criteria: * use on antiinflammatory drugs * use of antibiotics less then 6 months before therapy * smokers * positive for hiv * periodontal treatment less then 6 months before therapy * advanced complications of diabetes

Keywords: periodontal diseases type 2 diabetes mellitus hemoglobin a1c protein
modulation of microbial composition in ileostomy patients

Conditions: Ileostomy - Stoma

Summary: to determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology


Eligibility criteria:
inclusion criteria: * • ileostomy installed at least 3 years prior to participation * free of any complications originating from the colectomy procedure for at least 1 yr prior to participation, with the exception of possible skin irritation at the location of the stoma * bmi from 18 till 28 kg/m2 * age from 18 till 70 years * available for entire study protocol. * for female: if of child bearing potential, female subjects must be using or complying with methods of contraception (such as oral birth control pills, intra-uterine device, double barrier methods (like condoms and spermicide, etc.) exclusion criteria: * • history of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, heent (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy. * subject with known lactose intolerance or with known or suspected allergy or hypersensitivity to any component of the study product(s) (milk protein for example) + sucrose + rhamnose * severe gastrointestinal symptoms. in case of mild gastrointestinal symptoms, the principal investigator and the medically responsible md will judge eligibility to participate. * removal of more than 15 cm of the ileum during or at any moment after the colectomy procedure * abdominal surgery interfering with gastrointestinal function, upon judgment of the principal investigator and the medically responsible md * use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (but except oral contraceptives), within 14 days prior to and during participation. * consumption of any probiotic or prebiotic supplements or pre- and probiotics containing food products, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principal investigator), in the 4 weeks prior to the study and during study participation (e4 preprobiotics). * use of antibiotics in the 4 weeks prior to the start of study and during study participation * prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. a list with forbidden products will be provided' * history of any side effects towards intake of pro- or prebiotic supplements of any kind.

Keywords: probiotics, microbiota, ileostoma
adverse myocardial and vascular side effects of immune checkpoint inhibitors

Conditions: Cancer; Immune Defect; Cardiovascular Abnormalities

Summary: our knowledge on cardiovascular side effects of immune checkpoint inhibitors (icis) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). we aim at assessing the incidence of cardiovascular adverse side effects of icis by means of a prospective interventional single centre study using multiple biomarkers.

immune checkpoint inhibitors (icis) are drastically improving cancer prognosis. cardiovascular adverse side effects of icis are though to be rare but may be responsible for \~50% death rates. prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry. the aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ici therapy for cancer. biomarkers as ecg, echocardiography, cardiac magnetic resonance imaging and long-term ecg monitoring will be undertaken at inclusion (before ici therapy is started), and during the first cycle treatments and at 6 months follow-up. mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ici cycle. secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects. 4 ancillary studies based on patients' blood biobanking are also planned. their objectives are: * to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ici, * to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ici, * to bank cells to induce cardiomyocytes from stem cells * to bank dna to identify genetic factors related to occurrence of cardiovascular events under ici

Eligibility criteria:
inclusion criteria: - prescribed treatment by immune checkpoint inhibitors (ici) for cancer exclusion criteria: * previous treatment by any ici * any contraindication to cardiac resonance magnetic imaging * contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent * pace maker or automated implantable defibrilator * pregnancy, breastfeeding * women of childbearing potential who do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * patient under legal protection * renal failure defined by creatinine clearance \<30ml/min/m² (ckd-epi) * current participation or exclusion period of another interventional clinical study exclusion criteria for ancillary studies: - hemoglobinemia \< 9 g/dl

Keywords: cardiotoxicity immune checkpoint inhibitors cancer myocarditis pericarditis myositis thrombotic events
the effect of different obturation techniques on postobturation pain in single-visit root canal treatment

Conditions: Postoperative Pain

Summary: the goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (american society of anesthesiology class i or ii) and require nonsurgical root canal treatment the main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to ah plus sealer used with lateral condensation or warm vertical compaction. participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques group 1: single cone technique group 2: lateral condensation technique group 3: vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.


Eligibility criteria:
inclusion criteria: * patients aged 18-60 years who presented no systemic disease (american society of anesthesiology class i or ii) and required nonsurgical root canal treatment. * diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals. exclusion criteria: * presence of immature root apexes, root fracture, or periodontal disease * use of any analgesic, anti- inflammatory, or antibiotics before the treatment.

Keywords: postoperative pain bioceramic sealer obturation
role of statin on the gastric inflammation in patients at high risk of gastric cancer

Conditions: Early Gastric Cancer or Gastric Adenoma

Summary: statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. in addition, several recent studies of human cancer cell lines and animal tumor models indicate that statins may have chemopreventive properties through the arresting of cell-cycle progression. the chemopreventive effect of statins was demonstrated in some kind of human tumors including colorectal cancer. in addition, recent one large epidemiologic study showed that statins decreased risk of gastric cancer. on the other hands, it has been well known that helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are premalignant lesions of gastric cancer. progression of these premalignant lesions could be limited by h. pylori eradication. in addition, a recent double blind randomization study revealed that simvastatin as adjuvant to standard therapy improves significantly the h. pylori eradication rate. therefore, investigators conjecture that statins may have an adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the role of statins in gastric carcinogenesis by observing the changes of gastric inflammation under statins.


Eligibility criteria:
inclusion criteria: 1. age, between 20 and 70 2. early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection 3. ecog performance status 0 or 1 exclusion criteria: 1. previous subtotal gastrectomy or gastrostomy 2. repeated endoscopic submucosal dissection 3. two or more synchronous lesions 4. presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection 5. history of drugs which are able to induce gastric ulcer including aspirin, nsaids, and steroid (30 days or more, within 1 year at the time of screening 6. indication of statins, including dyslipidemia, myocardial infarction, and heart failure. 7. develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia 8. ldl \< 70 mg/dl 9. allergy to statins 10. pregnancy or breast milk feeding 11. active infection 12. significant cardiopulmonary disease 13. active hepatitis or severe hepatic dysfunction 14. severe renal dysfunction 15. severe bone marrow dysfunction

Keywords: statin; gastric inflammation; gastric cancer
the bio-clinical effects of the (sacubitril-valsartan) combination on patients with chronic heart failure

Conditions: Heart Failure

Summary: the aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with congestive heart failure. moreover, the investigators aim to evaluate side effects of this combination. - the following parameters were determined at baseline and at end of the study at 6 months of the beginning. 1. new york heart association (nyha) class. 2. frequency of hospitalization by acute exacerbation of chf 3. nt-probnp 4. left ventricular systolic function by echocardiography moreover, the side effects of the drugs used during study was assessed by 1. renal function (serum creatinine) was performed every month till the end of the study. 2. serum electrolytes (potassium and sodium) was performed every month till the end of the study.


Eligibility criteria:
inclusion criteria: 1. age 40 - 60 years 2. patients with chronic congestive heart failure class ( ii-iv) symptoms according to new york heart association (nyha) classification 3. left ventricular ejection fraction of 40% or less. 4. nt-probnp level of at least ≥400 pg per milliliter 5. ace-inhibitor or arb therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day. exclusion criteria: 1. patients with symptomatic hypotension. 2. pregnant and nursing women 3. systolic blood pressure \< 100 mmhg at screening or \< 95 mmhg at randomization 4. patients with glomerular filtration rate \<30 ml/min/1.73 m2 5. patients with history of angioedema 6. patients with unacceptable side effects with ace-inhibitors or arbs.
pediatric locking nail for the treatment of femoral fractures in children

Conditions: Femur Fracture

Summary: the purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.


Eligibility criteria:
inclusion criteria: 1. subject, representative willing to sign informed consent. 2. ability and willingness of the subject to follow postoperative care instructions until healing is complete 3. subject age must be between 8-16 inclusive. 4. subjects with a minimal canal diameter of 9mm or greater and any of the following fracture types 1. non-comminuted and comminuted mid-shaft fractures 2. distal third fractures 4 cm above the distal physis 3. fractures that are open or closed 4. subtrochanteric fractures exclusion criteria: 1. a subject has a bone or soft tissue infection. 2. subject has a systemic infection. 3. subject has a distal (supracondylar) fracture. 4. subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality). 5. subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions. 6. subject with conditions including blood supply limitation, and insufficient quantity or quality of bone. 7. foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.
different levels of guidance in icbt for depression (rct)

Conditions: Depressive Symptoms; Quality of Life; Self Esteem

Summary: the study examines the effectiveness of a internet-based self-help-program called selfapy for individuals who are experiencing mental stress. the main objective of the study is to investigate the extent to which selfapy leads to a significant reduction in depressive symptoms. as this study is the first to evaluate the program selfapy, also quality of life and acceptance of the program are evaluated. the study is conducted as a randomized-controlled trial with parallel assignment into three conditions. the groups were organized into one wait-list control group and two groups receiving access to selfapy with different levels of guidance.

the study examines the effectiveness of a internet-based self-help-program called selfapy for individuals who are experiencing mental stress. the main objective of the study is to investigate the extent to which selfapy leads to a significant reduction in depressive symptoms. as this study is the first to evaluate the program selfapy, also quality of life and acceptance of the program are evaluated. the primary outcome is the phq-9 as a measure of the severity of depressive symptoms, combined with the bdi-ii. secondary outcomes are rates of quality of life and satisfaction with the program, which were measured with the whoqol-bref and zuf-8. the study is conducted as a randomized-controlled trial with parallel assignment into three conditions over the course of three months. the groups were organized into one wait-list control group, one that received selfapy with additional peer support and one that received selfapy with therapeutic guidance.the wait-list control group received access to the program after completion of the post-survey.

Eligibility criteria:
inclusion criteria: subjective psychological distress caused by depressive symptoms, wish for treatment, access to internet, sufficient knowledge of the german language. exclusion criteria: acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.

Keywords: depressive symptoms, icbt, guidance, peer-support, rct
safety of autologous human umbilical cord blood mononuclear fraction to treat acquired hearing loss in children

Conditions: Hearing Loss

Summary: the objectives of this study are: 1. to see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and 2. to determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.

acquired sensorineural hearing loss is characterized by a loss of functioning hair cells in the organ of corti, with greater hair cell loss correlating with more severe hearing impairment. children with sensorineural hearing loss experience difficulty developing normal language which usually leads to poor academic and social development. currently, there are no reparative therapeutic options available, and treatments are designed to augment the diminished function of the injured organ of corti. pre-clinical data suggest progenitor cell infusions may enhance intrinsic repair mechanisms in the organ of corti which may restore hair cells. this treatment could ultimately lead to hearing improvement. human umbilical cord blood (hucb) is an available, autologous, stored progenitor cell population available for potential therapeutic use. the primary objective of this study is to determine the safety of autologous hucb infusion in children with acquired hearing loss. the secondary objective is to determine if functional, physiologic and anatomic outcomes are improved following hucb treatment in this patient population.

Eligibility criteria:
inclusion criteria: 1. evidence of a moderate to profound sensorineural hearing loss. 2. normally shaped cochlea, as determined by mri. 3. the loss must be considered acquired, not syndromic. 4. the patient must be fitted for hearing aids of the detection of the loss. 5. enrollment in a parent/child intervention program. 6. between 6 weeks and 18 months of age at the time of cord blood infusion. 7. ability of child and caregiver to travel to houston for treatment and all follow-up appointments. (patient's family is responsible for the cost of travel to and lodging in houston). exclusion criteria: 1. inability to obtain pertinent medical records. 2. known history or * recently treated ear or other infection. * renal disease. * hepatic disease. * malignancy. * hiv. * immunosuppression (wbc \< 3,000). * evidence of an extensive stroke (\> 100ml). * pneumonia, or chronic lung disease. 3. hucb sample contamination. 4. participation in a concurrent intervention study. 5. desire for organ donation in the event of death. 6. unwillingness or inability to stay 4 days following hucb infusion, and to return for the one month, six month and one year follow-up visits. 7. presence of a cochlear implant device. 8. evidence of a syndrome. 9. positive test for genetic hearing loss. 10. evidence of conductive hearing loss. 11. documented evidence of recurrent middle ear infections (\> 5/year). 12. otitis media at the time of examination. 13. mild sensorineural hearing loss. 14. over 18 months at the time of infusion.

Keywords: autologous stem cells hearing loss children
technology-assisted early mobilization program among patients in the intensive care units

Conditions: Intensive Care Unit Acquired Weakness

Summary: this single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). the technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. the interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. the systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. the control group will receive routine rehabilitation as usual. the primary outcomes include occurrence of intensive care unit-acquired weakness (icuaw). secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. measurements will be assessed on the day of enrollment, during the icu stay, on the day of icu discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * being mechanically ventilated ≥ 24 hours * richmond agitation-sedation scale (rass): 0 to -1 * no vision, hearing, or body movements restriction * with clear consciousness and ability to communicate in chinese * expected to stay in the icu \> 96 hours. exclusion criteria: * being pregnant, menopausal, or having a night shift within one month before admission to the icu * have developed delirium before enrollment (icdsc \> 4) * with acute physiology and chronic health evaluation (apache ii) score \> 25 after icu admission within 24 hours * with muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.
a phase 2 study of ly3209590 in participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the reason for this study is to see if the study drug ly3209590 is safe and effective in participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * participants must have type 2 diabetes mellitus according to the world health organization (who) criteria treated with a stable dose of metformin in combination with a stable dose of dipeptidyl peptidase iv (dppiv) inhibitor and/or a sodium-glucose co-transporter-2 (sglt2) inhibitor for at least 3 months prior to screening * participants must have a hba1c value of 7.0% to 9.5%, inclusive * participants must have a body mass index (bmi) between 20 and 45 kilograms per meter squared (kg/m²), inclusive exclusion criteria: * have type 1 diabetes mellitus or latent autoimmune diabetes * have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening * have any of the following cardiovascular (cv) conditions: acute myocardial infarction, new york heart association class iii or iv heart failure, or cerebrovascular accident (stroke) * have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease * have an estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73 m² * have active or untreated cancer * are receiving chronic (\>14 days) systemic glucocorticoid therapy