Kornimate/medical-research-clean huggingface dataset:
socioecological factors associated with ethnic disparities in bariatric surgery utilization and post-wls

Conditions: Obesity; Metabolic Syndrome

Summary: the goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (wls) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the wls. the main aims / objectives of this sub-study are: * aim 1. compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-wls and (2) 6-month post-wls participants. hypothesis: blood bacterial composition will resemble that of the gut microbiome among pre-wls participants. because the effect of wls on the blood microbiome is not known, our post-wls results will be mostly exploratory. * aim 2. determine racial differences in the blood microbiome of the pre- and post-wls groups. hypothesis2: ethnic differences will be detected in both the pre- and post-wls groups.

a subgroup of participants from the main study will be invited to participate in a cross-sectional sub study evaluating the relationship between blood and gut microbiotas. a total of 100 participants will be recruited, 50 participants will be recruited from the "non-completers" and the other 50 participants will be recruited from the "6 months post-wls" follow-up group of our main project.

Eligibility criteria:
inclusion criteria: * 18-60 years old * will belong to either non-hispanic whites (nhw) or non-hispanic blacks (nhb) ethnic groups * "no-wls" participants will have a bmi \>35 kg/m2 (threshold bmi for wls) whereas "6 months post-wls" participants will have no bmi requirements. exclusion criteria: * having taken antibiotics in the previous 6 months; * metformin, proton pump inhibitors, probiotics, or prebiotics in the previous month; * currently following a vegetarian diet; * pregnancy; * having any infection in the previous month; and * having a comorbid disease that might alter the blood microbiome composition (e.g., renal failure) or the intestinal permeability (e.g., ibs).

Keywords: weight loss surgery bariatric surgery gut microbiome blood microbiome
a prospective, multicenter study to evaluate the conformis itotal® (cr) knee replacement system

Conditions: Osteoarthritis of the Knee

Summary: this study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

if the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding both their itotal® cr knee and their standard total knee for all time points where questionnaires are required by the protocol.

Eligibility criteria:
inclusion criteria: * clinical condition included in the approved indications for use for the itotal® cr * osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a tkr procedure. disease status is assessed by clinical and radiographic assessment. * willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits * \> 18 years of age exclusion criteria: * simultaneous bilateral procedure required * bmi \> 40 * active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years * poorly controlled diabetes * neuromuscular conditions which prevent patient from participating in study activities * active local or systemic infection * immunocompromised * fibromyalgia or other general body pain related condition * rheumatoid arthritis or other forms of inflammatory joint disease * loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified * diagnosed with or receiving treatment for osteoporosis * other physical disability affecting the hips, spine, or contralateral knee. * severe instability due to advanced loss of osteochondral structure * prior arthroplasty of the affected knee, including high tibial osteotomy (hto) * compromised pcl or collateral ligament * severe fixed valgus or varus deformity of \>15º * extensor lag \> 15 º * fixed flexion contracture ≥ 15 º * unwilling or unable to comply with study requirements * participation in another clinical study which would confound results * allergy to any of the implant materials

Keywords: osteoarthritis knee replacement patient-specific
a prospective, single-arm, clinical trial of electrospun fiber matrix (restrata) in the treatment of surgical defects secondary to resection of malignant cutaneous neoplasms

Conditions: Surgical Wound

Summary: the goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix. this study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks.


Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years old 2. patient plans to undergo surgical resection of a cutaneous neoplasm 3. patient is willing and capable of complying with all protocol requirements 4. patient or legally authorized representative (lar) is willing to provide written informed consent prior to participation in study 5. post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2 exclusion criteria: 1. inability to give informed consent or to complete the procedures required for study completion 2. patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint 3. patient is pregnant, breast feeding or planning to become pregnant 4. patient has a known allergy to resorbable suture materials, e.g. polyglactin 910 (pgla), polydioxanone (pds) 5. patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery. 6. patient has a life expectancy less than six months as assessed by the investigator 7. patient has an additional non-study related wound within 3 cm of the study wound 8. study wound is located on the hands or feet 9. patient has been diagnosed with osteomalacia 10. resection defect from a squamous cell carcinoma arising from a chronic wound 11. patient has an uncontrolled thyroid disorder 12. hgb a1c \> 12% within 3 months prior to enrollment in patients with a known history of diabetes 13. patient has a bmi \> 34.9 14. patient has used any tobacco product within the past 30 days prior to surgery 15. patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15ml/min 16. patients with severe liver disease with active cirrhosis defined as a gross ascites upon clinical exam or a model for end-stage liver disease (meld)-na score greater than 15 17. patient not in reasonable metabolic control in the judgement of the investigator 18. patient has a known history of poor compliance with medical treatment 19. patient has a history of radiotherapy to wound bed of interest 20. patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 21. active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator
pilot study of vedic medicine for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the feasibility and effectiveness of a multimodality vedic medicine treatment protocol for the management of newly diagnosed type 2 diabetes.

maharishi vedic medicine (mvm) represents a synthesis of vedic sciences, including ayur-veda, into a single, comprehensive, natural approach to health care. the objectives of this phase ii pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality mvm intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.

Eligibility criteria:
inclusion criteria: * kaiser permanente members * newly diagnosed type 2 diabetes * baseline glycosylated hemoglobin level of 6.0-7.9. exclusion criteria: * pregnancy or nursing mother * currently taking warfarin * diagnosis of psychotic disorder or recent hospitalization for depression * unable to comply with or attend treatment sessions

Keywords: diabetes mellitus type 2 vedic medicine ayurveda transcendental meditation
physical activity in patients with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: background. systemic lupus erythematosus is a chronic autoimmune disease. among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. physical activity can improve the perception of quality of life and well-being of these patients. objective. to assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it. method. ambispective cohort study. sixty-three patients with systemic lupus erythematosus will be recruited. the primary variable will be the degree of physical activity (international physical activity questionnaire). secondary and modifying variables will be: fatigue (fatigue assessment scale), health-related quality of life (short form-36 health survey), sleep disorders (pittsburgh sleep quality index), depressive (beck depression inventory -ii) and anxiety symptoms (hamilton anxiety rating scale), age, and disease activity, duration and damage. possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. in the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients. expectedresults. to identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of systemic lupus erythematosus * of legal age * residents in spain * who sign the informed consent document. exclusion criteria: * patients dependent in the development of activities of daily living. * unable to ambulate without the help of third parties. * who have undergone surgery in the last 6 months.

Keywords: systemic lupus erythematosus physical activity prevention physiotherapy
14-day double therapy versus bismuth quadruple therapy in first-line treatment of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the researchers collected untreated h. pylori positive patients from outpatient clinics. subjects were randomized to 14 days of dual therapy with tegoprazan or 14 days of quadruple therapy with bismuth for eradication. at 6 weeks after treatment, subjects underwent another 13c-urea breath test. the eradication rate, adverse reaction rate and patient compliance were calculated.

1. informed consent: patients with positive helicobacter pylori were collected in the outpatient department, and the subjects receiving initial treatment signed informed consent. 2. safety evaluation: c13 urea breath test, blood routine test, urine routine test, electrolyte test and liver and kidney function test were performed to confirm helicobacter pylori infection. 3. confirm the inclusion of patients: fill in the case report form and enter group a or group b according to the randomization results. group a: 14-day tegoprazan high-dose dual therapy (hddt) tegoprazan 50mg bid amoxicillin 750mg qid group b: 14-day bismuth-containing quadruple therapy (bqt) esomeprazole 20mg bid amoxicillin 1000mg bid tetracycline 500mg qid potassium bismuth citrate 2g bid 4. supervised medication: follow up the medication situation and adverse reactions by telephone 14 days after taking medication, and remind the reexamination 6 weeks after stopping medication. 5. results: c13 urea breath test was repeated 6 weeks after drug withdrawal. blood routine, urine routine, electrolytes and liver and kidney function tests were performed. 6. complete the case report form: fill in the case report form accurately. 7. data analysis: spss software was used for statistical analysis.

Eligibility criteria:
inclusion criteria: * helicobacter pylori infection (either positive for helicobacter pylori culture, histopathological test, rapid urease test, c13/c14 urea breath test, or helicobacter pylori antigen test in feces). * patients who have not previously received helicobacter pylori eradication therapy. exclusion criteria: * serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%). * those who are not willing to take contraceptive measures during pregnancy, lactation or the trial. * active gastrointestinal bleeding. * history of drug allergy. * medication history of bismuth, antibiotics and ppi within 4 weeks. * other behaviors that may increase the risk, such as alcohol and drug abuse. * unable or unwilling to provide informed consent.

Keywords: helicobacter pylori infection high dose dual therapy bismuth-containing quadruple therapy
effect of obstetric anesthesia and delivery mode on neurodevelopmental and behavioural outcomes in a population-based birth cohort

Conditions: Neurodevelopmental Disorders; Behavior

Summary: the study aims to determine: 1. the association between obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes. 2. mode of delivery on pediatric neurodevelopmental and behavioural outcomes. 3. effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes. 4. to determine if these would differ between very preterm, moderate preterm, late preterm and term infants. the study team hypothesise that: 1. adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants. 2. delivery via a lower segment caesarean section (lscs) combined with a general anesthetic during delivery may be associated with adverse pediatric neurodevelopmental and behavioural outcomes. 3. the use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes. 4. these differences may be more pronounced in preterm infants as compared to term infants.

the relationship between the mode of delivery, type of anesthesia received, maternal anesthetic events at delivery and its effects on pediatric neurodevelopment and behavioral outcomes remains poorly defined with previous work showing conflicting results. furthermore, previous studies have failed to take into account the potential effect of other antepartum anesthetic events such as the type of anesthesia, hypotension or desaturation. furthermore, majority have failed to stratify between the subsets of premature infants, who may inherently be more susceptible to neurodevelopmental insult. the gusto study is well-placed to provide unique insight with regards to these domains, due to its comprehensive, sensitive and specific follow-up of pediatric neurocognitive development and in-depth maternal anesthetic delivery data. hence, previously collected, existing data from the growing up in singapore towards healthy outcomes (gusto) cohort study will be utilized for this study. this will be supplemented by additional maternal anesthetic and delivery data which the investigators aim to collect via a retrospective chart review.

Eligibility criteria:
inclusion criteria: * all mothers and infants recruited into the gusto database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study. exclusion criteria: * children who dropped out of the study before 18 months of age * children who had subsequent exposure to general anaesthesia/surgeries/sedatives

Keywords: obstetric anaesthesia
mrna-2736 for participants with relapsed or refractory multiple myeloma (rrmm)

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this study is designed to evaluate the safety and tolerability of mrna-2736 in participants with rrmm.

this open-label, phase 1, dose-escalation, first-in-human (fih) clinical study of mrna-2736 in participants with rrmm is designed to evaluate the safety and tolerability of escalating doses of mrna-2736, administered intravenously (iv), to determine maximum tolerated dose and/or recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mrna-2736.

Eligibility criteria:
key inclusion criteria: * rrmm with prior exposure to a proteasome inhibitor, an immunomodulatory drug (imid), and an anti-cluster of differentiation (cd38) monoclonal antibody. participants must have received at least 3 prior lines of therapy or be triple-class refractory. participants that are intolerant of a proteasome inhibitor, imid, or acd38 are eligible. * measurable disease defined as at least 1 of the following: * serum m-protein ≥0.5 grams/deciliter * urine m-protein ≥200 milligrams (mg)/24 hour * involved free light chain (flc) ≥100 mg/liter and an abnormal flc ratio * plasmacytoma with a single diameter ≥2 centimeters * bone marrow plasma cells \>30% key exclusion criteria: * known central nervous system (cns) myeloma or clinical signs and symptoms of cns involvement of myeloma. * active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. history of plasma cell leukemia is allowed. * radiotherapy or cytotoxic chemotherapy within 2 weeks prior to day 1 (baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the sponsor medical monitor. * antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate, radioimmunoconjugate) within 21 days prior to day 1 (baseline). * proteasome inhibitor therapy within 14 days prior to day 1 (baseline). * immunomodulatory agent therapy within 7 days of day 1 (baseline). * autologous hematopoietic cell transplant within 100 days prior to day 1 (baseline). * allogeneic hematopoietic cell transplant within 180 days prior to day 1 (baseline). participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease. * genetically modified adoptive cellular therapy (for example, chimeric antigen receptor t cell, chimeric antigen receptor natural killer) within 12 weeks prior to day 1 (baseline). * corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to day 1 (baseline). * active hepatitis b or c, or laboratory evidence for a chronic infection with hepatitis b or c at the time of screening. participants with a past or resolved hepatitis b infection (presence of hepatitis b core antibody and absence of hepatitis b surface antigen) are eligible. participants positive for hepatitis c virus (hcv) antibody are eligible only if negative for hcv rna. note: other inclusion and exclusion criteria may apply.

Keywords: mrna-2736 first-in-human fih dose-escalation
expanded access (compassionate use) treatment protocol rindopepimut

Conditions: Recurrent GBM

Summary: celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. requests for expanded access to rindopepimut in patients with egfrvlll expressing recurrent glioblastoma will be considered.


Eligibility criteria:
inclusion criteria: * the patient has histologically confirmed relapsed or recurrent gbm. * egfrviii expression in tumor tissue, as assessed by a central laboratory using the celldex assay. * prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate. * systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day. * the patient does not have a known allergy or hypersensitivity to klh, gm-csf or yeast derived products, or a history of anaphylactic reactions to shellfish proteins. * the patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy. * the patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing. * males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut. * the patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut. exclusion criteria: -
temporary simultaneous two-arterial occlusions during laparoscopic myomectomy

Conditions: Myoma

Summary: the aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (testo) on operative blood loss during laparoscopic myomectomy.

significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.

Eligibility criteria:
inclusion criteria: * women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility * women who were planning to undergo laparoscopic myomectomy * women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm * women with regular menstrual bleeding * women who were not pregnant at the surgery * women between 19 and 48 years of age. exclusion criteria: * women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis * women who were in postmenopausal or climacteric status * women with a history of oophorectomy or salpingo-oophorectomy * women with any suggestion of malignant uterine or adnexal diseases * women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance * women who refused to participate or give consent to the procedures