Kornimate/medical-research-clean huggingface dataset:
impact of periodontal bacteria on the effectiveness of periodontal therapy

Conditions: Periodontitis

Summary: in light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either srp in addition to full mouth periodontal debridement.

this trial was conducted in accordance with the world medical association's declaration of helsinki of 1975, and reviewed in 2008. patients were enrolled from january 2020 to december 2022. the local ethical committee of approved the study protocol (125/po) and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. in all subjects, subgingival plaque will acquired from 4 separate proximal periodontal sites.

Eligibility criteria:
inclusion criteria: 1. good condition of general health, 2. a minimum of 2 teeth for each quadrant with a pocket depth (pd) ranging from 4-6 mm, 3. no involvement of the furcation, 4. a minimum of a six teeth per quadrant, respectively. exclusion criteria: 1. periodontal therapy during the last 12 months, 2. assumption of antibiotics during the last 6 months, 3. pregnancy, 4. any systemic condition which might affect the effects of the study treatment, 5. previous or current radiation or immunosuppressive therapies, 6. use of mouthwash containing antimicrobials during the previous 3 months, 7. no use of hormonal contraceptives, 8. medication by anti-inflammatory and immunosuppressive drugs, 9. previous history of hard-drinking, 10. smoking, 11. class ii and iii tooth mobility.

Keywords: periodontitis
activity of chronic inflammation in pcos

Conditions: Polycystic Ovary Syndrome

Summary: chronic inflammation in polycystic ovary syndrome (pcos) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. tnf, il-1, il-6) in relation to anti-inflammatory ones (il-10). this condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. however, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. there is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various pcos phenotypes.

the study population will be characterized in terms of demographic (age, bmi), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. pcos syndrome (and its phenotypes: a, b, c, d) will be recognized by the rotterdam criteria. during hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

Eligibility criteria:
inclusion criteria: * age 18-45 years * pcos syndrome confirmed by the rotterdam criteria exclusion criteria: * absence of at least one ovary * diagnosed and/or treated other metabolic disease * diagnosed and/or treated other endocrine disease

Keywords: pcos phenotypes chronic inflammation metabolic disorders ovarian reserve
phase ii pilot randomized study of sodium dichloroacetate in patients with congenital lactic acidemia

Conditions: Lactic Acidosis

Summary: objectives: i. determine the pharmacokinetics of sodium dichloroacetate (dca) in patients with congenital lactic acidemia. ii. determine the efficacy of dca in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.

protocol outline: this is a randomized, double blind, cross over study. patients are randomized to start with one of two different doses of sodium dichloroacetate (dca). patients receive one of two doses of oral dca for 6 months, then switch to the alternate dose for 6 months. this course is repeated once. patients are followed for up to 2 years. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of stable, persistent lactic acidemia venous lactate at least 3 mm under basal conditions defined as: at least 4 hours postprandial no concurrent illness or * diagnosis of cerebral lactic acidemia with elevated lactic acid in csf but not in the blood * no organic acidemias or defective gluconeogenesis --patient characteristics-- * hematopoietic: hemoglobin at least 7 mg/dl * hepatic: bilirubin no greater than 3 times upper limit of normal (uln) ast, alt, or ggt no greater than 10 times uln * renal: creatinine no greater than 2 mg/dl * cardiovascular: ejection fraction at least 25% * other: no hypoglycemia (blood sugar less than 50 mg/dl at no greater than 12 hours fasting) no severe peripheral neuropathy interfering with normal activities of living

Keywords: inborn errors of metabolism lactic acidosis rare disease
evaluation of eye health benefits of black tomato extract

Conditions: Eye; High Myopia

Summary: verification of the efficacy of black tomato extract for eye health.


Eligibility criteria:
inclusion criteria: * age greater than 20 and capable of providing informed consent. * daily usage of 3c (computer, communication, and consumer electronics) for more than 6 hours (osdi screening - those experiencing dryness and fatigue in the eyes). * bmi between 22 and 35. * high myopia population (-5.00 to -9.00d) exclusion criteria: * history of any eye surgery (e.g., strabismus surgery, refractive surgery). * presence of systemic diseases affecting the anterior surface of the eye. * long-term use of medications affecting the anterior surface of the eye.
a study comparing ibi362 vs semaglutide in chinese overweight or obese adults with metabolic dysfunction-associated fatty liver disease （mafld）

Conditions: Overweight; Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

Summary: this is a multicenter, randomized, open-label phase 3 clinical study comparing the efficacy and safety of ibi362 9 mg qw versus semaglutide 2.4 mg qw in overweight or obese (bmi≥27kg/m2) mafld subjects. subjects will be randomly assigned to ibi362 9 mg and semaglutide 2.4 mg groups. all study treatment will be administered once-weekly and subcutaneously. the entire trial cycle includes a 4-week screening period, a 48-week open-label treatment period, and a 12-week drug withdrawal safety follow-up period.


Eligibility criteria:
inclusion criteria: 1. male or female, age 18 years or older at the time of signing informed consent 2. diagnosed as mafld according to the chinese guideline for the prevention and treatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (version 2024) 3. liver fat content ≥8% measured by mri-pdff 4. bmi≥27 kg/m2 5. weight change ≤5% within 3 months before screening 6. hba1c≤10% exclusion criteria: 1. subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. used drugs or alternative therapies with weight loss effects within 3 months before screening, including but not limited to: glp-1 receptor agonists, orlistat, phenylpropanolamine, chlorpheniramine, phentermine etc. 3. received chronic (\>2 weeks) systemic glucocorticoid treatment within 3 months before screening (excluding topical, intraocular, intranasal, and inhaled administration) 4. previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes) 5. active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
effects of chocolate consumption in elderly patients with cancer in palliative care

Conditions: Nutrition Related Cancer; Aging

Summary: elderly patients with advanced cancer stage constitute an important demand for palliative care, a scenario in which metabolic and nutritional status changes may be present. the aim of this study was to evaluate the effects of chocolate consumption for 4 continuous weeks on nutritional status, quality of life, body composition, oxidative stress and inflammatory activity of elderly cancer patients in palliative care.

clinical trial designed as a comparative, randomized, non-blind intervention study involving elderly patients with cancer and palliative care in outpatient follow-up at the university hospital of the ribeirão preto medical school - university of são paulo. patients were randomized into 3 blocks of 15 subjects in the control (cg), 55% cocoa intervention (gi1) and white chocolate (gi2) intervention groups. the volunteers were evaluated before and after 4 weeks (28 days) for clinical and laboratory nutritional parameters, quality of life analysis and presence and grading of symptoms. the nutritional status of the patients was evaluated using the mini nutritional assessment (mna) and the current and usual food intake through the 24-hour recall survey (ir24h) and the food frequency questionnaire (ffq), respectively. the body mass index (bmi), arm circumference and calf circumference of the volunteers were obtained and the body composition was evaluated by the deuterium oxide method. the inflammatory profile was analyzed by serum interleukin 6 levels and the antioxidant capacity was evaluated by the quantification of reduced glutathione (gsh) and ascorbic acid. serum lipid peroxidation was measured by determining malonaldehyde levels and the presence and quantification of damage to genetic material by 8-hydroxy-2'-deoxyguanosine levels. to analyze quality of life, the european organization for cancer research and treatment (eortc) - quality of life questionnaire (qlq) - c30 was administered and the edmonton symptom assessment system (esas) scale was used to assess the frequency and intensity of symptoms. data were analyzed by sas statistical software (version 9.3; sas institute, inc. cary, nc) and r core team (2016). initially, a descriptive analysis of the data was performed. chi-square test was used to evaluate categorical variables. for the comparison between the groups at each moment and between the moments in each group was used linear regression model with mixed effects. the significance level established was \<0.05.

Eligibility criteria:
inclusion criteria: * elderly patients with cancer and palliative care in outpatient follow-up, with karnofsky palliative scale (kps) of 60% or more exclusion criteria: * karnofsky palliative scale (kps) of less than 60%

Keywords: palliative care aging
predictors of anesthesia complications in patients undergoing bariatric surgery

Conditions: Bariatric Surgery; Anesthesia, General; Postoperative Complications; Obesity; Risk Factors

Summary: this study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. by looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these procedures.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years) * patients who underwent a longitudinal gastrectomy (sleeve) between january 1, 2020, and june 30, 2021, at chg, as part of bariatric surgery treatment. exclusion criteria: * minor patients * patients who underwent a bariatric surgery other than sleeve gastrectomy * patients who objected to the use of their data for research purposes
effects of lidocaine patch on intradermal capsaicin induced pain and hyperalgesia

Conditions: Pain; Hyperalgesia

Summary: to determine the effects of lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin

a randomized, double-blinded, placebo controlled methodology will be conducted. at the session subjects will be exposed to placebo patch and lidocaine patch. prior to study drug administration, a baseline neurosensory test on the volar aspect of both forearms will be performed and baseline vital signs will be measured. a placebo patch and a lidocaine patch will then be applied to the volar aspect of each forearm. the arms will be randomized to which arm receives placebo and which one receives the lidocaine patch. after four hours of application the right forearm patch will be removed the neurosensory testing will be repeated on the right forearm. after completing the testing, capsaicin (10µl, 10 mg/ml) will be injected intradermally on the volar aspect of the right forearm. elicited and spontaneous pain scores, blood pressure, heart rate, and respiratory rate will be measured at the time of injection and every 2.5 minutes for 10 minutes. a mcgill pain questionnaire will be administered at the time of capsaicin injection only. ten minutes after the capsaicin injection, the hyperalgesic area will be established to von frey hair, stroking, and heat; the flare response will be outlined; and neurosensory testing will performed halfway between the edge of this defined area and the capsaicin injection site. at the completion of the testing on the right forearm, the left forearm patch will be removed and the procedures described for the right forearm will be repeated for the left forearm.

Eligibility criteria:
inclusion criteria: * age 18 and above exclusion criteria: * pregnancy. * allergy to lidocaine * current painful condition * current use of analgesics for the treatment of pain * lack of ability to understand the experimental protocol and to adequately communicate in english. the neurosensory testing we plan to perform requires the complete cooperation and understanding of the subject. it would be impossible to perform these studies on patients who do not adequately communicate in english.

Keywords: pain hyperalgesia capsaicin
urine nt-probnp in neonatal respiratory distress

Conditions: Neonatal Respiratory Distress

Summary: there is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease. urine nt-probnp, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn. the investigators aim to evaluate the prognostic value of urine nt-probnp in respiratory diseases in newborns by a controlled trial.

neonatal diseases such as respiratory distress and transient tachypnea of newborn may require high level of intensive care. on the other hand, some minor difficulties in respiration can resolve within hours. therefore, there is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease. serum nt-probnp level has been evaluated in transient tachypnea of newborn and found compatible with the clinical progress. urine nt-probnp has recently been evaluated in patent ductus arterioses and found compatible with the cardiac progress. however, urine nt-probnp, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn. the investigators aim to evaluate the prognostic value of urine nt-probnp in respiratory diseases in newborns by a controlled trial.

Eligibility criteria:
inclusion criteria: * study group; newborns who are admitted to the neonatal intensive care unit within first 2 days of life and have transient tachypnea of newborn or respiratory distress syndrome signed informed consent form * control group: newborns without any respiratory distress exclusion criteria: * any cardiac anomaly sepsis acute renal insufficiency syndromic cases low apgar score at 5th minute (\<7) lung malformations no informed consent inability in collection of urine

Keywords: nt-probnp, newborn, preterm
efficacy study of the medical device trp snorless™ in the treatment of snoring

Conditions: Snoring

Summary: the tongue right positioner (trp snorless™) is a medical device designed to restore physiological tongue positions when functioning or at rest and increase tongue muscles tone. patient wears trp snorless™ daily at least 5 hours during night. published data suggested that trp snorless™ increases oropharynx diameter and nasal patency, favouring airflow in upper airways. independently of patient's adherence to daily myofascial exercises, the trp snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring during sleep.


Eligibility criteria:
inclusion criteria: * man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent * listed as continuous snorer (snoring at least 4 nights/week) * answer "extremely loud" or "very loud" to question 1 of sbps at screening * answer "very severe" or "severe" to question 2 of sbps at screening * answer "extremely" or "quite a bit" to question 3 of sbps at screening * dated and signed informed consent * bmi ≤ 35 exclusion criteria: * severe mandibular retrognathia and micrognathia * narrow and deep palate (less than 3 cm wide) * lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28). * lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers) * intolerable gag reflex * known nasal septal deviation * neck circumference \> 46 cm * patient currently treated for osa * patient with ahi≥30 events/hour or with ahi\>15 and (sfi) sleep fragmentation index \> 20 * patient currently treated for central sleep apnoea * addiction to alcoholic beverages (5 drinks per day per niaaa) * under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia * hypertrophy of tonsils * macroglossia * hypertrophy of uvula * primary gastroesophageal reflux * any other pathology preventing subject from complying with the protocol * subject with recent oropharyngeal surgery or likely during the study * mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures * pregnancy * patient with severe chronic obstructive pulmonary disease * asthmatic patient under inhaled corticoid therapy

Keywords: medical device retraining snoring trp tongue
the study of personalized health check-up programs and standards for high-altitude migrant populations

Conditions: High Altitude

Summary: by using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on high-altitude populations, the study aims to provide a basis for developing personalized health assessment protocols for high-altitude migrants. the formulated assessment protocols and standards will then be validated.


Eligibility criteria:
inclusion criteria: * men and women aged ≥18; * those living in plains and preparing to move to the plateau for a short-term or medium-term period; * can understand the research requirements and be willing to sign a written informed consent form (icf). exclusion criteria: * past history of contraindicated plateau travel: such as advanced copd (fev₁\ 90mmhg), sickle cell anemia, unstable angina pectoris, high-risk cerebrovascular abnormalities that have not been treated, etc.
safety, tolerability and pharmacokinetics of efavirenz in hiv-infected children

Conditions: HIV Infections

Summary: the primary purpose of this study is to find the dose of efavirenz for young children. the safety and how the medication is tolerated will also be studied.


Eligibility criteria:
inclusion criteria: * hiv-1 infected; \>=3 months of age to \ =1000 copies/ml exclusion criteria: * genotypic or phenotypic resistance to efv, ddl, or ftc/lamivudine (3tc) at screening

Keywords: hiv, pediatric
azd0486 as monotherapy in participants with relapsed/refractory (r/r) b-cell nhl

Conditions: B-cell Non-Hodgkin Lymphoma; Follicular Lymphoma (FL); Diffuse Large B-Cell Lymphoma (DLBCL)

Summary: this is a phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of azd0486 monotherapy in adult participants with relapsed/refractory b-cell non-hodgkin lymphoma (nhl) who have received at least two prior lines of therapies. the study has 2 modules: module 1 for fl and module 2 for dlbcl.

this is a modular, phase ii, multicenter, single-arm, open-label study to evaluate the efficacy and safety of azd0486 monotherapy administered as an intravenous (iv) infusion in participants with relapsed or refractory b-nhl. the purpose of this study is to determine the efficacy and safety of azd0486 administered at the rp2d in adults 18 to 80 years of age with relapsed or refractory b-nhl.

Eligibility criteria:
1. key inclusion criteria: * aged 18 to 80 years old * histologically confirmed relapsed refractory fl (module 1) and dlbcl (module 2) after at least 2 prior lines of therapy * ecog performance status 0 to 2 * locally confirmed cd-19 expression in lymphoma cells after progression from last cd 19 directed therapy * fdg-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension) * adequate hematological function: anc ≥ 1000/mm3, platelets * 75,000/mm3, hemoglobin ≥ 9 g/dl. transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening * adequate liver function: total bilirubin \<1.5x uln, ast/alt ≤ 3xuln note: patients with documented history of gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible) * adequate renal function: creatinine clearance (crcl) of ≥ 45 ml/min the above is a summary, other inclusion criteria details may apply. 2. key exclusion criteria: * diagnosis of cll, burkitt lymphoma, or richter's transformation * active cns involvement by b-nhl * leukemic presentation of b-nhl * history or presence of clinically relevant cns pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis * prior therapy with t-cell engager (tce) within 8 weeks, car t- cell therapy or autologous hematopoietic stem cell transplantation (hsct) within 12 weeks, or prior allogeneic hsct within 24 weeks of first dose of azd0486 * requires chronic immunosuppressive therapy * unresolved non hematological aes ≥ grade 2 from prior therapies; history of ≥ grade 3 crs or neurotoxicity from prior car-t or tce therapy * history of major cardiac abnormalities. * if female, participant must not be pregnant or breastfeeding. the above is a summary, other exclusion criteria details may apply.

Keywords: azd0486 follicular lymphoma (fl) diffuse large b-cell lymphoma (dlbcl) non-hodgkin lymphoma (nhl) relapsed/refractory