Kornimate/medical-research-clean huggingface dataset:
chronic periodontitis and polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Chronic Periodontitis

Summary: background: the aim of this study was to investigate the levels of malondialdehyde (mda), total antioxidant status (tas), 8-hydroxy-2´- deoxyguanosine (8-ohdg) in blood serum and saliva samples in female patients with chronic periodontitis (cp) and to compared healthy individuals. materials and methods: a total of 88 women were into four groups each which were consisted of twenty-two subjects. groups were designed as periodontally and systemically healthy women (pcos-cp-); periodontally healthy women with polycystic ovary syndrome (pcos) (pcos+cp-), systemically healthy women with cp (pcos-,cp+) and women with pcos and cp (pcos+cp+). serum and salivary samples were obtained, clinical periodontal parameters were recorded. mda, tas, 8-ohdg levels were measured as biochemically.

results: salivary 8-ohdg levels in the pcoscp and cp groups were statistically higher than those in both the pcosph and the ph groups (p \ 0.05). highest serum 8-ohdg and mda levels and lowest serum tas levels were seen in the pcoscp group (p \< 0.05). serum 8-ohdg and mda levels in the pcosph group were higher than those in both systemically healthy groups (ph and cp) (p \< 0.05). salivary tas levels were highest (p \< 0.05) in the ph group. there was no statistical difference between the cp and pcosph groups, but serum tas levels were lower than those in the ph group (p \< 0.05). conclusions: cp, which led to an increase in serum and salivary 8-ohdg and mda levels and a decrease in serum tas levels in patients with pcos, contributed to increased os. this effect was more prominent in serum levels than in salivary levels.

Eligibility criteria:
inclusion criteria: * newly diagnosed non-obese pcos patients * never smokers * had no history of systemic disease * bmi\<25 kg/m2 * participants had ≥20 teeth present. exclusion criteria: * pregnancy * lactation * hemoglobin a1c (hba1c) ≥ 6.5% * 2-h oral glucose tolerance test (ogtt-2h) ≥200 * cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors * any drug use within the past 6 months * periodontal treatment within the past 6 months

Keywords: 8- hydroxy -2´- deoxyguanosine malondialdehyde total antioxidant status oxidative stres
hd16 for early stage hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (pfs).


Eligibility criteria:
inclusion criteria: * hodgkin lymphoma * cs i, ii without risk factors * large mediastinal mass (\> 1/3 of maximum transverse thorax diameter) * extranodal involvement * elevated esr * 3 or more involved nodal areas * written informed consent exclusion criteria: * leucocytes \< 3000/µl * platelets \< 100000/µl * hodgkin lymphoma as composite lymphoma * activity index (who) \> 2

Keywords: hodgkin lymphoma early stage pet
study to evaluate the safety and efficacy of prx-102 on gastrointestinal symptoms in naïve fabry disease

Conditions: Fabry Disease

Summary: the study will be a randomized, double blind, placebo-controlled study of the safety and efficacy of prx-102 in ert naïve male patients randomized 1:1. patient age will be 14 to 45 years. patients must have diarrhea defined as ≥ 3 stools a day with an average consistency of ≥ 5.5 on the bristol stool form scale (bsfs) by patient electronic diary and moderate to severe gastrointestinal symptoms as defined by the irritable bowel symptom severity score (ibsss) part 1 average \> 175 derived from at least two ibsss assessments during screening period. patients will receive intravenous infusions of prx-102 1 mg/kg or placebo every two weeks for 6 months.


Eligibility criteria:
inclusion criteria: * males, age 14-45 years, naïve to enzyme replacement therapy (ert) or off ert or off chaperone treatment for at least 6 months and negative for anti-prx-102 antibodies * a documented diagnosis of fabry disease: plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (lln) * egfr by ckd-epi \> 30 ml/min/1.73 m2 * moderate to severe gastrointestinal symptoms as defined by: * average score of \> 175 from at least two irritable bowel symptom severity score (ibsss) part 1 assessments before randomization. * average stool consistency of ≥ 5.5 on the bristol stool form scale (bsfs) by patient diary during 2 weeks prior to randomization out of the 4 week of screening period and * ≥ 3 stools a day with a consistency of ≥ 5 on the bsfs during the week before randomization. * completed electronic bsfs diary on at least 6 of the 7 days during the week prior to randomization and at least 11 of the 14 days during the 2 weeks prior to randomization. exclusion criteria: * patients will be evaluated to rule out other gastrointestinal comorbidity than fabry disease as responsible for the gastrointestinal symptoms by: i. medical history for non fabry gastrointestinal comorbidity ii. occult blood in stool iii. stool culture for bacteria and parasites iv. calprotectin in stool v. sigmoidoscopy * use of any kind of laxatives * initiation of anti-diarrheal medications during the screening period * history of renal dialysis or transplantation * use of, or change in dose of, angiotensin converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb) for less than 4 weeks prior to screening * cardiovascular event (myocardial infarction, unstable angina) in the 6 month period before randomization * congestive heart failure nyha class iv * cerebrovascular event (stroke, transient ischemic attack) in the 6 month period before randomization * known history of hypersensitivity to gadolinium contrast agent * known allergies to ert * presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the investigator and/or medical director, would interfere with the patient's compliance with the requirements of the study

Keywords: gastrointestinal symptoms diarrhea abdominal pain
ultrasonographic fetal soft markers and aneuploidy

Conditions: Soft Markers

Summary: the purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.


Eligibility criteria:
inclusion criteria: 1. pregnant woman between (16-24) weeks of gestation. 2. singelton pregnancy. exclusion criteria: 1. multiple pregnancies. 2. mental condition rendering the patients unable to understand the nature and scope of the study.

Keywords: anomaly scan anuploidy
comparison of telavancin and vancomycin for hospital-acquired pneumonia due to methicillin-resistant staphylococcus aureus

Conditions: Bacterial Pneumonia

Summary: study 0019 (nct00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration. exclusion criteria: * received more than 24 hours of potentially effective systemic (iv, im or po) antibiotic therapy for gram-positive pneumonia immediately prior to randomization.
study of esr1 mutations in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of the study is to determine the frequency esr1 mutations by digital pcr in patient with metastatic breast cancer.

breast cancer is the most common cancer in woman. aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists. esr1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment. the purpose of the study is to determine the frequency esr1 mutations by digital pcr in patient with metastatic breast cancer. the significance of the digital pcr technique will be determined first in plasma issued from healthy volunteers. at the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. during their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too. when the patient progress clinically or radiologically the plasma concomitant to this progression will be analysed by digital pcr to detect esr1 mutations. the patient will be followed during 2 years.

Eligibility criteria:
inclusion criteria: * woman aged superior to 18 years old * inform consent signed * metastatic breast cancer or loco-regionnaly advanced breast cancer * inoperable * with an indication to treat with aromatase inhibitor * treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease * without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution * treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus) exclusion criteria: * no inform consent signed * patient under guardianship, curatorship * psychosocial disorder * no affiliated or beneficiary of a social benefit system

Keywords: metastatic esr1 aromatase inhibitor breast cancer
comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Conditions: Tobacco Dependence

Summary: comparative pharmacokinetic study of new oral nicotine replacement therapy products.

this study compares new oral nicotine replacement therapy (nrt) products containing 2 and 4 mg nicotine with niquitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. single doses of treatment a, b, c, and d are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment e or f. the study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. the study will be performed at two sites with 52 subjects at each site. subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation, nicotine pharmacokinetics
a study of the possible effects of medication on young onset colorectal cancer (yocrc)

Conditions: Colorectal Cancer

Summary: this study will collect biospecimens (including blood, tissue, and stool samples) and health information to create a database-a type of collection of information-for better understanding young onset colorectal cancer (yocrc). the study will include both people with yocrc and healthy people.


Eligibility criteria:
inclusion criteria: crc cohort: * 18-49 years old * histological or cytological diagnosis of colorectal adenocarcinoma * planned crc resection biopsy, or colonoscopy ,including surveillance colonoscopies and/or have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample) * enrollment in irb# 20-315, young onset gastrointestinal cancer prospective registry (andrea cercek, pi) healthy control cohort: * 18-49 years old at time of diagnosis * scheduled for standard-of-care colonoscopy at msk * underwent surgical resection of a traumatic injury to the colon at shaare zedek medical center (szmc) exclusion criteria: * crc cohort: * antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample) * known inherited cancer susceptibility gene * history of inflammatory bowel disease healthy control cohort: * antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample) * history of or prior treatment for cancer ≤ 5 years prior to registration. exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix. * colonoscopy for indications of ibd, anemia and/or genetic predisposition (only patients providing tissue sample).

Keywords: pharmacologic colectomy specimens 22-254
glucose tolerance and prevention of diabetes mellitus type 2 by polyherbal formulation

Conditions: Diabetes Mellitus; Pre Diabetes

Summary: primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out phase-ii, iii and iv. it also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. to see the for prevention of diabetes mellitus (dm) and stopping / delaying the onset of dm.

this study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. for this purpose, volunteers will be enrolled in the study by observing the helsinki declaration for clinical trials. volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2. on screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into a and b. biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation. collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. one year followup of participants was conducted.

Eligibility criteria:
inclusion criteria: * age: 18-59 * impaired fasting glucose (100-125mg/dl) * impaired glucose tolerance (140-199mg/dl) 2h-75gm ogtt * history of diabetes in first degree relation with one condition * at high risk with bmi \> 35% * early onset diabetic / accidental on screening (glucose \>200mg/dl) exclusion criteria: * on renal dialysis; * an acute or terminal illness or serious mental illness; * history of recent coronary event within the last 12 months; * a recent history of acute medical problem or admission to hospital; * any other severe medical conditions that need intervention / treatment * has poor short-term prognosis (expected death in \<2 years); * is planning to travel for longer than 6 weeks during the 6-week intervention period; or * is with compromised liver / kidney / cardiac function * older patients of dm taking any form of medication / intervention

Keywords: impaired fasting glucose impaired glucose tolerance 2hr -75gm oral glucose tolerance test diabetes mellitus prevention
use of alivecor ecg monitoring to replicate ecg lead recording

Conditions: Arrhythmia

Summary: the researchers are trying to determine whether the alivecor device can simulate other electrocardiogram (ecg) leads to record electrical activity.


Eligibility criteria:
inclusion criteria: * individuals greater than 18 years old getting an ecg exclusion criteria: * patients unwilling or unable to provide informed consent
an observational study on the correlation between time of initiation of avastin (bevacizumab) treatment and progression-free survival in patients with colorectal cancer (cronos 1)

Conditions: Colorectal Cancer

Summary: this single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic colorectal cancer. patients will be followed for up to 12 months after progressive disease occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= the 18 years of age * previously untreated metastatic colorectal cancer * scheduled to start 1st line chemotherapeutic treatment * ecog performance status 0-1 exclusion criteria: * any conditions included in contraindication list for avastin * prior chemotherapy for metastatic colorectal cancer * adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic colorectal cancer completed \<6 months prior to treatment start
the evaluation of tci378 and tci507 probiotics on weight-lowering efficacy in adults

Conditions: Weight Reduction

Summary: obesity is a serious global public health issue. many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc. tci378 (lactobacillus plantarum tci378) is a probiotic extracted from korean kimchi, and tci507 (lactobacillus plantarum tci507) is a probiotic extracted from the oranges peels. these two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. therefore, we want to evaluate whether the probiotics tci308 and tci507 have effects on reduction of body weight.


Eligibility criteria:
inclusion criteria: 1. adults between the ages of 20 and 65 who are willing to sign the consent form of the subject. 2. for those with bmi ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30% 3. those who are not pregnant and are willing to cooperate with contraception during the trial period. 4. those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history). exclusion criteria: 1. pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history). 2. those who had undergone major surgery or bariatric surgery (according to medical history). 3. currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability drugs (according to medical history).
distribution of regional lung function by vibration response imaging

Conditions: Emphysema; COPD

Summary: assessment of regional contribution of different areas of the lung to its integrated function is often required, such as prior to lung resection in the presence of tumor or emphysema. this assessment is derived from the proportion of zonal radionuclear perfusion or ventilation. the investigators hypothesized that lung vri may provide an alternative approach to assess regional lung function.

patients diagnosed with moderate-to-severe copd by lung function studies and clinical evaluation presented in stable clinical condition and were evaluated by lung sound recordings and quantitative v/q lung scintigraphy. regional signals (percentage of lung sounds) for left and right lungs were compared with the corresponding regional count percentages of each radionuclide scan, by v/q scan regions of interest.

Eligibility criteria:
inclusion criteria: * patient is able to read and understand the informed consent form and he/she will provide written informed consent. * male or female in the age range of 18-85 years. * the patient will undergo v/q scan (up to one week from the vri recording) * the patient presented for evaluation of copd. * body mass index \>21. exclusion criteria: * unstable clinical status such as fever, acute shortness of breath, cough, hemoptysis, cheat pain, or acute chest illness. * chest wall deformation; * spine deformation (including severe scoliosis); * hirsutism; * potentially contagious skin lesion on the back; * skin lesion that would interfere with sensor placement; * any additional chronic lung disease of any findings such as past tuberculosis, visualized on cxr. 8. previous resection lung surgery and history of lung tumor; 9. cardiac pacemaker or implantable defibrillator

Keywords: emphysema copd lung sounds vibration response imaging
safety and efficacy of a glaucoma drug delivery system

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: the purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * man or woman 21 years of age or greater * must have open angle glaucoma or ocular hypertension. * corrected visual acuity in each eye of 20/200 or better. exclusion criteria: * previous glaucoma intraocular surgery or refractive surgery. * planned contact lens use during the study. * clinically significant ocular or systemic disease that might interfere with the study. * use of chronic corticosteroids by any route.
a perspective multicenter controlled study on application of mesenchymal stem cell(msc) to prevent rejection after renal transplantation by donation after cardiac death

Conditions: Disorder Related to Renal Transplantation; Renal Transplant Rejection

Summary: although donation after cardiac death(dcd) is the major source of renal transplantation in china, high incidence rate of rejection and delayed graft function(dgf) is existing due to the prolonged ischemia time. according to the previous single center study, mesenchymal stem cell (msc) had an effect to prevent rejection and dgf after renal transplantation, but there was no perspective multicenter controlled study to confirm it. this perspective multicenter controlled study will focus on clarifying the key role of msc applied via renal arterial or peripheral vein injection, to reduce the rejection and dgf after renal transplantation. the investigators have established gmp workshop and solid research foundation of transplant rejection. this study will provide a new reasonable way for immune induction of renal transplantation by dcd.


Eligibility criteria:
inclusion criteria: 1. study on prevention of msc to rejection after transplantation * age between 18-60 years * having the indication of renal transplantation * having no absolute contraindication * renal transplantation by donation after citizen death * the first time to receive renal transplantation * signed informed consent 2. study on treatment of msc to rejection after transplantation * renal transplantation by donation after citizen death * bpar * having no contraindication of renal biopsy * signed informed consent exclusion criteria: * loss to follow-up * serious adverse events

Keywords: renal transplantation mesenchymal stem cell transplantation rejection donation after cardiac death