Kornimate/medical-research-clean huggingface dataset:
prophylactic cervical cerclage in twin pregnancies with non-shortened cervix

Conditions: Preterm Birth; Twin Pregnancy, Antepartum Condition or Complication; Cervical Cerclage

Summary: this randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. ten percent of all twin births take place before 32 weeks of gestation.1 preterm births are responsible for more than 70% of all neonatal and infant deaths.2 prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced iq, and cerebral palsy. a cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. use of cerclage in twin pregnancies is controversial. some experts claim that placing a cervical cerclage could increase the risk of preterm births5, fuchs and senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of ptb. this conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 available meta-analytic data remained of limited value in view of the few and small clinical studies that were included. although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the us standard certificate of live birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 such practice is still in need for further validation by well-structured and powered randomized controlled trials.

Eligibility criteria:
inclusion criteria: * age between 18-50 years. * dichorionic twins. * history of ≥1 preterm birth. * transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age. * asymptomatic. exclusion criteria: * triplets and quadruplets. * monochorionic twins. * threatened/ inevitable miscarriage * bulging membranes through the external os. * extremes of age. * major fetal anomalies. * known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc. * fetal demise. * fetal reduction in the current pregnancy.
a clinical study of cht102 in msln-positive advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancers

Summary: evaluate the safety and efficacy of mesothelin-targeting ucar-t cells in the treatment of mesothelin-positive advanced pancreatic cancer

3 planned dose cohorts will be evaluated during dose escalation phase. the dose expansion will be initiated after src (safety review committee) review the avaliable safety, pk and preliminary efficacy data.

Eligibility criteria:
inclusion criteria: 1. ability to understand and sign a written informed consent documen； 2. at the date of signing icf, 18 \~70 years old, male or female； 3. histopathological confirmed advanced or metastatic pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment； 4. positive mesothelin expression; 5. at least one measurable lesion at baseline per recist version 1.1； 6. the expected survival time is more than 12 weeks; 7. ecog 0-1 points; 8. adequate organ functions.

Keywords: allogeneic car-t safety efficacy pk
the effects of red wine polyphenols on microvascular dysfunction

Conditions: Obesity

Summary: rationale: epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. in addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. experimental studies with mixed or separate red wine polyphenols (rwps) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. moreover, rwps have shown to improve endothelial no-mediated relaxation using the same pi3-kinase/akt pathway as does insulin. however, data in humans are remarkably scarce objective: to study effects of rwps on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness. study design: randomized controlled trial (double blind). study population: obese (bmi \>30); n=30, men or women, aged 18-60 years. intervention: mixed rwp 600mg/day or matching placebo for a total duration of 8 weeks.


Eligibility criteria:
inclusion criteria: * caucasian * age 18-60 years * obese (bmi \>30) exclusion criteria: * cardiovascular disease * smoking * diabetes mellitus * recent history (\ 4 u/day * use of medication potentially affection insulin sensitivity or microvascular function * pregnancy
a phase 1 study of the safety and pharmacokinetics of ags-8m4 in subjects with advanced ovarian cancer

Conditions: Carcinoma; Ovarian Cancer; Ovarian Diseases; Ovarian Neoplasms

Summary: this is the first in human study of ags-8m4 given every 2 weeks to subjects with advanced ovarian cancer. ags-8m4 will be administered as an iv infusion until the disease worsens.

all subjects will receive ags-8m4 treatment. subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. a disease assessment will be performed at study week 9 (+/- 3 days). the assessment will be based on clinical signs and symptoms, changes in radiographic images, and changes in ca-125 levels. subjects without evidence of disease progression may continue to receive ags-8m4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression intolerability of ags-8m4 or consent withdrawal. for subjects that continue dosing, disease assessments will be performed every 8 weeks during the extended treatment period. a safety follow-up visit will occur 4 weeks after the last infusion of ags-8m4.

Eligibility criteria:
inclusion criteria: * subjects with recurrent disease or histologically or cytologically confirmed stage iii/iv diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma * subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime exclusion criteria: * no epithelial ovarian tumors of low malignant potential * active infection requiring treatment with systemic anti-infectives within 72 hours of screening * use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer) * prior monoclonal antibody therapy

Keywords: clinical trial, phase 1 carcinoma pharmacokinetics safety ovarian
the effect of intraurethral lidocaine gel on pain perception during flexible cystoscopy

Conditions: Flexible Cystoscopy

Summary: flexible cystoscopy is routinely performed by urologists. many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy. in this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.


Eligibility criteria:
inclusion criteria: * men 18 - 80 years * given indication for flexible cystoscopy * written informed consent exclusion criteria: * allergy to amid anesthetics * urinary tract infection * use of analgesics in the previous 24 hours and chronic intake of analgesics * dementia * presence of a sensory disorder such as or spinal cord injury * indwelling catheter carrier
the effect of lamina-g on gastrointestinal symptom after gastric biopsy

Conditions: Gastrointestinal Symptom

Summary: sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy and biopsy. the aim of this study is to investigate the effect of sodium alginate (lamina-g®) on biopsy-related gastrointestinal symptom.

this study is an open labeled, single-center randomized controlled trials. patients who underwent upper enoscopy with biopsy were randomly assigned to medication and control group. in the medication group, sodium alginate was administered after egd during 3 days. all patients underwent a questionnaire to check the presence of gastrointestinal symptoms at baseline and on the day after return home. after 3 days, gastrointestinal symptoms were investigated by telephone survey. gastrointestinal symptom was scaled by upper gastrointestinal symptom rate score (gsrs). upper gsrs contains 8 items and 3 scales; abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom (heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).

Eligibility criteria:
inclusion criteria: age from 18 to 80 years persons who assigned on the written consent for the clinical trial. persons who underwent upper endoscopy and gastric biopsy exclusion criteria: gastrectomy severe cardiovascular, pulmonary, or endocrine disease renal or hepatic dysfunction hematologic disease gastric cancer active peptic ulcer user of proton pump inhibitor, h2 blocker, mucoprotectant immediate significant bleeding after biopsy pregnant women allergy history for sodium alginate
pemetrexed plus gemcitabine for patients with locally advanced or metastatic nsclc who have not had previous chemotherapy.

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purposes of this study are to determine: 1. the safety of pemetrexed plus gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. whether pemetrexed plus gemcitabine can help patients with non-small cell lung cancer live longer. 3. whether pemetrexed plus gemcitabine can make the tumor smaller or disappear, and for how long. 4. to see if patients feel better while taking pemetrexed plus gemcitabine.


Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer that can be treated with chemotherapy * have received no prior chemotherapy for non-small cell lung cancer * have at least one measurable lesion * have an adequate performance status * sign an informed consent exclusion criteria: * a female who is pregnant or breastfeeding * treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed * treatment with radiation therapy within the last 1-2 weeks * brain metastasis that is uncontrolled * active infection or other serious condition
using technology to improve eating disorders treatment

Conditions: Eating Disorders

Summary: the purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of students report receiving treatment. inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. over the past 20 years, we have developed a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the eating disorder risk and diagnostic spectrum, using minimal person-based resources. the newest intervention in our suite of programs, student bodies-eating disorders (sb-ed), has not yet been tested in a large-scale trial or via platform delivery. the aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, sb-ed, yields measurable and significant improvements in access, costs, and outcomes for eating disorder treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center). twenty-eight colleges will be randomly assigned to receive either sb-ed or referral to usual care. we will enroll at least 650 students from these campuses who screen positive for a dsm-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants more intensive medical monitoring). outcomes will be measured at 6-months, 1-year, and 2-years following the completion of the online screen.

Eligibility criteria:
inclusion criteria: * student at a participating college or university ages 18-30 * screen positive for dsm-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder exclusion criteria: * screen positive for dsm-5 anorexia nervosa * no access to the internet * acutely suicidal
the influence of bisphosphonates in the oral cavity in children

Conditions: Oral Cavity; Osteomyelitis; Necrosis of the Jaws

Summary: the use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. there is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates. osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients. to our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity. aim of the study: to examine the influence in the oral cavity of bisphosphonate in children

the use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. there is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates. osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients. to our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity aim of the study: to examine the influence in the oral cavity of bisphosphonate in children materials and methods population: 50 children treated with bisphosphonate will be included in the study. the following data will be recorded: 1. age, gender, initial disease, age at diagnosis, additional diseases 2. duration and dosage of the bisphosphonate medication (kind of bisphosphonate, age at the beginning of the drug treatment, duration of treatment, frequency of intake, additional medications) 3. clinical dental examination was performed for detection of; caries, gingival inflammation and oral hygiene, sequence of dental eruption, teeth extractions, and presence of exposure bone. 4. unstimulated whole saliva was collected using the spitting method as previously described. sialochemistry analysis will be performed. 5. serum analysis findings including: calcium (ca), phosphorous (p), alkaline phosphatase (alp) and parathyroid hormone (pth),vitamin d cross-linked telopeptides (ctx, ntx), bone density. (these examination are performed routinely, in these patients, as part of medical follow up.

Eligibility criteria:
inclusion criteria: * children treated with bisphosphonate

Keywords: bisphosphonates children dental osteomyelitis medication
temperature and healing in treatment of gingival enlargement

Conditions: Gingival Enlargement

Summary: aim: gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. the aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy techniques including er:yag laser, nd:yag laser, electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival enlargements. material and method: a split-mouth designed study was conducted on 37 systemically healthy patients consisting of 19 females and 18 males, who had gingival enlargement areas on the left and right of maxillary and mandibular anterior regions. gingival crevicular fluid (gcf) samples were collected, clinical periodontal parameters and gingival temperature levels were recorded at baseline and in the postoperative period. the gingival temperature was measured during surgical procedures. gingival temperature and epithelization levels in 3rd, 7th, 10th and 15th days; gcf levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours and between 1st-7th days of post-operative healing process were evaluated.


Eligibility criteria:
inclusion criteria: * systemically healthy individuals * the existence of at least 20 functioning teeth, the existence of chronic inflammatory gingival enlargement in anterior quadrants. exclusion criteria: * pregnancy/lactation * drug use, previous periodontal therapy within 6 months * previous antibiotic use within 6 months, smoking * the existence of attachment/bone loss. .

Keywords: gingival enlargement, er:yag, nd:yag, electrosurgery
early access program for alxn1840 in patients with wilson disease

Conditions: Wilson Disease

Summary: this is an open-label, single-arm, multi-center eap, designed to provide early access to alxn1840 for eligible patients with wd.

to provide access to alxn1840 treatment, an investigational medicinal product (imp) that has not yet been granted marketing authorization, to participants who complete studies alxn1840-wd-205, wtx101-301, or alxn1840-wd-302, or other studies with alxn1840 who, in the opinion of the treating physician, may benefit from continued treatment with alxn1840, and who meet the eligibility criteria described in this protocol.

Eligibility criteria:
inclusion criteria: 1. ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with alxn1840. 2. confirmed diagnosis of wd. 3. has completed one of the following alxn1840 clinical studies: 1. alxn1840-wd-205 2. wtx101-301 3. alxn1840-wd-302 4. other alxn1840 studies 4. in the treating physician's medical opinion, the potential benefits of treatment with alxn1840 outweigh the potential risks for the participant. 5. participant or legal representative provided informed consent/assent to be treated with alxn1840 through this eap. 6. female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance. exclusion criteria: 1. eligible for and able to participate in an alexion-sponsored study of alxn1840. 2. unwilling or unable to comply with the treating physician's treatment plan related to this eap for any reason. 3. has decompensated hepatic cirrhosis. 4. model for end-stage liver disease (meld) score \> 13. 5. modified nazer score \> 7. 6. end-stage renal disease on dialysis (chronic kidney disease stage 5 \[ckd 5\]) or creatinine clearance \< 30 ml/min. 7. known hypersensitivity to alxn1840, alxn1840 excipients, or any of the ingredients contained in alxn1840. 8. women who are nursing or pregnant (or women who are planning to become pregnant during treatment with alxn1840).

Keywords: wilson disease alxn1840
a safety, tolerability and preliminary efficacy study of bbi-4000 in subjects with axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of bbi-4000 when topically applied to subjects with axillary hyperhidrosis.

this is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied bbi-4000 for 14 days. safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology). efficacy will be assessed though the gravimetrically measured sweat production and the hyperhidrosis disease severity score (hdss). pharmacokinetic information will also be collected.

Eligibility criteria:
inclusion criteria: * male or female subjects from 18 to 45 years of age in good general health. * primary axillary hyperhidrosis of at least 6 months duration. * hyperhidrosis disease severity score (hdss) of 3 or 4 at baseline. * gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period. * use of a medically appropriate contraceptive method. exclusion criteria: * prior axillary use of botulinum toxin within 2 years of study entry. * prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry. * prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason. * use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis. * history of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities. * known condition that may cause hyperhidrosis. * use of an investigational drug within 30 days prior to entry into this study.
tampa associating microwave liver ablation with portal vein ligation for staged hepatectomy (tamlaps)

Conditions: Liver Cancer; Liver Tumor; Hepatocellular Carcinoma; Hilar Cholangiocarcinoma

Summary: this is a study following the outcomes and survival of patients undergoing the tamlaps hepatectomy at florida hospital tampa by dr. iswanto sucandy


Eligibility criteria:
inclusion criteria * patients scheduled to undergo the tamlaps procedure by dr. iswanto sucandy. exclusion criteria: * subjects with history of noncompliance. * subjects with physical health, substance abuse, or mental health problems that will limit the subject's ability to meet study requirements