Kornimate/medical-research-clean huggingface dataset:
a phase 2b study evaluating the safety and efficacy of ar-15512 ophthalmic solution for the treatment of dry eye disease

Conditions: Dry Eye Disease

Summary: this is a phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. all subjects enrolled will have dry eye disease. the study consists of screening and baseline visits to determine eligibility, followed by efficacy assessments at day 14 (visit 3), 28 (visit 4) and 84 (visit 5/study exit). safety will be assessed at all study visits.

at the end of the screening visit, all qualified subjects will be assigned to administer ar-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). after the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of dry eye disease (ded). subjects who requalify based on inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to receive ar-15512 0.0014% (lower dose), ar-15512 0.003% (higher dose) or ar-15512 vehicle administered as 1 drop in each eye twice daily for 84 days. this study will utilize a controlled adverse environment (cae) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. subjects will be exposed to the cae for approximately 90 minutes during each cae visit. subjects will be exposed to the cae at the screening and baseline visits as well as on day 28 (visit 4) and day 84 (visit 5). efficacy endpoints will be evaluated pre- and post- exposure to the cae. aerie pharmaceuticals was acquired by alcon on november 22, 2022.

Eligibility criteria:
key inclusion criteria: * previous history of dry eye disease (ded) within the previous 6 months; * have used and/or desired to use artificial tears for ded symptoms within 2 months prior to the screening visit; * signs and symptoms of ded at the screening and baseline visits; * best corrected visual acuity (bcva) of 20/200 (+0.70 logmar) or better in both eyes at both the screening and baseline visits; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * history or presence of any ocular disorder or condition (other than ded) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety; * current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation; * use of contact lenses in either eye within 7 days prior to the screening visit or planned use during the study; * regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the screening visit; * positive pregnancy test at screening or baseline visits or currently breastfeeding. * other protocol-specified exclusion criteria may apply.
calcium carbonate to augment labor contractions

Conditions: Labor Dystocia; Labor Induction; Labor Augmentation

Summary: the investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.

this study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process. the study aims to find if the use of calcium carbonate will lead to better labor contractions and increase the percentage of vaginal deliveries and improve delivery outcomes.

Eligibility criteria:
inclusion criteria: * 18 years or older * nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation) * gestational age above 36 weeks, at enrollment * present for induction or augmentation of labor inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of labor after cesarean * singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable) * ability to give informed consent * planned to undergo initiation of oxytocin infusion by their maternity care provider exclusion criteria: * unable to understand or read english * presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment * non-vertex presenting fetus at enrollment * planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy) * multi-fetal gestation (twins, triplets, and higher order multiples) * known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity. * deliveries with fetal chronic and/or pregnancy-related conditions, iufd (intra uterine fetal death) or premature \&lt; 36 weeks of gestation. * major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission) * suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission) * known severe fetal growth restriction (estimated fetal weight \&lt;3rd percentile) or abnormal umbilical artery doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission) * participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality * known allergic reactions to synthetic oxytocin intravenous solution or to calcium carbonate * significantly impaired consciousness or executive function (e.g., intubated or sedated) * patients treated with calcium channel blockers such as nifedipine or magnesium. * chronic renal failure and hyperphosphatemia. * inability to tolerate oral intake (i.e., nausea/vomiting)

Keywords: labor pregnancy labor augmentation calcium carbonate labor induction
to investigate the cumulative live birth rates using gnrh antagonist or agonist protocol for cos in art treatment

Conditions: Sterility

Summary: this is a phase iv, prospective, randomized controlled study to investigate the cumulative live birth rates (clbrs) of gonadotrophin-releasing hormone (gnrh) antagonist protocol (gnrh-ant group) compared with the standard gnrh agonist long protocol (gnrh-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

this is a phase iv, prospective, randomized controlled study to investigate the cumulative live birth rates (clbrs) of gonadotrophin-releasing hormone (gnrh) antagonist protocol (gnrh-ant group) compared with the standard gnrh agonist long protocol (gnrh-a group) for controlled ovarian stimulation in supposed normal ovarian responders. in this study, patients who are planning to undergo ivf/icsi cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. approximately 888 patients will be enrolled at approximately 5 centers in china over a period of 10 months. about 12-20 visits will be performed in this study for each patient. the clbr with first live birth resulting from one initiated cos cycle will be compared between gnrh-a group and gnrh-ant group.

Eligibility criteria:
inclusion criteria: * infertile women planning to undergo ivf/icsi cycle using conventional gnrh agonist long protocol or gnrh antagonist protocol * age ≤ 38 years old * basal afc 8\~20 * basal fsh≤10 iu/l * basal e 2 \<200pmol/l * normal uterus and at least one side of the normal ovary * informed consent form signed * willing to follow the study protocol, and able to complete this study exclusion criteria: * previous ivf/icsi cycles \>2 * severe hydro-salpinx (ultrasound shows hydro salpinx﹥2cm) * severe endometriosis (grade iii - iv) * polycystic ovarian syndrome (pcos) * history of recurrent miscarriages (\>2 times of miscarriages) * plan to undergo ovarian stimulation for preimplantation genetic diagnosis or preimplantation genetic screening, oocyte donation, and social or medical freezing of oocytes * any major systemic disease that as per investigator's discretion precludes subject for participation in the study * with pregnancy contraindications * alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease * according to the judgment of the investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications * simultaneous participation in another clinical study * plan to use urinary gonadotrophin during cos treatment

Keywords: assisted reproductive technology live birth fertilization
assessment of three formulations of the candidate vaccine ama 1 in healthy dutch adult volunteers

Conditions: Plasmodium Falciparum Malaria

Summary: the objective of this study was to evaluate the safety of a candidate malaria vaccine (pfama-1) at 3 doses given at monthly intervals of 2 different dosages of ama-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or as02a or montanide isa 720 in healthy adults not previously exposed to the parasite plasmodium falciparum.


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 45 years healthy volunteers. * general good health based on history and clinical examination. * all volunteers have to sign the informed consent form. * negative pregnancy test. * use of adequate contraception for females up to three months after the third injection (d140). * reachable by phone during the whole study period (18 months). exclusion criteria: * history of malaria or residence in malaria endemic areas within the past six months. * positive serology for malaria antigen pfama-1 * previously participated in any malaria vaccine study * symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers. * any laboratory abnormalities on screened blood samples beyond the normal range, as defined at umc st radboud. positive hiv, hbv or hcv tests. * volunteers should not be enrolled in any other clinical trial during the whole trial period. * volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period. * pregnant or lactating women. * volunteers unable to give written informed consent. * volunteers unable to be closely followed for social, geographic or psychological reasons. * previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrollment in the study. * volunteers should not perform exercise four hours before blood draw and should not donate blood for non study-related purposes during the entire duration of the study. * known hypersensitivity to any of the vaccine components (adjuvant or peptide). * volunteers are not allowed to receive any vaccination or gammaglobulin during a period three months prior to the first immunization and up to six months after the 3rd immunization. if a vaccination is necessary during this period, the volunteer will be withdrawn from the study. * volunteers are not allowed to travel to malaria endemic countries during the study period.
evaluating the efficacy of resveratrol containing mouthwash as adjunct treatment periodontitis:

Conditions: Periodontitis

Summary: to evaluate the effectiveness of resveratrol mouthwash as adjunct to nsp treatment of periodontitis

* measuring and comparing the efficacy of rv mouth wash in comparison with chx and placebo mouth wash in improving the clinical periodontal parameters; * measuring the salivary cytokines (il-6) before and after 4weeks of the use of rv mouth wash as adjunct to nsp treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay. * measuring the salivary rankl before and after 4weeks of the use of rv mouth wash as adjunct to nsp treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay. * correlate the salivary cytokines il-6 and salivary rankl with clinical periodontal parameter and with each other. * evaluate the intervention by using visual analog scale (vas)- score-based questionnaire will be filled out by each participant at the end of the trial.

Eligibility criteria:
inclusion criteria: - the inclusion criteria: 1. participants need to be systemically healthy with age \> 18 years old. 2. not taking antibiotic and anti-inflammatory drugs in the last three months. 3. at least 20 teeth should be present 4. should have unstable periodontitis (ppd ≥ 5 or bop at 4mm pocket) the exclusion criteria: 1. patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances) 2. those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women. 3. those currently using any mouthwash. 4. those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study. 5. those having a history of hypersensitivity to any product used in the present study. 6. those who are smokers or alcoholics. 7. those who refuse to participate in the trial. -

Keywords: mouthwash periodontitis resveratrol
the risk for clostridium difficile colitis during hospitalization in asymptomatic carriers

Conditions: Clostridium Difficile; Colitis

Summary: the investigators hypothesize that development of symptoms characteristic of clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.


Eligibility criteria:
inclusion criteria: * history of hospitalization in recent year, residence of a nursing home or institutions * expected more than 48 hours hospitalization exclusion criteria: * colitis/ diarrhea * rectal swab performed ≥48 hrs post arrival to hospital.

Keywords: asymptomatic carriage colonization clostridium difficile colitis rectal swab
pragmatic weight loss intervention during menopause

Conditions: Menopause; Menopause Related Conditions

Summary: the investigators are using a community-based participatory research (cbpr) model to develop a lifestyle intervention targeting weight loss that is specifically tailored to women in perimenopause.

this is a participatory research study which will enroll women (n of up to 56) with experience of menopause to help identify preferred strategies (modalities) for weight loss, which will combine calorie (dietary) restriction and exercise tactics. aim 1: explore attitudes and perceptions about weight gain during the menopause transition, and identify weight loss strategies from the patient (peer) perspective. - the investigators will apply these learnings: 1) to understand barriers for weight management during menopause; 2) to establish strategies to guide retention; 3) to finalize the intervention structure, including feedback on the frequency and duration of the study visits; and 4) to gather feedback on menopause-specific education resources set to be provided throughout the intervention. aim 2: engage the community advisory board (cab) of the louisiana clinical and translational center (la cats) to understand scalability and community-based implementation of an intervention tailored for women in perimenopause. - the investigators will then utilize the louisiana clinical \& translational science center (la cats) community advisory board (cab) to help us tailor a lifestyle intervention in perimenopausal women with emphasis on scalability and community-based implementation using learnings obtained from the focus groups.

Eligibility criteria:
inclusion criteria: * age 45 to 60 years * currently experiencing (or have experienced) the one of the following menopause-related traits: * vasomotor symptoms including hot flashes and/or night sweats * irregular menstrual cycle * african-american (black) or caucasian (white) race * self-report having a desire to lose (or maintain) weight during menopause * willing to be recorded during the focus group for transcription purposes exclusion criteria: * are pre-menopausal * non-english speaking
evaluation of bladder volumes in patients receiving radiotherapy to the rectum, using kilovoltage cone-beam imaging

Conditions: Rectal Cancer

Summary: the purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.


Eligibility criteria:
inclusion criteria: * patients receiving radical radiotherapy to rectal malignancies. * age \> 18 years old * no previous lower gi radiotherapy * written informed consent according to good clinical practice (gcp) and national / local regulations. exclusion criteria: * patients receiving palliative radiotherapy to rectal malignancies. * patients receiving radical short course preoperative radiotherapy for rectal malignancies. * patients unable to give informed consent.
dose-finding study of asp2151 in subjects with herpes zoster

Conditions: Herpes Zoster

Summary: to investigate the efficacy and safety of three different doses of asp2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.


Eligibility criteria:
inclusion criteria: * subjects aged from 20 years to under 80 years on the day informed consent is obtained * subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster * subjects in whom protocol-specified observations and assessments are considered possible exclusion criteria: * subjects with extremely compromised immune function due to underlying diseases, treatment with immunosuppressive agents etc., or radiotherapy * subjects with a serious underlying disease that corresponds to grade 3 in the classification criteria for teh seriousness of adverse drug reactions * subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years

Keywords: valacyclovir hydrochloride herpes zoster asp2151
ebl versus ebl and propranolol for the prevention of variceal rebleeding in pts with previous variceal treatment

Conditions: Cirrhosis; Variceal Bleeding

Summary: this study is performed to compare the efficacy and safety of ebl alone and ebl combined with propranolol in patients who were previously performed endoscopic variceal treatment.

both propranolol and endoscopic band ligation (ebl) are effective for prevention of variceal rebleeding. recently several studies compared the efficacy of ebl alone and with a combination of propranolol and ebl. however, the results of recent studies showed discrepancy. in addition, most of all recent studies included patients without previous endoscopic treatment for varices. this study is performed to compare the efficacy and safety of ebl alone and ebl combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * age between 18 and 70 years * successful control of esophageal variceal bleeding within 6 weeks before enrollment exclusion criteria: * gastric variceal bleeding * patients with systolic blood pressure \<100 mmhg or basal heart rate \<60/min * portal vein thrombosis * prominent hepatic encephalopathy * coexisting untreated malignancy * severe cerebrovascular or cardiovascular disease, renal failure * no previous history of endoscopic, radiologic, or surgical treatment for varices or ascites * contraindication to beta-blocker * pregnancy * refusal to give consent to participate in the trial

Keywords: cirrhosis esophagus disorders varicose veins
a randomised controlled trial of hysteroscopic resection of mild septum/arcuate uteri.

Conditions: Arcuate Uterus

Summary: at least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3d-tvs) and hysteroscopy, will be recruited. the subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. the pregnancy rates (\>12 weeks) of the two groups will befollowed and compared.

this study will be carried out at the hysteroscopy center of the fuxing hospital, beijing, china. at least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. the patients will be explained the study and sign the informed consent. according to the random number table, the corresponding cases were divided into treatment group and control group. the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. the follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.

Eligibility criteria:
inclusion criteria: 1. women with arcuate/mild septum uteri 2. women with unexplained recurrent miscarriage (less than 12 weeks) 3. having a second time fertility requirement 4. having informed consent before entering this study, and be willing to receive hysteroscopic treatment exclusion criteria: 1. 3d-tvs and hysteroscopy suggest uterine fibroids (submucosal and iii type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion 2. endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer 3. ultrasound or hsg suggest hydrosalpinx 4. chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage 5. semen abnormality in male 6. fsh \> 10
dip home-based dipstick analyzer performance evaluation

Conditions: Urine Detectable Acute and Chronic Diseases

Summary: the dip home-based dipstick analyzer (henceforth hbda) is composed of a kit and a smartphone application. the device will be provided to the subject in a simulated home-use environment. all subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the color-board. the user will also complete a questionnaire to collect information regarding the use of the hbda device. following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. the use of the hbda device will be evaluated for accuracy and identified risks. additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility criteria:
inclusion criteria: * men and women 18-80 years of age * subjects who are healthy or pregnant; or * subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, ph, protein, urobilinogen, leukocytes, and nitrite * subject is capable and willing to provide informed consent. * subject has facility with both hands. * subject is capable and willing to adhere to the study procedures