Kornimate/medical-research-clean huggingface dataset:
effect of probiotics on the preterm delivery rate in pregnant women at high risk for preterm birth

Conditions: Preterm Birth

Summary: preterm birth (pb) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. despite improvements in health, pb prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. shortening of the uterine cervix in early stages of gestation is a risk factor for pb. the presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for pb. however, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the pb in high-risk pb patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% pb risk before 34 weeks, and 50% pb prior to 37 weeks (\> 6-10% pb). similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.

hypothesis * pregnant women with threatened preterm labour (tpl) will present vaginal microbiome different from those without tpl. * treatment with probiotics will modify the vaginal microbioma of pregnant women with tpl. * the pb rate before 37 weeks in pregnant women with tpl who have received probiotics since their diagnosis will be reduced by at least 30%. goals * to correlate the use of probiotics of pregnant women with tpl with the pb rate before 37 weeks. * to ascertain the pb rate before 28, 30, 32 and 34 weeks in both groups. * to assess neonatal morbidity between both groups. methods prospective, randomised, longitudinal, prospective, double-blind study. relevance this study will determine whether the use of probiotics in pregnant women with tpl is associated with a lower risk of pb before 37 weeks. if so, it would allow us to act on the tertiary prevention of pb and treatment of tpl, the main cause of perinatal morbidity and mortality in our setting. it will also facilitate understanding of the pathophysiology of pb, influence of vaginal microbiota and the mechanism of action of probiotics.

Eligibility criteria:
inclusion criteria * threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol. * single gestation. * echographically-normal foetal morphology. * minimum age 18 years. * ability to understand informed consent. * signed informed consent. exclusion criteria * multiple gestations. * pregnant women with diagnosis of chorioamnionitis. * cervical dilation.

Keywords: probiotics preterm birth threatened preterm labour
a study to evaluate the efficacy and safety of enlicitide decanoate (mk-0616, oral pcsk9 inhibitor) compared with ezetimibe or bempedoic acid or ezetimibe and bempedoic acid in adults with hypercholesterolemia (mk-0616-018) coralreef addon

Conditions: Hypercholesterolemia

Summary: the main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing ldl-c in participants with hypercholesterolemia, and to evaluate its safety and tolerability. the primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in ldl-c at week 8.


Eligibility criteria:
inclusion criteria: * has either a) history of a major atherosclerotic cardiovascular disease (ascvd) event or b) if no history of a major ascvd event, has intermediate to high risk for development of a first major ascvd event * has fasted lipid values (evaluated by the central laboratory) at visit 1 (screening) as follows: a) history of a major ascvd event with ldl-c ≥55 mg/dl (≥1.42 mmol/l) or b) no history of a major ascvd event with ldl-c ≥70 mg/dl (≥1.81 mmol/l) * is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \[llt\]) * is on a stable dose of all background llts with no planned medication or dose changes during the study * is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent exclusion criteria: * has a history of homozygous familial hypercholesterolemia (fh) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (hefh), or double hefh * has new york heart association class iv heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before visit 1 (screening) * participants with a history of tendon disorder or tendon rupture * participants with a history of gout * is undergoing or previously underwent an ldl-c apheresis program within 3 months before visit 1 (screening) or plans to initiate an ldl-c apheresis program * was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (pcsk9) inhibitors without adequate washout
a completed-cycle local audit of patient load in the sho-led ent casualty clinic

Conditions: ENT Disease

Summary: ent uk guidelines recommend booking no more than 6 patients during each 4-hour clinic session. retrospectively, the investigators counted patients booked for each clinic on ourbooking system. the second cycle showed improved compliance with guidelines.

background the investigators' centre runs a regular ent casualty clinic, run by an sho, for rapid assessment and treatment of simple, acute ent cases. ent uk guidelines from 2017 recommend that no more than 6 patients be booked for an sho to see during a 4-hour clinic session. this study aims to assess whether this centre meets those guidelines. method data was retrospectively collected from medway, the centre's networked booking system. the number of patients booked for each ent casualty clinic was counted over a period of two months. this was repeated two months after intervention to close the loop. result in the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. our intervention was to inform clinic booking staff of the guidelines. in the second cycle, 20 of 24 clinics were compliant (83%). discussion anecdotally, prior to intervention, shos would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. clinic booking staff were not previously aware of ent uk guidelines, and the number of clinic slots was set arbitrarily. this was easily and effectively resolved by educating staff. it can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.

Eligibility criteria:
inclusion criteria: * all ent casualty clinics with patients booked within the study time period exclusion criteria: * all clinics that were not staffed by an sho
study of adjuvant radiochemotherapy for gastric cancer

Conditions: Stomach Neoplasms

Summary: in 1991, the south west oncology group (swog) conducted a randomized study of adjuvant chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cgy/25 fractions) versus surgery alone for patients with completely resected gastric carcinoma. this landmark study showed the benefit of adjuvant treatment for gastric cancer and radically changed the treatment of this disease. however, the resulting standard treatment has severe acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. the investigators hope to develop a modified protocol using active chemotherapy agents, but with reduced acute toxicity. such an approach could ultimately be studied against the current swog approach to determine whether or not the addition of cisplatinum improves efficacy. patients who decide to participate in the study will receive a chemotherapy drug called 5-fluorouracil (5fu)through an intravenous catheter continuously over 12 weeks. patients will not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to carry a small pump that will deliver the medication. they will however need to make regular visits to have their medication bags changed. patients will also receive cisplatin intravenously every 2 weeks for 4 doses. in addition, patients will also receive radiation to their stomach, lymph nodes, and the area where they had their surgery. this study also comprise of a questionnaire for us to see how patient's cancer and treatment is affecting their quality of life. patients will have regular follow-up by their physicians.


Eligibility criteria:
inclusion criteria: * r0 resection (no microscopic residual) of adenocarcinoma of stomach or gastroesophageal (ge) junction, prior to starting chemotherapy and radiation * tumor must not extend more than 2 cm along the esophagus; bulk of the tumor must be in the stomach. * adequate pre-operative cross-sectional imaging (computed tomography \[ct\] or magnetic resonance imaging \[mri\]) * international union against cancer (uicc)/american joint committee on cancer (ajcc) stage ib - iv, excluding patients with metastatic disease (t1n1, t2n0 to t4n1, n2, and any t, n3). t2n0 eligible only if disease extends beyond muscularis propria. * no previous abdominal radiotherapy or contraindication to radiotherapy * eastern cooperative oncology group (ecog) performance status \< 2 * adequate major organ function * nutritional intake of at least 1500 calories per day at nutrition assessment * treatment started within 20-90 days post-op of surgery date. * informed consent exclusion criteria: * less than 70 years of age
ryan companion robot for assisting elderly people with alzheimer's disease

Conditions: Alzheimer Disease, Early Onset

Summary: the objective of this project is to conduct research and a pilot study to demonstrate the potential clinical impact and technical feasibility of a socially-assistive robot, called ryan companionbot (hereafter ryan), for life improvement and intervention of persons with early stage alzheimer's disease (ad) and ad related dementia (adrd). earlier phases of this project demonstrated the feasibility and scalability of using emotion recognition technology based on cutting-edge natural language processing and artificial intelligence technologies to improve mood and lessen depression symptoms of persons with early stage ad/adrd. in this phase, the investigators will utilize an aesthetically pleasing updated ryan (v2.0) with emotion recognition and natural language processing for enhanced conversations to address the needs of the individuals with ad/adrd and their healthcare providers as well as to test the effectiveness of ryan by comparing participants pre- and post-treatment by analyzing several blood biomarkers related to ad/adrd and depression. the investigators will recruit thirty participants from local senior living facilities based on their cognitive performance as assessed by the saint louis university mental status (slums) score. slums is commonly used as a simple screening/assessment test in senior living facilities. as part of the recruitment, the investigators will show prospective participants a video recording of a previous senior volunteer interacting with ryan to give new recruits an idea of the socially assistive robot technology.


Eligibility criteria:
inclusion criteria: * having early stage ad/adrd as assessed by the slums score (between 15-26), * verbal skill to interact, * being available for a period of 8-10 weeks to interact with ryan, * healthy individuals weighing at least 110 pounds (for safe collection of blood samples). exclusion criteria: * aggressive behavior * diagnostics of severe dementia or memory loss * acute physical illness that impairs ability to participate * during the study if a participant's mid-study slums score is less than 15 (indicating more severe dementia) and/or the phq-9 is equal to or greater than 20, the cutoff for severe depression, the researchers will remove the participant from the study * if a person is uncomfortable with blood draw, he/she is excluded from the study.
assessing the performance of lotrafilcon a lenses during a three month period

Conditions: Myopia

Summary: the purpose of this trial is to assess the performance of an investigational contact lens over a three month period.


Eligibility criteria:
inclusion criteria: * on examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses. * be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent. * be able to wear the study lenses in the available powers. * currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks of enrollment. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in an ophthalmic clinical trial. * evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * history of corneal refractive surgery. * other protocol-defined inclusion/exclusion criteria may apply.
oncoplastic partial mastectomy with intraoperative radiation therapy (iort) in early stage breast cancer patients with prior history of chest wall radiation.

Conditions: IORT-Intra-Operative Radiation Therapy

Summary: prospective, non-randomized, single-arm.the objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (iort) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. secondary objectives include evaluating effectiveness of partial mastectomy with iort, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.


Eligibility criteria:
inclusion criteria: * age ≥ 50 y.o. * histologically proven in situ and invasive ductal or lobular breast recurrence * prior history of whole breast/chest wall radiation therapy * disease span ≤ 3 cm, unifocal * no nodal disease (n0) * no evidence of metastatic disease (m0) * time from initial bct should be ≥ 1 year * patients have refused the standard of care of mastectomy * skin distance of ≥ 0.8 cm between applicator and skin exclusion criteria: * multifocal and/or multicenter recurrence * n1-3 status: regional cytological or histologically proven node recurrence * m1 status: metastatic disease * ct4 (skin or muscle involvement) or paget's disease of the nipple * patients undergoing mastectomy * patients undergoing neoadjuvant systemic therapy * connective tissue disease or scleroderma, contraindicating radiotherapy
effectiveness of kinesiotaping in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases. dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. it is a common cause of absenteeism and reduced quality of life in women. treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms. first line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. however these present side effects and some women have contraindications to these treatments. consequently, it´s necessary to study alternative treatments to drug treatments. alternative treatments like heat, massage therapy, acupuncture also are used. the kinesiotaping uses an adhesive elastic cotton tape color invented by dr. kase in the 1970s. it is water resistant and retains its properties up to 5 days. it has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. this would have the effect of reducing nociceptive stimuli.

Eligibility criteria:
inclusion criteria: * women presenting menstrual pain, 4 or more in vas. * have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea * not have been diagnosed with secondary dysmenorrhea * regular menstrual cycles (cycle typical range of 21 to 35 days) * do not use an intrauterine contraceptive device (iud) or taking oral contraceptive pills * nulliparous * ability to complete questionnaires in spanish. exclusion criteria: * women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10); * women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days); * women using an intrauterine contraceptive device (iud) or taking oral contraceptive pills. * women who suffer from diseases diagnosed added * women to which it has undergone a surgical procedure for the treatment * provide skin lesions in the abdominal wall or in lumbar region * use or abuse of drugs or alcohol

Keywords: primary dysmenorrhea kinesio taping
in vivo investigation of initial stages of enamel erosion

Conditions: Tooth Erosion

Summary: this exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. the study will use fluoride as positive control to explore the validity of this design.


Eligibility criteria:
inclusion criteria: * demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * aged at least 18 years * good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination. * absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements. * two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations. exclusion criteria: * pregnant or breast feeding women * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit * recent history (within the last year) of alcohol or other substance abuse * presence of a disease or medication which in the opinion of the investigator, will impact on assessments * gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening * surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading * daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications * any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
journey ii bcs cms total knee system compared to other ps total knee systems in pt setting

Conditions: Osteoarthritis; Degenerative Arthritis; Traumatic Arthritis

Summary: the primary objective of the study is to determine how the short-term outcome of subjects implanted with the journey™ ii bcs total knee system compares to subjects implanted with other ps total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer. to address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.


Eligibility criteria:
inclusion criteria: * undergone unilateral primary total knee replacement with a journey™ ii bcs total knee system or other non-smith \& nephew posterior stabilized knee system * will be initiating outpatient pt ≤ 7 days post-operatively * has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis * has pre-operative rom ≥ 90° * is skeletally mature in the pi judgment * is 21 years of age of older * is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires * has consented to participate in the study by signing the irb/ec approved informed consent for the study * agrees to follow post- operative physical therapy program exclusion criteria: * significant preoperative varus or valgus deformities (\>15º) * has received a constrained or deep dish tibial insert * morbid obesity (bmi \> 40) * has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit * other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection * fibromyalgia requiring treatment * current or impending incarceration or is a prisoner * in the opinion of the pi has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse * is known to be at risk for lost to follow-up, or failure to return for scheduled visits * undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement * requires a legally authorized representative to consent to the study

Keywords: posterior stabilized knee total knee arthroscopy journey ii bcs