Kornimate/medical-research-clean huggingface dataset:
clinical efficacy and safety of using 3.0mg liraglutide to treat weight regain after roux-en-y gastric bypass surgery

Conditions: Obesity

Summary: this is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following roux-en-y gastric bypass (rygb) who are experiencing weight regain. this study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, hba1c, and waist circumference) and quality of life (as assessed by phq-9 (patient health questionnaire), versus placebo in patients at least 18 months following rygb who are experiencing weight regain as well as the safety of liraglutide in this patient population.

the specific aims of this study are to: * to evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following rygb. * to evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following rygb. * to evaluate the safety of liraglutide in post-rygb subjects. * to evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following rygb.

Eligibility criteria:
inclusion criteria: * ≥18 months status-post rygb * bmi 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition * bmi 30 kg/m2 or greater * regain of ≥10% of maximum tbwl post-rygb * ability to provide informed consent before any trial-related activities * express willingness to follow protocol requirements exclusion criteria: * pregnancy at time of enrollment * intention of becoming pregnant or breast feeding in the next 12 months * females of childbearing potential who are not using adequate contraceptive methods * presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol * presence of biliary disease * known or suspected allergy to liraglutide or any product components * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * history of pancreatitis * history of alcoholism * history of type 1 dm (diabetes mellitus) * history of previous bariatric surgery other than rygb except h/o lagb and band removal. * \>10 years status-post rygb * \< 25% tbwl at post-rygb weight nadir * \>50% post-operative tbwl at time of screening * simultaneous use of any weight loss medications * use of insulin at the time of enrollment * current use of any glp-1 agonist medication * history of taking any glp-1 agonist medication * participation in another ongoing clinical study * conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study

Keywords: roux-en-y gastric bypass (rygb)
a study of th-sc01 in the treatment of radiation-induced rectal injury

Conditions: Rectal Injury

Summary: the purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.

radiation-induced rectal injury (rri) is a common clinical disease. the symptoms of rri often include: abdominal pain, diarrhea, hematochezia, etc., especially chronic radiation-induced late rectal injury (rlri), are easy to cause the disease to prolong and not heal. some patients will have severe complications such as massive rectal bleeding, rectal stenosis, intestinal obstruction, deep ulcer, intestinal perforation, and fistula formation after the disease progresses to the advanced stage, most of which occur 2-5 years after the end of radiotherapy. the incidence of radiation rectal injury is high, which has a serious impact on the health and quality of life of patients. currently, the commonly used treatment methods include non-steroidal anti-inflammatory drugs, mucosal protective agents, hemostatic agents, compound enema preparations, hyperbaric oxygen, surgical treatment, etc., but there is still no standard treatment strategy and effective plan, and clinical treatment is extremely difficult. mesenchymal stem cells have the properties of proliferation, differentiation, immune regulation and angiogenesis. there are few clinical studies on the use of mesenchymal stem cells in the treatment of radiation-induced rectal injury. good therapeutic effect was achieved in vivo and in vitro in the preliminary experiment. the aim of this study was to verify the safety and efficacy of allogeneic mesenchymal stem cells from healthy donors in rri patients. primary objective: to assess the safety (incidence of treatment emergent adverse-events) of th-sc01.

Eligibility criteria:
inclusion criteria: 1. fully understand and sign the informed consent form; 2. age ≥18 years and \<80 years; 3. patients diagnosed with chronic radiation rectal injury after radiation therapy; 4. patients with lent-soma scale score ≥1; 5. good physical condition (who functional status score 0-1). exclusion criteria: 1. the patient had severe liver and kidney disease; 2. severe congestive heart failure or coronary heart disease; 3. patients have allergic constitutions or severe systemic immune diseases; 4. the patient had active gastrointestinal hemorrhage or acute intestinal obstruction; 5. patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
enhancement of circadian rhythms in icu patients through light intervention

Conditions: Circadian Dysrhythmia

Summary: the investigators will examine the effects of dynamic light therapy on circadian rhythms in intensive care unit (icu) patients. in a randomized controlled trial (rct), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.


Eligibility criteria:
inclusion criteria: * patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit * male and female patients with age ≥ 18 years * expected intensive care unit stay ≥ 2 days exclusion criteria: * participation in other clinical studies during the study period and ten days before * previous icu treatment during the current hospital stay * patients with psychiatric diseases * patients with a history of stroke and known severe residual cognitive deficits * patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay * analphabetism * anacusis or hypoacusis with hearing aid device, * amaurosis * accommodation in an institution due to an official or judicial order * history of sleep-related breathing disorders * history or suspicion of hypoxic brain damage * history or suspicion of elevated intracranial pressure in the last 7 days before study inclusion * patients with an open chest after cardiac surgery * patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial * the informed consent of the patient or the subject's legally acceptable representative can't be obtained in time * history of photoallergic reactions or history of visually triggered seizures * severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light * patients with liver cirrhosis * patients with a probability of survival \<24h * optic neuritis within the last 3 months * travel across two time zones within 3 months prior to study screening * women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial
high protein intake to decrease emesis and promote patient satisfaction in labor

Conditions: Emesis

Summary: the purpose of our study is to determine if the incidence of emesis can be lowered with the addition of a high protein drink during labor. emesis and nausea are the leading causes of parturient dissatisfaction, results in a delay of returning to normal, daily living and can hugely impact the mother's postpartum experience. to date, no studies have been done on the relationship of protein intake during labor and incidence of emesis. to the best of our knowledge, the use of a high protein drink during labor has not been evaluated in the literature.

the investigators plan to enroll women (n=150) who requested epidural anesthesia for labor. after placement of their labor epidural catheter, parturients will be randomized by a computer generated number table into one of two groups. group p - high protein drink with 30 grams of protein and ice chips prn, or group c - control group consisting of ice chips prn. the protein drink that will be used is premier nutrition protein shake, which contains 30 grams of protein in 11 ounces. measured variables will include; nausea and emesis at epidural placement, at hourly intervals until delivery, and 1 hour post delivery. nausea will be evaluated using a visual analog scale (vas); 0 = no nausea and 10 = worst nausea ever. episodes of emesis will be recorded as (yes/no). the parturient will be seen the day following delivery and evaluated for overall patient satisfaction. parturients will rate their satisfaction level using a scale from 0-100 with 0=not satisfied and 100=very satisfied. the investigators believe that the incidence of emesis will be decreased in parturients who receive high protein intake during labor, and overall patient satisfaction will be increased.

Eligibility criteria:
inclusion criteria: all women of childbearing age who request labor epidural analgesia, ≤ 5cm cervical dilatation at the time of epidural insertion, \> 36 weeks gestation, singleton pregnancy, vertex presentation, and npo more than 4 hours prior to epidural insertion. both nulliparous and multiparous women will be included. minors under the age of 18 years will be included and a separate informed consent will be presented to these individuals. exclusion criteria: women with diabetes (at increased risk for gastroparesis and fetal macrosomia), multiple gestation, non-vertex fetal presentation, chronic opioid use (delayed gastric emptying), history of gastric bypass surgery (abnormal anatomical stomach), severe morbid obesity (bmi \> 40kg/m2 due to increased intragastric pressure), and history of known obstetric or medical complication (i.e. preeclampsia) that may increase the likelihood of a complicated or operative delivery (i.e. cesarean section).

Keywords: emesis nausea
hydroxychloroquine may be beneficial for preeclampsia

Conditions: Pre-Eclampsia

Summary: the purpose of this research is to investigate the impact of hydroxychloroquine on the incidence of hypertensive pregnancy disorders in women with a history of recurrent spontaneous abortion (rsa).

preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000 maternal deaths annually, remaining an important cause of death and complications for the mother and baby. however, no treatment yet has been found that affects disease progression except for termination of pregnancy which may cause iatrogenic preterm labor. therefore, keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed. hydroxychloroquine (hcq), an antimalarial drug, is commonly used in the treatment of pregnant women with rsa and has proven to be safe for both the mother and the fetus. because of the antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of hcq, it has been thought to be beneficial in the prevention of preeclampsia. therefore, we conducted a retrospective cohort study to evaluate the impact of hcq treatment on the prevention of preeclampsia in rsa pregnancies.

Eligibility criteria:
inclusion criteria: 1. singleton pregnant women 2. with a history of two or more miscarriages exclusion criteria: 1. indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, malignancy, 2. major malformation of the fetus diagnosed at 11-13 weeks of gestation. 3. known paternal, maternal, or embryo chromosome abnormality; 4. abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain rm in the first trimester of pregnancy; 5. maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.
food-for-families: experimental grocery store study

Conditions: Overweight; Obesity

Summary: this is a study about how the price of foods affects buying choices at the grocery store. the price of foods can have a big impact on what people choose to buy and prices change over time. this study is being done to see how changes in food prices affect what mothers choose for their families.

it is well known that the price of a given food affects the amount of that item individuals will purchase. yet little is known about how specific groups, such as obese/overweight individuals and those with lower incomes, change their food purchasing decisions depending on food price changes. evidence shows that these groups have lower quality diets and worse health outcomes than their normal weight and higher income counterparts. therefore, it is important to gain a better understanding of how food price changes affect purchasing decisions among these population groups in order to develop targeted nutrition interventions to improve their diet quality. to investigate this, the researchers will create a laboratory-based grocery store, in which pictures of foods will be used in lieu of actual foods. food prices will be indicated on each picture. the participants will be given play money and a budget, and asked to "purchase" foods in the mock grocery store. the price of foods will be changed throughout the study to investigate how participants change their purchasing decisions based on these price changes.

Eligibility criteria:
inclusion criteria: * have at least one child up to 18 years of age residing in the household * primary grocery shopper for the household * no health conditions or food practices that substantially limit food choice * not currently pregnant * consent to the study design exclusion criteria: * male * \< 18 years of age * not a mother, or children not living with subject in their household * no children below the age of 18 years of age * not the primary grocery shopper for their household * health conditions or food practices that substantially limit food choice * currently pregnant

Keywords: low income
a retrospective study on laser treatment of nevus of ota in thai patients

Conditions: Focus on Laser Treatment of Nevus of Ota in Thai Patients

Summary: a retrospective study on efficacy and complication of laser treatment (q-switched nd:yag and picosecond laser) of nevus of ota in thai patients

nevus of ota is a benign dermal melanocytic nevus found most commonly in asians. about 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. it typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. based on selective photothermolysis theory, q-switched lasers (ruby 694nm, alexandrite 755nm, nd:yag 1064nm) have been used for the treatment of nevus of ota with a success rate of 95% after 6-8 sessions. reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). siriraj skin laser center provides laser treatment for nevus of ota using mainly q-switched nd:yag laser and picosecond laser. the study of efficacy and complications of q-switched nd:yag and picosecond laser in the treatment of nevus of ota in thai patients has never been reported. therefore, we conduct a retrospective study on efficacy and complication of laser treatment (q-switched nd:yag and picosecond laser) of nevus of ota in thai patients.

Eligibility criteria:
inclusion criteria: * patient with nevus of ota * complete data between january 2008 - december 2018 exclusion criteria: * incomplete data

Keywords: nevus of ota, laser treatment, thai
device for age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: this study involves user acceptability and feedback of kaleyedoscope, a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration (amd).

this is a patient-experience study being conducted at the kellogg eye center in ann arbor in the outpatient setting. patients who agree to enroll in the study will test the device and provide user feedback via a questionnaire as well as complete questionnaires about their visual function. the preliminary study looks at the usability of using this device for monitoring of age-related macular degeneration, obtaining user feedback to enhance the design. in the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss. to gather user feedback on a digital, non-invasive, handheld device in the outpatient amd patient population, with the goal of developing a user-friendly, portable device to monitor amd progression, this study assesses the usability, comfort, duration, ergonomics, and ease of use of the device among amd patients in a single session. data collected during the test may include but is not limited to the length of the test, boot time, screen transition time. the participants will then fill out the visual function questionnaire-25, the system usability scale (sus), and may include targeted questions designed by the study team to evaluate the participant experience with the device and visual function.

Eligibility criteria:
inclusion criteria: * any patient aged 18 years or older with age-related macular degeneration who is seen at the kellogg eye center. exclusion criteria: * pregnant women, prisoners, severe cognitive impairment, and diagnoses (mental or neuromuscular disorders) which could preclude independent use of the device.

Keywords: age-related macular degeneration macular degeneration amd home monitoring
gestational immunity for transfer

Conditions: Covid19; Breastfeeding; Vaccine Exposure Via Breast Milk

Summary: this is a study prospective cohort study at an urban academic centre, with two parts: 1. health outcomes, and maternally transferred antibodies, in babies born to mothers who had antenatal covid-19 and convalesced before delivery, followed up until 12 months of age 2. safety and protective properties of breast milk after lactating women are vaccinated against covid-19

this proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of covid-19. we first recruit all babies delivered to mothers convalescent from antenatal covid-19, to 1) follow up their growth and development, and 2) study the protective effects of antibodies transferred from mother to child transplacentally during pregnancy, as well as postnatally through breastfeeding. we compare these to a cohort of healthy controls whose mothers did not have covid-19 during pregnancy. next, we compare the protective effects of antibodies transferred during breastfeeding from mother to child after lactating mothers are vaccinated against covid-19, to that of natural infection. we also study the safety of breastfeeding after vaccination by looking for vaccine components in the breast milk.

Eligibility criteria:
inclusion criteria: lives in singapore exclusion criteria: prematurity congenital abnormalities primary immunodeficiencies autoimmune disorders
ros in tbi patients in relation to level of oxygenation.

Conditions: Systemic Oxygenation vs ROS Formation in TBI Patients

Summary: this project an observational study performed on patients with severe traumatic brain injury (tbi) treated at neurosurgical icu (nicu) at karolinska university hospital. the purpose of this study is to evaluate the effects of various oxygenation levels on production rate of reactive oxygen species (ros) in patients with severe traumatic brain injury (tbi). the patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (codman), microdialysis (md), and licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pbto2). intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (cpp), oxygenation, dosage of vasoactive drugs etc. despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the md and pbto2 data and implement it in clinical decision making. one of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ros or facilitating pulmonary atelectasis, contributing to adverse outcome. the purpose of this study is to investigate the effect of various oxygenation levels on ros production in tbi patients. this pilot study is designed to measure short-lived ros in blood and microdialysis fluid samples of tbi patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).


Eligibility criteria:
inclusion criteria: 1. severe isolated tbi (gcs\<8, ais =\<3), ct-verified tbi (tsdh,tedh, tsah, contusion bleedings) caused by blunt or penetrating trauma. 2. established intracranial monitoring (icp, md, licox pbto2) at nicu. 3. age \>= 18 4. time from trauma from 0 to 4 days. 5. informed consent from close relative. 6. systemic hyperoxygenation can be used in patients with pbto2 \<20 mmhg, based on clinical decision. exclusion criteria: 1. major extracranial injury, ais \>3 2. brain dead or expected survival \<24 hours 3. pregnancy 4. respiratory insufficiency fio2\> 40% 6. no consent from relative.

Keywords: tbi, ros, oxygenation, cerebral monitoring, neurointensive care