Kornimate/medical-research-clean huggingface dataset:
dietary carbohydrate and gerd in veterans

Conditions: Gastroesophageal Reflux Disease; Obesity

Summary: 4-arm diet intervention investigating effects of dietary carbohydrate type and amount on gastroesophageal ph, gastroesophageal reflux disease (gerd) symptoms and medication use.

delayed due to covid related research shutdown specific hypothesis: the preliminary findings suggest a physiological mechanism between dietary intake and gerd that may be related to type of dietary carbohydrate intake (complex vs simple carbohydrate). the investigators hypothesize that modifying the type of dietary carbohydrate consumed - by reducing the proportion of simple carbohydrate (sugars) consumed - will reduce or resolve gerd symptoms and medication use in obese veterans with chronic gerd. the investigators further hypothesize that the mechanistic effects of reducing simple carbohydrate intake is related to either: a) improved dietary fiber intake and/or glycemic load, and thus, reduced amount and duration of esophageal acid exposure; and/or b) improved insulin sensitivity which would positively influence the function of key gastrointestinal hormones (ie, gastrin, glucagon, glp-1, ghrelin11) that regulate gastric motility and/or lower esophageal sphincter function. aim 1: to determine effects of dietary carbohydrate consumed (amount and type) on percent time with esophageal ph \< 4.0, as well as number of reflux episodes, gerd symptoms and gerd medication use, in 200 obese veterans who have chronic high frequency of gerd symptoms. to meet this aim the investigators will use a randomized controlled trial in which the investigators manipulate amount of total and simple dietary carbohydrate intake for duration of 9 weeks. aim 2: to assess associations between gerd resolution variables and factors related to potential mechanisms by which modifying dietary carbohydrate intake could resolve/reduce gerd in obese veterans. 2a: the investigators will investigate associations related to whether the effect is nutritionally mediated by measuring change in dietary fiber load and dietary glycemic load, and thus, whether these changes are related to improved gastric acid secretion (% time ph \< 4), gastric motility, and/or the other parameters that comprise the johnson-demeester score. 2b: the investigators will also investigate whether effects are associated with changes in the hormonal milieu by measuring hormonal response of gastrin, glucagon, glucagon-like peptide-1 (glp-1), ghrelin and insulin, which could potentially influence gastric acid secretion, gastric motility and/or lower esophageal sphincter function.

Eligibility criteria:
inclusion criteria: age 21 or over bmi 30-39.9 gerd exclusion criteria: * history of type 1 diabetes * hernia or strictures * gastroparesis * extra-esophageal gerd * barrett's esophagus or esophageal adenocarcinoma * history of gastric or bariatric or esophageal surgery, radiation or cancer * history of gastrointestinal malabsorption * alcohol averaging \> 2 drinks per day during past 3 months * pregnancy / lactation

Keywords: gerd diet carbohydrate obesity
the effect of cord blood serum eyes drops administer in patients with severe keratopathy related to egfr-i treatment

Conditions: Dry Eye

Summary: the study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.

patients undergoing treatment with egfr inhibitor for lung cancer might develop corneal damage. the study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.

Eligibility criteria:
inclusion criteria: * age over 18 years * oncology and advanced cancer patients who have egfr mutation and who require treatment with antiegfr drugs * signing of informed consent exclusion criteria: * patients who are unable to store/administer the csco independently, or with the help of care-givers.
a long-term safety study of tenapanor for the treatment of ibs-c

Conditions: Constipation Predominant Irritable Bowel Syndrome

Summary: this phase 3, open label study will evaluate the safety of tenapanor 50 mg bid in subjects with constipation-predominant irritable bowel syndrome (ibs-c) defined by the rome iii criteria. subjects who have completed either ten-01-301 (16 weeks) or ten-01-302 (26 weeks) studies may be enrolled. subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

during the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. subjects will undergo safety assessments at these visits, which may include a physical exam, ecg, vital signs, and clinical labs. adverse events and concomitant medications will be recorded. medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Eligibility criteria:
inclusion criteria: * subjects completed all 16 weeks of ten-01-301 or all 26 weeks of ten-01-302 * subject demonstrated adequate compliance with the study procedures during either the ten-01-301 or ten-01-302 studies * females must be of non-childbearing potential; if of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception * males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization exclusion criteria: * subject has been withdrawn or discontinued prematurely from either ten-01-301 or ten-01-302 * the subject reports using any prohibited medication and is not willing to abide by the restrictions for intake * pregnant or lactating women
eeg alterations of uterine contractions in the first stage of labor predicting postpartum depression

Conditions: Postpartum Depression

Summary: severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. numerous studies have shown that resting frontal electroencephalogram (eeg) asymmetry is closely related to depression. therefore, the investigators hypothesize that the frontal alpha asymmetry in eeg during uterine contractions in the first stage of labor be associated with the risk level of postpartum depression. the objective of this research is to investigate, in a 1-year period, the incidence of postpartum depression in natural birth mothers in relation to frontal alpha asymmetry in eeg during uterine contractions and resting state.

severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. it is characterized by lack of motivation and behavioral changes, potentially producing serious negative consequences for offspring. in addition, eeg alpha asymmetry is one of the commonly studied biomarkers for depression. there are multiple previous studies regarding the symmetry of eeg in left and right brain hemispheres, especially at frontal electrodes. besides, there are many other eeg indicators that predict depression which are also likely to be strong contributors to postpartum depression. the objective of study is to investigate if there is any association between eeg alterations of uterine contractions in the first stage of labor and factors that are associated with postpartum depression.

Eligibility criteria:
inclusion criteria: * parturient women with a singleton pregnancy; * capable of understanding the research requirements and willing to cooperate with the study instructions; * aged 18-45; * american society of anesthesiologists(asa) physical status i or ii; * right handed; * not taking any drug known to influence the eeg; * epds scale (edinburgh postnatal depression scale, epds) is used in the last prenatal examination in outpatient clinics , with scores \< 10; * informed consent is gained from all individual subjects taking part in the study. exclusion criteria: * history of neurological or psychiatric disease; * personality disorder; * cerebral disease; * epidural anesthesia contraindication; * multiparous pregnancy.

Keywords: electroencephalogram uterine contractions in the first stage of labor postpartum depression frontal alpha asymmetry
comparison of epidural and tap block in abdominal surgery

Conditions: Acute Pain; Surgery; Regional Anesthesia

Summary: this study will compare the infiltrative transversusabdominis plane (tap) block with liposomal bupivacaine to epidural analgesia (ea) in major abdominal surgery . the efficacy of the tap block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. the investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but tap blocks will decreased costs, urinary retention, and hypotension.

this study intends to examine this rational by comparing the infiltrative transversusabdominis plane (tap) block with liposomal bupivacaine to ea in major abdominal surgery. the efficacy of the tap block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. the investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. the investigators anticipate that patients who have undergone tap blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.

Eligibility criteria:
inclusion criteria: * subject \>/= 19 years of age * undergoing major abdominal surgery * able to provide written informed consent exclusion criteria: * chronic opioid use * allergies to amide anesthetics * inability to undergo general anesthesia * pregnancy * any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs * or evidence of gross neurological dysfunction of the lower extremity
the effect of robot-assisted gait training on gait ability in children with cerebral palsy through changing gait speed

Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Bilateral Spastic Cerebral Palsy

Summary: robot-assisted gait training (ragt) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. there is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the ragt system, and intervention intensity for an appropriate intervention program has not been presented. therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (gmfcs) by identifying gait variables according to differences in gait speed during ragt.


Eligibility criteria:
inclusion criteria: * patients 4-12 years old diagnosed with cerebral palsy * children who have not received botulinum toxin treatment or surgery within 3 months * children in stage 2 of the gross motor function system * children who can express pain, fear, or discomfort on their own exclusion criteria: * severe lower extremity contracture and fracture * bone instability * osteoporosis * severe bones grow disproportionately * unhealed skin lesions on the lower extremities (thromboembolic disease) * thromboembolic disease * cardiovascular instability * mild scoliosis with a cobb's angle of more than 20 degrees
surgical site infection rates in obese patients after cesarean delivery

Conditions: Surgical Site Infection

Summary: the aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at cesarean delivery in obese patients.

this is a randomized controlled trial conducted in ain-shams university maternity hospital on the period from march 2012 till august 2012. it included 130 pregnant women who underwent elective cesarean section. the aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at cesarean delivery in obese patients.

Eligibility criteria:
inclusion criteria: * age: any female in childbearing period. * women planned for elective cesarean section. * obese women (bmi ≥ 30 kg/m2). our study calculated the bmi of patients from their weight and height at admission, because the pre-pregnancy bmi was not available for all patients, and we hypothesized that the bmi at admission was a better indicator of body mass during the at-risk time for development of ssi than was the pre-pregnancy bmi. exclusion criteria: * women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection). * women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss). * women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy. * patients who had non pfannenstiel incision.

Keywords: surgical site infection cesarean section
a clinical trial of endobronchial ultrasound for the diagnosis of mediastinal lymphadenopathy (remedy)

Conditions: Isolated Mediastinal Lymphadenopathy; Sarcoidosis; Tuberculosis; Lung Cancer; Lymphoma

Summary: enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. in the past an operation (mediastinoscopy) was required to diagnose the glands. endobronchial ultrasound (ebus) is a new procedure that may be able to diagnose these glands without the need for mediastinoscopy. the remedy trial aims to examine whether ebus can reduce the number of mediastinoscopies and healthcare costs in patients with enlarged glands in the chest.

although the literature is replete with data on the utility of endobronchial ultrasound for lung cancer, there are very few data available on its role in the diagnosis of isolated mediastinal lymphadenopathy due to other causes such as sarcoid, tuberculosis or lymphoma. the remedy trial aims to evaluate the accuracy of ebus in this setting and assess any reduction in the number of mediastinoscopies and healthcare costs.

Eligibility criteria:
inclusion criteria: * consecutive patients with undiagnosed mediastinal lymphadenopathy (\>1cm in short axis) on ct or pet-ct scan for whom pathological evaluation is clinically indicated. exclusion criteria: * patients without informed consent, those with anterior mediastinal lesions or with contra-indications to ebus or mediastinoscopy will be excluded.

Keywords: mediastinal lymphadenopathy ebus bronchoscopy sarcoidosis
a study of gzr18 tablet in chinese healthy subjects

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of gzr18 tablet in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. subjects sign informed consent voluntarily. 2. age 18-55 at screening (both included)，male or female（male only for part a）. 3. at screening, 20.0 kg/m2 ≤ bmi ≤ 24.9 kg/m2, body weight≥54.0 kg. 4. female subjects were hcg negative at screening and baseline exclusion criteria: 1. female subjects who are pregnant or lactating at screening. 2. history of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing. 3. abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening. 4. history of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results. 5. those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
quantitative icg fluorescence angiography in colorectal surgery

Conditions: Colorectal Cancer; Anastomotic Leak

Summary: fluorescence angiography with indocyanine green (icg-fa) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage. while qualitative icg assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, icg dose and white-light contamination). the alternative is quantitative icg assessment, which is performed by evaluating the time-intensity curve of the icg-fa with an external analyzing software. the procedure is showing promising results, but the methodology is still reported very heterogeneously. this study is a multi-center, prospective, standardized, surgeon-blinded observational trial. the key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the icg perfusion measurement, providing no chance of influencing the course of the operation. assessment of perfusion will be performed postoperatively blinded to the outcome. assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. the primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.


Eligibility criteria:
inclusion criteria: * age 18 years or older * capable of giving informed consent * asa classification: status i-iii * planned for pme or tme with minimally invasive approach and primary anastomosis * strong suspicion of or biopsy-verified sigmoid or rectal cancer stage i-iv cancer exclusion criteria: * known allergy to icg or iodine * emergency procedure * pregnancy or if the patient is currently nursing * surgeons decide to do unblinded quantitative or qualitative icg-fa

Keywords: indocyanine green colon cancer primary anastomosis anastomotic perfusion anastomotic leak
virtual reality helmet to test for problems with memory

Conditions: Memory

Summary: the purpose of this research study is to compare a virtual reality display device with the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

since many individuals with mild cognitive impairment (mci) appear to function normally, mci may often be recognizable through testing in advance of any changes noticed by family members or caregivers. early and frequent testing can therefore trigger an earlier diagnosis, which may increase the effectiveness of currently available medications used to delay onset of alzheimer's symptoms. primary care and geriatric physicians currently lack the necessary tools required for quick and accurate mci screening in the doctor's office environment. the current industry-standard is a battery of pen \& paper neuropsychological tests that require 1.5 hours in a quiet room with a neuropsychologist. comparison: virtual reality display device compared to the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Eligibility criteria:
inclusion criteria: * 65 yrs of age and older * mmse of 18 or greater or mini-cog of 4 or greater * ability to read * informed consent given exclusion criteria: * visual, hearing or physical impairment that would limit ability to use the virtual reality helmet or control device * non-english speaking

Keywords: memory display enhanced testing
pediatric post-approval registry

Conditions: Obstructive Sleep Apnea

Summary: this registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the inspire upper airway stimulation (uas) system for the treatment of moderate or severe obstructive sleep apnea (osa). implanted subjects will be followed for 5 years post-implant.

this registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the inspire upper airway stimulation (uas) system for the treatment of moderate or severe obstructive sleep apnea (osa). implanted subjects will be followed for 5 years post-implant. subjects will be recruited in accordance with the approved inspire uas indication for use and will only include those subjects who are within the new age indication (18-21 years of age). implanted subjects must meet the registry eligibility criteria. those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures. this registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the united states. study data will be collected at the following timepoints: baseline (pre-implant) implant activation (1 month post-implant) 6 months post-implant 1, 2, 3, 4, 5 years post-implant

Eligibility criteria:
inclusion criteria: 1. subject is between 18 and 21 years of age; 2. subject has a diagnosis of moderate to severe osa (15 ≤ ahi ≤ 65) based on a recent sleep study; 3. subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance; 4. subject is contraindicated for, or not effectively treated by, adenotonsillectomy; 5. subject has followed standard of care in considering all other alternative/adjunct therapies; 6. subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation; 7. subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry; 8. subject is willing and able to provide informed consent. exclusion criteria: 1. subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (ahi); 2. subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate; 3. subject has any condition or procedure that has compromised neurological control of the upper airway; 4. subject is unable, or does not have the necessary assistance, to operate the patient remote; 5. subject is pregnant or plans to become pregnant; 6. subject has an implantable device that may be susceptible to unintended interaction with the inspire system; 7. subject has a terminal illness with life expectancy \< 12 months; 8. any other reason the investigator deems the subject is unfit for participation in the registry.

Keywords: pediatric apnea-hypopnea index sleep breathing disorders
pf-06372865 in subjects with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: pf-06372865 in subjects with chronic low back pain


Eligibility criteria:
inclusion criteria: - exclusion criteria: -