Kornimate/medical-research-clean huggingface dataset:
a trial of iw-3718 for 8 weeks in patients with persistent gastroesophageal reflux disease (gerd) receiving proton pump inhibitors (ppis)

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the objective of this study is to evaluate the safety and efficacy of iw-3718 administered to patients with gerd who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (qd), standard-dose ppis.


Eligibility criteria:
inclusion criteria: each patient must meet all of the following criteria to be eligible for enrollment in this study: * patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the screening visit. * patient has a diagnosis of gerd and reports experiencing gerd symptoms (heartburn or regurgitation) while taking standard ppi therapy. * patient has evidence of pathological acid reflux. * female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study. * patient must comply with study procedures. exclusion criteria: patients who meet any of the following criteria will not be eligible to participate in the study: * patient has a history of complete lack of gerd symptom response to ppi therapy. * patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia). * patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the screening visit. * patient has received an investigational drug during the 30 days before the screening visit, or is planning to receive another investigational drug or use an investigational device at any time during the study. note: other inclusion and exclusion criteria apply, per the study protocol.

Keywords: gastroesophageal reflux disease gerd proton pump inhibitors iw-3718
selexipag for the treatment of schistosomiasis-associated pulmonary arterial hypertension

Conditions: Pulmonary Hypertension; Schistosomiasis

Summary: pulmonary arterial hypertension (pah) is a severe, progressive and potentially fatal disease that impairs the pulmonary circulation and leads to right ventricular failure. one of the world most prevalent etiologies of pah is schistosomiasis-associated pulmonary arterial hypertension (sch-pah). new drugs have emerged to treat other forms of pah, but their benefits cannot be automatically translated for sch-pah patients, since this etiology was not included in the pivotal pah trials. one of the most promising therapies for the treatment of pah to emerge in recent years is selexipag, an oral ip receptor agonist, which acts on the prostacyclin pathway. the present study aims to evaluate the efficacy, safety and tolerability of selexipague for the treatment of schistosomiasis-associated pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * patients with symptomatic sch-pah. sch-pah diagnosis necessarily include the three criteria below 1. invasive confirmation of pah, according to the criteria defined in the pulmonary hypertension sixth world symposium: mean pulmonary artery pressure higher than 20 mmhg, at rest, and the presence of pulmonary vascular resistance (pvr) equal to or greater than 3 w, and a pulmonary capillary pressure considered normal (equal to or lower than 15 mmhg (1)). 2. at least one epidemiological criteria for chronic schistosomiasis: patient from a highly prevalent region for schistosomiasis or previous history of parasitic treatment for schistosomiasis or the presence of schistosoma mansoni eggs in the patient's feces 3. evidence of long-term hepatosplenic involvement by schistosomiasis, via compatible ultrasound findings (peri-portal fibrosis or enlarged left lobe) all patients will necessarily already be receiving at least one specific treatment for pah, either with phosphodiesterase v inhibitor or with an endothelin receptor antagonist, with a stable dose for at least 12 weeks before inclusion in the study. exclusion criteria: * patient without clinical condition to perform the 6-minute walk test * patient with gastro-intestinal bleeding for over 12 weeks

Keywords: pulmonary arterial hypertension schistosomiasis selexipag treatment efficacy safety
lifestyle interventions for the treatment of early onset alzheimer's disease study

Conditions: Alzheimer Disease, Early Onset

Summary: the purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and tai chi- qi gong training in participants with early-onset alzheimer's disease. it is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.

this study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and tai chi- qi gong exercise lifestyle intervention in participants diagnosed with early-onset alzheimer's disease (eoad). participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) computerized cognitive training + tai chi exercise or (2) active control. outcome measures will be repeated immediately post-treatment and at 6-months post-treatment follow-up. specific aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with eoad. specific aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. specific aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.

Eligibility criteria:
inclusion criteria: * enrolled in the longitudinal early-onset ad study (leads) parent study, and being classified via leads consensus criteria as having amyloid-positive early onset alzheimer's disease * aged 40-64 years at the time of enrollment into leads * fluent in english * in good general health and absent another neurological disorder * have a knowledgeable informant. * have had a clinical dementia rating scale of 0.5 to 1.0 at the time of enrollment into leads * have sufficient vision, hearing, comprehension, and manual dexterity to participate in the testing and training program exclusion criteria: • have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week

Keywords: lifestyle intervention cognitive training exercise training cognition
thermographic examination of skin temperatures in individuals with focal onset epilepsy

Conditions: Focal Onset Epilepsy; Partial Epilepsy

Summary: the specific aim is to determine if there are patterns of temperature differences in the abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a non-epileptic control group. the hypothesis is that individuals with partial/focal onset epilepsy will have colder recorded temperatures in the abdominal area than individuals in a matched control group.

the concept of "abdominal epilepsy" has been described in the neurology literature. the present study seeks to amplify understanding of this clinical entity by measuring abdominal area and low back skin temperature changes which may be affected through the function of the abdominal ganglia, specifically the celiac, superior mesenteric and inferior mesenteric ganglia. this not an intervention study. it is study comparing abdominal area and low back skin temperature in individuals with the partial/focal onset epilepsy with a match control group of individuals with no epilepsy history. the implications of the outcome of the finding any significant temperature changes between the experimental and control groups is great enough to warrant the highest level of scientific scrutiny that this registration permits.

Eligibility criteria:
inclusion criteria experimental group: 1. diagnosis of partial/focal onset epilepsy (icd9-cm 345.4 and 345.5) 2. ages 18-70 exclusion criteria experimental group: 1. pregnancy 2. recent trauma such as motor vehicle accident or injury to the musculoskeletal system 3. currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. glaucoma medication 4. if diagnosed with a condition which could affect abdominal area neurophysiologic functions. 1. irritable bowel syndrome 2. crohn's disease 3. ulcerative colitis 4. migraine headache with abdominal manifestation inclusion criteria control group: 1. no history or diagnosis of any seizure disorder 2. ages 18-70 exclusion criteria control group: 1. pregnancy 2. recent trauma such as motor vehicle accident or injury to the musculoskeletal system 3. currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. glaucoma medication 4. if diagnosed with a condition which could affect abdominal area neurophysiologic functions. 1. irritable bowel syndrome 2. crohn's disease 3. ulcerative colitis 4. migraine headache with abdominal manifestation

Keywords: epilepsy thermography
management of patients with diagnosis of hypothyroidism, as hospitalized and as outpatients, in internal medicine units: observational study before & after educational programme

Conditions: Hypothyroidism

Summary: there is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in internal medicine (im) departments in italy. the aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (cprs) in evidence-based guidelines (ebgs); 2) the improvement of patient management by means of a standardized educational programme (ep). methods: a nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening ep (phase 2) in half of the centres and no ep in the other half, was conducted. the ep was based on outreach visits. centres were assigned to the two arms of the study, labelled the training group (tg) and control group (cg) respectively, by cluster randomization.

hypothyroidism (ht) is a common disorder that affects more than 4% of the general population. since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality. although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the internal medicine setting it is not very well known so far. this study has the aim to take a real-life picture of internal medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program. the fadoi-tiamo study is designed as a replicate of two cross-sectional surveys (phase 1 and 3) interspersed with an educational program (phase 2) to be conducted in 11 out of the 22 participating centres. the data collection in phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of ht observed in each centre (globally, 1200 patients).

Eligibility criteria:
inclusion criteria: * known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the im department for any condition exclusion criteria: * none
melatonin treatment for tardive dyskinesia in schizophrenia

Conditions: Tardive Dyskinesia

Summary: this is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (td). this study addresses a free radical hypothesis of td.

1. since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of td, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms. 2. due to increased cognitive deficits in patients with td and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with td may be improved by melatonin simultaneously.

Eligibility criteria:
inclusion criteria: 1. diagnosis of both schizophrenia and td; 2. duration of td symptoms longer than 1 year; 3. on stable doses of antipsychotic drug for at least 6 months; 4. between 18 and 70 years of age. exclusion criteria: 1. comorbid neurological illness other than td; 2. if they have received vitamin c or vitamin e within 1 month before the start of the study; 3. alcohol/drug abuse; 4. acute, unstable medical condition; 5. pregnant or breastfeeding female; 6. use of other antioxidants.

Keywords: tardive dyskinesia schizophrenia melatonin oxidative stress antioxidant
the role of narrow band imaging videobronchoscopy in lung cancer

Conditions: Lung Cancer

Summary: narrow band imaging (nbi) videobronchoscopy is an optical technique in which filtered light enhances superficial neoplasm based on their neoangiogenic pattern. the objectives of this study investigate its better diagnostic yield in the assessment of lung cancer than conventional flexible bronchoscopy.

inspection with high resolution endoscopy was followed by nbi. detected lesions were biopsied. applied the system of shibuya et al. to analyze and classify vascular patterns by nbi into four categories (spiral and screw pattern, dotted pattern, tortuous pattern, avascular pattern) compared with the known diagnostic yield of conventional white light bronchoscopy, an equivalent or superior result will also significantly impact on patient care this technology could aid not only early-stage lung cancer diagnosis but also more accurate local staging of lung cancer.

Eligibility criteria:
inclusion criteria: * endobronchial lesion on chest ct exclusion criteria: * age \< 18 years old * inability to consent for the study * inability to tolerate bronchoscopy * active pulmonary infection (bronchitis, pneumonia) * st elevation or depression on ecg * prothrombin time prolongation(\<70%) * platelet \<10,000

Keywords: narrow band imaging malignant lesion lung cancer nbi
linking former inmates to primary care

Conditions: Hypertension; Substance Abuse; Asthma; Depression

Summary: the transitions clinic network (tcn)aims to connect former inmates to primary care using trained, culturally competent primary care providers and community health workers (chws). the purpose of this project is to support ongoing quality improvement at the 13 participating sites by training culturally competent chws and measuring the health, health care utilization, and the costs of caring for former inmates.

the transitions clinic network (tcn) is a network of 13 community-based transitional healthcare programs, which aim to improve health, improve health care, and lower costs for vulnerable, high-risk medicaid patients returning from prison across the united states. the tcn aims to connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (chws). the providers and chws, help patients obtain timely healthcare; promote healthy reintegration into their communities; provide care coordination and chronic disease management; and prevent unnecessary emergency department utilization and hospitalizations. the project supports ongoing quality improvement at each of the 13 clinical sites by measuring the health, health care utilization, and the costs of caring for recently released patients. we will prospectively examine the rates of primary care engagement, acute care utilization, substance abuse and reported health, and recidivism in a cohort of 2000 patients recently released from prison receiving primary care at the 13 tcn programs. we will compare these rates of utilization at 6, 12, 18, 24, 30, 36 months to patient self-reported utilization prior to incarceration and historical controls. additionally, we aim to describe the implementation of, fidelity to, and sustainability of the tcn model in each of these clinical programs. specifically, we aim to capture assets and barriers to starting and sustaining primary care programs targeting returning prisoners.

Eligibility criteria:
inclusion criteria: * recently-released from prison (within one month) * has \>=1 chronic disease condition , and/or age \>=50 years * plans to live in the tcn area for the duration of the study * understands english or spanish and able to provide consent exclusion criteria: * does not plan to live in the tcn area for the duration of the study * does not understand english or spanish, or unable to provide consent * does not plan to receive healthcare through a tcn clinic

Keywords: prison reentry health care utilization
the effect of immersive virtual reality application on anxiety, pain and family satisfaction in the perioperative process of children

Conditions: Anxiety; Pain; Satisfaction

Summary: an immersive virtual reality (vr) tour of the operating theater before surgery could reduce preoperative anxiety. the aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

children who will undergo surgery for the first time and their families were randomly allocated into the control or vr group. the control group received conventional education regarding the perioperative process of surgery. the vr group watched a 1.5-minute vr video showing the operating theater and explaining the perioperative process. the main finding was preoperative anxiety evaluated using the children's state anxiety (csa) before surgery. secondary findings included children's postoperative pain ratings using wong-baker faces pain rating scale and parental satisfaction scores using pedsql health care satisfaction scale

Eligibility criteria:
inclusion criteria: * children 4-10 years old * asa grade i or ii * general anesthesia * elective surgery exclusion criteria: * children who have had previous surgery history * local anesthesia or emergency surgeries * premature or congenital disease history * having visual and hearing impairment * mental and developmental retardation * having a history of epilepsy and seizures * patients taking psychoactive drugs

Keywords: anxiety pain parental satisfaction virtual reality
a study in patients with wet age-related macular degeneration or diabetic macular edema to assess the frequency of use of intravitreal aflibercept in routine clinical practices in latin america

Conditions: Macular Degeneration

Summary: the main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wamd or dme in routine clinical practice in latin america for a study population of treatment naive patients and those who have received prior therapy (anti-vegf injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.


Eligibility criteria:
inclusion criteria: * age: ≥18 years of age for dme patients, * age: ≥55 for wamd patients * decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local product monograph recommendations. patients who are treatment naïve (no previous intravitreal treatment received, including, anti- vegf agents, steroids, steroid implants and/or pdt) and patients that are switching from a different anti-vegf therapy are both eligible to be included. dme patients that have received previous laser only will be classified as treatment naïve. * if of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice. * patients currently being treated with intravitreal aflibercept in the study eye. * patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. for a complete listing, see the dosage forms, composition and packaging section of the local product monograph. * ocular or peri-ocular infection in either eye. * active intraocular inflammation in the study eye. * scar, fibrosis, or atrophy involving the center of the fovea in the study eye. * patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye. * concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-vegf agents. * patients receiving a different anti-vegf agent other than intravitreal aflibercept for the fellow eye.

Keywords: wet age-related macular degeneration(wamd) diabetic macular edema(dme)
butterfly sensor with rev k version

Conditions: Blood Loss

Summary: the primary purpose of this study is to assess the accuracy of the newly released masimo sphb butterfly sensor with revk version and compare the results to a blood hemoglobin level analyzed in the ucsf clinical laboratories. a secondary purpose is to assess the blood hemoglobin using the masimo pronto-7 hand-held device immediately prior to surgery.

* masimo sphb™ continuous hemoglobin monitoring the masimo sphb™ monitor with the butterfly sensor with revk version will be used to continuously monitor hemoglobin electronically. the butterfly sensor will be connected to the 3rd or 4th finger on either the right or left hand. * masimo pronto-7™ intermittent hemoglobin monitoring the masimo pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. the device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. a reading from the pronto-7 will be taken immediately before surgery. * blood sampling for hemoglobin determination for the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the ucsf clinical lab.

Eligibility criteria:
inclusion criteria: * male of non-pregnant female 18 y/o or older * american society of anesthesiologists classification 1,2 or 3 * scheduled to undergo spine or hip surgery exclusion criteria: * pregnant or nursing * patients who in the investigators clinical judgement would not be suitable for research