Kornimate/medical-research-clean huggingface dataset:
abdominal massage for people with learning disabilities and constipation

Conditions: Constipation

Summary: background and study aims: constipation, which is difficulty going to the toilet to do a 'poo' is common in adults with learning disabilities (ld), but there is not a lot of knowledge (information) about the best way to help treat constipation experienced by adults with learning disabilities. adults with learning disabilities who have constipation should be assessed and treated. there is knowledge to suggest that abdominal massage may help some people with constipation so that people with constipation can go to the toilet more easily. there is also knowledge to suggest that the use of a device to do the massage may be as beneficial as getting a carer to do it for the participant. this research wants to invite 40 adults with learning disabilities with constipation to take part. 30 will be offered the abdominal massage, either by a carer or the device, and 10 will not be offered the massage. however, the participants will be shown how to do it at the end of the study. this research wants to find out if people with ld are willing to take part in such a study and if the participants are more willing to let a carer do the massage, or would rather use the device. it is also important that the investigators know if the participants who are in the group not getting the massage are willing to continue in the research. taking part for 6 weeks will provide the investigators with this important information before the investigators undertake a much larger study which the investigators need to do to find out if it helps with constipation.


Eligibility criteria:
inclusion criteria: 1. a person with a learning disability who is known to suffer from constipation including: 1a-those on long term laxatives but still prone to constipation 1b- those who have been admitted to hospital due to impaction 1c- those who use enemas regularly but still have emptying problems. exclusion criteria: 1. a history of malignant bowel obstructions or abdominal growth 2. a history of inflammatory bowel disease of the intestine e.g. chron's disease 3. unstable spinal surgery 4. recent scarring or abdominal surgery 5. abdominal skin lesions 6. abdominal hernia 7. pregnancy 8. indwelling catheter 9. increased sensitivity to touch 10. has undertaken abdominal massage within the last 3 months.
how respiratory pathogens panel results affect patients' plan of care

Conditions: Respiratory Disease

Summary: reviewing providers' current standard operating procedure on respiratory pathogen testing

the general design of this study is collecting data and reviewing principal investigators' standard operating procedures on respiratory pathogen testing and changes made to their specific sop.

Eligibility criteria:
inclusion criteria: * must be a medical practitioner * medical doctor (md) * doctor of osteopathic (do) * physician assistant (pa) * advanced practice registered nurse (aprn) * nurse practioner (np) * must have a current standard operating procedure that includes obtaining/reviewing medical history. exclusion criteria: * government-funded insurance data cannot be included in the study.
safety and immunogenicity of two doses of h5n1 influenza vaccine in children

Conditions: Pandemic H5N1 Influenza

Summary: evaluate safety, tolerability and immune response of adjuvanted h5n1 cell culture derived influenza vaccine in children.


Eligibility criteria:
inclusion criteria: 1. healthy pediatric subjects 6 months to 17 years of age, 2. individuals' parent(s) or legal guardian(s) willing to provide written informed consent, 3. individuals in good health, 4. individuals/individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period, 5. individuals willing to provide informed assent (where applicable). exclusion criteria: 1. individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures, 2. history of any significant illness, 3. history of any chronic medical condition or progressive disease, 4. presence of medically significant cancer, 5. known or suspected impairment/alteration of immune function, 6. presence of any progressive or severe neurologic disorder, 7. presence of any bleeding disorders or conditions that prolongs bleeding time, 8. history of allergy to vaccine components, 9. receipt of any other investigational product within 30 days prior to entry into the study, 10. history of previous h5n1 vaccination, 11. receipt of any other type of seasonal vaccination within 2 months prior to entry into the study, 12. receipt of any other vaccine within 2 weeks prior to entry into the study, 13. body temperature ≥38°c (≥100.4° f) and/or acute illness within 3 days of intended study vaccination, 14. pregnant or breast feeding, 15. females of childbearing potential refusing to use acceptable method of birth control, 16. body mass index (bmi) ≥ 35 kg/m2, 17. history of drug or alcohol abuse, 18. any planned surgery during study period, 19. individuals conducting the study and their immediate family members, 20. individuals with behavioral or cognitive impairment or psychiatric diseases, 21. individuals diagnosed with any growth disorders.

Keywords: influenza, pandemic, h5n1, children
the effect of granulocyte colony stimulating factor versus human chorionic gonadotropin in females with a history of rif

Conditions: Fertility Disorders

Summary: one hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (icsi) were allocated in the study. on ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (g-csf) and the other 50 were injected with intrauterine human chorionic gonadotropins (hcg). the clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome

one hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (icsi) were included in the study. the patients were randomly allocated into two groups. the intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (g-csf). the other group (the control group) consisted of 50 patients and injected with intrauterine human chorionic gonadotropins (hcg). both groups received the interventions at ovum pick-up day. the main outcome was the clinical pregnancy rate which has been evaluated after 2 weeks of the positive pregnancy test. the secondary outcome was an ultrasound image of the gestational sac after 6 weeks of pregnancy.

Eligibility criteria:
inclusion criteria: * females suffering from recurrent implantation failure and undergoing icsi exclusion criteria: * presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
can singing kangaroo improve outcome of preterm infants

Conditions: Neurocognitive Dysfunction; Language Development

Summary: to assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin sessions (kangaroo care) would improve the language development of the preterm infant. infants will be randomized to singing or silence during the kangaroo care from the age corresponding to 30th gestational week until term age (40 gestational weeks).

the outcomes are: a 2- (3-)year neurodevelopmental follow up - bayley scales of infant and toddler development, third edition (in finnish in finland and in swedish in sweden) at the age corresponding to term (40 gestational weeks) * auditory event related potentials (aerps) in electroencephalography (eeg), in helsinki cohort * auditory event related magnetic fields in magnetoencephalgraphy (meg) in karolinska cohort * parental stress with the state trait anxiety inventory (stai)

Eligibility criteria:
inclusion criteria: * preterm infants at 30th gestational week capable of being in kangaroo care exclusion criteria: * intensive care preventing kangaroo care

Keywords: kangaroo care meg aerp preterm infant
pivotal test: wb001

Conditions: Postpartum Depression

Summary: the purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to : 1. an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily cognitive behavioral therapy (cbt), and accessible via an ios and android application, or to 2. a comparison condition without cbt and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.


Eligibility criteria:
inclusion criteria: * women aged 18-45 years who had onset of a major depressive episode within the third trimester of pregnancy or within 4 weeks following delivery as measured by the mini (mini international neuropsychiatric interview). * current mild-moderate depression as measured by the ham-d (ham-d score\>13 and \<24) * women were \</= to 6 months postpartum at the time of screening * owns a smartphone (anrdroid or ios smartphone with a recent, supported operating system) * available and committed to engage with the program and complete assessments for a 3-month duration * able to read and write in english * u.s. resident exclusion criteria: * ham-d score ≥ 24 (severe depression) * active psychosis * suicidal attempt or ideation with a plan and intent to harm oneself during the current episode of ppd * history of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report) * current pregnancy or plans to become pregnant within the next 4 months * fetal demise within the past 24 months * previous woebot user
capsule endoscopy vs standard of care for obscure intestinal bleeding

Conditions: Iron Deficiency Anemia

Summary: the role of capsule endoscopy (ce) in patients with obscure / occult gastrointestinal (gi) bleeding remains unclear. this pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure gi bleeding who receive ce compared to those who receive usual standard care.

patients with iron deficiency anemia from suspected occult gi bleeding will be randomized to receive ce or usual standard care following a negative gastroscopy and colonoscopy. our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. patients with have a minimum of one year of clinical followup. direct health care costs in each arm of the study will be determined after a minimum of two years of followup. an economic evaluation based on the results of the clinical trial is also planned.

Eligibility criteria:
inclusion criteria: 1. adult patients age over 18years with iron deficiency anemia (ida). ida is defined as hemoglobin \<137g/l in men or \<120g/l in women with serum ferritin level \<22ug/l in men and \<10ug/l in women. 2. eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study. 3. negative celiac screen and /or negative small bowel biopsies exclusion criteria: 1. overt gastrointestinal bleeding 2. premenopausal women with menorrhagia 3. known or suspected small bowel obstruction 4. serious medical co-morbidities precluding surgery given the risk of capsule impaction 5. pregnancy 6. inability to provide informed consent

Keywords: iron deficiency anemia wireless capsule endoscopy obscure-occult gastrointestinal bleeding
active cycle of breathing techniques on respiratory distress symptom cluster

Conditions: Lung Neoplasms

Summary: this study was designed as a randomized, control group, experimental study to examine the effect of active cycle of breathing techniques application on respiratory distress symptom cluster in patients with lung cancer.

the sample of the study will consist of patients who received chemotherapy treatment with the diagnosis of stage iv non-small cell lung cancer in the outpatient chemotherapy service of a training and research hospital and met the inclusion criteria. data in the study will be collected using the patient information form, eastern cooperative oncology group (ecog) performance scale, cancer dyspnea scale, leicester cough questionnaire and cancer fatigue scale. in order to test the applicability and comprehensibility of the forms to be used before the study, a preliminary application will be made with 5 patients. this study is planned to prepare a video describing the application for patients to use while performing the active cycle of breathing techniques application. on the 1st day of the study, a 10-minute face-to-face training will be given to the intervention (experimental) group by the researcher using the video about the active cycle of breathing techniques. in the research, the intervention (experimental) group will be asked to follow the video to be prepared and apply the active cycle of breathing techniques twice a day for 28 days. the intervention (experimental) group will be monitored by telephone call once a week and 3 times using the patient follow-up form (days 7, 14 and 21). on the other hand, only the pre-test and post-test will be applied to the control group.

Eligibility criteria:
inclusion criteria: * being 18 years or older * being diagnosed with stage iv non-small cell lung cancer * being diagnosed with lung cancer in the type of adenocarcinoma and squamous cell carcinoma * receiving outpatient chemotherapy treatment * receiving the first course of chemotherapy treatment * ecog performance scale score \< 3 * having all the symptoms of dyspnea, cough, and fatigue * not having a cognitive disorder or a diagnosed psychiatric illness * being able to speak turkish * volunteering to participate in the research exclusion criteria: * experiencing a chronic obstructive pulmonary disease (copd) exacerbation in the last 4 weeks * having an active lung infection * not volunteering to participate in the research * not having dyspnea, cough, and fatigue symptoms * not speaking turkish

Keywords: active cycle of breathing techniques lung neoplasms symptom cluster nursing care
to evaluate the therapeutic equivalence and safety of tretinoin cream, 0.1% and rld in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: bioequivalence study comparing tretinoin cream, 0.1% to retin-a®.

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing tretinoin cream, 0.1% (taro pharmaceuticals u.s.a., inc.) to retin-a® (tretinoin) cream, 0.1% (valeant) and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility criteria:
inclusion criteria: * healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the investigator's global assessment (iga). * subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation.
tolerance of an extensively hydrolyzed protein infant formula versus a premature infant formula

Conditions: Feeding Intolerance

Summary: to evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.


Eligibility criteria:
inclusion criteria: * premature infant 28 to 33 weeks gestational age, inclusive, at birth * infant has never received enteral feedings or current enteral intake is less than 30 ml/kg/day * birth weight is greater than or equal to 700g to 1750g * appropriate birth weight for gestational age * singleton or twin birth * signed informed consent exclusion criteria: * infant's mother plans to exclusively breast feed * 5 minute apgar score is less than or equal to 4 * major surgery that required general anesthesia prior to randomization * ventilator-dependent or requiring greater than 40% fio2 on day of randomization * grade iii or iv intraventricular hemorrhage diagnosed prior to randomization * infant is currently participating in another clinical study
botox vs occlusal splint for masseter pain

Conditions: Pain, Face

Summary: this randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. for the splint group, a rigid splint will be worn by the patient every night. for the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. oral health related quality of life, pain, and cervical neck position will be evaluated. paired t-test and chi-square will be used for statistical analysis.


Eligibility criteria:
inclusion criteria: * between 18 and 70 years old; * at least 20 teeth in the mouth; * occlusal stability; * presenting pain in face muscles. exclusion criteria: * angle's class iii * kennedy's class ii or i removable partial denture wearer; * complete denture wearer; * individuals that have taken any anti inflammatory drugs in the last 3 months; * individuals with temporomandibular joint disorders.
management and outcomes following emergency surgery for traumatic brain injury

Conditions: Traumatic Brain Injury; Head Injury; Brain Injuries; Brain Trauma; Brain Injuries, Traumatic; Head Injury Trauma

Summary: primary aim: the primary aim of the study is to compare survival to discharge (or survival to 14 days post-operatively, whichever comes first) following emergency surgery for traumatic brain injury (tbi) across human development index settings. primary outcome measure: the primary outcome measure will be survival to discharge (or survival to 14 days post-operatively, whichever comes first) primary comparison: between country groups defined by human development index. centre eligibility: any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. patient eligibility: all adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study. team: individual hospital teams with up to four people, collecting data for 30 days. time period: local study teams may select any 30-day period from the 1st of november 2018 and the 31st of december 2019 to start their study. patients operated on who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included. validation: we will employ a method of data validation in every centre that will give us a quantitative estimate of case ascertainment that is feasible even in low-resource centres.


Eligibility criteria:
centre inclusion criteria: any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. in the majority of institutions, emergency surgery for tbi is provided by neurosurgeons - however, centres in which emergency surgery for tbi is provided general surgeons, trauma surgeons, general medical doctors or even non-physician clinicians are also eligible to participate. inclusion criteria: - all adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study. exclusion criteria: * patients who only have an external ventricular drain or intraparenchymal wire (or other monitoring device) inserted for the diagnosis and/or management of intracranial hypertension. * patients who undergo procedures for chronic subdural haematoma(s), including burr holes or mini-craniotomies. * elective (planned admission) or semi-elective (where patient initially admitted as an emergency, then discharged from hospital, and re-admitted at later time for surgery) procedures. * patients who have previously had emergency cranial surgery for traumatic brain injury rendering them eligible for inclusion in this study (regardless of whether they were included)
improving gout care after an ed visit

Conditions: Gout

Summary: the prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the southeastern u.s. - particularly in african americans. through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. a secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the deep south.

the prevalence of gout has been steadily increasing and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the southeast u.s. - particularly in african americans. many patients with acute gout receive care at the emergency department (ed), particularly underserved urban populations in the deep south. appropriate outpatient follow-up for an acute flare after an ed visit is variable. indeed, in a preliminary analysis of a retrospective cohort study of patients with acute gout treated at our urban medical center ed, only 46% of patients followed up with an outpatient clinician in our healthcare system within 6 months of their ed visit. even fewer (36%) had an outpatient visit specifically addressing gout care within 6 months post-ed visit. this population of patients that seek acute gout care in the ed represent an important group that may benefit from interventions focused on improving gout quality of care, such as promoting outpatient follow-up. while having a mechanism to identity acute gout patients in the ed is fundamental for enhancing care for patients with acute gout, recruiting people with acute gout who receive care in the ed outside regular business hours is challenging. one potential solution involves approaching patients after their ed visits remotely using patient navigators. the 36-72 hour period after their ed visit represents a critical time during which patients may be more receptive to efforts focused on improving healthy behaviors including scheduling outpatient follow-up (i.e., a "teachable moment). patient navigators are trained, lay individuals of similar cultural background, and region, who provide personal guidance to patients and engage "hard-to-reach" groups, reduce access barriers, and encourage healthy behaviors such as engaging in outpatient chronic disease management.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * able to communicate and understand english or spanish * confirmed acute gout flare by emr review at ed visit exclusion criteria: * enrollment in an ongoing rct (nct04075903) testing a behavioral intervention employing "storytelling".