Kornimate/medical-research-clean huggingface dataset:
sage leaf 2: an online program to reduce dementia caregiver burden

Conditions: Caregiving Stress; Caregiver Burden

Summary: the goal of this clinical trial is to learn if the sage leaf (social augmentation of self-guided electronic delivery of the life enhancing activities for family caregivers) online positive emotion skill-building program delivered through caregiver serving organizations can help family caregivers of individuals with dementia cope with stress. the main questions it aims to answer are: * how does sage leaf affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? * what are the challenges and successes when rolling out an online program in partnership with caregiver serving organizations? participants will complete the 8-week online sage leaf intervention as well as two survey assessments, one before the intervention and one after.

the sage leaf 2 study is a single-arm fully online implementation trial of the sage leaf program delivered to family caregivers through caregiver serving organizations (csos). the sage leaf intervention is 8 weeks long and involves weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting, all housed on the sage leaf website. the website also includes social features, such as a discussion board and profile pages, to facilitate social connection among participants. up to n=140 family caregivers of individuals with dementia will be recruited through csos and the general population. to participate, caregivers must (1) identify as the primary family caregiver of a person with alzheimer's disease, (2) be at least 18 years old, (3) speak and read english, and (4) have access to high-speed internet. participants will complete survey assessments via redcap before and after they go through the sage leaf intervention. all study activities will take place online. individual level effectiveness will be assessed using self-reported outcomes, such as positive affect, caregiver burden, loneliness, and depression. these outcomes will be measured both pre- and post-intervention. implementation barriers and facilitators will be assessed using follow-up qualitative interviews.

Eligibility criteria:
inclusion criteria: * identifies as primary family caregiver of someone with alzheimer's disease * speak and read english * has access to high speed internet and wi-fi enabled device exclusion criteria: * care recipient lives in care facility * does not speak/read english * does not have access to internet * care recipient does not have alzheimer's disease

Keywords: caregiving alzheimer's disease positive emotion psychological well-being dementia
high-flow nasal cannula oxygen therapy with or without niv during the weaning period

Conditions: Acute Respiratory Failure Requiring Reintubation

Summary: prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in icu patients at high risk of extubation failure. patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.


Eligibility criteria:
inclusion criteria: * duration of mechanical ventilation prior to extubation at least 24h * planned extubation decided by the physician in charge of the patient after success of a weaning trial * patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease. exclusion criteria: * patient admitted for traumatic brain injury * periphal neuromuscular disease as reason for intubation * usual lon-term treatment with niv for chronic desease * usual lon-term treatment with cpap for obstructive apneas syndrome * contraindication to niv * unplanned extubation * do-not-reintubated order at time of extubation * terminal extubation for end of life * people under legal protection * opposition to participate
free amino acid-based formula to treat children cow's milk protein allergy

Conditions: Cow's Milk Allergy

Summary: it is a study to assess the tolerance to a new commercially available infant formula in children affected by cow's milk allergy.

in the present study, the children will be followed-up during the treatment with the new formula for cow's milk allergy. they will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.

Eligibility criteria:
inclusion criteria: * children with cow's milk allergy exclusion criteria: * children without cow's milk allergy
ear acupuncture for acute sore throat in patients unable to take non-steroidal anti-inflammatory agents (nsaids)

Conditions: Acute Sore Throat

Summary: the purpose of this study is to assess the effect of ear acupuncture alone in subjects with a contraindication to anti-inflammatory medications in the reduction of pain and hours lost from work in acute sore throat.


Eligibility criteria:
inclusion: * male and female subjects (dod beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat. * minimum pain score of 5 points on a 11 point scale (0-10 with 10 being the worst pain) the above with any one of the following: * allergy to non-steroidal anti-inflammatory agents (nsaids) * history of significant gastrointestinal bleed * previous documented history of stage 2 kidney disease or worse * history of gastric bypass surgery * chronic oral steroids use exclusion: * absence of one or more ears * known pregnancy * known peritonsillar abscess (pta) * throat, mouth or esophageal cancer * active cellulitis of ear * ear anatomy precluding identification of acupuncture landmarks * use of hearing aids that preclude the use of ear acupuncture * non-english speaking

Keywords: acute sore throat ear acupuncture
comparison of insulin detemir morning, insulin detemir evening and nph insulin evening in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this trial is to compare the use of insulin detemir once a day (morning or evening) to nph insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months * currently treated with oral antidiabetic drugs * bmi lesser than or equal to 40 kg/m2 * hba1c greater than or equal 7.5 and lesser than or equal to 11% exclusion criteria: * proliferative retinopathy or maculopathy * recurrent major hypoglycaemia * uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the investigator makes the subject unsuitable for participation in the trial
the effect of using virtual reality glasses on post-care pain and comfort level in intensive care patients

Conditions: Copd; Heart Failure; Intensive Care Unit Syndrome; Renal Failure; Gastro Esophageal Reflux

Summary: the aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit. the research will be conducted in the internal medicine intensive care unit of a university hospital.

the aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit. the study will be conducted in the internal medicine intensive care unit of a university hospital. the study population will consist of patients admitted to the internal medicine unit who are between 18 and 65 years of age, are conscious with a glasgow coma scale (gcs) score of 10 or above, have no auditory or visual impairments, and are not receiving mechanical ventilation support. a total of 60 patients will be included in the study and randomly assigned into two groups: 30 in the experimental group and 30 in the control group. data will be collected through face-to-face interviews using a sociodemographic characteristics and information description form, a visual analog scale (vas), and the general comfort scale - short form (gcs-sf). the intervention for the experimental group will include viewing calming videos using a virtual reality headset before nursing care. pain and general comfort levels will be evaluated 24 hours after the nursing care procedure. statistical analyses such as percentage calculations, t-test, mann-whitney u test, and spearman correlation analysis will be used to evaluate the data.

Eligibility criteria:
inclusion criteria: * individuals who are hospitalized in the intensive care unit (with diagnoses such as cancer, chronic renal failure, heart failure, gastrointestinal bleeding, copd, dm, etc.) and volunteer to participate in the study. * between the ages of 18-65, * having clear consciousness, orientation to place, time and person, and having a gcs score of 10 and above, * individuals who do not have any hearing or visual impairment, * they were determined as individuals who were not on mechanical ventilation support. exclusion criteria: * receiving mechanical ventilation support * individuals under 18 years of age and over 65 years of age

Keywords: nursing virtual reality pain comfort intensive care unit
accuracy of trephination-based versus drilling-based guided dental implant placement

Conditions: Single Tooth Lost; Partially Edentulous Maxilla

Summary: this study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.

this study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol. the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (cbct ) will be performed to compare the virtual implant position and the actual implant position.

Eligibility criteria:
inclusion criteria: 1. single missing maxillary premolar or molar tooth. 2. both genders aged from 20-50 years. 3. patients should be systematically free from any disease as according to cornell medical index-health questionnaire. (pendleton et al,.2004) 4. mesio-distal space ≥ 7 mm. 5. bone width in bucco-lingual direction ≥ 6 mm. 6. uniform alveolar ridge with no undercuts. 7. present mesial and distal sound neighboring teeth. 8. at least 4 natural remaining teeth on the same arch. 9. mouth opening at least 30 mm. exclusion criteria: 1) pregnant and lactating females. 2) smokers. 3) poor oral hygiene. 4) vulnerable groups of patients' e.g. (handicapped patients). -

Keywords: guided implant surgical guide dental implant dental trephination guided trephination
enhanced provision of male circumcision (mc) for hiv prevention, rakai, uganda

Conditions: Neonatal Male Circumcision

Summary: background: medical male circumcision (mmc) for hiv prevention is a priority in 14 east and southern african countries, and the long-term sustainability of mmc programs could best be achieved by early infant male circumcision (eimc.) however, the acceptability and safety of eimc provided by non-physicians is unknown. methods: we conducted a trial of eimc using the mogen clamp provided by newly trained clinical officers (co) and nurse midwives (nmws) in 4 health centers in rural rakai, uganda. 501 healthy neonates aged 1-28 days with normal birth weight and gestational age were randomized to co (n=256) and nmws (n=245), and were followed up at 24 hours, 7 and 28 days. combined analgesia was provided by paracetamol suppository, eutectic mixture of local anesthetics (emla) cream and a 24% sucrose solution.

the objective was to assess the acceptability and safety of neonatal male circumcision performed by clinical officers (equivalent to us physician assistants) and nurse midwives, using the mogen clamp. this was a randomized, blinded trial of circumcision using the mogen clamp under topical anesthesia in healthy male infants aged 1-28 days, with normal birth weight and gestational age, performed by trained clinical officers or nurse midwives, randomized 1:1 in rakai district, uganda. mothers of male infants born in 4 health centers were invited to participate and signed an informed consent for screening and enrollment. infants were screened on enrollment prior to randomization (1;1) to clinical officer and nurse midwife circumcision providers. follow up was via a phone call at 24 hours, 7 days and 4 weeks post-circumcision.

Eligibility criteria:
inclusion criteria: * age 1-28 days * birth weight \>= 2,500 gm * gestational age \>=37 weeks * no illness. normal temperature * no genital anatomic abnormality exclusion criteria: * age \>28 days * birth weight \<2,500 gm * gestational age \<37 weeks * ill health * genital abnormality

Keywords: neonatal male circumcision clinical officers vs nurse midwives rakai, uganda acceptability and safety of neonatal male circumcision
to evaluate the efficacy and safety of fe 999315 in japanese subjects with mild to moderate active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: to demonstrate non-inferiority in efficacy of fe 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.


Eligibility criteria:
inclusion criteria: * male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis. * diagnosis of ulcerative colitis in active phase of mild to moderate entity. * female patients must fulfill at least one of the following criteria: post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period. * male patients must agree to use medically approved contraception throughout the trial period. exclusion criteria: * patients with limited distal proctitis. * patients with infectious colitis. * patients with history of colectomy. * patients with severe diseases in other organs and systems. * evidence or history of toxic megacolon. * women who wish to become pregnant during the trial period

Keywords: ulcerative colitis fe999315 mesalazine colitis colitis, ulcerative
fecal transplant for hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the purpose of the study is to determine if fecal microbiota transplant (fmt) can reverse hepatic encephalopathy (he) in cirrhotic patients who continue to have breakthrough episodes of he despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

subjects receive fmt from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. he is measured by inhibitory control test (ict) and stroop test as well as fasting serum ammonia levels.

Eligibility criteria:
inclusion criteria: * adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis * abnormal ict (\>5 lures) or abnormal stroop test (\>200 seconds) * baseline conn score 0 or 1 * infectious etiology of he has been ruled out exclusion criteria: * those with tense ascites * those who do not provide assent * life expectancy \<3 months * tips within the past 3 months * neurologic disease such as dementia, parkinson's, structural brain lesions * pregnancy * intestinal obstruction * alcoholic hepatitis * active alcohol or substance abuse * those without stable social support * concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection * creatinine clearance less that 50% compared to baseline * hospital admission for he within one month of enrollment * active hepatocellular carcinoma * active gi bleed

Keywords: hepatic encephalopathy, fecal microbiota transplant
dysphagia severity and functional independence level

Conditions: Dysphagia; Neurologic Disorder

Summary: functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. the functional independence depends on physical, social, cognitive and psychological abilities of the person. therefore, full functional independence requires the harmony of all these parameters. dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. pain and fatigue are also frequently observe. these patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding. dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. in a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (adl). these studies also suggest that dysphagia may be associated with functional independence in geriatric group. therefore, functional independence may also reduce in patients with neurogenic dysphagia. however, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases.


Eligibility criteria:
inclusion criteria: * aged between 18-65 years * independent to walk 3 meters * underwent a modified barium swallowing study (mbss). exclusion criteria: * having any cervical pathology that may affect swallowing physiology, * history of rheumatological diseases * having any orthopedic surgery in the previous 6 months * using a wheelchair.

Keywords: dysphagia functional independance
mathematical modeling to predict the duration of thrombocytopenia in neonates

Conditions: Neonatal Thrombocytopenia

Summary: parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent to enter the study. for the purposes of the study, thrombocytopenia will be defined as a platelet count \<60,000/ul or a platelet count \<100,000/ul that prompted a platelet transfusion. following enrollment, the platelet count will be followed in each infant. participants will enter the study if on day 5 or later after the onset of thrombocytopenia (defined as above) infants either have a platelet count \<60,000/ul or a platelet count \<100,000/ul for which a platelet transfusion is ordered.

parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent to enter the study. for the purposes of the study, thrombocytopenia will be defined as a platelet count \<60,000/ul or a platelet count \<100,000/ul that prompted a platelet transfusion. following enrollment, the platelet count will be followed in each infant. participants will enter the study if, on day 5 or later after the onset of thrombocytopenia (defined as above), infants either have a platelet count \<60,000/ul or a platelet count \<100,000/ul for which a platelet transfusion is ordered. if criteria are met, eligible infants will have a single blood sample drawn (approx. 800 mcl total) for a complete blood count with immature platelet fraction (ipf) and for determination of a panel of factors important in the regulation of thrombopoiesis (including tpo, il-6, il-11, il-3, pf-4, vegf, hgf, pdgf, and epo). importantly, in patients who are being transfused for platelet counts \<100,000/ul, this sample will need to be obtained immediately prior to the platelet transfusion. if the patient has a platelet count \<60,000/ul and is not being transfused, the blood can be obtained at any time. following this initial sample, a platelet count with ipf will be obtained any time a cbc is ordered for clinical indications, using left-over blood stored in the clinical laboratory for \ 60,000/ul for five days without platelet transfusions. in addition, research nurses will collect and record the infants' demographic data (including gestational age, days of life, birth weight), diagnoses, clinical condition at the time of study entry (respiratory and/or hemodynamic support), time and volume of platelet transfusions, coagulation tests, liver enzymes, and tests of kidney function. moderate and severe bleeding will also be recorded, using criteria defined a priori.

Eligibility criteria:
inclusion criteria: 1. are admitted to one of the participating nicus or the cicu at bch; 2. have a post-conceptional age (gestational age + age in weeks) between 23 and 48 weeks; and 3. have had thrombocytopenia, defined as a platelet count \<60,000/ul or a platelet count \<100,000/ul but receiving platelet transfusions, for ≥ 5 days. exclusion criteria: 1. are on ecmo; or 2. are not expected to survive by the attending neonatologist.

Keywords: thrombocytopenia neonates
study of abatacept (orencia) to treat primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the purpose of this study is to determine if abatacept (orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (udca, urso, ursodiol, actigall).

this is an open label, active treatment trial to assess the efficacy and safety of abatacept in subject with pbc who have had an incomplete biochemical response to udca. in this trial, 20 subjects with pbc who have had an incomplete biochemical response to udca will be assigned to treatment with weekly subcutaneous injections of 125 mg of abatacept. the treatment phase of the study will last 24 weeks with an off-treatment follow up at week 36. inclusion criteria include: * confirmed diagnosis of pbc * alkaline phosphatase \> 1.67 times the upper limit of normal after 6 months of treatment with udca

Eligibility criteria:
inclusion criteria: * confirmed pbc diagnosis based upon at least 2 of 3 criteria 1. anti-mitochondrial antibody (ama) titer \> 1:40 2. alkaline phosphatase \> 1.5 times the upper limit of normal for at least 6 months 3. liver biopsy findings consistent with pbc * incomplete response to udca defined by an alkaline phosphatase \> 1.67 x the upper limit of normal after 6 months of udca at a minimum dose of 13 mg/kg/d * taking a stable dose of udca for at least 3 months prior to day 0 * aspartate aminotransferase (ast) and alanine aminotransferase alt \< 5 times the upper limit of normal exclusion criteria: * presence of concomitant liver diseases including viral hepatitis, primary sclerosing cholangitis, alcoholic liver disease, wilson's disease, hemochromatosis, or gilbert's syndrome. * prior liver transplantation * decompensated liver disease * use of immunosuppressants within 6 months of day 0 * use of biologic agents within 12 months of day 0

Keywords: primary biliary cirrhosis ursodeoxycholic acid abatacept cytotoxic t-lymphocyte antigen 4 (ctla-4)