Kornimate/medical-research-clean huggingface dataset:
9 week extension study of asenapine and olanzapine in treatment of mania (p07007)(completed)

Conditions: Bipolar Disorder

Summary: bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. sometimes, symptoms of both depression and mania are present (mixed episodes). asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. patients who completed the 3 week trial (a7601004 or a7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. the short term studies (a7501004 and a7501005) were not unblinded until the 9 week extension study was unblinded. patients treated with placebo in the 3 week short term study were crossed over and treated with asenapine in the 9 week extension study. patients who complete the 9 week extension study were eligible to continue in another extension (a7501007) study for an additional 40 weeks.


Eligibility criteria:
inclusion criteria: * have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (a7501004 or a7501005) that they completed. exclusion criteria: * patients with unstable medical conditions or clinically significant laboratory abnormalities.
maintaining behavior change: a 6-year follow-up of adolescent 'night-owls'

Conditions: Circadian Dysregulation

Summary: a follow-up of a cohort of participants recruited for a prior study will be conducted. in the prior study, 10-18 years olds were provided one of two treatments to improve the sleep of adolescent night-owls. the follow-up will be approximately 6-years following participation in the prior study. the goal is to establish long-term outcomes in sleep and circadian functioning, in the five health-relevant domains and in engagement in sleep health behavior.

a follow-up of a cohort of participants recruited for a prior study will be conducted. in the prior study, 10-18 years olds were provided one of two treatments to improve the sleep of adolescent night-owls. this follow-up will be conducted approximately 6-years following participation in the prior study. the participants will be 18-28 years of age. specific aim 1: at the 6-year follow-up, participants recruited for the prior study will be assessed for sleep and circadian functioning and functioning in five health- relevant domains. specific aim 2: the sample will also be assessed for their engagement in sleep health behavior. this research will advance knowledge on: (a) longer-term outcomes and (b) the role of eveningness as a mechanism contributing to poorer outcomes.

Eligibility criteria:
inclusion criteria: * the inclusion criteria is individuals who participated in a previously-funded behavioral intervention (r01hd071065). exclusion criteria: * n/a

Keywords: risk: emotional, cognitive, behavioral, social, physical
less tep vs. three port tep for inguinal hernia repair

Conditions: Inguinal Hernia

Summary: this study aim to compare efficacy and safety of laparoendoscopic single site total extraperitoneal inguinal hernia repair /less tep/ and traditional total extraperitoneal hernia repair with 3 ports /tep/.

this is a prospective, double blinded, randomized trial. it compared of laparoendoscopic single site total extraperitoneal inguinal hernia repair /less tep/ and traditional total extraperitoneal hernia repair with 3 ports /tep/. inguinal hernia is one of the most common surgical diseases. laparoscopic hernia repairs include two types, tep and tapp. laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. this has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery. 200 patients will undergo tep inguinal hernia repair. they will be randomized in two groups by sealed envelope method. group a: standard tep with 3 ports (10mm. and 2 ports of 5mm.). in case of difficulty in standard 3 port tep inguinal hernia repair, the procedure will be converted to tapp. group b: less tep with single skin incision 2-3cm. in case of difficulty in less tep inguinal hernia repair, the procedure will be converted to standard 3 port repair or tapp. patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. the blind will only be lifted after pain score and area of pain has been recorded before discharge.

Eligibility criteria:
inclusion criteria: * age between 18 and 90 years * willing to participate in this study and signed an informed consent. * diagnosed inguinal hernia - primary or recurrence * asa class i, ii and iii exclusion criteria: * age under 18 years and above 90 years * strangulated hernia * patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia * patients who prefer a certain surgical approach * patients who undergo surgery procedures for chronic pain after inguinal hernia repair

Keywords: tep less tep inguinal hernia laparoscopic surgery recurrence inguinal hernia primary inguinal hernia
exploring the use of myfood24 (an online nutritional assessment tool) in clinical dietetic practice

Conditions: Nutritional Disorders; Nutrition Therapy; Food Habits

Summary: dietary assessment is a key component of the dietetic care process. assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. this study will examine the feasibility of using an online dietary assessment tool, myfood24 as an alternative to current dietary assessment practices and explore the barriers and facilitators to its use within dietetic clinical practice. this will be a mixed method study using questionnaires and semi structures interviews with both dietitians and patients. dietitians, and patients with a range of clinical conditions referred to an nhs dietetic service, will be recruited. patients will be asked to trial the system to record their food intake prior to their dietetic appointment. this data will then be used for the dietary assessment within the consultation. following this, patients and dietitians will be interviewed about their experiences. quantitative data will be statistically analysed, and thematic analysis will be used to analyse qualitative data.


Eligibility criteria:
inclusion criteria: * aged over 18 years * referred to the sth dietetic department * willing and able to attend a dietetic out-patient appointment * can read and understand english * have access to the internet * willing to engage in technology as part of their care * have or willing to obtain their own email address exclusion criteria: * under 18 years * unable or unwilling to attend a dietetic out-patient appointment * unable to read and understand english * no access to the internet * unwilling to engage in technology as part of their care * does not have or unwilling to obtain their own email address

Keywords: nutrition dietary recall
pediatric pain assessment in the emergency department

Conditions: Pain; Acute Pain

Summary: to examine pediatric pain assessment in the emergency department

phase 1 is a qualitative assessment of how pain is currently evaluated in the pediatric emergency department (ed). initial triage encounters will be observed and audio recorded. in addition to determining how often the wong baker faces pain rating scale (wbf) is administered with the intended script, the investigators will determine if there are common variations from the recommended script. the investigators will also evaluate how often a caregiver's perception of the child's pain is considered when completing the wbf. phase 2 is a quantitative assessment to determine if neurocognitive development impacts the responsivity of the wbf and the faces pain scale - revised (fps-r) as well as the cognitive age equivalent required to use these scales accurately. patients presenting with acute pain will report their level of pain before and after analgesic intervention using both the wbf and the fps-r. they will also subjectively report their change in pain following analgesic intervention. once the patient's pain has improved, he/she will complete the brigance early childhood screens iii to determine his/her cognitive age equivalent. he/she will also complete a series of tasks aimed to assess ability to successfully use the wbf and fps-r (matching, grouping, classification, and seriation skills). the results of the child's self-report of pain will also be compared to the caregiver's estimate of the child's pain.

Eligibility criteria:
inclusion criteria: * verbal patients * pain score ≥ 6/10 * caregiver speaks english or spanish exclusion criteria: * altered mental status * history of traumatic brain injury (tbi) * history of developmental delay * history of autism * history of chronic pain, defined as persistent or recurrent pain in children with chronic health conditions * non-verbal patients

Keywords: pediatric children faces pain scale revised wong baker faces pain scales brigance
age bias on biopsychosocial factors in persons with non-specific low back pain.

Conditions: Low Back Pain

Summary: low back pain is a debilitating condition experienced by people of all age groups. this study will be completed in two stages in which back pain assessment tools will be first translated to urdu language and later on age-related bias on biopsychosocial factors will be assessed using various biopsychosocial tools over a period of six months.

low back pain (lbp) is an extremely common symptom experienced by people of all ages. the current incidence, prevalence and disability-adjusted life years (dalys) account for 245.9 million cases/year (15th worldwide cause; 32.4% cases associated with leg pain), 577.0 million cases (15th worldwide cause) and 64.9 million dalys (6th worldwide cause), respectively. in recent decades, the biopsychosocial model has been applied as a framework for understanding the complexity of low back pain disability in preference to a purely biomedical approach. considering the large population of patients with lbp and limited medical resources, the development of brief and efficient prognostic clinical tools for use in routine practice is particularly significant. recent data from epidemiological studies suggest that lbp could affect the physical function of young and older individuals differently. the age-related differ¬ences in the prevalence of some low back pathologies may explain the differential treatment outcomes. the aim of the study is to explore the age bias on biopsychosocial factors in persons with non-specific low back pain.

Eligibility criteria:
inclusion criteria: 1. both male \& female patients 2. age group 20-60 years 3. diagnosed with nonspecific low back pain for more than 3 months (i.e., pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific spinal pathology, for a period of at least twelve weeks) exclusion criteria: any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
tap block vs cwi for total abdominal hysterectomy, a rct

Conditions: Postoperative Pain

Summary: this no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (cwi) when compared to transversus abdominis plane (tap) block for postoperative pain control after total abdominal hysterectomy.

after signing the informed consent, patients will be enrolled and randomly allocated into either the study group (cwi) or the control group (tap). both groups will receive standard general anesthesia. at the end of the surgery, the cwi patients will receive a preperitoneal catheter in the surgical wound and cwi of ropivacaine 2 mg/ml, 5 ml/h for 24 hours; with the tap block patients will receive a bilateral, standard lateral tap block with 5 mg/ml ropivacaine 24 ml per side. all patients will receive multimodal analgesia with ketorolac 30 mg e.v. plus 90 mg/24h iv, paracetamol 1g plus 1g tid, dexamethasone 0,1 mg/kg iv preoperatively, oxycodone 5 mg per os upon request.

Eligibility criteria:
inclusion criteria: * asa i - iii * laparotomic hysterectomy with pfannenstiel incision * signed informed consent exclusion criteria: * asa iv * allergy to local anesthetics or other components of multimodal analgesia * inability to walk or eat
investigation of association between ugt1a1 polymorphisms and irinotecan toxicity in korean patients

Conditions: Stage IV Colorectal Cancer; Gastric Cancer

Summary: the purpose of this study is to investigate the association between ugt1a1 polymorphisms and neutropenia and diarrhea in korean patients with advanced colorectal or gastric cancer treated with folfiri regimen.


Eligibility criteria:
inclusion criteria:subjects should meet all of the following criteria to participate in the trial. * histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy * subjects who are expected to receive toxicity test at least once after folfiri treatment. * aged 18 years or older. * ecog performance status of ≤ 2. * anticipated life expectancy of ≥ 3 months. * clinically acceptable function of bone marrow, kidney and liver function as below. 1. anc ≥ 1500/mm3 and platelet count ≥ 100,000/mm3 2. serum total bilirubin ≤ 1.5 x uln, alkaline phosphatase ≤ 2.5 x uln, serum alt and ast ≤ 2.5 x uln (serum alt and ast ≤ 5 x uln, if liver metastases are present) 3. serum creatinine ≤ 1.5 mg/dl or clcr \> 60 ml/min * subjects whose written informed consent can be obtained prior to their participation in the trial. exclusion criteria: subjects who meet any of the following criteria should not be included in the trial. * pregnant or breast feeding women * serious concurrent complication, severe active infection. * subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis * subjects with epilepsia or severe psychiatric disorders. * subjects who are regarded to be unsuitable for this trial by the investigator. * subjects who are participating in other clinical trials * subjects who have received prior chemotherapy including irinotecan.

Keywords: colorecatal cancer gastric cancer irinotecan ugt1a1 neutropenia
the effect of 12 lead ecg telemetry on reperfusion time in resource-limited settings

Conditions: Myocardial Infarction; STEMI

Summary: this study aims to determine whether prehospital 12 lead ecg telemetry decreases the time to reperfusion in patients presenting with stemi. a randomised controlled trial will be conducted in gauteng and the western cape among 100 adult patients (\>18 years) presenting with st-elevation myocardial infarction according to a specific inclusion and exclusion criteria outlined in the full protocol. consenting patients will be randomly assigned to have their prehospital ecg sent to the receiving cardiac facility or not. the onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the two groups by using the fisher's exact test and a simple unpaired student's t-test. data will also be subjected to multivariate analysis of variance to test for statistical significance within a variety of factors that may influence reperfusion times.


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years of age) * patients presenting within the gauteng or western cape areas * current chest pain or dyspnoea, presumed to be of cardiac origin * st-elevation (stemi) on the ecg (defined as st-elevation of 0.1 mv in two or more contiguous leads). exclusion criteria: * non-adult patients * chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology) * non-consent to inclusion within the study * patients without medical aid or who states that they cannot afford private healthcare. * non-st-elevation myocardial infarction
hypothermia and the effect of ambient temperature

Conditions: Hypothermia

Summary: neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. the investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. operating room temperature will be randomized to the current institutional standard (67°f) or a temperature of 73°f on a weekly basis for a period of six months.


Eligibility criteria:
inclusion criteria: * all pregnant women and their neonates undergoing cesarean delivery by the parkland hospital obstetrics service on the labor and delivery "west" unit (operating rooms 1, 2, 3, and 5) during the study period. exclusion criteria: * subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
dcs versus des for one-month dapt in patients with acs: one-pass trial

Conditions: Acute Coronary Syndrome

Summary: to test whether the polymer-free drug-coated stent (dcs) biofreedom is noninferior to the biodegradable polymer drug-eluting stent (des) ultimaster in terms of 1-year patient-oriented composite endpoint (poce, composite of all-cause mortality, any mi, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (dapt) strategy (1-month dapt followed ticagrelor monotherapy) after acute coronary syndrome.

this trial is an open-label, randomized, multi-center study. patients with acs requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of dcs group or des group. after the index procedure, dapt (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. after this, ticagrelor monotherapy will be maintained for 11 months. clinical events will be evaluated within 12 months after randomization.

Eligibility criteria:
inclusion criteria: 1. age ≥19 years 2. all subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome 3. provision of informed consent exclusion criteria: 1. current or potential pregnancy 2. need of oral anticoagulation therapy 3. inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Keywords: acute coronary syndrome drug-eluting stent dual-antiplatelet therapy ticagrelor
the genetic basis for familial cardiomyopathy in patients with idiopathic cardiomyopathy

Conditions: Cardiomyopathy

Summary: in many of the patients with cardiomyopathy, the etiology is not clear . in about 30% there is a family history of cardiomyopathy .our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.

a total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.

Eligibility criteria:
inclusion criteria: * history of cardiomyopathy * etiology not known * family history of cardiomyopathy * ability to understand and sign the informed consent exclusion criteria: * refusal to participate * pregnancy * current participation in another active treatment study

Keywords: familial cardiomyopathy genetics analysis
a study of ak112 in advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: phase ib/ii open label, multicenter study to evaluate the efficacy and safety of ak112 (anti-pd-1 and vegf bispecific antibody) combined with ak117（anti-cd47 antibody）with or without chemotherapy in advanced malignant tumors


Eligibility criteria:
inclusion criteria: 1. 18 to 75 years old. 2. have a life expectancy of at least 3 months. 3. have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. phase ib:histologically or cytologically confirmed advanced solid tumor. 5. phase ii: cohort 1 : has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or gej adenocarcinoma. cohort 2 : has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic biliary tract cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. cohort 3 : has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma. cohort 4 : has a histologically or cytologically confirmed stage iiib/iiic (american joint committee on cancer \[ajcc\] 8th edition) nsclc that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous nsclc;have previously received egfr-tki treatment and have progressed on or following. 6. have at least one measurable lesion based on response evaluation criteria in solid tumors (recist) 1.1 assessed by investigator. 7. has adequate organ function. exclusion criteria: 1. undergone major surgery within 30 days prior to the first dose of study treatment. 2. active central nervous system (cns) metastases. 3. history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. active hepatitis b or hepatitis c. 5. received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. history of severe bleeding tendency or coagulation disorder.