Kornimate/medical-research-clean huggingface dataset:
resistance exercise effects on fear avoidance and physical function in obese older adults with low back pain

Conditions: Low Back Pain; Obesity

Summary: the purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.


Eligibility criteria:
inclusion criteria: * chronic low back pain for \>6 months * \>3 pain episodes per week * waist circumferences ≥102 cm for men * waist circumferences ≥ 88 cm for women * willing and able to participate in regular exercise for 14 weeks * using pain medications to control low back pain * free of abnormal cardiovascular responses during a screening graded maximal walk test exclusion criteria: * unable to walk * participating in regular resistance exercise training (\>3x week) in the past 6 months * pain symptoms are too severe and prevent strength testing or walking * acute back injury * spinal stenosis that precludes walking one block due to neurogenic claudication * back surgery within the past 2 years * current use of weight loss interventions (drugs; exercise interventions)

Keywords: low back pain obese fear avoidance disability and low back pain chronic low back pain in obese older adults
uncovering the difference between ranibizumab and aflibercept, focusing on systemic anti-vascular endothelial growth factor (vegf) effects in patients with neovascular age-related macular degeneration (amd)

Conditions: Neovacular Age-related Macular Degeneration

Summary: this study assessed systemic vascular endothelial growth factor (vegf) level in patients with neovascular age-related macular degeneration following treatment with ranibizumab or aflibercept. free plasma vegf-a level was measured in this study .


Eligibility criteria:
key inclusion criteria * newly diagnosed age-related macular degeneration (amd) * no previous treatment received for diagnosed amd * visual acuity 6/7.5 to 6/96 key exclusion criteria: * standard exclusion criteria for anti-vegf treatment * visual acuity \<6/96 * namd in both eyes, or any condition in other eye which may have required anti- vegf treatment during study period * other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period * participation to other clinical study with 'not approved' treatment within a year prior to unravel study participation.

Keywords: namd, vegf, vegf agent, bcva, crt, ranibizumab, lucentis, aflibercept, eylea
paragon platform for outcome, quality of life, and translational research on pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: due to the generally poor prognosis, with no chance of long-term survival, health related quality of life is a very important objective in the treatment of patients with pancreatic cancer. the non-interventional, prospective, multicentre paragon study is desinged to evaluate the health-related quality of life in patients with metastatic pancreatic cancer, by analyzing the course of qol throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to eortc scoring manual and patient reported outcome.

pancreatic cancer is often diagnosed at an advanced stage, because most of the patients have no symptoms until the cancer metastasized. in the majority of study cases pancreatic cancer research focuses on therapy outcomes and prognosis. with poor prognosis and no chance of long-term survival, quality of life becomes a very significant purpose of pancreatic cancer care. the paragon study is designed to see a bigger picture by acquiring data on quality of life (qol) and further outcome of patients with localized, locally advanced and metastatic pancreatic cancer and moreover to establish a sample collection for future biomarker analysis. the multicenter, prospective, permanent, register study paragon collects outcome data, patient reported outcomes (pro), and tumor tissues of pancreatic cancer patients of both sexes and ages over 18 at approx. 80 german study sites. patients diagnosed with pancreatic adenocarcinoma planned for (or recently started with) neoadjuvant, adjuvant or 1st line therapy can be included into the study. the data assessment includes data on demography, basic parameters, anamnesis, comorbidities, therapies, outcome and survival data as well as patient reported outcome in qol at baseline and every 8 weeks. paragon's first objective is to determine the course of qol throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to eortc scoring manual and patient reported outcome. secondary outcome measurements are e.g. progression-free, disease-free and overall survival according to treatment line.

Eligibility criteria:
inclusion criteria: * written informed consent and signed data protection form before any study specific intervention, including screening, will be done * age ≥ 18 years * histologically or cytologically confirmed pancreatic adenocarcinoma * systemic neoadjuvant, adjuvant, 1st line systemic therapy is planned or recently started (within last 14 days) exclusion criteria: * patients who are unable to consent because they do not understand the nature, significance and implications of the study * patients who are unable to understand or fill out the qol survey * patients in 2nd or further treatment lines that have not been documented for 1st line therapy within the study

Keywords: pancreas quality of life pro pancreatic adenocarcinoma
hrt versus etidronate for osteoporosis and fractures in asthmatics receiving glucocorticoids.

Conditions: Osteoporosis

Summary: to determine and compare the effects of hormone replacement therapy (hrt), etidronate, hrt plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

multicentre trial involving 13 hospitals in united kingdom, with patients entered by 17 consultant chest physicians. consenting patients were randomised in a central office to either hrt, etidronate, hrt plus etidronate or no treatment. information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.

Eligibility criteria:
inclusion criteria: * postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year. exclusion criteria: * hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

Keywords: hrt etidronate fractures osteoporosis asthma glucocorticoids
bioequivalence study (candesartan 16 mg and amlodipine 10 mg)

Conditions: Hypertension

Summary: the purpose of this study is to compare the safety and pharmacokinetics of hl068 (candesartan 16 mg and amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy male volunteer in the age between 19 and 55 years old. * body mass index (bmi) in the range of 18.5 to 27.0 kg/m2 * understand the requirements of the study and voluntarily consent to participate in the study. exclusion criteria: * previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease. * history of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. * subjects with a hereditary problems, for example, galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * subjects whose clinical laboratory test values are outside the accepted normal range. especially, astor alt \>1.5 times of the upper normal limit or total bilirubin \> 1.5 times of the upper normal limit * positive test results for hepatitis b antibodies, hepatitis c virus antibody, and syphilis regain test * participation in any clinical investigation within 3 months prior to study drug administration * subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing. * sbp ≥ 140 mmhg or\< 115 mmhg, dbp ≥ 90 mmhg or \< 70 mmhg * caffeine \> 400mg/day * alcohol \> 30g/day * cigarette \> 10 cigarettes/day. * subjects who are judged unsuitable by investigators
long-term study of teduglutide in pediatric subjects with short bowel syndrome who completed the ted-c13-003 study

Conditions: Short Bowel Syndrome

Summary: the purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (sbs) who completed the ted-c13-003 study over a long-term period. it will evaluate how these children fared after the ted-c13-003 study ended. this study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in ted-c13-003.


Eligibility criteria:
inclusion criteria: 1. subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures. 2. subject completed the ted-c13-003 study (including subjects in the standard of care treatment arm). 3. subject understands and is willing and able to fully adhere to study requirements as defined in this protocol. exclusion criteria: there are no exclusion criteria for this study.
safety and efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naive

Conditions: Prostate Cancer

Summary: the purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of ipilimumab (yervoy™) in patients with metastatic castration resistant prostate cancer.

prostate cancer clinical trials working group 2 (pcwg2) response evaluation criteria in solid tumors (recist)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * prostate cancer with metastases * prostate cancer should be castration resistant * progression during hormonal therapy exclusion criteria: * visceral metastases (eg liver, lung or brain metastases) * prior treatment with any immunotherapy for prostate cancer * prior or ongoing cytotoxic therapy for prostate cancer * autoimmune disease * inadequate hematologic, renal, or hepatic function
bacteria elimination in retreatment cases using different disinfection techniques

Conditions: Root Canal Infection; Periapical; Infection

Summary: nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.it has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. supplementary disinfection techniques such as irrigation agitation methods can help elimination of bacteria from root canal systems. the aim of this in vivo study was to compare the effect of passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic retreatment cases with periradicular lesion by using polymerase chain reaction (pcr)in a single visit root canal treatment.

thirty-six teeth with a single root and a single canal with posttreatment apical periodontitis which needed retreatment were selected for this study. teeth were randomly divided into 3 groups according to the supplementary disinfection techniques used: passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy. microbiological samples were taken before any intervention, after conventional chemo-mechanical preparation, and after disinfection techniques with sterile paper points and held in thioglycollate broth, and then were transferred to the microbiological laboratory. the amounts of e.faecalis in these samples was measured by using pcr.

Eligibility criteria:
inclusion criteria: patients with no clinical symptoms endodontically treated teeth single rooted teeth exclusion criteria: teeth with fractured instrument, resorption, perforation, ledge, over fillings periodontal pockets deeper than 4 mm

Keywords: photodynamic therapy diode laser
rectal misoprostol and blood loss during abdominal hysterectomy

Conditions: Blood Loss

Summary: hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.

in this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. the reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

Eligibility criteria:
inclusion criteria: a- age: adult female \>18 years old. b- any women undergoing abdominal hysterectomy. c- no contraindications to misoprostol. exclusion criteria: a -women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease. b- known history of or active medical disorder as dm . c- pelvic endometriosis and adnexal mass. d- those who had undergone previous myomectomy. e- women who received gnrh analogues and mifepristone and who are allergic to prostaglandins. f- women with mental impairment or incompetent in giving consent. g- women who don't wish to participate in the study.

Keywords: hysterectomy misoprostol blood loss
open pilot trial evaluating an avatar-guided intervention for emerging adults with alcohol use problems and suicide risk

Conditions: Binge Drinking; Suicidal Ideation

Summary: this study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.

this study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. the main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge. ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department). all ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (ea-avatar) for 12 weeks in addition to usual emergency department care. participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. they will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols. based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.

Eligibility criteria:
inclusion criteria: * emergency department admission for alcohol- or suicide-related reason * aged 18-29 * speak, read, and understand english * binge drinking and alcohol use problems in the past month * active suicidal ideation in the past month * owning and having access to a personal smartphone exclusion criteria: * severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation * at imminent safety risk and need to be on a 1:1 observation, in which case research may interfere with their clinical care in the emergency department * under arrest or a prisoner/inmate * not interested or are unwilling to use an avatar-guided digital intervention

Keywords: alcohol suicidal thoughts open pilot trial
comparing the efficacy of wechat-based patient education and conventional patient education in the management of helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education

Summary: we conducted a retrospective study to compare the efficacy of wechat-based patient education and conventional patient education in the management of helicobacter pylori eradication.

this is a single-institute retrospective study comparing the efficacy of wechat-based patient education and conventional patient education in the management of helicobacter pylori eradication. we identified all patients aged between 18-75 years old and had been prescribed a 14-day course of bismuth-contained quadruple therapy for h. pylori infection in our outpatient clinics between 1 july 2019 and 31 july 2021. h. pylori infection was confirmed by any two positive outcomes of rapid urease test,13c-urea breath test (ubt) and histopathology. patients who had h. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved. the main indicator is eradication rate, as the secondary indicators are compliance and adverse events.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75 years old and have not been treated before. exclusion criteria: * patients who had h. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

Keywords: helicobacter pylori eradication patient education wechat group
a study of (ly3527727) pirtobrutinib in participants with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma

Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma

Summary: study j2n-mc-jz01 (jz01) is an individual-study appendix (isa) under master protocol j2n-mc-jzny, and represents participants from the completed originator study, clinical study loxo-btk-18001/j2n-ox-jzna. participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. this study will evaluate the long-term safety and efficacy of pirtobrutinib.


Eligibility criteria:
inclusion criteria: * are currently enrolled and active in the originator study, 18001. a participant is considered active in the study if they are: * receiving study intervention * in the short-term follow-up period, or * in the long-term follow-up period. exclusion criteria: * were a participant in the phase 1b cohort of study 18001. * are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend to breastfeed during the study or within 1 week of the last dose of study treatment.
nutritional and metabolic disorders in hiv infected children and adolescent

Conditions: HIV-1

Summary: the advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal hiv infection in senegal. however, the transformation of hiv into a chronic disease needing lifelong antiretroviral treatment (art) raises new challenges, among others related to a disturbance of glucose metabolism, lipid abnormalities, in addition to the potential effects on children's growth and puberty. little is known on nutritional and metabolic changes in hiv-infected children on art in africa, while implementation of the latest who recommendations should eventually lead to an increase in the number of children on art in this region. moreover, bio-clinical evolution of untreated children is poorly documented in the african context. it therefore urgently needed to institute a cohort study to evaluate, in the long term, the impact of hiv infection and/or art on nutritional and metabolic disorders and to characterize the risk factors of their occurrence in children and adolescents infected as they move through adolescent into adulthood.


Eligibility criteria:
inclusion criteria: * hiv-1 infection * age equal or above 2 years and bellow 16 years * follow-up in the participating site * informed consent signed by at least on of the parents or legal guardian who is aware of the child's hiv status exclusion criteria: * hiv-2 or hiv-1+2 infection * children represented by a legal guardian who is not informed about the child's hiv status * unable to comply with study requirements or procedures according to the investigator's opinion

Keywords: hiv-1 child adolescent growth lipodystrophy arv treatment senegal
influence of patient choice of intrathecal morphine on post-cesarean delivery pain.

Conditions: Pain

Summary: this is a randomized controlled study that will place patients into a "choice" and a "no choice" group. the choice group will be able to choose between receiving 100 mcg or 200 mcg intrathecal morphine. the no choice group will be randomized to receive either 100 mcg or 200 mcg of intrathecal morphine. following casarean delivery, pain scores will be measured at 3, 6, 12, 24, and 36 hours.

this randomised controlled study will include pre-operative screening with a 2 simple questionnaires and the patient will be randomised into a "choice" and "no choice" groups. the group with the choice will be offered 2 different doses of intrathecal morphine (100, 200 mcg) which they can decide on after being given a standard script explaining advantages and disadvantages of each dose. following cesarean section patients will be followed up at 3, 6, 12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus.

Eligibility criteria:
inclusion criteria: * women age 18-50 with singleton, term gestation fetuses and scheduled for their 1st, 2nd, or 3rd elective cs (not in labor) will be included. exclusion criteria: * patient refusal.
pharmacodynamic study to compare acute effects of dihydroergotamine mesylate (dhe) on pulmonary arterial pressure

Conditions: Healthy

Summary: compare the acute effects and tolerability of dihydroergotamine mesylate (dhe) delivered by oral inhalation (map0004) versus by intravenous (iv) infusion in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: 1. able to provide a signed, executed written informed consent 2. healthy non-smoking adult volunteers: male or female subjects 18 to 45 years old 3. female subjects who are practicing adequate contraception 4. stable cardiac status 5. normal hemoglobin values 6. normal echocardiogram 7. normal or not clinically significant 12-lead electrocardiogram 8. demonstrated ability to properly use the tempo® inhaler 9. subject has not donated blood in the last 56 days exclusion criteria: 1. contraindication to dihydroergotamine mesylate (dhe) 2. use of any excluded concomitant medications within the 10 days prior to visit 1 3. history of hemiplegic or basilar migraine 4. participation in another investigational trial during the 30 days prior to visit 1

Keywords: healthy volunteers