Kornimate/medical-research-clean huggingface dataset:
promoting caregiver-child attachment and recovery through early intervention (pcare): a pilot randomized control trial

Conditions: Opioid-use Disorder; Substance Use Disorders; Parenting

Summary: this purpose of this study is to use the existing infrastructure and therapeutic relationships developed by early intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, mothering from the inside out, more readily accessible to postpartum women with substance use disorder. this study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. we will also identify key implementation domains that impact successful delivery. we hypothesize that the intervention will be feasible and acceptable to the study participants.


Eligibility criteria:
inclusion criteria: * english speaking * 18 years of age or older * mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery * engaged in formal recovery supports (including but not limited to: recovery coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months * willing to receive parenting supports for the index child through ei * geographically based within the catchment area of participating ei programs exclusion criteria: * severe mental health problems (suicidal, homicidal, psychosis episodes within the past year) * significant cognitive impairment (unable to give informed consent) * has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)
protocol for a feasibility cluster randomised controlled trial of a home-based depression care for older people delivered by lay providers in nigeria

Conditions: Depression in Old Age

Summary: the aim of this hybrid (effectiveness-implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the who mental health gap action programme intervention guide (emhgap-age) in routine home-based care of older nigerians with depression. the main questions it aims to answer are: 1. whether the emhgap-age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial? 2. what are the logistical, programmatic, and operational requirements for a home-delivered emhgap-age in a sample of older people with depression in nigeria? consenting older participants with depression in the intervention arm will receive treatment based on emhgap-age which consists of; * adapted electronic generic version of the who mental health gap action programme intervention guide (emhgap-ig) * adapted problem-solving therapy (pst-pc) * support/supervision of providers * links to social support resources. researchers will compare with treatment based on the basic specification in the generic emhgap-ig (consisting of basic psychoeducation and stress reduction) for effects on depression remission.


Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years, 2. phq-9 score of ≥11 during routine consultation exclusion criteria: 1. severe co-morbidity requiring urgent attention. 2. severe cognitive impairment/dementia (community screening instruments for dementia score≤ 20) . 3. active suicidal intention. 4. evidence of bipolar/psychosis/severe substance use disorders. 5. planning to move out of the study catchment area within 6 months. 6. refusing/lacking capacity to consent/accent
alert frequency, nurse, and patient satisfaction with a wcvsm software across health care systems and cultures

Conditions: User Experience; Postoperative Complications; Acute Medical Conditions

Summary: the goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. the patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. they will in addition have vital signs monitored as per standard practice. the nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. the main aims are: to determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

the participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge. monitoring devices used in this study will be validated fda or/and ce approved devices used within their original purpose. centers can choose to use sotera visimobile or isansys lifeguard with accompanying sensors. these devices will be used together with the ce approved ward web and mobile application. study sites include: st. olav hospital trondheim, royal liverpool university hospital, university medical centre hamburg-eppendorf,university medical centre groningen, the netherlands and the cleveland clinic.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) * expected stay in the hospital ≥2 days * admitted for surgery with expected duration of surgery \>2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff * rr \> 21 breaths pr minute * rr \< 11 breaths pr minute * pulse (p) \> 91 beats pr minute * pulse (p) \< 50 beats pr minute * spo2 \< 94 % without oxygen supplementation * systolic bp \< 110 mmhg * systolic bp \> 220 mmhg exclusion criteria: * participant expected not to cooperate with study procedures. * allergy to plaster or silicone. * pacemaker or implantable cardioverter defibrillator (icd) device. * inability to give informed consent.

Keywords: continuous wireless vital sign monitoring vital sign deviation healthcare system and culture user experience postoperative complications acute medical conditions
use of 68ga-dotatate pet scan in neuroendocrine carcinoma of the gi tract

Conditions: Neuroendocrine Carcinoma

Summary: the purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . this may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (prrt), can be a potential alternative in the future. at this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female ≥ 18 years old * histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary * evidence of measurable disease per recist 1.1 on another imagine modality (ct, mri or fdgpet) with at least 3 tumors \>1cm in largest diameter. ct, mri or fluorodeoxyglucose (fdg)-pet must have been performed within 2 months of the study scan. (of note, participants may sign consent for the study prior to scheduling of said ct, mri or fdg-pet, but will be considered screen failures if the ct/mri/fdg-pet does not reveal at least 3 tumors \>1cm). exclusion criteria: * participants with well-differentiated neuroendocrine tumors * participants who have undergone 68ga-dotatate pet scan in the past * pregnant women and/or breastfeeding women. women of child bearing potential must have a negative pregnancy test prior to scan.
turbopower + dcb treatment of femoropopliteal de novo/ restenotic and in-stent restenosis lesions

Conditions: Peripheral Arterial Disease

Summary: a retrospective study to evaluate turbo power laser atherectomy + drug coated balloon (dcb) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (isr).


Eligibility criteria:
inclusion criteria: * all patients treated for femoropopliteal de novo/restenotic lesions or in-stent restenosis using turbo power laser atherectomy plus drug coated balloon angioplasty exclusion criteria: * any incomplete data on procedural approach and treatment
mechanistic underpinnings of preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is a dreadful disease with significant morbidity and mortality. despite decades of research, we still need a proper diagnostic test or therapeutic option to treat this disorder. the proposed study will determine the diagnostic value of pbmc-secreted sflt1 and determine the molecular mechanisms involved in its secretion. the molecular mechanisms can be novel therapeutic targets to treat this disorder.


Eligibility criteria:
healthy adults: • healthy non-pregnant with previous normal pregnant women non-health adults: • patients will be admitted with the diagnosis of preeclampsia according to the internationally accepted definition of preeclampsia: blood pressure measurement of 140/90 mm hg or an increase of 30 mm hg systolic or 15 mm hg diastolic over baseline values on at least two occasions, six or more hours apart and proteinuria; 300 mg/24 hour after 20th week of gestation. pregnant women: groups 3 - 6 will include pregnant women at different trimesters. criteria common to all groups: * the study will be conducted only in females aged 18 or above. * patients in all the groups will be matched for age, which will be 18 or above. * women will be matched for body mass index; criteria for normal body mass index will be used based on the center for disease control and prevention guidelines. * patients with premature rupture of the membrane, non-preeclamptic preterm labor, iugr, placental abruption, twin? any other complications during the pregnancy will be excluded from the study. * patients with any evidence of genetic or non-genetic malformations of the fetus will be excluded from the study. * the study will be conducted on women who are non-smokers and do not consume alcohol or recreational drugs. * the study will be conducted only on primigravida females to minimize phenotyping variability. * the women with a known history of any chronic disorder, including but not limited to hypertension, diabetes, pulmonary, renal, cardiac, or cerebrovascular disorders, will be excluded from the studies.
safety, tolerability and efficacy of icv ax 250 treatment in mps iiib -ole

Conditions: MPS III B

Summary: this is a phase 3b/4, multicenter, multinational, open label study to further evaluate intracerebroventricular (icv) delivered ax 250 treatment in mps iiib subjects that complete study 250-202 for up to an additional 3 years (144 weeks) of treatment with ax 250 administered by icv infusion every other week. subjects will be evaluated for neurocognitive function, communication, adaptive behavior, quality of life, imaging characteristics and biochemical markers of disease burden. safety will be assessed by adverse events, clinical labs, and physical exams.


Eligibility criteria:
inclusion criteria: 1. must have completed 240 weeks of study 250-202 and enter 250-401 within 8 weeks of dosing completion. 2. provides written informed consent from parent or legal guardian and assent from subject, if required 3. has the ability to comply with protocol requirements in the opinion of the investigator 4. if female with childbearing potential, must have a negative pregnancy test at the screening visit and be willing to have additional pregnancy tests during the study exclusion criteria: 1. has (1) a cognitive age equivalent (aeq ) score ≤ 18 months, (2) a development quotient (dq) score ≤ 20, and (3) no evidence of improvement during the 250-202 study in secondary or exploratory efficacy endpoints 2. would not benefit from enrolling in the study in the opinion of the investigator 3. has received stem cell, gene therapy or enzyme replacement therapy (other than ax 250) for mps iiib 4. has a history of poorly controlled seizure disorder 5. is prone to complications from icv drug administration including patients with hydrocephalus or ventricular shunts 6. has received any investigational medication within 30 days prior to the baseline visit or is scheduled to receive any investigational drug during the course of the study 7. has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's well-being or safety, or the interpretability of the subject's clinical data
jarvik 2000 heart as a bridge to cardiac transplantation - pivotal trial

Conditions: Heart Failure

Summary: the purpose of the study is to determine the safety and effectiveness of the jarvik 2000 heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.

the jarvik 2000 heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. the pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. a vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. the impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven l/minute. at higher speeds the pump can produce 10 l/minute. power is provided through an abdominal drive line.

Eligibility criteria:
inclusion criteria: (the following are general inclusion criteria; more specific criteria are outlined in the study protocol). * transplant listed unos status ia or ib patients. * bsa \>1.5 m2 and \<2.3 m2. * dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (iabp). exclusion criteria:(the following are general exclusion criteria; more specific criteria are outlined in the study protocol). * known risk factors or conditions that would contraindicate lvad implantation or adversely affect patient survival. * evidence of end organ dysfunction. * known coagulopathy or contraindication of anticoagulation or antiplatelet agents. * systemic infection. * malignancies not in remission. * current participation in investigational trials with other devices, drugs, or biologic agents.
colon cancer laparoscopic or open resection

Conditions: Colonic Neoplasms

Summary: color trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. clinical and operative data will be collected centrally in the coordinating centre in rotterdam, the netherlands. quality of life and costs will be assessed on a national basis.

the design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. the trial will be stratified according to participating centre, resection type and gender. disease free survival for all tnm stages after 3 years is currently about 70%. to detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). all analyses will be performed on an intention to treat basis.

Eligibility criteria:
inclusion criteria: * solitary colon carcinoma observed at colonoscopy or on barium enema x-ray within 28-days before operation (no biopsy required) * polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation * suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection * sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema * bmi \< 30 kg/m2 * informed consent according to local requirements exclusion criteria: * carcinoma of the splenic flexure * carcinoma of the transverse colon * signs of acute intestinal obstruction * more than one colon tumour * scheduled need for other synchronous colon surgery * synchronous surgery ofr other intra-abdominal organs * pre-operative indication of invasion of adjacent organs * pre-operative evidence of distant metastases * previous ipsilateral colon surgery * other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease * pregnancy
gemcitabine with curcumin for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. that is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic adenocarcinoma of the pancreas * no prior chemotherapy * performance status 0-2 * adequate hematology and chemistry exclusion criteria: * serious concurrent medical condition

Keywords: carcinoma pancreas gemcitabine curcumin
eosinophilic cystitis mimicking urothelial neoplasia

Conditions: Urinary Bladder Diseases

Summary: we explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. surgical procedure and clinical outcome also evaluated. t

a pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.we explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. surgical procedure and clinical outcome also evaluated. transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.

Eligibility criteria:
inclusion criteria: * clinically suspected urothelial neoplasia exclusion criteria: * patients who did not complete the follow up period
cyclasol for the treatment of signs and symptoms of dry eye disease in subjects who completed cys-004

Conditions: Dry Eye Disease (DED)

Summary: the objective of this trial is to evaluate safety and tolerability of cyclasol during long-term use in subjects with dry eye disease.

phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of cyclasol in subjects with signs and symptoms of dry eye disease. subjects who completed the trial cys-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed cyclasol bilaterally bid for 12 months.

Eligibility criteria:
inclusion criteria: * have completed the clinical trial cys-004 and habe been compliant with trial procedures * signed icf (informed consent form) * subject-reported history of ded in both eyes * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * early termination of cys-004 * clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters * have a history of herpetic keratitis; * have an ocular or periocular malignancy; * be unwilling to avoid wearing contact lenses during the trial; * have any planned ocular or eyelid surgeries during the trial period * be a woman who is pregnant, nursing or planning a pregnancy * unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential * women of childbearing potential not using an acceptable means of contraception * presence of known allergy and/or sensitivity to the study drug or its components * be currently using an investigational drug or device or have used an investigational drug or device within 60 days before visit 1 other than for cys-004 * have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly
nurse-led exercise improves shoulder pain, shoulder disability, and quality of life in head and neck cancer

Conditions: Head and Neck Cancer; Cancer of Head and Neck; Head and Neck Neoplasms

Summary: background: this study aimed to the postoperative patients with newly diagnosed head and neck cancer. the nurse-led counselling and after intervention improved shoulder pain, shoulder disability, and quality of life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks. methods：participants were identified for eligibility from the otorhinolaryngology outpatient department of a medical center in eastern taiwan. the data of 40 patients were collected between aug 1, 2017, and jul 31, 2018. 40 participants were randomly assigned to an experimental (n = 20) and a control group (n = 20). the experimental group received the nurse counselling and after intervention exercise intervention , and the control group received usual care. study tools used were the shoulder pain and disability indices, university of washington quality of life questionnaire.

head and neck cancer (hncs) is malignancies . globally, hncs was the seventh most common cancer in 2018. in taiwan, have high incidences . primary treatments for hncs are surgery alone or in combination with radiation . the radical neck dissection and radiotherapy inevitably damage nerves and muscles, resulting in various complications such as shoulder pain and disability; the shoulder disability and chronic neck pain occur following radical neck dissection, these complications may considerably limit the individual's capacity to undertake various tasks, affecting daily physical activities. immediate postoperative rehabilitation has been advocated to improve these complications in hnc participants . but rticipants often fail to achieve this thresh old, which emphasizes the need to change their inactive behaviour. nurses are involved in patient care and have the necessary skills and knowledge about the medical and practical aspects of head and neck cancer treatment . nurses can provide information, support and coaching to hnc participants .nurses are in a key position to deliver an intervention to improve qol . the investigators designed a randomised controlled trial (rct) to investigate the effectiveness of a comprehensive 12weeks nurse-led intervention, the nurse counselling and after intervention (nucai), in hnc participants follow exercise intervention

Eligibility criteria:
inclusion criteria: aged \>20 years old newly diagnosed with hnc scheduled to receive surgery had no serious complications had no history of mental illness had no comorbidities had no sensory-cognitive problems could understand chinese or taiwanese exclusion criteria: could not communicate or comprehend the questionnaires had a history of shoulder dysfunction before neck dissection had preexisting shoulder pain, dysfunction, or weakness had any disorders that could influence movement performance.

Keywords: head and neck neoplasms