Kornimate/medical-research-clean huggingface dataset:
child healthcare at mater - pediatric study

Conditions: Opioid Use Disorder

Summary: the objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. qualitative and quantitative data will be collected at multiple time points. the efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

this is a single-site cluster randomized controlled trial. over an 18-month period, 108 pregnant women receiving treatment for opioid use disorder will be identified, screened, and enrolled into the study. beginning with the birthdate of the first infant born in the study, 18 consecutive 1-month birth intervals will be randomized in a 1:1 ratio to one of two study arms: (1) group well child care or (2) individual well child care. nine birth clusters will be randomized to individual well child care(control arm) and nine birth clusters will be randomized to group well child care(intervention arm), with concealment of randomization from enrolled participants until they give birth. all study participants will be included in the study until their child is approximately 18 months of age. all study participants will have a total of 5 assessment visits with research personnel; visits will occur immediately following enrollment into the study (baseline), prior to the participant's child turning 1 month of age, and within 4 weeks of the participant's child turning 6, 12, and 18 months of age. the efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

Eligibility criteria:
inclusion criteria: * at least 28 weeks pregnant or less than 2 weeks postpartum * receiving treatment for opioid use disorder * ability to read and speak english * plans to parent infant after delivery * intent to seek pediatric care within nemours/thomas jefferson university system * intent to remain in the philadelphia area for the next 2 years exclusion criteria: * inability to speak english * plans to move outside of the philadelphia area in the next 2 years * plans to not parent infant after delivery * plans to seek pediatric care outside of the nemours/thomas jefferson university system following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.

Keywords: group well child care child developement parenting behavior healthcare quality healthcare experience
the efficacy and safety of adjuvant immunotherapy after pathological complete response following neoadjuvant chemoimmunotherapy in patients with resectable nsclc

Conditions: Resectable/Potentially Resectable NSCLC

Summary: this is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of nsclc patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.


Eligibility criteria:
inclusion criteria: 1. 18 years ≤ age ≤ 80 years; 2. histologically or cytologically confirmed nsclc; 3. resectable stage ib, ii, iiia, or iiib (n2) nsclc according to the staging criteria of the american joint committee on cancer (8th edition); 4. eastern cooperative oncology group (ecog) performance status score 0-1 at baseline; 5. with measurable or evaluable diseases according to the response evaluation criteria in solid tumors, version 1.1 (recist 1.1) at baseline; 6. achieving pathological complete response (pcr) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens; 7. with or without adjuvant immunotherapy postoperatively; 8. signed and dated written informed consent provided by the patient prior to admission to the study. exclusion criteria: 1. egfr or alk aberrations positive; 2. with primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases; 3. with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration; 4. with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs; 5. receipt of other investigational drugs during the observation period; 6. unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.
wb-dwi for early prediction of therapy response in patients with advanced metastatic gist treated with regorafenib

Conditions: Gastrointestinal Stromal Tumors

Summary: the purpose of this study is to evaluate wb dwi as early predictor of response to treatment with regorafenib or placebo in patients with advanced metastatic gist.

aim of the study - to assess whole body diffusion-weighted magnetic resonance imaging (wb-dwi) for the assessment and early prediction of response of treatment with regorafenib or placebo in patients with advanced, metastatic gastro-intestinal stromal tumors (gist) 1. evaluation of pretreatment apparent diffusion coefficient (adc) and b1000 signal intensity (si) of gist visualized on the wb-dwi as predictor of time to progression, determined by progression-free survival (pfs) 2. evaluation of wb-dwi using changes of high b-value si and adc early during treatment (2weeks after start of therapy; allowed optimal window 10-14 days) as early predictor of time to progression or patient benefit according to recist (stable disease + partial response + complete response) 3. evaluation of wb-dwi for treatment follow-up 3 months after initiation of treatment. confirmation of prior published pilot study (dunet v et al, j nucl med 2010) 4. comparison of wb-dwi with conventional ct imaging for response assessment

Eligibility criteria:
inclusion criteria: * patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo exclusion criteria: * in case of a known contraindication for mri (eg. pacemaker), the patient will not be admitted to the study

Keywords: advanced metastatic gastro-intestinal stromal gist regorafenib
angiosculpt scoring balloon catheter for bifurcation coronary lesions (abc study)

Conditions: Bifurcation Coronary Disease

Summary: assess the impact of lesion preparation using the angiosculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

the purpose of the angiosculpt® scoring balloon catheter for bifurcation coronary lesions (abc registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the angiosculpt scoring balloon catheter (angioscore, inc., fremont, ca) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries

Eligibility criteria:
inclusion criteria: * patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (medina class (x,x,1)). exclusion criteria: * concomitant use of rotablator, cutting balloon, or investigational coronary devices. * additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.

Keywords: angiosculpt bifurcation lesion side branch ivus
quantifying effects of treatment of pediatric dysphonia

Conditions: Voice Disorders; Gastroesophageal Reflux

Summary: the diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. the long-term goal of this research program is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal pathology in children. in the present small grant, our objective is to define assessment methods that are appropriate for use in determining response to treatment. our main focus, therefore, is the issue of assessment responsivity. the first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (eerd). because we are treating children suspected of eerd, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric eerd. accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of eerd. our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment. the proposed research is significant in filling a gap in knowledge in childhood dysphonia assessment and treatment, which are important clinical issues consistent with the mission and intent of the nidcd. because phonatory disorders in children may have lasting negative effects, studies geared toward accurate assessment and treatment are very important.


Eligibility criteria:
inclusion criteria: * chronic dysphonia with suspected extraesophageal reflux exclusion criteria: * previous reflux treatment. * laryngeal disorder treated primarily with surgery

Keywords: behavior therapy combination therapy gastrointestinal disorder chemotherapy human therapy evaluation larynx disorder middle childhood (6-11) lansoprazole reflux esophagitis quality of life clinical research human subject laryngoscopy patient oriented research questionnaire
assessment of actigraphy procedures on the initiation of an apomorphine treatment delivered through a pump to patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of parkinson's disease (pk) patients using an apomorphine pump. to do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.

the two groups are: referent group with one actimetric report at baseline actimetry group with one actimetric report at baseline and during the follow-up. using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient. it is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice: 1 visit before the installation of the pump 1 visit after the pump installation straight after the patient comes out the hospital 1 visit at 6 months

Eligibility criteria:
inclusion criteria: adult suffering from parkinson's disease aged up to 75 years (included) patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines patient who chose the optipark package (orkyn nurses) patient willing to wear the actigraphy bracelet as per the protocol patient who read, understood and signed the consent form. exclusion criteria: patient not willing to take part in the study patient who had a previous set-up of an apomorphine pump patient with dementia dependant patients or patients living in institutional care patient with a temporary pump of apomorphine compromising a six months follow-up patient with non-major motor fluctuations patient already enrolled in an interventional study.

Keywords: actimeter apomorphin pump
comparing inhalation and total intravenous anesthesia methods

Conditions: Children; Hernia, Inguinal

Summary: comparison of anesthesia by target-controlled infusion and inhalation methods on pediatric patients undergoing inguinal hernia repair: effects on patient outcomes

compari̇son of the effect of anesthesi̇a appli̇ed by target controlled infusi̇on method and inhalati̇on anesthesi̇a method on pati̇ent outcomes i̇n pedi̇atri̇c pati̇ents undergoi̇ng ingui̇nal herni̇a repai̇r

Eligibility criteria:
inclusion criteria: * children aged 3-12 years * patients weighing over 10 kilograms * patients who will undergo inguinal hernia surgery * asa (american society of anesthesiologists) classification i and ii pediatric patients. exclusion criteria: * absence of systemic illness. * asa (american society of anesthesiologists) classification iii pediatric patients.

Keywords: bis tiva i̇nfusi̇on i̇ngui̇nal herni̇a
efficacy of ondansetron in lars treatment

Conditions: Rectal Cancer

Summary: patients will be randomized (1:1 ratio) to receive either 4 weeks of ondansetron followed by 4 weeks of placebo (o-p sequence) or 4 weeks of placebo followed by 4 weeks of ondansetron (p-o sequence). it will be one week of washout between the two treatments. during the treatment questionnaires will be completed by the patients to evaluate the efficacy of the study treatment and the quality of live.

this is a multi-centre randomized, double-blind, placebo-controlled, cross-over study aimed at testing the efficacy of ondansetron in the low anterior resection syndrome (lars) occurring as a consequence of surgery for rectal cancer. patients will be randomized (1:1 ratio) to receive either 4 weeks of ondansetron followed by 4 weeks of placebo (o-p sequence) or 4 weeks of placebo followed by 4 weeks of ondansetron (p-o sequence). neither the investigator nor the patient will be aware of the sequence (o-p or p-o) assigned to the patient. one week will elapse between the end of the first treatment and start of the second treatment. the hypothesis to be tested is that 4 weeks of oral ondansetron at the dose of 4mg bid induce a variation of the lars score at least 7 points (20%) greater than the variation occurring after 4 weeks of placebo. the sample size calculated for the primary analysis is 38 evaluable patients. considering an expected attrition rate of about 20%, it is expected to enrol approximately 46 patients in total.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients willing and able to comply with the study procedures * female patients of childbearing potential must agree to use a reliable method of contraception * written informed consent patients who have undergone low anterior resection (lar) for rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy * presence of functioning anastomosis * presence of significant lars symptoms assessed by lars score exclusion criteria: * known hypersensitivity or allergy to ondansetron * previous ondansetron antiemetic therapy completed less than 4 weeks before study entry * antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry * congenital long q-t syndrome * ongoing treatment with drugs causing prolongation of the q-t interval * uncorrected hypokalemia or hypomagnesemia * women who are pregnant or breast feeding or are willing to become pregnant during the study * clinically significant concomitant disease states or anastomotic complications which could impair the ability of the patient to participate in the trial * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
preemptive and preventive use of paracetamol for pain relief after cesarean section

Conditions: Cesarean Section; Dehiscence

Summary: the investigators designed a prospective randomized study to investigate the efficacy of intravenous (iv) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.


Eligibility criteria:
inclusion criteria: 38 weeks pregnancy, elective cesarean section. - exclusion criteria: morbid obesity, cardiac failure, depression.
sugammadex-dosing in bariatric patients

Conditions: Neuromuscular Blockade

Summary: should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? the main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a tof-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). the research hypothesis is that both dosing regimens are equivalent the secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (tof-count 1 - 3) will be compared with very deep block (tof count = 0 and ptc \< 5)


Eligibility criteria:
inclusion criteria: adult patients undergoing bariatric surgery according to the respective criteria of the french medical authority (has) and having given their written informed consent after appropriate information exclusion criteria: not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding

Keywords: bariatric surgery residual paralysis surgical conditions
lactobacillus plantarum and hormonal regulation in obese women

Conditions: Obesity, Women

Summary: to evaluate the regulatory effect of lactobacillus plantans lp90 formula on visceral fat metabolism and sex hormone balance in obese women.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 40 years old, female, bmi ≥ 25 kg/m2. 2. be willing to receive follow-up during the intervention period. 3. be willing to provide two blood, urine and fecal samples during the intervention period. 4. be willing to take the compound probiotics by oneself every day during the intervention period. 5. have good hearing and be able to hear and understand all instructions during the intervention period. - exclusion criteria: 1. suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, crohn's disease). 2. suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia). 3. have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder. 4. take medication for depression or low mood. 5. suffering from internal organ failure (such as heart, liver or kidney failure, etc.). 6. have received radiotherapy or chemotherapy in the past. 7. have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial. 8. have suffered from hepatitis (hepatitis b, hepatitis c), hiv or syphilis in the past. -
a double balloon endoscopic platform for esd

Conditions: Colon Adenoma; Colon Polyp

Summary: the purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.

endoscopic removal of complex colon polyps (benign polyps \>=2cm) is a technically challenging procedure. complex benign polyps have a greater chance of becoming cancerous if not removed. the dilumen™ endolumenal interventional platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. the device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment. the device received 510k clearance on dec 6, 2016. the study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps.

Eligibility criteria:
inclusion criteria: * subjects \> 18 years of age * subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection * subjects willing and able to give informed consent * subjects who in the opinion of the principal investigator have no medical contraindication to endoscopic mucosal resection (emr) or endoscopic submucosal dissection (esd) exclusion criteria: * subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture. * subjects with a history of open or laparoscopic colorectal surgery * subjects with a history of inflammatory bowel disease (ibd) * subjects with a suspected malignancy on polyp assessment

Keywords: endoscopic submucosal dissection
comparison between colloids and crystalloids on coagulation and blood loss

Conditions: Coagulopathy

Summary: infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. however, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids. ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before ringer's. voluven (hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion. the effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode. the amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.

when considering the optimum fluid of choice to achieve hemodynamic stability and the least morbidity, colloids have a theoritical and intuitive advantage. being composed of molecules \>35 kda, colloids have traditionally been thought to have greater fluid efficacy (i.e. they remain in the intravascular space for longer ,thus contributing a greater effect on cardiac output) compared with crystalloids. these theoritical benefits of colloids led to their routine use in goal-directed therapy (gdt). studies in healthy volunteers have demonstrated that crystalloids tend to expand the intravascular volume by about 20% of the infused volume ;however when physiological endpoints have been used in clinical studies , the fluid efficacy of crystalloids increases up to 60%. this discrepancy may be explained by a number of factors, including the time taken for fluid to equilibrate throughout the extracellular fluid , the vaodilating effect of anethetic-indused hypotension on vascular capacitance, and the impairment of fluid elimination because of the surgical stress response. while colloid has been the default fluid choice in most gdt studies to date, recent evidence from both the perioperative anesthestic setting and from intensive care have raised concerns that these agents may produce adverse effects on renal function and coagulation . recent studies have sought to compare the use of crystalloid solutions with colloids for gdt.

Eligibility criteria:
inclusion criteria: * age between 18 to 75 years * undergoing elective colorectal surgery exclusion criteria: * refusal by the patient * patient with cardiac disease * hepatic disease * renal disease * blood disease * patient on regular anticoagulant drug