Kornimate/medical-research-clean huggingface dataset:
the analysis of immuno-nutrition index in advanced gastric cancer receiving preoperative treatments

Conditions: Gastric Cancer; Neoadjuvant Chemotherapy; Neoadjuvant Chemoradiotherapy; Systemic Inflammatory Response Syndrome (SIRS); Nutrition Aspect of Cancer

Summary: based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. with the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

the immune (systemic inflammation) index includes: nlr (neutrophil-to-lymphocyte ratio); plr (platelet-to-lymphocyte ratio); sii (systemic immune-inflammation index); gps (glasgow prognostic score); mgps (modified glasgow prognostic score); pi (prognostic index); the nutrition index includes: nrs2002; pni (prognostic nutrition index);

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma * received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy * diagnosed clinical advanced gastric cancer or esophagogastric cancer exclusion criteria: * lack of immuno-nutrition data
rebeccamycin analogue in treating patients with refractory stage iii or stage iv ovarian epithelial cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage iii or stage iv ovarian epithelial cancer.

objectives: i. determine the response rate to rebeccamycin analogue in patients with refractory stage iii or iv ovarian epithelial cancer who have failed platinum in combination with paclitaxel chemotherapy. ii. determine the toxicities of this treatment regimen in these patients. outline: patients receive rebeccamycin analogue iv over 60 minutes on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients with complete response after receiving 3 courses receive 3-6 additional courses. patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses. patients with complete response are followed every 2 months for 2 years, and then every 3 months thereafter. all other patients are followed every 3 months. projected accrual: a total of 18-39 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed stage iii or iv ovarian epithelial cancer platinum resistant disease as defined by disease progression during or within 6 months of receiving prior paclitaxel combined with cisplatin or carboplatin no elevated ca-125 as only evidence of disease recurrence measurable disease at least 20 mm in diameter by conventional techniques or at least 10 mm in diameter by spiral ct scan no known brain metastases patient characteristics: age: 21 and over performance status: ecog 0-2 life expectancy: greater than 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin normal ast and alt no greater than 2.5 times upper limit of normal renal: creatinine normal or creatinine clearance greater than 60 ml/min other: no history of allergic reactions to compounds of similar chemical or biologic composition to rebeccamycin analogue no other prior cancer within the past 5 years except nonmelanomatous skin cancer no other medical problems that would preclude study not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 4 weeks since prior chemotherapy endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: no other concurrent therapeutic agents for cancer

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer
the analgesic efficacy of continuous sub-fascial bupivacaine infusion and lidocaine patches in post-cesarean patients with opiate use disorder: a comparative efficacy analysis

Conditions: Opioid-use Disorder; Opioid Use; Opioid Dependence; Opioid Abuse; Medication Assisted Treatment; Infusion Catheter, Wound; Lidopatch; Ambu ACTion; Pregnancy Related; Cesarean Section

Summary: pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after cesarean delivery. post-operative pain scores and opioid usage in the post-operative period will be recorded.

pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (mat), will be enrolled in the study and randomly assigned to one of two study groups. the first group will receive a lidocaine/menthol patch at the time of her cesarean delivery, the second will receive placement of the ambu action infusion pain system at the time of the c-section. this device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Eligibility criteria:
inclusion criteria: * pregnancy * undergoing a cesarean delivery via a transverse incision at york hospital labor and delivery * documented history of chronic opioid use or documented oud, or currently utilizing medically assisted treatment (mat) exclusion criteria: * patients with a history of clinically significant cardiovascular, hepatic, or renal disease * non-english speaking * allergy to bupivacaine, lidocaine, zinc, silver or menthol * unable to consent, due to lack of decisional capacity or need for emergent cesarean delivery * history of glucose-6-phosphate deficiency * use of anti-arrhythmic drugs such as tocainide or mexiletine
clinical efficacy and safety of neoial hc for intra-articular use in the treatment of severe knee osteoarthritis

Conditions: Osteoarthritis of Knee

Summary: osteoarthritis (oa) is one of the most frequent causes of pain and disability in adults. according to the osteoarthritis research society international (oarsi), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. knee osteoarthritis (oa) is the eleventh leading cause of years lived with disability according to the world health organization. the guidelines show that treatment with intra-articular injections of hyaluronic acid (ha) leads to a slow, prolonged pain relief (up to six months after the first injection); on the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis. the present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of neoial hc for the treatment of symptomatic knee oa


Eligibility criteria:
inclusion criteria: * age * knee oa * vas \> 3 * kellegren radiographic stage 3-4 exclusion criteria: * presence of joint effusion, * vas score \<3 according to the american college of rheumatology criteria * neoplasms, * haematological diseases, * specific rheumatological pathologies, * bleeding disorders, local infections, * refusal or non-compliance of the patient, * candidacy for knee joint replacement or any intra-articular injection during the previous year, * addiction to opioid drugs, * recent heart attack or stroke.

Keywords: osteoarthritis knee hyaluronic collagen neoial gonarthrosis
intrathecal morphine vs. us-guided bilateral posterior quadratus lumborum block in cesarean section

Conditions: Anesthesia; Postoperative Pain

Summary: in this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (qlb2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.

postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. an ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. different options for pain control include central blocks, peripheral blocks, and systemic medications. intrathecal morphine (itm) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. however, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. on the other hand, the quadratus lumborum block (qlb), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. the aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (itm) and posterior quadratus lumborum in the management of acute postoperative pain after a cesarean section. this study is a single-center, double-blind, prospective observational study. patients will be divided into 2 groups. group 1: the group receiving intrathecal morphine (itm) group 2: the group receiving posterior quadratus lumborum block in elective cesarean section cases under spinal anesthesia, the patient group receiving itm and posterior qlb will be evaluated for obstetric general well-being during the first 24 hours and at discharge. total morphine consumption in the first 24 hours, pain scores (nrs) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.

Eligibility criteria:
inclusion criteria: * pregnant for at least 37 weeks * aged between 18 and 45 * asa (american society of anesthesiologists) physical status score ii * patient planned for elective cesarean section under spinal anesthesia * patient receiving qlb-ii block or intrathecal morphine exclusion criteria: * asa score of iii or iv. * planned cesarean section under general anesthesia. * requirement for conversion to general anesthesia after failed spinal anesthesia. * contraindication to spinal anesthesia and regional anesthesia techniques. * bmi greater than 35 kg/m². * history of opioid use disorder or opioid use for more than 4 weeks. * inability to assess pain scores. * pregnancies of less than 37 weeks gestation. * history of allergy to local anesthetics and systemic opioids. * patient refusal

Keywords: cesarean section intrathecal morphine posterior quadratus lumborum block
clinical study investigating the efficacy of a mouthwash in providing long term relief from dentinal hypersensitivity

Conditions: Dentin Sensitivity

Summary: the aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (dh) compared to brushing with a standard fluoride dentifrice alone. this will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline schiff sensitivity score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline visit. participants will be assessed at baseline, and at four and eight weeks to monitor clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: * participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years. * participants with minimum of 20 natural teeth. * at screening, a minimum of four, non-adjacent teeth. 1. teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. 2. teeth with gingival index score ≤1 and a clinical mobility of ≤1. 3. teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin. exclusion criteria: * presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. * any condition which, in the opinion of the investigator, causes dry mouth. * tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. * in the 8 weeks prior to screening use of an oral care product indicated for the relief of dh.
post market clinical follow-up of euroscup fixe acetabular cup

Conditions: Hip Arthropathy; Hip Osteoarthritis; Hip Necrosis; Hip Fractures; Hip Dysplasia; Hip Arthritis

Summary: euroscup fixe is intended for use in primary and revision total hip replacement surgery. hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. as part of post market vigilance, euros will collect data on euroscup fixe performances and safety

post market observational study. this study is retropective and prospective, non comparative.

Eligibility criteria:
inclusion criteria: * patient who received euroscup fixe. * patient informed of its participation to the study * patient aged between 18 and 80 years old (\<80). exclusion criteria: * patient presenting a contraindication to euroscup fixe implantation. * patient who refused to participate to the study * vulnerable subjects
intranasal oxytocin for infants with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with prader-willi syndrome who are in nutritional phase 1a. videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

the overall objective of this phase 2 trial is to compare the change from baseline to morning of day 6 of internasal oxytocin (in-ot) on suck and swallow competency in infants/children with prader-willi syndrome (pws) who are in nutritional phase 1a. study hypothesis 1: the study team hypothesize that replacing oxytocin (ot) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding. study hypothesis 2: the study team hypothesize that replacing ot in infants and children with pws will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant.

Eligibility criteria:
inclusion criteria: 1. individuals with genetically confirmed pws who are in nutritional phase 1a, as determined by pi 2. physical exam and laboratory results that are within the normal range. 3. presence of a parent/caregiver/guardian that is able to consent for their participation. exclusion criteria: 1. exposure to any investigational agent in the 30 days prior to randomization. 2. prior chronic treatment with oxytocin. 3. a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.
the efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with su (sulphonylurea) alone or in combination with metformin. all subjects will continue their pre-trial su treatment with or without metformin treatment without changing the frequency or dose throughout the trial.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * hba1c 7.0-9.0% (53-75 mmol/mol) (both inclusive) * subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (visit 1) * body mass index (bmi) below or equal to 40 kg/m\^2 exclusion criteria: * any use of oral anti-diabetic drugs (oads) (other than su in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (visit 1) * use of any drug (other than su in monotherapy or in combination with metformin), which in the investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids) * previous treatment with glucagon-like peptide-1 (glp-1) receptor agonist (e.g. exenatide, liraglutide) * treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator) * screening calcitonin above or equal to 50 ng/l * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2) * cardiovascular disorders defined as: congestive heart failure (new york heart association (nyha) class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures * proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the investigator's opinion * subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus),neurological, genitourinary or haematological system that in the opinion of the investigator,may confound the results of the trial or pose additional risk in administering trial product * history of chronic pancreatitis or idiopathic acute pancreatitis
beyond performance status: electronic activity monitoring to assess functional activity of patients with gastrointestinal malignancy during chemotherapy.

Conditions: Gastrointestinal Cancer

Summary: electronic activity monitoring (eam) devices are wearable electronic devices that monitor functional activity and provide personal feedback on activity progression. this study aims to determine if eam can provide an objective, assessment of patient functional activity. the study will also examine the change in functional activity experienced by patients during the first cycle of chemotherapy. another objective of the study will be to see if baseline functional activity and the change in functional activity that occurs during the first cycle of chemotherapy can be used to predict patient tolerability of subsequent cycles of chemotherapy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gastrointestinal malignancy. * age ≥ 18 years * planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. subjects may enroll prior to chemotherapy or during the first cycle of treatment. exclusion criteria: * restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months. * refusing systemic chemotherapy. * concurrent radiotherapy with chemotherapy * have received at least one cycle of chemotherapy in the current chemotherapy regimen.

Keywords: electronic activity monitoring (eam) 16-493
cali sin tos aim 2

Conditions: Tuberculosis

Summary: the overall objective of this aim is to design and iteratively adapt a home-based, mhealth- and oral testing facilitated strategy for implementing tuberculosis (tb) contact tracing in cali, colombia. investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mhealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial. this protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mhealth strategy (i.e., nominal group technique).

this study will examine the diagnostic performance of oral samples for tb molecular testing in clinic and household settings; as well as utilize a community-engaged design methodology to iteratively refine a mhealth strategy for implementing contact tracing optimized for feasibility, acceptability, usability, and appropriateness. there is a certificate of confidentiality in place for this study. after contact tracing procedures have concluded, investigators will administer study instruments to characterize the feasibility, acceptability, appropriateness, and usability of the chatbot. investigators will also conduct up to \~12 key informant interviews with purposively sampled index persons with tb and their household contacts to elicit views on the mhealth strategy during each cycle (for a total of up to \~36 key informant interviews). after \~40 households (index persons with tb and their household contacts) have been enrolled using these procedures, and all scales and key informant interviews have been completed, the mhealth implementation strategy will be adapted using nominal group technique. investigators will repeat this cycle twice for a total of three rounds of design and adaptation of chatbot-facilitated contact tracing procedures.

Eligibility criteria:
inclusion criteria: for index persons with tb: * assigned by the soph to receive contact investigation services from the study community health worker * may be of any age (represented by a parent or legal guardian for those age\<18) for contacts of index persons with tb: * include the index person's named household contacts, defined as those spending one or more days or nights within the past 3 months sleeping under the same roof as the index person; * may be of any age (represented by a parent or legal guardian for those age\<18). exclusion criteria: for index persons with tb: * who are living outside the city of cali; * who lack capacity to agree to testing. for contacts of index persons with tb: * who have already been diagnosed with and treated for active tb within the past two years; * who lack capacity to agree to testing.