Kornimate/medical-research-clean huggingface dataset:
monitoring response to neoadjuvant chemotherapy by the use of breast proton mr spectroscopy

Conditions: Breast Cancer

Summary: this study is being done to evaluate if mr spectroscopy will give us more information about whether or not your chemotherapy will work for you. spectroscopy is a special set of pictures taken with magnetic resonance imaging (mri) that gives us information about the chemical composition of your breast cancer.

the study aim is to perform mr spectroscopy (1h mrs) on 1.5 tesla (1.5t), using a software package from general electric medical systems, milwaukee, wi on 115 patients with biopsy proven adenocarcinoma of the breast, who will be receiving neoadjuvant chemotherapy as per standard therapeutic protocol, prior to surgical management. the spectroscopic data will be analyzed to determine whether this can enable early prediction of therapeutic response as assessed by recist and ultimately surgical pathology after the completion of the full course of drug treatment. the 1h mrs, which is performed at baseline, prior to treatment, halfway through and at the end of the chemotherapy course, just prior to surgery, will be added to the routine mri examination for the affected breast. since chemotherapy courses vary in length, the exact timeline will depend on the specific course given. 1h mrs will add 10 minutes to the routine mri examination, but will not involve additional injections of contrast. in addition, we will perform two extra mris combined with 1h mrs examinations for the affected breast, one set the day after and the second set one week after the initiation of chemotherapy. the mri and 1h mrs will be performed at memorial sloan-kettering cancer center, 1275 york avenue, ny, ny 10021 or at any offsite of mskcc.

Eligibility criteria:
inclusion criteria: * patients need to be ≥ 18 years of age * patients with biopsy confirmed adenocarcinoma of the breast, scheduled to receive neoadjuvant chemotherapy prior to surgical management. exclusion criteria: * patients who would normally be excluded from undergoing an mri examination include: * patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field * patients who are pregnant * patients who are unable to comply or complete the mri exam such as patients with claustrophobia and patients who have electrically, magnetically, or mechanically activated implants, such as heart pacemakers, certain types of artificial joints, inner ear implants, eye implants, or certain surgical clips used in vascular surgery. * patients who are not candidates for neoadjuvant chemotherapy

Keywords: breast cancer mr spectroscopy neoadjuvant chemotherapy
my health coach app rct

Conditions: Fetal Alcohol Spectrum Disorders

Summary: the goal of this clinical trial is to learn if the my health coach app helps adults with fetal alcohol spectrum disorders (fasd). the main questions it aims to answer are: does the my health coach app improve the quality of life of adults with fasd? does the my health coach app help adults with fasd manage their day to day life? all participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. half of the participants will be given the app at the study start to use. the other half of participants will get the app after the 12 week surveys are complete. researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.

this trial involves a 2-arm randomized controlled trial. participants will be randomized (50:50 allocation) into the (1) my health coach group, or the (2) wait-list control group. the my health coach app is designed to support the quality of life of adults with fasd by providing tools to help with self-management, advocacy, health literacy, use of supports, and engagement in meaningful activities. this study is designed to: (1) evaluate the efficacy of the my health coach app with adults with fasd, (2) test whether changes in competence, autonomy, and/or relatedness mediate intervention outcomes on reported quality of life, and (3) identify app usage patterns that relate to greater outcome improvement. primary outcomes include perceived well-being, the degree to which basic psychological needs of competence, autonomy, and relatedness are met, and readiness for self-management. we are also interested in participants' perceptions of app quality and patterns of app usage. all participants will complete the study assessment battery measuring these outcomes at baseline (t1), 6 weeks (t2), and 12 weeks (t3). wait-list participants will receive the app after t3.

Eligibility criteria:
inclusion criteria: * adult 18 years or older * have a fetal alcohol spectrum disorder (fasd) or history of prenatal alcohol exposure * have sufficient fluency in written english * own a smartphone exclusion criteria: * participated in the past feasibility trial of the my health coach app
reconstruction method and delayed gastric emptying after pancreatic surgery

Conditions: Pancreatic Cancer; Surgery; Improvement of Perioperative Outcome

Summary: pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. for reconstruction, pylorus-preservation (pppd) has been shown to be technically and oncologically equivalent to the traditional whipple operation. one issue with this technique is delayed gastric emptying (dge), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. patients with severe dge can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition. there is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying. the investigators have conducted a prospective randomized trial in order to test this hypothesis. patients were randomized to either undergo antecolic or retrocolic reconstruction after pppd. on day 10 after surgery, dge was assessed by clinical criteria. in addition, a test meal including 1g paracetamol was administered to check for clinically inapparent dge. of these serum samples, kinetics of intestinal peptides like glp-1, pyy and glucagon was alos measured.


Eligibility criteria:
inclusion criteria: * verified cancer of the pancreatic head/neck/uncinate process or distal bile duct, radiographically suspicious tumor requiring pancreaticoduodenectomy * pylorus-preserving reconstruction planned * no evidence of distant metastases * written informed consent exclusion criteria: * age \ 90 years * status post surgical resection of stomach or duodenum * locally unresectable: * invasion of the hepatic artery/superior mesenteric artery * \>180 deg invasion of portal vein/superior mesenteric vein * gastric invasion * hypersensitivity to paracetamol * clinically significant anastomotic dehiscence * postoperative pancreatitis \> day 10 * preoperative evidence of gastroparesis

Keywords: pancreatic cancer pylorus-preserving pancreaticoduodenectomy delayed gastric emptying reconstruction
a randomized controlled trial of cannabidiol (gwp42003-p, cbd) for seizures in tuberous sclerosis complex (gwpcare6)

Conditions: Tuberous Sclerosis Complex; Seizures

Summary: this trial consists of 2 parts: a double-blinded phase and an open-label extension phase. the blinded phase only will be described in this record. participants will receive 1 of 2 doses of gwp42003-p or matching placebo. the primary clinical hypothesis is that there will be a difference between gwp42003-p and placebo in their effect on seizure frequency.


Eligibility criteria:
key inclusion criteria: * participant has a well-documented clinical history of epilepsy. * participant has a clinical diagnosis of tuberous sclerosis complex (tsc) according to the criteria agreed by the 2012 international tsc consensus conference. * all medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for 1 month prior to screening and the participant is willing to maintain a stable regimen throughout the trial. key exclusion criteria: * participant has a history of pseudo-seizures. * participant has clinically significant unstable medical conditions other than epilepsy. * participant has an illness in the 4 weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator could affect seizure frequency. * participant has undergone general anesthetic in the 4 weeks prior to screening or randomization. * participant has undergone surgery for epilepsy in the 6 months prior to screening. * participant is being considered for epilepsy surgery or any procedure involving general anesthesia. * participant has been taking felbamate for less than 1 year prior to screening. * participant is taking an oral mtor inhibitor. * participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal product (imp), such as sesame oil. * participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the c-ssrs in the last month or at screening. * participant is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the 3 months prior to screening and is unwilling to abstain for the duration for the study. * participant has tumor growth which, in the opinion of the investigator, could affect the primary endpoint. * participant has significantly impaired hepatic function at the screening or randomization visit * participant has received an imp within the 12 weeks prior to the screening visit.
satir model for self-esteem, mental health, and family function among individuals with substance use disorders

Conditions: Drug Abuse; Self Esteem; Mental Health Wellness 1; Family Dysfunction

Summary: self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (sud). the satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. it offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. the aim of the study is to investigate the acceptability and preliminary efficacy of the satir model on self-esteem, mental health, and family function among individuals with sud in china. the study will adopt a mixed-method approach. the quantitative phase will employ a randomized control trial (rct) utilizing a pre-post study design. the qualitative phase will involve conducting semi-structured individual interviews.the data will be analyzed by using spss software package (ibm spss statistics version 26.0). the individual-interview will be analyzed by using the six-phase thematic analysis. the study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with sud. it can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.


Eligibility criteria:
inclusion criteria: 1. aged 18 or above; 2. are able to speak, read, and write chinese; 3. are willing to participate in the study and share their experience of the intervention with the research group; 4. have informed consent to participate in the study. exclusion criteria: 1. have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder; 2. have a diagnosed memory and cognitive impairment; 3. are undergoing psychotherapeutic or psychopharmacologic treatment; 4. are participating in similar studies.
a phase 1 study of single agent veliparib in japanese subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent veliparib in japanese subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed malignant solid tumor, and any of the following: \* subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; \* subjects with brca-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; \* subjects with deleterious mutations of brca with advanced solid tumors who have received available standard therapies. * eastern cooperative oncology group (ecog) performance status of 0-1. * life expectancy of greater than 12 weeks. * adequate organ and marrow function· measurable or non-measurable disease. exclusion criteria: * major surgery and/or radiation within (\<) 4 weeks prior to study enrollment. * chemotherapy or hormone therapy within (\<) 4 weeks prior to study enrollment except for mitomycin c and nitrosoureas, in which case it is 6 weeks. * any investigational agents within (\<) 4 weeks prior to study enrollment. * any anti-cancer chinese medicine/herbal remedies within 14 days prior to study enrollment. * toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.

Keywords: breast cancer parp primary peritoneal cancer fallopian tube ovarian cancer veliparib abt-888 brca
study evaluating amg 424 in subjects with multiple myeloma

Conditions: Relapsed/ Refractory Multiple Myeloma

Summary: a multi-center phase 1, first-in-human study conducted in 2 parts, testing amg 424 in subjects with relapsed/ refractory multiple myeloma.

part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of amg 424 while determining the maximum tolerated dose (mtd) and/or biologically active dose in subjects with relapsed/ refractory multiple myeloma. part 2 of the study will further evaluate safety and tolerability of the amg 424 mtd dose determined in part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.

Eligibility criteria:
inclusion criteria: * multiple myeloma meeting the following criteria: * pathologically-documented diagnosis of multiple myeloma that has relapsed after at least two prior lines of therapy that must include a proteasome inhibitor (pi), immunomodulatory drug (imid), and, where approved and available, anti-cd38 therapy in any order or that is refractory to pi, imid, and anti-cd38 therapy. ◾subjects who could not tolerate a pi, imids, or a cd38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study. * measurable disease as per imwg response criteria * eastern cooperative oncology group (ecog) performance status of ≤ 2 exclusion criteria: * known central nervous system involvement by multiple myeloma * previously received allogeneic stem cell transplant and one or more of the following: * received the transplant \< 6 months prior to study day 1 * received immunosuppressive therapy \< 3 months prior to study day 1 * any active acute graft versus host disease (gvhd), grade 2- 4, according to the glucksberg criteria or active chronic gvhd requiring systemic treatment * any systemic therapy against gvhd \< 2 weeks prior to study day 1 * autologous stem cell transplantation less than 90 days prior to study day 1 * multiple myeloma with igm subtype * poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * evidence of primary or secondary plasma cell leukemia at the time of screening * waldenstrom's macroglobulinemia * amyloidosis * dexamethasone at cumulative doses of greater than 160 mg or equivalent \<3 weeks prior to study day 1 is not allowed. use of topical or inhaled steroids is acceptable * anticancer treatment (chemotherapy, imid, pi, molecular targeted therapy) \< 2 weeks prior to study day 1 * treatment with a therapeutic antibody targeting cd38 \< 12 weeks prior to study day 1 * systemic radiation therapy or major surgery \< 28 days prior to study day 1 as well as focal radiotherapy \< 14 days prior to study day 1. * major surgery within 28 days prior to study day 1

Keywords: relapsed/ refractory multiple myeloma multiple myeloma oncology/hematology immunotherapy
efficacy and safety study of cd2027 ointment 3 microgram per gram (mcg/g) twice daily treatment for adults with at least moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this was a multi-center, randomized, double-blind, parallel group study. efficacy objectives: to evaluate the efficacy of cd2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis. safety objective: to evaluate safety of cd2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved body surface area (bsa) (excluding head/neck) in adult participants with at least moderate atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male or female participant, 18 years of age or older * clinical diagnosis of atopic dermatitis according to hanifin and rajka criteria, of at least moderate intensity according to investigator global assessment (iga greater or equal to 3) * body surface affected by the disease between 5% and 20% of total bsa, based on rule of nine's, excluding head/neck * at least one area (target lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm\^2, presented a total severity score of at least 6/15 (total severity score defined as the sum of erythema, excoriation, papulation/induration, oozing/crusting and lichenification) with oozing/crusting severity at most 1 exclusion criteria: * the participant had albumin-adjusted calcium above the upper normal range from screening evaluation * the participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, paget's disease, adrenal insufficiency, hyperthyroidism) * the participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the screening visit

Keywords: dermatitis, atopic
association of survival with maintenance therapy in patients with metastatic breast cancer after first-line chemotherapy

Conditions: Metastatic Breast Cancer

Summary: to investigate the benefits and risks of maintenance chemotherapy (mct), maintenance endocrine therapy (met) and none maintenance therapy after first-line treatment of metastatic breast cancer (mbc).

there are several options for mbc patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (mct), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (met) for hormone receptor (hr) positive patients. since the role of maintenance therapy in prolonging the overall survival (os) and progression-free survival (pfs) of mbc was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with mbc after first-line chemotherapy. and the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.

Eligibility criteria:
inclusion criteria: * patients with pathologically clear invasive breast cancer between 2003 and 2018; * female,18-75 years old; * measurable metastatic lesion according to recist 1.1 evaluation criteria; * the first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the nccn guidelines; * first-line chemotherapy is effective (according to recist1.1 evaluation criteria, the efficacy is evaluated as complete response (cr), partial response (pr), or steady state (sd)); * after the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks; * patients' karnofsky performance status (kps) scores were ≥70. exclusion criteria: * unmeasurable metastatic lesion according to recist 1.1 evaluation criteria.

Keywords: metastatic breast cancer maintenance chemotherapy maintenance endocrine therapy overall survival safety
intraoperative nociception monitoring with medstorm, medasense and anspec-pro during total intravenous anesthesia

Conditions: Pain Measurement

Summary: the randomized controlled trial study aims to validate a new pain monitor during general anesthesia by comparing the new anspec-pro monitor (non-ce marked) with already ce-marked pain monitors (medstorm and medasense). one hundred and eighty patients will be randomized into six groups, wherein each group has 30 patients. patients preparing for a surgical operation under general anesthesia will be included to be monitored for pain during surgery procedure, while the standard monitoring, medication, and standard care will not be disturbed. pain monitoring is done with the anspec-pro, medasense, or medstorm in the operation room, before and during general anesthesia: the pain monitor will record data continuously, while the following will be recorded in parallel: blood pressure, heart rate, saturation, co2, o2 end-tidal concentrations, electromyogram, signal quality, the given amount of analgesics and hypnotics, and tof (train-of-four).

primary objective: validation of anspec-pro as pain monitor during general anesthesia. secondary objectives * evaluation of quality of monitoring anspec-pro compared with other pain monitors (medasense and medstorm); * evaluation of the correlation between measurements of pain monitors (anspec-pro, medstorm and medasense) and the level of analgesia represented as tci infusion of remifentanil; * to determine the most suitable device for the development of a mimo pharmacodynamic interaction model of propofol and remifentanil for use in closed- loop drug-delivery systems for anesthesia; * evaluation of the interaction between analgesics and hypnotics measured by anspec-pro and bis/neurowave.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years and younger than 80 years 2. patients able to comprehend, sign, and date the written informed consent document to participate in the clinical trial. 3. asa class i, ii, iii classified by the anesthesiologist. 4. patients planned for a surgical procedure under general anesthesia. exclusion criteria: 1. patients having epidural analgesia infused by a pain pump during the operation. 2. patients with chronic pain or getting medication used for chronic pain, like anti-epileptics, antidepressants, opioids. 3. pregnant women (asked at the patient before the operation) 4. patients with electrically sensitive life support systems (e.g. implanted pacemaker, defibrillator)