Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of gx-i7 plus adjuvant temozolomide combination in patients with newly diagnosed glioblastoma

Conditions: Newly Diagnosed Glioblastoma

Summary: this is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of gx-i7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (ccrt)

in dose escalation stage (phase 1 part), low/intermediate/high dose of gx-i7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose. phase 2 part will be randomized, placebo controlled study and gx-i7 or placebo will be administered in combination with adjuvant temozolomide treatment.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form (icf) 2. age ≥ 19 years 3. gross total resection equal to or greater than 80% based on post-op mri, compared to pre-op mri (patients requiring biopsy only is not eligible) 4. patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (ccrt) and adjuvant temozolomide chemotherapy with curative intent 5. karnofsky score ≥ 60 6. life expectancy \> 12 weeks exclusion criteria: 1. gliomatosis cerebri 2. isocitrate dehydrogenase 1 \& 2 mutation 3. pregnant or breast feeding women
stimgenics open-label, post market study

Conditions: Chronic Low Back Pain

Summary: the purpose of this investigational study is to study the effects of stimgenics spinal cord stimulation (sgx-scs) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.

this is an open-label prospective, randomized, controlled, multi-center study comparing stimgenics spinal cord stimulation (sgx-scs) programming approach to standard scs programming approach. subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * test treatment group with sgx-scs programming approach * control treatment group with standard scs programming approach data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

Eligibility criteria:
inclusion criteria: 1. be a candidate for scs system (trial and implant) per labeled indication (back and leg pain) 2. has an average back pain intensity ≥ 5.0 cm on the 10.0 cm visual analog scale (vas) at the time of enrollment with moderate to severe chronic leg pain 3. be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided. 4. be willing and capable of subjective evaluation, read and understand english-written questionnaires, and read, understand and sign the written inform consent in english. 5. be 18 years of age or older at the time of enrollment 6. be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study 7. be willing to not increase pain medications from baseline through the 3-month visit 8. be willing and able to comply with study-related requirements, procedures, and visits exclusion criteria: 1. has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available intellistm scs systems as determined by the investigator 2. be concurrently participating in another clinical study 3. has an existing active implanted device such as a pacemaker, another scs unit, peripheral nerve stimulator, and/or drug delivery pump, etc. 4. has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the investigator 5. has mechanical spine instability as determined by the investigator

Keywords: back pain, spinal cord stimulation
early detection of heart problems in cancer patients receiving chemotherapy

Conditions: Heart Failure

Summary: subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.

* patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance * follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study * clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later. * patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival. * patient records will be reviewed at 5 years to check cardiac status and survival.

Eligibility criteria:
inclusion criteria: * males and females 18 years and above * willing and able to provide consent * able to read * patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab. * patients at increased risk of cardiotoxicity with one or more risk factors for heart disease: * lvef 50-54% by baseline echocardiogram * age ≥ 65 * bmi ≥ 30 kg/m2 * current or prior anti-hypertensive therapy * diagnosis of coronary artery disease (cad) * diabetes mellitus * atrial fibrillation/flutter exclusion criteria: * children * patients who are pregnant * only single encounter without follow up * cancer diagnosis other than breast or hematological cancer * chemotherapy treatment other than anthracycline or trastuzumab * no prior chemotherapy treatment
patient-reported outcomes among women wtih gynecological cancer (the connect study)

Conditions: Gynecologic Cancer; Gynecologic Neoplasm; Ovarian Cancer; Endometrial Cancer

Summary: systematic nurse-led consultations based on electronic patient-reported outcomes (epro) will be tested among women with ovarian - and endometrial cancer receiving first-line chemotherapy.

women with ovarian- and endometrial cancer often experiences a high disease and treatment-related physical and psychological burden. patient-reported outcomes (pro) have the potential to improve patient-clinician communication, symptom management, involvement, and quality of life. electronic patient-reported outcomes (epro) can facilitate appropriate and continuous symptom monitoring reported by the patients. nurses are with their holistic approach and their specialized knowledge and experience in a prominent position to address and facilitate symptom-management in a multidisciplinary context. the overall aim of this study is to develop a model of care for systematic nurse-led consultations based on epro facilitating symptom management and to investigate how these consultations can be a part of the multidisciplinary treatment regimen for women with ovarian- and endometrial cancer receiving chemotherapy.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years * newly diagnosis of ovarian- or endometrial cancer * scheduled to receive first-line standard chemotherapy * having an active email, internet access and a device * able to understand, read and speak danish exclusion criteria: * severe cognitive impairments/psychiatric disorder * participating in other interventional clinical trials

Keywords: patient-reported outcome electronic patient-reported outcome nurse-led consultations quality of life
herresolve™ in detecting the presence of endometriosis among symptomatic women

Conditions: Endometriosis

Summary: endometriosis (ems) is a common gynecological disease that affects 176 million girls and women globally. ems affects 5-10% of women and adolescents within the reproductive age range of 15-49 years, and for those facing infertility, this figure may climb up to 50%. ems can start at the first menstrual period and last until menopause. shockingly, between 50% and 80% of women grappling with pelvic pain are found to have ems. the formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body can cause severe pain and lead to infertility.


Eligibility criteria:
inclusion criteria: * females aged 18 to 49 with mild to severe symptoms of pelvic pain and/or abnormal bleeding. * diagnostic laparoscopy is scheduled with histology on any visually suspected endometriosis, and all reports (surgical and pathology) to confirm a positive result. if no visually suspicious endometriotic lesions are seen, biopsies from random areas during the laparoscopy procedure to confirm a negative histopathology result. * blood drawn during secretory or proliferative phase of the menstrual cycle * provide written informed consent to participate in the study and provide medical history on medications. exclusion criteria: * patients who object to medical history collection and data requests * patients with cancer and/or undergoing chemotherapy and/or radiotherapy * patients who are unable or do not undergo laparoscopic surgery * patients participating in additional interventional clinical studies * pregnant, lactating, or subjects who are not healthy enough for blood donation. * blood drawn during menses or ovulation phase of menstrual cycle * females who are post-menopausa
a study of the safety and effectiveness of infliximab (remicade) in patients with rheumatoid arthritis.

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the safety and effectiveness of infliximab (remicade) in patients with rheumatoid arthritis. infliximab (remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.

this is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) trial of the safety of anti-tumor necrosis factor (tnf) chimeric monoclonal antibody (infliximab) in combination with methotrexate (mtx) compared to methotrexate alone in patients with rheumatoid arthritis on standard disease-modifying anti-rheumatic drug background therapy. the purpose of the study is to better understand the safety and occurrence of infections in patients treated with either placebo or 3 mg/kg and 10 mg/kg of infliximab in combination with methotrexate (mtx). patients will receive infusions of either placebo or 3 to 10mg/kg infliximab at weeks 0, 2, 6, and 14 then every 8 weeks through week 46. safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. patients will receive 3 to10mg/kg infliximab (remicade) or placebo via infusion at weeks 0, 2, 6, and 14 then every 8 weeks through week 46.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of rheumatoid arthritis at least 3 months before screening * if the patient is of childbearing potential, must have been using adequate birth control measures * patients must be receiving mtx for =3 months before randomization and at a stable dose(=25 mg/week) for =4 weeks before randomization exclusion criteria: * patients must not be pregnant, nursing, or planning a pregnancy within 18 months of enrollment * patients must not have rheumatic disease other than rheumatoid arthritis or had any systemic inflammatory condition * patients must not be confined to a wheelchair * patients must not be treated with any approved or investigational biologic agent except for approved vaccines for immunizations

Keywords: rheumatoid arthritis infliximab anti-tnf methotrexate safety and efficacy remicade
impact of a plant-based diet on indices of cardiovascular health in african americans

Conditions: Cardiovascular Diseases; Hypertension; Diet, Healthy

Summary: the role of diet in preventing hypertension and cardiovascular diseases in african americans, who have a much higher risk of developing these diseases, is not well understood. therefore, this project will investigate whether african americans following a 100% plant-based diet have more optimal blood pressure, vascular function, and blood lipid profiles, along with lower systemic inflammation relative to african americans following a typical american diet.


Eligibility criteria:
inclusion criteria: * self-identify as african american/black * self-reported adherence to either a typical american diet (not following a specific diet pattern) or 100% plant-based (vegan) diet * age 18-40 exclusion criteria: * history of smoking within 2 years or being a current smoker * taking vasoactive medications * having overt cardiovascular, metabolic, or neurological disease * pregnant individuals

Keywords: health disparity endothelial function hypertension vegan diet black americans inflammation
promoting child inhibitory control skills around food

Conditions: Obesity

Summary: today's environment provides many hedonic stimuli that promote consumption of unhealthy energy-dense snack foods. it is widely recognized that a systems approach is required to deal with this complex problem. however, individuals, particularly children, also need to develop the personal capacity to deal with tempting stimuli and inhibit responses to these energy-dense foods. therefore in this proposal, we will focus on enhancing higher level executive functions, particularly inhibitory control, which is needed to counterbalance impulsive behavior and is crucial for growth and development. we have chosen to focus on developing inhibitory control in preschool-age children because executive functioning/inhibitory control and eating habits are developing at this time. among preschool-age children, inhibitory control is fostered through social play-based curriculums and has been found to be related to greater school readiness and academic skills. therefore, the goal of this proposal is to adapt a play-based curriculum, the tools of the mind program, to promote greater inhibitory control skills in preschool children and decrease consumption of energy-dense snack foods. in phase i, we will develop and pilot a child inhibitory control play-based program (chic play) among children age 4- to 6-years old. we will adapt the learning tools used in the tools of the mind curriculum and employ naturalistic play scenarios, drawings (visual support), and games to teach children to inhibit their responses to energy-dense snack foods. once developed, we will test the efficacy of chic play in the preschool setting. parent groups will also be conducted to support the adoption of these skills at home. the primary outcome of interest is caloric intake and age- and gender-adjusted percent of daily caloric intake as measured by the eating in the absence of hunger (eah) free access procedure and a snack time procedure. inhibitory control skills will also be measured using executive functioning tasks. feasibility and acceptability of this program will be determined from parent, child, and teacher surveys. the purpose of this study is to develop a new innovative method of decreasing energy-dense snack food consumption by promoting the development of inhibitory control or impulse control. if successful, this program has the potential to play a role in the treatment and prevention of childhood obesity.


Eligibility criteria:
inclusion criteria: * 1) child age between 4 and 6 years * 2) child bmi ≥5th %ile (children below this bmi percentile may have an underlying biological mechanism that influences eating behaviors.) * 3) active parental consent exclusion criteria: * 1) child with major psychological diagnosis, developmental delay, or other medical disorder that affects weight, eating behaviors, and cognition * 2) food allergies to the foods used in the study * 3) plans to leave the preschool within the timeframe of the study

Keywords: inhibitory control executive functioning childhood obesity preschool snack foods caloric intake
effects of body awareness therapy in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to investigate the effect of body awareness therapy (bat) on pain, balance and functional capacity in patients with knee osteoarthritis. individuals will divided into two groups: training group and control group. both groups will receive exercise training as a home program. individuals in study group will participate in bat training 3 days for 6 weeks. assessments will be made before and after the 6-week study program.

symptoms such as pain, morning stiffness, and decreased muscle strength lead to a decrease in functional capacity and quality of life in knee osteoarthritis. it is estimated that 80% of patients with osteoarthritis have movement limitation and 25% are unable to perform significant daily activities. it is also stated that increases the risk of falls due to decrease proprioception in patients with knee osteoarthritis. in addition to physical symptoms, it is reported in the literature that symptoms such as sleep disturbance, depression and anxiety are seen and play a role in pain experience. it is stated in the literature that hypersensitivity of the central nervous system causes painful perception of normal body functions in chronic osteoarthritis, which leads patients to compensatory and dysfunctional movement strategies. body awareness therapy (bat) is a mind-body treatment approach directed towards awareness of body senses and how the body is used. the aim is to integrate the body and soul in the individual's experiences and to restructure body awareness and control. the aim of this study is to investigate the effect of bat on pain, balance and functional capacity in patients with knee osteoarthritis. the study will consist of patients with stage 2-3 knee osteoarthritis according to kellgren-lawrence classification. the individuals included in the study will be divided into two groups as training and control groups using a computer-based randomization program. both groups will be given a home program consisting of joint range of motion, stretching, strengthening and proprioceptive exercises. the control group will perform home exercise program and follow up will be made at once a week. the training group will participate in bat for 3 days/week for 6 weeks in addition to home exercise program. assessments will be made before and after the 6-week study program.

Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * stage 2 -3 according to kellgren - lawrence classification exclusion criteria: * previous surgery in the lower extremity * neuromuscular disease * vestibular pathology * physiotherapy intervention or intra-articular injection within the last 6 months

Keywords: knee osteoarthritis body awareness therapy pain functional capacity
the effect of care-oriented practical training on nurses' intensive and critical care competency and hais indicators

Conditions: Intensive Care Unit; Health Care Associated Infection; Patient-Centered Care; Competence

Summary: it was aimed to evaluate the effect of care-oriented practical training on the intensive and critical care competencies of nurses, the hand hygiene compliance rate of nurses and care support staff, and hai indicators.

does care-oriented practical training increase nurses\&#39;s intensive and critical care competencies? does care-oriented practical training increase the hand hygiene compliance rate of nurses and care support staff? does care-oriented practical training reduce hai indicators in intensive care units?

Eligibility criteria:
inclusion criteria: * working as a nurse in the adult intensive care unit * working as a care support staff in an adult intensive care unit * volunteering to participate in research exclusion criteria: * wanting to withdraw from the research * not being able to attend the final test (due to illness, leave, report, etc.)

Keywords: intensive care nursing care-oriented practical training health care associated infection intensive and critical care nursing competence
progression-free survival after mwa plus durvalumab and tremelimumab for unresectable locally advanced pancreatic cancer

Conditions: Pancreatic Cancer Non-resectable

Summary: this phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.

research hypothesis does mis-mwa combined with durvalumab (medi4736) plus tremelimumab and gemcitabine prolong progression-free survival in patients with unresectable non-metastatic adenocarcinoma of the pancreas? investigational product(s) and reference therapy: combination of durvalumab (fixed dose of 1500 mg) and tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery. minimally invasive surgical microwave ablation (mis-mwa) of the pancreatic tumor will be performed two weeks after the first dose of durvalumab and tremelimumab after 4 doses of durvalumab and tremelimumab, only durvalumab 1500mg is provided q4w until disease progression. systemic gemcitabine will be started 6 weeks after mis-mwa. gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest. objectives: primary objectives: progression-free survival (pfs) secondary objectives: * safety: clinical and hematological toxicity (nci ctcae v. 5.0) of chemotherapy and immunotherapy * safety: number and type of postoperative complications of the mis-mwa procedure * length of hospital stay tertiary objectives overall survival (os)

Eligibility criteria:
inclusion criteria: * patients with unresectable non-metastatic locally advanced pancreatic cancer (lapc) defined according to nccn guidelines version 2.2017 * histologically proven adenocarcinoma of the pancreas located in the head, body or tail * lapc tumor greatest diameter maximum 5 cm * male or female, age 18 years and older, ecog ps 0-1 * life expectancy of at least 12 weeks * only patients who did not receive chemotherapy for their pc are allowed * patients without distant organ metastases on conventional diagnostic imaging * pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients * patients fit for mis-mwa * able to receive durvalumab and tremelimumab. * patients with good liver and renal function and with good hematology * effective contraception for both male and female patients if applicable. women of childbearing potential must have negative blood pregnancy test at screening visit. * written informed consent (+ optional for tr) must be given according to ich/gcp and national/european regulations exclusion criteria: * pregnancy * metastatic pc on conventional diagnostic imaging or staging laparoscopy * lapc tumor greatest diameter is larger than 5 cm * borderline or resectable pc defined according to the nccn guidelines version 2.2017 * systemic chemo(radio)therapy is not allowed before mis-mwa * major surgical procedure within 28 days prior to the first dose of investigational products * classic contraindications for pdl and ctla antibodies