Kornimate/medical-research-clean huggingface dataset:
stimulation for bowel emptying

Conditions: Neurogenic Bowel Dysfunction

Summary: the investigators are testing the effect of electrical stimulation of the rectum on colonic motility. most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. this slowed movement may result in chronic constipation and difficulty emptying the bowels. individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. the investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. therefore, this study will compare the two methods. if electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.


Eligibility criteria:
inclusion criteria: * suprasacral spinal cord injury * diagnosed neurogenic bowel dysfunction and using digital rectal stimulation * bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation * neurologically stable * at least 18 years old * at least 12 months post neurological injury or disease diagnosis exclusion criteria: * active sepsis * open pressure sores on or around pelvis * significant colon trauma or colostomy * crohn's disease * colonic obstruction or gastrointestinal surgery within last 3 months * significant history of autonomic dysreflexia
safety and efficacy study of botulinum toxin type a for the treatment of neurogenic overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to assess the safety and effectiveness of botulinum toxin type a in treating overactive bladder in spinal cord injury or multiple sclerosis patients.


Eligibility criteria:
inclusion criteria: * urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * inadequate response to anticholinergic medication used to treat overactive bladder exclusion criteria: * history of evidence of pelvic or urologic abnormality * previous or current diagnosis of bladder or prostate cancer * urinary tract infection at time of enrollment
preferences and chemotherapy in breast cancer patients

Conditions: Female Breast Cancer

Summary: the aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment. the benefit should be evaluated in terms of survival rate trade off and survival time trade off value. the analyses will be conducted into three different groups of patients to value the survival benefit expected: 1. before to start the chemotherapy 2. during chemotherapy 3. after the end of chemotherapy

the chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. however chemotherapy is associated with side effects that impact the quality of life of the patients. patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. the interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment.

Eligibility criteria:
inclusion criteria: * patients with early or locally advanced breast cancer * patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy * sufficient literacy in italian to complete the questionnaires * patients must provide signed, written or advanced electronic signature (aes or ades), informed consent exclusion criteria: * none

Keywords: early breast cancer locally advanced breast cancer
btae-haic combined with system therapy for intermediate-advanced huge hcc

Conditions: Liver Diseases; Hepatocellular Carcinoma; Immunotherapy; Camrelizumab; Lenvatinib

Summary: this study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (btae-haic) plus lenvatinib and camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

blank-microsphere transcatheter arterial embolization (btae) and hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. camrelizumab, a programmed cell death protein-1 (pd-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. no study has evaluated btae-haic plus lenvatinib and camrelizumab. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of hcc. 2. age between 18 and 75 years; 3. the maximum tumor size ≥10 cm, and the total tumor size ≥15 cm; 4. intermediate-advanced huge hcc, advanced hcc with pvtt type i or type ii or limited metastases (≤5). 5. child-pugh class a or b; 6. eastern cooperative group performance status (ecog) score of 0-2; 7. hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 8. prothrombin time ≤18s or international normalized ratio \< 1.7. 9. ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: 1. diffuse hcc; 2. extrahepatic metastasis \>5; 3. obstructive pvtt involving the main portal vein. 4. serious medical comorbidities. 5. evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. known history of hiv 7. history of organ allograft 8. known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. evidence of bleeding diathesis. 11. patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
a study of a values-based intervention to promote weight loss

Conditions: Obesity; Weight Loss

Summary: more than 160 million american adults are overweight or obese. existing weight loss interventions from self-help to gold standard behavioral treatments, while often effective, do not sufficiently maintain motivation to adhere to dietary goals in the face of powerful biological and environmental influences to consume highly palatable foods. clarification and awareness of values, a staple of acceptance-based treatments drawn from acceptance and commitment therapy, are thought to enhance autonomous motivation to engage in behaviors consistent with one's personal life values (e.g., health) in the presence of countervailing forces (e.g., hunger, deprivation). however, the independent efficacy of values clarification and awareness in facilitating weight control has never been tested. this pilot study seeks to investigate the feasibility and acceptability of a series of three weight loss workshops (based off the gold standard) infused with values clarification and awareness techniques to promote weight control. participants will be asked to follow a reduced-calorie dietary prescription while holding their values in mind in moments of dietary decision-making over the course of one month. the primary aims of this study are to: 1) develop the series of values-infused workshops, using participant feedback to iterate and improve the treatment manual; and 2) evaluate treatment acceptability. secondary aims are: 1) to evaluate whether clinically meaningful changes in measures of values clarification and values awareness occur; 2) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in values-congruent weight control behaviors; 3) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in weight; and 4) to evaluate theorized mechanisms of action in the intervention.


Eligibility criteria:
inclusion criteria: * bmi of 25-55 kg/m2 * 18-70 years of age * have a desire to lose weight * own a smartphone * live in the philadelphia area * provide informed consent exclusion criteria: * any medical or psychiatric conditions (e.g., eating disorder, diabetes) that may pose a risk to the participant during the intervention, cause a change in weight or appetite, or interfere with ability to adhere to diet recommendations * recent change in medication dosage that could affect weight or appetite * current or planned pregnancy in the next month * planned move out of the philadelphia area in the next month * history of bariatric surgery * weight loss of ≥5% in the last six months * concurrent behavioral therapy targeting weight control

Keywords: obesity weight loss behavioral treatment values values-based behavior change autonomous motivation acceptance and commitment therapy
safety study of bj-001, an il-15 fusion protein, for locally advanced/metastatic solid tumors

Conditions: Locally Advanced/Metastatic Solid Tumors

Summary: the purpose of this study is to assess the safety and tolerability of bj-001, a human il-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab in adult patients with locally advanced/metastatic solid tumors


Eligibility criteria:
inclusion criteria: * phase 1a patients must have locally advanced or metastatic solid tumors, * phase 1b patients must have locally advanced or metastatic and/or non-resectable head and neck squamous cell carcinoma, cholangiocarcinoma, stomach cancer, melanoma, pancreatic cancer, nsclc (as high expression of αvβ3, αvβ5, or αvβ6 have been reported for these tumors) * measurable disease: for phase 1a patients can have non-measurable or measurable disease. for all other parts: measurable disease defined by recist v1.1 is required * for phase 1a part 3 and phase 1b patients (combination treatment) must be refractory or relapsed to anti-pd-1, anti-pd-l1 or anti-ctla4 checkpoint inhibitors for all tumor types, for part 1 and part 2 of phase 1a (bj-001 single agent treatment) both checkpoint inhibitor naïve or refractory/relapsed patients will be considered. * patient who have diagnosis for which treatment with pembrolizumab to be enrolled. patients previously treated with pembrolizumab and who have progressed are eligible. to be enrolled. * adequate hematologic function, * adequate hepatic function, defined by all of the following: * adequate renal function defined by estimated creatinine clearance ≥ 45 ml/min (cockcroft and gault formula * ecog performance status (ps) of 0-2. * no history of any hematopoietic malignancy. * no active or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy). exclusion criteria: * pregnant or nursing females. * receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. exceptions: hormone replacement therapy, testosterone, or oral contraceptives (lhrh antagonists are allowed). * patients previously treated with an anti pd-1/pd-l1 targeting agent who have had any prior history of immune-mediated pneumonitis, any immune-mediated toxicity of ≥ grade 3, * patients with a history of severe allergic or anaphylactic reactions to human mab therapy or known hypersensitivity. * patients with a history of pneumonitis, myocarditis, history of stevens-johnson syndrome or toxic epidermal necrolysis. * patients who have undergone a bone marrow transplantation, solid organ transplantation, or stem cell transplant. * patients with unresolved aes \> grade 1 from prior anticancer therapy. * patients who have received prior interferon or il-2 therapy less than 4 weeks prior to enrollment. * uncontrolled primary central nervous system (cns) tumors or cns metastases; based on screening. * patients with active autoimmune disease or a documented medical history of autoimmune disease managed by replacement therapy.

Keywords: fih solid tumors
considering racial and acculturation stress in addressing trauma

Conditions: Trauma-related PTSD

Summary: investigators plan to offer two evidence based interventions - trauma focused cognitive behavioral therapy (cbt) (tf-cbt) and trauma systems therapy (tst) to traumatized children and their families. the investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress


Eligibility criteria:
inclusion criteria: * child/adolescent aged 5-17 years of age who has experienced trauma with associated and related emotional dysregulation (i.e ptsd) and one of their parent/guardian * have capacity and willingness to provide consent or age-appropriate assent exclusion criteria: * individual with intellectual disability with an iq\<70 * individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization
nature sounds as a pain and anxiety reducing strategy in patients undergoing breast core biopsy

Conditions: Breast Cancer

Summary: patients will be randomly assigned to one of two groups: the group exposed to ns, or the standard care group exposed to supportive dialogue. patients assigned to the former group will be exposed to continuous ns throughout the cnb procedure.

for stereotactic biopsies, the experiment consists of six different parts: (1) a baseline 5 min biopsy planning period during which only imaging occurs after patient positioning and breast compression is complete, (2) one 2-min local anesthesia administration period during which the skin is injected with local anesthetic and an incision is made to insert the biopsy needle into the breast occurs ("stressor 1"), (3) one 2-minute post local anesthesia administration period during which imaging is obtained to confirm the position of the needle with respect to the target, (4) one 1-minute sampling period when the breast tissue is sampled ('stressor 2"), (5) one 2-minute post-cnb period, during which adequacy of obtained samples is confirmed and the need for additional sampling determined, and (6) one 2-minute period during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site. for ultrasound biopsies, the experiment also consists of six different parts: (1) a baseline 5 min biopsy planning period during which only imaging occurs after patient is positioning, (2) one 2-min local anesthesia administration period during which local anesthesia is given at the site of biopsy and a skin incision performed ("stressor 1"), (3) one post local anesthesia administration period during which intra-procedure imaging and confirmation of adequate targeting occurs, (4) one 1-minute first-pass sampling period ('stressor 2") during which the biopsy device is advanced to the target for the first time and fired to acquire the first tissue sample, and (5) one 2-minute post-cnb period, following the first needle pass while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6) one 2-minute post-cnb period, during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site. the total time for a single site cnb is approximately 30 minutes when performed under us-guidance, and 30-45 minutes when performed under stereotactic guidance. the added physiological recordings for this experiment are not expected to significantly prolong the duration of cnb procedures.

Eligibility criteria:
inclusion criteria: * 1) ≥ 21 years old * 2) present for cnb * 3) to be able to read and speak english * 4) provide written informed consent. exclusion criteria: -

Keywords: breast core biopsy core needle biopsies
a comparison of mbsr and cbt for the treatment of insomnia in cancer

Conditions: Cancer; Insomnia

Summary: sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. there are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. this study will determine whether mindfulness-based stress reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, cognitive-behavioral therapy. this will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.


Eligibility criteria:
inclusion criteria: * english speaking * non metastatic cancer * 1 month post chemotherapy/radiation treatment (hormone treatment okay) * diagnosis of primary or secondary insomnia exclusion criteria: * presence of another sleep disorder * presence of another axis i diagnosis (not in remission) * inability to attend at least 5 out of the 8 treatment sessions * randomization refusal * previous participation in cbt-i or mbsr * shift work

Keywords: mindfulness-based stress reduction cognitive behavior therapy actigraphy noninferiority mbsr cbt-i
first in human clinical investigation of the fire1 system in heart failure patients (future-hf)

Conditions: Heart Failure

Summary: first in human clinical investigation of the fire1 device/system to evaluate the feasibility and safety of implanting the fire1 system in up to 50 stable hf patients.

eligible patients who have hf and were hospitalised/treated for an episode of worsening hf within the last 6 months. this non-randomised fih trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. safety measures will include an assessment of all adverse events. subjects will remain in this study for 24 months.

Eligibility criteria:
main inclusion criteria * adults 18 years or older with heart failure with any of the following in the past 6 months: a decompensation due to heart failure resulting in a heart failure hospitalisation, heart failure treatment in a hospital day-care setting or urgent outpatient heart failure visit * receiving treatment in accordance with internationally recognised guidelines. * signed patient informed consent form main exclusion criteria: * significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol * patients with an estimated glomerular filtration rate (egfr) \< 30 ml/min * patients with ivc filter placement in situ, abnormal ivc or femoral venous anatomy or known congenital malformation or absence of ivc or occlusive or free-floating thrombus in the ivc * patients with implantable ventricular assist device (lvad, rvad, bivad) in situ * patients with cardiovascular implantable electronic device (cied) implanted ≤ 3 months prior to enrolment * patients with conditions associated with occlusion of the ivc, iliac or common femoral veins (e.g. venous leg ulcers)

Keywords: cardiovascular disease
a phase iii trial of neoadjuvant sintilimab and chemotherapy for nsclc harboring no driver mutations

Conditions: NSCLC, Stage IIIA; EGF-R Negative Non-Small Cell Lung Cancer; ALK Negative NSCLC

Summary: this is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant pd-1 antibody plus chemotherapy followed by surgery in resectable stage iiia non-small cell lung cancer. the primary endpoint: pcr rate the second endpoint: mpr, dfs, mrd

this study is a prospective, multicenter, phase iii randomized controlled clinical study. stage iiia nsclc patients with egfr mutation negative and alk rearrangement negative were enrolled, and after 2 courses of treatment with sintilimab combined with platinum-based chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment). the primary endpoint is pcr rate. the second endpoints are mpr, dfs, and mrd.

Eligibility criteria:
inclusion criteria: 1. resectable stage iiia nsclc, egfr mutation-negative and alk rearrangement negative (8th uicc tnm staging); 2. no prior anti-tumor therapy for nsclc; 3. age from 18 to 75 years old; 4. adequate organ function: hemoglobin ≥9.0g/l; white blood cell count 4.0\~10×109/l; the absolute value of neutrophils (anc) ≥ 1.5×109/l; platelet count ≥100×109/l; total bilirubin ≤ 1.5 times the upper limit of normal; alt and ast≤2.5 times the upper limit of normal; the international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; creatinine ≤ 1.5 times the upper limit of normal; 5. no chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of other malignant tumors, excluding patients who have received hormone therapy for prostate cancer and have had dfs for more than 5 years; 6. ecog 0～1; exclusion criteria: 1. double primary or multiple primary nsclc; 2. egfr mutation or alk mutation was positive 3. patients with psychosis; 4. pre-existing or coexisting bleeding disorders; 5. other uncontrollable and inoperable patients; 6. patients whose previous operations have prevented this operation from being performed; 7. female patients who are pregnant or breastfeeding; 8. for patients who are allergic to the drugs in the program.

Keywords: neoadjuvant pd-1 nsclc phase iii platinum-based locally advanced