Kornimate/medical-research-clean huggingface dataset:
digital signals in chronic pain (discover project)

Conditions: Chronic Pain

Summary: the discover project is a 1-year longitudinal case-control observational study. in this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. one of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.


Eligibility criteria:
inclusion criteria: * age 18 years or older * resides in the united states * case inclusion criteria: self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the numeric pain rating scale * control inclusion criteria: self-reported not having chronic pain exclusion criteria: * less than 18 years old * is not able to read or understand english
cat-pad follow on study

Conditions: Cat Allergy; Rhinoconjunctivitis

Summary: cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. the purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the eec among subjects who completed all dosing visits in study cp005 approximately one year after the start of treatment.

subjects who completed all dosing visits and the post treatment challenge (ptc) in study cp005 will be invited to attend the screening visit for cp005a. subjects will attend for 4 visits to the eec on successive days. following the last eec visit a follow-up visit will be performed 3-10 days later.

Eligibility criteria:
inclusion criteria * previously randomised in study cp005, completed all treatment visits and the post treatment challenge (ptc). exclusion criteria * "partly controlled" and "uncontrolled" asthma * history of anaphylaxis to cat allergen * fev1 of less than 70% of predicted * subjects who cannot tolerate baseline challenge in the eec * treatment with beta-blockers,alpha-adrenoceptor blockers, tranquillizers or psychoactive drugs * a history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Keywords: cat allergy rhinoconjunctivitis
a study of adjunctive aripiprazole in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * experienced a major depressive disorder with the current episode of minimally 8 weeks in duration. * treatment history of an inadequate response to at least one and no more than three antidepressants.
independence spacer for lumbar fusion

Conditions: Degenerative Disc Disease

Summary: the primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the independence® integrated plate and spacer with revolve® stabilization system for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

a total of thirty subjects will be enrolled at scott \& white healthcare. the independence spacer will be filled with autogenous bone graft material. the devices subject to this agreement have received 510(k) clearance from the fda for the indications specified in this agreement. patients will be followed for 2 years with evaluations at the following time intervals: preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Eligibility criteria:
inclusion criteria: * • objective evidence of degenerative disc disease at 1 or 2 level(s) between l2 and s1 with degeneration confirmed by patient history and radiographic examination * experience pain, functional deficit and/or neurological deficit for a minimum of six months * unresponsiveness to documented non-surgical treatment modalities for a minimum of six months and/or presentation with progressive symptoms of nerve root or spinal cord compression prior to enrollment * at least 18 years of age and maximum 65 years of age * ability to provide informed consent for study participation and to return for all follow-up visits exclusion criteria: * • presence of systemic or localized infection at the site of surgery * more than 2 levels to be instrumented * previous fusion attempt at the involved level(s) * more than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s) * trauma at the level(s) to be fused * more than grade 1 spondylolisthesis * previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated * diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing * presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, hiv, long term use of steroids, etc.) * immunosuppressive disorder * pregnant or interested in becoming pregnant during the duration of the study * history of substance abuse (drugs or alcohol) * any known allergy to a metal alloy * mentally incompetent or prisoner * currently a participant in another study
improve the treatment of thoracic esophageal cancer

Conditions: Thoracic Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is 1. to compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the international association of esophageal disease(isde) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy. 2. to compare the effects of chemotherapy group (docetaxel + nedaplatin) with control group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.

according to different location of the primary lesion，the subject can be allocated to two sub-groups: the patient with upper or middle thoracic esophageal cancer may be assigned to two field(t)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly. after the operation,the patient whose primary lesion is completely(r0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

Eligibility criteria:
inclusion criteria: 1. age≤70 years old; 2. karnofsky performance status（kps）≥80; 3. pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially; 4. clinical stage is c t 1 \~ 3 n 0 \~ 1 according to the results of endoscopic ultrasonography，chest and abdomen ct and neck ultrasonic. 5. the preoperative evaluation of organ function is tolerant of surgery and chemotherapy; 6. the subject can understand and sign the informed consent form (icf); 7. the following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; hemoglobin（hgb）≥9.0g/l; absolute neutrophils count（anc）≥1.5×109/l; platelet count（plt）≥100×109/l; total bilirubin（tbil）≤1.5n;aspartate aminotransferase (ast)≤2.5n;alanine aminotransferase(alt)≤2.5n;prothrombin time(pt)≤1.5n, and activated partial thromboplastin time(aptt) is in normal range;endogenous creatinine clearance rate(cre)≤1.5n. exclusion criteria: 1. cervical esophageal cancer and non-squamous cell carcinoma of thoracic esophageal cancer; 2. advanced esophageal cancer; 3. prior malignancy in 5 years recently; 4. history of previous chest radiotherapy; 5. history of cardio-cerebral vascular accident in 6 months lately; 6. the subject can not understand and sign the informed consent form(icf).

Keywords: esophageal squamous cell carcinoma
virtual reality and its use in reducing perioperative stress in cataract surgery

Conditions: Virtual Reality; Eye Disease; Cataract Surgery Anesthesia; Cataract Surgery

Summary: this project is to evaluate the benefits of utilising virtual reality (vr) headsets with the aim of reducing peri-operative anxiety in cataract surgery and hence reducing the need for sedation in patients with significant stress levels noted during preassessment. this is a novel study, and with the increased use of vr technology throughout medicine, we may be able to offer our patients alternative management modalities to reduce stress and reduce need for medications with their subsequent potential side effects. it may also improve the quality of care provided and patients' experience with the cataract extraction procedure and might reduce the social care burden associated with standard sedation procedures. all patients will need to fill a quick preoperative anxiety and information scale questionnaire to assess their level of anxiety utilising the amsterdam preoperative anxiety and information score. patients will be randomised into 2 groups: 1. conventional group: patients will be prepared as per the standard routine clinical and further explanation of the procedure will be given. before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out. 2. interventional group: patients will be prepared as per the standard routine clinical care; they will then be wearing the vr mask for 10 minutes. before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out. post operation, a record will be taken of the surgeon's decision on whether they want the second eye cataract surgery to be done under sedation (this is already standard practice at our centre). finally, the patient will be asked to fill in one final grading score on whether they are happy with their decision to take/not take sedation.


Eligibility criteria:
inclusion criteria: 1. patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned. 2. first eye cataract procedures will only be included. 3. capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire exclusion criteria: 1. epilepsy 2. severe vertigo 3. poor visual acuity (below 6/60 best corrected in the best seeing eye) 4. significant hearing impairment 5. recent facial injury/burn.

Keywords: cataract surgery, sedation, anxiety, virtual reality
primary chemotherapy with anthracycline followed by nab-paclitaxel and trastuzumab

Conditions: Breast Cancer; HER-2 Positive Breast Cancer; Effects of Chemotherapy

Summary: the purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pcr) rate and the efficacy to preoperative administration of anthracycline-based regimen followed by nab-paclitaxel and trastuzumab in patients with her2 positive operable breast cancer.

four cycles of anthracycline-based regimen followed by four cycles of nab-paclitaxel and trastuzumab are administrated. anthracycline-based regimen (d1, q3w): ec (epirubicin 90mg/m2 and cyclophosphamide 600mg/m2) ac (doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2) fec (fluorouracil 500mg/m2, epirubicin 100mg/m2 and cyclophosphamide 500mg/m2) nab-paclitaxel 260mg/m2 (d1, q3w) trastuzumab (d1, q3w) is given at a dose of 8 mg/kg iv on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer * t1c-3 n0-2a * confirmed of hormonal receptor status * her2 positive confirmed by ihc 3+ or fish+ * lvef \> 50% by echocardiogram or muga * adequate ekg * no prior treatment for breast cancer * ps 0-1 * required baseline laboratory data wbc \> 4,000/mm3 and neut \> 2,000/mm3 plt \> 100,000/mm3 hb \> 9.0g/dl ast and alt \< ulnx2.5 t-bil \< 1.5mg/dl serum creatinin \< 1.5mg/dl * written informed consent exclusion criteria: * with history of hypersensitivity reaction for important drug in this study * with history of invasive breast cancer * bilateral invasive breast cancer * patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe diabetes mellitus * positive for hbs antigen and with history of hvb * with history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension * with severe edema * with severe peripheral neuropathy * with severe psychiatric disorder * pregnant or nursing women * cases who physician judged improper to entry this trial

Keywords: trastuzumab neoadjuvant chemotherapy primary chemotherapy
post market data collection protocol to evaluate the performance of the synergy disc

Conditions: Cervical Degenerative Disc Disease

Summary: this is a real world data collection observational study at a single site. there are both prospective and retrospective cohorts. the study will examine the safety and effectiveness of the synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria:
inclusion criteria: * age 21 or above at the time of the surgery. * have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted * skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy * intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: * herniated disc and/or osteophyte formation * symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) * failed a minimum of 6 weeks conservative treatment * written informed consent given by subject. exclusion criteria: * exclusion criteria: all answers must be no to be eligible for the study. * moderate to advanced spondylosis * diagnosis of osteoporosis * active systemic infection or infection at the operative site * pregnancy * marked cervical instability on lateral, coronal, or flexion/extension radiographs * cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level * severe pathology of the facet joints of the involved vertebral bodies * previous diagnosis of osteopenia or osteomalacia * more than one immobile vertebral level between c1 and t1 from any cause * morbid obesity * vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
impact of anxiety and depression on implicit and explicit memory performance

Conditions: Major Depressive Disorder (MDD); Generalized Anxiety Disorder (GAD); Memory Bias; Implicit Memory; Explicit Memory

Summary: this study examines the effect of anxiety and depression on memory processes, focusing on implicit and explicit memory. implicit memory involves unconscious recall, such as recognizing familiar words without effort, while explicit memory requires conscious recollection of specific information. the study aims to investigate whether individuals with depression and anxiety show differences in these types of memory, which may contribute to biases related to their emotional states. participants were divided into three groups: individuals with depressive disorder, individuals with generalized anxiety disorder, and a control group with no emotional disorders. each group was assessed using tasks designed to measure both implicit and explicit memory performance. the goal is to enhance understanding of memory biases in individuals with depression and anxiety, potentially supporting more targeted interventions.

this cohort study is designed to explore potential memory biases in individuals with depressive and anxiety disorders compared to a control group. the study includes 27 participants divided into three groups: nine individuals diagnosed with major depressive disorder, nine with generalized anxiety disorder, and nine control subjects with no history of emotional disorders. all participants were matched by age and education level. participants completed standardized tasks and assessments, including the spielberger state-trait anxiety inventory and various memory tasks such as word decoding and recognition memory tasks. these tasks aim to evaluate mood-congruent biases in memory recall. data collection will focus on analyzing any distinct memory processing patterns in depression and anxiety to improve psychological treatment approaches.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older * individuals diagnosed with major depressive disorder (group 1) * individuals diagnosed with generalized anxiety disorder (group 2) * healthy individuals with no history of emotional disorders (group 3) exclusion criteria: * history of neurological disorders * visual impairments * substance abuse or drug addiction * psychiatric hospitalizations unrelated to primary diagnosis (for groups 1 and 2)

Keywords: anxiety depression cognitive bias memory processing emotional influence on memory word recognition task mood-congruent memory psychological disorders
efficacy of an attention guidance vr intervention for social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: social anxiety disorder (sad) is a prevalent mental health concern that impacts approximately 12% of the population. one mechanism thought to maintain sad is avoidance of faces (i.e. avoidance of negative evaluative threat). however, research on attentional processes in sad has been confined to paradigms presented on computer monitors. to investigate attentional processes in a more naturalistic way the investigators developed an immersive, 360º-video virtual reality environment using real actors, as part of a pilot study. participants with a range of social anxiety symptoms (from none to severe) completed a 5-minute speech in this virtual reality environment while their eye movements were recorded. results from the study showed that greater symptoms of social anxiety were associated with avoidance of looking at faces (i.e. fewer fixations on faces). while existing treatments for sad are moderately effective, a large number of individuals do not experience meaningful reductions in their symptoms. the overarching goal of this project is inform future treatment research for sad. the investigators will test a brief attention guidance intervention for sad that specifically targets avoidance of faces as a potential mechanism maintaining the disorder. the proposed research will use the eye tracking hardware and naturalistic virtual reality environment from the pilot study. the investigators will also collect eye tracking data prior to the intervention in order to investigate potential heterogeneity in the attentional processes of sad. the investigators will test the hypotheses that (a) the attention guidance intervention, compared to the control intervention, will result in a greater reduction in symptoms of social anxiety, and (b) this effect will be mediated by the number of fixations on faces during a brief public speaking challenge following the intervention. these results will provide causal evidence related to a hypothesized mechanism maintaining sad.


Eligibility criteria:
inclusion criteria: 1. age 18-65; 2. fluent in english; 3. personal report of public speaking anxiety score \> 98; 4. leibowitz social anxiety scale \> 30; 5. peak fear ≥ 50 on the behavioral approach task during the baseline assessment; 6. meets dsm-5 criteria for social anxiety disorder. exclusion criteria: 1. currently receiving cbt for social anxiety disorder; 2. significant visual impairment precluding the use of virtual reality equipment; 3. unstable dose of psychotropic medications within 3 weeks prior to baseline assessment; 4. current alcohol or substance use disorders; 5. current, or history of bipolar disorder; current, or history of psychosis; 6. serious suicidal risk, as determined by clinical interview.
the feasibility of a diet and exercise intervention in diabetics during treatment for non-muscle invasive bladder cancer

Conditions: Bladder Cancer; Diabetes Mellitus

Summary: the purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.

this study will examine the effects of a carbohydrate restricted (cr) diet in bladder cancer patients with diabetes. the goal of this pilot study is to determine if the cr diet and exercise routine are feasible for this patient population to follow. participants in this study will receive meals tailored to their specific needs. a registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study. participants will be asked to be in this study for up to 12 months. a participant will be asked to make a total of 16 in-person visits over the course of 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of non-muscle-invasive bladder cancer * have completed transurethral resection of bladder tumor (turbt) procedure * diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening exclusion criteria: * evidence of muscle-invasion or metastatic disease * bmi less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (pgsga) * unable to complete the exercise regimen or deemed a fall risk * participating in a research study involving any form of treatment intervention
acthar as rescue therapy for transplant glomerulopathy in kidney transplant recipients

Conditions: Proteinuria; Transplant Glomerulopathy

Summary: the goal of this study is to evaluate the benefit of acth (acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy. * failed standard therapy (\>25% reduction in proteinuria) including maximum use of an ace inhibitor, arb, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression exclusion criteria: * diabetes