Kornimate/medical-research-clean huggingface dataset:
pilot study to assess gut mucosal b cells in individuals with hcv and hiv

Conditions: HIV Infections; Hepatitis C Virus

Summary: this pilot study aims to study gut b cells in hcv+hiv+, hcv+hiv-, hcv-hiv+, and hcv-hiv- volunteers. volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy.

hepatitis c virus (hcv) infects approximately 170 million people worldwide and is the leading indication of liver transplantation in the united states. hcv is primarily a blood-borne infection, and heterosexual transmission is rare. however, acute hcv infection is increasingly being reported among hiv-positive men who have sex with men (msm) with no risk factors for parenteral hcv transmission, suggestive of a possible mucosal route of infection in these individuals. while it is possible that hcv may be transmitted into the bloodstream via mucosal tears induced by sexual activity, is also possible that a mucosal immune defect predisposes hiv+ persons to mucosal hcv transmission. our pilot study aims to study gut b cells in hcv+hiv+, hcv+hiv-, hcv-hiv+, and hcv-hiv- volunteers. volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy. we will isolate peripheral and mucosal mononuclear cells and we will perform hcv-specific elispot and single b cell immunoglobulin (ig) rt-pcr to assess volunteers' gut b cell repertoire. if successful, we would like to expand the study so as to better assess ig repertoire differences among hcv+hiv+ and hcv+hiv- individuals.

Eligibility criteria:
inclusion criteria: 1. between 18 and 75 years of age. 2. ability to give informed consent. 3. platelets greater than 70,000/mm3. 4. hb at least 9.5 g/dl. 5. inr \< 1.5. exclusion criteria: 1. decompensated cirrhosis. 2. serious uncontrolled medical illness. 3. ingestion of aspirin within 72 hours of sigmoidoscopy 4. ingestion of non aspirin nsaids within 8 hours of sigmoidoscopy 5. receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide. 6. psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements. 7. alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. 8. medical illness requiring prescribed aspirin or nsaids.

Keywords: hcv hiv
outpatient left laparoscopic colectomy

Conditions: Colonic Neoplasms; Colonic Diverticulosis

Summary: the success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. to this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. the objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.

in france, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. this surgery is associated with numerous postoperative complications. since the start of enhanced recovery after surgery (eras) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. at the same time, the average length of post-operative stay has decreased. in 2014, eras was the subject of recommendations by the french society of anaesthesia and resuscitation, taken up by the french health authority (has) in 2016, and which are now an integral part of surgical management in colorectal surgery. more recently, two teams have set up an outpatient colectomy program. the three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications. in accordance with the recommendations on eras published by the has, a program involving pre-, per- and post-interventional investment, has been put in place. patients are discharged on d0, followed by close monitoring by a home care nurse twice daily. this nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification (asa) score i and ii, * patient with an indication for scheduled left colectomy due to neoplastic (stage 1) or diverticulitis, * patient residing less than 30 minutes from la rochelle hospital, * presence of a companion from the anaesthesia consultation onwards, * presence of an attendant at the patient's discharge, * perfect understanding of outpatient care, pathology and surgical procedure of the patient and accompanying person, * informed of the study. exclusion criteria: * asa score 3 et 4, * indication for a straight or transverse colectomy, * neoplasia evolution \> stage 1, * presence of anticoagulant treatment, * intraoperative bleeding \> 500ml, * conversion to laparotomy, * severe anesthetic complication (anaphylaxis, difficult intubation), * persons deprived of their liberty by a judicial or administrative decision, * persons of full age who are subject to a legal protection measure, * persons unable to consent, * persons who are not members of or beneficiaries of a social security scheme, * patient's refusal to participate in the study.
endovascular treatment for acute ischemic stroke in china (detect2-china)

Conditions: Stroke, Ischemic

Summary: this is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a chinese population.


Eligibility criteria:
inclusion criteria: * age: ≥ 18; * ischemic stroke confirmed by head ct or mri; * patients receiving endovascular treatment; * first ever stroke or pre-stroke mrs≤2; * signed informed consent. exclusion criteria: * prestroke mrs≥3; * other serious illness that would confound the clinical outcome at 90 days; * unavailable neuroimaging data; * other unsuitable conditions judged by the investigator
azd5069 neutrophil function study

Conditions: Chemokine Receptor 2 (CXCR2) Antagonist

Summary: study in healthy volunteer to see effect of azd5069 and placebo on neutrophil number and function (phagocytosis and oxidative burst) in the circulation, following a burst of strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating factor (g-csf)

a randomised, double-blind, placebo-controlled, two-way cross-over, single centre study in healthy subjects to assess the effect of oral dosing of azd5069 on neutrophil number and function in peripheral blood and the ability to recruit neutrophils into the circulation after exercise and subcutaneous

Eligibility criteria:
inclusion criteria: * healthy caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening * only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal * non-smokers or ex-smokers with no smoking history the last 12 months prior to visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening * body mass index (bmi) \>18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg exclusion criteria: * subjects with a history of or active or latent tuberculosis (tb), or close contact with anybody with active tb * subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin) * subjects who are pyrexial with a body temperature of greater than 37.7 c at visit 2, or as judged by the investigator * alanine aminotransferase (alt)/aspartate aminotransferase (ast) level ≥1.5 x upper limit of normal (uln) at screening (visit 2) * peripheral blood neutrophils above or below the laboratory reference range at screening (visit 2) hscrp above the upper limit of the laboratory reference range at visit 2

Keywords: phase 1, azd5069, safety and tolerability, healthy volunteer,
exploratory study to assess delivery of lmn-201 components via enteric capsules in the gut of individuals with ostomies

Conditions: C. Diff. Infections

Summary: this is a phase 1, single-site, open label, exploratory study to assess delivery of lmn-201 components via enteric capsules in the gut of individuals with ostomies.


Eligibility criteria:
inclusion criteria: * willing to participate in the clinical trial * able and willing to provide informed consent * stable ostomy (no revisions in the last 6 months) * at least 19 years old * medically stable, but may be on medications for chronic conditions exclusion criteria: * unable or unwilling to provide adequate informed consent * non-english speakers * clinically significant disease * women who are pregnant, intending to become pregnant, or breastfeeding * use of anti-diarrheal medicine * suffer gastroparesis * opioid use
nimotuzumab concurrent with chemoradiotherapy for esophageal cancer patients

Conditions: Esophageal Cancer; Nimotuzumab; Chemoradiotherapy; Chemotherapy; Immunotherapy

Summary: elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (escc) had poor prognosis. radiotherpy was an important and effective treatment in treating escc. the present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable escc. the study objectives include r0 resection rate, complete pathological response and treatment toxicity, etc. nimotuzumab is a recombinant humanized monoclonal antibody against egfr. its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. the current prospective phase ii study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and s-1 and concurrent radiotherapy for patients who are elderly or malnourished.


Eligibility criteria:
inclusion criteria: * histologically confirmed esophageal squamous cell carcinoma. * no previous treatment for the esophageal carcinoma. * kps score ≥70. * nrs-2002 score≥2. * main organs and bone marrow function are normal: routine blood tests: hemoglobin (hb) ≥100g/l ; absolute neutrophil count (neut)≥1.5×109/l; platelets (plt) ≥100×109/l; white blood cell (wbc)≥3.5×109/l,biochemical examination: alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤1.5×unl; serum total bilirubin (tbil) ≤1.5×unl; serum creatinine ( cr) 1.0×1.5unl, and bun≤1.0×unl; exclusion criteria: * previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy. * those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * at the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites * there are active infections, such as active tuberculosis and hepatitis * there are contraindications to targeted therapy.
a study on diagnosis and treatment strategies for atlantoaxial dislocation

Conditions: Atlantoaxial Dislocation; Treatment; Diagnostic

Summary: the most effective treatment for atlantoaxial dislocation is surgical treatment, with the principle of achieving reduction, reconstruction, and fusion of the atlantoaxial joint. the surgical strategies mainly include simple anterior approach, simple posterior approach, and combined anterior posterior approach. the investigators have summarized 904 cases of atlantoaxial instability or dislocation from 1998 to 2010 and preliminarily published the diagnosis and treatment strategy tree of the third hospital of beijing medical university. this strategy is divided into four types based on the severity of atlantoaxial dislocation: unstable, reversible, difficult to recover, and skeletal, and enters different surgical treatment processes. with the increase in the number of cases, accumulation of experience, and technological improvements in the past decade, spinal surgery colleagues have updated their classification diagnosis, diagnosis and treatment processes, and surgical techniques for atlantoaxial instability or dislocation. however, the selection of treatment strategies for atlantoaxial dislocation is mostly based on the surgeon's own experience, and there is a lack of standardized, large-scale, and high-level evidence-based medical research on the safety and effectiveness of current empirical strategies. based on this, this study intends to adopt a multicenter, retrospective, and prospective study to construct a high-quality clinical cohort of atlantoaxial dislocation, update the classification and diagnosis and treatment strategies of atlantoaxial dislocation. and conduct long-term follow-up on patients to evaluate their safety and effectiveness, guide the surgical treatment of atlantoaxial dislocation, and thus form a recognized diagnostic and treatment standard for atlantoaxial dislocation.


Eligibility criteria:
inclusion criteria: * patients diagnosed with atlantoaxial dislocation and treated with surgery exclusion criteria: * disagree to participate in this study.
treatment effect of saxagliptin compared with placebo in patients with type 2 diabetes and renal impairment

Conditions: Type 2 Diabetes

Summary: saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. this study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * documented history of crcl \<50 ml/min within the 3 months prior to enrollment * hba1c ≥7.0% and ≤11.0% exclusion criteria: * type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma * previous or current treatment with any dpp-iv inhibitor and/or glp-1 mimetic.

Keywords: dpp-4 inhibitors hba1c incretins renal impairment
antibiotic prescription in children hospitalized for community-acquired pneumonia

Conditions: Community Acquired Pneumonia in Children; Antibiotic Stewardship

Summary: a study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. parent satisfaction will also be recorded.

an observational study to document the antibiotic treatment rate of children hospitalized for community acquired pneumonia at a pediatric department with longstanding practice of restrictive antibiotic prescribing. patients will be enrolled consecutively and treated according to in-house standard operating procedure. antibiotic treatment rate, severity of disease and medical complication rate in antibiotic and non-antibiotic managed children, frequency of predefined factors in physician decision making on antibiotic use, and parental satisfaction will be recorded. parents will be contacted at least 4 weeks after discharge to inquire about recurrence or readmission.

Eligibility criteria:
inclusion criteria: * hospital admission at the pediatric department of the filderklinik or at the pediatric department of the herdecke community hospital * admission diagnosis pneumonia or pneumonia diagnosis within 48 hours of admission * written informed consent by care giver * all inclusion criteria have to be fulfilled exclusion criteria: * insufficient knowledge of german to understand the written patient information and questionnaire

Keywords: community acquired pneumonia antibiotic use pediatrics hospitalised children integrative medicine
collar use for cervical radicular pain

Conditions: Cervical Radiculopathy

Summary: to evaluate the effectiveness of treatment in subjects with cervical radicular pain with vista therapy collar, using a visual analog scale, a neck disability index and the sf-36 quality of life survey.

to evaluate the effective of treatment with vista therapy collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years 2. cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following: * provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm. * muscle weakness in one or more adjacent myotomes. 3. neck disability index (ndi) score \>= 10 points 4. vas for neck pain \>= 40 5. subject has signed and dated the patient informed consent /patient information sheet prior to any study-related activities being conducted 6. subject is willing and able to attend visits as scheduled and to comply with the study protocol exclusion criteria: 1. serious somatic or psychiatric disorder 2. previous neck surgery 3. whiplash as the primary incident 4. history of spinal tumor or infection 5. cervical instability per opinion of pi 6. morbid obesity (bmi\>40) 7. tmj issues 8. subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study 9. subject is involved in current litigation regarding neck pain or injuries associated with neck pain 10. subject is involved in worker's compensation litigation 11. non-english speaking

Keywords: neck pain
subjective and objective changes in muscle-stiffness

Conditions: Healthy; Muscle Soreness

Summary: the purpose of this study is to investigate muscle stiffness in relation to delayed on-set muscle soreness following exercise and to investigate how well the change in muscle stiffness correlates with the subjective experienced degree of stiffness.


Eligibility criteria:
inclusion criteria: * healthy participants aged 18-80 * able to speak, read and understand danish and/or english exclusion criteria: * have performed resistance training on a regular basis during the past month * experience of delayed onset muscle soreness (doms) during the last two weeks leading up to the first test session * current use of analgesics * any current neurological, musculoskeletal or mental illnesses that could interfere with the results. * pregnancy * lack of ability to cooperate
sevoflurane for treatment-resistant depression

Conditions: Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Summary: this study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.


Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. meeting dsm-v criteria for major depressive disorder 3. a pretreatment score ≥17 on hdrs-17 4. meeting criteria for trd, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode. 5. current treatment drugs were stably used for at least 4 weeks exclusion criteria: 1. mdd with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al 2. drug, tobacco or alcohol abuse 3. active suicidal intention 4. previous administration of nmda receptor antagonists (e.g., ketamine) 5. previous (\<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ect) or transcranial magnetic stimulation (tms) 6. pregnancy or breastfeeding 7. morbidly obese, bmi\>35kg/m2 8. other diseases that could interfere with the results

Keywords: treatment-resistant depression (trd) major depressive disorder (mdd) sevoflurane
qualitative exploration of a mobile stress management intervention for mental health workers

Conditions: Work-Related Stress; Coping Behaviour; User Experience of Mobile Application

Summary: the goal of this qualitative intervention study is to explore the experiences of mental healthcare workers using the stapp@work app to manage work-related stress. stapp@work is a mobile self-monitoring app designed for the workplace, that supports users in recognizing, understanding, and managing daily stress. the app measures stress levels multiple times per day by asking what you were doing, how you were feeling and your stress signals. it offers real-time feedback and a visual overview of stress levels at both the daily and weekly level, including the context. this allows users to recognize their own stress triggers and patterns. in addition, the app provides practical suggestions to help users cope with stress. the main question this study aims to answer is: - how do mental healthcare workers experience the use of the stapp@work app in daily work life? participants will: * use the stapp@work app for a period of 2 weeks. * participate in a semi-structured interview after the use of the intervention to discuss their experiences with the app. this is a single-group qualitative study. there is no control or comparison group. the findings will contribute to understanding how mobile health interventions can support employees in high-pressure healthcare environments, and provide insight into user experiences, perceived benefits and limitations, and factors that may influence engagement and implementation.


Eligibility criteria:
inclusion criteria: * employee at ggz centraal exclusion criteria: * not employed at ggz centraal * prior participation in a stapp@work research study

Keywords: user experiences work-related stress self-management stress management mobile health mhealth qualitative study self-monitoring mental healthcare workers healthcare professionals
a dose and schedule finding trial with amg 531 for chemotherapy induced thrombocytopenia (cit) in adults with lymphoma

Conditions: Chemotherapy-Induced Thrombocytopenia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Cancer; Oncology; Thrombocytopenia

Summary: the purpose of this study is to identify a well-tolerated, effective dose and schedule of amg 531 for the treatment of chemotherapy induced thrombocytopenia (cit) in subjects with lymphoma receiving multi-cycle chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed hodgkin's lymphoma or non-hodgkin's lymphoma receiving q14, q21, or q28 day chop, ice, eshap, or dhap chemotherapy; with or without rituximab * has adequate bone marrow function; platelet count \> 100 x 10\^9/l on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, anc \> or = 1 x 10\^9/l, and hemoglobin \> or = 9.5 g/dl * eastern cooperative oncology group (ecog) performance status of 0 or 1 * has adequate liver function * must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle * must experience common terminology criteria (ctc) grade 3 or 4 thrombocytopenia (platelet count \< 50 x 10\^9/l) as a result of the chemotherapy administered in the cycle immediately preceding study entry * has serum creatinine concentration \< or = 2 mg/dl exclusion criteria: * more that 1 prior relapse chemotherapy regimen * sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia * significant bleeding (ctc grade 3 or 4) * history of thromboembolic disease * subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis b or c infection or to be hiv positive * use of any nitrosourea or mitomycin-c * has received any thrombocytopenic growth factor * has received a marrow or peripheral blood stem cell infusion * known hypersensitivity to any recombinant e. coli-derived product

Keywords: nhl chemotherapy induced thrombocytopenia cit ice rice hodgkin's lymphoma non-hodgkin's lymphoma chop eshap dhap r-chop r-eshap r-dhap