Kornimate/medical-research-clean huggingface dataset:
acupuncture combined with mindfulness: acumind

Conditions: Chronic Pain

Summary: this study aims to gather preliminary data regarding acupuncture and mindfulness in the treatment of chronic pain.

neither acupuncture nor mindfulness have been studied with respect to chronic pain in an outpatient integrative health (ih) oncology clinic in the usa. likewise, the combination of acupuncture and mindfulness combined as not been studied. given that both acupuncture and mindfulness have demonstrated some analgesic relief in an acute pain setting, each merit study for pain relief in an outpatient setting. the investigators are evaluating the impact of two different acupuncture approaches for patients reporting chronic pain. acupuncture will be provided by a licensed acupuncturist for patients reporting chronic pain. participants will be randomized to one of two treatments - acupuncture as usual or acupuncture plus mindfulness. the investigators will collect data regarding chronic pain, interoceptive awareness, emotion regulation, and acceptability. the study is open to participants with any etiology and any location of chronic pain.

Eligibility criteria:
inclusion criteria: * patient is age 18 or older. * patient is experiencing pain (rated ≥3 on a 0-10 scale) lasting for three or more months. * able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * only for those with a diagnosis of cancer: ecog status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, \<50% in bed during the day). exclusion criteria: * patient has received 5 or more acupuncture treatments in the last 2 months.

Keywords: chronic pain acupuncture mindfulness interoceptive awareness
effects of high altitude on ampk activation

Conditions: Pregnancy; IUGR; Preeclampsia

Summary: pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high altitude and may contribute to the observed 3-fold increase in intrauterine growth restriction (iugr) and preeclampsia (pree). the investigators propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (summit county) and low altitude (denver) in colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (ma). if altered ma vasoreactivity is found, further studies may be able to link these changes to the increased rates of pree and iugr at altitude and contribute to the understanding of these two disorders.

the investigators will determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries. this will be novel information regarding pregnancy at altitude and of significance not just for women and families in colorado, but also at high-altitude locations throughout the world. if altered ma vasoreactivity is found, further studies may be able to link these changes to the increased rates of pree and iugr at altitude and contribute to the understanding of these two disorders. the investigators will also determine whether the chronic hypoxia of high altitude alters dna methylation patterns and expression of key genes involved in metabolic homeostasis in maternal, placental and fetal cells and, in turn, the relationship of these changes to fetal growth and maternal well-being.

Eligibility criteria:
inclusion criteria: * women scheduled for cesarean delivery at university of colorado hospital (denver, 1600 m) and st. anthony's summit medical center (summit county, 3000 m) * cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation exclusion criteria: * women will be excluded if there are co-existing medical diagnoses that are known to affect vascular parameters (i.e., diabetes mellitus, gestational diabetes, any hypertensive disorder of pregnancy, or a current smoker). * women with multiple gestations and preterm deliveries will also be excluded.

Keywords: pregnancy high altitude vasoreactivity myometrial arteries
biodiversity intervention and atopic sensitization

Conditions: Atopy; Allergy; Allergic Rhinitis; Allergic Sensitisation

Summary: children will receive biodiversity intervention or placebo. the proof of concept trial is double blind. intervention will start at the age of 2 months and last 10 months. children will be randomized to arms. ige sensitization is the primary outcome.

newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. the proof of concept trial will be double blind. intervention will start at the age of 2 months and it will end when children become 12 months old. children will be randomized to the two arms. ige sensitization is the primary outcome at the age of two and three years.

Eligibility criteria:
inclusion criteria: * both parents have atopy * newborn exclusion criteria: * severe disease, particularly immune system deficiency or down syndrome or cancer * medication affecting immune system * birth before week 35 in pregnancy * being a twin * only one of the parents have atopy * none of the parents have atopy * children have passed the age of two months * immune system disorder such as rheumatoid disease, colitis ulcerosa, crohn disease, diabetes or genetic risk to type 1 diabetes * no participation in national vaccination programme

Keywords: biodiversity intervention ige atopy
a phase 2 trial of alimta (ly231514, pemetrexed) plus oxaliplatin administered every 21 days for first-line treatment of patients with advanced colorectal cancer.

Conditions: Colorectal Cancer

Summary: the purpose of this study is to assess the antitumor activity of alimta plus oxaliplatin combination therapy in patients with previously untreated advanced colorectal cancer


Eligibility criteria:
inclusion criteria: * diagnosis of primary cancer of the colon or rectum * must have measurable disease * must be able to comply with study procedure exclusion criteria: * prior chemotherapy for advanced disease * pregnancy or lactation * candidates for surgical resection of one or more metastatic foci * second primary cancer * inability to take folic acid or vitamin b12
assessment of a personalized health care intervention for frequent headache

Conditions: Frequent Headaches

Summary: the research project is a component of a mentored research career enhancement award. the purpose of the award is to help the pi and his collaborators prepare for future research grant opportunities through the patient centered outcomes research institute (pcori). the research project is a feasibility study with the following specific aims; 1) to assess outcomes associated with a personalized health plan for frequent headaches; 2) to identify measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create a patient stakeholder group to inform patient-centered outcomes research for frequent headaches. specific aim #1 will be achieved by recruiting and enrolling 40 established patients at the duke family medicine center who have frequent headaches. the intervention consists of 3 study visits with the pi, 2 clinical consultations with subjects' established primary care provider at the duke pickens family medicine center, and participation in 2 focus groups. personalized health plans might consist of a combination of medical management, lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. data analysis will be descriptive; no formal hypotheses will be tested.


Eligibility criteria:
inclusion criteria: * patients with chronic headache exclusion criteria: * patients who do not understand english language

Keywords: frequent headaches personalized health plan
coronavirus disease 2019 (covid-19) study of hospitalized patients in hong kong

Conditions: Coronavirus Infections

Summary: covid-19 may cause another world-wide epidemic. this study is divided into 2 arms: (1) prospective longitudinal observational study involving patients with laboratory-confirmed covid-19 and (2) retrospective study on patients with laboratory-confirmed covid-19. arm 1: we will collect edta blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. arm 2: the remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. assistance from the public health laboratory service, department of health, will be invited to retrieve samples as well as participate in this study. patients hospitalized for pneumonia in medical wards and icu at the prince of wales hospital tested negative for covid-19 will be recruited as controls. understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.


Eligibility criteria:
inclusion criteria: * case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed covid-19 * controls are patients admitted for community-acquired pneumonia exclusion criteria: * patients who refuse to consent for study

Keywords: sars-cov-2 coronavirus disease 2019
immunosuppressive effects of smoking and hiv-1 on the development of lung disease

Conditions: HIV; Smoking; COPD

Summary: this study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (hiv/aids). even though antiretroviral therapy (art) has dramatically decreased the number of opportunistic infections and deaths in hiv infected patients, pulmonary complications (including chronic obstructive pulmonary disease (copd) development and pneumonias resulting in decreased lung function) of hiv/aids continue to be a major cause of morbidity and mortality in this population. the mechanisms underlying the increased risk of copd and decreased lung function in hiv infected individuals is not well understand and needs to be studied. the investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to hiv and cigarette smoke combine to increase the risk of lung infection and injury in hiv infected smokers, hastening the development of copd. the mechanisms will be directly tested using blood and bronchial alveolar lavage (bal) cells from smokers and nonsmokers with and without hiv infection.

the first component of this study will be a longitudinal, prospective, 24 weeks study of the effects of hiv-1 infection on innate and acquired immunity in the lung (cohort a). the second component of this study will be a cross-sectional, case-control study of lung function and immune dysregulation of hiv-1 infected persons on long-term art (cohort b). cohort a will consist of 120 subjects, stratified by hiv-1 and smoking status cohort b will consist of 90 subjects stratified by chronic obstructive pulmonary disease (copd) and hiv-1 infection.

Eligibility criteria:
inclusion criteria (cohort a): * subjects with chronic hiv-1 infection (cohorts a1 and a2) * art naïve or off all art for \>6 months (cohorts a1 and a2) * hiv-1 rna level \>1,000 copies/ml (cohorts a1 and a2) * hiv-1 seronegative with no high-risk exposure in the past 30 days (cohorts a3 and a4) * 18 years and older (all cohort a) * active cigarette smoker (cohorts a1 and a3) inclusion criteria (cohort b): * age from 30 to 70 years * subjects with chronic hiv-1 infection (cohorts b1 and b2) * subjects on stable 3-drug art regimen with plasma hiv-1 rna \<50 copies/ml for past 6 months (cohorts b1 and b2) * hiv-1 seronegative with no high-risk exposure in the past 30 days (cohort b3) copd: forced expiratory volume at one second (fev1)/forced vital capacity (fvc) \<70% and forced expiratory volume (fev), 45-100% of predicted (cohort b1 and b3) * non-copd: fev/fvc \>70% and an fev, \>80% of predicted (cohort b2) exclusion criteria (cohort a and b): * pregnancy * weight less than 110 pounds (for venipuncture) * patient inability to participate in the study and undergo venipuncture and bronchoscopy procedures * use of systemic or inhaled corticosteroids in the past 3 months.
nebulized resveratrol plus carboxymethyl-β-glucan for reducing il-5 in children with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: single-center, randomized, placebo-controlled study to: * characterize the subjects at baseline and discriminate groups of children based on il-5, il-17, il-23 and inf-γ; * investigate the effect of resveratrol plus carboxymethyl-β-glucan, two sprays (100µl/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (il-5) in children with allergic rhinitis (ar). secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nno) levels, nasal cytology and acoustic rhinometry.


Eligibility criteria:
inclusion criteria: * history of ar in the previous year; * positive skin prick test to seasonal allergens. exclusion criteria: * acute upper respiratory infections in the last 4 weeks; * lifetime history of asthma (doctor diagnosis); * use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks; * anatomic nasal defects (ie, septum deviation), or nasal polyps; * active smoker.
exploring the potential benefits of probiotic yogurt

Conditions: Chronic Constipation

Summary: this study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.


Eligibility criteria:
inclusion criteria: 1. meet the rome iv diagnosis criteria for chronic constipation; 2. patients who are able to understand clinical studies and are committed to complying with study requirements and procedures; 3. age 18-65. - exclusion criteria: 1. systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota; 2. patients who are pregnant or lactating; 3. have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks; 4. patients who changed their diet type during the study; 5. patients who are allergic or intolerant to any component of the investigational product formulation; 6. patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients; 7. stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data; 8. short-term use of objects related to the function of the test, affecting the judgment of the result; 9. have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months; 10. current or past excessive use of alcohol, drugs, or supplements that may cause intestinal dysfunction or interfere with the evaluation of the efficacy of the study product -
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for cp

Conditions: Cerebral Palsy

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of cerebral palsy

studies have shown that stem cell treatment is safe and efficacious for the treatment of cerebral palsy (cp). this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of cp. patients with cp will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety * previous organ transplant * seizure disorder * hypersensitivity to sulfur

Keywords: cerebral palsy cp stem cell treatment
innovative treatments in pneumonia (itip) 3

Conditions: Pneumonia

Summary: this is a prospective observational study assessing the clinical outcomes of children 2 to 59 months of age with both pneumonia and other co-morbidities presenting to a tertiary hospital outpatient setting in malawi, africa who are most at risk for mortality or have other complications and thus, are typically excluded from childhood pneumonia studies.


Eligibility criteria:
inclusion criteria: * male or female, 2 to 59 months of age. * excluded from enrollment in innovative treatment in pneumonia (itip) 1 and itip2 clinical trials due to presence of any of the following: * hypoxia (sao2 \< 90% on room air, as assessed by a pulse oximeter). * severe respiratory distress (e.g., presence of grunting, nasal flaring, head nodding, or severe chest-indrawing). * severe malaria, classified by world health organization (who) guidelines on hospital care for children, including a positive malaria rapid antibody test result. * severe anemia, classified by who integrated management of childhood illness (imci) guidelines (i.e., severe palmar pallor) only if a positive malaria rapid antibody test result. * severe acute malnutrition (sam) (i.e., weight for height/length \< -3 sd, mid-upper arm circumference (muac) \<115, or edema). * hiv-1 seropositivity or hiv-1 exposure, assessed as follows: an hiv-positive result upon rapid antibody testing. * if a child is less than 24 months of age and has an hiv-negative result upon rapid antibody test documented from the past three months, the child's biological mother's hiv status will need to be assessed. if the mother is hiv-positive, the child will be included. if the mother does not have documentation of an hiv-negative test result from the past 3 months, she will be tested via rapid antibody testing to determine the child's eligibility for this study. * ability and willingness of child's caregiver to provide informed consent and to be available for follow-up (in the inpatient ward, returning to kch for a scheduled study follow-up visit, and by phone) for the planned duration of the study. exclusion criteria: * possible tuberculosis (coughing for more than 14 days). * stridor when calm. * severe anemia, classified by who imci guidelines (i.e., severe palmar pallor) if a negative malaria rapid antibody test result. * known allergy to penicillin or amoxicillin. * receipt of an antibiotic treatment in the 48 hours prior to the study based on caregiver's self-report and/or documentation in child's medical record. * living outside lilongwe urban area, the study catchment area. * any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the child's health. * participation in a clinical study of an investigational product within 12 weeks prior to enrollment or planning to begin participation during this study. * prior participation in itip1, itip2 or itip3 during a previous pneumonia diagnosis.
prospective study for the outpatient treatment of patients with very low risk acute symptomatic pulmonary embolism.

Conditions: Acute Pulmonary Embolism; Outpatient Treatment

Summary: objectives: to evaluate the safety of outpatient treatment of patients with very low-risk pulmonary embolism (pe), and the satisfaction and quality of life of this management. methods: an experimental study of routine clinical practice will be carried out in which 300 consecutive hemodynamically stable patients with acute symptomatic pe will be included, who meet all the inclusion criteria and none of the exclusion criteria. all patients included in the study will be treated on an outpatient basis, that is, they will be discharged within the first 24 hours of the diagnosis of pe in the emergency department. the computerized registry of thromboembolic disease riete (registro informatizado de enfermedad tromboembólica) will be used to collect the data in electronic case report form (crf) and ensure the quality of the data. setting: emergency, pneumology and internal medicine services of 10 spanish hospitals. analysis: an intention-to-treat (itt) analysis will be performed on all patients who sign the informed consent and are included in the study (regardless of whether or not they receive the assigned strategy). additionally, an analysis of all patients who are treated on an outpatient basis without deviations or violations of the protocol will be performed. the primary outcome considered will be the composite of recurrent pe, major bleeding, or death from any cause during the first 30 days after enrollment in the study. patient satisfaction and quality of life will be considered as secondary outcomes.


Eligibility criteria:
inclusion criteria: * confirmation of suspected pulmonary embolism (pe) by multidetector chest angio computed tomography (ct), if a contrast-encircled partial intraluminal defect or complete pulmonary artery occlusion is demonstrated on two consecutive ct slices (13); * right ventricle (rv) diameter equal to or less than that of the left ventricle (lv) (rv/lv ratio ≤1) on chest ct angiography (see study procedures); and * negatively modified simplified pulmonary embolism severity index (spesi) scale at the time of evaluation of the patient in the emergency department. exclusion criteria: * inability to obtain informed consent * pregnancy * hemodynamic instability at diagnosis (defined by systolic blood pressure (sbp) \<90 mm hg, indication of fibrinolytic treatment or inferior vena cava filter, need for vasoactive drugs at the discretion of the attending physician, cardiopulmonary resuscitation or orotracheal intubation) * contraindication for anticoagulation, at the discretion of the responsible physician; * estimated survival of less than 3 months * need for thrombectomy, vena cava filter insertion, or need for fibrinolytic treatment of the pe episode at the time of diagnosis * participation in a clinical trial for the treatment of venous thromboembolic disease * impossibility of follow up
acupuncture for pre-procedure anxiety

Conditions: Anxiety

Summary: it is common for patients undergoing spinal injections to report anxiety prior to the injection. although sedation, general anesthesia, and medications can be used to reduce anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord injury. the purpose of this study is to see if receiving acupuncture before a spinal injection can effectively reduce patients' anxiety. only patients who are scheduled to receive a spinal injection at this institution will be eligible for the study.


Eligibility criteria:
inclusion criteria: * age 18+ * spine pathology that meets criteria for lumbar epidural injection exclusion criteria: * unable to provide consent * contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear) * previous experience of acupuncture * age \<18 * pregnant women * non-english or non-spanish speaking