Kornimate/medical-research-clean huggingface dataset:
cohort for research and innovation in chronic inflammatory respiratory diseases

Conditions: Chronic Inflammatory Pulmonary Diseases

Summary: chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (copd), interstitial lung diseases (ild), bronchiectasis, and cystic fibrosis (cf) are characterized by lung inflammation and remodelling. clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. a precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies. the objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with copd, ild, bronchiectasis, and cf. the associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed. the cohort for research and innovation in chronic inflammatory respiratory diseases (the rinnopari project: recherche et innovation en pathologie respiratoire inflammatoire) is a monocentric study conducted at the university hospital of reims, france. adult patients (\>18 year-old) followed at the university hospital of reims and diagnosed with copd, ild, bronchiectasis, or cf will be considered for inclusion. patients will sign an informed consent for inclusion. exclusion criteria include "subjects protected by the law" as required by the french authorities. control patients with no respiratory diseases after clinical and pulmonary function tests assessment will be also included. the expected number of patients included is 225 (copd, n=100; cf, n=25; bronchiectasis, n=25; ild, n=25; controls, n=50). inclusion will be conducted for 36 months from september 2016 (9/30/2016) to september 2019 (9/30/2019). for all copd, ild, bronchiectasis, and cf patients included, data will be registered at inclusion, and at follow-up visits for 10 years. patients will be followed-up as usual care with no specific therapeutic intervention. for control patients, data will be registered at inclusion with no follow-up. data will be registered in a centralized anonymized database. the characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. comparisons and associations between groups and variables will be analyzed by student, wilcoxon, chi2, fischer exact, and spearman tests as applicable. a p\<0.05 will be considered as significant. this study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 year-old) with copd, cf, bronchiectasis or ild exclusion criteria: * \<18 year-old
iv pulsed-nicotine as a model of smoking: the effects of dose and delivery rate

Conditions: Nicotine Dependence

Summary: this project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. will use pulsed iv nicotine administration which closely matches nicotine delivery by inhaled tobacco use.

seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. in each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. while receiving the pulsed infusions, participants will inhale a tobacco-flavored ec without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. there are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. for those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. for those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions.

Eligibility criteria:
inclusion criteria: * female and male, aged 21 to 55 years; * past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests * women, -using acceptable birth control methods. exclusion criteria: * history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study * risk factors for evali (e-cigarette or vaping product use-associated lung injury) including history of lung diseases (e.g., asthma or copd), vaping thc or cbd * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) * current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine * for women, pregnant as determined by pregnancy screening, or breast feeding * seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.
risk factors and prevention of severe pain upon cessation of a peripheral nerve block

Conditions: Surgery

Summary: risk factors and prevention of severe pain upon cessation of a peripheral nerve block. a prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.

pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time. severe post-operative pain is a risk factor for chronic pain. use of a well-known molecule, regularly used in anesthesiology. prospective double-blind study on 120 patients. pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients. the anti-hyperalgesic properties of ketamine could be a benefit against this effect. no studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release. this may improve patients' post-operative comfort. the patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10ml saline or 10 ml 0.9% saline after the realization of pnb, before tourniquet set up and beginning of surgery.

Eligibility criteria:
inclusion criteria: * any ambulatory upper limb bone surgery carried out under axillary pnb exclusion criteria: * refusal to participate * contraindication to the use of ketamine * contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol * pregnant woman * diabetic patient * vascular patient * cognitive disorders * inability to answer perioperative questionnaires (language problem)
dengue effectiveness study in the philippines

Conditions: Dengue; Severe Dengue; Virologically Confirmed Dengue

Summary: this is an observational study that aims to determine the effectiveness of a tetravalent dengue vaccine (cyd-tdv) when given through a community-based immunization program against hospitalized and /or severe virologically confirmed dengue.

this is a matched case-control study. cases will be children who are admitted with a clinical suspicion of dengue at the study hospitals and were eligible to have received the dengue vaccine during the mass immunization. the outcome of interest is hospitalized and/or severe virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. each case will be matched to two controls who were also eligible to have received the dengue vaccine and lives in the same area as the case. cases and controls will be matched by age and sex.

Eligibility criteria:
inclusion criteria: case-control studies * for a suspected case to be enrolled in the study, he/she should: * provide signed informed consent and assent (as applicable) * be within the age group eligible to receive the dengue vaccine at the time of mass vaccination (i.e. no condition that would have made him/her ineligible for dengue vaccination) * be admitted in any of the participating hospitals for suspected dengue * have ≤5 days history of fever. * for the case to be included in the analysis, the participant must meet all the inclusion criteria above plus have virologically-confirmed dengue infection by rt-pcr * for controls to be recruited into the study, he/she should: * provide signed informed consent and assent (as applicable) * be age and sex-matched to the case * be from the same community as the matched case * be eligible to have received dengue vaccine during the community-based dengue immunization campaign in 2017 (i.e. no condition that would have made him/her ineligible for dengue vaccination) * have had no episode of clinically-diagnosed or laboratory-confirmed dengue fever from the start of the community -based dengue immunization campaign to the focal time (the date of onset of dengue fever in the matched case) * should not have been previously recruited as a control. exclusion criteria: • any subject whose parent/guardian refuse to provide informed consent and/or assent. * in addition, the following conditions automatically exclude children from the dengue mass immunization: * children \<9 years or adults older than 45 years of age * anyone who is allergic or has had an allergic reaction to a prior dose or to any component of the dengue vaccine * recipient of blood product in the last 3 months * immunocompromised individuals, due to but not limited to genetic defects, hiv infection, or therapies that affect the immune system such as high-dose corticosteroids or chemotherapy * recipient of any vaccine within the past month * history of bleeding disorder * pregnant or breastfeeding women * enrolled in dengue vaccine phase 3 clinical study
evaluation of the efficacy of sawyer point one filters in schools and homes in the dominican republic

Conditions: Diarrhea

Summary: nathan tintle, in conjunction with others at dordt college including dr. kristin van de griend and undergraduate student research assistants, have agreed to collaborate with hope college to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. the distribution of the water filters will begin in september 2018 to child hope schools in 4 different countries (dominican republic, guatemala, honduras, and nicaragua). in order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms including schools, homes, simultaneous home/school and a control group

nathan tintle, in conjunction with others at dordt college including dr. kristin van de griend and undergraduate student research assistants, have agreed to collaborate with hope college and sawyer products, inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. the distribution of the water filters will begin in september 2018 to child hope schools in 4 different countries (dominican republic, guatemala, honduras, and nicaragua). in order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms: arm 1: simultaneous installation of filters in schools and the villages sending children to the school arm 2: initial installation of the water filters in a school, with later installation in the corresponding village arm 3: instillation of the water filters in villages, with later installation in the corresponding school arm 4: control arm. no filter installation initially but, ultimately, installation of filters in both the schools and villages. self-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. the major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.

Eligibility criteria:
inclusion criteria: * lives in selected villages and has children that attend the local school exclusion criteria: * no children attending the local school
clinical trial to evaluate mycobacterium w in preventing covid-19 in subjects at risk of getting infected with covid-19

Conditions: COVID-19

Summary: this clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of mycobacterium w in combination with standard care as per hospital practice to prevent covid 19 in subjects at risk of getting infected with covid 19.

approximately eligible 4000 subjects who are at risk of getting infected with covid-19 (i.e. person living in same household as covid-19 patients / healthcare workers providing direct care to covid-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria. initially, 400 subjects at risk of getting infected with covid-19 will be enrolled in the study and randomized in 1:1 ratio to receive either mw (n=200) or placebo (n=200). after the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from dsmb / mc, modification in study design, objective or sample size will be considered. study duration for each subject will be of 8 weeks.

Eligibility criteria:
inclusion criteria: * healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with covid-19 patients. * subjects with sars cov 2 negative test (icmr approved test kit) at screening visit. * female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing. * the subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an informed consent form. exclusion criteria: * any febrile illness with oral temperature \> 100°f within 3 days prior to randomization. * subject with past history of covid-19 infection. * pregnant and / or lactating female subjects. * presence of any illness requiring hospital referral. * any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or individuals on immunosuppressant's as azathioprine, cyclosporine, mycophenolate etc. * history of allergic reactions or anaphylaxis to mw or its component.
the new geneswell bct in vitro diagnosis of breast cancer prognosis

Conditions: Breast Cancer

Summary: geneswell bct is a precise and qualitative in vitro diagnostic test. the expression of 9 genes was obtained from the formalin fixed paraffin embedded block (ffpe) of breast cancer tissue samples by rt-qpcr, and the patients were divided into high-risk group and low-risk group. this test provides prognostic information to assess the risk of recurrence. the bct score calculated by geneswell bct was associated with the risk of recurrence. the higher the bct score, the more likely it is to relapse, and vice versa.


Eligibility criteria:
inclusion criteria: * the patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (her2) * axillary lymph node assessment : pn0 or pn1 * women aged 18 and over * patients without chemotherapy after operation exclusion criteria: * patients with negative hormone receptor （both estrogen and progesterone receptor are negative） * human epidermal growth factor receptor 2 （her2） positive * pathological nodule evaluation: pn2 or pn3 * male patients * patients receiving chemotherapy after surgery
hydrus microstent as a quality of life consideration

Conditions: Open Angle Glaucoma

Summary: the study aims to identify if hydrus microstent implantation in patients with open angle glaucoma (oag) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.

prospective, interventional single arm study of patient-reported outcomes (pro) via gss with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and hydrus implantation; study will also explore other qol factors that may motivate patients to accept hydrus via glauc-qol36 and customized questions.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and hydrus microstent * current treatment with one or more ocular hypotensive medication * corneal thickness between 470 to 610µm * potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logmar (20/25) postoperatively exclusion criteria: * clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma) * corneal opacity or angle abnormalities that make visualizing the angle difficult * past ocular surgery * history of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy) * severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts
neurofeedback training of metacognition in subjects with alcohol use disorder. disorder induces neural modifications: an event-related potentials study

Conditions: Alcohol Use Disorder

Summary: addressing cognitive deficits in alcohol use disorder (aud) supports recovery. impaired metacognitive functioning in aud causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. by promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence. the main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in aud.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years old undergoing a 3- to 4-week detoxification treatment program at the alcohol unit of chu brugmann hospital (brussels, belgium), who have been diagnosed with severe aud (alcohol use disorder) according to the dsm-v-tr. exclusion criteria: * history of neurological disorders * other serious medical conditions * neuroleptic treatment are excluded.
a registered cohort study of inflammatory demyelination disease

Conditions: Demyelinating Autoimmune Diseases, CNS

Summary: this study will provide further insights into the natural course of inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect


Eligibility criteria:
inclusion criteria: 1. outpatient or inpatient 2. meet the diagnostic criteria of inflammatory demyelination disease. 3. voluntary participation and informed consent signed by the applicant or his/her family. exclusion criteria: 1. severe complications 2. poor prognosis (\<1 year survival) 3. severe mental disorder and inability to cooperate with the examination.
to verify the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease

Conditions: Peripheral Arterial Disease

Summary: a prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.


Eligibility criteria:
inclusion criteria: * patients with arteriosclerosis obliterans of lower extremities, and rutherford's rating is 2-5. * patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within p1 stage) * patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion) * those who agree to participate in this clinical trial and sign the informed consent form exclusion criteria： * this operation is planned to intervene patients with bilateral lower limbs. * patients whose guide wire fails to pass through the target lesion. * patients whose target lesion is in stent restenosis (isr). * ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion). * patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment. * patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment). * there is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis\<50%). * residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ grade d) flow limiting dissection. * patients with obviously abnormal renal function (creatinine \> 2.5mg/dl or 220umol/l) or undergoing dialysis. * patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery. * patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery. * patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past. * patients who received local or systemic thrombolytic therapy within 48 hours before surgery. * patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation. * patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin. * pregnant or lactating women and patients with family planning during the study * patients who are participating in clinical trials of other drugs or medical devices but are not included in the group. * patients with life expectancy less than 12 months * patients not suitable for this study.