Kornimate/medical-research-clean huggingface dataset:
vir-1111: a prototype human cmv-based vaccine for human immunodeficiency virus (hiv) in healthy volunteers

Conditions: HIV I Infection

Summary: this is a phase 1a, first in human study in which healthy adult participants who are considered to be at low-risk for hiv infection and are seropositive for cytomegalovirus (cmv) will receive two doses of vir-1111 or placebo. these participants will be assessed for safety, reactogenicity, tolerability and immunogenicity. there is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.


Eligibility criteria:
inclusion criteria: * healthy males or healthy females of non-child-bearing potential between the ages of 18 to 50 at the time of screening * positive cmv serostatus * assessed by clinic staff as being low risk for hiv infection and committed to maintaining behavior consistent with low risk of hiv exposure through the last protocol visit * willing to use condoms during intercourse through week 36 or the end of the study * willing to undergo hiv testing, risk reduction counseling, and receive hiv test results * willing to comply with the protocol requirements regarding donation of blood, sperm or other tissues * in the opinion of the investigator, generally in good health as determined from medical history and no clinically significant findings from physical examinations, vital signs, and laboratory values exclusion criteria: * live in a home with children under the age of 6 * routine provision of child care to children under the age of 6 * have close contact with immunocompromised individuals * have close contact with pregnant women or a partner planning to become pregnant during the course of the study * health care provider who routinely comes into contact with immunosuppressed patients or pregnant women * participant is immunocompromised * participant has an autoimmune disorder * positive hiv test at the time of study screening * receipt of another investigational hiv or cmv vaccine candidate

Keywords: hiv vaccine cmv cytomegalovirus
comparison between two methods of oral care on the incidence of vap

Conditions: Pneumonia, Ventilator-Associated

Summary: patients on ventilator are in high risk to develop ventilator associated pneumonia (vap). this acquired infection significantly increases morbidity and mortality of these patients. studies that investigated the factors influencing the incidence of vap proved that infectious agents located in the throat and oral cavity are important factors. the assimilation of oral cavity treatment, including teeth brushing, cleaning and removal of secretions may significantly decrease the incidence of vap. choosing the method of oral cavity cleaning is based on few studies that demonstrated the optimal influence of combining mechanical cleansing, the use of a non alcoholic antiseptic material and lubrication of the lips and the oral cavity. most of these studies are retrospective. the study will compare the traditional method of oral cavity treatment with the use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity. the current study is a prospective, open label, statistically balanced study that will investigate the connection between the method of oral cavity treatment and the incidence of vap. 100 patients will be included. all ventilated patients in the icu will be eligible and will be included after an informed consent will be signed by the patient, or by his legal guardian. exclusion criteria include age less than 18 y/o, pregnancy, expected survival of less than 48 hours, immunosupression (excluding patients on steroids), severe burns, existing pneumonia and patient already included in another study. the main outcome will be 30 days all cause mortality. secondary outcomes include the development of vap, days on ventilator, los in the icu and los in the hospital.


Eligibility criteria:
inclusion criteria: * all ventilated patients in the icu * older than 18 y/o exclusion criteria: * age less than 18 years * pregnancy * immunosuperessed patients * expected survival of less than 48 hours * burns * existing pneumonia

Keywords: vap oral care acquired pneumonia mortality los in icu los in hospital all patients on ventilator in the icu
barrier function measurement in dry eye patients after using systane ultra for 30 days

Conditions: Dry Eye

Summary: the primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.


Eligibility criteria:
inclusion criteria: * patients must have moderate corneal staining and exhibit a need to use artificial tears. exclusion criteria: * patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.

Keywords: dry eye signs barrier function
safety and toxicity study of intravesical instillation of tara-002 in adults with high-grade non-muscle invasive bladder cancer (phase 1a)

Conditions: Non-muscle Invasive Bladder Cancer

Summary: this study is an open-label dose escalation study (phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade nmibc (hgta or cis, including cis with concomitant ta) after transurethral resection of bladder tumor (turbt) and/or biopsy using tara-002 in adults unable to obtain intravesical bacillus calmette-guérin (bcg), adults who have received at least one dose of intravesical bcg or adults who have received at least one dose of intravesical chemotherapy. dosing will start in subjects with hgta or cis (including cis with concomitant ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age or older at the time of signing the informed consent * subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * subjects with a histologically confirmed, high-grade ta or cis (including cis with concomitant ta) urothelial cell carcinoma of the bladder on central review * subjects who are treatment naïve, are unable to obtain intravesical bcg for the treatment of nmibc, have received at least one dose of intravesical bcg, or at least one dose of intravesical chemotherapy exclusion criteria: * penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin blood allergy testing prior to inclusion in the study) * predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review * concomitant prostatic or upper tract urothelial involvement, per investigator's assessment * nodal involvement or metastatic disease that existed at any time (past or present disease) * bladder cancer stage ≥ t1 within the last 36 months according to central histology review * bladder cancer stage cis with concomitant t1 for more information on eligibility criteria, please contact the sponsor.

Keywords: non-muscle invasive bladder cancer bladder cancer high grade ta carcinoma in situ high-grade nmibc
randomized controlled trial of acupuncture for functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "acupuncture effect is based on meridians, and gathering of meridian qi is the key point."

the purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using itopride as controlled group, and try to provide clinical evidence for the hypothesis that"acupuncture effect is based on meridians, and gathering of meridian qi is the key point."

Eligibility criteria:
inclusion criteria: 1. consistent with the diagnostic criteria of functional dyspepsia. 2. age of a subject is older than 18 and is younger than 65.（including 18 and 65） 3. did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial. 4. informed consent is signed by a subject or his lineal relation. exclusion criteria: 1. patients with any contraindications of itopride. 2. patients who are unconscious, psychotic. 3. patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding. 4. with serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on. 5. pregnant women or women in lactation.

Keywords: acupuncture meridian acupoint
nivolumab in combination with chemotherapy for fgfr2-positive metastatic gastric cancer

Conditions: Metastatic Gastric Cancer; PD-L1 Gene Amplification; FGFR2 Amplification

Summary: the goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with capox in patients with fgfr2-positive/pd-l1-positive/her2-negative metastatic gastric cancer.

on april 16, 2021, the food and drug administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. patients with pd-l1 expression benefit the most from this treatment. fibroblast growth factor receptor 2 (fgfr2) is a predictor of poor overall survival and a potential target for targeted therapy. however, there is no data of nivolumab efficacy in patients with combined expression of pd-l1 and fgfr2. the aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.

Eligibility criteria:
inclusion criteria: * previously untreated, unresectable advanced or metastatic gastric adenocarcinoma * measurable lesions according to the recist 1.1 criteria * pd-l1 combined positive score (cps) of five or more assessed by dako pd-l1 immunohistochemistry 28-8 pharmdx assay * positive fgfr2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells * possibility to assess the amplification of fgfr2 * her2-negative status * ecog ps 0-2 * age \>= 18 years old * adequate function of organs * absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study * signed informed consent exclusion criteria: * participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study * presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study * presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study * any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease * pregnancy * known positive status for human immunodeficiency virus (hiv) or active hapatitis b and c * surgery within 7 days before the first dose of the study drug * signs of bleeding or hemorrhagic diathesis
cell therapy by autologous bmc for large bone defect repair

Conditions: Humerus Fracture Displaced Proximal

Summary: in the present phase-ii clinical trial the researchers investigate efficacy and proof of concept of the augmentation with preoperatively isolated autologous bmc cells seeded onto ß-tcp in combination with an angle stable fixation (philos plate®) for the therapy of proximal humeral fractures.


Eligibility criteria:
inclusion criteria: * patients aged between 50. and 90. years with proximal humerus fractures * indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (philos, synthes, oberdorf, swiss): * 2-, 3- or 4-fragment fracture according to neer * dislocation of \>10 mm between fragments and/or * angle of \> 45° between fragments and/or * dislocation of tuberculum majus \> 5 mm * negative pregnancy test of premenopausal women * signed informed consent for surgery and participation in the clinical trial exclusion criteria: * contraindications against administration of investigational medicinal product (imp) is pregnancy and nursing * dislocation fracture * known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression) * pathologic fractures caused by other underlying diseases * fracture-induced nerve damage * tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases * known hypersensibility against components of the transplant * participation in a clinical trial during the last 3 months prior to this study

Keywords: large bone defect bone marrow-derived mononuclear cells
the effects of resveratrol supplement on biochemical factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis

Conditions: Non Alcoholic Fatty Liver

Summary: to study the effects of resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with nonalcoholic fatty liver (nafld), 50 patients who referred to gastrointestinal (gi) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age 18 and older; * evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography; * no history of alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men; * absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders; * absence of pregnancy or lactation; * absence of taking any medications in the past three months; * absence of weight loss in the recent three months; * absence of endocrine and metabolism disorders. exclusion criteria: * weight loss more than 10% of baseline body weight during the intervention period. * pregnancy; * disliking to continue the study.
time interval for endoscopic variceal ligation

Conditions: Variceal Bleeding

Summary: patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). the current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. however there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. we will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.


Eligibility criteria:
inclusion criteria: * patients who presented with acute upper gi bleeding due to esophageal varices and underwent successful endoscopic variceal ligation. * patients who would normally receive repeat endoscopic ligation therapy to eradicate varices. exclusion criteria: * persistent bleeding despite endoscopic and medical therapy * platelet count \< 40,000

Keywords: gastrointestinal hemorrhage esophageal varices gastrointestinal endoscopy ligation
mri biomarkers of effective tissue reperfusion after thrombectomy of an acute proximal occlusion of the anterior circulation

Conditions: Ischemic Stroke, Acute

Summary: cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences. mri is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial mri (before reperfusion) are predictive of neurological prognosis. however, their spatiotemporal evolution in the suites of reperfusion is unclear. close monitoring by mri would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize mri biomarkers associated with efficient tissue reperfusion. the aim of the mr-reperfusion study is to characterize new mri biomarkers of efficient tissue reperfusion.


Eligibility criteria:
inclusion criteria: * to be over 18 year-old * perfusion mri assessment on admission; * admission for an acute infarction of the anterior circulation with proximal occlusion (tandem, distal internal carotid, or m1 segment of the middle cerebral artery); * initial mtici = 0-1 on the initial angiography before treatment; * patient in complete autonomy (mrs ≤ 2) before the onset of symptoms; * mechanical thrombectomy (in combination or not with intravenous thrombolysis), within the first 6 hours of the onset of symptoms, or within 24 hours in case of clinical-radiological or radiological mismatch; * success of reperfusion estimated by an mtici = 3 at the end of the procedure; * availability of mri within 3 hours of angiographic reperfusion; * to be able to understand the instructions given; * written consent given by the patient or a trusted person; * to be enrolled in a social security plan; exclusion criteria: * posterieur circulation obstruction; * 3 months follow-up impossible with the completion of the mri; * subject under a measure of legal protection
individualized exercise prescription with a data-driven approach in individuals with stroke

Conditions: Stroke Gait Rehabilitation; Stroke Patients; Stroke

Summary: the goal of this clinical trial is to evaluate if the exercised via data-driven approach is effective in enhance the gait pattern in people with stroke. it will reduce burdun of patient consultations for clinicians in reality.the main questions it aims to answer are: does individualized exercise training programmes via data-driven approach could improve gait patterns in individuals with chronic stroke? does individualized exercise training programmes via data-driven approach could improve improve motor recovery, motor functions (including gait speed and balance performance), and community integration in individuals with chronic stroke? participants will: undergo 12 supervised-exercise (training sessions (60 minutes, two times a week, for six weeks), participants will receive a data-driven exercise prescription or conventional exercise prescription which consists of 5 different exercises. they will be assessed on baseline assessment before training (a0); after six sessions (a1); after 12 sessions (a2); and three months after training (a3).

based on the results of the gait patterns and electromyography (emg) analysis, the principal investigator (pi) will design appropriate exercises that target the specific gait impairment at a specific time period during the gait cycle. exercises will utilize various modalities that are commonly used in clinical practice, including theraband, gym equipment, free weight. the training may target single-joint movement or targeting a movement pattern that involves multiple joint holistically. a body harness system will be used to protect the participant during the exercise training. the participant will be supervised by a research assistant who has rich experience in conducting exercise training on people with disability. below are potential exercises that will be prescribed to the participant based on their impairment revealed by the analyses. eg. lack of hip flexion during swing phase: open kinetic chain strengthing exercise for hip flexor in a concentric manner...

Eligibility criteria:
inclusion criteria: * between 45 and 75 years old; * have received a diagnosis of stroke more than six months earlier; * able to walk 10 m independently; * able to score at least 6 of 10 on the abbreviated mental test; * able to follow instructions and give informed consent. exclusion criteria: * any existing medical condition such as uncontrolled hypertension that hindered training or assessment; * unable to offer consent due to impaired cognitive function.

Keywords: stroke lower extremities gait rehabilitation
prognostic factors of a favorable outcome following an exercise program for soldiers with low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) encompasses heterogeneous patients unlikely to respond to a unique treatment. identifying sub-groups of low back pain may help to improve treatment outcomes. our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic lbp participating in a multi-station full-body supervised exercise program. the results obtained may permit generation of potential treatment effect modifiers that will eventually have to be validated before being recommended for clinical practice.

all participants took part in the 6-week exercise program, as well as in the two evaluation sessions (pre- and post- exercise program). at the initial evaluation, subjects completed forms and questionnaires on sociodemographics, symptomatology, comorbidities, work restrictions, pain and functional limitations and fear-avoidance beliefs. a physiotherapist measured their lumbar and hip mobility, conducted diagnostic and pain provocation tests and assessed endurance of the trunk muscles. following the initial evaluation, subjects took part in the 6-week multi-station full-body supervised exercise program (2 to 3 sessions per week). the oswestry disability questionnaire (odi) was completed at the initial and at the final evaluations. the change in odi score following the program was considered the principal measure reflecting favorable or unfavorable outcome. an improvement of 50% in the initial odi score was considered the reference standard to determine a favorable outcome. univariate associations with favorable outcome were tested using chi-square or paired t-tests. variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable.

Eligibility criteria:
inclusion criteria: * episode of subacute or chronic lbp with or without radiation to the lower limbs * minimal score of 17% on the modified oswestry disability index exclusion criteria: * previous surgery to the spinal column, * lumber spine injection in the past two weeks * signs of upper motor neuron lesions * serious medical conditions (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis) * unavailability to participate in the 6-week exercise program