Kornimate/medical-research-clean huggingface dataset:
alcoholic chlorhexidine compared to povidone iodine to limit perineural catheter colonisation

Conditions: Infection of Catheter Exit Site; Catheter Related Infection

Summary: implementation of perineural catheters may lead to infection by catheter colonization. catheters may be colonized by the bacteria present on the skin. this is most often commensal organisms as staphylococcus or gram negative bacilli. in a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. this colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). the germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).

potential interest of alcoholic chlorhexidine 2% to reduce the colonization of implanted catheters more recently, it is the antiseptic solution that has been the subject of several studies, including the latest on laying intravascular central catheters, highlights the superiority of alcoholic chlorhexidine 2% compared to povidone iodine alcohol \[ 5\]. indeed, it was observed a reduction in the risk of bacterial infection 6 (rr 0 • 15, 95% ci 0 • 05-0 • 41) and of colonization by 5 (rr: 0.18 (95% cl 0.13-0.24) through the use of alcoholic chlorhexidine with 2% applicator. such a study comparing the efficacy of the antiseptic (chlorhexidine vs povidone-iodine) on the establishment of perineural catheters does not exist what motivated the establishment of our study.

Eligibility criteria:
inclusion criteria: * patient classified i, ii or iii by the american society of anesthesiology * perineural catheterization use for pain management * patient should have an orthopaedic surgery exclusion criteria: * an allergy to povidone iodine * an allergy to alcoholic chlorhexidine 2% * pregnant women * breastfeeding women
a phase 2a study of llx-424 in patients with a history of kidney stones

Conditions: Kidney Stones

Summary: this is a phase 2a study of glycolate oxidase inhibitor llx-424 in patients with a history of kidney stones. eligible subjects with a history of kidney stones will be randomized to receive study drug (llx-424 or placebo) for 8 weeks.

this is a phase 2a, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, pk, and pd effects of llx-424 in patients with a history of kidney stones. following completion of screening procedures, on study day 1, eligible subjects will be randomized in a 2:1 ratio to receive either llx-424 or matching placebo, respectively. an outpatient safety follow-up visit will be scheduled on day 63 or 7 days after the last dose (end of study visit).

Eligibility criteria:
inclusion criteria: * history of kidney stones documented in medical records * 24-hour urine oxalate excretion * body mass index 18.5 to 38 kg/m2 inclusive * estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 exclusion criteria: * history or medical record evidence of kidney stones that are not calcium oxalate * unstable kidney function * spot urine protein to creatinine ratio ≥ 1 mg/mg at screening * history of kidney transplantation * hemoglobin a1c \> 9.5% at screening * history of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease * history or evidence of cirrhosis

Keywords: oxalate glycolate oxidase
progressive mobility program and technology to improve the level of physical activity and functionality of icu patients

Conditions: Critical Illness; Muscle Weakness

Summary: the purpose of this study is to verify if a protocol of early and progressive mobility which includes the use of technology is able to increase the level of physical activity and improve functionality and respiratory and muscular function of intensive care unit patients compared with conventional physical therapy.

the evolution of treatment in the intensive care unit (icu) has increased the survival and morbidity post hospital. functional disability in these patients has its main factor in the weakness and loss of muscle mass, which is the major complications reported by these patients. the most negative result in long-term post icu is the impact on quality of life and functional decline due to muscle disorders and fitness. this is achieved by the period of inactivity and prolonged rest, leading to losses and changes in various body systems. given these facts, interventions for greater mobility in bed and out of it are very important. early mobility programs has proved beneficial, however, as in other types of rehabilitation, the exercises should be prescribed with its specific characteristics, including the intensity. however, little has been described in the researches abut the activity level in the icu, and using a quantitative measure. the use of technology seems to facilitate the offering of this type of therapy, supplying the limitations. therefore, there are little evidences about these topics and randomized controlled studies to investigate these factors.

Eligibility criteria:
inclusion criteria: * admitted to the emergency intensive care unit of clinical hospital, medical school, university os sao paulo * inspired oxygen fraction ≤ 60% * positive end expiratory pressure ≤ 10 points * peripheral oxygen saturation ≥ 90% * respiratory rate ≤ 35 * without cardiac arrhythmia or acute ischaemia * heart rate \> 50 bpm and \< 140 bpm * without high or raising dose of vasoactive drugs * mean body pressure \> 60 mmhg and \< 120 mmhg * without active bleeding * without prescribed bedrest exclusion criteria: * transference from other hospital * diagnosis of neurological disorders * intensive care unit stay \< 4 days * contraindication to mobilization

Keywords: intensive care units physical therapy specialty critical illness muscle weakness bed rest
enhancing prospective thinking in early recovery (nerf)

Conditions: Alcohol Use Disorder

Summary: the goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (eft) cues in alcohol use disorder persons and related brain mechanisms. the main question\[s\] this trial aims to answer are: will high-intensity eft cues will produce greater delayed reward preference than low-intensity cues? will high-intensity eft cues effect greater treatment-seeking interest? will high-intensity eft cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) will nucleus accumbens-precuneus resting connectivity correlate with behavioral ss? will the novel behavioral ss decision-making task activate the nucleus accumbens? researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.


Eligibility criteria:
inclusion criteria: * abstinence between 30 days ≤ 1 year * verbal endorsement of commitment to recovery * english comprehension exclusion criteria: * unstable medical disorders * outside the age range of 18-60 * habitual substance or alcohol use * smell/taste disorders * unstable psychiatric conditions
treatment patterns and outcomes study in patients with unresectable stage iii and metastatic (stage iv) melanoma in the united states

Conditions: Melanoma

Summary: this study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (part 1) and an oversample (part 2).


Eligibility criteria:
inclusion criteria: * adults 18 years or older * diagnosis of unresectable stage iii and/or metastatic (stage iv) melanoma before 01-nov-2015 * initiating a new line of therapy during the index period between 01-jan-2015 and 31-may-2016, irrespective of advanced melanoma diagnosis date * medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) exclusion criteria: * physicians unwilling or unable to follow study instructions * patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage iii and/or metastatic (stage iv) melanoma
the effect of kinesiophobia on physical activity, balance and falling in parkinson's disease patients

Conditions: Parkinson Disease; Kinesiophobia; Physical Activity; Balance; Falling

Summary: the kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. it develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. it is known that functional problems such as balance problems and decrease in physical activity level occur in patients with parkinson's disease. however, in the literature, there is no study investigating the presence of kinesiophobia in patients with parkinson's disease. therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.


Eligibility criteria:
inclusion criteria: * being diagnosed with parkinson's disease according to the criteria of united kingdom brain bank and diagnosed as parkinson's disease by neurologist * according to hoehn-yahr scale 1-3 * mini-mental test score 24 and above exclusion criteria: * another disease that will prevent walking * visual impairment and vestibular dysfunction * cognitive impairment

Keywords: parkinson's disease, kinesiophobia, physical activity, balance, falling
home-sampling in partner notification of chlamydia

Conditions: Chlamydia

Summary: though partner notification is mandatory to perform of chlamydia trachomatis infected individuals in sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission. the investigators wanted to determine whether there was any difference in time between home-sampling and clinical testing as a tool of partner notification measured from eliciting of partners to date of testing.


Eligibility criteria:
inclusion criteria: * sexual partners to chlamydia infected index patients accepting to participate in the study. exclusion criteria: index patients not living in sweden or not speaking swedish. * msm. * sexual partners living in another county or abroad.

Keywords: contact tracing home sampling cluster randomisation
gpc3-car-t cells for immunotherapy of cancer with gpc3 expression

Conditions: Hepatocellular Carcinoma; Immunotherapy; CAR; GPC3 Gene Inactivation; T Cell; Squamous Cell Lung Cancer

Summary: the third/fourth generation of car-t cells that target gpc3 (gpc3-cart cell) and/or soluble tgfβ (gpc3/tgfβ-cart )have been constructed and their anti-hcc function has been verified by multiple in vitro and in vivo studies. clinical studies will be performed to test the anti-cancer function by the gpc3/tgfβ-car-t cells in human hcc patients with gpc3 expression. in this phase i study, the safety, tolerance, and preliminary efficacy of the gpc3/tgfβ-car-t cell immunotherapy on human will firstly be tested.

1. choose appropriate patients with advanced hepatocellular carcinoma,with written consent for this study; 2. perform biopsy to determine the expression of gpc3 of the tumor by western blotting or ihc; 3. collect blood from the patients and isolate mononuclear cells, activate the t cells and transfect the t cells with gpc3/tgfβ targeting car (or/and scfv/cytokines-secreting), amplify the number of transfected t cells as needed, test the quality and killing activity of the gpc3/tgfβ-cart cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed; 4. to enhance the killing capability, cd4+ t cells are genetically engineered to express tgfβ-car and secret il7/ccl19 and/or scfvs against pd1/ctla4/tigit; cd8+t cells are constructed to express gpc3-dap10-car with knockdown of pd1/hpk1; 5. evaluate the clinical results as needed. 6. will also perform the similar clinical trial on lung squamous carcinoma with the gpc3 expression.

Eligibility criteria:
inclusion criteria: 1. patients with advanced hcc,which express gpc3 protein. 2. life expectancy \>12 weeks 3. child-pugh-turcotte score \<7 4. adequate heart,lung,liver,kidney function 5. available autologous transduced t cells with greater than or equal to 20% expression of gpc3 car determined by flow-cytometry and killing of gpc3-positive targets greater than or equal to 20% in cytotoxicity assay 6. informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent. - exclusion criteria: 1. had accepted gene therapy before; 2. tumor size more than 25cm; 3. severe virus infection such as hbv,hcv,hiv,et al 4. known hiv positivity 5. history of liver transplantation 6. active infectious disease related to bacteria, virus,fungi,et al 7. other severe diseases that the investigators consider not appropriate; 8. pregnant or lactating women 9. systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. other conditions that the investigators consider not appropriate. -

Keywords: hepatocellular carcinoma immunotherapy car-t cell therapy gpc3 or tgfβ targeting phase i clinical study squamous cell lung cancer interventional radiology il7-ccl19-secreting scfv against pd1/ctla4/tigit knockdown of pd1/hpk1 dap10
a nutritional approach to minimal hepatic encephalopathy

Conditions: Minimal Hepatic Encephalopathy

Summary: this trial will study a possible effect of standard israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.


Eligibility criteria:
inclusion criteria: * all consented adults (age \> 18), with the diagnosis of child a cirrhosis with meld score of \< 10. * diagnosis of liver cirrhosis as documented by liver biopsy (stage iv) and / or fibroscan (score \> 12 kpa) and / or fibrotest (score \> 0.74) and /or imaging. exclusion criteria: * history of \> grade ii hepatic encephalopathy (he). * diagnosis of dementia, parkinson disease, schizophrenia (patients with major depression will be noted but not excluded). * use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling use of antibiotics for any length of period during and/or 2 weeks prior to enrolling. * current use of lactulose or neomycin. * use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.

Keywords: encephalopathy cirrhotics
parp inhibitor with cdk4/6 inhibitor and endocrine therapy in hr+/ her2-advanced breast cancer

Conditions: Breast Cancer Metastatic

Summary: this study is a prospective, open-label, phase ii clinical study for patients with hr+/her2- advanced breast cancer.

patients with snf3 subtype of hr+/her2- advanced breast cancer confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital are planned to be enrolled. the main purpose is to evaluate efficacy of parp inhibitor in snf3 subtype of hr+/her2- advanced breast cancer and prepare for subsequent randomized controlled phase iii clinical studies with larger sample size.

Eligibility criteria:
inclusion criteria: * females ≥18 years and ≤ 75 years old; * histologically confirmed hr + / her2- invasive breast cancer (specific definition: immunohistochemical detection of er\> 10% tumor cell positive is defined as er positive, pr\> 10% tumor cell positive is defined as pr positive, er and / or pr positive is defined as hr positive; her2 0-1 + or her2 is ++ but negative followed by fish detection, no amplification, defined as her2 negative); * subtype of similarity network fusion-3 (snf-3) confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital • locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /l; platelet count \> 75x10ˆ9 /l, hemoglobin \> 9g/dl; * patients had received no previous chemotherapy or targeted therapy for metastatic disease * has adequate liver function and kidney function: serum creatinine * ecog score ≤ 2 and life expectancy ≥ 3 months; * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: * treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * symptomatic, untreated, or actively progressing cns metastases(glucocorticoids or mannitol needed to control symptoms); * significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).

Keywords: first-line therapy
observational study for melanoma adjuvant treatment with tafinlar® + mekinist® (dabrafenib + trametinib)

Conditions: Malignant Melanoma

Summary: the primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in portugal through disease specific fact-m questionnaire and generic eq-5d-3l questionnaire. the secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. in addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.

the prospective registration of completely resected high-risk stage iii melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience. patients were recruited from participating centers in the routine setting. this was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. all patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion. health related quality of life had to be assessed by fact-m and eq-5d-3l questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.

Eligibility criteria:
inclusion criteria: * patients with complete surgical resection of histologically confirmed ajcc (8th edition) clinical stage iii (iiia, iiib, iiic, iiid) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study * v600e/k mutation-positive cutaneous melanoma * adjuvant treatment with combination therapy of dabrafenib (tafinlar®) and trametinib (mekinist®) as indicated in the smpc and by prescription, that has been started before inclusion of the patient into the study; * ≥ 18 years of age * written informed consent signed. exclusion criteria: * lack of basic demographic (gender, age, age at diagnosis) and staging data (stage at diagnosis; breslow index; clark level; braf mutation; braf test date; surgery date).

Keywords: malignant melanoma tafinlar mekinist dabrafenib trametinib fact-m questionnaire generic eq-5d-3l questionnaire adjuvant
an efficacy and safety study of rpt193 in adults with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: phase 2 study of rpt193 in adults with atopic dermatitis

randomized, placebo-controlled phase 2 study of rpt193 in adults with moderate-to-severe atopic dermatitis

Eligibility criteria:
inclusion criteria: * clinically confirmed diagnosis of active atopic dermatitis (ad), according to the revised hanifin and rajka criteria * 12-month history of ad and had no significant flares in ad for at least 4 weeks before screening * inadequate response to a ≥1 month treatment with topical medications * atopic dermatitis covering ≥10% of the body surface area * easi score ≥16 * validated investigator global assessment (viga) ≥3 * use of emollient(s) at least 2x daily for 1 week prior to baseline * negative coronavirus disease (covid)-19 results at screening exclusion criteria: * uncontrolled moderate-to-severe asthma * uncontrolled diabetes * stage iii or iv cardiac failure * severe renal condition * major surgery within 8 weeks of screening * immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline * use of systemic janus kinase (jak) inhibitor within 8 weeks of baseline * received live or live-attenuated vaccine within 4 weeks of baseline * prior receipt of rpt193

Keywords: atopic dermatitis
a randomized, controlled study of two at-home self-guided virtual reality interventions for adults with social anxiety disorder.

Conditions: Social Anxiety Disorder (SAD)

Summary: this study is to compare two virtual reality (vr)-based interventions, bvr-100 and bes-100, for the treatment of social anxiety disorder (sad).


Eligibility criteria:
inclusion criteria: * subject is male or female, aged 18 or above. * subject has english fluency and literacy. * subject meets the diagnostic and statistical manual of mental disorders, fifth edition, (dsm-5) criteria for social anxiety disorder * subject has a total liebowitz social anxiety scale (lsas) score at screening of ≥ 70. exclusion criteria: * subject has significant visual, auditory or balance impairment * subject has history of photosensitive epilepsy or seizure disorder * subject has history of motion sickness or medical condition predisposing to nausea or dizziness. * subject has injuries, inflammation or infection affecting the eyes, ears or face that would make the use of the hardware uncomfortable. * subject has, current or lifetime history of meeting dsm-5 criteria for schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the subject's ability to consent, follow study directions, or otherwise safely participate in the study; posttraumatic stress disorder, major depressive disorder (mdd) with psychotic features, borderline or antisocial personality disorder * subject has met dsm-5-based criteria for alcohol or substance use disorder (other than nicotine or caffeine) within one (1) year prior to screening. * subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg, psilocybin, methylenedioxymethamphetamine \[mdma\]) for mdd or any psychiatric condition within one (1) year prior to screening. * in the opinion of the investigator: (a) study participation may pose a significant or undue risk to the subject; (b) the subject is unlikely to successfully complete all of the requirements of the study per protocol; or (c) study participation may adversely impact the integrity of the data or the validity of the study results.

Keywords: social anxiety disorder, social phobia