cyrilzakka/clinical-trials huggingface dataset:
Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety

Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.

This will be a single center, randomized, controlled, phase 3 pragmatic clinical trial. Forty-eight operating rooms will be randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms will be included and followed until 30-days after their surgery. Clinicians in operating rooms randomized to 'intervention' will receive decision support from clinicians in the ACT. In operating rooms not randomized to receive decision support from the ACT, the current standard of anesthesia care will be delivered. The intention-to-treat principle will be followed for all analyses.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO

Exclusion Criteria:

-
An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB

A Phase I/ II, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIB patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronological age of \<18 years
* Confirmed diagnosis of MPS IIIB

Exclusion Criteria:

* Prior experience to gene therapy or HSCT with successful engraftment
* Past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing ICF
* Current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures
* Past use of Genistein or Kineret (anakinra) within 4 months before signing ICF
* Serious drug allergy or hypersensitivity
* Contraindication for lumbar puncture or MRI
* History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture

The above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.
Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI

Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.

Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.

Eligibility Criteria:
Inclusion Criteria:

* routines TDM of antiinfectives

Exclusion Criteria:

* TDM is not available
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

Measuring EFS depending on induction therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
* written informed consent

Exclusion Criteria:

* pretreatment of leukemia
* no informed consent
* simultaneous inclusion in other studies
* mental disability
* contraindication for intensive chemotherapy
* AML FAB M3
* contraindication for allogeneic stem cell transplantation
* restriction of following organ functions:
* creatinine-clearance \< 50 ml/min
* cardiac ejection fraction \< 40 %
* severe pulmonary restriction
* bilirubin \> 2x ULN; SGOT and SGPT \> 4x ULN
* uncontrolled hypertension
* severe uncontrolled metabolism disturbance
* Karnofsky-performance-score \< 70%
* hepatitis C
* other malignancy
* age of unrelated donor \>70 years and age of related donor \>75 years
Transverse Thoracic Plane Block in the Pediatric Cardiac Patient

Postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. These patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane block (TTMPB) is a recently described regional anesthetic technique showing improvements in postoperative pain management. Further investigation is needed to establish the potential of the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.


Eligibility Criteria:
Inclusion Criteria:

* Congenital Heart Surgery

Exclusion Criteria:

* Over 18
Drug Provocation Test (DPT) to Paracetamol

Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).

Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.

Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).


Eligibility Criteria:
Inclusion criteria:

- Patients with a positive or negative DPT to paracetamol

Exclusion criteria:

* Patients refusing to take part in the study
* Patient under 10 years old
Nutritional Education for Dependant Patients

Objective: To assess the effect of a nutritional educational intervention on the risk of malnutrition dependent patients aimed at the caregivers.

Material and methods:

Intervention study with control group, with 200 patients randomized selected, in a Home Care Program of 5 Primary Care Centers, malnourished and dependents, older than 65 years and with a caregiver.

Socioeconomic and cultural characteristics of the patient and the caregiver are collected. Mini Nutritional Assessment (MNA), food intake, anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron, ferritin, are evaluates on 0- 6-12 months. Also evaluated dentures, basic activities of daily living (Barthel test), cognitive state (Pfeiffer test) status of mood (Yesavage test).

Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses make an initial session for caregivers and monitored the education at home monthly (4 visits) up to 6 months. NANDA (NORTH AMERICAN NURSING DIAGNOSIS ASSOCIATION) specific methodology of the Nursing profession is used. The investigators studied the effect of the intervention on the caregivers on the patient's nutritional status by the MNA test, diet, anthropometry and biochemical parameters.

Bivariate normal test statistics and multivariate models were created to adjust the effect of the intervention.

The program SPSS / PC was used.


Eligibility Criteria:
Inclusion Criteria:

* Be included in the program ATDOM,
* 65 years or more,
* have an MNA between 17 and 23.5 points,
* have a caregiver.

Exclusion Criteria:

* have a MNA outside the range of 17 to 23.5 points,
* conducting enteral feeding
* have severe dysphagia,
* have any serious illness that progresses to malnutrition,
* take vitamin supplements and / or dietary supplements.
The Effect of Otago Exercises in the Elderly

Home-based and individually designed exercise program; It consists of warming up, strengthening, balance exercises and walking plan. The number, intensity and duration of the movements are personalized according to preference and ability and are progressed gradually. Elderly individuals are expected to do this set of exercises three times a week and walk for 30 minutes twice a week. Since the Otago Exercise Programme includes combined exercises, the outputs of the effectiveness of the program will be different. For this purpose, the effect of otago exercises on fear of falling, balance, strengthening and functional mobility will be determined in the elderly living in nursing homes.

The first four weeks will be Otago Exercise Programme training and practice. For the next weeks, there will be institution visits and telephone interviews. Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process. The research will be conducted in small groups (average 6-8). The control group is expected to continue their daily life. No attempt will be made by the researcher during the research process. Stratified randomization method according to age and gender was used in the study. The website was used to assign individuals meeting the inclusion criteria in each stratum to a determined number of groups. Masking will be done in terms of research data/output measurements (evaluator), statistician and reporting.

Eligibility Criteria:
Inclusion Criteria:

* To be 65 years or older
* To be literate
* Having no problem in verbal communication
* Not having a disability based on sight, hearing and lack of limbs
* Obtaining at least 91 points or more according to the Barthel Activities of Daily Living Index (to be mildly dependent or completely independent)
* Mini Mental Test to be 24 points and above
* Having a doctor's report that it will not interfere with exercise

Exclusion Criteria:

* Having a medical contraindication for exercise
* Having acute or terminal illnesses and serious chronic illnesses that limit participation in exercise sessions
* Having a lower extremity fracture in the past year
* Having had an operation in the last month
* Being diagnosed with any neuropsychiatric disease
Processed Meat and Colon Carcinogenesis

Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.

18 healthy volunteers will be randomized and will start the study. The study will last 4 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Body mass index 20 \<= BMI \<= 30 kg/m2
* Affiliated to French National Health Insurance
* Subject giving his written informed consent
* Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

* Positive serologies to HIV or HCV, determined on blood samples
* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Previous familial of colon, ovarian or breast cancer
* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
* Dislike ham
* Heavy consumer of alcohol
* Practising intensive physical exercise
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file
* Dietary habits unreliable to controlled food intake
* Being in exclusion on the National Volunteers Data file
Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly

Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.

The investigatorswould therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.

Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations, but above all a different population than the one the investigators are interested in. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.

Evaluating the value of these socks could allow to recommend them with solid data. Preventing this iatrogenic loss of autonomy would have a positive impact on the motor capacities of patients, a quicker and easier return home, and a reduction in health costs.

The investigators would therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.

Eligibility Criteria:
Inclusion Criteria:

* Patient in Geriatric acute care or Post-Emergency Medicine,
* Patient 75 years and older,
* Patient requiring physiotherapy,
* Patient with a minimum of 7 days of physical therapy
* Patient arrived with unsuitable footwear (assessment at the discretion of the clinician: no back support, unsuitable size, etc.) or without footwear,
* Patient able to walk at least 10 m with or without technical assistance,
* Patient who has given oral consent
* Patient with social security coverage.

Exclusion Criteria:

* Inability to understand or perform study-specific clinical tests
* Known cognitive impairment, disease or condition that compromises comprehension of information or informed consent by the patient
* Blind patient
* Patient under guardianship or curatorship
* Patient participating in an interventional clinical research protocol that may alter the assessments of this protocol.
* Patient previously included in the Charm study
* Patient with an identified risk of being unable to wear socks or to walk barefoot within the next 7 days (need for compression stockings or socks, wound, excessive edema, orthostatic hypotension, other)
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo

This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

At the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the clinical parameters.

The study involves a follow-up of 6 months after the end of the initial participation to the IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study IMCY-T1D-001.

For each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). The patients will undergo planned assessments and procedures as outlined in the table of study procedures.

In this Long-Term Follow-Up (LTFU) study, the below objectives will be assessed 36 and 48 weeks after the first injection of IMCY-0098 in the study IMCY-T1D-001, in patients treated with IMCY-0098 at three doses or placebo:

Primary Objective The primary objective of this study is to assess the long-term safety. Secondary Objective The secondary objective of this study is to evaluate the clinical response to IMCY-0098 by assessing disease activity.

Exploratory Objectives

* To evaluate the proinsulin-specific cytolytic CD4+ T cells induced by IMCY-0098
* To evaluate the impact of IMCY-0098 on autoreactive T-cell responses specific for autoantigens expressed by islet β-cells (proinsulin, GAD65, IGRP) on the longer-term.
* To evaluate the impact of IMCY-0098 on autoantibodies against GAD65, IA 2, ZnT8 and insulin
* Transcriptomic analysis on mRNA extracted from samples collected for Immunogenicity

Eligibility Criteria:
Inclusion Criteria:

* All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical trial who are willing to participate to this long-term follow-up study.

Exclusion criteria:

* Ongoing pregnancy or lactation
* History of or current malignancy (except excised basal cell skin cancer)
* Primary or secondary immune deficiency disorders
* Human Immunodeficiency virus (HIV) infection.
* Ongoing treatment with immunosuppressive agents with the exception of topical or intra nasal corticosteroids.
* Treatment with an investigational drug within the past 3 months
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.

The long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure.

Two possible strategies to do this were tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. All patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the Campath-1H arm).

At six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). Patients were then followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).

Eligibility Criteria:
Inclusion Criteria:

* men or women aged over 18 years
* recipient of kidney transplant (planned in next 24 hours)

Exclusion Criteria:

* recipients of multi-organ transplant
* previous treatment with Campath-1H
* active infection (including HIV, hepatitis B or C)
* history of anaphylaxis to humanized monoclonal antibody
* history of malignancy (except adequately treated non-melanoma skin cancer)
* loss of kidney transplant within 6 months not due to technical reasons
* medical history that might limit the individual's ability to take trial treatments for the duration of the study
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Eligibility Criteria:
Inclusion Criteria:

* Men \& women ≥18 years of age
* Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease
* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
* Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment with Docetaxel
* Treatment with any investigational agent within 14 days of first administration of study treatment

Other protocol-defined inclusion/exclusion criteria apply
Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.

The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years or older
* Ability to provide informed consent

Exclusion Criteria:

* Subjects with a history of Inflammatory Bowel Disease
* Lesions less than 6mm or greater than 15mm in largest dimension