cyrilzakka/clinical-trials huggingface dataset:
SI-EVLP Study: STRESS INDEX in Lung Reconditioning

In order to minimize mechanical stress the investigators propose to implement EVLP procedure with a ventilation monitoring guided by the analysis of the Paw-t shape.

Increase of interest about technique of Ex-Vivo Lung Perfusion (EVLP) has highlighted the need of new approaches to respiratory mechanics monitoring to prevent lung stress in atypical physiological settings.

Airway pressure/time curve (Paw-t) shape analysis at constant flow ventilation (Stress Index, SI) is thought to be predictor of lung stress; so the SI coefficient may therefore identify and quantify mechanical stress during ventilation. (1) In experimental studies, the threshold values for SI that best discriminated lungs with signs of Ventilator Induced Lung Injury ranged between 0.9 and 1.1. (2) During EVLP, the isolated lungs are free from the effect of chest wall impairment and represent the effective response of lung parenchyma to ventilatory setting.

Use of SI monitoring in isolated and perfuse lung reconditioning, may be an useful tool to prevent hyperinflation and opening-closing conditions by titrating optimal protective ventilation As previously reported by our group, in the first trial of lung reconditioning, signs of mechanical stress were detected with Paw-t curve. (3) Therefore we implemented EVLP procedure with continuous stress index analysis to detect and quantify the occurrence of hyperinflation or opening closing condition.

Eligibility Criteria:
Inclusion Criteria:

* High risk donor lung, define as:
* the ratio of partial pressure arterial oxygen and fraction of inspired oxygen less than 300
* pulmonary edema
* poor lung deflation or inflation
* blood transfusions exceeding 10 units
* donation after cardiac death as defined by Maastricht category III o IV

Exclusion Criteria:

* donors lung with established pneumonia
* donors lung with severe mechanical lung injury
* donors lung with gross gastric aspiration
The Use of Narrative in Public Health Research and Practice: Patient Experience of Wellness Acupuncture

This study examined the experiences of individuals undergoing acupuncture to gather information on patient-provider communication and on the therapeutic effects of acupuncture.

Authentic voice is a approach involving the use of first-hand narratives from members of a target population in order to accomplish public health goals. In the first paper, a discussion of the potential of using narratives from the target population as 1) a direct intervention; 2) a form of persuasive communications; and 3) a source of information for research into various topics. The main premise is that traditional narrative methods can be adapted to the public health context by providing the narrator with the topic of the narrative. The second paper examines the patient experience of acupuncture using narrative drawn from interviews with and letters from acupuncture patients using a content oriented approach. The third paper examines the importance of meaning shift over the course of acupuncture treatment and demonstrates the usefulness of patient narratives as a data source for examining meaning. Findings include the need for intervention studies comparing authentic voice approaches to existing health communication tools for effectiveness in creating attitude and behavior change efficiently. Authentic voice approaches also need to be researched to understand and systematize concepts such as validity in relation to target-group derived narratives. Effectiveness of authentic voice for advocacy and research should also be further tested. Concerning acupuncture, the second and third papers show that acupuncture patients report a variety of benefits far wider than previously reported in the literature. Study designs should consider this wide range of benefits when assessing acupuncture outcome. Meaning shift is also reported by acupuncture patients and may play an important (but non-specific) role in the healing associated with acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* individuals seeking acupuncture from private practice in Baltimore/Washington metro area.

Exclusion Criteria:

* prior patients
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing hip fracture surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.

Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed between 7 to 11 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Standard surgery for fracture of the upper third of the femur including femoral head and neck.

Exclusion Criteria:

* Estimated time of injury/fracture \> 24 hours before admission to hospital;
* Any major orthopedic surgery in the 3 months prior to study start;
* Multiple trauma affecting more than one organ system;
* Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
* High risk of bleeding;
* Known allergy to heparin, or enoxaparin, or pork products;
* End stage renal disease or patient on dialysis;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Transplanting Hepatitis C Positive Organs

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are age ≥ 18 years
* Active on either the cardiac, lung, or kidney transplant waiting list
* Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria:

* Hepatitis B NAT or viral load positive
* Evidence of cirrhosis or clinically significant liver disease
Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

This clinical trial tests whether a new imaging technique called magnetic resonance elastography (MRE) is useful in determining the consistency of brain tumors and whether this could be used to guide surgical planning and choice of approach (the type of surgery that is needed) for patients with brain tumors. Comparing MRE with the typical magnetic resonance imaging (MRI) scan may help researchers assess the quality, reliability, and diagnostic utility of this scan when evaluating brain tumors.

PRIMARY OBJECTIVES:

I. Examine tolerance interval of MRE measurement in kilopascals (kPa) and associated distribution of percent stiff (hard) and soft tumors above the higher limit and below the lower limit.

II. Through machine learning with MRE and clinical/demographic factors, to identify diagnostic thresholds in separating stiff tumor from soft tumor.

OUTLINE:

Patients undergo MRE scan over 25 minutes before surgery at the time of standard of care pre-operative MRI scan. On the day of surgery, the surgeon grades and records tumor consistency/stiffness during the operation and afterwards.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or older who undergo surgical resection for brain tumor at Keck Medical Center of University of South Carolina (USC) are eligible for inclusion into this study

Exclusion Criteria:

* Patients who cannot tolerate MRE
* Those ineligible for MRI due to metallic implants, claustrophobia, or body habitus too large to fit in our MRI machine
* Those not undergoing surgical resection of brain tumor
* Children under the age of 18, pregnant women, wards of the state, and prisoners
* There will be no exclusion of patients based on gender, racial or ethnic origin
Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.

Introduction: The placement of a peripheral inserted central catheter (PICC) is a common practice in the hospital setting. However, despite all the advances reported, venous devices are not free of complications and catheter-related thrombosis (CRT), being one of the most prevalent. Electro muscular stimulation therapy can be a measure for the prevention of CRT. Objective: To know the efficacy of electro muscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters. Methodology: A multicenter Randomized Clinical Trial (RCT) will be carried out at the Dr. Josep Trueta University Hospital in Girona, Hospital del Mar in Barcelona, Althaia Foundation in Manresa. With a total of 68 patients with PICC catheters in critical care units, they will be randomly assigned to the intervention group (n=34) to whom, in addition to the usual protocolized care related to the vascular catheter, will be applied e Eco-EMS protocol, or the control group (n=34) to which only the usual protocolized care related to the vascular catheter was applied. Intervention: It will consist of the application of electrostimulation therapy five days a week, two daily sessions of 20 minutes in the intervention group. Both groups underwent five ultrasound examinations after the placement of the PICC to determine the appearance of CRT. Expected results: It is expected to observe that the application of the Eco-EMS protocol reduces thrombosis in the patients of the intervention group, compared to those of the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the critical unit with a PICC whose insertion is done by the EIAV of the same hospital.
* Patients between 18 and 80 years of age.
* Treatments related to the device protocolized by the same hospital as the EIAV implanter.

Exclusion Criteria:

* Patients who do not sign informed consent.
* Patients with pacemakers and/or implantable automatic defibrillators.
* Patients with epilepsy.
* Removal of the device within the first 15 days after insertion.
* Hospital discharge, transfer to another hospital or death lethalis during the duration of the study.
* Displacement of the tip of the catheter outside the lower ⅓ of the superior vein cava during the study period.
* Presence of lesions in the place where the electrodes must be placed to perform the electrostimulation therapy.
* Non-compliance with catheter monitoring: Of the five ultrasound controls protocolized in the study, 80% were not complied with.
Reducing Fear of Childbirth Among Pregnant Women

Pregnant women often experience fear of childbirth or anxiety toward the labor pain or uncertainties associated with labor process. To develop and evaluate the efficacy of childbirth educational interventions on reduction of fear or anxiety is an important issue in maternal health care.

Fear of childbirth is a common clinical problem among perinatal women and link to adverse health effects on mother's and offspring's well-being. Recently, reducing the childbirth fear becomes a highly important maternity care issues as a result of the fact that the birth rate has been declining rapidly as well as Cesarean rate increased steadily. However, the studies on fear of childbirth among perinatal population in Taiwan were limited. In this proposal the investigators plan to conduct a randomized controlled study examining the effects of mindfulness-based childbirth education. In the randomized controlled study, women will be recruited and randomized into the experiment group (receiving mindfulness-based childbirth education and traditional childbirth education),or will be allocated in the control group receiving traditional childbirth education. Intention-to-treat analysis as well as mixed regression modeling will be used to estimate the effectiveness of the interventions.

Eligibility Criteria:
Inclusion Criteria:

1. aged of 20 years or greater;
2. 12-25 week of gestation, Singleton pregnancy;
3. able to communicate with Mandarin or Taiwanese;
4. High levels of fear of Childbirth (greater 9 or above on Numeric Rating Scale).

Exclusion Criteria:

1. Current having psychological diseases or substance abuse, unable to follow the mindfulness-based childbirth education;
2. unable to attend every class or each assessment;
3. received any cognitive training in past one year.
Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community

In this trial the researchers plan to recruit 25,000 volunteers to be randomly allocated either wearing sunglasses or ordinary glasses in public spaces where they are close to other people, or not wear glasses in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about results of COVID-19 tests during the trial period.

A systematic review of observational studies indicated that eye protection may be an effective measure to prevent SARS-CoV-2 infections. Randomized trials are needed to assess whether the observed associations are caused by protection of the eye or confounding factors such as other systematic differences between users and non-users of eye protection, co-interventions, or changes in COVID-19 incidence when comparisons were done over time.

This is a pragmatic, virtual, parallel group, 1:1 randomized, superiority trial. The researchers will recruit and randomize participants via an online portal. The trial will be fully remote and virtual without any personal interaction between investigators and participants. All members of the public are eligible who confirm that they are at least 18 years of age, do not regularly wear glasses, have not contracted COVID-19 since December 15th 2021, and are willing to be randomized to wear, or not wear glasses in public when close to other people, for a 2-week period. Persons who are dependent on visual aids but typically use contact lenses are eligible. The participants will be randomized (1:1) to wear glasses (sunglasses or other types of glasses) in public spaces when close to others (public transport, shopping centers etc.), or to the control group. The control group will be asked not to wear glasses in public spaces when close to others. The primary outcome is positive test for COVID-19.

The researchers aim to include about 25,000 participants to have a statistical power of 80% to detect a relative risk reduction of 25% for the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* owns or can borrow glasses that can be used (e.g. sun-glasses)
* willing to be randomized to wear, or not wear glasses outside the home when close to others, for a 2-week period.
* provides informed consent

Exclusion Criteria:

* does regularly wear glasses (contact lenses are accepted)
* contracted COVID-19 after December 15th 2021.
AZD5672 Bioavailability Study in Healthy Male and Female Subjects

The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells

This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)

Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®. ProTrans® will be administered at a fixed dose of 100 million cells per patient in a single infusion at bedside.

Placebo: Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group (NextCell Pharma).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years-old or older
* Laboratory-confirmed SARS-CoV-2 infection determined by reverse-transcription polymerase chain reaction (RT-PCR) prior to randomization
* Hospitalized patients
* Severe COVID-19 pneumonia defined as patients who cannot saturate \> 96% on 4 L/min but are NOT on "non-invasive" ventilation nor invasive mechanical ventilation nor Extracorporeal membrane oxygenation (ECMO). Patients on high flow would be eligible if they receive treatment in a non-critical care unit only.
* Use of contraception or acceptable birth control for the duration of the study in women of childbearing potential
* Provision of written or verbal informed consent by the patient or designated substitute decision maker

Exclusion Criteria:

* Inability to provide informed consent
* Patients expected to survive less than 24 hours
* Advanced directives of patient's wishes to refuse intubation.
* Patients on mechanical ventilation
* Pregnant women \[pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test\]
* Breastfeeding
* Weight \> 100 kg or \< 50 kg
* Cancer not in remission or active serious illness unrelated to COVID-19.
* Any of the following laboratory results at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) \< 50 G /L, Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 5N, eGFR \< 30 mL/min
* Current documented bacterial infection
* Known infection with Human immunodeficiency virus, Treponema pallidum, Hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or Hepatitis C
* On-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
* Known allergies to a component of the ProTrans® product
* Pre-existing chronic respiratory diseases requiring long-term oxygen therapy or severe pulmonary hypertension (PAPS \>30 mm HG) or pulmonary fibrosis
* Pre-existing cirrhosis with basal Child and Pugh of C
The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients

To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated under N2O + sevoflurane and O2 + sevoflurane general anesthesia.

40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry specular microscopy results at before surgery and 1 week and 1 month after surgery will be analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia

Exclusion Criteria:

* None
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent
* 18-70 years of age
* Males and females with reproductive potential: Willing to use a reliable method of contraception
* Diagnosis of ulcerative colitis
* Eligible to receive biologic therapy
* Disease duration of \>=12 weeks

Exclusion Criteria:

* Requirement for hospitalization due to severity of ulcerative colitis
* Moderate to severe anemia
* Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with \>20 mg/day of prednisone, or prednisone equivalent, during the course of the study
* Pregnant or lactating
* Lack of peripheral venous access
* Inability to comply with study protocol
* History or presence of contraindicated diseases
* Congenital immune deficiency
* Active or prior infection with HIV or hepatitis B or C
* History of severe systemic bacterial, fungal, viral, or parasitic infections
* History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
* Received a live attenuated vaccine within 4 weeks prior to screening
* Hospitalized within 4 weeks prior to screening
* Received any contraindicated therapy within 12 weeks prior to screening
Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy

This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.


Eligibility Criteria:
Inclusion Criteria:1) newly diagnosed, histologically confirmed World Health Organization (WHO) type II-III NPC; 2) stage I-IVa (T1-4 N0-3M0) according to the staging system of the 8th American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC); 3) no prior antitumor therapy; 4) no tumor involvement in salivary gland; 5) no parotid glands disorder and no history of parotid glands surgery; 6) ages between 18 and 70 years; 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and 8) adequate organ function Exclusion Criteria: 1) used salivary stimulating or protecting agent; 2) metachronous or synchronous malignancy; 3) pregnancy or lactation; or 4) severe comorbidities. The pretreatment evaluation included a complete history and physical examination, nasopharyngoscopy, chest X-ray, complete blood count, liver and renal biochemistry, and magnetic resonance imaging (MRI) of the head and neck.