cyrilzakka/clinical-trials huggingface dataset:
Assessment of Fit of Novel N95 Style Transparent Face Masks

Face masks have become a critically important public health intervention after the COVID-19 pandemic. Multiple types of masks ranging from full face filtering to cloth masks have been developed and commercialized to facilitate protection against respiratory pathogens. Most of these systems are made with opaque fabrics and may prevent individuals from expressing emotions or for those who are deaf and hard of hearing, communicating. To date, few transparent face masks which also confer respiratory pathogen protection have been developed. This study will test the feasability and acceptability of two new masks, the SEEUS-95 mask and CrystalGuard mask which are both transparent versions of N-95 filtering face masks.

This is a randomized crossover trial to evaluate the feasibility, acceptability and choice between the use of the SEEUS-95, CrystalGuard transparent face masks or a standard N95 mask. Otherwise healthy individuals will be prescreened and then scheduled for a single study visit. Participants will be randomized to wear each of the three masks (SEEUS-95, CrystalGuard, N95). They will be taught how to wear the mask, and we will assist participants with correctly wearing the mask for a good fit. Next, participants will undergo standard FIT testing where a clear hood will be placed over the participant's head, and a bitter solution (Bitrex) is sprayed into the hood. A positive test is indicated if the participant is able to taste Bitrex demonstrating that there is a detected leak within the mask. After a few minute washout period, participants will undergo FIT testing of subsequent masks. We will ask participants to rate the comfort of wearing the masks, willingness to wear masks in public and suggestions for improvement in mask design. Finally, we will conduct a discrete choice test to ask participants which mask they would prefer to wear in public.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* No history of asthma, restrictive lung disease, interstitial lung disease, or emphysema
* Lack of significant facial hair that precludes wearing a N-95 mask

Exclusion Criteria:

* Less than 18 years old
* Unable to smell Bitrex solution used for fit testing
Qualitative Pain Measurement at Patients With Degenerative Low Back Pain

The purpose of the study is:

* to measure sensitization of the nociceptive system at patients with low back pain in order to carry out a necessary surgical procedure
* to examine a possible association between low back pain and degenerative changes
* to analyse if low back pain is related to the clinical result 6 months after surgery
* to set up a model for pre-operative measurement of pain.


Eligibility Criteria:
Inclusion Criteria:

* patients who are going to be treated surgically for spondylitis
* ability to understand Danish in order to filling in a questionnaire
* a written signed statement of consent

Exclusion Criteria:

* removal of implants
* diabetic neuropathy or another neuropathic disease
* neurological diseases
* unability to read or understand Danish
Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women

Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant women. Investigators hypothesize that more regular self-monitoring, text messages and feedback as provided by home carbon monoxide monitoring device combined with medical feedback on results will reduce smoking during pregnancy compared to only receiving text message and no self-monitoring by home monitoring device and no feedback by home carbon monoxide monitoring device . The periconceptual period is a life period, where given the immediacy of the fetus and future child, a pregnant woman is willing to try and modify potentially harmful behaviors.

Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease and cancer risk, has proven remarkably difficult in traditional medical practice settings, and successful medical trials have been costly and labor intensive. This proposal aims to utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation among pregnant women who smoke. Investigators hypothesize that women who have access to a self-monitoring device more frequently (i.e., at home) and receive feedback about their carbon monoxide level will have greater reductions in smoking as determined by declining serum cotinine levels over the course of the study compared to women who do not have access to a self-monitoring device and do not receive feedback about their carbon monoxide level, but only receive text messages.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-40 years old
* Participants will be pregnant women estimated to be between 6 and 20 weeks into their pregnancy
* Pregnant women have smoked at least at least one cigarette in the prior 7 days
* Own a smartphone capable of delivering and receiving text messages

Exclusion Criteria:

* Project materials and text messages are in English, potential participants will be excluded if they cannot read English and if there are concerns about the ability to comprehend or comply with study procedures
Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis

A common complication post hip replacement is hip dislocation or hip instability which can lead to the hip implants being revised. A new generation of Dual Mobility hips was designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing 2 dual mobility hips manufactured by Stryker Orthopaedics Inc. The ADM and the MDM.

Hip replacement is a procedure in which the hip joint is replaced by a prosthetic implant or prosthesis. Post op hip dislocation or hip instability is a common complication which can lead to the hip implants being revised. There are many types of hip prostheses manufactured with the aim of prolonging longevity of the prosthesis and minimizing postoperative complications. One of these is a new generation of dual mobility hip manufactured by Stryker Orthopaedics. The Anatomic Dual Mobility (ADM) and the Modular Dual Mobility (MDM) were designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing the outcome of the ADM and MDM hip system.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female
* Skeletally mature
* 18 to 75 years old
* Stryker Dual Mobility Hip prosthesis
* BMI between 20 and 35
* Follow-up x-rays between 3 years and 6 years postop

Exclusion Criteria:

* Dual Mobility Hip implant that is not the ADM or MDM
* BMI that is 19 or less
* BMI that is greater than 36
* Most recent x-rays less than 3 years postop
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators.

The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.

The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail.

Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.

64 patients were included.

Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo).

Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any sex,
* age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
* treated with open or closed reduction and intramedullary reamed blocked nail.

Exclusion Criteria:

* Patients were excluded if they had a pathological fracture,
* an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
The Effect Of Progressıve Relaxatıon Exercıses

This study was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group.

The Effect of Progressive Relaxation Exercises Applied to Nurses Working in The İntensive Care Unit on Sleep Quality and Fatique İntensity The study was planned to determine the effect of progressive relaxation exercises applied to nurses working in intensive care units on sleep quality and fatigue intensity.

The study will be conducted with a randomized controlled experimental research design in order to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit on sleep quality and fatigue intensity. This randomized controlled study will be conducted on nurses working in Adana City Training and Research Hospital Intensive Care Unit. Nurses will be divided into 2 groups as experiment and control. It will be carried out on 60 people in total, 30 for the experimental group, 30 for the control group. Progressive relaxation exercises will be applied by nurses for 45 minutes, 3 days a week for an average of 1 month.

The data of the study will be collected after the purpose of the study is explained to the nurses and their verbal and written consents are obtained. In the collection of research data, the Personal Information Form prepared by the researchers and containing the introductory information of the nurses, the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index Scale PSQI), the Fatigue Severity Scale for fatigue (FSS) will be collected from control and intervention groups through face-to-face interviews.

There are a limited number of studies showing the effects of progressive relaxation exercises applied to intensive care nurses on sleep quality and fatigue intensity in our country. With the study, the use of these exercise programs, which can be easily applied by nurses who work under heavy workloads in the intensive care environment, will increase, and it will be ensured that nurses work more fit and efficiently and are supported in terms of sleep fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Without a psychiatric diagnosis,
* Having a score of PUKI ≥5 and YŞÖ≥4,
* Nurses who volunteered to participate in the study were included in the research sample.

Exclusion Criteria:

* Experience of working in intensive care for less than 3 months,
* Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality,
* Pregnant nurses were not included in the research sample.
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

This expanded access program will provide continued access to cerdulatinib to eligible participants who experienced clinical benefit from cerdulatinib in Study 13-601 (NCT01994382) and who otherwise meet the eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Participant has completed Portola Study 13-601 and wishes to continue treatment with cerdulatinib.
* In the opinion of the Investigator, the potential benefit to the participant of continuing to receive cerdulatinib outweighs the risks.
* Female participants of childbearing potential and male participants must agree to continue to abstain from sexual intercourse or to remain on an effective method of contraception during treatment and for 90 days following the last dose of protocol therapy (examples of effective methods of contraception include oral contraceptives or double barrier methods, such as condom plus spermicide or condom plus diaphragm).
* Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules.

Exclusion Criteria:

* Participant requires chronic treatment with a strong CYP3A4 inhibitor or inducer.
* Participant has a known hypersensitivity to any of the components of cerdulatinib.
* Participant is female and is breast-feeding, pregnant, or intends to become pregnant.
* Participant is participating in any therapeutic clinical study.
The Value of Infectious Biomarkers for Prediction of Complication After Hepatopancreatobiliary Surgery

Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study is to assess the predictive value of biomarkers for early complication after hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.

Postoperative complication after major abdominal surgery, such as pancreatic surgery and hilar cholangiocarcinoma surgery, is higher, up to 30 to 50%.It is the mainly reason for the patient to admit to ICU. Among this, the most common and difficult to handle complication is mainly anastomotic fistula, abdominal effusion and subsequent secondary infection. Delayed diagnosis can cause systemic inflammatory response syndrome (SIRS), multiple organ failure ( MODS), and even death. From a surgical point of view, it leads to surgical failure and often need the second surgery. However, the diagnosis and treatment of postoperative infection is also facing two problems: it is difficult to confirm the diagnosis and make treatment decision. Hence, there is a strong need of an additional tool to early diagnose post operative complication.

Serum procalcitonin (PCT), is a 116 amino-acids protein produced by C-cells of the thyroid gland. PCT baseline levels are low (\<0.05 ng/ml), but increase significantly in patients with severe bacterial infections. Therefore, PCT levels are used to monitor the course and prognosis of systemic bacterial infections and to tailor the therapeutic interventions more efficiently. Furthermore, PCT could serve as an early predictive marker for the clinical course of septic complications after abdominal surgery. The aim of this study is to demonstrate if PCT is a more sensible, specific and reliable biomarker of post operative complication than other biomarkers

The investigators conducted a observational, prospective study. All patients undergoing electively hepatopancreatobiliary surgery in seven centres are recruited. In all cases white blood count (WBC), C-reactive protein (CRP) and PCT levels are measured in 1st, 3rd and 5th postoperative day (POD). Informed consent was obtained in all patients.The study is approved by the hospital's Ethical Committee.

Eligibility Criteria:
Inclusion Criteria:

* age \> = 18 years
* Hospitalized patients with elective hepatopancreatobiliary surgery

Exclusion Criteria:

* age \<18 years
* emergency operative patients
* Preoperative fever, white blood cell elevation and preoperative infection
* Systemic inflammatory disease
* renal failure
* hematology disease
* preoperative abnormal PCT, IL-6, IL-8, CRP
* Laparoscopic cholecystectomy
* Bile duct infection
Real World Evidence Study of Danish Fabry Patients

Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat.

Research Question:

Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy?

Objectives:

* To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy.
* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.
* To describe FACEs in accordance with different geno- and phenotypic groups.
* To investigate the incidence and time to a first fatal or non-fatal cardiac, renal, and cerebrovascular clinical event, separated by each category.

Primary outcomes - Time to first FACE (cardiac, renal, and cerebrovascular) with particular focus on Migalastat on clinical outcomes and treatment outcomes preceding Migalastat therapy.

Secondary outcomes

* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.
* To describe FACEs in accordance with different geno- and phenotypic groups To investigate the incidence and time to a first fatal or non-fatal cardiac, renal and cerebrovascular clinical event, separated by each category.

Exploratory outcomes

- To describe disease progression with focus on organ involvement.

The study design is a retrospective clinical and paraclinical follow-up of the Danish National Fabry cohort in the period 01.01.2001-31.12.2022. Patient followed a structured yearly monitoring program as part of routine clincal care.


Eligibility Criteria:
Inclusion Criteria:

* Genetically-verified Fabry disease
* Age above or equal to 18
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial

The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cardiac, respiratory or cardiorespiratory failure and 1 of the 5 following sets of findings:

  1. A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \< 100 mm on \> 0.9 FIO2;
  2. Uncompensated hypercapnia with pH \<7.2 despite a Pplateau \> 30 cm H20;
  3. Significant air leak/bronchopleural fistula;
  4. Need for intubation in a patient on lung transplant list;
  5. Immediate cardiac or respiratory collapse (pulmonary embolus, blocked airway, unresponsive to optimal care);
* Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.

Exclusion Criteria:

* High pressure ventilation (FIO2 \> 0.9 and Pplateau \> 30 cm H2O) or high FIO2 requirements for more than 7 days;
* Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated
* Excessive weight (\> 180 Kg)
* Severe irreversible brain injury (e.g., hypoxic brain injury)
* Inability to accept blood products;
* Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer;
* Immunosuppression with an absolute neutrophil count \< 400/mm3;
* Patient has been treated with ECMO ≤ 48 hours.
* For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:
* Severe pulmonary hypertension (mPAP \> 50 mm Hg)
* Severe right or left sided heart failure (EF \< 25%)
* For veno-arterial ECMO in the setting of cardiac insufficiency:
* Severe aortic regurgitation
* Aortic dissection.
* The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.
* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.

PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by bexarotene works in treating patients with cutaneous T-cell lymphoma.

OBJECTIVES:

Primary

* Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell lymphoma treated with doxorubicin HCl liposome followed by bexarotene.

Secondary

* Determine the complete and partial response rate in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks. Patients who achieve a complete or partial response may continue to receive bexarotene in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cutaneous T-cell lymphoma

  * Stage IB-IV disease
* Measurable disease
* Newly diagnosed or previously treated disease

  * No demonstrated resistance to prior bexarotene

PATIENT CHARACTERISTICS:

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
* No New York Heart Association class II-IV heart disease
* No clinical evidence of congestive heart failure

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
* No history of hypersensitivity reactions attributed to doxorubicin HCl liposome or its components
* No active potentially life-threatening infection
* No other acute disease

PRIOR CONCURRENT THERAPY:

Chemotherapy

* See Disease Characteristics
* Prior doxorubicin allowed provided the cumulative dose is ≤ 300 mg/m\^2
* Prior epirubicin hydrochloride allowed provided the cumulative dose is ≤ 540 mg/m\^2