cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.

The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.

This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of non-healing venous leg ulcer by the following criteria:

  * dependent peripheral edema, dermatitis, hyperpigmentation.
  * an ankle to arm arterial pressure ratio \> 0.7 as measured by arterial Doppler.
* Venous Stasis Ulcer is ≥ 2 cm² in size.
* If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.

Exclusion Criteria:

* Subject known to be allergic to Aquacel dressing or components.
* Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
* Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
* Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
* Involvement in another experimental drug trial within the last month.
* Clinical evidence of cellulitis or infection in or around the ulcer.
* History of non-compliance to medical regimens and is not considered reliable.
* Unable to understand the study evaluations and provide a written informed consent.
The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia

The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients.

The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.

Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue.

This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions.

Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients.

Methods:

Inclusion: 40 men and women \>60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with community acquired pneumonia
* \>60 years
* Patients who are able to speak and understand Danish

Exclusion Criteria:

* Patients with hospitalized acquired pneumonia
* Patients with septic shock
* Patients with an active cancer and in cancer treatment
* Patients in dialysis
* ICU patients
* Patients unable or unwilling to give informed consent
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy

The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.

In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada

Exclusion Criteria:

* none
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery

Sinus surgery is a common, day surgery procedure performed by general and subspecialty trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of complications. When there is significant bleeding or enough bleeding to obscure important anatomical landmarks, there is a higher chance of complications. These complications can include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients taking oral tranexamic acid three days before surgery and six days after, there will be less intraoperative bleeding, better surgical visualization and less postoperative bleeding events.


Eligibility Criteria:
Inclusion Criteria:

* Chronic sinusitis requiring bilateral functional endoscopic sinus surgery
* Between the ages of 18-65
* Willing to comply with standard followup
* No coagulopathy
* Not pregnant

Exclusion Criteria:

* Pregnant
* On anticoagulants within 3 months of the surgery
* Coagulopathy
* \<18 or \>65 years of age
Effects of Thoracic Mobilization on Shoulder Range of Motion

The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.

Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in shoulder range of motion, specifically, flexion (elevation) as well as external and internal rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder motion, but little is known about interventions targeting adjacent sites which may also improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint manipulation on active and passive shoulder range of motion.

Eligibility Criteria:
Inclusion Criteria:

* Adults 19-45 years

Exclusion Criteria:

* Individuals who are pregnant
* History of cervical or thoracic surgery
* Bone or joint disease
* Current infection or tumor
* Osteopenia/osteoporosis
* Spinal fracture
* Rheumatologic pathologies
GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).

Biliary Tract Carcinoma (BTC) has an insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy.

Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects with a histopathological or cytologically diagnosis of BTC

  * The participants must be required to sign an informed consent
  * At least one measurable lesion (RECIST 1.1)
  * No previous systematic treatment for BTC
  * Child-Pugh Score, Class A
  * ECOG performance status 0 or 1
  * Adequate organ function
  * Life expectancy of at least 3 months

Exclusion Criteria:

* • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma

  * Known history of a serious allergy to any monoclonal antibody
  * Known central nervous system metastases and/or leptomeningeal disease prior to treatment
  * Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
  * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
  * Any active malignancy prior to the start of treatment
  * Active or history of autoimmune disease
  * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
  * Pregnant or lactating women
Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)

Alzheimer's disease (AD) is usually associated with aging, age being the principal identified risk factor. However, younger subjects also develop AD and the prevalence of early onset AD is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age of 65 in France. There is evidence that early onset AD differs from AD in older patients. In particular, clinical and neuroimaging studies suggest early involvement of neocortical brain regions and their functions in early onset AD, while mediotemporal areas and memory might be more involved in late onset AD. These differences could partly explain the atypical clinical and imaging features of younger patients, the diagnostic difficulties in these patients and the specific problems related to medical care of this age group. The present study uses a multidisciplinary approach with longitudinal followup in order to establish the impact of age on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another aim of the project is to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Arm Alzheimer Disease : first symptoms from 1 to 5 years before the inclusion, Clinical Dementia Rating = 1, efficient contraception for women
* Arm Control : efficient contraception for women

Exclusion Criteria:

* Important general disease : diabetes, neoplasia, alcoholism
* First symptoms less than 1 year or more than 5 years before the inclusion
* Pregnancy, breast feeding
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. Summary of the Study: If you choose to participate, you will complete a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also be asked to call in and answer study questions at other times during the day, especially after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype. Participants will receive and return study materials through the mail.

Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D) than the general population. Yet what accounts for the increased prevalence of ED in T1D, and how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with ED not only engage in behaviors common among non-diabetic ED patients (like binge eating), but also might omit insulin to prevent weight gain. The goal of this study is to understand the psychophysiological precipitants to ED behavior among T1D patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (aged 18-65)
2. Diagnosed with type 1 diabetes
3. Clinically significant eating disorder symptoms
4. Currently monitored by a physician

Exclusion:

1. Severe hypoglycemic unawareness
2. Pregnancy
3. Current or history of psychosis or mania
4. Current substance abuse
5. Non-English speaking
6. Significant deficits in intellectual functioning
qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis

The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general wards. Despite an alternative process by using a simplified qSOFA score, many patients may still be left out. Whether these patients matter or not is unknown. This prospective cohort includes patients from ten general wards with high incidence of infection during a consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to compare patients under different groups, eventually to evaluate the diagnostic accuracy of qSOFA score in diagnosis of sepsis.

The sepsis, which is considered as multi-organ dysfunction induced by infection, is a one of leading causes of death in hospital. In 2016, the third international consensus has modified the definition of sepsis from infection with \>=2 of systemic inflammatory response syndrome (SIRS) criteria to infection with \>=2 of sequential organ failure assessment (SOFA) score. This new definition, which well reflects the organ dysfunction nature of sepsis, however makes it difficult to diagnose sepsis in general wards. An alternative of process was put forward to compensate this weakness. For each infection patient in general, access a quick SOFA (qSOFA), if it is above 2 score, then conduct laboratory examination to get a SOFA score. This process is helpful to find out sepsis, but undoubtedly leave out some patients who meet the SOFA criteria without qSOFA \>=2. Besides, there are also some patients who has a qSOFA \>=2 however do not meet the SOFA criteria. Whether those patients have better survival rate is unclear. This prospective cohort is aimed to compare prognosis of patients with different SOFA, qSOFA score, therefore access the diagnostic accuracy of qSOFA in the diagnosis of sepsis, eventually evaluate the feasibility of using qSOFA as a complete replacement of SOFA in general wards.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18;

Exclusion Criteria:

* Hospital stay less than 24h just for chemotherapy,biotherapy or endoscopy.
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.

The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.

It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
* Successful in-lab titration polysomnography (PSG)
* General (at home) sleep habits of:
* At least 7 hours in bed on most nights
* Lights out at 12 midnight or earlier
* Fluency in both written and spoken English.

Exclusion Criteria:

* Participants prescribed and fitted with any PAP device in the past 2 years
* Contraindicated for CPAP or AutoCPAP therapy.
* Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
* Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
* Patients who are prescribed hypnotics and sedating medications.
* Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
* If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
* If the physician objects to their patient taking part in the study.
Kind Minds Program for Youth with Anxiety and Depression

Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously.

This pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention.

Adolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Participants will include:

  1. one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder)
  2. one of their parents/caregivers.
  3. Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English.
  4. Parent and youth must have a smart phone and be willing to download the online mindfulness program.

Exclusion Criteria:

* Exclusion criteria apply to both caregiver and adolescent and include:

  1. current alcohol or substance use disorder or suicidality
  2. lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator;
  3. English reading level below 4th grade
  4. non English speaking
  5. currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.
Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia

Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* children aged 1 to 10 yrs.
* ASA 1-2

Exclusion Criteria:

* Allergy to soya (propofol)
* Allergy to Pentobarbital
* Allergy to Remifentanil
* Allergy to Sevoflurane
* Children undergoing blood tests or further examinations in conjunction with the MRI
* Children with unexplained fever
* Children which are evaluated not to be able to keep a open airway
Immunogenicity and Safety of Gardasil-9 and Cervarix

A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.

The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.

Eligibility Criteria:
Inclusion Criteria:

* 9-10-year-old girls and boys

Exclusion Criteria:

* previously received an HPV vaccine
* immunosuppressed
* known allergy to a vaccine component