cyrilzakka/clinical-trials huggingface dataset:
Ambulatory Oxygen for ILD

People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to increase oxygen levels in the blood during daily activities. The best way of delivering this type of oxygen has not been established. The aim of this study is to compare two devices for delivering oxygen in people with interstitial lung disease - the traditional method using portable cylinders and a newer method using a portable concentrator. The investigators hypothesise that oxygen levels during exercise will be significantly higher when using a portable cylinder, but this difference will be small.

Exercise-induced hypoxaemia (EIA) is very common in individuals with ILD, due to progressive lung fibrosis which results in impaired gas exchange. It is common for people with EIA to be prescribed ambulatory oxygen, in order to normalize oxyhaemoglobin saturation, improve oxygen delivery to the tissues and relieve breathlessness during daily activities.

Ambulatory oxygen is traditionally delivered via a refillable portable oxygen cylinder containing compressed gaseous oxygen. More recently, portable oxygen concentrators (POCs) have emerged as a solution to the problem of finite cylinder life and to improve portability. Because a concentrator is constantly extracting oxygen from air, oxygen supply can continue as long as the battery is charged. This is typically around eight hours, but POCs can be recharged from an AC or DC power source. Portable oxygen concentrators usually weigh around 3.5kg, which is significantly lighter than oxygen cylinders, and are much easier to maneuver. However, there are some theoretical disadvantages to POCs. Like all concentrators, they do not deliver 100% oxygen. Concentrations typically range from 85-95%, depending on the flow rate. Differences in pulse timing and peak pulse flow between POCs may affect the fraction of inspired oxygen (FiO2) that is delivered. However, the clinical implications of these differences have not been documented.

The aim of this study is to compare the effects of ambulatory oxygen delivered during exercise using the EverGo POC to ambulatory oxygen delivered with a standard portable cylinder in individuals with ILD. We hypothesise that oxyhaemoglobin saturation during exercise will be significantly higher when using a portable cylinder, but this difference will not be clinically important.

Eligibility Criteria:
Inclusion Criteria:

* a confident diagnosis of ILD made according to established criteria and
* desaturate to less than 90% during a 6-minute walk test

Exclusion Criteria:

* primary diagnosis of a respiratory condition other than ILD (eg COPD)
* currently using continuous oxygen therapy
* oxyhaemoglobin saturation (SpO2) is less than 90% on room air
* unable to perform a 6-minute walk test or comorbidities that limit walking
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus

This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.

If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.

Eligibility Criteria:
Inclusion Criteria:

* All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE
* Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks
* To be able to come for all follow-up visits for nine months
* No contraindications to undergoing MRI
* Age 18-75 years

Exclusion Criteria:

* Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal
* Elevated CPK at baseline
* Pregnancy or Lactating
* Allergy to a statin
* Current or recent use of a statin within 3 months
Genetic Risks for Bicuspid Aortic Valve Disease

Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies.

To be included in the study, patients must have a bicuspid or unicuspid aortic valve, documented by clinical history or imaging studies. If the aortic valve was replaced surgically, they may still be eligible. Participants will be asked to donate a single tube of blood and fill out a questionnaire. Patients will also be followed up by telephone or email about once a year to determine if they experience any medical complications related to Bicuspid Aortic Valve (BAV), such as aortic aneurysms, aortic dissections or valve disease. Patients may not be included if they are less than 18 years old at the time of recruitment or have a recognized genetic syndrome or genetic mutation such as Marfan or Ehlers-Danlos syndrome.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of bicuspid or unicuspid aortic valve

Exclusion Criteria:

* Less than 18 years of age
* Recognized syndrome or identified genetic mutation
Efficacy of an Oral Hygiene Implant Protocol

This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.

The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. This is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks. Photographs of the tissue and denture will be taken.

Eligibility Criteria:
Inclusion Criteria:

* have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
* Good general health, with no diseases which could impact periodontal health
* able to read and understand English
* willing to return for all appointments
* at least 30% BOP
* probing depths less or equal to 5mm

Exclusion Criteria:

* subjects who are currently pregnant
* mobility of implant
* subjects who have diabetes
* subjects who smoke
* subjects with any serious medical condition which the investigator feels may impact participation in the study
A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
* Measurable disease as determined by RECIST 1.1

Exclusion Criteria:

* Primary CNS tumor or CNS tumor involvement
* Diabetes mellitus
* Unacceptable ocular/retinal conditions
* Clinically significant cardiac disease or impaired cardiac function
Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles

The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).

The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patient age at time of embryo freezing: 18 to 40.9 years
* Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)
* Blastocysts frozen by vitrification at Brigham and Women's Hospital
* Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital

Exclusion Criteria:

* Fresh or cleavage-stage embryo transfer planned
* Gestational carrier cycles
* Natural and modified natural cycles
* Embryos frozen more than once or derived from thawed oocytes
* Embryos frozen at centers other than Brigham and Women's Hospital
* Embryos frozen using techniques other than vitrification (i.e. slow frozen)
* Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies
* Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx
* Patients with three prior failed embryo transfers (fresh or frozen)
* BMI\<18 or \>40 kg/m2 at screening
* Currently breast feeding or pregnant
* Embryo biopsy performed
* Current smoking, alcohol or illicit drug use
* Allergy to study drugs
* Refusal or inability to adhere to study protocol
* Participation in other experimental drug trials concurrently within the past 60 days
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
* Current wear of spherical contact lenses.
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
* Other protocol-defined exclusion criteria may apply.
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain

To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear leukocytes (PMNL) and macrophages, systemic and local inflammatory response and postoperative pain

we detect COX-2mRNA, COX-2 protein expression in inflammatory cells and PGE2 concentration in patients with abdominal surgery. The differences of COX-2 expression in PMNL are compared between peripheral blood and partial incision transudate to the same individual, and at the same time, the COX-2 expression differences in PMNL and macrophages, and PGE2 concentration in partial incision transudate also compared interindividually, to show the relevance between the difference and postoperative pain. In addition, the effects of Parecoxib Sodium on COX-2 expression of the amount in PMNL and macrophages are investigated during the development of postoperative inflammatory pain. Finally, we will clear the dose-effect relations among the expression of COX-2 in inflammatory cell, systemic and local inflammatory response and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* The trial is approved by Tongji hospital's Ethics Committee, Tongji Medical College of Huazhong University of Science and Technology, and is registered through Clinical Trail. All patients give written informed consent
* American Society of Anesthesiologists (ASA) physical status of I or II
* 20 years to 55 years
* Weight 50 \~ 70 kg, BMI 19 \~ 24
* Duration of operation time in the range of 2-4 hours
* A normal leukocytes level before the operation
* No alcohol or smoking abuse
* Without major trauma, history of psychiatric disease and history of chronic pain
* Patients agreement with the trial and having ability to complete the requirements of this study
* Patients receiving intravenous patient controlled analgesia (PCA)

Exclusion Criteria:

* Allergy or contraindication to selective COX-2 inhibitors
* Received NSAIDs treatments before the operation
* Used enzyme inhibitor (such as Ketoconazole, Fluconazole, Itraconazole), enzyme inducer (such as Rifampicin, Phenytoin sodium, Carbamazepine, Dexamethasone), anticoagulant (such as Warfarin, Aspirin) and other drugs which increase the drug toxicity (such as Erythromycin, Clarithromycin, Cyclosporin Ciclosporin, ACE inhibitor or Diuretics, Lithium) from the first 3 days before the operation to postoperative observation period
* Blood transfusion, hemodilution measures in the operation
* Infection of the incision
Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction

A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes).

The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Physically active
* History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)

Exclusion Criteria:

* History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
* Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament \[MCL\], posterior cruciate ligament\[PCL\]), chondral defects \>2cm, fracture, bilateral knee injury
* Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
* Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)
Respiratory Support and Treatment for Efficient and Cost-Effective Care

This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.


Eligibility Criteria:
Inclusion Criteria:

* \<2 years of age Bronchiolitis WOB Score \>2

Exclusion Criteria:

* Immunocompromised
* Immunosuppressed
* Chronic lung disease
* Congenital heart disease with baseline cardiorespiratory manifestations
NGS Strategy Effectiveness in Molecular Diagnosis

The coming out of Next Generation Sequencing (NGS) technologies, with documented advantages and reduced costs respect to Sanger sequencing, has provided new appealing approaches to diagnostic testing. Despite this, its use for routine diagnostic purposes requires certification in terms of reliability, as well as a cost-effectiveness evaluation.

To test the feasibility of using the Ion Torrent Personal Genome Machine (PGM) in clinical diagnosis, we assessed its performance to detect point mutations and big rearrangements previously identified with standard techniques. The diagnostic accuracy and the cost-effectiveness will be evaluated by Health Technology Assessment (HTA) analyses.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Osteochondroma
* Clinical diagnosis of Osteogenesis Imperfecta
Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The main purpose of this study is to find out if participants experience any differences in the amount of coughing and mucus problems when using the new range of Provox Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is sponsored by Atos Medical.

Study Design: Participants will use the new Provox Life™ HME range and their attachments during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase), participants will use the new Provox Life™ HMEs in a similar way as they currently use their existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME devices following an optimal Day/Night regimen - with the aim to achieve the best possible humidification at all times. Prior to each study phase, participants will meet with their speech pathologist to learn about the new devices and how to use them. Once comfortable using them they will commence each observation phase.

Data Collection: Experiences using their existing HMEs (prior to study) and then using the new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2 and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and mucus problems, skin integrity, overall experiences of using the new devices and any impacts on sleep and quality of life. Participants will complete some of the questionnaires at home (approx. 30mins) and the others during an interview session with one of the study team (approx. 30mins). The interview session can be conducted via telephone, videoconferencing or in person - depending on the patients preferences and any COVID restrictions.


Eligibility Criteria:
Inclusion Criteria:

* Total laryngectomy, irrespective of pharynx reconstruction method
* 18 years or older
* HME user
* Longer than 3 months after total laryngectomy
* Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria:

* Current day/night routine with Provox Luna
* Daily use of Provox Micron HMEF
* Medical problems prohibiting the use of HME
* Active recurrent or metastatic disease (medical deterioration)
* Recent pulmonary infections/unstable pulmonary condition
* Reduced mobility of arms and/or hands, unable to insert or remove an HME
* Unable to understand the Participant Information and/or unable to give Informed Consent
* Insufficient cognitive ability to manage HME or adhesive use
Identifying Local Signs at the Catheter Insertion Site With Artificial Intelligence

Deepcath is the first step to the introduction of artificial intelligence in catheter care. A better use of visualisation of catheter exit site should be used not only by the HCWs but also by the patients and their family.

A deep learning system able to detect visual abnormalities of the catheter exit site will be an helpful tools to develop a continuous follow-up of intravascular catheters.


Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years of age Patients with one or more implanted central venous, midline, piCCline, arterial, or peripheral catheters.

Patient and/or trusted person and/or family who have verbally stated their non-objection to the study Patient affiliated or beneficiary of a social security plan

Exclusion Criteria:

Patients presenting a peripheral identification sign close to the catheter insertion point cannot be masked when the photograph is taken. Thus, jewelry, clothing, tattoos, scars, and birthmarks are identifying features.

Patients whose catheter insertion point is not visible.