cyrilzakka/clinical-trials huggingface dataset:
Molecular Diagnosis of Respiratory Viral Infections on Sputum From Cystic Fibrosis Patients

The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.

Viral respiratory infections in cystic fibrosis (CF) have a significant impact on the progression of the disease. It is therefore essential to look for these viruses. No recommendations are made for the virological follow-up of CF patients and no optimal strategy for the type of sampling required. In non-CF patients, the search for a viral infection is performed by nasopharyngeal sampling. This method of sampling is invasive and uncomfortable for the patient. In CF patients, sputum, non-invasive sampling, is routinely used for bacterial research and may be used for viral infections to avoid invasive nasopharyngeal sampling in patients whose management is heavy.

After giving consent, both sputum and nasopharyngeal swab are collected for each participant. A record of clinical and biological data is also made at inclusion. A molecular viral search is performed on both samples by a multiplex technique detecting a broad spectrum of respiratory viruses. A bacteriological analysis is carried out on sputum. The molecular results will be interpreted blindly according to the main criterion of evaluation, presence or absence of viral infection.

Comparison of expectoration to nasopharyngeal sampling of CF patients for respiratory virological diagnosis should analyse agreement of the molecular viral detection and position CF sputum as an optimal assay for respiratory viruses with the advantage of not being invasive and in all cases routinely taken for the control and bacterial follow-up.

The promotion of sputum as an ad hoc sampling for viral research and epidemiology would facilitate the establishment of surveillance for viral infections in cystic fibrosis and thereby contribute to the CF register data.

Eligibility Criteria:
Inclusion Criteria:

* participant with Cystic Fibrosis
* participant with sign of acute respiratory infection
* participant able to expectorate

Exclusion Criteria:

* participant not able to expectorate
* participant refusing to participate
Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
3. The subject must be between 18 and 69 years of age.
4. The subject must be willing to participate in a 9-month study.
5. The subject must require a visual correction in both eyes.
6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
7. The subject must have best-corrected visual acuity of 0.20 or better in each eye.
8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

Exclusion Criteria:

1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
5. Any active ocular infection.
6. Current use of topical ophthalmic medications.
7. History of binocular vision abnormality or strabismus.
8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
10. History of severe allergic reaction or anaphylaxis.
11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
12. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients

Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

* known coagulation disorder
* Using deep hypothermic circulatory arrest
* Using partial cardiopulmonary bypass
Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets

A 52 week, open label trial to assess the safety and efficacy of KRN23, an investigational antibody to FGF23, in a single pediatric patient with Epidermal Nevus Syndrome(ENS) and associated hypophosphatemic rickets

A 26 weeks extension to original study to monitor patient lab results for her safety.

1.1 Primary Objective

The effect of KRN23 treatment on normalizing age-adjusted serum phosphorous levels in a single pediatric patient with Epidermal Nevus Syndrome associated hypophosphatemic rickets

1.2 Secondary Objectives

1. The PD profile of KRN23 as assessed by changes from baseline over time 1,25(OH)2D, iPTH, Serum Calcium, TRP and TmP/GFR (the ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate)
2. Changes in underlying skeletal disease/rickets as assessed by standard radiographs utilizing the Radiographic Global Impression of Change (RGI-C) rating scales
3. Effects of KRN23 on biochemical markers of bone turnover that reflect rickets severity, alkaline phosphatase (ALP)
4. Walking ability as assessed by 6-Minute Walk Test (6MWT)
5. Patient/parent-Reported Outcomes as assessed by PROMIS and FPS-R rating scales

1.3 Exploratory Objective

1. Dual-energy X-ray absorptiometry (DXA)

1.4 Safety Objective Assess the safety of KRN23 administration in a single patient with ENS-associated hypophosphatemic rickets, based on adverse events (AEs), laboratory assessments, cardiac imaging and renal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has confirmed ENS by physician diagnosis
2. Patient has confirmed FGF23 elevations in the context of low serum phosphorous \< 4.1 mg/dL
3. Patient able to tolerate KRN23 treatment
4. Have a corrected serum calcium level \< 10.8mg/dL
5. Have an eGFR \>60 ml/min
6. Must be willing in the opinion of the investigator, to comply with study procedures and schedule
7. Provide written informed consent by a parent after the study has been explained and prior to any research related procedures begin

Exclusion Criteria:

1. Concomitant use of active vitamin D (i.e calcitriol) and/or exogenous phosphate supplementation. Patient will be allowed OTC Vitamin D should levels drop below \<20 ng/ml
2. The use or enrollment in studies using other investigational therapies including other monoclonal antibodies
3. Subject and their parent not willing or not able to give written informed consent
4. In the Investigators opinion, the patient may not be able to meet all the requirements for study participation
5. Patient has a history of hypersensitivity to KRN23 excipients that in the opinion of the investigator, places the patient at an increased risk of adverse effects
6. Patient has a condition that in the opinion of the investigator could present a concern for subject safety or data interpretation.
RCT of an Acceptance-based Behavior Therapy for GAD

The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.


Eligibility Criteria:
Inclusion Criteria:

* principal diagnosis of GAD
* at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
* willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
* fluent in English
* 18 years or older

Exclusion Criteria:

* bipolar disorder
* psychotic disorders
* substance dependence
* active suicidal intent
* if anxious symptomatology is due to a medical/physical condition
Microwave Ablation for Uterine Fibroids

This study is aimed to evaluate the clinical safety and effectiveness of Microwave ablation (MWA) in treating patients with uterine fibroid.

Percutaneous radiofrequency ablation (RFA) is another form of thermal ablation that has been used for the treatment of uterine fibroids. Although RFA is more invasive when compared to High-Intensity-Focused-Ultrasound (HIFU), the treatment is less limited by the location of the lesions, and the treatment procedure is more time efficient. To further improve the technology of thermal ablation for uterine fibroid, percutaneous microwave ablation (MWA) could be a promising option because it allows increased efficiency of energy transmission and reduction in procedure time, and may allow effective treatment of large lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic fibroids with or without focal adenomyoma
2. Female gender
3. Age between 30 and 50
4. Pre or peri menopausal with FSH less than 40 mIU/ml
5. Negative urine pregnancy test
6. Uterine size less than 22 weeks based on physical exam assessment
7. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging.
8. Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team.
9. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.
10. Willing and able to give informed consent.
11. Willing and able to comply with study requirements.
12. Normal menstrual cycle with endometrial pathology excluded

Exclusion Criteria:

1. History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
2. Other pelvic pathology as indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease
3. Pregnant or Positive pregnancy test
4. Unexplained vaginal bleeding
5. Untreated severe cervical dysplasia
6. Abnormal adnexal /ovarian mass
7. Intrauterine device
8. Known recent rapid growth of fibroids, defined as a doubling in size in 6 months
9. Known bleeding tendency
10. Contraindication to MRI due to severe claustrophobia or implanted metallic device.
Reference Population for Speckle Tracking Imaging

The SCAR study uses a software program entitled QLAB, a proprietory program, developed by Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is minimal. Accumulation of data relevant for a population of subjects will provide a set of normal values for interpretation of 2DSTE and minimize any influences from differences in data produced from different companies. This data may also assist other researchers investigate other cardiac diseases and abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 20 - 80 years at study entry
* Provide written informed consent and be able to comply with study procedures, including permission to access medical records
* Have a BMI index equal to or less than 35
* Less than 5% risk of developing coronary artery disease as determined using the Combined Diamond/Forrester and CASS data (ACC Stable CAD Guidelines)

Exclusion Criteria:

* Have taken cardioactive drugs within 6 months prior to examination

  * These include but are not limited to beta-blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors
* Currently clinically significant chronic or acute illness
* Documented cardiovascular disease
* Possess abnormal cardiac structure and function after examination with routine ECHO

  * This may include valvular defects, left ventricular hypertrophy, cardiomyopathies or pericardial disease
* Documented congenital heart conditions or defects
* History of diabetes
* Be unwilling to provide voluntary consent
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

The current study aims to explore and analyse the decision making process of couples in regards to continuing or discontinuing infertility treatment. A longitudinal, prospective cohort design is used which allows the monitoring of patients over a longer period of time. Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth interviews) to allow for a more specific and in depth experience than can be obtained by using a questionnaire study. Innovative aspects of the study include:

1. exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth)
2. exploration of gender differences in the decision making process in continuing or discontinuing treatment
3. longitudinal and prospective arm of the study will allow to gain insight into the 'process'
4. prediction of continuing/discontinuing treatment based on psychological variables.


Eligibility Criteria:
Inclusion Criteria:

* first IVF/ICSI treatment
* sufficient knowledge of Dutch to fill out questionnaires
* heterosexual couples

Exclusion Criteria:

* insufficient knowledge of Dutch
* having had previous IVF/ICSI treatment
Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB

This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.

Current National Institute for Health and Care Excellence (NICE) guidance (NICE, 2009) supports the use of ultrasound-guidance for regional anaesthesia (UGRA) procedures as a consensus of clinical opinion agrees that nerve blocks are more successful and safer with ultrasound (US) guidance. Despite this, UGRA remains a difficult technique to master. This study will be used to determine whether ScanNav Anatomy PNB can support the performance of non-expert anaesthetist in UGRA scanning by highlighting key anatomical structures on the US image in real time.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study
3. Available to travel and attend the study day in person in Cardiff, UK
4. Medical professional (currently practicing anaesthetist or similar clinician) who is qualified to perform UGRA
5. Do not self-identify as an expert in the field of UGRA:

   1. Has not completed advanced training or hold a qualification (e.g., EDRA, MSc, MD, PhD) related to UGRA
   2. Does not regularly deliver anaesthesia for 'awake' surgery (excluding central neuraxial techniques)
   3. Does not teach on formal RA courses

Exclusion Criteria:

1. Aged \<18 years of age
2. Unwilling or unable to provide informed consent
3. Expert in UGRA (see definition above)
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries

This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age 18 or older
4. Seeking care for a musculoskeletal injury
5. Experiencing pain greater than 3 out of 10 on a visual analog scale
6. English or Spanish speaking
7. Owns a compatible Android or iOS smartphone device (excluding tablets)

Exclusion Criteria:

1. Unable to understand the goals of the study due to cognitive difficulty
2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
3. Pregnant (contraindication for TENS unit)
4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
5. Hypersensitivity to flashing light or motion
6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women;
* metastatic breast cancer suitable for endocrine therapy;
* positive hormone receptor status;
* Human epidermal growth factor receptor 2 (HER2) overexpression.

Exclusion Criteria:

* patients on hormone replacement therapy;
* previous chemotherapy for metastatic disease;
* uncontrolled cardiac disease and history of cardiac failure.
Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer

Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery.

As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered.

The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors.

By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.


Eligibility Criteria:
Inclusion Criteria:

The investigators will examine data from consecutive patients at each site treated between 1/1/1999 and 12/31/2020. Patients must fulfil all these criteria:

i. Been treated for oral cavity, oropharyngeal, carcinoma of unknown primary, laryngeal, or hypopharyngeal squamous cell carcinoma and be over the age of 18.

ii. The participants must have been treated with curative intent via surgery, radiotherapy, or chemoradiotherapy or a combination within the study inclusion period.

iii. The participants must have had CT or/and MRI scans of the neck, performed within 12 weeks before the start of treatment.

iv. Results for the presence or absence of extranodal extension on CT or/and MRI scans, or ability to report them within the deadline period.

v. For surgically-treated patients: Results for the presence or absence of both extranodal extension on histopathology and on radiology, or ability to report them within the deadline period.

vi. Must have had at least two years of follow-up, or death. vii. Data on staging must be available at least in TNM 7th edition or later editions.

Exclusion Criteria:

i. Patients who were diagnosed with distant metastasis at presentation. ii. Patients treated palliatively at first presentation iii. Patients presenting with recurrent disease who don't meet all the eligibility criteria above

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