cyrilzakka/clinical-trials huggingface dataset:
Validation of Patient E-tool to Measure Systemic Lupus Activity

Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

Systemic Lupus Erythematosus (SLE) is a rare and chronic autoimmune disease. Disease activity (DA) is marked by remissions, spontaneous relapses or induced by therapeutic modifications. SLE exposes to serious complications requiring close medical follow-up, but flares cannot be predicted and often do not coincide with medical consultations. SLE DA is measured during a consultation using the SLEDAI tool, but cannot be completed by patients. There is therefore high at stake to develop tools allowing patients to measure DA, predict flares and subsequently tailor the medical follow-u to each patient. Using the same framework as a previous nationwide study related to COVID-19 impact (EPICURE survey), we aim to develop and validate, in collaboration with the French national Lupus Reference Centers and Hometrix Health, a patient-tailored tool (SLEDAI-P/LUPIN).

SLEDAI-P/LUPIN was designed by expert lupulogist and patients. It is available as a paper questionnaire and a smartphone app. It consists of simple patient-oriented questions allowing numerical score calculation. In order to validate the SLEDAI-P/LUPIN, we will recruit 500 SLE patients who satisfy the 2019 ACR/EULAR classification criteria. All patients will complete the self-questionnaire and have a follow-up consultation with a clinician within 7 days. The validity of the SLEDAI-P self-questionnaire will be assessed by calculating the correlation between SLEDAI-P/LUPIN and the clinical SLEDAI-2K provided by the clinician (blindly of the SLEDAI-P/LUPIN results). We will also collect information about the quality of life via the SF-36 questionnaire to evaluate if the SLEDAI-P/LUPIN predicts patient-reported outcome measures.

The results of this survey will permit the validation of the SLEDAI-P/LUPIN as a self-questionnaire carried by the patient.

The development of self-administrated disease activity questionnaires such as the SLEDAI-P/LUPIN may allow to better tailor the treatment and follow-up of SLE patients, and empower SLE patients for the control and management of their disease.

Eligibility Criteria:
Inclusion criteria:

Clinical diagnosis of systemic lupus Patient residing in Metropolitan France or in the french Ultra-Marine Departments and Territories Patient who has both completed the SLEDAI-P/LUPIN, SF-12 and been assessed by a specialist via the SLEDAI-2K within 15 days

Exclusion criteria :

Non-lupus patient/participant Patient residing outside France Patient who has not completed the SLEDAI-P/LUPIN OR has not been assessed by a specialist via the SLEDAI-2K within 15 days
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

Oxygen has been used in the care of small and sick newborn babies for over 60 years. However, to date there has been no reliable evidence to guide clinicians regarding what is the best level to target oxygen saturation in preterm infants to balance the four competing risks of mortality, lung disease, eye damage and developmental disability.

Five high quality randomised controlled trials are now underway assessing two different levels of oxygen saturation targeting (USA - SUPPORT; Australia - BOOST II; New Zealand - BOOST NZ; UK - BOOST II UK; Canada - COT). The value of these gold-standard trials can be further enhanced when, with careful planning, they are synthesised into a prospective meta-analysis (PMA). A PMA is one where trials are identified for inclusion in the analysis before any of the individual results are known.

We have established the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration, comprising the investigators of these five trials and a methodology team. The trials are sufficiently similar with respect to design, participants and intervention and, with planning, will have enough common outcome measures to enable their results to be prospectively meta-analysed. Together they have a combined sample size of almost 5000 enrolled infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants \< 28wks gestation

Exclusion Criteria:

* Infants \> 28wks gestation
Molecular Signatures of Cutaneous Dupilumab Response

This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7

Exclusion Criteria:

1. Known pregnancy
2. Known immunodeficiencies
3. Known parasitic infection -
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

This study is a randomized controlled trial of electroacupuncture (referred to as EA) versus sham acupuncture (referred to as EA) as effective treatments for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain in cancer survivors.

During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

Eligibility Criteria:
Inclusion Criteria:

* English-proficient men and women aged ≥18 years
* Free of oncologic disease by clinical examination and history
* Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
* Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia73
* Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
* Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week
* On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications
* Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments

Exclusion Criteria:

* Patients with a pacemaker or other electronically charged medical device
* Use of acupuncture for symptom management within the past 12 months
Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.

The suspension of vaccination resulted in girls receiving 3 doses (days 1, 60 and ≥180), receiving 2 doses (days 1 and ≥180), receiving 2 doses at days 1 and 60 due to incomplete treatment ("by default"), and receiving one dose by default. A first age and site-matched cohort of unvaccinated married women was recruited, starting in May 2012 to serve as the unvaccinated control group of women for the analysis of HPV incidence and persistence outcomes. A second age and site-matched (age and site matched to the vaccinated women undergoing screening) cohort of unvaccinated married women is being recruited starting in June 2017 and is to be used in addition to the first unvaccinated cohort for the assessment of the cervical neoplasia outcome.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy, ambulant girls aged 10 - 18 years
* Unmarried girls
* Girls with intact uterus
* Resident in the villages chosen for the study

Exclusion Criteria:

* Girls with any severe and/or debilitating illness
* Past history of allergy to any medication
DRy Eye Outcome and Prescription Study

The DRy eye Outcome and Prescription Study (DROPS) is a large observational multicentre study exploring the 'real world' effectiveness of artificial tears in dry eye disease and determinants of efficacy. The aim is to include at least 635 symptomatic dry eye patients who are prescribed artificial tears. All trainees and fellows in London are invited to become collaborators: collaborators are asked to consent patients, assess signs at baseline, and give patients questionnaires at baseline and 4 weeks (for home completion). In tandem, we are conducting a qualitative review of ophthalmologists' prescribing behaviours for dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 years and over) with symptoms\* of dry eye disease (with or without signs, with or without blepharitis) who start one or more artificial tears. \*Symptoms of dry eye disease include: foreign body sensation, dryness, irritation, itching, burning, stinging or grittiness. When signs are present, symptoms of visual disturbance such as poor vision and blurred vision are sufficient as a symptom of dry eye disease too
* must have best corrected visual acuity in at least one eye of at least 6/12.

Exclusion Criteria:

* lacks capacity (e.g. dementia)
* poor understanding of English
* active other apparent ocular surface disease (including conjunctivitis, abrasion, recurrent erosion syndrome, episcleritis, inflamed pingueculum or pterygium, tumour, infectious keratitis).
* immune ocular pathology (including scleritis and uveitis).
* recent (within the last 3 months) or planned ocular surgery or intravitreal injections.
* current use of other ocular medication, e.g. antiglaucoma drops, g ciclosporine.
* use of artificial tears or ointment in the last 1 month.
* gross lid abnormalities, including significant ectropion or entropion; facial nerve palsy; thyroid eye disease; trichiasis.

For the qualitative interview study:

Subject inclusion criteria

- London NHS Consultant with at least 6 months experience as a Consultant, with a special interest in Cornea and External Diseases, Accident and Emergency and Primary Care, or General Ophthalmology
The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.

The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.

Eligibility Criteria:
Inclusion Criteria:

* No previous history of any mental disorder meet the DSM-IV diagnosis
* aged 18-49 years old , men and women
* junior high school or higher education
* use of amphetamine-type substances time for more than one year
* cumulative use of amphetamines, substances dose of 50 grams or more.

Exclusion Criteria:

* Current or past had suffered neurological diseases
* exclusion of antisocial personality disorder and borderline personality disorder
* addicts in addition to other substances in tobacco , coffee, social drinking outside
* AIDS virus (HIV) detection positive patients .
Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

To establish the efficacy of a community-based POL (Popular Opinion Leader) intervention with two different trainings designed to increase COVID-19 vaccine and booster uptake and reduce hesitancy among social networks of Black individuals with rheumatic conditions. The investigators will also determine the structure and composition of the personal and outreach social networks of POLs.

Through community-academic partnerships in Boston and Chicago, investigators will recruit and randomly assign POLs who identify as Black with rheumatic conditions to two training arms in each city. Arms 1 and 2 will receive the same core curriculum addressing COVID-19 vaccine hesitancy, safety and efficacy. POLs will work in their communities to distributed information they learned in the trainings to members of their social network. The investigators will gather information about these social networks, assessing for differences in characteristics such as size, location, and who is in it (percentage of family, percentage Black, percentage with rheumatic conditions).

Eligibility Criteria:
Inclusion Criteria:

POLs:

18-85 years old; All genders; English-speaking; Self-identify as Black and/or African descent; Received ≥1 dose of a COVID-19 vaccine after 8.31.2022 (bivalent booster or updated COVID-19 vaccine \[2023-2024\] formula)

Social network members:

At least 18 years of age; All genders; English-speaking or Haitian Creole or Spanish-speaking if the POL also speaks Haitian Creole or Spanish; Not have received the updated COVID-19 vaccine 2023-2024 formula; Recent (within 3 months) COVID-19 infection and either undecided or no intention of receiving the vaccine.

Exclusion Criteria:

Both POLs and social network members:

Under 18 years of age Pregnant women Institutionalized or incarcerated Those who are up to date on COVID vaccinations
Sorbent Therapy of the Cutaneous Porphyrias

The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Four adults with proven EPP volunteered as subjects for this study. First period: Subjects received 1 gm colestipol twice daily for \~45 days, then 2 gm twice daily for \~45 days. Labs included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations \~monthly for 5-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult over age 21
* healthy

Exclusion Criteria:

* Intercurrent illness
* pregnancy
Optimizing Abiraterone Therapy

The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
* Age ≥18 years
* Feasible to collect blood samples from
* Life expectancy of \> 6 months
* Measurable disease
* Able and willing to give written informed consent prior to screening and enrollment

Exclusion Criteria:

* other anticancer therapies
* potent CYP3A4 inducers
* herbal medicine that could interfere with abiraterone exposure
GreenLight XPS Laser System Retrospective Chart Review

The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.

This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.

Eligibility Criteria:
Inclusion Criteria:

* Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.

Exclusion Criteria:

* Subject has had prior radiation.
* Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))
* Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)
* Subject has an artificial urinary sphincter
Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.

Methods:

This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.

Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Less than 70 years old
* Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:

  1. Hand pain, aching or stiffness most of the days during the preceding month
  2. Hard tissue enlargement of at least two of 8 selected joints \*
  3. Hard tissue enlargement of at least two distal interphalangeal joint
  4. Swelling of fewer than three metacarpophalangeal joint
  5. Deformity of at least one of 10 selected joints \* Patients have to fulfil criteria 1, 2 AND 3 + 4 OR 5 \* the 8 selected joints are the second and third distal interphalangeal joint and the second and third proximal interphalangeal of both hands Then confirm by experts' committee
* Exclusively symptomatic treatment
* For women of child-bearing age, use of an effective contraceptive method
* French spoken and read

Exclusion Criteria:

* Male gender
* More than 70 years old
* Hemochromatosis
* Inflammatory arthritis
* Cristal induced arthritis
* Active diseases such as infection or cancer
* Use of DMARDs
* Pregnant or breast-feeding woman
Breathing Exercises and Adhesive Capsulitis

The purpose of this study was to determine the effects of abdominal breathing exercises on pain, sleep quality and quality of life with adhesive capsulitis patients. The 41 adhesive capsulitis patients, 29 women and 12 men aged between 40-65 years, had divided into two groups by simple random sampling. In the study group, abdominal breathing exercise training was applied to routine physiotherapy program, in the control group routine physiotherapy program was applied for 8 weeks. Individuals were assessed for lung function test, range of motion, pain, sleep quality and quality of life. First assesment were performed at the beginning of treatment, 2nd assesment were performed at the end of 8 th week.

Pain in the early stages of adhesive capsulitis leads to many symptoms such as sleeping problems. Breathing exercises also began to take place among the applications towards pain. Abdominal respiration is considered the easiest method to reveal relaxation response. Slow breathing increases parasympathetic activity in the body and reduces sympathetic activity. This is the first and fundamental step of real healing. The reduction of pro-inflammatory markers with respiratory exercises suggests that respiratory exercises are effective in inflammation.

On study group; Hotpack was applied for 15 minutes and TENS was applied for 15 minutes and ultrasonics for 5 minutes. Then, scapular mobilization and passive stretching exercises were applied in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase joint range of motion by physiotherapist. Then abdominal respiratory exercise training was given 3 times a week as 30 sets of 3 times a week and patients were treated for 8 weeks.

For the control group; Hotpack was applied for 15 min and TENS was applied for 15 min and ultrasonics for 5 min. Then scapular mobilization and passive stretching exercises were applied for 8 weeks in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase joint range of motion by physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Those who have received an adhesive capsulitis diagnosis,
* Those in the age range 40-65

Exclusion Criteria:

* Those who take medicine for pain,
* Those with a primary sleep problem,
* Those with respiratory system disease,
* Those with cognitive problems,
* Non-volunteer