cyrilzakka/clinical-trials huggingface dataset:
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2022 guidelines for at least 3 months prior to randomization.
2. Participants who are either:

   * Currently untreated
   * Treated with daily maintenance ICS or ICS/LABA
3. ACQ-6 score ≥1.5 at randomization.
4. Participants must be able to complete the study questionnaires.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Recent history of life-threatening asthma
2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
3. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
5. Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization.
6. Ongoing need for biologic therapy or recent use of a biologic therapy
7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
11. Participants with a history of hypersensitivity to any of the study medications
Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

The purpose of this study is to test whether disease-related expressive writing is effective in the treatment of Irritable Bowel Syndrome (IBS).

Expressive writing involves writing about traumatic, stressful or emotional events. Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, and pain. Given its simplicity, and obvious advantages in terms of cost efficiency, expressive writing appears to have great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in irritable bowel syndrome (IBS), a common gastrointestinal condition, which is lacking well-defined etiology or treatments and is best understood in a biopsychosocial context.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

* Non-English Speakers
Corneal Crosslinking in Keratoconus and Corneal Ectasia

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus with documented progression over the previous 12 months.
* Diagnosis of corneal ectasia
* Must be able to complete all study visits.

Exclusion Criteria:

* Prior corneal surgery in keratoconus group
* Corneal scarring
* Pregnancy
Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder

Clinical preventive services (CPS) are fundamental to early disease detection and improvement of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder is a web-based tool developed by the Office of Disease Prevention and Health Promotion (https://healthfinder.gov). This study tests the "prescription" of myhealthfinder to engage patients in CPS, improve patient-clinician communication and increase uptake of CPS.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled wellness appointment with primary care provider

Exclusion Criteria:

* Inability to read English
Impact of Local Biopsy to the Endometrium Prior to Controlled Ovarian Stimulation on Clinical Pregnancy

In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.

They are possible mechanisms by which endometrial sampling may increase receptivity and improve clinical pregnancy rate of IVF-ET. First, local injury to proliferative phase endometrium might induce the decidualization of the endometrium, and increase its implantation rate. Second, local injury to the endometrium might provoke the wound healing, involving a mass secretion of different cytokines and growth factor, which are beneficial for embryo implantation. Last, the injury might make the endometrium maturation.

This study proposes to evaluate the efficiency of an endometrial injury in the first controlled ovarian hyperstimulation cycle on the rate of clinical pregnancy, in assisted reproductive technologies. This study will compare 2 groups of patients. The first group will undergo biopsy of the endometrium before the IVF; the second will undergo the IVF alone. Inclusions will be conducted on 33 months; the patients will be in the study for a period of 36 weeks. The total duration of the study is 39 months

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary infertility
* first or second IVF attempt
* aged ≥18 and ≤38 years
* regular menstrual cycles
* FSH≤ 12IU/L
* Informed consent signed

Exclusion Criteria:

* ovocyte donor
* pathology of the uterus or annexes
* Body mass index (BMI)\> 35
* ongoing vaginal infection
* undetermined vaginal bleeding
* contraindication to the Cornier pipette or to these treatments : Gonal F®, Puregon®, Ovitrelle®, Utrogestan®,
* women included in another study on medically assisted procreation
* any administrative or legal supervision
The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

Genital erosive lichen planus (GELP) is a chronic inflammatory disease causing painful genital sores and scarring in women. Treatment options are limited and often unsatisfactory. This trial will study the effects of treatment with apremilast and quality of life and sexual function in women with GELP.

Genital erosive lichen planus (GELP) is a chronic, inflammatory and scarring genital disease. The disease may have a significant impact on daily living, quality of life and sexual function. There is a considerable lack of high-quality evidence on treatment options for GELP and few effective therapeutic facilities available in current clinical practice.

The aims of this study are to investigate clinical and immunohistochemical effects of a new oral anti-inflammatory treatment, apremilast, for women with moderate-to-severe GELP in a double-blinded, randomized, placebo-controlled trial (RCT). Apremilast is an inhibitor of phosphodiesterase 4 (PDE4) with documented effect in several inflammatory skin diseases, but it has not yet been studied in patients with GELP. The drug dose and study design have been chosen based on relevant experience from other studies on apremilast, and is equivalent to the dose used for approved indications (chronic plaque psoriasis and psoriatic arthritis).

The main objective of this trial is to assess the efficacy of apremilast in the treatment of GELP in women.

Secondary objectives include

* Description of immunohistochemical changes in lichen planus lesions
* Assessment of safety of apremilast in the treatment of GELP
* Assessment of quality of life and sexual function

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory
* Informed consent from the patient to the protocol and clinical procedures.

Exclusion Criteria:

* Patients receiving other systemic immune modulating therapy
* Concomitant use of strong CYP3A4 enzyme inducers
* Inadequate birth control, pregnancy and/or breast-feeding
* Depression and suicidal ideation
* Patients with severe renal impairment
* Patients with active tuberculosis, serious infections or cancer
* Unexplained and clinically significant weight loss in underweight patients
* Hypersensitivity to the active substance(s) or to any of the excipients
* Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial
Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer

The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying hidden metastasis, and assessment of treatment responses in clinical oncology. Although there are important studies suggesting potential associations between PET-based parameters and oncologic outcomes, the calculation and official documentation of individual PET-based parameters might not be routine in clinical practice because these processes usually require time- and labor-consuming processes for the radiologists. In this study, the investigators prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in pancreatic cancer and compare oncologic outcomes between the types.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for radical pancreatectomy due to pancreatic cancer without neoadjuvant treatment
* Age between 20 years old and 80 years old
* General performance status greater than 70
* Results of peroperative PET-CT available

Exclusion Criteria:

* Unresectable, locally advance and metastatic pancreatic cancer
* Patients not wanting operation
* ASA score of greater than 3
* History of chronic alcoholism ot drug abuse
* Lack of patient compliance
* Patients not agreeing to enroll in the study.
* Patients unable to understand and sign the study agreement.
* History of neoadjuvant treatment
Use of Corticosteroids in Children With Cellulitis

The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.

Cellulitis is a common skin and soft tissue infection in the pediatric population.

Although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. Using corticosteroids during antibiotic treatment may reduce inflammation and length of stay.

Objective: to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis.

Patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. It will include children aged 1 month to 18 years, admitted due to cellulitis. Once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. Considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Children Aged 1 month to 18 years
* Hospitalized due to cellulitis
* Patients who have given their written informed consent to participate

Exclusion Criteria:

* Skin chronic diseases
* Immunodeficiency (primary or acquired)
* Chronic use of systemic corticosteroids
* Sepsis
* Varicella
* History of adrenal insufficiency
* Pregnancy or breast feeding
* Uncontrolled diabetes mellitus
* Known hypersensitivity to systemic or topical corticosteroids
* Patient undergoing immunosuppressive therapy for another disease
* Participation in another drug biomedical research
* Any other contraindication for treatment with corticosteroids
Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease

Crohn's disease exclusion diet (CDED) is a whole-food diet coupled with partial enteral nutrition. The main objective of this trial is to assess whether CDED is superior to corticosteroids, in terms of endoscopic response, in patients active CD. The primary endpoint is endoscopic response at week 16, without corticosteroids or further therapeutic intervention, assessed by a centralized, anonymous and blinded, double lecture panel of panenteric PillCam Crohn's Capsule. This is a multicentre, open-label, comparative, randomized, 2:1, controlled, single-blind, superiority trial. Patients included are aged 16 to 70 years, have mild to moderate, luminal, active CD, and have active endoscopic lesions. Eighty patients will be randomized between CDED (n=56) and corticosteroids (n=24) in centres in France, Israel and the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 to 70 years,
* With mild to moderate, luminal, active CD, defined by a CDAI of 150 to 350,
* Involving the small bowel, and/or the colon
* Not treated with corticosteroids at baseline
* Patent small bowel as assessed by the patency capsule
* Active endoscopic lesions, as defined by Lewis score ≥ 225 in the small bowel and/or SES-CD≥ 4 in the colon. The eligibility of the patient will be determined by the site investigator and a central reader.
* Informed consent to participate in this study. In patients from France and Israel who are aged less than 18: parents' informed consent to participate in this study (parents' agreement is not required in patients aged 16 to 18 in the Netherlands)
* Affiliation to social security or any health insurance

Exclusion Criteria:

* Inability to follow the CDED during 16 weeks.
* Prior intolerance to corticosteroids.
* Ongoing infections, evolving virus diseases.
* Live vaccines.
* Psychotic state not controlled by treatment.
* Arthritis or uveitis as main presenting symptoms.
* Patients with severe and/or predominant rectal or perianal disease.
* Heavy smokers (more than 10 cigarettes per day).
* Infliximab, adalimumab, methotrexate or azathioprine initiated less than 3 months before inclusion in this trial.
* Vedolizumab, ustekinumab initiated less than 6 months before inclusion in this trial.
* Change in methotrexate, azathioprine, infliximab, adalimumab, vedolizumab or ustekinumab dosage less than 3 months before inclusion.
* Pregnant or lactating women.
* Patients already included in a biomedical research other than an observational study (e.g. registry, cohort, biobank).
* Severe pubertal delay (Tanner 1 or Tanner 2) and/or height velocity z-score \< 2.5 and/or Bone mineral density z-score (hip or lumbar spine) \<2.5.
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)
Enhancement of Physical Fitness in Older Adults

Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.

The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.

The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.

The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.

Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.

Main parameters are: physical fitness, nocturnal cramp severity and frequency.

Eligibility Criteria:
Inclusion Criteria:

* For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
* The participants had to agree to the study protocol and complete the program.
* After eligibility was verified, written informed consent was obtained.

Exclusion Criteria:

* Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.
Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70 causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85% of patients with some subtypes of CMT. These cramps impact quality of life and have been identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of effective therapy for muscle cramps.

This study will provide data on the short term efficacy of oral mexiletine in helping to prevent muscle cramps in adults with CMT. The study will also assess the short-term safety and tolerability of low dose mexiletine in adults with CMT.

Eligibility Criteria:
Inclusion Criteria:

* The subject has known CMT, previously diagnosed by a neurologist with subspeciality expertise in neuromuscular disorders/peripheral neuropathy. The diagnosis of CMT relies on a combination of clinical history (including family history), neurological examination electrophysiological features, and prior genetic testing results.

  * The subject is at least 18 years old, and has signed the Informed Consent Form.
  * The subject is ambulatory (cane, walker, orthoses allowed).
  * The subject has experienced muscle cramps and has known provokable hamstring or calf muscle cramps on MVC.
  * The subject has a reliable method of birth control (if a female subject of child bearing potential). Reliable birth control is defined as Hormonal contraception Intrauterine contraception/device Any two barrier methods (combination of male or female condom with diaphragm sponge or cervical cap) together with spermicidal foam/gel/film/cream/suppository True abstinence

Exclusion Criteria:

* The subject has a known neuropathy from another source (e.g., diabetes, drug induced, alcohol, etc.).

  * The subject has an untreated medical disorder known to predispose to muscle cramps
  * The subject is pregnant or nursing, has a known mexiletine allergy or has taken mexiletine in the past 12 weeks.
  * The subject is participating in another therapeutic trial.
  * The subject has second or 3rd degree heart block, atrial flutter/fibrillation, ventricular arrhythmias, or is receiving treatment of a cardiac arrhythmia.
  * The subject is currently taking another agent for muscle cramps or a muscle relaxant (e.g., benzodiazepine, baclofen, tizanidine, soma, meprobromate).
  * The subject is on another sodium channel blocker or medication that precludes administration of mexiletine.
  * The subject has known diabetes mellitus, liver or kidney disease requiring ongoing treatment, untreated thyroid dysfunction, symptomatic cardiomyopathy, or symptomatic coronary artery disease.
  * The subject, in the opinion of the investigator, is unsuitable for enrollment for any other reason
Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo

To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, aged 18 through 45 years, inclusive
* Currently sexually active
* If female, non pregnant and agree to use acceptable for of contraception during
* If male, be sterile or have partner use contraception.

Exclusion Criteria:

* Have sexual dysfunction
* Have history of diagnosis or treatment of any disorder related to sexual functioning.
* Clinically significant disease state, in the opinion of the examining physician, in any body system
* History of alcohol or other substance abuse or dependence within the previous 5 years
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear

Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.


Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 60 years of age
* free of any medical condition that might be exacerbated by physical testing
* patients: major thickness supraspinatus tear
* control subjects: no history of significant injury or pathology in either upper limb

Exclusion Criteria:

* contraindication to undergoing MRI
* history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, Parkinson's, or spinal cord injury, or being confined to a wheelchair)