cyrilzakka/clinical-trials huggingface dataset:
A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).

This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.

Eligibility Criteria:
Inclusion Criteria:

* Lupus nephritis (LN) confirmed by biopsy
* Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
* Written informed consent

Exclusion Criteria:

- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses

The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

Cataract is affecting over 95 million people worldwide and remains the leading cause of vision impairment and blindness. Cataract surgery is an effective method for restoring visual acuity (VA). With the advancement of cataract surgery technique and intraocular lenses (IOL) technologies, expectations of patients from cataract surgery have good vision at distance and near ranges without using spectacles. The standard IOLs design were monofocal, which offered only fixed focal distance. One of the main factors for dissatisfaction after monofocal pseudophakic eyes is lack of accommodation. Previous studies demonstrated that this problem can be resolved by using diffractive trifocal IOLs. Diffractive trifocal IOLs provide effective near, intermediate and distance visual restoration, and has been widely used in patients who want to achieve spectacle independence after surgery. However, some possible optical side effects of trifocal IOLs have been reported, including halos and other dysphotopsias, reduced contrast sensitivity (CS), glare disability, which can significantly affect visual quality and patient satisfaction. The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent cataract surgery with trifocal intraocular lenses implantation in one or both eyes

Exclusion Criteria:

* Amblyopia
* Axial length (AL) over 25 mm
* Previous history of corneal or refractive surgery
* Ocular comorbidity (corneal scars, keratoconus, and corneal endothelial dystrophy, chronic or recurrent uveitis, macular degeneration, diabetes mellitus with retinal changes, glaucoma or intraocular pressure equal or higher than 24 mmHg)
* Patient inability to understand and/or fill in patient questionnaires
Evaluation of Therapeutic Effects of LED (627 +/- 10nm) The Initial Phase of the Ankle Sprains Treatment

The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm) with respect to the localized pain and local swelling of ankle sprains in the initial phase.

A variety of therapies for the treatment of sprains has emerged as they occur advances in technological applications. Therapy with coherent and non-coherent light is a treatment modality for a variety of musculoskeletal injuries. The main benefits certificates for phototherapy are the reduction of nociceptive processes, tissue remodeling, among others. The aim of the present paper is to analyze the changes caused by the use of LED (627 +/- 10 nm) with an energy density of 10 J / cm2 in 40 subjects divided into two groups (placebo and LED). All volunteers participating in this study had ankle inversion sprain grade II treated with the price technique. The study was performed in six days. And the results were verified by review of all individuals, through the Visual Analogue Scale (VAS) of pain, McGill Pain Questionnaire and Titrimetry. Measurements were performed at first, third and sixth day's of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Active individuals
* With medical referral
* With clinical diagnosis of inversion sprain grade II
* The day he suffered the injury
* Without prescriptions

Exclusion Criteria:

* Individuals who had previous trauma and orthopedic disorders such as fractures, tendinopathy, previous surgical procedure
* Other systemic diseases.
Homocysteine in Acute Coronary Syndrome

This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients

Cross sectional study to:

assess homocysteine level in young adult patients presenting with acute coronary syndrome

Eligibility Criteria:
Inclusion Criteria:

1. - The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features:

   1. Electrocardiogram (ECG) changes:

      * ST elevation
      * ST depression
      * T wave inversion
      * recent left bundle branch block
   2. Troponin T elevation (Norma value \< 0.06)

      2- Age: -Between 18- 40 years (Group A) - Age \> 40 years (Group B)

      Exclusion Criteria:
      1. Chest pain not consistent with acute coronary syndrome
      2. Chronic kidney disease (CKD)
      3. Rheumatic heart disease (RHD)
      4. Congenital heart disease
      5. Anemia
      6. Cancer
Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to \< 15 years with perennial allergic rhinitis will be evaluated compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* 6 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
* Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
* Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
* ALT \< 2xULN; alkaline phosphatase and bilirubin \<= 1.5xULN
* Average of 3TNSS is \>= 4.0 in the last consecutive 4 days prior to Visit 2.
* Completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to Visit 2

Exclusion Criteria:

* Has a seasonal pollen as an allergen
* A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
* Bacterial or viral infection of upper respiratory tract or eye
* Concurrent disease/abnormalities: Clinically significant uncontrolled disease
* Known hypersensitivity to corticosteroids or any excipients in the investigational product
* Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
* Use of the following medication and/or its combination drug within the specified time:

Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1

* Affiliation with Investigator's Site: Relative or employee
* History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
* Average of 3TNSS is \>= 8.0 in the last consecutive 4 days prior to Visit 2.
* Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Impact of Intestinal Microbiota on Uremic Toxins Productions

Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of TUs in patients not yet in dialysis. The dysregulation of the intestinal microbiota observed during CKD increases the generation of UTs in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of UTs and the comorbidities associated with CKD. Some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of UTs, but the effects remain unclear. In order to test the interest of probiotics during CKD, the investigators have, in collaboration with the Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. For this the investigators would need a collection of fresh stools. The fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on UTs production.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Non diabetic (fasting blood glucose \<1.26 g / L, or lack of insulin or oral antidiabetic treatment)
* BMI between 18 and 30 kg / m²
* Patient with CKD stage 4-5 ( eDFG \< 30 ml/min/1.73m2 CKD-EPI)
* Not dialyzed
* No history of kidney transplant
* Patient followed in the nephrology department of Pr FOUQUE at the Lyon Sud hospital center

Exclusion Criteria:

* Active inflammatory, infectious, cardiovascular or neoplastic disease
* Colectomy, resection of the small intestine or cholecystectomy
* Patient having received antibiotics, prebiotics, probiotics in the last 3 months.
* Patient using laxatives (more than 2 doses per day for the last 3 months)
* Known renal pathology or known urologic malformation (healthy volunteer only)
Dienogest for Treatment of Adenomyotic Uteri

Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.

Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-40 years
* Women with ultrasonographic evidence of adenomyosis
* Woman complains of vaginal bleeding or pelvic pain related to adenomyosis

Exclusion Criteria:

* Women with a history of malignancy or histological evidence of endometrial hyperplasia
* any adnexal abnormality on ultrasound
* undiagnosed vaginal
* contraindication to receive Vissane or gynera .
The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents

The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.

This study is designed as a single-center, crossover, randomized study. 70 high-school aged males aged between 15 and 18 years with a diagnosis of ADHD who are being treated pharmacologically using stimulants (such as Ritalin, Concerta, Vyvanse etc) will be recruited. The study will investigate motor performance using several motor function tests both with and without the influence of stimulant ADHD medications.

Participants will be assessed on two separate occasions, both sessions will occur during the morning in their regular school environment. During the sessions, participants will be randomized, 50% will be assessed one hour after taking their usual stimulant ADHD medication and the other 50% will be asked to postpone taking their usual stimulant ADHD medication until the session is finished. During the two separate sessions, all participants will be asked to perform the following motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility tests and 20 m shuttle run tests (beeps).

Eligibility Criteria:
Inclusion Criteria:

* High school male students
* Diagnosis of ADHD
* Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).

Exclusion Criteria:

* Students with concomitant chronic disease (including asthma, cardiac, motor, neurological and gastrointestinal disturbances)
* History of acute illness in the previous two weeks
* Any injuries that would inhibit the ability to exercise or play sport
* Students unable to obtain parental/guardian consent
* Students unwilling to participate
A Study of MRx-4DP0004 in Asthma

This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
* Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
* ACQ-6 score \>1.5 and \<=4
* FEV1 \>50% of predicted normal
* Following protocol specified contraception requirements.

Exclusion Criteria:

* Non-compliant with prescribed asthma maintenance treatment.
* At significant risk of exposure to a change in environmental sensitising substances during the study.
* Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
* Hepatitis B or C or HIV.
* GI fistula, feeding tubes or inflammatory bowel disease.
* GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.
* History of life-threatening asthma.
* Systemic corticosteroids within 6 weeks of first dose.
* Allergy to all of ampicillin, clindamycin and imipenem.
* Probiotic supplements.
* Immunosuppression or immunosuppressant medication.
* Use of ICS and LABA as Maintenance and Reliever Therapy.
* Smokers or nicotine users within 3 months of screening.
* Former smokers \>15 pack years.
* Systemic antibiotics within 6 weeks of first dose.
* Clinically significant haematology and serum biochemistry.
* Sensitivity to any constituent of IMP.
* Diastolic blood pressure \<45 or \>90, systolic blood pressure \<95 or \>155mmHg, Pulse rate \<40 or \>100 bpm.
* Clinically significant ECGs or structural cardiac abnormalities.
* Any other condition that may interfere with primary objective.
* Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP
Pronase Granules in Gastric Cleaning

Magnetically controlled capsule endoscopy (MCE) is now widely used all over the world. However, the standard gastric preparation method by dimethicone we used clinically still has mucus at the bottom of the stomach. In this study, we aimed to determine whether pronase granules is helpful to improve the cleanliness of gastric mucosa in MCE.

As a non-invasive and well-tolerated gastrointestinal examination method, magnetically controlled capsule endoscopy (MCE) is being increasingly used in different populations in recent years. Gastric preparation is extremely important for the completion rate (CR), image quality, and diagnostic efficiency because of the plica of gastric mucosa and the autonomous movement of the capsule in the gastrointestinal tract. After a series of explorations including air-producing powder, defoamer, protease preparation, patients are asked to drink about 800 ml-1000 ml water in a short time for standard gastric filling. However, the existing problems of gastric preparation such as abdominal distension, insufficient gastric filling, and long gastric retention time deserve attention. Different from the results of Zhu et al. (DLD, 2017), the current clinical experience shows that the addition of pronase granules in gastric preparation can often reduce the mucus in the stomach. But the standardized use of pronase granules remains to be further explored.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese People's Liberation Army General Hospital after January 2020.
3. Able to provide informed consent.

Exclusion Criteria:

1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation;
2. congestive heart failure, renal insufficiency, use of anticoagulant medication,
3. implanted metallic devices such as pacemakers, defibrillators, artificial heart valves or joint prostheses (although the low magnetic field used technically should not interfere with such devices);
4. pregnancy;
5. currently participating in another clinical study.
6. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
7. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
8. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
9. The patient's basic information in the database is incomplete#
10. Patient fail to be followed up.
Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
* Age ≥20 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Adequate Liver and Renal Function

Exclusion Criteria:

* Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
* Any past or current CNS involvement, including leptomeningeal leukemia
* Extramedullary disease only
* Major surgery or radiotherapy within 14 days prior to registration
* History of clinically significant or uncontrolled cardiac disease
* Patients with active, uncontrolled bacterial, fungal, or viral infection
* Recent or ongoing clinically significant GI disorder
* History of another malignancy within 5 years prior to registration
* Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
* Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
* Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
* Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
* Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments

Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A\&E) Departments of hospitals. This is often the case for those in hard to reach groups, who are also those often at highest risk of TB. This study seeks to assess whether A\&E Departments are effective sites for the identification and onward management of TB, both in its latent and active forms.

This proposal is focused upon early diagnosis, referral and treatment of active tuberculosis, which has two key components: 1) ensuring optimal outcome for individuals; 2) contributing to disease control in public health terms by preventing further spread.

A\&E Departments are an important point of testing and referral for the client group that constitute those at greatest risk, as for many this will be their only interaction with the health service. Currently, A\&E Departments contribute about 20% of those diagnosed with TB. The majority of these individuals are most likely to have presented with symptoms indicative of disease, compared to those attending for other reasons who would have been unlikely to have been tested or referred.

This study will seek to evaluate specific measures currently being undertaken by Public Health England and the NHS to control TB as well as investigate whether case finding for active TB in A\&E departments would improve TB control. The economic impact of these interventions will be evaluated, providing a measure of its value for money.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals 16 years or older, who are new entrants from high incidence countries who have arrived in the UK within the past 2 years or those born in high incidence countries who entered the UK more than five years ago, but have spent more than one year (cumulative) in the past five years in a high incidence country.
2. Those with social risk factors who have signs and/or symptoms of TB.

Exclusion Criteria:

1. Individuals who are under 16 years
2. Individuals who were born in the UK or a low incidence countries and do not have risk factors