cyrilzakka/clinical-trials huggingface dataset:
Tapinarof for Cutaneous Lupus Erythematosus

We hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to improvement of cutaneous lupus lesions. To test this hypothesis, we will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. This trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical AHR agonist application. The goals are to 1) identify if topical AHR agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical AHR agonist treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patients with a histopathological or clinical diagnosis of chronic and/or subacute CLE
* Patients with at least one active cutaneous lupus lesion with a diameter ≥ 1cm and CLA-IGA-R score of ≥ 3 at screening and baseline

Exclusion Criteria:

* Unwillingness or inability to complete informed consent process or comply with the study protocol
* Patients who are pregnant or breast-feeding
* Other dermatologic diseases whose presence or treatments would interfere with evaluation of the study drug or interpretation of participant safety or trial results
* History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the study drug
* Application to cutaneous lupus lesion(s) being assessed of topical corticosteroids, topical calcineurin inhibitors, or topical janus kinase inhibitors within 1 weeks of study drug initiation
* Application to cutaneous lupus lesion(s) being assessed of topical tapinorof within 4 weeks of study drug initiation
* Prior use of anifrolumab within the last 6 months
* New initiation of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 12 weeks of study drug initiation
* For patients already on the following treatment(s) prior to enrollment: unstable or changing of dosing of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 4 weeks of study drug initiation
* Patients with active infections.
Airway Inflammation in Swimmers

Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the airways of elite athletes might differ from the inflammation seen in the airways of "ordinary" asthmatics and it might represent a different kind of asthma.

The primary purposes are

1. To investigate the type of airway inflammation in young swimmers.
2. To investigate the acute changes in airway inflammation after a short training session.


Eligibility Criteria:
Inclusion Criteria:

* Swimmer

Exclusion Criteria:

* Current smoker or more than 3 pack-years
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
* With a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, MET fusion)

Exclusion Criteria:

* Active infection including tuberculosis and HBV, HCV or HIV
* Known active or untreated CNS metastases
* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
* Participants with serious cardiovascular or cerebrovascular diseases
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.

Treatment:

* RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
* RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
* RSV mRNA / LNP 1 at 1 dose or,
* hMPV mRNA / LNP 1 at 1 dose

Study duration per participant is approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

-Informed consent form (ICF) has been signed and dated

Exclusion Criteria:

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

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Routine Follow up After Total Hip Arthroplasty Prior Periacetabular Osteotomy

Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome.


Eligibility Criteria:
Inclusion Criteria:

* PAO and THA

Exclusion Criteria:

* time since THA less than 4 yrs
Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects

To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine


Eligibility Criteria:
Inclusion Criteria:

- All participants in the study should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy), which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland)
* Use of any drugs that might influence the results of the trial (within one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL, within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance
Masticatory Muscles Electromyography in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders

The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.

It has been demonstrated by a previous study that a strong relationship exists between forward head posture and temporomandibular disorders and that individuals with forward head posture and temporomandibular disorders exhibit alterations in masticatory muscle electromyographic activity either as a result of the disorder itself or due to a compensatory mechanism associated with the symptoms of temporomandibular disorders . As a consequence, the aim of the study was to evaluate the electromyographic activity of the masticatory muscles in post-pubertal females with forward head posture and temporomandibular disorders as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 17 to 22 years.
* Body mass index ranging from 18 to 25 kg/m2.
* Having a normal menstrual cycle.
* Spending four to six hours per day with bad posture on computer, laptop or smart phones.
* Fully dentate subjects.

Exclusion Criteria:

* Having dental loss, acquired dental anomalies, current use of dental prostheses, malocclusion, sleep bruxism.
* Having inflammatory diseases of the face or jaw, fibromyalgia, or any fractures or surgeries in the orofacial or neck areas.
HAE Burden and Crisis Management

The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives.

The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

For the patient population:

1. Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.
2. Aged ≥12 years
3. Having consulted for HAE in the last 3 months and with a medical file.

For the caregiver population:

1. A person identified by the patient as part of their support group and who provides support with the management of the patients HAE (including family members, friends, spouse, etc.)

Exclusion Criteria:

For the patient population:

1. Opposes to participating in the study.
2. Patients is under guardianship or deprived of their liberty.
A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
* Are a candidate for phototherapy and/or systemic therapy.
* Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
* Have ≥10% body surface area (BSA) involvement at screening and baseline.
* If a male, agree to use a reliable method of birth control during the study.
* If female, agree to use highly effective method of contraception.

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
* Have a history of drug-induced psoriasis.
* Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
* Use of tanning booths for at least 4 weeks before baseline.
* Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept \<28 days; infliximab, adalimumab, certolizumab pegol, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent (e.g., ustekinumab) \<5 half lives.
* Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
* Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
* Have had a live vaccination within 12 weeks of baseline.
* Have a known allergy or hypersensitivity to any biologic therapy.
* Have had any major surgery within 8 weeks of baseline.
* Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
* Are women who are pregnant, or who are lactating (breast-feeding).
RINEW Randomized Controlled Trial 7-year Follow-up

This study is designed to evaluate the impact of the RINEW multicomponent early child development intervention on child development and risk factors for poor child development in middle childhood. This study is a follow-up assessment of the children and primary caregivers enrolled in the RINEW cluster randomized controlled trial approximately 6 years following intervention completion.


Eligibility Criteria:
Inclusion Criteria: Child's primary caregiver was enrolled in the RINEW cluster randomized trial
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome \[PCOS\] subjects).


Eligibility Criteria:
Inclusion Criteria:

* Married infertile women at the age of 21-38.
* BMI\<28kg/m2.
* According to the detection level of serum estradiol (E2), prolactin (PRL), progesterone (P), testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH), subjects were diagnosed of WHO class II anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and FSH\<10IU/L.
* Bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. If the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. If it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed.
* Vaginal B-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma\<4cm, and does not affect the endometrial function.
* Two examinations of spouse semen are normal within six months, or comply with the IUI standard.
* No history of drug abuse.
* Voluntarily sign the informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol.

Exclusion Criteria:

* The subject use gonadotropin therapy within the past three months (regardless the result of treatment).
* The uterine factors affect pregnancy and other tumors.
* Pregnancy contraindication, such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency.
* Obscure vaginal bleeding.
* Subjects are allergic to the application of FSH/HMG and HCG in the past.
* Other conditions that the researchers think they are not suitable for the clinical trials.
Study of HST5040 in Subjects With Propionic or Methylmalonic Acidemia

This is an interventional study to assess the safety, PK, and efficacy of HST5040 in 12 subjects - 6 with Methylmalonic Acidemia (MMA) and 6 with Propionic Acidemia (PA). The study consists of 3 parts:

* Part A: Open-label, within-subject, dose escalation study in PA and MMA subjects ≥ 2 years old to identify a safe and pharmacologically active (optimal) dose of HST5040 for use in Part B. Subjects will continue in a Part A open-label extension until all subjects complete Part A and the optimal dose of HST5040 is identified for use in Part B.
* Part B: 6-month, randomized, double-blind, placebo-controlled, 2-period crossover in the same subjects from Part A to evaluate safety and efficacy of the optimal dose of HST5040 in addition to standard of care (SoC).
* Part C: open-label long-term extension study in PA and MMA subjects ≥ 2 years old (N = approximately 12, 6 each) to evaluate the long-term safety and efficacy of the optimal dose of HST5040.

This study will determine whether HST5040 can improve levels of disease-associated toxins that accumulate in patients with PA and MMA.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of symptomatic PA or MMA (Mutase)
* Ages ≥ 2 years old.
* History of Inadequate metabolic control while receiving standard of care (SoC).
* Plasma MCA concentration \> 3x upper limit of normal of the reference range at screening.
* Stable supplementation dose of carnitine for at least 1 week prior to the entry in the study.

Exclusion Criteria:

* Moderate-to-severely impaired cardiac function with LVEF \< 45% by ECHO.
* Clinically significant arrhythmia by Holter monitor.
* QTcF \> 450 msec
* Moderate to severe chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2.
* Exposure to any investigational therapy, apart for a COVID-19 vaccine, within the past 6 months prior to study entry.
* Exposure to gene therapy for PA or MMA at any time prior to study entry.
* History of organ transplantation (Part A and B only)
* History of severe allergic or anaphylactic reactions to any of the components of HST5040.
Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure

Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).

Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may become inappropriate in these patients, increasing myocardial oxygen demand and decreasing diastolic filling time and might lead to hemodynamic deterioration, ventricular dysfunction (tachycardiomyopathy) and clinical deterioration.

Studies show the elevated HR is a predictor of poor prognosis in DHF. Subanalyses of large clinical trials using beta blockers (BBs) demonstrate the adequate control of HR correlates with a better outcome in patients with stable chronic heart failure (HF). However, use of BBs in patients with DHF is limited due to negative inotropic and hypotensive effects of these drugs.

As alternative to BBs, ivabradine has shown to increase survival of patients with chronic stable systolic HF. Compared to BBs, ivabradine has the advantage of "pure" negative chronotropic effect, no effect on myocardial contractility or peripheral vascular resistance. Despite the inhibition of I (f) has been validated as a therapeutic option in patients with stable HF, there are no studies available on this strategy in patients with DHF.

We hypothesized that HR control by ivabradine might improve clinical, hemodynamic and neurohormonal parameters in patients with DHF. The aim of this study was to evaluate the efficacy of HR control with ivabradine in patients with DHF.

Eligibility Criteria:
Inclusion Criteria:

* Sinus node rhythm
* HR\> 80 bpm
* Hospitalization for DHF
* Ejection fraction ≤ 40%
* Sign informed consent

Exclusion Criteria:

* Systolic blood pressure \<85 mmHg
* Signs of hypoperfusion
* Dobutamine\>15 mcg/Kg/min
* Acute myocarditis
* Primary valvular disease requiring surgery
* Stroke in the last three months
* Hypertrophic or restrictive cardiomyopathy
* Sinus node disease
* Atrial fibrillation or flutter
* Second or third degree atrio-ventricular blockade
* Long QT syndrome
* Severe pulmonary disease
* Pulmonary embolism in the last three months
* Need for invasive ventilatory support
* Septicemia or septic shock
* Hepatic failure
* Creatinine \> 2.5 mg/dL
* Hemodialysis
* Advanced malignancy
* Pregnancy or lactation
* Immunosuppressive therapy
* Use of cytochrome P450 inhibitors
Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of stage III-IV periodontitis.
* Completed steps I-II periodontal therapy.
* FMPS \<15% at 3-month re-evaluation.
* FMBS \<15% at 3-month re-evaluation.
* At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.
* Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).
* Signed informed consent.

Exclusion criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
* Pregnant or nursing women.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.