cyrilzakka/clinical-trials huggingface dataset:
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
* Aged between 18 and 75 years (both inclusive)
* Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
* Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria:

* A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
* An active or latent tuberculosis
* Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
* A known significant cardio-vascular disease
* Vaccination against live virus or bacteria within 4 weeks prior to randomization
* The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
* A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
* Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases.

The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

Peri-implant infections (mucositis and peri-implantitis) depict an increasing focus in dental practice and implantology. mean prevalence of mucositis is of 43% and periimplantitis of 22%. Consequences for the implant without successful treatment range from local reversible inflammation (mucositis) to implant loss (periimplantitis). These lead to functional, social and esthetic prejudices for patients. The main factor for establishment of peri-implant infections is the formation and maturation of the bacterial biofilm. Peri-implantitis and mucositis treatment require the removal of the bacterial biofilm and the disinfection of the implant surface. Because of special surface conditions and structures, it is more difficult to remove bacterial biofilms from implant surfaces than teeth. the key to controlling the inflammation due to the bacterial biofilm is to prevent its installation and progression. The procedure tested in this study is an air abrasion device, the Air-Flow Master Piezon® with erythritol and chlorhexidine powders on implants presenting clinical and radiographic signs of mucositis and peri-implantitis along with renewal of local oral hygiene instructions in order to reduce the inflammation locally by disorganizing and eliminating the biofilm. Follow-up of the patients will be held every 2 months for 6 months by scoring the bleeding on probing, the plaque index and measuring clinical attachment level in order to compare it with the initial measure. At 6 month an X-ray will also enable to compare bone level and mineralization. This initial study will help establish a standardized protocol for peri-implant infection management.

Eligibility Criteria:
Inclusion Criteria:

* adult patients,
* possessing one or more implants prosthetically engaged with local peri-implant mucosa inflammation assessed by bleeding on probing
* affiliated with a social security scheme

Exclusion Criteria:

* patients with implant mobility or implants associated with vestibular cellulitis
* not available patients for the follow-up visits
* patients with known allergy to erythritol and/or Chlorhexidine powder
* patients with chronic bronchitis
* patients with asthma
* patients with endocarditis
* patients with contagious disease
* patients with immunodeficiency
* patients under radiotherapy and/or chemotherapy and/or antibiotics
* not mastery of plaque control on the part of the patient (after education)
* subjects under legal protection
* pregnant or breastfeeding women
A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor.

To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor.

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A, Inc.) to Ketoconazole Shampoo, 2% (Reference Standard) and both active treatments to a placebo control in the treatment of tinea versicolor.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 18 years
2. Subjects must have provided IRB approved written informed consent.
3. Subjects must have clinical diagnosis of tinea versicolor.
4. Subjects must be willing to refrain from using all other tinea versicolor medications or antifungals during the study, other than the investigational product.
5. Female Subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.

Exclusion Criteria:

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. Subjects with a history of hypersensitivity or allergy to ketoconazole, other imidazole antifungals, and/or any of the study medication ingredients.
3. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of tinea versicolor (e.g., vitiligo, pityriasis alba, post inflammatory hypopigmentation and hyperpigmentation, seborrheic dermatitis, pityriasis rosea, guttate psoriasis, tinea corporis, nummular eczema, secondary syphilis, confluent reticulated papillomatosis of Gougerot and Carteaud, and mycosis fungoides).
4. Treatment for tinea versicolor within the past 6 months that had been unresponsive to prescription topical or oral antifungals.
B Cell Functions in Periodontitis

The inflammatory response involves many players from the immune response, including B lymphocytes. These cells are responsible for the synthesis of immunoglobulins in response to the presence of an antigen. They are characteristic of chronic inflammation. There are several subsets of B cells characterized by specific membrane markers. Once activated, these cells express many factors contributing to tissue destruction seen in periodontitis and particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-B ligand, tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and Monocyte Chemoattractant Protein-3).

During the establishment of a periodontal disease, an important inflammatory infiltrate is observed in the gum. This infiltrate is characterized by the presence of many B lymphocytes. B cell subsets in the blood and the gum of patients with periodontitis have been little studied. However, the number of autoreactive B cells (cluster of differentiation (CD)19+, CD5+) has been reported to be higher in the blood of patients with periodontal disease. In the gum, the rate of B and T cells increases with the level of inflammation and is correlated with the severity of the inflammatory process. Activation of B cells is a prerequisite for the progression of gingivitis to periodontitis. B cell distribution could then be an indicator of disease progression, but also allow to study the response to treatment.

The aim of this pilot study is to characterize B cell subsets in the blood and the gum of patients with periodontitis, according to disease activity. Analysis of B cells in the blood could highlight the association of a particular subpopulation with aggressive periodontal disease and evidence a particular biological profile of the host response. The investigators also wish to observe the evolution of this phenotype following an unconventional surgical therapy.

This study would better understand the pathogenesis of periodontal disease and refine the diagnosis, prognosis and treatment of periodontitis, and thus participate in the development of personalized medicine. Biological monitoring of therapeutic effects may be initiated and allow more effectively prevent recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Requiring periodontal surgery
* In good health
* Having signed consent

Exclusion Criteria:

* Minor
* Patient having taken antibiotics in the previous 3 months
* Patients with systemic diseases including chronic inflammatory disease
* Pregnancy
* orthodontic treatment ongoing
Does Guanfacine Attenuate Stress-Induced Drinking?

Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* Able to read and write English
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for current (past 6 months) alcohol abuse or alcohol dependence

Exclusion Criteria:

* Participants with any significant current medical conditions, seizures, delirium or hallucinations, or other unstable medical conditions including HIV
* Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol dependence, or nicotine dependence
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current (past 6-month) mental illness
* Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD)
* Specific exclusions for administration of guanfacine not already specified include: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3x normal or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
* Subjects likely to exhibit clinically significant alcohol withdrawal during the study.
* Individuals who are seeking treatment for drinking
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)

The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.

Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient pediatric participants, male or female, aged 6 months to 11 years
* Diagnosis of allergic rhinitis or chronic idiopathic urticaria

Exclusion Criteria:

* Known hypersensitivity to desloratadine
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs

The aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis

Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is a radiological measurement. However, in continuous follow-up, the search for other methods to obtain objective data that will provide a short term evaluation on the patient in determining the efficacy of conservative treatment continues.

In our study, individuals who meet the criteria will be evaluated at the beginning and end of the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of bone maturation according to Risser, apex, vertebra rotation angle) will be recorded. Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) . Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation Scale. Scoliosis Research Society-22 will be used to measure quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with scoliosis diagnosed and followed up by the attending physician
* 10-16 age group,
* Patients who voluntarily agreed to participate in the study
* Living in Antalya/TURKEY

Exclusion Criteria:

* Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease
* İndividual who does not sign the consent form
Pediatric Cardiac Output Monitoring Observational Study

To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 12 to 18 years of age
* Subjects who have signed the Informed Consent Form
* Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
* For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
* Subjects with planned pressure monitoring with an arterial line

Exclusion Criteria:

* Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
* Subjects with contraindications for Arterial Line Placement;
* Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
* Subjects with a physical site area too limited for proper Sensor placement
* Subjects with finger size less than the smallest finger cuff size
* Documented ≥ moderate pulmonary hypertension (PAPm \> 25mmHg, PVRI \> 3.0 WUxm2)
* Presence of intracardiac shunting (i.e., ASD, VSD)
* Aorto-pulmonary collaterals
* ≥ Moderate tricuspid regurgitation, per echocardiogram criteria
* \> Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
* Persistent cardiac arrythmias during the cardiac catheterization period (\> 3min)
* Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)
Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer

Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. For those patients, microwave ablation (MWA) could be an alternative treatment. Several small sample retrospective studies verified that MWA could be an efficacy and safe treatment.

Patients with stage I non small cell lung cancer unfit for or refused surgery will be treated with MWA in the primary tumor sites.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a histologically or cytologically verified NSCLC,
2. The tumors small enough to treat (usually \<4 cm), and without chest pleura invasion.
3. Clinical stage I NSCLC with no other sites of disease,.
4. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
5. Patient is not a candidate for radiation therapy, or refused radiation therapy.
6. Patient has \> 6 month life expectancy.
7. Eastern Cooperative Oncology Group performance status of 0 to 2.
8. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
9. Sufficient organ functions.
10. Written informed consent.

Exclusion Criteria:

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Uncontrollable diabetes mellitus.
6. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Sustained-release Morphine Pharmacokinetics in Roux-en-Y Gastric Bypass Subjects

The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

This is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and Body Mass Index (BMI). In the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.

Eligibility Criteria:
Inclusion Criteria:

RYGB Group (n=12) :

* Subjects who undergone RYGB for at least 24 months
* Stable weight since almost one year (or weight loss below 10kg over the last year)

Control group (n=12) :

* Volunteers subjects, matched for age, sex, and Body mass index
* No history of bariatric surgery

Same characteristics

* Subjects volunteers for the study
* Age 20-65 years
* Written consent

Exclusion Criteria:

* Known allergy to morphine or naloxone
* Patients not affiliated to the french social security system
* Subjects yet recruited in a study with remuneration
* Abnormalities in liver function Prothrombin ratio \<70% and/ or aspartate transaminase \> 5 times the usual values and/ or alanine aminotransferase \>5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) \< 60ml/ min
* Respiratory insufficiency defined by an oximetry below 90%
* Pregnancy and breastfeeding
* Use of drugs contra-indicated or not advised with morphine:
* Agonists-antagonists opioids ( buprenorphine, nalbuphine, pentazocine ), naltrexone
* Alcohol intake \> 30g by day
* Cough medicine morphine-like ( dextromethorphan, noscapine, pholcodine )
* Codeine, ethylmorphine
* Other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol )
* Barbiturates, benzodiazepines
* Rifampicin
Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia

1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate if this test correlates with cardiovascular risk, independent of traditional risk factors; 3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function and composition


Eligibility Criteria:
Inclusion Criteria:

* The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy
* Aged over 20
* Consent form signed

Exclusion Criteria:

* pregnant or lactating women
* subjects with familial hypercholesterolemia
* uncontrolled hypertension or DM
* Thyroid dysfunction
* Active liver disease (transaminase or bilirubin \> 1.5 x NL)
* Serum creatinine \> 2 mg/dL
* Included in other clinical trials within 3 months
* using of other medication: fish oil, fibric acid derivatives, niacin, systemic corticosteroid, thiazolidinedione
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.


Eligibility Criteria:
Main Inclusion Criteria:

1. Provide informed consent voluntarily.
2. Male and female patients ≥ 18 years of age.
3. Patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer.
4. In case of women, both premenopausal and postmenopausal patients can be enrolled in the study.
5. Confirmed diagnosis of HR+, HER2- breast cancer.
6. For Stage 1 dose exploration phase, patients with or without PIK3CA mutation may be enrolled; For Stage 2 dose expansion phase, patients with PIK3CA mutations are required.
7. Patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy.
8. Patient has measurable disease per RECIST v1.1.
9. ECOG ≤ 1.
10. Patient must have adequate organ and bone marrow function.

Main Exclusion Criteria:

1. Previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment.
2. Previously received treatment with any PI3Kα inhibitor, AKT inhibitor, or mTOR inhibitor.
3. Radical radiation therapy within 4 weeks prior to the first dose of the study treatment.
4. Patient with an established diagnosis of diabetes mellitus.
5. Any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance.
6. Patient with clinically significant cardiovascular disease.