cyrilzakka/clinical-trials huggingface dataset:
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
2. 18 to 75 years of age, inclusive, at the time of informed consent
3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

Exclusion Criteria:

1. Functional Class IV as defined by ACR classification of functional status in RA
2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
5. History of recurrent clinically significant infections
6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
7. History of severe allergic or anaphylactic reactions to other biologic agents
8. History of allergies to murine protein
9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
10. History of tuberculosis or latent infection currently undergoing treatment
11. History of malaria
12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization
14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
15. Abnormal laboratory value at Screening or Day -1 considered clinically significant
16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
17. Positive for human immunodeficiency virus (HIV) antibody
18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)
Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis

The aim of the present study was to compare the effect of aqueous extract of garlic with nystatin mouthwash in denture stomatitis.

Denture stomatitis is the most common form of chronic oral candidiasis manifested as chronic inflammation of the mucous membrane t supporting the movable prosthesis that may have a local or systemic nature. This inflammation is presented as mucous erythema and occasionally with pain and burning. The standard treatment for denture stomatitis is administration of nystatin which is accompanied with complications such as bitter taste as well as the high number of drug application that result in reduced tendency of patients in using this medication hence, efforts are continuously being made to substitute other types of therapies for this condition.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age and older
* confirm of denture stomatitis by the oral medicine specialists

Exclusion Criteria:

* Patients with a history of using anti-fungal drugs, antibiotics, and corticosteroid within the previous month
* allergy to garlic and nystatin mouthwash
* immunodeficiency
* uncontrolled diabetes
* those with garlic rich diet
* inability in using mouthwash
* loose and discolored dentures
* psychologic disorder and alzheimer
Formula PTX Renal Stent Clinical Study

The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* renal artery stenosis
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag

ARDS is frequent in ICU and may lead to many complications and to death. Prone position is widely used in ADRS patients and demonstrated to decrease mortality. Regarding the chest wall compliance data are missing but the theorical response is that this compliance is decreased in a prone position mainly due to anterior chest and abdomen compression in this position which are more compliant that dorsal part of the body. As well prone position could be associated with complications as pressure ulcers. Because prone position is associated with complications, air bag were developped to decrease pressure on the chest and abdomen and to decrease pressure ulcers. Then, trying to improve chest compliance in prone position and reducing the risk of pressures ulcers could be a challenge with this system in comparison with standard care.


Eligibility Criteria:
Inclusion Criteria:

* patients with ARDS under mechanical ventilation with P/F ratio\<150
* Age \>18 y/o
* Admitted in the medical ICU of Amiens under mechanical ventilation sedated,
* With signed informed consent (patient or relative if patient is not conscious)

Exclusion Criteria:

* patients not eligible for a prone position
* Patients with tracheostomy
A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
* ESSDAI score ≥6
* IgG \>16 g/L
* Positive anti-SS-A/Ro antibody at screening

Exclusion Criteria:

* Pregnancy or breast feeding
* Secondary Sjogren's syndrome
* severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection
* Prior administration of any of the following:

  1. Rituximab in the past 12 months prior to randomization;
  2. Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
  3. Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
  4. live vaccine in the past 12 weeks prior to randomization
* Corticosteroids: \> 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-36 years
* Body mass index (BMI) between 18 and 26
* Prolactin within the laboratory normal range
* Couples affected by sterility able to treat by IUI (intrauterine insemination)
* Patients undergoing Menopur® treatment
* Normal thyroid function
* Regular menses (21-35 days)
* Couples willing to participate in the study that have signed the informed consent form
* Seminal sample REM\>3 million

Exclusion Criteria:

* Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
* Policystic ovarian syndrome
* Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
Effect of Squat Training on Body Composition, Muscular Strength and Motor Fitness for Youth- Randamized Trial

The purpose of this study is to determine the effects of body mass-based squat training on body composition, muscular strength and motor fitness in adolescents.

Body composition Percent body fat by bioimpedance muscle thickness at the thigh anterior by ultrasound

Muscle strength Maximal voluntary knee extension torque by myometer

Motor fitness sprint velocity by non-motorized treadmill Jump height by a matswitch system.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents

Exclusion Criteria:

* Participants do not have medical and orthopedic disorder.
The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or above,
* with a scheduled ERCP procedure
* with the ASA grade level of I-II clinically
* without a hearing/speech impairment
* willing to participate in the research
* without a mental problem or diagnosis of psychiatric disorder
* without any a diagnosis of depression

Exclusion Criteria:

* Patients with an emergency ERCP procedure
* with a hearing/speech impairment
* not willing to participate in the research
* with a mental problem or diagnosis of psychiatric disorder
* with a diagnosis of depression
PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

Proximal femoral nail \[PFNA\] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures

compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures

Eligibility Criteria:
Inclusion Criteria:

* patients with trochanteric unstable fractures.
* age 60 or above
* recent fracture time within 2 weeks time period
* trochanteric starting point in pfna
* patients medical condition is stable

Exclusion Criteria:

* stable trochanteric fractures
* delayed or neglected fractures
* unstable patients medical conditions
* pirformis fossa starting point in pfna
A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy

The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.

The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.

Eligibility Criteria:
Inclusion Criteria:

All subjects must:

1. Be willing and able to provide written Informed Consent.
2. Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study.
3. Be male or female of any race at least 18 years of age.
4. Have medically uncontrolled glaucoma for which they have elected to undergo surgery.
5. Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma.

Exclusion Criteria:

No subject may:

1. Have any contraindication to intraocular surgery.
2. Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
3. Have any active ocular disease other than glaucoma that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
4. Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
5. Require use of ocular NSAID or systemic steroids.
6. Have known allergy or sensitivity to mitomycin C
7. Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
8. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
9. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
10. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
Registry of Febrile Neutropenia and Invasive Fungal Infections

Objectives：

1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
2. To explore the percentage/distribution of infectious origins of febrile neutropenia
3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes

Objectives：

1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
2. To explore the percentage/distribution of infectious origins of febrile neutropenia
3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes

Study Design：

* This is a single institute, prospective, non-interventional registry for monitoring events of febrile neutropenia in hematological patients
* Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry

Study Procedures： Data collection will include patients' basic information, underlying disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up, clinical response, microbiology (including bacteria and fungus culture), renal and liver function, clinical diagnosis, work-up and intensive procedures and results, antifungal and antibacterial agents (including dosage, duration, and route), other drugs used (including antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes

Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia episodes in 500 chemotherapy cycles will be collected. This is an observational and exploratory study without hypothesis tests. Study subjects will be collected and monitored under normal clinical practice, and the sample size will be limited due to the hospital scale and disease characteristic (the sample size calculation is inapplicable here). All evaluations will be shown by exploratory and descriptive data analysis. The number of cases for each investigative definition, the corresponding percentage and the 95% confidence interval will be described.

Eligibility Criteria:
Inclusion Criteria:

* Patients with new diagnosed hematological diseases (acute and chronic myeloid and lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, myelodysplastic syndromes)
* Patients who are receiving chemotherapy and have ongoing febrile episodes

Exclusion Criteria:

* None
Oral Formulation of Insulin for Preterm Infants

The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-term infants 26-33 weeks gestation.
CES1 Carriers in the PAPI Study

This study builds, in part, upon preliminary results generated as part of the Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1) on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The investigators hypothesize that participants who carry alleles that modify the activity or expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older
* Of Old Order Amish descent

Exclusion Criteria:

* Currently pregnant or less than 6 months have passed since delivery
* Currently breast feeding
* Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
* Has severe hypertension, defined by a blood pressure above 160/95 mm Hg
* Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
* Is taking vitamins or other supplements and is unwilling to discontinue use for at least 1 week prior to study
* Has a coexisting malignancy
* Has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
* Has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
* Is currently taking aspirin, clopidogrel, or anti-coagulants, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place the participant at increased risk from withdrawal of these medications 14 days prior to protocol initiation
* History of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
* Has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
* Has thrombocytopenia, defined by a platelet count less than 75,000
* Has had surgery within the last 6 months
* Has an aspirin or clopidogrel allergy
PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury

The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU with expected mechanical ventilation \>48h

Exclusion Criteria:

* Ultrasound RRI evaluation non available
* Patients with arrhythmia
* Pregnancy
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

This is a 60 week study including a double-blind phase followed by an open-label extension phase.


Eligibility Criteria:
Inclusion Criteria:

* Frequent migraine (\>=15 headache days per month)
* \>=4 distinct headache episodes lasting \>=4 hours
* \>=50% of baseline headache days migraine/probable migraine days

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
* Any medical condition that puts the patient at increased risk with exposure to BOTOX
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
* Use of prophylactic headache medication within 28 days prior to week -4
* Unremitting headache lasting continuously throughout the 4-week baseline period
* Known or suspected Temporomandibular Disorders (TMD)
* Diagnosis of fibromyalgia
* Beck depression inventory score \>24 at week-4
* Psychiatric problems that may have interfered with study participation
A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.

The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess the pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, age 18-40, weight ≥ 50 kg
* Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test

Exclusion Criteria:

* History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
* History or presence of drug addiction or excessive use of alcohol
* Symptomatic or asymptomatic Orthostatic Hypotension at screening
* Current smokers and former smokers
* Heavy caffeine drinker
* History of frequent and severe headache
* Any drug treatment
* Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
* Subjects on a controlled sodium diet
* Subject has made a blood donation or had a comparable blood loss