cyrilzakka/clinical-trials huggingface dataset:
Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.

Immune thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.

Corticosteroids increase the platelet count in about 80 percent of patients. However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Eltrombopag, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin, has been shown to be effectively raise the platelet count in adult patients (aged 18 years and over) who have had their spleen removed or where splenectomy is not an option and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work (refractory ITP). There are a few case reports where eltrombopag was an option as first line treatment for IT.

The purpose of this study is to determine the response rate and response duration with the combination of rituximab (100 mg weekly four weeks), eltrombopag (50mg PO once a day, day 1-28) and high-dose dexamethasone (40mg PO days 1-4) in untreated adult patients with \<30\*109/L platelet count diagnosed with immune thrombocytopenia.

A complete response is defined as an increase in platelet counts to \>150×109/L on two consecutive occasions. A clinical response is defined as an increase in the platelet count between \>30×109/L on two consecutive measures and no bleeding. Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count \<30×109/L) or to time of analysis Patients will be evaluated each week during 4 weeks and then every month for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed immune thrombocytopenic (IT) Platelet count less than 30,000/mm3 on two ocasionts with bleeding.
* Subject ≥ 16 years
* Subject has signed and dated written informed consent.
* No sepsis or fever or active infection
* Not pregnant or nursing

Exclusion Criteria:

* Previous treatment (only corticosteroids at dose or prednisone equivalent of 300 mg)
* Performance status above or equal to 2.
* Pregnancy and lactation
* Previous splenectomy
* Connective tissue disease
* Autoimmune hemolytic anemia
* Relapse
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Eligibility Criteria:
Inclusion Criteria:

* Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to have residual function
* Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening
* Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as documented in the participant's medical record
* Stable CF disease as judged by the investigator

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* An acute upper or lower respiratory infection, pulmonary exacerbation
* History of solid organ or hematological transplantation
* Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor \[VX-809\], and/or ivacaftor) within 30 days of screening
* Pregnant and nursing females
* Sexually active participants of reproductive potential who are not willing to follow the contraception requirements
MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
* Age ≤ 21 years
* Adequate organ function within 14 days of enrollment, i.e. Creatinine: \< 1.5 x ULN and Hepatic: ALT, AST and total bilirubin \< 3 x ULN
* Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

Exclusion Criteria:

* Has received voriconazole within 5 days prior to starting study therapy
* History of hypersensitivity or severe intolerance to azoles
* History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
* Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
* Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
* Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
* Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure
Volatile Versus Propofol Anesthesia in OPCAB

Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.

Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.

Eligibility Criteria:
Inclusion Criteria:

* OPCAB

Exclusion Criteria:

* On pump conversion
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection

The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR \<30).


Eligibility Criteria:
Inclusion Criteria:

* Referred for contrast-enhanced MRI using gadoversetamide;
* Have a documented estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and
* Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.

Exclusion Criteria:

* Have experienced a previous hypersensitivity reaction to a GBCA;
* Have pre-existing NSF or NSF-like symptoms; or
* Have been exposed to a GBCA within 12 months prior to the index procedure; or
* Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.
Zenith® Dissection Endovascular System

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.


Eligibility Criteria:
Inclusion Criteria:

* Branch vessel obstruction/compromise
* Peri-aortic effusion/hematoma
* Resistant hypertension
* Persistent pain/symptoms
* Transaortic growth \>5 mm within 3 months
* Transaortic diameter \>40 mm.

Exclusion Criteria:

* Age \<18 years;
* Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 24 months;
* Unwilling or unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
* Additional medical restrictions as specified in the Clinical Investigation Plan, or
* Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets

The different types of brackets (e.g., self-ligating and conventional brackets), and the various acceleration methods (e.g., corticotomy) cause varying degrees of pain and discomfort. This study will assess pain, discomfort, and other patient-centered outcomes in adults with severe crowding on the upper jaw requiring two first premolars extraction.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender and any previous treatment experiences, which are negatively or positively reflected on the patient's cooperation. As for the factors related to the type of orthodontic treatment provided, the pain and discomfort are proportional to the brackets system used and the forces applied, especially in the leveling and alignment stage. The amount of tooth movement is directly affected by the friction between the brackets and the wires used. The physical properties of the wire and brackets used and the dimensions of the applied wires, in addition to the type of ligation play a significant role in the amount of friction generated.

Eligibility Criteria:
Inclusion Criteria:

1. The patient's age is between 18 and 25 years
2. Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
3. Little's Index of Irregularity is greater than 7 mm
4. Overbite ranging between 0-4 mm
5. Normal inclination of the upper incisors
6. No missing teeth (except for third molars)
7. Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0)

Exclusion Criteria:

1. The presence of any systemic disease affecting orthodontic movement
2. The presence of congenital syndromes or cleft lip and palate
3. Poor oral health with a plaque index greater than (1)
4. Skeletal maxillary constriction
A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis

The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis. This is an experimental medical research study. A total of 200 people in North America and Europe participated in this study during the 17 month study period. Patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (Remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintenance infusions every 8 weeks until week 46. In the placebo group, patients may early escape at week 16 and crossover at week 24 to infliximab;. In the 5mg/kg group, dose escalation if needed at week 38.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed psoriatic arthritis for \>= 6 months
* active arthritis with \>= 5 tender and 5 swollen joints
* active psoriasis

Exclusion Criteria:

* Have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
* Received any systemic immunosuppressives within 4 weeks prior to enrollment in the study
MRI & MRV in Pelvic Congestion Syndrome in Females

To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.

Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound imaging does not readily show the gonadal veins. Phlebography is the "gold standard" for anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.

In this prospective study, we will investigate the feasibility of using magnetic resonance venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in comparison to phlebography.

Eligibility Criteria:
Inclusion Criteria:

* All patients with signs and symptoms of PCS.

Exclusion Criteria:

* Patients with general contraindications to MRI as presence of any para-magnetic substance as pacemakers, or in severely ill patients or those with claustrophobia, arrhythmic patients.
Effect of Vitamin Supplementation in Glaucoma Patients

The impact of targeted vitamin supplementation on retinal venous pressure (RVP) and steady state pattern ERG (SSpERG) in patients with RVP 15mmHg or more above intra-ocular pressure (IOP) and serum homocystein 12µmol/l or more, with signs of progression in spite of adequate IOP control, as evidenced by SSpERG abnormality with or without structural progression or visual field progression,

Provided the inclusion criteria were met, RVP measurement was repeated, and a 1 capsule/day regimen of Ocufolin® forte was subsequently carried out for a duration of 3 months, after which repeat measurements of IOP, SSpERG, and RVP were performed, along with dilated fundoscopy. .

Eligibility Criteria:
Inclusion Criteria:

* glaucoma and/or ocular vascular disease in at least on eye
* abnormal SSpERG
* RVP measured using an ophthalmodynamometer at least 15 mmHg higher than intra-ocular pressure (IOP),
* fasting serum Hcy level \> 12 µmol/l
* stable and well-controlled IOP (with or without IOP-lowering treatment)

Exclusion Criteria:

* starting other systemic or ocular medications with potential impacts on RVP within a month before entering the study or during the course of the study
* starting or changing the dosage of other medications with potential impact on SSpERG within 3 months before entering the study or during the course of the study
* non-adherence to the follow-up schedule
* inability to perform a proper RVP measurement using ophthalmodynamometry.
Bone Health in Type 1 Diabetes

An increased skeletal fracture risk in diabetes has only recently been recognized. This human study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on structure.

An increased skeletal fracture risk in diabetes has only recently been recognized. Human studies of patients with diabetes using bone mineral density and bone markers have noted low bone mass and mixed results on remodeling activity. Mouse models of diabetes have suggested that low bone turnover is the underlying problem. Low bone turnover could lead to an accumulation of microdamage that is not repaired causing compromised bone strength. Low bone turnover has not yet been confirmed in humans. This human study is designed to elucidate the effect of Type 1 diabetes on 1) bone remodeling, including histomorphometric and biochemical measures of bone formation and resorption, and 2) on structure, including micro architectural arrangement of trabeculae and bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 19 yrs or \< 50 yrs.
* The diabetic subjects must have a diagnosis of Type 1 diabetes clinically defined as diabetes onset before age 50, acute presentation or diabetic ketoacidosis, with normal BMI. If history is equivocal, GAD antibodies \> 1.45 U/mL will be used to define diagnosis.
* Diabetic subjects must be on insulin treatment.
* All subjects must have BMI between 18-30

Exclusion Criteria:

* On any medications that are known to interfere with bone metabolism including loop diuretics, steroids, anticonvulsants, bisphosphonates, metformin, glitazones
* Have normal or only mildly impaired kidney function defined as a calculated GFR greater than 60 mL/min/1.73m2
* History of cancer other than skin cancer
* Unstable angina, myocardial infarction, uncontrolled hypertension, malabsorption, active rheumatoid or collagen disease.
A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)

The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM).

Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Subjects aged 20 years or older on the day of consent
* Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent
* Subjects with an Osame's motor disability score (OMDS) of ≥4 and ≤6 at Screening and on the first day of the Treatment period (predose)
* Subjects with no change in OMDS for at least 3 months before the day of consent
* Subjects with a CSF concentration neopterin of ≥6 pmol/mL at Screening
* Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to ≤10 mg/day of prednisolone for at least 3 months before the day of consent

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
* Subjects exhibiting or with a history of malignant tumor.
* Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
* Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
* Subjects with psychiatric disorders, epileptic seizures, or dementia.
* Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
* Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
* Subjects with the novel Coronavirus disease 2019 (COVID-19)
* Subjects with severe illness
* Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
* Female subjects who are pregnant, lactating, or may be pregnant
* Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
* Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent
Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

Determine the efficiency of a myéloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.


Eligibility Criteria:
Inclusion Criteria :

* Informed consent signed,
* Patient affiliated to a social security system or benefiting from such a system,
* Related HLA identical donor or unrelated HLA identical donor :

all patients aged \> 55 years with hematological malignancy and deemed eligible for an allogeneic transplant from a geno-identical donor and pheno-identical 10/10

- the basic pathology should be considered "chemo-sensitive" complete or partial remission (CR, PR) or stable disease

Exclusion Criteria :

* Pregnant or lactating woman or without contraception (for child bearing potential women)
* Patient deprived of liberty or under supervision of a guardian
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
* Usual contra-indications for allogenic transplant
* Aged \< 55 years
* History of allogenic transplant
* Concomitant neoplastic disease
* Evolutive psychiatric disease
* HIV seropositivity or C hepatitis under treatment
* Women of childbearing age or man, in the absence of effective contraception during treatment and up to 12 months after treatment discontinuation