cyrilzakka/clinical-trials huggingface dataset:
Medication Reconciliation in Pulmonary Hypertension

Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

Medication reconciliation (MR) will be done for patients hospitalized in the French referral center for PH for PAH or CTEPH. Detected medication errors will be tracked and fixed by the physician before the end of hospitalization. A synthesis of new/stopped and modified treatments will be given to the patient as well as his related healthcare professionals (community pharmacist and general practioner) to ensure the maintaining of the new therapeutic management and the understanding of drugs modification. To compare the potential decrease of medication errors promoted by MR, a retrospective MR will be also done for patients without MR at 1st hospitalization but at the next one (3 to 12 months after).

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* At least 18 years old
* Patient with enlightened information of the study and not opposed with it.
* For patient without MR: patient hospitalized for the first re-evaluation of PAH or CTEPH within 12 months following the first assessment hospitalization (ie: first right heart catheterization at bicetre Hospital).
* For patient with MR: patient hospitalized for first assessment (first right heart catheterization at bicetre Hospital) of PAH or CTEPH

Exclusion Criteria:

* Patient suffering from another form of PH
* Patient under guardianship or curator
* Inability to give information to the patient either due to language barrier or to cognitive impairment
* Patient hosted in institution on discharge from hospital (follow-up care and long-term rehabilitation)
* Patient with a life expectancy of less than 1 year
* Patient on transplant list
* Patient refusal
* Length of stay \< 48 hours
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease

This trial will assess whether long-acting levodopa taken at night improves obstructive sleep apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.

Participants with Parkinson's disease and sleep apnea will take long-acting levodopa and placebo at bedtime for 2 weeks each, in a randomized order, with a 2-week washout period in-between. Sleep studies will be done at the end of each period. The primary outcome will be the apnea-hypopnea index change from baseline to on-medication, comparing active medication to placebo. Other outcomes will include other polysomnographic parameters such as oxygenation measures and sleep architecture variables, as well as the Epworth Sleepiness Scale, the Montreal Cognitive Assessment, the Parkinson's disease sleep scale and the Unified Parkinson's Disease Rating Scale. Adverse events will be closely monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD consistent with the UK Brain Bank;
2. Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
3. Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study

Exclusion Criteria:

1. Other major neurological disorder;
2. Already taking long-acting levodopa (at any time of day);
3. Taking short-acting levodopa at bedtime or during the night;
4. Any contraindication to long-acting levodopa (see below);
5. Severe levodopa induced dyskinesias;
6. Already on or requiring treatment for restless legs syndrome ;
7. Body mass index \>35 kg/m2;
8. Intercurrent upper respiratory tract infection;
9. Other known cause of OSA (e.g. craniofacial malformation);
10. Active treatment of OSA (CPAP, dental appliance or other), unless willing to stop treatment 2 weeks prior to start and during the duration of the study.
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).


Eligibility Criteria:
Inclusion Criteria:

* Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous \< 6 months or recurrent or metastatic cancer)
* Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study
* Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
* Patients who are willing to participate in this study (signed informed consent)
* Patients who are available for follow-up with a life expectancy \>6 months

Exclusion Criteria:

* The contra-indications according to the local marketing authorization must be considered
* Patients who developed an index VTE event despite chronic anticoagulant therapy
* Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event
* Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
Visual Education for Spinal Anesthesia Acceptance

Primary outcome: To determine the incidence of spinal anesthesia preference after exposure to the visual information catalog.

Secondary outcomes: To analyze independent (age, education, profession, previous experiences) and dependent (fear, anxiety) factors influencing patient choices.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45
* who are undergoing elective cesarean sections
* and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale

Exclusion Criteria:

* patients under 18 or over 45 years old,
* emergency cesareans,
* preeclampsia,
* cardiovascular disorders,
* fetal abnormalities,
* those not receiving spinal anesthesia or converted to general anesthesia during surgery,
* those who refuse to participate in the study,
* hospital clinical or administrative staff,
* patients with psychiatric disorders
Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension

This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception
* Clinical diagnosis of POAG or OH
* For study eyes not previously treated with anti-glaucoma medications

  * IOP must be ≥ 22 mm Hg at least at two assessment time-points at Screening, and
  * IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline, and
  * IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Screening and Baseline assessment time-points.
* Or for study eyes previously treated with anti-glaucoma medications

  * IOP must be ≥ 14 mm Hg and ≤ 24 mm Hg at least at two assessment time-points at Screening.
  * IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline (after wash-out)
  * IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Baseline assessment time-points

Exclusion Criteria:

* History of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study.
* History or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to:

  * Uncontrolled hypertension with systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg measured at more than one blood pressure reading at Screening or Baseline;
  * myocardial infarction within the 3 months period prior to randomization;
  * active severe viral infections such as active encephalitis, meningitis, hepatitis, herpes simplex, or herpes zoster (minor viral upper respiratory infections such as colds do not require exclusion.)
* Presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at Baseline Visit.
* Argon laser trabeculoplasty or any prior IOP lowering surgery in the study eye.
* Ocular surgery in the study eye within 3 months prior to the Screening Visit.

Other protocol-defined inclusion/exclusion criteria may apply
Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy

This study intends to establish the clinical staging of chronic pancreatitis based on histopathology through pancreatic duct biopsy technology.

Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice.

Pathological features of CP include pancreatic parenchymal atrophy and interstitial fibrosis resulting from chronic inflammatory damage. Although there are numerous criteria for clinical staging and severity grading of CP, they all have their own limitations, and none of them have been validated by randomized controlled trials. There is also no clear definition of the clinical stage and severity of CP in the guidelines for the diagnosis and treatment of CP. According to the "Clinical Guideline: Chronic Pancreatitis" issued by the American College of Gastroenterology in 2020, histopathology is the "gold standard" for the diagnosis of CP.

In the past ten years, the technology of mother-daughter scope has developed rapidly. The duodenoscope is used as the mother scope, and the cholangiopancreatoscope is used as the daughter scope. The optical fiber or digital imaging system carried by the daughter scope can directly observe the internal situation of the pancreatic and bile ducts. The channel allows the endoscopist to precisely biopsy the wall of the main pancreatic duct with a biopsy forceps. This technology improves the predicament of pancreatic tissue biopsy in the past, allowing ERCP treatment in patients with CP and pancreatic tissue biopsy to be carried out simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;
* In line with the indications for ERCP treatment.

Exclusion Criteria:

* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* bile duct stricture secondary to cholangitis or chronic pancreatitis;
* acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis;
* coagulation dysfunction (INR≥1.5 or platelet count≤50×10\^9/L);
* pregnant or breastfeeding women;
* patients who refused to participate in the study.
Hereditary Cerebral Small Vessel Diseases Registry-Trial Ready Cohort

We took hereditary cerebral small vessel disease (hCSVD) patients as our main subjects, aiming to establish a platform for a comprehensive evaluation and long-term follow-up. Deeply explore the pathophysiological mechanism of hCSVD, which may render the theoretical basis for the treatment and management of hCSVD.

Cerebral Small Vessel Disease is a series of clinical, imaging, and pathological syndromes caused by a variety of risk factors affecting cerebral arterioles, arterioles, capillaries, and venules, accounting for 20% of stroke and 45% of dementia.

Although the incidence rate of hereditary small cerebral vascular disease is low, because of its early onset, high disability rate, and lack of effective treatment, it also brings a heavy burden to the patients and their families. Therefore, it is important to study the pathogenic gene, pathogenesis, clinical characteristics, and imaging manifestations of hereditary cerebrovascular disease to provide a theoretical basis for the treatment and prevention of hereditary cerebrovascular disease in the future.

This multi-center, prospective, continuous, registry study, runs from 2022 to 2027. The study is expected to recruit 100 subjects, according to the sample size design of the registry study.

We recruited patients with the hereditary cerebral small-vessel disease (hCSVD) intending to establish a platform for a comprehensive assessment and long-term follow-up by collecting genetics, imaging, and clinical symptoms of the primary disease and its relatives. With long-term follow-up of the development and prognosis of imaging and clinical symptoms combined with genetics, we will work on the correlation between genes and phenotype and deeply explore the pathophysiological mechanism of hCSVD, which may render the theoretical basis for the treatment and management of hCSVD.

Eligibility Criteria:
Inclusion Criteria:

1. All ages, male or female
2. Carriers of the pathogenic genes mutation (mutation with unknown clinical significance/ suspected pathogenic mutation/ pathogenic mutation) of hCSVD confirmed by the gene tests, including but not limited to NOTCH3, HTPA1, CTSA, GLA, TREX1, COL4A1/2, or highly-suspected hCSVD2
3. CSVD related abnormalities on brain MRI, any 1 or more of:

   1. White matter hyperintensities, Fazekas score3 ≥1
   2. ≥1 newly-occurred lacunar infarcts
   3. ≥1 old lacunar infarcts
   4. ≥3 cerebral microbleeds
4. Informed consent signed

Exclusion Criteria:

1. Diagnosis of mental disorders according to DSM-V and unable to be compliant to the research
2. Patients with life expectancy less than one year due to any advanced disease, e.g., malignant tumor
3. Patients unable to return for follow-up visits due to some reasons
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.

Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory scleroderma

Eligibility Criteria:
Inclusion Criteria:

1. Scleroderma with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
2. Estimated survival time\> 12 weeks;
3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

* Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
  8. Other uncontrolled diseases that were not suitable for this trial;
  9. Patients with HIV infection;
  10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
  11. Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
  12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.
Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.

The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye.

The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye. Treatment success will be measured after 6 months of using the implant.

The treatment will be considered successful if two things happen:

1. No swelling in the back of the eye called cystoid macular oedema;
2. A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.

Participants will:

1. Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months.
2. Be followed for 36 months for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Males and females of ≥6 and \<18 years of age at time of consent
* Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
* Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the judgment of the Investigator
* Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1

Exclusion Criteria:

* History of intraocular surgery in the study eye within 90 days of the screening visit.
* Hypersensitivity to FA or any component of ILUVIEN®
* History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
* Increased intraocular pressure \>25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects

The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any significant acute or chronic medical illness or relevant trauma (e.g., history of chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle accident resulting in significant head trauma or internal injuries)
* History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery)
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.

Eligibility Criteria:
Inclusion Criteria:

* patients that are willing and able to provide written informed consent
* age ≥ 18 years
* HCV RNA ≥ 103 IU/mL
* HCV genotype 1 or 4
* screening ultrasound excluding hepatocellular carcinoma (HCC)
* acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)
* general good health
* ability to comply with study procedures
* HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA \< 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL

Exclusion Criteria:

* current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
* active tuberculosis
* other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder
* active Hepatitis B infection
* difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
* any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence