cyrilzakka/clinical-trials huggingface dataset:
Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis

This study examines the effect of adjuvant therapy with the oral beta-agonist Salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.

Myasthenia Gravis (MG) causes various degrees of increased muscular fatigue and ocular, bulbar, respiratory and extremity symptoms.

Residual symptoms often remain despite treatment with acetylcholinesterase inhibitors and immunosuppressive agents. Escalation of immunosuppressive treatment may provide additional benefit but is associated with potentially severe side effects, and high economic costs.

Treatment with beta-agonists has been investigated in animal models of MG, and in small, randomized pilot studies of generalized MG. Adjuvant therapy with oral beta-agonists in MG may be safe and cheap and may improve symptoms.

The trial will examine the tolerability and efficacy of adjuvant therapy with the oral beta-agonist Salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.

Present study is an investigator-initiated, randomized, placebo-controlled, rater and subject-blinded crossover study.

Study consists of Screening Period (4 weeks), Treatment Period 1 (8 weeks), Washout Period (4 weeks), Treatment Period 2 (8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Generalized myasthenia gravis (MGFA IIa-IVb) at screening, verified by ≥ 1 of the following: 1) AchR-antibodies in medical history, 2) Abnormal decrement on repetitive nerve stimulation in medical history
* Disease duration of ≥ 1 year
* Stable dose of antimyasthenic medications at screening
* Residual symptoms with a MG-QOL15 score of ≥ 10
* Age ≥ 18 years
* Ability to understand the requirements of the trial and provide written, informed consent

Exclusion Criteria:

* Evidence of malignancy ≤ 3 years prior to screening, unless deemed completely cured
* Thymectomy ≤ 6 months prior to screening
* Impending MG crisis or respiratory insufficiency
* Worsening of MG symptoms due to other diseases or medications (e.g. infection, beta-blockers, aminoglycosides, etc.)
* Other factor(s) or medical condition(s) that may explain residual symptoms
* Pregnancy or breast-feeding
* Treatment with beta-agonists
* Uncontrolled diabetes
* Ischemic Heart Disease, Cardiac Arrhythmia or Heart Failure (including hypertrophic cardiomyopathy)
* Uncontrolled Hypertension (≥ 160/110)
* Known hypersensitivity to any of the study drug components
* Treatment with tricyclic antidepressants, monoamineoxidase inhibitors, digoxine, or methylxanthines.
Bioimpedance Spectroscopy Compared to CardioMEMS™

Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Eligibility Criteria:
Inclusion Criteria:

Patient:

1. has an CardioMEMs device implanted
2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
3. is able to give informed consent

Exclusion Criteria:

Patient:

1. has pacemaker/ICD
2. is pregnant or breastfeeding
3. is an amputee
4. has been diagnosed with multiple medical conditions that would make participation burdensome
5. not able to co-operate with impedance measurements
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers

Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* A non-healing chronic lower leg ulcer
* Platelet ranges of 150000 per ml circulating blood

Exclusion Criteria:

* Presence of a tumor or metastatic disease
* Hypersensitive to collagen regenerated cellulose
* Hemodynamic unstable patient
* Hypercoagulability
* Heart decompensation or angina pectoris
An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients

This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

Eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Eligibility Criteria:
Inclusion Criteria:

* age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography

Exclusion Criteria:

* pregnancy
* reception of reperfusion treatment before admission
* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.
A Study to Assess the Safety and Pharmacokinetics of AD-104-A

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-A

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment

Eligibility Criteria:
Inclusion Criteria:

For all subjects

* Adults aged 19 years and older
* Body mass index(BMI) of 18 to 30 kg/m2
* Voluntarily given written informed consent

For renal Impairment subjects

* 30 ≤ eGFR \< 90 mL/min/1.73m\^2

For healthy subjects

* eGFR ≥ 90 mL/min/1.73m\^2

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with moderately to severely active rheumatoid arthritis
* Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein) greater than or equal to 3.2 at baseline (there is no minimum CRP score required to qualify)
* Subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at screening or baseline
* Subject must treated with and MTX (methotrexate) dose (oral and/or injectable) of 15 mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening
* Subject is either biologic-naïve or has only one prior biologic disease-modifying antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, or tocilizumab)

Exclusion Criteria:

* Previous exposure to adalimumab (Humira), rituximab (Rituxan), natalizumab (Tysabri), efalizumab (Raptiva)
* Subject has been treated with intra-articular or parenteral administration of corticosteroids within 4 weeks of screening
* Subject has diagnosis or history of gout or pseudogout
* Subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by ultrasound)
* Subject has history of chronic arthritis diagnosed before age 16 years
Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers

Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 30 - 60 years
* At least 15 years of smoking
* Current smoker, at least 10 cigarettes per day

Exclusion Criteria:

* Any acute or chronic disease (except COPD oder hypertension)
* Any regular medication (except drugs against hypertension)
* FEV1 \< 80% predicted
* Oxygen saturation \< 90%
* Acute infections of the lower respiratory tract in the last 7 days before the first day of the study
Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

This study (contRAst 3 \[202018: NCT04134728\]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD\[s\]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD\[s\]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X \[209564: NCT04333147\]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).


Eligibility Criteria:
Key inclusion criteria:

* \>=18 years of age
* Has had RA for \>=6 months and was not diagnosed before 16 years of age
* Has active disease, as defined by having both:\*

  * \>=6/68 tender/painful joints (tender joint count \[TJC\]), and
  * \>=6/66 swollen joints (swollen joint count \[SJC\])
* Has had an inadequate response despite currently taking at least one and at the most two concomitant csDMARDs for at least 12 weeks, from the following:

  * Methotrexate (MTX)
  * Hydroxychloroquine or chloroquine
  * Sulfasalazine
  * Leflunomide
  * Bucillamine
  * Iguratimod
  * Tacrolimus
* Has had inadequate response to at least one bDMARD at an approved dose and/or at least one JAK inhibitors at an approved dose. In both cases this may be with or without combination with a csDMARD.

  * If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

Key exclusion criteria:

* Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
* Has received prior treatment with an antagonist of GM-CSF or its receptor.
* Has known infection with human immunodeficiency virus (HIV) or current acute or chronic hepatitis B and/or hepatitis C.
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC who are eligible to receive a 6 week course of RT
* Part 1 - not candidates for definitive RT
* Part 2 - candidates for definitive RT

Exclusion Criteria:

* Severe COPD, pulmonary infection or interstitial pneumonitis
* Recent cellulitis
* Autoimmune disease
A Randomised Controlled Trial (RCT) to Evaluate Use of an Individual Auditory Cueing Device's (IACD's) on Freezing and Gait in People With Parkinson's Disease (PD)

The primary aim of the study is to evaluate the effect of an IACD i.e. Apple iPod-shuffle, on freezing and gait speed in people with a diagnosis of PD through the implementation of a randomised controlled trial. A secondary aim of the study is to evaluate the impact of such a device on the quality of life of people with stroke through the administration of a self-report questionnaire. The IACD will be pre-loaded with an individualised auditory cueing frequency (metronome sound) matched to the walking speed of the individual with PD.

The investigators calculated and pre-loaded 100 baseline frequencies (less 10%) in the sound of a metronome beat in an MP3 format (30 - 130 BPM) \[38\] onto a DVD-Rom. A user manual was created with a set of instructions that gives each physiotherapist a step-by-step guide on how to calculate the correct beat for their participants and how to successfully upload this beat onto the iPod. In addition physiotherapists in participating centres attended a training session on how to complete the tasks. A pack including the DVD-Rom, user manual, information leaflet and consent was sent to participating centres. Recruitment is due to commence in September 2008.

Eligibility Criteria:
Inclusion Criteria:

* PD
* medically stable
* willing to give informed consent
* freeze at least once per week (minimum score of 2 on item 3 of the FOGQ) for at least 2 seconds(minimum score of 1 on item 4 of FOGQ)
* MMSE Score greater than 24

Exclusion Criteria:

* attending physiotherapy at time of recruitment
* unwilling to give informed consent
* not medically stable
* cognitive impairment (MMSE score less than 24)
* acure co-morbidity that prevents mobility
Real World Study of Chronic Viral Hepatitis

This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.

Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers.

Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies.

This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent of patients.
2. Evidence of persistent virus infection for greater than six months \[hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive\]

Exclusion Criteria:

1. Serious psychiatric history, especially depression.

   * Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.
2. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
3. Patients with malignant tumors (excluding those cured).
Detecting Bladder Cancer Using the UroMark Test.

DETECT I is a prospective multicentre observational diagnostic study to assess the performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The study will recruit consecutive patients attending haematuria clinics as well as patients referred to urology outpatient clinics for investigation of haematuria. Consenting patients will be provided with a urine sample collection kit and asked to provide a urine sample. An additional urine sample for control assay testing will be provided after the clinic attendance.

Transitional cell carcinoma (TCC) of the urinary bladder is responsible for \>12,000 new cases of cancer and \>5,000 deaths per year in England and Wales. Most bladder cancers are non-muscle invasive bladder cancer (NMIBC) and do not invade deeply at presentation, but 80% of tumours recur within 3 years. For muscle invasive bladder cancer (MIBC), the 5 year survival is around 50%. Cystoscopy is the standard test for detection of bladder cancer along with imaging to assess the upper tracts and the common presenting symptom is haematuria. Cystoscopy is an invasive procedure and results in urinary infection in up to 5% of cases. Cystoscopy is performed under local anaesthetic and patients are required to attend hospital clinics for the test. About one in 10 patients who are investigated for haematuria will be found to have bladder cancer. Frequently, patients are not referred for investigation of haematuria at the time of first presentation and there is a delay in diagnosis of the disease. The early detection of bladder cancer by means of a non-invasive tumour marker test would impact on the management of the disease. There is an unmet need for a simple, non-invasive, highly sensitive and specific method for detecting bladder cancer.

This study will determine the accuracy of UroMark a high-throughput multiplex PCR test to detect bladder cancer in DNA from urine. The study will address the unmet clinical need to improve detection of bladder cancer. The rationale for the trial is based on proof of concept studies which provide compelling evidence that a panel of methylation markers can be applied to detect bladder cancer with high sensitivity and specificity. It will be also be possible to collect and store fractions of urine for assessment of other DNA related biomarkers as well as non-DNA assays for example cellular proteins, soluble biomarkers in urine supernatant and RNA transcripts in sediment cells. In this study we will compare the UroMark assay with established assays including urinary cytology, FISH as well as developing assays such as MCM5. In this proposal excess urine will be stored for these studies.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over 18 years of age.
* Participants undergoing investigation for visible and non-visible haematuria.
* Able to give informed written consent.

Exclusion Criteria:

* Unwilling to have standard haematuria investigations.
* Unable to give informed consent.
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery

The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of TBI and a GCS 7-12
* Only isolated TBI
* CT
* Pre-Trauma Karnofsky-Index = 100
* Age 18-60 years
* Male and female patients
* Time to needle for study medication within 6 hours after injury
* Patient is not pregnant or lactating during the trial and is not of childbearing potential
* Patient was able to speak, read and write in a pre-defined study language before the accident.
* Reasonable expectation of completion of outcome measures at follow-up
* Written informed consent

Exclusion Criteria:

* Evidence of pre-existing major health problems
* Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures
* Injury of writing hand influencing cognitive or other outcome measures
* Clear clinical signs of intoxication influencing the evaluation
* Major drug dependency including alcohol
* Chronic treatment with steroids, Ca2+-channel blockers or major anticoagulants
* Penetrating high-velocity missile head trauma
* Stab wound trauma into the brain
* Patients with spinal cord injury
Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.

The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients reporting persistent developmental disfluency.

Exclusion Criteria:

* Patients reporting no changes in disfluency severity or frequency
Evaluation of Intermittent Triple Therapies in Real Life

The strategy of intermittent triple therapy for people living with HIV was validated in France following the randomized clinical trial QUATUOR. There is little data in real life, as shown in the meta-analysis of Parienti JJ et al.

Currently this strategy is proposed by some teams in France, but is not recommended internationally.

The research hypothesis is that intermittent treatment is an effective and safe option in a therapeutic lightening strategy in people living with HIV People living with HIV adults followed in Strasbourg who have benefited from intermittent treatment The expected results will consist of an improvement in knowledge on the efficacy and tolerance of this therapeutic strategy.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥ 18 years old)
* Living with HIV monitored at the Trait d'Union/Infectious Diseases department in Strasbourg
* Having benefited from intermittent triple therapy between 01/01/2017 and 31/01/2024

Exclusion criteria:

* Subject (and/or their legal representative if applicable) having expressed their opposition to the reuse of their data for scientific research purposes.
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma

This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 \> 60 %
* ICS taking ≤ 1000 μg BDP per day, or equivalent
* Methacholine PC20 \< 4 mg/mL

Exclusion Criteria:

* Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
* Currently a smoker or who has ceased smoking within 6 months of Visit 1.
* Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis