cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity

Specific objectives:

* Evaluation of morbidity and mortality associated with the severity of pharyngeal residue in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the "The Yale pharyngeal residue scale"
* Evaluation of the accuracy of screening protocol of Dysphagia at the Emergency Department in patients admitted for stoke based on the "Emergency Department Dysphagia Screening Tool"

Dysphagia after stroke is common, affecting 27% to 64% of patients. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, inability to rehabilitate, increased risk of infection, prolonged length of stay in hospital, and an increased risk of death.

Deglutologists who use FEES have long lamented the fact that there was no reliable, validated, anatomically defined, image-based, and easily used pharyngeal residue severity rating scale. All that one had to rely on was the "impression" of residue severity, the definition of which varied from endoscopist to endoscopist In order for any scale to gain widespread acceptance, it must be user friendly, easy to learn, reliable to interpret, and generalizable to all patients undergoing FEES. Such a scale now exists, and it is the Yale Pharyngeal Residue Severity Rating Scale

Need for a trial: The relation between the severity of the pharyngeal residue and the risk of aspiration and subsequently the morbidity and mortality in stroke patients is not well defined yet.

Thus, the purpose of this study was to determine the morbidity and mortality associated with the severity of pharyngeal residue in a specific population: stroke patients

Another objective of the study is to evaluate the accuracy of Emergency department (ED) dysphagia screening in stroke patients compared to a standard swallowing evaluation with FEES.

All patients admitted to Hotêl-Dieu de France university hospital for stroke will be evaluated for dysphagia using the ED dysphagia-screening tool. Preliminary data on the accuracy of the "ED dysphagia screening tool" are promising (Sensitivity of 96%)

In this study outcomes between 2 groups will be evaluated; (ED failed screening group and ED Screening passed group) and thus be able to validate results of previous studies concerning sensitivity and accuracy of the screening tool mentioned previously and finally to be able to identify stroke patients eligible for early oral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients admitted for Stroke (Ischemic or hemorragic)
* Patients reachable by phone call

Exclusion Criteria:

* Previous history of major head and neck surgery
* Previous or actual history of treatment by chemotherapy or radiotherapy for a head and neck neoplasm
* Current Head and neck neoplasm
* Previous or current history of esophageal carcinoma
* Esophageal motility disorder
The Role of Platelet Rich Plasma for Erectile Dysfunction

Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.

Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25).

Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis.

Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means

Eligibility Criteria:
Inclusion Criteria:

* history of mild to moderate erectile dysfunction measured by IIEF

Exclusion Criteria:

* history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
Transcriptome Analysis of the Peripheral Blood in CIDP

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.

We study the change of the:

* gene profile on transcriptome analysis of peripheral blood
* T cell repertory
* igG dosage
* immunological profile

Before IVIG (T1 time) and and 3 weeks after IVIg treatment (T2 time). On a population of patients having: CIDP, autoimmune muscular disease, Clarkson syndrome, or autoimmune diseases.

We also search for polymorphism of FCgammareceptor, TKPC et CASP3 genes in CIDP patients

Eligibility Criteria:
Inclusion criteria :

* Age ≥ 18 years old
* Obtained informed consent
* Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two EFNS/PNS supportive criteria
* Or
* Patient having a muscular autoimmune disease, or a Clarkson syndrome or other autoimmune disease
* Currently treated by IVIG

Exclusion criteria :

* pregnancy
* breastfeeding
Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within past years. However, evidence defining the exact role of apheresis treatment in the therapeutic sequence is still incomplete. INCIDENT-MS evaluates the mechanism of action of immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory MS relapses and thereby will help to identify predictive markers for optimal treatment choice and will generate further insights into the pathophysiology of MS relapses.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised McDonald-criteria
* Incomplete remission of relapse symptoms following initiation treatment with 1000mg/d intravenous methyl prednisolone
* Absence of fever or clinically apparent signs of infection

Exclusion Criteria:

* Baseline EDSS score \>6.5 points
* Previous administration of less than 3x1000mg or more than 5x1000mg IVMPS for initiation treatment
* Known pregnancy or rejection to perform a pregnancy test (female patients only)
* Immunosuppressive treatment for conditions other than multiple sclerosis
* Ongoing neoplastic disorder or past neoplastic disorder within previous five years
* Known or newly diagnosed HIV-, HBV- or HCV-infection
* Regular intake of ACE inhibitor drugs
* Known bleeding disorders (including laboratory abnormalities such as: (I) platelet count\<50.000/µL; (II) international normalized ratio\>1.5, (III) activated prothrombin time\>50s) or intake of oral anticoagulant drugs
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Inclusion Criteria:

- Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

* Age ≤ 18
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment
* Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment
* Any of the following six months prior to and including day of enrollment:

  * Creatine clearance \< 30 ml/min
  * Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3 ULN
  * Bacterial endocarditis
  * Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA
  * Systolic blood pressure \> 180 mgHg or diastolic blood pressure \> 110 mgHg
  * Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding
* Life expectancy \< 3 months in the last year prior to and including day of enrollment
* Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment
* Symptomatic pulmonary embolism two weeks prior to and including day of enrollment
Cold Application on Pain During Chest Tube Removal

Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain.

Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.


Eligibility Criteria:
Inclusion Criteria:

* (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of \< 30 kg/m2, and (f) normal vital signs.

Exclusion Criteria:

* cold urticaria
Oral Liposomal Glutathione Supplementation in Healthy Subjects

This trial is designed to provide evidence of the efficacy of liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions.

This is a randomized study on healthy individuals. The study design includes the recruitment of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and urine samples will be obtained from all subjects at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule: Group A, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000 mg daily)

Eligible participants who sign the informed consent will be randomly assigned to either low dose or high dose glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental liposomal glutathione between subjects. Participants are to limit their consumption of alcohol in the study to no more than 5 oz. of alcohol per week. Supplementation will continue for 1 month with biological samples collected at 1, 2 and 4 weeks after baseline.

Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma. The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary 8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte proliferation and natural killer (NK) cell cytotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy English-speaking male and female volunteers
* Baseline blood glutathione level of ≤ 0.9 mmol/l
* Non-smoking individuals

Exclusion Criteria:

* No history or evidence of disease including cancer, diabetes, heart disease.
* Not taking glutathione as a dietary supplement
* Not taking high-dose antioxidant supplements
A Natural History Study in Participants With DOK7 Congenital Myasthenic Syndromes (CMS)

Participants will attend up to 3 study visits to collect clinical assessments. The assessments will evaluate participants' symptoms and quality of life to understand disease activity in patients with DOK7-CMS better and may inform future study design.


Eligibility Criteria:
Inclusion Criteria:

* Can understand the requirements of the study and can provide written informed consent, and willingness and ability to comply with the study protocol procedures
* Is male or female and ≥18 years of age at the time of providing informed consent
* Has a diagnosis of DOK7-CMS due to biallelic pathogenic mutations in DOK7
* Has a total Quantitative Myasthenia Gravis (QMG) score of ≥3
* For participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine), participant must have been receiving the medication for ≥3 months before screening/baseline

Exclusion Criteria:

* Known medical condition that would interfere with an accurate assessment of DOK7-CMS, in the investigator's opinion
* Is currently participating in any interventional clinical study with a study drug at the time of providing informed consent
* Diagnosis of CMS due to mutation of any gene other than DOK7
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* English-speaking
* Aural-oral verbal communication as primary communication modality
* Post-lingual hearing loss (Audiometric pure tone averages \[0.5-4kHz\] in both ears \>25 dB)
* Does not currently use a hearing amplification device or hearing aid
* Signed informed consent to participate in all study related activities
* Willing to regularly use listening device once provided for the remainder of their time in the study
* Hearing handicap as measured by HHIE-S score \>8
* Able to follow study instructions

Exclusion Criteria:

* Individuals who do not fulfill inclusion criteria
* Evidence of ear disease or pathology requiring further medical evaluation
Study Evaluating the Safety and Tolerability of RCT1100 in Healthy and PCD Subjects

This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.

The primary objective of this study is to assess the safety and tolerability of a single ascending dose of inhaled RCT1100 administered via nebulizer to healthy participants and patients with Primary Ciliary Dyskinesia caused by a pathogenic mutation in the DNAI1 Gene.

Eligibility Criteria:
Major Inclusion Criteria:

* Healthy, adult, male or female of, 18-75 years of age, inclusive, at screening.
* Participant has disease causing mutations in the DNAI1 gene
* The participant has a forced expiratory volume in one second (FEV1) of at least 50% predicted.

Major Exclusion Criteria:

* History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
* History of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin.
* Medically significant hemoptysis
* Anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening.
* Active tuberculosis infection.
* Laboratory abnormalities in clinical laboratory tests at screening:

  1. Serum creatinine level
  2. Total bilirubin, aspartate aminotransferase or alanine aminotransferase values
  3. Hematological or coagulation values outside the normal reference range
* Any medical history of disease that has the potential to cause a rise in total bilirubin over the ULN
* History of alcohol abuse or drug addiction with the last year of screening.
* Active smoker (vaping included).

Other protocol defined inclusion/exclusion criteria may apply.
A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy


Eligibility Criteria:
Inclusion Criteria:

* Age 45 or older, \>/=2 tender and 2 swollen joints, inadequate response to NSAID therapy, hand radiographs with evidence of erosive changes, acceptable form of birth control

Exclusion Criteria:

* Autoimmune arthropathy, History of psoriasis, Previous TNF therapy, current use of any DMARD, evidence of TB, history of Hep C, B, or HIV
An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy

This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Has a definitive diagnosis of DMD prior to Screening based on documentation of clinical findings and confirmatory genetic testing.
* Is currently receiving or has been prescribed to start chronic glucocorticoid therapy at the time of this observational study enrollment.

A participant recruited to Cohorts 1a or 2:

* Is at least 4 years of age at the time of enrollment.
* Is ambulatory per protocol specified criteria.

A participant recruited to Cohort 1b:

- Is non-ambulatory per protocol-specified criteria.

For Delandistrogene Moxeparvovec-treated Participants:

- Will be initiating usual care treatment with delandistrogene moxeparvovec at the time of study enrollment.

For Comparators:

- Is unexposed to DMD gene therapy at the time of study enrollment.

Exclusion Criteria:

* Has any deletion of exon 8 and/or exon 9 in the DMD gene.
* Is currently participating in any DMD interventional study at the time of this observational study enrollment.
* Has a medical condition or confounding circumstances (for example, prior traumatic limitation for mobility or significant behavioral comorbidity) that, in the opinion of the Investigator, might compromise:

  * The participant's ability to comply with the protocol-required procedures,
  * The participant's wellbeing or safety, and/or
  * The clinical interpretability of the data collected from the participant.

Other inclusion/exclusion criteria may apply.
Observational Study to Collect Safety Data and PROMs on Primary THA

This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).

Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Adult subjects.
* Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.
* The subject is willing to comply with the required follow-up visits as per protocol.
* The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion Criteria:

* Subjects under guardianship.
* Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.