cyrilzakka/clinical-trials huggingface dataset:
Validation of a Clinical Assessment Scale Specific to Alternating Hemiplegia

Alternating Hemiplegia of Childhood (AHC) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. The disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. The true prevalence of AHC may be underestimated due to a lack of understanding of the disease and a high degree of phenotypic heterogeneity.

It should be noted that, to date, it is difficult to assess the clinical characteristics of AHC patients in a homogeneous way. The lack of disease-specific clinical outcome measures therefore constitutes a critical node for advancing AHC research. In addition, recognition of the pattern of movement disorders and the ability to classify their severity are very important and useful for the clinician. Homogeneous disease assessment will help plan rehabilitative and pharmacological interventions, facilitate monitoring of treatment outcomes, and predict prognosis.

This is why an AHC assessment scale have been developed in collaboration with clinical teams from the IAHCRC consortium.

The scale has already been tested and validated on Italian and Spanish patients. The aim of this study is therefore to validate the use of this same scale on our French population of AHC patients. The hypothesis of the study is that the practical use of this scale specific to alternating hemiplegia is reproducible. To this end, all the items on the scale will be scored independently for each patient by 4 neuropediatricians with expertise in the disease, in order to observe the reproducibility of the results obtained with this scale. The scale will be used for twenty AHC patients of all ages.


Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed diagnosis of AHC, unrestricted age range 0-99 years
* At least one parent and/or legal guardian who understands and speaks the national language

Adult patients :

* Gathering of the non-opposition of the patient and/or his legal representative

Minor patients :

* Collection of non-opposition from parents/guardians

Exclusion Criteria:

* Patient's refusal to participate in the study
* Patient under court protection, unable to give consent
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

The purpose of this feasibility study is to determine if a new emerging technology called photoacoustic tomography (PAT) can be adapted for use in humans for the detection of chronic rheumatoid arthritis.

The objective of this proposal is to adapt photoacoustic tomography (PAT), a novel, nonionizing, noninvasive, laser-based technology, for structural and functional imaging of human peripheral joints affected by inflammatory arthritis.

Combining the advantages of both light and ultrasound scanning, PAT holds promise to present objective optical information in subsurface joint tissues with high sensitivity and high spatial resolution.

This could be of considerable help in the early detection of inflammatory joint diseases. PAT may also prove useful in further understanding the pathophysiology of these disorders and assisting with therapeutic decisions, including assessment of new pharmacological therapies.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age or older can participate in this study.
* Patients can participate in this study if they have had rheumatoid arthritis for more than 2 years and their rheumatologist has referred them to this study.
* Patients can participate as a healthy volunteer with a known history of rheumatoid arthritis.

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients.
* Patients who is claustrophobic.
* Patients with impaired renal function cannot participate in this study such as elevate creatinine clearance, patients on kidney dialysis etc.
* Patients with shock hypotension or unstable low blood pressure.
* Patients with Rhabdomyolysis.
* Patients who have had a contrast enhanced (with gadolinium) MRA (magnetic resonance angiography)/ or MRI within the last 3 months. (Contrast is a medication injected into a vein during a imaging examination that helps produce clearer images/pictures).
Utility of Lung Clearance Index Score As a Noninvasive Marker of Small Airways Disease

To determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of small airways disease in adults with chronic lung conditions compared to healthy adults, adjusting for age, sex and smoking status.

Target Population and Enrollment. The study will recruit and consent 300 patients from our Occupational Medicine and Interstitial Lung/Rheumatology Clinics at National Jewish Health who have been referred for evaluation of chronic lung conditions. The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment. Inclusion criteria for the group with chronic lung disease will include physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years. Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension. Study participation will consist of one visit that will last between 90-120 minutes. The chronic lung disease group will fill out the informed consent and complete both LCI testing and spirometry. The healthy control group will complete informed consent, a brief questionnaire, LCI testing, and spirometry.

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years.

The healthy control group will comprise 300 volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment

Exclusion Criteria:

* Exclusion criteria will include recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension.
Study of the ReGelTec HYDRAFIL System

A study designed to treat patients with back pain associated with degenerative lumbar disc disease.

This study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial low back pain (LBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.

The primary objective of this study is to evaluate the safety and efficacy the HYDRAFIL System.

Eligibility Criteria:
Inclusion Criteria:

* Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration
* Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy)
* Male or female patients aged 22 to 80 years, inclusive
* Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI
* The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1
* Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation
* Signed an informed subject consent form in a language in which they are fluent

Exclusion Criteria:

* History of or current systemic or local infection
* Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography
* Presence of disc herniation that accounts for the majority of the patient's symptoms
* Subjects with Modic type 3 changes
* Subjects with trans-endplate disc herniations or Schmorl's nodes
* Neurogenic claudication due to spinal stenosis
* Previous back surgery at the target level of the lumbar spine
* Evidence of severe compression of cauda equina
* Spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), spinal canal stenosis, isthmus pathology, scoliosis \[Cobb angle \>20 at the incident level\] and other deformity conditions that may compromise the study
* Subjects with arachnoiditis
* Subjects who are prisoners or wards of the courts
* Subjects involved in active litigation including worker's compensation cases
* Subjects with low back pain of non-spinal or unknown etiology
* Subjects with severe osteoporosis or metabolic bone disease
* Subjects who have a history of or are current abusers of alcohol or drugs (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))
* If female, patients who are pregnant or are trying to become pregnant during the course of the trial. (due to risks of additional radiation exposures)
* Failure to understand informed consent or participation in any other clinical study
* Body Mass index (BMI) greater than 40
* Patients with active tumors in the spinal region
* Patients who have been diagnosed to diabetes mellitus
* Patients who have a sensitivity or allergy to the implant materials
The Effect of 4-7-8 Breathing Exercise Training on Sleep Quality

Research; it will be carried out Kilis 7 Aralik University Yusuf Serefoglu Health Sciences Faculty, Department of Nursing. The training will take approximately 20 minutes in an empty classroom and will be planned when the students' classes finish. Thus, educational activities in the institution will not be disrupted. Participants will be asked to do the taught exercise in half an hour before going to sleep every evening during the research period (4 weeks). Training will begin when the determined number of samples is reached. The training will be terminated when the 4-week research period determined to see the effect of the application expires.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer
* Studying in a nursing undergraduate program
* There is no condition that prevents nasal breathing (such as septal deviation)
* No known chronic sleeping disorder

Exclusion Criteria:

* No studying in a nursing undergraduate program
* There is condition that prevents nasal breathing (such as septal deviation)
* Having any chronic sleeping disorder
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
* Have a clinical SLEDAI-2K score ≥4 at randomization.
* Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
* Are receiving at least one of the following standard of care medications for SLE:

  * A single antimalarial at a stable dose for at least 8 weeks prior to screening
  * A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
  * An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Exclusion Criteria:

* Have severe active lupus nephritis.
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Vasculogenic ED for at least 6 months
* International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
* Positive response to PDE5-I (able to penetrate on demand, Responders)
* Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Psychogenic ED
* Neurological pathology
* Hormonal pathology
* Past radical prostatectomy
* Recovering from cancer during last 5 years
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region
Prevalence and Subjective Impairment of Quality of Life (QoL) Due to Dermatologic Diseases in Internal Medicine Patients

This is a 3 months single centre clinical patient-oriented study to evaluate the prevalence and impairment in QOL of dermatologic diseases in patients hospitalised in internal medicine.

Up to 200 patients hospitalised at the division of internal medicine for any reason are going to be offered participation by a patient information form given to patients at the time of admission, as well as oral information about the study. Written informed consent will be obtained by the investigators after patients have had adequate time to consider their participation in the study.

Participating patients will be examined clinically for dermatologic pathologies at a single visit. In the case of signs of dermatologic disease, investigators are going to recommend further diagnostic procedures to the physician in charge and/or the referring physician, depending on the urgency of the suspected diagnosis. This procedure is meant to avoid giving referring physicians the impression that active patient acquisition for the department of Dermatology is an aim of this study. Diagnostic procedures that are performed upon suspicion of a specific dermatologic disease at the Division of Internal Medicine are going to be performed during the hospitalisation period. All other diagnostic or operative procedures are going to be advised to the referring physician.

Study participants are going to be interviewed by the investigators about impairment in QOL of their illnesses. Two separate questionnaires are going to be filled in by each participant. For measurement of general QOL, the widely used SF-12 questionnaire (8 questions) is going to be used. To measure specific impairment in QOL by dermatologic disease, participants are going to be asked to fill in the DLQI (Dermatology life quality index, 10 questions). Photographic documentation of specific identified lesions will be made and pictures stored exclusively in the secured electronic patient file (KISIM). Medication and all identified diseases will be noted. All diagnostically useful information is going to be recorded in the patient file and transmitted to the referring physician in the discharge letter.


Eligibility Criteria:
Inclusion criteria: Patients will be eligible for enrolment if they fulfil the following criteria:

1. Male or female patients, age ? 18 years of age and
2. Hospitalised at the Division of Internal Medicine, University Hospital Zurich
3. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2).

Exclusion criteria: Patients will be excluded from the study if they fulfill any of the following criteria:

1. Ability to communicate orally severely impaired due to any reason, namely illness or inability to speak German.
2. Terminal patients or other patients where participation in a visit with oral and physical examination would represent an unreasonable exertion.
3. Pregnant women
Small Bowel Obstruction in Virgin Abdomen

A retrospective study conductet at Estonia's two regional hospitals. The data of patients hospitalised for SBO (small bowel obstruction) between 2015-2019 is retrospectively analysed. All other patients are excluded- except for previously unoperated ones (virgin abdomen). Study group analyses whether patients were operated on or was conservative management initiated. It will be studied, if any further medical studies have been done within 2 years of hospitalisation.

Background: The surgical dogma of mandatory operative management of small bowel obstruction (SBO) in patients without prior abdominal operations was re-evaluated by the World Society of Emergency Surgery (WSES) in 2021. A few publications exist on this topic, with a modest number of patients included. The purpose of this study was to analyze the causes and management of small bowel obstruction (SBO) in patients without prior abdominal surgeries.

Methods: Study group retrospectively examined the data of patients hospitalized with SBO from 2015 to 2019. Patients without previous abdominal surgeries-virgin abdomen (VA) were included. Eligible patients' data was evaluated. It was noted whether surgery was performed or conservative management was initiated. In the latter case, information about radiological or endoscopic studies, hospitalizations, or surgeries performed within 2 years after the primary hospitalization was extracted

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with SBO Have not been operated previously

Exclusion Criteria:

Age less than 18 years History of previous operatsions Large bowel obstruction Dynamic ileus

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Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

Qualifying patients who are scheduled for angiogram with endothelial function testing are approached to participate in this protocol (consent form reviewed with patient). Those who are willing to participate will have additional measurements taken during their angiogram as part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of a clinically indicated angiogram will be eligible to participate in a 6 month medication trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely during the 6 month trial via phone calls and blood testing for assessment. At the end of the 6 months they return to Mayo for a repeat angiogram to assess endothelial function for any changes or improvements.

Aim I: To determine the activity of the endogenous endothelin system in the coronary circulation in humans with coronary endothelial dysfunction and atherosclerosis risk factors. Aim II: To assess the potential of chronic endothelin receptor antagonists to improve preexisting coronary endothelial dysfunction and myocardial perfusion in humans and Aim III: To assess the effect of chronic endothelin receptor antagonism on the endogenous nitric oxide system in association with oxidative stress in humans with early coronary disease risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 85 years
* Male or female

Exclusion criteria:

* Left dominant circulation
* Heart failure with EF \<40%
* Unstable angina
* MI or angioplasty of the LAD or circumflex with 6 months prior to entry into the study
* Use of radiographic contrast agent within 12 hours of entry into the study
* Use of investigational agents within one month of entry into the study
* Patients who require treatment with positive inotropic agents other than digoxin during the study
* Patients with cerebrovascular accident within 6 months prior to entry into the study
* Significant endocrine, hepatic, renal disorders; local or systemic infectious disease within 4 weeks prior to entry into study
* Pregnancy or lactation
* Mental instability
* Federal Medical Center patients