cyrilzakka/clinical-trials huggingface dataset:
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.

The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Inpatient
3. Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
4. They present evidence in computerized axial tomography (CT) of pulmonary involvement attributed to the infection by COVID. Patients in whom CT scans are not performed must have suspected pulmonary involvement by clinical examination with simple compatible or suggestive radiology.
5. Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)

Exclusion Criteria:

1. The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
2. At the time of randomisation, patients require one of the following 4 ventilatory supports:

   1. high-flow oxygen devices.
   2. non-invasive mechanical ventilation.
   3. invasive mechanical ventilation.
   4. Extracorporeal membrane oxygenation (ECMO).
3. The patient is or has been treated in the 2 weeks prior to randomisation with glucocorticoids or inflammation modifying drugs, both conventional (thiopurines, cyclophosphamide, cyclosporine, tacrolimus), leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, hydroxychloroquine or chloroquine) as synthetics or biologics directed against therapeutic targets (abatacept, belimumab, CD-20, IL1, IL6, Il12. 23, IL-23, Il.17, TNF, integrin α4β7 or Janus kinase inhibitors JAK). Patients who are only on maintenance treatment with doses of steroids less than or equal to 7.5 mg of prednisone or equivalent per day will not be excluded.
4. The patient is pregnant or breastfeeding.
5. The patient has a chronic renal disease is stage 4 or 5 (CCr \<30 ml/min).
6. Moderate to severe dementia at the investigator's discretion.
7. Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation.
8. Untreated systemic infections not caused by COVID-19.
9. Active stomach or duodenal ulcer.
10. Recent vaccination with live vaccines.
11. Other infection or disease that explains the lung disorder.
12. Inability of the patient to understand the study or to sign the informed consent unless consent is delegated to a legal representative.
13. Active participation in another clinical study in the last 15 days.
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs

Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.

The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages \> 7 years old

  * Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing
  * Sputum SA CFUs \> 10,000 per mL
  * Ability to expectorate sputum
  * Ability to tolerate nasal lavage and collection of breath condensate
  * Willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential
  * Informed consent obtained from subject or legal guardian, and assent if appropriate

Exclusion Criteria:

* Burkholderia cepacia in sputum

  * Subjects who have had changes to their treatment regimen for CF in the past 6 weeks

    * Subjects can be screened 6 weeks after IV antibiotic completion
    * Subjects can be screened 7 days after oral antibiotic completion
  * Received an investigational drug within 30 days of study entry
  * Received any immune globulin or blood product within 30 days of study entry
  * History of hypersensitivity to immune globulin preparations
  * Undergoing any type of dialysis or expected to start dialysis within 30 days
  * Pregnant or nursing females
  * Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.

There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy.

Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5).

Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.

Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years
* Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician)
* EDSS 4.0-7.522
* Stable course of disease-modifying therapy over the past 6 months
* Asymptomatic (i.e., no underlying cardiovascular disease)
* Physician approval for exercise
* Willingness to visit the IU Health Neurosciences Center for testing and training

Exclusion Criteria:

* Pregnancy
* Current use of dalfampridine (Ampyra®)
* Conventional physical therapy or G-EO training within the past 6 months
* Height \<1m or \>2m
* Body weight \>150 kg
* Contraindications to G-EO gait training (e.g., bone instability)
Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Opioids have many side effects, such as constipation, urinary retention, itchy skin, respiratory depression, and postoperative nausea and vomiting. These side effects can lead to delayed recovery, longer hospital stays, and increased health care costs. Opioid-free anesthesia is the combination of anti-nociceptive drugs to block the different pathways involved in the transmission of nociceptive information, control pain, avoid opioid-related adverse reactions, and promote patient recovery. At present, opioid-free anesthesia is not widely used in craniocerebral surgery in neurosurgery, and the relevant clinical data are extensive. Therefore, the investigators urgently need to conduct a randomized controlled study to provide clinical evidence for the efficacy and safety of opioid-free anesthesia in neurosurgical patients.

Data sharing plan: The deidentified participant data reported in this study could be made available to researchers upon approval by the corresponding author (Dr. Ruquan Han, ruquan.han@ccmu.edu.cn) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo craniotomy for supratentorial tumors with general anesthesia;
* 18 years≤age≤65 years;
* American Society of Anesthesiologists (ASA) physical status of I to III;
* Signed informed consent.

Exclusion Criteria:

* Patients with a body mass index (BMI)≥35 kg/m2;
* Patients with severe hepatic and renal insufficiency;
* Patients with cognitive dysfunction, aphasia and other states that do not cooperate with the assessment;
* Preoperative magnetic resonance imaging of the head showed midline displacement \>5 mm;
* Patients undergoing electrophysiological monitoring during surgery;
* Pregnant or lactating patients.
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension

The purpose of this study is to evaluate the effect of complementary and alternative therapies, specifically alternate nostril breathing and foot reflexology, on intraocular pressure in patients with ocular hypertension.

11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had ocular hypertension and were between the ages of 48-74. Patients were excluded if they currently performed ANB or FR, were unable to perform the task, had previous eye surgery or laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout period. After a 30-day drug washout, patients completed either ANB or FR. After instruction, the assigned task was performed for 5 minutes. FR was done on a commercially available foot reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of both feet. Two weeks later, patients completed the alternate task. IOP was measured before the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests were used to evaluate IOP changes within and between each group.

Eligibility Criteria:
Inclusion Criteria:

* patients with ocular hypertension

Exclusion Criteria:

* currently performed alternate nostril breathing or foot reflexology
* were unable to perform the task
* had previous eye surgery or laser,
* were receiving other CAM for ocular hypertension
* were unable to complete a washout period if they using glaucoma eye drops
Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

Follow-up study within the Whitehall II study, selecting 800 participants for further neuropsychological, clinical and imaging (MRI) examinations to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes.

A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012-2013. A random sample of 800 of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and was completed by in 2016. The participants, for whom social and health records have been collected since 1985, were between 60-85 years of age at the time the MRI study started. The pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study have been published and are attached to this application.

Eligibility Criteria:
Inclusion Criteria:

* Member of Whitehall II cohort attending at UCL for phase 11

Exclusion Criteria:

* Not suitable for MRI, travelling to Oxford, seriously physically ill
Stick Together - Pilot Intervention Study

This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.

This one-arm feasibility study pilots the 'Stick Together' intervention among 20 women newly diagnosed with breast cancer at age 25-49 and their cohabiting partners. The intervention aims to strengthen couples' positive dyadic coping and communication, as well as participants mental health and quality of life, as well as quality of life of underage children.

Eligibility Criteria:
Inclusion Criteria (patients):

* women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
* living with a romantic partner

Inclusion Criteria (partners):

* living in romantic partnership with a patient eligible for the intervention

Exclusion Criteria (both patients and partners):

* severe relationship difficulties or current couples counselling
* severe, untreated mental illness in one or both partners
* capable of participating (mastery of Danish language, available smartphone, tablet or other device, no cognitive impairment)
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

The purpose of this study is to evaluate the excretion pathway of orally administered \[14C\]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
* Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and total body weight ≥ 50 kg

Exclusion Criteria:

* Any significant acute or chronic medical illness as determined by the investigator.
* A history of clinically significant hepatic or pancreatic disease.
* Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Catastrophism in Chronic Inflammatory Rheumatism

Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).

Recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.

In chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.


Eligibility Criteria:
Inclusion Criteria:

* Major patients, hospital follow-up, with RA according to ACR 2010 criteria, or spondyloarthritis according to ASAS 2009 criteria or according to AMOR or psoriatic arthritis according to Caspar 2006 criteria.
* Patient who has given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated or benefiting from a health insurance plan.
* Adult patient (≥18 years old).

Exclusion Criteria:

* Patient under the protection of justice, under guardianship or curatorship.
* Patient unable to express consent.
* Patient for whom it is impossible to provide informed information.
* Poor command and understanding of the French language making it impossible to complete self-questionnaires
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

The purpose of this study is to determine if an herbal over-the-counter cream can decrease skin site reactions in multiple sclerosis patients who currently take either Betaseron, Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis. Injection site reactions have been indicated as one of the major reasons for discontinuing treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple sclerosis.

Skin site reactions account for one of the most likely reasons for discontinuation of subcutaneous injections of MS medications. It is imperative that additional methods be determined to decrease the reactions and/or treat the reactions that occur. Individuals continue to use over the counter preparations (e.g. Benadryl or steroid creams) or other treatments recently described (warm compresses) to improve tolerance to the subcutaneous injections and the reactions. Both short (3 to 6 months) and long term skin reactions have been reported by patients. They complain about this at office visits and calls to nurses in clinics or to those who teach injection technique. Recently, this investigator and a nurse colleague found that an herbal cream (Bach's Rescue Remedy Cream) reduced the redness and skin site reactions. A small investigator funded mini-pilot demonstrated a decrease in resolution and in size of skin site reactions and satisfaction of herbal cream versus the placebo cream. This proposed research study builds upon Moore's previous success that documented significant decrease in injection site reactions by adding an air bubble to the injection before injection, which is now described in the injection instructions of Copaxone, Rebif, and Axonex. The specific hypotheses for this study as end points include:

1. The herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream.
2. The herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream.
3. Participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream

Eligibility Criteria:
Inclusion Criteria:

* Participants must demonstrate redness of skin site reactions
* Must demonstrate accurate injection technique prior to initiating the study

Exclusion Criteria:

* Cannot read the flexible measure and record the results.
* Are diagnosed with secondary progressive, primary progressive or Devic's MS.
* Are not taking one of the three subcutaneous injections (Betaseron®, Copaxone® or Rebif®).
* Are pregnant.
* Are younger than 18 years of age.
* Are using combination therapy (e.g., 2 of the immunomodulators, chemotherapy)
* Have allergies to any topical creams used on skin.
Hypotension Prediction Index for Shoulder Surgery in Beach Chair.

The beach chair position is the most commonly used position during shoulder surgery and offers the surgeon numerous advantages over the lateral decubitus position. However, the beach chair position can also lead to hemodynamic changes, including hypotension and cerebral hypoperfusion. It is therefore the anesthesiologist's job to prevent hypotension during the procedure.

The Acumen Hypotension Predictor Index or HPI for short is a software program that can predict the occurrence of low blood pressure during surgery shortly before it occurs. Studies have already demonstrated the effectiveness of HPI in various operations, where hypotension is defined as a mean arterial blood pressure \< 65mmHg for at least 1 minute. To our knowledge, the low blood pressure prediction index has not yet been investigated for the prevention of low blood pressure in shoulder surgery in the beach chair position.

The HPI is built into a monitor that is switched on in addition to the standard monitoring for monitoring blood pressure, pulse, saturation, among other things. The monitor gives a signal when an episode of low blood pressure will occur within 15 minutes. This gives the anesthesiologist the opportunity to anticipate in time so that the occurrence of low blood pressure can be avoided.

Goal The aim of this study is to evaluate the efficacy of the HPI in predicting and reducing the incidence of hypotension during shoulder surgery in the beach chair position.

Procedure A total of 144 patients will participate in this study. Patients will be randomized to the intervention group or the control group according to a 1:1 allocation. In addition to standard monitoring, the HPI monitor will be turned on for all patients. For patients in the control group, the HPI monitor screen will be blinded and the alarms muted.

Patients between 18 and 85 years of age with a BMI ≤ 40 kg/m2 undergoing elective shoulder surgery are eligible for the study.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 40 kg/m2
* Patient can give informed consent
* ASA I-IV
* Invasive blood monitoring
* General anesthesia combined with interscalene block

Exclusion Criteria:

* - Refusal of participation
* Hypotension before surgery (MAP\< 65 mmHg)
* History of stroke
* Dementia
* Contra-indication for interscalene block
* Contra-indication for general anesthesia
* Dialysis
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)

The Centers for Disease Control and Prevention estimates that 1 in 59 U.S. children have been diagnosed with an autism spectrum disorder (ASD). Peer relationships, social skills, and repetitive behaviors are a challenge for those with ASD. Exercise in the ASD population has been examined as a means to improve some of these challenges for children with ASD. This research study will try to see if a structured exercise program called CrossFit Kids can help with these challenges. This study is potentially beneficial in developing an exercise program for children with ASD that can help promote social skill development, reduce stereotypical behaviors, and provide overall health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Autism Spectrum Disorder
* Full Scale IQ \>80 on standardized testing
* English speaking
* Parents must be able to bring children to class twice a week for 14 weeks.

Exclusion Criteria:

* Non-English speaking
* Medical condition or physical impairment precluding them from safely participating in classes (eg. spastic quadriplegic cerebral palsy, critical congenital heart disease, uncontrolled asthma, uncontrolled seizure disorder, etc.)