cyrilzakka/clinical-trials huggingface dataset:
Effects of N-acetylcysteine on Low T3 Syndrome

The propose of this study is to determine whether N-acetylcysteine is effective in reversing the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.

The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low levels of TSH. These changes affect up to 75% of patients and have prognostic implications.

Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal illness. There is evidence that the reduction in serum T3 was inversely associated with serum IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the metabolism of thyroid hormones has not been determined and the potential role of cytokines on the deiodases has been the focus of research.

In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing the oxygen reactive species and by consuming gluthathione or some gluthathione dependent cofactor.

Considering the absence of human studies evaluating the use of N-acetylcysteine in nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect on changes of thyroid hormones.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute myocardial infarction with less than 12 hours of evolution
* reperfusion therapy (primary angioplasty)

Exclusion Criteria:

* Thyroid disease
* Chronic renal disease with renal replacement therapy
* hepatic insufficiency
* immunosuppression
A Safety Study of ARRY-371797 in Healthy Subjects

This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48 healthy subjects from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female between the ages of 18 and 60 years.
* Females must be of nonchildbearing potential.
* Body weight \> 50 kg (110 lbs) and \< 113 kg (250 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* A positive test for drugs or alcohol.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.
Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors

The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared to multicomponent exercise training.

This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm, parallel group, randomized controlled trial in which 140 community-dwelling older adults at high risk of falls are randomly assigned to receive either a music-based multitask training intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed at three time points: baseline (before intervention initiation), 6-month (intervention mid-point), and 12-month (intervention termination). Outcomes of interest include physical and cognitive performances, and falls. In addition, the investigators specifically address brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 65 years (no upper age limit)
* living in the community, even in protected housing
* identified as being at high risk of falls (i.e., one or more self-reported falls after the age of 65 years or balance impairment as assessed by a simplified Tinetti test or presence of one or two indicators of physical frailty based on Fried's criteria)
* willing to comply with all study requirements

Exclusion Criteria:

* neurological or orthopaedic disease (e.g., stroke with residual motor deficit, Parkinson's disease) with a significant impact on gait and balance performances
* fully dependent on a technical aid for walking such as canes or walker
* diagnosis of dementia based on a comprehensive neuropsychological assessment
* participation in a Jaques-Dalcroze Eurhythmics program or a supervised multicomponent exercise program in the past 12 months
* serious medical conditions or other factors that may limit adherence to interventions or affect conduct of the trial (e.g., terminal illness)
Genetic Polymorphism and Israeli Top-level Athletes

It is still unknown whether different genetic elements play a role in athletes' ability to create their area of specificity.In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of these genes were found to be associated with athletic performance and area of specificity. Since then a few more genes have been found that are related to athletic performance, and our aim in the current study is to expand our research to these new genes which include 3 genetic cascades: genes associated with body fluid balance and homeostasis, genes associated with muscle strength, and genes associated with bioenergy.


Eligibility Criteria:
Inclusion Criteria:

* Top-level athletes
* Other athletes

Exclusion Criteria:

* All others
Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients.

Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients.

Study design: A randomized double blinded controlled clinical trial. Study population:CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab.

Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion.

All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.

Study design: A randomized double blinded controlled clinical trial.

Study population:

CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study.

Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup.

Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.

Eligibility Criteria:
Inclusion Criteria:

1. Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
2. Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)

Exclusion Criteria:

1. CD patients in remission (HBI\<5) or with sever disease (HBI\>16)
2. Patients with a stoma
3. Hospitalized patients
4. Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
5. Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
6. Pregnant/lactating women
7. Inability to sign an informed consent
8. Inability to complete the study protocol
9. An ongoing or planned antibiotics therapy
10. Severe food allergies
SARS-COV-2 Screening in Dialysis Facilities

Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.


Eligibility Criteria:
Inclusion Criteria:

* Facility

  * An established US Renal Care in-center hemodialysis facility located in a county with at least two US Renal Care facilities
  * Facility governing board (Medical Director, Facility Manager, Social Worker and Charge Nurses) willingness to participate Patient
  * Treatment at US Renal Care in-center hemodialysis facility
  * Age ≥ 18 years

Exclusion Criteria:

* Patient

  * Unwillingness to share anonymized clinical (electronic health record) or serum samples drawn during routine dialysis care (i.e., without an additional needlestick). If a patient declines offered testing he/she will still be part of the analyses as long as he/she is willing to share clinical data
  * Dementia or cognitive impairment, with inability to comprehend 'opting out' of participation
Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial

The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage \[without train-of-four (TOF) ratio response and post-tetanic count (PTC) \< of 2 induced and maintained with Rocuronium in pediatric patients for short-term elective surgery.

Muscle relaxing facilitates endotracheal intubation and surgical access. Muscle relaxants have a long duration with the possibility of residual muscle relaxation after surgery (over 40% of patients), and ventilatory problems (hypoxia, hypercapnia, atelectasis, airway collapse) that raise postoperative morbidity and mortality.

All of these facts are accentuated in the pediatric patient due to the reduced airway caliber which tends lead to obstruction and bronchospasm. So far, the effect of muscle relaxants has only been partially reversed by anticholinesterase (neostigmine), which has the limitation of its short duration of action (8-9 minutes) and has many side effects (bradycardia, hypotension, increased salivation, vomiting, dyspnea and bronchoconstriction). It also needs to be combined with anticholinergic (atropine), which causes a dry mouth, blurred vision and tachycardia.

At present, the introduction of sugammadex (Bridion®), an antagonist of nondepolarizing the neuromuscular relaxant rocuronium, may lead to an extraordinary breakthrough. It is the only antagonist able to encapsulate and fully eliminate the muscle relaxant to avoid residual effects and respiratory complications. Muscle strength can be retrieved at any time, without waiting for relaxant metabolism (30 to 40 minutes) and without using the usual classical antidotes (neostigmine and atropine), which produce many undesirable effects that become more troublesome in the postoperatory phase. Sugammadex lacks intrinsic activity and is considered safe, without significant side effects and can be used in cardiovascular or respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes,
* Aged between two and eleven years who have undergone surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.
* Informed consent signed by parents or guardians

Exclusion Criteria:

* No signed informed consent by parent/guardian,
* Anticipated difficult airway,
* Neuromuscular disease,
* Liver and/or renal failure,
* Personal or family history of malignant hyperthermia,
* Previous allergic reaction to any anesthetic.
* Treated at the time of the study with aminoglycosides, magnesium, or anticonvulsants.
Efficacy and Safety of a Purified Standardised Wasp Venom Preparation

The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy


Eligibility Criteria:
Inclusion Criteria:

* History of wasp venom allergy,
* Positive RAST to wasp venom,
* Positive skin prick test to wasp venom

Exclusion Criteria:

* Serious chronic diseases
Brief Pain Exposure Therapy (BPET) for Nociplastic Pain

This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM) and Lupus learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia and Lupus (such as depression or anxiety).

This project was amended and approved by the University of Michigan Medical School Institutional Review Board. These changes include a title update and adding Lupus participants on to the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write and speak English
* Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home

Fibromyalgia participants must have:

* Physician diagnosis of fibromyalgia
* OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9
* OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician.

Lupus participants must have:

* Physician diagnosis of systemic lupus erythematosus
* AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map
* AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease).

Exclusion Criteria:

* Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer)
* Currently receiving cognitive-behavioral therapy or other psychological therapies for pain
* Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
* Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
* Pregnant or breastfeeding
* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
* Lupus group only: taking \>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications)
A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder

Alge as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate

Aerzhi as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate. Once a week, continuous treatment for 5 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Based on clinical symptoms and range of motion (ROM) limitation: abduction is not more than 135 degrees, external rotation is not more than 20 degrees or the maximum internal rotation arrives at the first lumbar spinous process (the tip of the patient can touch) to diagnose the patients with periarthritis of shoulder
2. Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more)
3. At zeroth weeks, according to the pain assessment scale (NRS, range: 0-10), the subjects' self rating pain score was no less than 5 points
4. Fully informed consent signed voluntarily informed consent

Exclusion Criteria:

1. Lead to other diseases of shoulder disorders, such as acute rotator cuff tear, calcific tendinitis. If the diagnosis is necessary, the MRI scan is performed
2. Patients who are not suitable for medical treatment (e.g. patients with surgical indications)
3. Patients who received opioids before the first study of the drug
4. Patients who received the following or more treatment within 2 weeks before the first use of the drug(Bilateral or unilateral shoulder joint movement therapy/Treatment of periarthritis of shoulder with proprietary Chinese Medicine)
5. Patients who received the following or more treatment within 4 weeks before the first use of the drug(Corticosteroids were injected locally or bilaterally on either side of the shoulder or on the other side of the shoulder (bilateral or unilateral shoulder joint);Oral corticosteroids, suppositories or intravenous preparations for the treatment of glucocorticoids)
6. Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug
7. It is diagnosed as rheumatic disease
8. Patients unable to assess their clinical manifestations
9. Skin disease or skin infection around the injection site can cause the risk of injection infection
10. Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus
11. There is a history of hypersensitivity to any component in the research drug (IMP)
Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients

AOC 1001-CS2 (MARINA-OLE) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients

This study will continue to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AOC 1001 in participants that enrolled in the randomized, placebo-controlled, First-In-Human Phase 1/2 AOC 1001-CS1 (MARINA) clinical study.

Participants from AOC 1001-CS1 are eligible to enroll in AOC 1001-CS2 if they have satisfactorily completed AOC 1001-CS1.

The total duration of active treatment in AOC 1001-CS2 is up to 58 months. Once participants have completed active treatment, they will be followed through an 8-week safety follow-up period. The sponsor may extend active treatment beyond 58 months at a future timepoint.

As of September 2024, the dosing regimen was updated to every 8 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Completion of AOC 1001-CS1 (MARINA) study with satisfactory compliance and no significant tolerability issues

Key Exclusion Criteria:

* Pregnancy, intent to become pregnant, or active breastfeeding
* Unwilling or unable to continue to comply with contraceptive requirements
* Any new conditions or worsening of existing conditions that in the opinion of the investigator or sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study
Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting

This is a national, multicentre, prospective, open, two-arm, non-interventional study with hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension, wherein the patients are assigned to a treatment arm based on the department.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients, who received IV treatment (bolus administration) with cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterial hypotension
* Consent to use of data is available
* Patient under careful blood pressure and pulse monitoring (at least 2 minutes measuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutes after the first application of cafedrine/theodrenaline or ephedrine)

Cohort A:

* Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 20% syst. compared to preoperative base value (syst.)
* Patients ≥ 50 years old
* Pre-existing comorbidities (ASA classification 2-4)
* Elective surgery
* General anaesthesia with propofol/fentanyl ≥ 0.2 mg (or equivalent)

Cohort B:

* Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 10% syst. compared to preoperative base value (syst.)
* Patients ≥ 18 years old
* Caesarean section under spinal anaesthesia

Exclusion Criteria:

* Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information

  * Hypersensitivity to any product ingredient
  * Hypertensive blood pressure readings
  * Mitral stenosis
  * Narrow-angle glaucoma
  * Hyperthyroidism
  * Pheochromocytoma
  * Prostatic adenoma with urinary retention
  * Bronchial asthmatics with sulphite sensitivity
  * Hyper-excitability
  * Arteriosclerosis
  * Aneurysm
  * Treatment with other indirect sympathomimetic drugs (Example: phenylpropanolamine, phenylephrine, pseudoephedrine or methylphenidate)
  * Use of Monoamine oxidase (MAO) inhibitors (including within the last two weeks)
* Prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives
* Sepsis, septic shock or systemic inflammatory response syndrome (SIRS)

Cohort A:

• Intra-cranial surgery or heart surgery

Cohort B:

* High-risk pregnancy (emergency Caesarean, severe infantile malformation)
* Multiple pregnancy
* Amniotic infection syndrome