cyrilzakka/clinical-trials huggingface dataset:
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease

This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10).

The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).


Eligibility Criteria:
Inclusion Criteria:

* Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol
* ≥18 years of age
* Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
* Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment
* Patient agrees to not participate in another clinical trial from screening until day 56

Exclusion Criteria:

* Patient is moribund or has an estimated life expectancy \<1 month (e.g., terminal cancer, etc.)
* Patient is anticipated to be discharged from hospital within 48 hours
* Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
* Patient requires invasive mechanical ventilation
* Patient is known to have active tuberculosis
* Patient is known to have hereditary fructose intolerance.
* Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus \[RSV\], parainfluenza viruses, respiratory adenoviruses).
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes

The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (\~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.

Exposure to hypoxia has been advocated as a possible therapeutic aid against obesity. Indeed, our laboratory has provided the first evidence that intermittent, nightly exposure to moderate hypoxia is beneficial in improving insulin sensitivity in healthy obese patients and, therefore, lowers the risk of developing type 2 diabetes. Benefits included reduced fasting glucose levels and improved whole-body (skeletal muscle) and hepatic insulin sensitivity. Whether such intermittent hypoxia improves glucose metabolism in people with type 2 diabetes is unknown.

Eligibility Criteria:
INCLUSION CRITERIA:

* Aged 20-65 yrs
* Body mass index (BMI) \< 55 kg/m2
* Body weight 450 lbs or less (to accommodate body composition assessment)
* Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c ≥ 6.5%
* Non-smokers
* Weight stable over the previous 3 months (\<3 kg fluctuation)
* Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent
* If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea

EXCLUSION CRITERIA:

* Diagnosed with T2DM ≥ 15 years ago
* Pregnant Women
* Current insulin treatment
* Treatment with sulfonylureas or glitinides
* Treatment with a GLP-1 agonist
* Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator.
* Chronic Obstructive Pulmonary Disease (COPD)
* Congestive heart failure
* Prior severe cardiovascular events such as stroke or myocardial infarction
* If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
* Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent
* Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent
* History of high altitude sickness
* History of altitude sickness
* Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.

This non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer (mCRPC) initiating lutetium (177Lu) vipivotide tetraxetan using patient questionnaires.

Data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177Lu) vipivotide tetraxetan), during treatment, at EoT, and during follow-up.

The duration of a treatment cycle is 6 weeks (± 1 week). Patients will be treated for up to 6 cycles (as per local label).

EoT visit / assessments will be performed after the last lutetium (177Lu) vipivotide tetraxetan application.

Follow-up period: patient data will be collected if available up to 1 year after EoT.

Eligibility Criteria:
Inclusion Criteria:

All patients must meet the following inclusion criteria during the identification period:

* Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
* ≥ 18 years old at the time of enrollment
* Written informed consent must be obtained prior to any data collection
* Willing to participate in Quality of Life post treatment date collection for 1 year

Exclusion Criteria:

Patients must not meet the following exclusion criterion during the identification period:

- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan
Therapeutic Effect of Shoulder Anterior Capsular Block Versus Suprascapular Nerve Block in Patients With Frozen Shoulder

he study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups suprascapular nerve block and Shoulder anterior capsular block

The study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups according to the treatment performed .

Shoulder anterior capsular block group

Description:

Ultrasound guided injection For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .

Suprascapular nerve block group

Description:

Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine the needle will be inserted .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed

* A volume of (10ml) of 2% lidocaine (2ml), 3% Mepivacaine (2ml) , 1 ml methyl-prednisolone acetate (40 mg) and dextrose 5% (5ml) will be injected to both groups.
* All patients in both groups will receive immediate stretching exercises and post injection 3 times weekly followed by home exercises

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.

  * Both sexes, males and females.
  * History of complaint \>6 weeks
  * Restricted shoulder movement unilaterally in at least 2 planes including abduction, external rotation, and internal rotation and restricted passive movement.

Exclusion Criteria:

* Patient refusal.

  * -Allergy to local anaesthetics.
  * -Infection at the site of injection .
  * -Coagulopathy
  * -Prolonged opioid medication
  * -Pregnancy
  * -Acute trauma, fracture of the shoulder
  * People who had received an intra-articular shoulder injection within the last 6 months.
  * Patients with tendon tear
Enlighten Study: the EV-ICD Post Approval Registry

Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.

The Enlighten Study is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's post-market surveillance platform.

Eligibility for enrollment is based on market release dates for EV-ICD System within the geography in which the subject is enrolled.

Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent).

Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The total estimated registry duration is through lifetime of device.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a EV-ICD device System and must be enrolled prior to the EV-ICD device implant procedure

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Patient is excluded by local local law
* Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the PSR results
High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock

This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD leads to a significant improvement of the hemodynamic status (mean arterial pressure, vasopressor requirements) in septic patients in comparison to CVVHD treatment with conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage of vasopressors needed to maintain an adequate organ perfusion.

Severe sepsis is a devastating disorder that results from a complex host response to insult after infection. Despite advances in intensive care technologies sepsis remains an important and life-threatening problem. Sepsis is the most common cause of death in the intensive care unit.

Local or systemic release of bacteria-derived compounds, leading to the production of proinflammatory cytokines, induce systemic inflammatory reactions in septic patients. Continuous renal replacement therapies (CRRT) such as hemodialysis (CVVHD), hemofiltration (CVVH) or hemodiafiltration (CVVHDF) with conventional high-flux membranes allow to control fluid and electrolyte balance, and to improve the hemodynamic status of the patients. However, conventional high flux membranes have a limited permeability for sepsis-associated mediators with molecular weights in the range of 15.000 to 60.000 Da.

A promising approach to enhance the mediator removal is to use membranes having larger pores and permeability characteristics than those currently used in CRRT.

For that purpose a High Cut-Off (HCO) membrane has been developed and is manufactured by Gambro Research.After demonstrating the safety as well as the cytokine removal effectiveness in a clinical pilot study this study will assess the influence of the HCO treatment on the disease progression in septic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Fulfilling at least two of the SIRS criteria as defined by the American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference
2. Having signs of renal dysfunction
3. Requirement for catecholamine administration (norepinephrine or others)
4. Acute Physiology And Chronic Health Evaluation (APACHE II) score at enrolment greater than or equal to 19 and less than or equal to 30

Exclusion Criteria:

1. Lack of written informed consent from patients or a legally authorized surrogate
2. Duration of septic shock greater than 4 days
3. Hypoproteinemia (characterized by serum albumin less than 18 g/l)
4. End stage renal failure
5. Known active malignancy
6. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
7. Age younger than 18 years or older than 80 years
8. Known pregnancy
9. Immunosuppression after transplantation
10. Participation in another clinical study
11. Renal replacement therapy greater than 24 hours before randomization
Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock

Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response to the ACTH stimulation test, it is recommended to systematically start steroid replacement therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not respond to fluid resuscitation and who continue to suffer from haemodynamic instability despite increasing doses of noradrenaline.

The interest of this corticosteroid therapy lies in its ability to reduce the duration of treatment with catecholamines, though the results are conflicting with regard to an eventual benefit for mortality.

Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood glucose dysregulation.

Today, there is no way to identify a population of patients who respond to corticosteroid therapy.

From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also exert mineralocorticoid effects able to compensate for the impaired renin angiotensin aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.

This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is defined by a plasma aldosterone/ plasma renin ratio \< 2. It is associated with natriuresis \>30 mmol/l.

We hypothesise that natriuresis \> 30 mmol/l will make it possible to identify patients who respond to steroid replacement therapy in terms of catecholamine use.


Eligibility Criteria:
Inclusion Criteria:

* persons who have consented to take part
* Patients aged 18 to 85 years
* Admitted to an ICU for a first episode of septic shock
* With a dose of noradrenaline ≥ 0.25µg/kg/min
* Undergoing treatment with Hydrocortisone Hemisuccinate (HCHS)

Exclusion Criteria:

* Adult under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* Immunodepression (AIDS, corticosteroid treatment \> 3 weeks, Organ graft, treatment with immunosuppressants)
* Recent intake of diuretics (\< 6 h)
* Long-term ACE inhibitors or ARAII
* Chronic kidney failure (clearance \< 60)
* Cirrhosis Child ≥ B
* Chronic heart failure (NYHA III and IV)
* Decision to limit or to stop treatment
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination

The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
* Able to participate in the entire trial.
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
* show evidence of acute disease within 28 days prior to the first IP administration.
* Have the medical history of bleeding symptom or bleeding disease
* Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
* Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
* Have hypersensitivity reaction histories for Clopidogrel or aspirin.
* Have abnormal laboratory result. AST or ALT \> 1.25 times of upper limit/ Total bilirubin \> 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count \<150X10\^9/L or \>350X10\^9/L
* A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Have donated whole blood within 60 days prior to the first IP administration.
* Participated in the other clinical trials within 90days prior to the first IP administration.
* Take medicine which affect to this trial within 10 days prior to the first IP administration.
* Appropriate subject for the trial judging from principal investigator.
Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).

Exclusion Criteria:

* Patients unable to consent to the study.
* Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
* Patients with active psychiatric disturbances (agitation, active hallucinations).
A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.


Eligibility Criteria:
Inclusion Criteria

* A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
* At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
* Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria

* No pigmented hair within any of the vitiligo areas on the face.
* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
* Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
* Conditions at baseline that would interfere with evaluation of vitiligo.
* Use of any protocol-defined treatments within the indicated washout period before baseline.