cyrilzakka/clinical-trials huggingface dataset:
Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 infection
* Confirmed or imminent respiratory failure
* At least one of the following conditions

  1. Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)
  2. Severe disease, defined as:

     * dyspnea,
     * respiratory frequency ≥ 30 bpm,
     * blood oxygen saturation ≤ 93%,
     * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
     * lung infiltrates \> 50% within 24 to 48 hours
  3. Life-threatening disease, defined as:

     * respiratory failure,
     * septic shock, and/or
     * multiple organ dysfunction or failure

Exclusion Criteria:

* No Exclusion
A Trial of SHR-4849 in Advanced Solid Tumors

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849 for Advanced Solid Tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent prior to initiation of any study-procedures
2. Age from 18 to 75 years old at the time of signing the informed consent
3. Histologically or cytologically confirmed advanced solid tumors
4. At least one measurable lesion was identified per RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Has a life expectancy of at least 3 months.
7. Adequate organ function
8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastasis.
2. Subjects with a history of malignant tumors within 5 years prior to the first dose
3. Subjects with uncontrolled cancer pain.
4. Subjects with severe cardiovascular disease.
5. Subjects with clinically significant hemorrhage
6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
7. Subjects highly suspected of interstitial lung disease
8. Subjects with serious infection within 4 weeks prior to the first dose
9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
12. Subjects who received major surgery within 4 weeks prior to the first dose
13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
15. Known allergic to any component of SHR-4849 products
16. Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
* Body weight of 20kg or less (actual, estimated, or measured)
* NPO for four hours or more
* Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.

Exclusion Criteria:

* Discretion of parents
* Discretion of provider
* Body weight greater than 20kg (actual, estimated, or measured)
* Starting Aldrete score \<9/10
* Known or suspected psychosis
* Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
* Significant elevation in blood pressure
* Known hypersensitivity to ketamine
* Non-English or Spanish speaking
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
* LVEF (left ventricular ejection fraction): 25-45%;
* Age between 18 and 70, borh gender;
* Women of childbearing age agreed to take contraceptive measures during the whole study period;
* No psychiatric illnesses and speaking dysfunction;
* Informed consent.

Exclusion Criteria:

* Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF\<24%;
* Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
* Patients suffered from severe arrhythmia;
* Patients suffered from stent thrombosis;
* Patients receiving immunosuppressive therapy;
* Patients have tumor or other lethal diseases (expectation of life\<6 months);
* Women who plan to be pregnant or are pregnant or nursing;
* Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
* Other clinical trial participants within 3 months;
* Investigators judge other conditions not suitable for inclusion.
Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuously. Breakfast and lunch meals will be provided and must be consumed at the International Diabetes Center.


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* Age 18 and older
* Diagnosed with type 2 diabetes for a minimum of 6 months
* Is taking metformin for diabetes management; no other diabetes medications
* Has been on a stable dose of metformin for at least 3 months
* HbA1c is 7% or greater and less than 9%; \>7% or \<9%
* BMI \<30kg/m2
* Willing to give informed consent
* No evidence of acute illness, fever, undue stress
* Motivated and capable of following the protocol and instructions provided by the healthcare professional
* Available for the study on the scheduled visit days
* Access to telephone communications

Exclusion Criteria:

* Under 18 years of age
* Has not been diagnosed with type 2 diabetes for a minimum of 6 months
* Is currently taking other diabetes medications in addition to metformin
* Has taken other diabetes medications within the past 3 months
* HbA1c \<7% or \>9%
* BMI \> 30kg/m2
* Unable to follow the study protocol
* No access to telephone communications
* Unable to read and write in English
* Unable to maintain their health, or have undue stress
* Skin abnormalities at the insertion sites that would confound assessment of the effect of the device on the skin
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of device performance
* Taken oral or inhaled prednisone or cortisone medications in the previous 30 days
Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients

The study is devoted to the comparative analysis of the data received in patients with COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).


Eligibility Criteria:
Inclusion Criteria:

* Patient Informed Consent;
* the diagnosis of COVID-19 or one of the following lung diseases: chronic obstructive pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease
* high resolution computed tomography scans performed not later than one month before pCLE (for non-COVID-19);
* planned or performed histology (for non-COVID-19)
* Severe respiratory failure,

Exclusion Criteria:

* pregnancy or breast feeding,
* lung bleeding,
* any acute or chronic disease that may be a contraindication to bronchoscopy,
* any diseases of hematopoietic system,
* taking part in other clinical trials
Self-compassion and Nutrition (SCAN) Study

The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI between 40 - 55 kg/m2
* Female
* Score high on internalized weight bias

Exclusion Criteria:

* Presence of any condition that would limit one's ability to exercise (i.e., orthopedic limitations)
* Recent weight loss (≥15 pounds within the past 6 months)
* History of bariatric surgery
* Current or recent enrollment (completed \<1 year ago) in a weight loss program at the Weight Control and Diabetes Research Center
* Currently taking any weight loss or other medication that could alter one's metabolism
* Women who are pregnant, planning on becoming pregnant in the next 6 months, or those pregnant within the past 6 months
* Serious psychiatric disorder (e.g., psychosis, major depression, suicidality) -
* Participants with a history of diabetes or heart disease will be considered for this study only if their heart disease or diabetes is well controlled, and physician consent will be required.
ZYNRELEF for Pain Management in Total Knee Arthroplasty

The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement.

The main questions it aims to answer are:

* How well does the study drug control pain in the days after surgery?
* Does the study drug reduce the amount of opioid analgesic consumed after surgery?

Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam).

Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients undergoing primary unilateral total knee arthroplasty \[Current Procedural Terminology Code: 27447\]
2. Patients with a diagnosis of primary osteoarthritis \[ICD-10 codes: M17.0, M17.10, M17.11, M17.12\]
3. Varus deformity less than 10 degrees
4. Flexion contracture less than 10 degrees
5. Age 35 - 70 years old
6. BMI \< 40
7. Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure

Exclusion Criteria:

1. Inflammatory arthritis
2. Post-traumatic arthritis
3. Valgus deformity
4. Severe varus (\> 10 degrees)
5. Severe flexion contracture (\> 10 degrees)
6. Overnight or longer hospital stay after surgery
7. Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair
8. Creatinine \> 1.2
9. Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease
10. Uncontrolled Diabetes mellitus (Glycated Hemoglobin \> 8.0%)
11. Current liver disease
12. Personal history of depression or anxiety disorder
13. Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)
14. Narcotic or tramadol use within 2 weeks of the planned procedure
15. Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics
16. Walking aid for anything other than the operative joint
17. Contraindication for use of the study drug (as specified by the manufacturer):

    * Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components
    * History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs
18. Patients taking the following medications:

    * Amitriptyline
    * Nortriptyline
    * Gabapentin
    * Pregabalin
    * Duloxetine (SNRI)
    * Des-Venlafaxine (SNRI)
    * Cyclobenzaprine
    * Baclofen
19. Pregnant or lactating females
20. Patients unable to provide informed consent
21. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
PRD-guided Analgesia During FESS for Intraoperative Blood Loss

The aim of this randomized trial is to assess the utility of Pupillary Dilatation Reflex (PRD) for monitoring pain perception intraoperatively and its influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane

Intraoperative blood loss during FESS constitutes a major problem for a surgeon because it influences quality of surgical field. Each incident of haemorrhage makes the operator stop the procedure in order to bring back the optimal visualization of the intranasal anatomy. In the end it prolongs the time of procedure.

Currently, intraoperative blood loss is estimated based on Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).

Recently, Pupillary Dilatation Reflex (PRD) was added as a surrogate variable showing the nociception-antinociception balance into above mentioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. PRD value \>5% reflects increased sensitivity to painful stimulus it constitutes the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of PRD-directed analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane Currently, FESS is most often performed using total intravenous anaesthesia (TIVA) which is by majority of anaesthesiologists believed to reduce the intraoperative blood loss compared to general anaesthesia using volatile anaesthetics, but current literature provides conflicting findings in this area if the sort of anaesthetic used influences quality of the surgical field.

Eligibility Criteria:
Inclusion Criteria:

* - written consent to participate in the study
* written consent to undergo functional endoscopic sinus surgery under general anaesthesia
* ASA (American Society of Anesthesiologists) I-III

Exclusion Criteria:

* age under 18 years old
* allergy to propofol
* pregnancy
* any anatomical malformation making PRD or SE measurement impossible
Peripheral Endothelial Function in Asthmatic Patients

The aim of the study is to assess the peripheral endothelial function in adult asthmatic patients and the relationship between the peripheral endothelial function and the pulmonary function.

The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the FEV1, the forced vital capacity (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. In addition, a relationship between peripheral endothelial function and the level of asthma control (Asthma Control Test (ACT)), the cardiovascular risk factors (SCORE INdex) and the treatment for asthma (controllers) will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a clear-cut history of asthma at the time of enrolment into the trial (eventually confirmed in the past and documented by an increased hyperresponsiveness to methacholine; or a bronchodilator reversibility to a beta-2-adrenergic drug).

Exclusion Criteria:

* Patients with unstable asthma
* Patients with a significant acute disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
* Pregnant or nursing women.
Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study

Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic symptoms. Despite cluster headache is called "suicide headache", its natural history has not been well investigated. The investigators aimed to investigate its disease course, overall prognosis, and treatment pattern in retrospective cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as cluster headache
* More than 5 years after the first visit

Exclusion Criteria:

* Subjects who refused the telephone visit
Short and Intensive Treatment of Children and Adolescents With Obsessive-Compulsive Disorder

Obsessive-compulsive disorders are very damaging illnesses; they can already appear in childhood and adolescence and become extremely chronic. With an average prevalence from 1-3%, they are among the most common psychiatric disorders in children and adolescents. 40% of diagnosed children and young adults display persistent and increasingly chronic symptoms and O-C disorders are highly complex syndromes with broadly varying manifestations. They arise from obsessive thoughts (ideas/thoughts or impulses, often senseless or tortured, that impose themselves or intrude) and obsessive behavior (ritualized patterns that must be frequently repeated).


Eligibility Criteria:
Inclusion Criteria:

* Obsessive-Compulsive Disorder diagnosis
* Male and female patients from 8-18 years
* Good German language speaking skills
* IQ of at least 75
* At least four days' participation in the treatment/therapy week
* Written agreement after clear explanation

Exclusion Criteria:

- No complete participation in the intensive week treatment/therapy
Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia

30 children with a diagnosis of hemiplegic cerebral palsy

children aged 6-9 years were randomized into 2 groups, control group and study group

Eligibility Criteria:
Inclusion Criteria:

* manual ability classification system level II or III, Modified ashwarth scale 1+ or 2

Exclusion Criteria:

* visual or auditory problems ,fixed deformities
Gait Evaluation of Experienced Below Knee Amputees

Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Post traumatic trans tibial amputees
* No stump pathology
* No assistive devices
* No technical difficulty

Exclusion Criteria:

* Vascular or DM background
* Stump pathology
* Gait difficulties
* Assistive device
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures


Eligibility Criteria:
Inclusion Criteria:Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).

* Esophagectomy performed at the same institution where patient enrollment and follow-up is planned.
* Two dilations to at least 16 mm in diameter since esophagectomy.
* 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm.
* Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
* Unable to pass a standard endoscope (approx. 9.8 mm diameter).
* Age 18 years or older.
* Willing and able to comply with the study procedures and provide

Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter.

* Dysphagia related to motility disorder.
* Non-anastomotic esophageal strictures.
* Esophagocolonic strictures.
* Planned adjuvant radiation therapy post esophagectomy.
* Prior esophageal stent placements post esophagectomy.
* Active erosive esophagitis.
* Sensitivity to any components of the stent or delivery system.
* Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
* Stricture length \> 5 cm.