cyrilzakka/clinical-trials huggingface dataset:
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19

This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* confirmed COVID-19 disease
* refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
* IL6 ≥ 500 ng/l
* Indication for CRRT or ECMO

Exclusion Criteria:

* Liver cirrhosis Child Pugh C
* "do not resuscitate"-order
* expected survival due to comorbidities \< 14 days
* pregnancy or breastfeeding
* participation in another interventional trial
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects

This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subject, between the ages of 28 and 55 years, both inclusive
2. Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3. Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)

Exclusion Criteria:

1. Subject was a female.
2. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).
3. Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.
4. Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.

   1. Subjects with known risk factors for hypocalcaemia
   2. Subjects with known intolerance to calcium or vitamin D supplements
   3. Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis
5. Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.
6. Subjects have or had any therapy that might significantly affect bone metabolism
Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis

Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.

Ankylosing spondylitis (AS) is a chronic inflammatory arthritis causing back pain, peripheral arthritis and enthesitis due to genetic background and autoimmunity. Patients with ankylosing spondylitis usually suffered from chronic pain over spine and peripheral joints since their second or third decades. It may also cause severe social and psychological burden to patients and their family.

Exercise and non-steroid anti-inflammatory drugs (NSAID) are the standard first-line treatments for AS（1）. Only 50% of patients with AS reach the ASAS response criteria（2） in clinical trials. Patients with severe disease activity should be put on disease-modifying anti-rheumatic drugs (DMARD), such as sulfasalazine（3） and anti-TNF biological agents. Add-on of acetaminophen and low dose anti-depressant （4）can slightly improve the response rate. However, there is no data if tramadol or ultracet can benefit AS.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis
2. Active AS, defined by Bath ankylosing spondylitis disease activity index (BASDAI) \>3 cm at screening visit.
3. Between 18 and 70 years of age.

Exclusion Criteria:

1. Change of dosage of disease modifying antirheumatic drugs (DMARDs) including glucocorticoid, hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline.
2. Change of dosage of biological agents within 4 weeks of baseline.
3. Abnormality in chemistry profiles: serum creatinine 3.0 mg/dl; alanine aminotransferase (ALT\[SGPT\]) 5 times the laboratory's upper limit of normal.
4. Pregnant or breast-feeding women.
Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
* presence of no contraindication for Stellate Ganglion Block;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient\&#39;s family members, indicating their full understanding of the study and agreement to participate.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Pain, Fatigue and Life Quality in COVID-19 Patients

The aim in this study is to evaluate pain, fatigue and quality of life in patients with Covid-19 pneumonia in long-term follow-up and to investigate their relationship with pneumonia severity, age, presence of comorbidity and depression level.

Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR, will be included in the study if the participants read the informed consent form and volunteer for the study.

Patients' age, comorbidities, initial symptoms, and pneumonia severity (mild/moderate/severe) will be recorded. Pain, fatigue and depression assessments will be made on the first day of hospitalization, at discharge, at the 1st month and 3rd month after discharge. The 1st and 3rd month evaluations of the patients will be made by contacting the participants by phone. In addition to the 1st and 3rd month evaluations, the quality of life will also be evaluated with the SF-12 questionnaire.

Eligibility Criteria:
Inclusion Criteria: Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR, will be included in our study.

* Patient with Covid 19 Pneumonia

Exclusion Criteria:

* Uncooperative Patient,
* Illiterate Patients,
* Pregnancy,
* Patients with Chronic Pain or Fatigue in the last 6 months (before COVID-19 disease),
* Patients who were admitted to the intensive care unit during their hospitalization
Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures

This study will assess the reliability of POC ultrasound in estimating right and left atrium pressures in patients with acute decompensated heart failure. This study will compare hemodynamic measurements obtained from pulmonary artery catheters with those estimated from POC ultrasound using inferior vena cava (IVC) measurements and the presence of atrial septal bulge.

For those patients admitted to the CCU who have pulmonary artery catheters placed by the primary team as part of their medical care, the investigators will collect hemodynamic data from their pulmonary artery catheters and echocardiographic data. Echocardiographic and hemodynamic data obtained from pulmonary artery catheters will be simultaneously collected at baseline (within 24 hours of catheter placement) and after 24 and 48 hours of intensive medical therapy if the pulmonary artery catheter is still in place at those times. The placement of the pulmonary artery catheter and the taking of hemodynamic measurements from the catheter will be done as per the primary medical team. The research team will not place any pulmonary artery catheters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced systolic heart failure (as defined by left ventricular ejection fraction of less than or equal to 35% and New York Heart Association Class III to IV symptoms) who are admitted to the CCU and require hemodynamic monitoring with a Swan-Ganz catheter.

Exclusion Criteria:

* Patients supported by mechanical ventilation (intubation or positive pressure ventilation)
* Patients requiring temporary mechanical circulatory support devices (intra-aortic balloon pump, Impella, CentriMag, extracorporeal membrane oxygenation)
* Patients requiring permanent mechanical circulatory support devices (right or left ventricular assist devices)
* Post-cardiac transplantation patients.
Carbon Monoxide-Saturated Medium for Islet Isolation

The goal of this study is to determine whether harvesting islets using carbon monoxide (CO)-saturated mediums can protect islet cell from death after autologous islet transplantation in patients with chronic pancreatitis.

Investigators plan to harvest human islets using carbon monoxide-saturated mediums. Survival and function of transplanted islets will be compared with islets harvested using regular mediums.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
2. Age between 18-69.

Exclusion Criteria:

1. Had prior pancreatic surgeries.

Note: The study was initially designed only to enroll diabetes free patients. To increase enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to participate the study. This revision was approved by the MUSC IRB on 11/10/2015.
Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients

Adequate and effective pain management and prevention of depression are essential in burn patients. This study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period.

Aim: Adequate and effective pain management and prevention of depression are essential in burn patients. This study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period.

Methods: The study was conducted with 67 patients between 18 and 65 years of age, who were ASA I-II class, had basic communication skills, no previous diagnosis of psychiatric illness, and no history of neuropsychiatric or cognitive disease or related treatment. After preoxygenation, anesthesia induction was performed with 2 mg/kg IV propofol and 1 mcg/kg IV fentanyl in the general anesthesia group. Anesthesia was continued with a mixture of 0.3-0.5 mcg/kg/min remifentanil, 2% sevoflurane, 50% air, 50% oxygen. In the sedation group, 1 mcg/kg IV fentanyl and 1 mg/kg IV ketamine were administered at induction; anesthesia was maintained by adding 30-50 mg IV propofol if necessary. The Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Beck Scale for Suicide Ideation (BSSI) were administered preoperatively and on postoperative day one by the psychiatrist.

Eligibility Criteria:
Inclusion Criteria:

* Who were ASA I-II class,
* Had basic communication skills,
* No previous diagnosis of psychiatric illness,
* No history of neuropsychiatric or cognitive disease or related treatment.

Exclusion Criteria:

* With a previous diagnosis of psychiatric illness,
* Neuropsychiatric or cognitive illness,
* Or a history of related treatment.
Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers

This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.


Eligibility Criteria:
Inclusion Criteria:

* Physically healthy volunteers
* Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)

Exclusion Criteria:

* History of clinically significant diseases or illness.
* Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.
The Effect of Interoperable Health IT on Efficiency in Ambulatory Practices

Goal: To evaluate the effects of Interoperable Health IT on provider work flow and work practices in the ambulatory care setting.

Interoperable health IT can produce a reduction of barriers in the exchange of health information that can allow for more efficient, timely, and a higher quality of patient care. This study seeks to evaluate the effects of the implementation of interoperable health IT on the work flow of medical providers in the care environments in which they are implemented.

Interoperable health IT allows for the reduction of barriers in the exchange of health information. Substantial work flow efficiencies and cost reductions may be realized by reducing these barriers, and integrating information exchange among different providers and healthcare systems. Some of the avenues in which these efficiencies and cost reductions are likely to be achieved are through easier access to test results, reduction in medication errors, quality monitoring and improvement methodologies, and increased consumer choice. In recognition of the potential for these improvements, New York State has provided funding to regional entities (Regional Health Information Organizations-RHIO'S) whose role is to assist practice providers in the development, implementation, and integration of these interoperable IT systems. New York State has also provided funding to evaluate the technology implementations facilitated by the RHIOs. The investigators will be working with health care providers that have been assisted by the Greater Rochester RHIO.

Depending on the unique characteristics of the hardware and software that is developed and implemented, there may be variations in operational flow that effect efficiency in the ambulatory care setting. The goal of our study is to measure and evaluate the effects of interoperable IT systems in the work flow practices of providers that have implemented them in the ambulatory care setting.

Eligibility Criteria:
Inclusion Criteria:

* Our population will include all of the providers and office workers within the ambulatory care settings that have implemented the interoperable IT programs, and are required to utilize the systems for their daily job functions. Our research population will not include patients, as the participants of our study are the health care workers.

Exclusion Criteria:

* Our population will be "all inclusive" of all office staff and providers that are required to utilize the systems in place in order to perform their day-to-day functions. There will be no exclusions except for those under 18 years of age, and non English speakers (neither of which are expected to be in the eligible population).
The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Recently, many studies show the potential effect of shock wave for the reinnervation for peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the number of cases is relatively too small to make a conclusive remark. Large and well-designed study would expand the new field.

Eligibility Criteria:
Inclusion Criteria:

Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled.

Exclusion Criteria:

The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS, were all excluded.
Urdu Version of Functional Gait Assessment Scale: Reliability and Validity Study

The aim of study is to translate and culturally adapt Functional Gait Assessment Scale into Urdu language and to investigate the reliability and validity in Pakistani Stroke patients. Also check its correlation with Berg Balance Scale and Barthel Index

The English version of the Functional Gait Assessment Scale will be translated and culturally adapted as per previous recommendation. In geriatric population, Urdu Version of Functional Gait Assessment Scale will distributed among 160 participants choose by convenience sampling technique based on pre-defined inclusion and exclusion criteria.To test inter and intra-observer reliability of the final Urdu Version of Functional Gait Assessment Scale, Barthel Index and Berg Balance Scale, questionnaire will be filled on the same day. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- retest reliability will be assessed for intra-class correlation coefficient. The Urdu Version of Functional Gait Assessment Scale was evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Post stroke patients past 3 months
* Both gender patients are included

Exclusion Criteria:

* Patient suffering from any neurological disorder
* Patient suffering from any musculoskeletal disorder
* Patients who are post stroke less than 3 months
Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.

To show the interest of the association of proprioceptive and orthophonic care of dyslexic children. The assumption is that proprioceptive support by correcting a centrally located spatial localization instability restores the ability to automate.

It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic children.

Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive)


Eligibility Criteria:
Inclusion Criteria:

* Developmental dyslexia, (CIM-10)
* Having benefited from 2 years of speech therapy.
* Pathological reading delay of more than 24 months or -2 standard deviations.
* Either in the course of orthophonic care, or having stopped any orthophonic care.

Exclusion Criteria:

* Refractive correction above +/- 1.5 diopters.
* Absence of binocular vision.
* Amblyopia.
* Convulsion.
Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer

This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.


Eligibility Criteria:
Main Inclusion Criteria:

* Signed written informed consent
* Age 18-80, female or male
* Histopathologically confirmed pancreatic ductal adenocarcinoma
* Patients with locally advanced pancreatic cancer who have previously received standard first-line anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
* Locally advanced pancreatic cancer is defined as follows: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: The tumor contacts the superior mesenteric artery \>180˚; c. Pancreatic body and tail: The tumor contacts the superior mesenteric artery or celiac artery \>180˚; The tumor contacts the celiac artery and infiltrates the abdominal aorta; d. The tumor invades the jejunal branch of the superior mesenteric artery. Portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, vein occlusion, or involvement of a large range of jejunal branches of the superior mesenteric vein.
* At least one measurable lesion (RECIST1.1)
* ECOG PS 0-1
* Expected survival time\>3 months
* Adequate organ function

Main Exclusion Criteria:

* Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ)
* Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices within 4 weeks before the first dose
* Active autoimmune disease
* Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
* Allergic to the active ingredients or excipients of this study drug, cadonilimab, S-1 or capecitabine
* Have not fully recovered from any toxicity and/or complications caused by the intervention before starting treatment
* History of HIV
* Active HBV or HCV
* Pregnant or breastfeeding women
* Any severe or uncontrolled systemic disease
* Active pulmonary tuberculosis
* People with mental disorders who are unable to cooperate with treatment
* Uncontrolled infection
* The investigators assess that the subjects are unable to complete the entire trial process or are otherwise unsuitable for participating in this trial