cyrilzakka/clinical-trials huggingface dataset:
PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.

Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.

The study protocol can be found in:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
* Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:

  * Respiratory frequency \>22
  * O2 saturation ≤93%
  * PaO2 50mmHg
  * PaO2/FiO2 \<300
* Or critical disease with one or more of the following criteria:

  * Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
  * Shock
* Inform consent signed by patient or direct family member.

Exclusion Criteria:

* Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
* Multiorgan failure, defined by a SOFA score of \>5
* hemodynamically unstable, with mean arterial pressure \<60 mmHg, refractory to vasopressors use
* Uncontrolled concomitant infection
* Disseminated intravascular coagulation
* Myocardial infarction
* Acute coronary disease
* Patient on dialysis
* Intracranial bleeding active within the last 7 days
* Pregnancy
Physical Activity and Nutrition in Cancer Survivors

This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with history of cancers were included

Exclusion Criteria:

* Participants with missing cancer investigation, dietary recall, and incomplete follow-up information were excluded from this study.
Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain

This study is comparing two different exercise programs, Qi Gong (gentle stretching, and breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain or fibromyalgia are able to take part in the program. We would also like to know if it is easy to take part in an exercise program.

We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong fitness training, will be more compliant, and have an equivalent or possibly superior improvement on measures of motor function (peak power, endurance, and metabolic efficiency) compared to children given an aerobic fitness exercise program.

Background: Childhood fibromyalgia (FM) and chronic musculoskeletal pain are common and sometimes devastating pediatric disorders resulting in widespread pain, fatigue, tenderness and significant disability. Exercises, including vigorous aerobics, and complementary and alternative health strategies - like Qigong - have shown to be safe and effective in the treatment of adult FM and chronic pain. Qigong may be more tolerable than more vigorous exercise. No data is available for this treatment in children.

Research Question: To test the feasibility of studying Qigong exercise versus aerobic fitness exercise to reduce symptoms and disability in children with FM or chronic pain.

Methods: Randomized single-blind pilot study of 30 childhood FM/chronic pain patients allocated to either 12 weeks of supervised Qigong therapy or 12 weeks of supervised graded aerobic exercise training (cardio-karate).

Expected Results: Physical exercise training - whether Qigong or aerobic exercise - represents a potentially feasible, safe and effective alternative therapy and may increase the ability for these children to resume their normal activities of daily life. Exercise training may therefore emerge as a pivotal mode of therapy for all children with FM/chronic pain. Results from our study will allow us to plan a definitive study.

Specific Objectives: 1. To study the feasibility of enrolling, randomizing and studying participants with FM/chronic pain using validated measures of symptoms, physical and psychosocial function, quality of life and exercise testing. 2. Acquire pilot data that will allow for the estimation of an effect size for the comparison of 2 forms of exercise - standard aerobic fitness exercise, and a specially designed Qigong program. This effect size estimate will be used in designing a subsequent definitive randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-18 years
* Diagnosis of childhood fibromyalgia or chronic musculoskeletal pain (ACR criteria)

Exclusion Criteria:

* Co-morbidity with cardiac, pulmonary or metabolic disease.
* Children who engage in more than 3 hours of structured extracurricular physical activity programs weekly, unless a physiotherapy pool program with emphasis on joint range of motion and stretching.
* Children who are unable to cooperate with testing procedures.
Lidocaine Injection: A Nove Block Therapy for Stroke-related Dysphagia

This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* Dysphagia caused by other diseases or reasons.
Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy

The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Inclusion Criteria:

Adult patients with:

• ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria

* General NIV or HFNC contraindications
* Immediate need for IOT
* Prone position intolerance
* Patients refusal to participate

Interventions:

* Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU)
* Nurse surveilance: at least every 15 minutes

Outcomes:

* Need for IOT
* Effects on the measurements specified above (particularly PaO2/FiO2)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with:

  * ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria:

* General NIV or HFNC contraindications
* Immediate need for IOT
* Prone position intolerance
* Patients refusal to participate
Satisfaction With Phosphodiesterase 5 Inhibitors Treatment In Patients With Cardiovascular Risk

Evaluate satisfaction in people treated with IPDE5 inhibitors over time

12 first patients that are eligible

Eligibility Criteria:
Inclusion Criteria:

* CV risk factors
* Male above 18

Exclusion Criteria:

* Non-informed consent
Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI

The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with traumatic brain injury (TBI). These patients, service members with TBI, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to improve cognitive and motor function, as well as mood.

Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system that provides a combination of cognitive as well as motor skill training in an engaging and repetitive manner \[1\]. This project objective is to assess the feasibility and clinical benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed to provide integrative, customized, intensive and self-guided therapy that simultaneously addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been effective for patients with cognitive deficits as the result of cerebrovascular accident or dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI. In addition to assessing the system's effect on patient's symptoms, we will also evaluate the feasibility of utilizing this system in a military environment by obtaining feedback from the patients and therapists, regarding system acceptance, reliability and ease of use.

Eligibility Criteria:
Inclusion Criteria:

* Male or female military health care beneficiaries 18-67 years of age;
* Presence of TBI (based on standard Veterans Affairs (VA)/ Department of Defense (DoD) criteria);
* With or without upper extremity dysfunction. Upper extremity dysfunction includes but is not limited to decreased coordination, increased tone, decreased strength, and decreased sensation;
* Ability to follow study instructions and likely to complete all required visits for the study;
* Ability to understand spoken and written English;
* At least 6 weeks post TBI.

Exclusion Criteria:

* Age less than 18 or greater than 67;
* Blind or otherwise visually impaired to the extent that lack of sight inhibits utilizing the system;
* Deafness;
* Inability to understand or comprehend consenting to the study;
* Active psychosis, suicidal or homicidal ideations or frequent violent episodes;
* Currently enrolled in active substance abuse treatment
* Inability to even minimally operate BBVR controllers.
Preoperative Laboratory Parameters and Scorings Systems on Postoperative Pulmonary Complications in Thoracic Surgery

Postoperative pulmonary complications (PPC) emerge as a major risk that determines the morbidity and mortality of patients after surgery. PPCs affect the length of hospital stay and increase health costs. Because of this reason, it is important to predict PPCs before surgery. There are many studies on scoring systems that can be effective in predicting PPCs. The most frequently used ones are the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk index, the Nutritional Risk Score (NRS), and the American Society of Anesthesiologist (ASA) score. ARISCAT risk index is mostly evaluated in operations performed other than thoracic surgery. Since the thoracic wall, mediastinum or lungs are directly intervened in thoracic surgery operations, the expected PPCs in these patients may be different from those expected in other surgical groups. Therefore, the ARISCAT risk index may be insufficient to evaluate PPCs in thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective thoracotomy or video assisted thoracic surgery with general anesthesia
* BMI \< 35 kg/m2
* Age 18 - 75 years old
* Expected operative time more than 60 minutes

Exclusion Criteria:

* History of lung surgery
* Advanced lung-heart disease
* Having a previous COVID-19 pneumonia
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults

The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.

The study is a multi-center, prospective, study without controls. The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.

Eligibility Criteria:
Inclusion Criteria:

1. Individual is 18 - 80 years of age at time of enrollment.
2. Subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
3. Subject has adequate venous access as assessed by investigator or appropriate staff.

Exclusion Criteria:

1. Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
2. Subject reports history of liver cirrhosis or liver problems that a health care provider told them they should not use acetaminophen because of liver disorder.
3. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
5. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
6. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
7. Subject is female of child-bearing potential and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
8. Subject is female and plans to become pregnant during the course of the study.
9. Subject is breast feeding.
10. Subject has a chronic heavy alcohol use as determined by investigator.
11. Subject has a history of a seizure disorder.
12. Subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
13. Subject has a history of adrenal insufficiency.
14. Subject is a member of the research staff involved with the study.
Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.

Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :

* as Basal/bolus therapy (B/B) in four-five injections per day .
* as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.

The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).


Eligibility Criteria:
Major Inclusion Criteria:

* Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
* Diabetes Mellitus Type 2 history of one year at least.
* HAb1C \< 7% and less
* Age 18-80 yrs
* Normal Liver function tests

Major Exclusion Criteria:

* History of substance use
* Pregnancy or breastfeeding mothers
* Abnormal liver or kidney functional tests
* Type 1 Diabetes or LADA
* any active disease ( like viral) at the period of investigation
The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.

This study will investigate the influence of injection speed on pain during injection of lidocaine. It is anticipated that a longer injection time will lead to less pain for the patient during the injection. This hypothesis will be tested on healthy volunteers, who will each receive three injections with the same amount of lidocaine subcutaneously on the abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes
Efficacy Study of Fine Needle Technique on Calcific Tendinitis

Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.

One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.

This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.

Our goal is to set a study that will evaluate this treatment between two groups:

1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)
2. Puncturing the calcium in the rotator cuff twice (the controlled group)


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above.
2. 6 months of pain in the shoulder.
3. Positive IMPING and sensitivity on SST.
4. Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
5. Completed conservative treatment: physiotherapy or analgesics.

Exclusion Criteria:

1. Diabetes, Nephrological diseases
2. RC tear according to US.
3. Prior operation in this shoulder
4. Steroids injection in the last three months.
5. A patient that is in the absorption phase of the tendinitis
6. Pregnancy
7. Coagulation System impairments
Efficacy of Sprint Interval Training on Anthropometric Measures

Due to the rising problem of overweight and obesity, many strategies are implemented to combat this issue and one of the most common ways is exercise training. Aerobic exercise is a popular and effective conservative strategy for weight and adiposity management and commonly used exercise protocols are moderate-intensity continuous training (MICT) and interval training (IT). MICT is typically defined as continuous effort that elicits 55%-70% of the maximal heart rate or promotes oxygen consumption equivalent to 40%-60% of the maximum oxygen intake. IT involves repeated exercise with periods of recovery, which includes high intensity interval training (HIIT) and Sprint interval training (SIT). HIIT is exercising at 80% to 100% of maximal heart rate while SIT involves "all-out" or "supramaximal" effort at the intensity of 100% of maximal oxygen uptake. Multiple systematic reviews on the effect of SIT on aerobic capacity or comparisons between other forms of exercise protocols to reduce body adiposity has been conducted, but so far no systematic review has been carried out to evaluate the efficacy of this protocol solely on anthropometric measures on young obese and overweight adults alone. Hence, in this study, a systematic review of the effect of SIT on anthropometric measurements in young obese or overweight adults will be reviewed, filtered and assembled.

Keywords using "obese", "overweight", "sprint interval training", "interval training", "anthropometric measures","body mass index", "fat %" lean muscle mass will be searched through e-databases namely Pubmed (including MEDLINE), Pedro-search, Science Direct, Google Scholar, Web of Science, Scopus and Cochrane Library for the suitable original full text studies. Only randomized control trails will be included in this study and the "Tool for the assEssment of Study qualiTy and reporting in EXercise" (TESTEX) would be utilized to assess each individual study. TESTEX has been validated and is specific to exercise training. The authors wish to use TESTEX as it addresses several shortcomings that PEDro does not e.g. exercise adherence, withdrawal, relative exercise training intensity. In addition, study quality assessment of training studies is more robust with TESTEX. 2 independent evaluators will examine and screen each study for its efficacy to be included in the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals aged 18-35 years old
* Overweight individuals with a BMI of 25.0 to \<30
* Obese individuals with a BMI of 30.0 or higher
* Original full texts with SIT as intervention, occurring 2 weeks or more

Exclusion Criteria:

* Male and female individuals aged below 18 and above 35 years old
* SIT as intervention, occurring less than 2 weeks