cyrilzakka/clinical-trials huggingface dataset:
SArcopenia Prevalence in Frail Older Adults. SAF Study

The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (\<0.789 men and \<0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years and over,
* Living independently (ADL score ≥ 5/6),
* Fail or pre-frail according to Fried criteria,
* Informed written consent,
* Subjects affiliated to a social security.

Exclusion Criteria:

* Robusts patients (no Fried criteria),
* Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments),
* Subjects under justice protection,
* Participation in another study at the same time.
Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.

There are two groups:

1. Experimental group: the patients in this group will be treated using a modified aligner appliance.
2. Control group: the patients in this group will be treated using conventional fixed appliances

Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between (18 - 25) years.
2. Mild crowding \< 4 mm in the lower dental arch with class I malocclusion
3. No congenitally missing or extracted teeth (except for third molars)
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Bimaxillary dentoalveolar protrusion.
2. Previous orthodontic treatment.
3. Severe skeletal discrepancy.
Contrast Enhanced Ultrasound in COVID-19

Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes.

This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. The investigators plan to enroll and evaluate 30 patients.

The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to measure the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients and, as exploratory analysis, to assess the significance of imaging findings by correlating to clinical outcomes.

Sulfur hexafluoride lipid-type A microspheres (LumasonTM, Bracco Inc) is an FDA-approved ultrasound contrast agent. Contrast-enhanced ultrasound scan with a duration of approximately 15 minutes will be performed when a COVID-19 diagnosis has been made (or is highly suspected) according to established clinical procedures. One CEUS will be performed per patient, with up to 2 intravenous injections of the contrast agent. The dosing plan will be weight-adjusted, based on a dose of 0.03 mL/kg (with a maximum dose of 2.4 mL per injection). Organ perfusion will be evaluated in the heart, kidneys, and/or brain. Clinical outcomes during hospital stay will be collected for correlation to CEUS-based measures.

Eligibility Criteria:
Inclusion Criteria:

1. Patient (male/female) hospitalized at the Children's Hospital of Philadelphia (CHOP).
2. Patient 17 years of age or younger.
3. Diagnosis of COVID-19 or high clinical suspicion for COVID-19 despite negative tests (according to the definition of probable case by the European Centre for Disease Prevention and Control).
4. Patients have evidence of cardiovascular compromise, myocardial injury, acute kidney injury and/or new-onset neurological symptoms.
5. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Medical history of Lumason hypersensitivity
A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB

The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB patients who have been on anti-HBV drugs but with poor effects, supposing to significantly improve anti-HBV efficacy, even to clean HBV from the patients.

Patients who have been on anti-HBV therapy Complying with the inclusion criteria will be enrolled into our research, Nucleoside analogues (NAs,entecavir） treatment for more than 1 year or interferon（IFN)-a-2a (IFN-a-2a,Pegasys） treatment for more than 24 weeks. The patients will be randomly assigned to experimental group and control group with the ratio of 2:1, one group (control group) will go on receive the anti-HBV drugs treatment solely; another group (experimental group) after enrollment will immediately receive the Hepatitis B Vaccine activated-DCs (HPDC-T cells) for 24 weeks (every 2 weeks once for 24 weeks, 12 times in total), at the same time co-use anti-HBV drugs treatment, as for Pegasys, it will go on to be used for 12 weeks after HPDC-T cells treatment completed.

The technical route of HBV-T cells prepared: First, investigators collect fresh blood of CHB, mononuclear cells were isolated, and induced to HBsAg pulsed DCs in Hepatitis B vaccine (Shenzhen kangtai, Shenzhen, China) and interleukin-4（IL-4)/granulocyte-macrophage colony-stimulating factor(GM-CSF） (Perprotech, New Jersey, USA) (7 days), then co-culture of DCs and Peripheral Blood Mononuclear Cell(PBMCs ）7days, obtain HBV specific T cells, return to the patient finally.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis B patients, aged 18\~65，Chinese
* have been on entecavir（ETV） or telbivudine（LDT） treatment for more than 1 year,and HBV DNA\<100 IU/ml（Roche Cobas）;or have been on
* have been on PEG-IFN treatment for more than 24 weeks,and 20 \< HBV DNA \< 20000 IU/ml（Roche Cobas）.
* HBsAg 100\~5000 IU/ml
* HBeAg 10\~500 COI

Exclusion Criteria:

* Superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
* other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
* ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
* liver cirrhosis (including compensated and decompensated cirrhosis) and liver failure;
* severe bacterial or fungal infections;
* a history of diabetes or cardiac disease or hypertension or nephrosis;
* pregnant women.
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19

The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19 infections .


Eligibility Criteria:
Inclusion Criteria:

* A patient, or legal authorized representative (LAR), has provided informed consent and a written informed consent form.
* Positive COVID-19 test.
* Must be receiving medical care in an intensive care nursing situation.
* Respiratory failure due to COVID-19 disease requiring invasive mechanical ventilation. This care may include but is not required to include the use of dexamethasone.
* Within 18 hours of tracheal intubation to support invasive mechanical ventilation. A goal of this study is that T0 will occur within 24 hours of tracheal intubation to support invasive mechanical ventilation.
* Age 18 to 80 years.
* Males and females (females of childbearing potential who are not pregnant confirmed by a negative serum pregnancy test) and not lactating if recently post-partum).
* Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.

Exclusion Criteria:

* Cardiovascular instability that precludes initiation of hemofiltration.
* Irreversible brain damage based on available historical and clinical information.
* Presence of any solid organ transplant at any time.
* Patients with stem cell transplant in the previous 100 days or who have not engrafted.
* Acute or chronic use of circulatory support device such as extracorporeal membrane oxygenation (ECMO), left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), biventricular assist devices (BIVADs).
* Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three-month period after study treatment.
* Chronic immunosuppression defined as use of any immunosuppressant medications (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine); prednisone use is excepted.
* Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
* Concurrent enrollment in another interventional clinical trial except trials of COVID-19 convalescent plasma, anti-severe acute respiratory syndrome (SARS)-CoV2 monoclonal antibodies, or RemdesivirTM. Patients enrolled in observational studies (without the use of an investigative device or drug), are allowed to participate. Any communication between the Principal Investigator (PI) of this Protocol and the PI of any other clinical study will include the Medical Director of the Sponsor; all such correspondence will be documented.
* Any reason the Investigator deems exclusionary
Dietary Supplements for COVID-19

This is a double blind, placebo controlled, phase III randomized controlled trial evaluating the effects of the dietary supplements vitamin C, vitamin D, vitamin K, and zinc versus placebo on the overall health, symptom severity, and symptom duration of outpatients diagnosed with SARS-CoV-2.

This study proposed is a double-blind, placebo-controlled, phase III randomized controlled trial powered to detect meaningful differences in the overall health and symptom severity of people with COVID-19 between the treatment and control arms. Eligible participants will be randomly assigned, using a web randomization system, in a ratio of 1:1 to one of the following groups: (1) nutrient therapy with vitamin D, vitamin C, vitamin K2, and zinc or (2) placebo. Total trial duration will be 12 weeks. Nutrients or placebo will be given for a period of 21 days following enrolment and randomization. Total trial duration will be 12 weeks. Adverse events will be collected during the treatment phase plus one additional week (maximum 4 weeks).

With respect to the primary outcome of participant-reported overall health, power calculations were conducted based on between-group differences at a single time point (21 days) and Cohen's guideline for a small effect size of 0.3. A sample size of 176 (88 per arm) provides 80% power to detect a difference at an α of 0.05. To account for an approximate 10-15% lost to follow-up we will enrol 200 participants (100 per arm).

Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥18) who test positive for SARS-CoV-2 in an outpatient setting
2. Access to internet

Exclusion Criteria:

1. Symptom onset greater than 4 days prior to enrolment
2. Supplementing regularly with \>500 mg vitamin C, \>1000 units vitamin D, \>120 mcg vitamin K (any form), or \>15 mg zinc taken daily within the past month
3. Currently taking warfarin or an equivalent vitamin K antagonist anticoagulant
4. End stage chronic kidney disease
5. History of calcium oxalate kidney stones
6. Active granulomatosis (sarcoidosis, tuberculosis, lymphoma)
7. Known hypercalcemia or hypervitaminosis D
8. Currently taking either of the following antibiotics: cephalexin, tetracyclines
9. Participating in an investigational study or participation in an investigational study within the past 30 days
10. Any reason which, under the discretion of the qualified investigator or delegate, would preclude the patient from participating.
Exercise and Nutrition for Head and Neck Cancer Patients

Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 Years of Age
* Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
* Will receive radiation as part of treatment plan
* Able to walk without assistance
* Received clearance for exercise from treating oncologist
* Lives in Calgary, Alberta area
* Can speak and write English
* Is interested in participating in the study
Evaluation of the Relationship Between Muscle Architecture and Muscle Strength in Female Gonarthrosis Patients

The goal of this cross-sectional study is to evaluate muscle architecture changes and it's effect on muscle strength in female patients with gonarthrosis.Main questions are:

* Is there any correlation between muscle strength and muscle thickness, pennation angle fiber length?
* Is there any muscle architecture difference in gonarthrosis and is it effecting the muscle strength? The investigators will enroll patients with unilateral gonarthrosis so that investigators can compare the changes within osteoarthritic and healthy knee with the same physical activity levels.

Knee osteoarthritis (OA) is a chronic disease characterized by morning stiffness, reduced joint range of motion, chronic pain, and decreased muscle strength, leading to functional limitations as the disease progresses . In patients with knee osteoarthritis, all muscles of the hip, knee, and ankle are affected in some way . Evidence suggests that impairments in muscle strength in the lower extremities contribute to increased pain and joint space narrowing. Voluntary muscle contractions lead to various changes in muscle architecture, including changes in fascicle angle and pennation angle as well as muscle thickness. While muscle cross-sectional area and thickness are primarily associated with the magnitude of generated force, parameters such as pennation angle have been found to be more related to explosive force. Ultrasonography (US) is a non-invasive imaging method that can visualize these changes. Muscle architecture parameters obtained from US can provide reliable data related to muscle contractility independently of surrounding muscles. Furthermore, US is considered to have similar validity to MRI imaging, which is the gold standard for displaying muscle architecture. Additionally, isometric muscle strength can be reliably measured using handheld dynamometers. Although studies have investigated the relationship between muscle strength and muscle architecture determined by US in patients with knee OA, these studies have predominantly examined the relationship in the quadriceps muscle, and muscles associated with the ankle have not been studied extensively.

Eligibility Criteria:
Inclusion Criteria:

* To be ≥18 years of age,
* Presence of unilateral knee OA (according to American College of Rheumatology criteria),
* Presence of knee OA with Kellgren/Lawrence (K/L) stage ≥2,
* Ability to live independently,
* Ability to walk without assistive devices.

Exclusion Criteria:

* History of surgery on the spine or lower extremities,
* History of inflammatory rheumatic disease,
* Severe cardiovascular disease,
* Neuromuscular disease affecting muscle strength,
* Individuals following a regular exercise program,
* Secondary osteoarthritis.
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection

The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.

This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 positive test result
* Mild to moderate respiratory symptoms of COVID-19.
* Systolic blood pressure ≥ 105 mmHg.
* Screen within 3 days of a positive COVID-19 test.
* Age ≥18 years old.
* Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls.
* Able to read/write/speak English or Spanish fluently.
* Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent.
* Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.

Exclusion Criteria:

* Severe allergy to any ARB or ACE-inhibitor, including angioedema
* In the intensive care unit at screening.
* Home meds include any kind of ACE inhibitor or ARB
* Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)
* Hyperkalemia \>5.0 mmol/L at baseline or any time during treatment in the study treatment arm
* Creatinine Clearance \< 30 ml/min at baseline or any time during treatment in the study treatment arm
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Intact uterus
* Generally health postmenopausal women 45 to 60 years of age, inclusive
* Sexually active
* No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion Criteria:

* Known or suspect estrogen-dependent neoplasia
* Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
* Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.