cyrilzakka/clinical-trials huggingface dataset:
Physical Activity Post COVID-19

THis study aims to examine PA trajectory, and potential behaviour-change factors least 12 months after COVID-19, across different levels of acute disease severity, and specifically in people with and without Long COVID.

Eligible participants will be contacted and invited for a first visit by a pulmonologist or a respiratory physiotherapist, during which those interested will provide informed consent. Participants will be interviewed and medical records reviewed to collect sociodemographic, anthropometric, and clinical data. Then, functional capacity, peripheral muscle strength, and lung function will be assessed using several tests, and dyspnoea, fatigue, anxiety, depression, and HRQoL through self-administrated questionnaires. Finally, people will be provided with a specific device and instructed on its use for measuring daily PA over one week. A pulmonologist, specialized nurse, or technician from the corresponding centre will perform and assess spirometry, while two respiratory physiotherapists will conduct and supervise all other tests in a reserved space at the same centre. The assessments were scheduled at three time points: at least 12 months after hospital/medical discharge (baseline), three and six months afterward.

Eligibility Criteria:
Inclusion Criteria:

* At least, 18 years of age;
* Diagnosis with COVID-19;
* Stable condition at hospital discharge or after 21 days of being treated at home (needed time to recover from an acute respiratory infection; however, patients treated at home should report a negative result in polymerase chain reaction \[PCR\] test).

Those reporting clinically relevant symptoms among dyspnoea, fatigue, anxiety, depression or impaired health-related quality of life will be considered affected from post-COVID-19 condition or Long COVID.

Exclusion Criteria:

* Presence of signs of cognitive impairment or significant cardiovascular, neurological, and/or musculoskeletal disease, which may prevent the assessment tests and therefore limit participation. In particular, reasons for exclusion will be the following: cognitive disorders, such as sequelae of Alzheimer's disease, senile dementia; comprehension disorders, such as Wernicke's aphasia; cognitive-motor disorders, such as hemiparesis/hemiplegia due to stroke; musculoskeletal disorders, such as unconsolidated fractures, external prostheses (including replacements in amputees); cardiovascular disorders, such as unstable angina, recent acute myocardial infarction, among others.
* Vacination before infection.
* Reinfections during follow-up.
Lymphovenous Bypass Manage Venous Leg Ulcers

Leg ulcers are areas of epidermal discontinuity in lower limbs with causes of venous, arterial, diabetic, pressure, traumatic, allergic, or inflammation. Chronic venous leg ulcers (VLUs) are defined as leg ulcers persisting for 4 weeks or more, a.k.a C6 in CEAP classification of chronic venous insufficiency (CVI) and account for up to 70% of all chronic leg ulcers exhibiting overall prevalence of up to 2% in the general population of western countries with significant morbidity and a negative socioeconomic impact. Wound care, debridement, bed rest with leg elevation, and compression are basic approaches for chronic VLUs. Meanwhile, numerous medical and surgical interventions were developed to promote wound healing and to prevent recurrence by focusing on pathophysiology of chronic VLUs. However, many strategies just have adjuvant effects or exert debatable benefits.

The lymphatic system been considered important for removal of excessive fluid from the interstitial space, absorption of fat from the intestine and the immune system, actively involved in regulation of immune cell trafficking and inflammation. Emerging lymphovenous bypass (LVB), a supermicrosurgical technique diverting lymphatic drainage into venous system in dealing with lymphedema, not only restores TH1 and TH2 imbalance, but decreases oxidative stress and increases antioxidant capacity in the serum of lymphedema patients. Clinically, LVB could be an alternative treatment option for patients with lymphorrhea.

Based on these facts, the investigators hypothesis that lymphatic hypertension and lymph impregnation contributes chronic venous leg ulcer formation and propose a novel strategy, using LVB to treat patients with refractory/recurrent chronic VLUs. The preliminary results revealed promising results and the investigators would go on clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20\~80 years
* Gender: All
* Poor wound healing after standard wound management for 4 weeks
* Deep vein thrombosis (DVT) has been ruled out by Duplex and Computer tomography or DVT has been treated
* Wound care with nursing specialty
* Recognize and agree to join this trial

Exclusion Criteria:

* Autoimmune status, such as systemic lupus erythematosus
* Heart, lung, kidney or liver failure patients
* Radiation related wound or cancer wound
* Those who cannot understand the trial
* Age less than 20 years or elder than 80 years
* Pregnancy
* Those who was Risky to receive general anesthesia or surgery
* Allergy to Patent Blue V or Gentian Violet
Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients

This is a prospective cohort single center study for assessment of normal value of acoustic radiation force impulse elastography and fibroscan in HIV patients without abnormal liver function and chronic liver disease.

HIV positive patients who have liver dysfunction have shown to be correlated with high mortality and morbidity. To date, ARFI elastography has been known to correlate with the degree of liver fibrosis in chronic liver disease. However, ARFI velocity has not yet been reported in HIV patients. The aim of this study was to identify the normal range of ARFI velocity and liver stiffness value by recruiting HIV patients without abnormal liver function and chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* HIV positive patients
* The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria:

* Co-infected with HIV and HBV or HCV
* History of any other forms of liver disease
* Any gross abnormality on the imaging finding including MRI and CT
* Any laboratory abnormalities regarding liver condition (Platelet count \< 150 x 103/ul, Fasting glucose \> 110 mg/dl, AST \> 40 IU/L, ALT\> 40 IU/L, Albumin \< 3.3 g/dl, Total bilirubin \> 1.2 mg/dl, GGT\> 54 IU/L, ALP \> 115 IU/L , Ferritin \> 322 ng/ml)
Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.

Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.

This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.

TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.

Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.

Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.

TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.

Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.

With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.

The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.

Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions:

* Differences in the risk of infectious complications
* Differences in the overall cancer detection rate and the high-grade cancer detection rate
* Differences in the hemorrhagic and urinary side effects
* Tolerability of both techniques with local anesthesia alone
* Difference in the results of of MRI/US fusion targeted biopsy
* Differences in the cost of the procedures

Eligibility Criteria:
Inclusion Criteria:

* All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
* Either with or without an MRI

Exclusion Criteria:

* Patients with no access to rectum (due to previous rectal surgery)
* Any abnormalities of the perineal skin (e.g. infection)
* Patients whose procedure requires sedation or general anesthesia
Exercises with Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears

There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together.

The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC tears.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral, non-traumatic massive rotator cuff tears according to Deorio and Cofield classification
* Age older than 50 years and attend 1-year follow-up assessment

Exclusion Criteria:

* Patients with symptomatic lesions in the contralateral shoulder
* Cuff tear arthropathy
* Glenohumeral osteoarthritis
* Pseudoparalytic shoulder
* Grade 3-4 fatty degeneration according to Goutallier classification
* History of involved shoulder surgery
* Major systemic conditions that disallowing exercise
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults

This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life.

Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.

Eligibility Criteria:
Inclusion Criteria:

* Indication of anesthesia induction

Exclusion Criteria:

* Protocol violation
* Monitoring problems
Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents

This study examines if the use of antipsychotic medications might contribute to an interruption in bone mineral development and/or a reduction in bone mineral content in adolescents.

Studies have shown that some antipsychotic medications, including Risperdal, can increase prolactin levels in both adult and pediatric populations. Prolactin is a hormone made by the central nervous system. The main function of prolactin is to regulate lactation in females. However, having too much prolactin over time can interrupt bone mineral accrual and a decrease in bone density. Since peak bone mass is reached during adolescents, this is a key determinant of a lifetime risk of osteoporosis. On the other hand, there ahve been no reports of increased prolactin using Abilify. In fact, in adults Abilify has been shown to normalize or even lower prolactin levels. In this study, we will compare the amount of prolactin and bone mineral density of adolescents who take Risperdal or Abilify with bone mineral density of adolescents who do nto take antipsychotic medications. We will also compare the amount of prolactin and bone mineral density of adolescents who take Risperdal with those who take Abilify. This study will also help us to learn about the relationship between medications, prolactin levels, sex steroids, and bone formation markers in adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 11 and 17 years
* Females and males on aripiprazole or risperidone monotherapy for minimum one year
* Within 10th and 90th percentile for height and weight

Exclusion Criteria:

* Pregnancy
* Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis, on chronic systemic steroid therapy for past 12 months
* Menstrual irregularities secondary to excessive physical activity
* History of anorexia nervosa and/or bulimia nervosa
* Subjects on hormonal contraception
Impact of Phytosterol-Rich Extract on Lipid Profile

The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.

The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18 YO)
* Total cholesterol levels at screening ≥ 200 mg/dL

Exclusion Criteria:

* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Use of prescribed medication which may interfere with study measurements.
* Unwillingness or inability to comply with clinical trial procedures.
* Subjects whose condition makes them ineligible for the study at the investigator's discretion.
* Pregnant or having the wish to become pregnant, or lactating.
* Recent participation in another nutritional or medical trial
Postoperative Pain Control in Total Shoulder Arthroplasty

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.

This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

Eligibility Criteria:
Inclusion Criteria:

• Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

Exclusion Criteria:

* Patients under the age of 50 years
* Patients over the age of 85
* Patients undergoing a revision shoulder procedure
* Documented drug or alcohol abuse
* Active narcotic use within 3 months prior to surgery
* Neurological deficit
* Allergy to amide anesthetics
* Oxycodone intolerance
* Unable to take Celebrex
* Enrollment in another clinical trial
* Comorbidity that is contraindicated with the administration of an interscalene block
* Cognitive or mental health status that interferes with study
Bone Flap Fixation Systems For Craniotomy Procedures

Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.


Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 years or older.
* The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
* At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
* Life expectancy higher than 6 months.
* The subject is willing to give his/her informed consent and to comply with the required follow-up.

Exclusion Criteria:

* The subject presents any of the contraindications of the assigned craniotomy closure system.
* Orbitozygomatic or mastoid craniotomies.
* Posterior fossa (skull base) surgeries.
* Combined used of craniotomy systems (plates and clamps).
* The subject is currently participating in an investigational drug or device study.
Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method

Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause. Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. The current study aims to evaluate effects of motilitone on gastric accommodation and emptying after a meal in a group of healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI. The primary endpoint is gastric accommodation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 20 and 70 years of age without upper abdominal pain or discomfort and a structural abnormality on upper gastrointestinal (GI) endoscopy performed within the preceding 6 months were eligible for the trial.

Exclusion Criteria:

* Patients were excluded if they met any of the following criteria:

  1. any functional GI disease or previous abdominal surgery
  2. diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment
  3. significant cardiopulmonary diseases or any malignancies
  4. significant renal (serum creatinine level ≥ 1.5 × the upper normal limit) or liver disease (serum aspartate aminotransferase and alanine aminotransferase levels ≥ 2.5 × the upper normal limits
  5. taking medications that may alter gastric function within 2 weeks prior to the start of the study
  6. pregnancy or lactation
  7. females with inadequate contraception during the study period
  8. contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip)
  9. allergic history to motilitone
  10. other conditions likely to interfere with study procedures, as judged by the investigator
Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)

This is a study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in adult male and female patients with moderate to severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 55 years (inclusive) at the time of screening
* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
* Participants must have had chronic atopic dermatitis (AD) for at least 1 year before Screening.
* Moderate to very severe eczema as determined by Eczema Area and Severity Index (EASI) score of at least 16 at the baseline visit.
* A validated Investigator Global Assessment (vIGA) score of at least 3 at the baseline visit, indicating moderate to severe AD.
* At least 10% body surface area (BSA) of AD involvement at the baseline visit.
* Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit.
* Documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for AD.
* Application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit.

Exclusion Criteria:

* Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, ophthalmological, or connective tissue diseases or disorders.
* Participants who have any surgical or medical procedure planned during participation in the study.
* Participants with a history of alcohol or substance abuse within the previous 2 years.
* Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
* Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening.
* Participants who have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.
* Participants with a history of lack of response to any medication targeting interleukin (IL)-4, IL-13, and/or janus kinase (JAK)- signal transducer and activator of transcription (STAT) pathways (e.g. dupilumab, tralokinumab, upadacitinib, abrocitinib) at approved doses after at least 16 weeks of therapy.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* Female participants of childbearing potential with a positive or undetermined pregnancy result at the Screening and baseline visits.
* Participants with a known sensitivity to any of the components of KT-621.
* Participants who are a member of the investigational team or his/her immediate family.