cyrilzakka/clinical-trials huggingface dataset:
Effects of Beef Consumption on Skeletal Muscle Protein Homeostasis and Inflammatory Factors in Pre- and Postmenopausal Females

This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.

A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females. A premenopausal normal/overweight group consuming beef containing study meals will also be recruited to serve as a healthy control comparison.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women ages 50-65 (absence of menstruation for at least 12 months).
2. Premenopausal women ages 35-45 (presence of normal monthly menstruation for the past 12 months).
3. BMI of 20.0 - 34.9 kg/m2.
4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Any substantial musculoskeletal injuries/diseases that have limited daily activities in the past month.
2. Unable to stop the use of anti-inflammatory drugs for the week prior to and during study.
3. Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
4. Currently pregnant.
5. Gave birth or was lactating within previous 12 months.
6. Undergone gastric bypass/bariatric surgery.
7. Clinically significant weight gain or loss (\>5% change) in the last 12 months.
8. Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin, thyroid medication).
9. Unable or unwilling to suspend anti-clotting medications including aspirin use for 5 days prior to Visit 4.
10. Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.
11. Unwilling to fast overnight.
12. Surgical menopause.
13. Having undergone hormone replacement therapy in the last 12 months.
Pruritus and Pemphigoid in Nursing Home Patients

The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.

Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient of a nursing home
* Age 65 years or above
* Subject or their official representatives have signed informed consent

Exclusion Criteria:

* Age below 65 years
* Subjects who do not have signed informed consent
* Receiving treatment with any systemic immunosuppressive agents
* Terminally ill patients with a life expectancy of less than 4 weeks
Association Between Mortality and Diabetes in Elderly Koreans: the South-West Seoul (SWS) Study

Diabetes mellitus is known to increase the risk of premature death in the general population. In this study, the investigators examine the impact of body mass index (BMI) levels, waist circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in elderly Koreans.

The investigators analyze follow-up data from the South-West Seoul (SWS) Study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.

Briefly, the study population was selected from four urban districts (Guro, Yangcheon, Gwanak and Gangseo) located in the south-west area of Seoul. A total of 1737 apparently healthy individuals (between 60 and 92 years of age) eventually participated in this survey starting in 1999. A follow-up examination was performed in 2002, and an additional 873 subjects who had not participated in the first examination were newly recruited.

After a median follow-up of 10 years, each subject's vital status or cause of death as of 31 December 2011 was determined after linking these cohort data with death certificate data from the Korean National Statistical Office. Terminology and codes from the International Classification of Disease, Tenth Revision (ICD-10), were used to classify the underlying cause of death due to cardiovascular disease (ICD-10 codes I00-I79), cancer (ICD-10 codes C00-C97) and others.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy individuals
* Over the age of 60 years

Exclusion Criteria:

* Those with a mismatched identification number
* Missing data regarding BMI, waist circumference, and presence of diabetes
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures

As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.

Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years or elder；
* Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
* Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
* Participants who are willing and able to perform hepatectomy or tissure biopsy.

Exclusion Criteria:

* Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
* Diagnosis of malignant tumors before recruitment；
* Anti-tumor therapy before recruitment ；
* HIV infection；
* Pregnancy；
* Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;
* Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.
* Participants with any other factors that may leading to termination of the study.
Adaptability and Resilience in Aging Adults-2

Chronic low back pain is a major health concern among older adults and is associated with increased economic, functional, and psychological burden. Resilience has been highlighted as a crucial factor in positive health-related functioning, and a growing body of literature supports the use of resilience-based interventions in chronic pain. Therefore, the goals of this project are to examine the feasibility and acceptability of a resilience intervention for chronic low back pain among older adults.

Chronic pain is one of the leading causes of disability, affecting over 100 million people in the United States and resulting in tremendous health care costs and psychological burden. Older adults are disproportionately impacted by pain, with an estimated 60-70% of people over the age of 65 reporting persistent pain. Despite this, pain management is frequently suboptimal among older adults as pharmacological therapies show limited clinical efficacy and a greater risk of adverse effects, and nonpharmacological (e.g., psychological) treatments are often underutilized.

Resilience is conceptualized as adaptive functioning in the face of adversity and comprises a range of psychological, social, and physical resources. Increasing evidence suggests that modifiable resilience factors are associated with more favorable pain outcomes, including lower clinical pain/disability, higher quality of life, and enhanced psychological and physical functioning. Although cross-sectional research supports the significance of these resilience factors in pain adaptation, and positive psychological therapies have been shown to yield improvements in health and well-being, strategies to augment resilience are understudied in individuals with chronic pain.

Using a Stage Model approach,the aim of this project is to conduct a Stage I pilot study and examine the feasibility and acceptability of a resilience intervention for chronic low back pain among older adults. Intervention modules will specifically engage hope, self-efficacy, positive affect, and pain acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older
* Low back pain on at least half the days over the previous 6 months
* Average daily back pain score ≥3 on a 0-10 numerical rating scale
* At least moderate (≥3/10) CLBP-related interference on a 0-10 numerical rating scale
* Able to read/write in English

Exclusion Criteria:

* Current participation in another psychological treatment
* Severe psychiatric illness not adequately controlled by medication (e.g., schizophrenia, bipolar disorder) or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence)
* Presence of chronic, malignant pain (e.g., HIV, cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.)
* Significant cognitive impairment on the MoCA
* If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for ≥4 weeks prior to the baseline assessment
Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures.

Primary outcome: duration of postoperative analgesia. Secondary outcome: include \[The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.

Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone .

Dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres .

Tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures
* Both sexes

Exclusion Criteria:

* Patients with known allergy to the study drugs
* Skin infection at site of needle puncture
* Significant organ dysfunction
* Coagulopathy
* Drug or alcohol abuse
* Epilepsy and psychiatric illness that would interfere with perception and assessment of pain
Safety, Tolerability and Effects of Mannitol in Parkinson's Disease

Parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. Currently, no disease-modifying therapy exists for this disease. Mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. In this phase II, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with Parkinson's disease for 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and signing of informed consent form.
2. Age 40-75 years at the day of visit 1.
3. Diagnosis of Parkinson's disease that is based on the United Kingdom brain bank criteria diagnosed after the age of 40.
4. Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit 1.

Exclusion Criteria:

1. Patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1.
2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion).
3. Patients with dementia reflected by a Mini-mental state examination (MoCA) ≥ 24.
4. Patient with legal guardian.
5. History of psychosis or use of dopamine receptor blocking agent on the year proceeding at the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed for indication other than psychosis is allowed.
6. Suspected Parkinsonian syndrome other than Parkinson's disease.
7. Use of medical marihuana on the month proceeding visit 1.
8. Pregnant or lactating women, or fertile woman who does not use contraceptive. Woman of child-bearing potential must have a negative urine Human chorionic gonadotropin (hCG) and will be monitored by repeated urine tests.
9. Patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit).
10. Diabetes mellitus.
11. Clinical evidence for congestive heart failure.
12. Patient with symptomatic orthostatic hypotension.
13. Based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.
Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients

The effect of supplemental oxygen on surgical site infections was already investigated in several studies before. Although, oxygen is one of the most used medical therapy in hospitalized patients, the influence on the cardiovascular system is still unknown. Available data indicate beneficial effects of supplemental oxygen on cardiovascular function. Because, no evidence exists concerning the perioperative period, it is our objective to investigate supplemental oxygen in cardiac risk patients undergoing major abdominal surgery. Due to the significant reduction of BNP by inhibiting sympathetic nerve activity we hypothesize that supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery:

1. History of coronary artery disease
2. History of peripheral arterial disease
3. History of stroke OR
4. Any of 3 of 7 A) Age ≥ 70 years B) Undergoing major surgery C) History of congestive heart failure D) History of transient ischemic attack E) Diabetes and currently taking an oral hypoglycemic agent or insulin F) History of Hypertension

Further inclusion criteria are:

1. Written informed consent
2. Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery)

Exclusion Criteria:

1. Symptoms of infection or sepsis
2. Preoperative inotropic therapy
3. Patients under ICU treatment
4. Oxygen dependent patients
5. History of severe heart failure and/or ejection fraction \< 30%
Balance and Weight Distributions at Kneeling

This study aims to examine balance parameters and weight distributions at different kneeling positions.

A cross-sectional study design was used to describe the balance parameters and weight-bearing distributions on knee in different kneeling positions with different ankle conditions. The participants signed informed consent forms before the study was performed on a voluntary basis. Inclusion criteria were defined as being between 18-30 years old and not having knee pain with kneeling. Exclusion criteria were previous history of lower limb pain/pathology, trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance, have performed high intensity physical activities last 72 hours before test day, and BMI \> 25. Balance parameters and weight distribution to each knee were evaluated three times at upright kneeling (UK) and full kneeling (FK) positions, in different ankle conditions (dorsiflexion and plantarflexion) with static balance device. Test-retest ICC values were calculated for all procedures.

Eligibility Criteria:
Inclusion Criteria:

* being between 18-30 years old
* not having knee pain with kneeling

Exclusion Criteria:

* previous history of lower limb pain/pathology,
* trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance,
* have performed high intensity physical activities last 72 hours before test day,
* BMI \> 25
Edentulous Sites Augmented With Collagen Matrix or CTG

Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
* At least 18 years old
* At least 6 months from tooth extraction at the study area.

Exclusion Criteria:

* Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
* Smoking ≥ 10 cigarettes a day;
* Pregnant or nursing women;
* Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
* Patients who need use of medications affecting bone metabolism or oral mucosa;
* Presence of a congruous FDP at the edentulous area;
* History of soft tissue augmentation surgery in the study area;
* Active periodontitis
* Uncompliant patients
Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
* Age 40 and older
* Astigmatism of at least 0.75Diopters in one eye
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Diabetes mellitus
* Pseudoexfoliation syndrome
* Systemical anticoagulation
* Antiphlogistic therapy
* Antiglaucomatosa
* Uncontrolled systemic or ocular disease
* Preceding ocular surgery or trauma
* Intraoperative complications
* Pregnancy/Nursing
* Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the reference vessel diameter.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥20 years and are able to undergo CABG
2. Females who are not pregnant
3. Patients who present with angina symptoms or myocardial ischemia
4. Patients available for post-procedural observation and coronary angiography at 24 months
5. Patients who have signed patient informed consent
6. Lesion which is eligible for only one 2.5mm paclitaxel-eluting stent
7. De novo lesion or non-stented restenosed lesion

Exclusion Criteria:

1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
2. Patients with significant allergic reaction to contrast medium
3. Chronic total occlusion
4. Lesion with TIMI0
5. Lesion which is needed more than two stents
6. Patients with chronic renal failure (SCr\>3.0mg/dl) -
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in this study.
* Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Exclusion Criteria:

* Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)