cyrilzakka/clinical-trials huggingface dataset:
A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient at least 18 years of age with stage II or III multiple myeloma
* One or more lytic bone lesions
* If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
* If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT
* Has planned HSCT for the duration of the study
* Has moles or lesions that are currently undiagnosed, but are suspect for malignancy
* Has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.

Key Exclusion Criteria:

* Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
* History of polyneuropathy ≥ grade 3
* Patients with plasma cell leukemia
* Planned stem cell transplant (HSCT) or radiation for the duration of the study
* Skeletal related event within 2 weeks of study enrollment
* Has received erythropoiesis-stimulating agents (ESAs) within the last 21 days or is planned to receive ESAs during the course of the study
* Has received anti-myeloma therapy within the last 21 days
* Is scheduled to receive local radiation to bone during the course of the study
* Has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment
* Woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
Strength Training and Resveratrol

The main goal of this study is to find out if supplementing with resveratrol improves skeletal muscle adaptations to strengthening exercise (resistance training or strength training) in adults age 60+, and to determine whether circulating vehicles of inter-organ communication (extracellular vesicles) and their cargo might help explain those responses. The investigators will also examine whether resveratrol supplementation improves blood vessel function and cognitive function (brain health) in response to strength training.

After screening and providing informed consent, participants (healthy older adults, age 60+, minimally active) will be familiarized with the procedures and undergo pre-testing. After pre-testing, participants will be assigned to supplement with resveratrol or placebo (double-blinded) daily while undergoing a strength training intervention. Strength training will be performed 3x/week for two 6-week blocks, and each visit will be supervised by a member of the study team. An additional week of testing will follow each of the two 6-week blocks.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+
* Minimally active (less than 1 hour of structured exercise/week other than walking)
* No resistance training for the previous 6 months
* Not currently taking resveratrol supplements
* Stable medication, supplement, dietary, and physical activity regimens for the previous 3 months and no plans to change throughout the study period

Exclusion Criteria:

* Medical complications that could increase risk during exercise (e.g., cardiovascular disease, uncontrolled hypertension, type 1 or 2 diabetes, orthopedic contraindication to exercise, kidney disease, etc.)
* Cannabis or nicotine use
* Consume more than 7 alcohol-containing beverages per week
A Study to Assess the Safety, Tolerability, Ciliary Rescue, and Pharmacodynamics of RCT1100 in Adults With PCD

This is the second in-human study with RCT1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.

The primary objective of this study is to assess the safety, tolerability, ciliary rescue, pharmacodynamic biomarkers, and preliminary efficacy of RCT1100 following multiple doses of inhaled RCT1100 administered via nebulizer to participants with Primary Ciliary Dyskinesia caused by disease-causing mutations in the DNAI1 gene.

Eligibility Criteria:
Major Inclusion Criteria:

* Healthy, adult, male or female of, 18-70 years of age, inclusive, at screening.
* Participant has clinical diagnosis of PCD and disease-causing mutations in the DNAI1 gene
* Participant has a forced expiratory volume in one second (FEV1) of at least 50% predicted.

Major Exclusion Criteria:

* History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
* History of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin.
* Predisposition to bleeding or clinically meaningful hemorrhagic event in the 12 months prior
* Medically significant hemoptysis.
* Anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening.
* Active tuberculosis infection.
* 12-lead ECG with QT interval \&amp;gt;450 msec (or \&amp;gt;480 msec for BBB)
* Laboratory abnormalities in clinical laboratory tests at screening:

  1. Serum creatinine level
  2. Total bilirubin, aspartate aminotransferase or alanine aminotransferase values
  3. Hematological or coagulation values outside the normal reference range
* Any medical history of disease that has the potential to cause a rise in total bilirubin over the ULN.
* COVID-19 infection within 4 weeks of Screening or receipt of COVID-19 vaccine within 2 weeks prior to first dose of RCT1100.
* Receipt of vaccine with live virus, attenuated live virus, or live viral components within 2 weeks prior to first dose of RCT1100 or to receive these vaccines during treatment or within 8 weeks of completion of study treatment.

Other protocol defined inclusion/exclusion criteria may apply.
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia


Eligibility Criteria:
Main Inclusion Criteria:

1. Adult subjects, 18 years of age and older at screening
2. Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2
3. Total score of Pittsburgh Sleep Quality questionnaire is \> 5
4. Latency to persistent sleep is \> 30 minutes based on Pittsburgh questionnaire
5. Able to understand and provide written informed consent

Main Exclusion Criteria:

1. Patients using any pharmacological treatments for insomnia for 14 days
2. Patients currently using stimulants drugs 7 days
3. Patients currently using antidepressants causing sleepiness
4. Patients who are unable to commit to avoid consumption alcohol during the study
5. Patients who are unable to commit to avoid consumption caffeine after 12 pm
6. Patients who have a clinical significant or unstable medical or surgical condition
CERENOVUS Neurothrombectomy Devices Registry

A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion.

The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, Large Bore Catheter/EMBOVAC Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. The participant or the participant's legally authorized representative has signed and dated an Informed Consent Form. In the event that local regulations allow for alternative approaches of consent, these must be fulfilled as approved by the sponsor and site's ethics committee/regulatory authority (if applicable)
3. Participants experiencing acute ischemic stroke with angiographic confirmation of intracranial vessel occlusion
4. A clinical decision has been made to use a CERENOVUS neurothrombectomy device (EmboTrap® Revascularization Device, Large Bore Catheter/ EMBOVAC Aspiration Catheter, or CEREGLIDE 71 Intermediate Catheter) independently and prior to enrollment in the research study
5. A CERENOVUS neurothrombectomy device is the first attempted primary device/technique for mechanical thrombectomy for the intracranial occlusion in the participant. The following primary devices/techniques are eligible for this study: a) EmboTrap® Revascularization Device alone b) EmboTrap® Revascularization Device + co-aspiration with the Large Bore Catheter/EMBOVAC Aspiration Catheter or CEREGLIDE 71 Intermediate Catheter c) EmboTrap® Revascularization Device + co-aspiration with any other aspiration catheter d) Large Bore Catheter/EMBOVAC Aspiration Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique) e) CEREGLIDE 71 Intermediate Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique)

Exclusion Criteria:

1. Currently participating in an investigational (drug, device, etc) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
2. Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication)
3. Use of multiple stent retrievers on the first pass
A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women

The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal females, as determined by medical history and physical examination
* Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive
* Acceptable clinical laboratory test results, blood pressure and heart rate
* Have given written informed consent

Exclusion Criteria:

* Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
* Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer
* Known allergies to LY2541546, its constituents, or related compounds
* Persons who have previously participated in this study or any other study of LY2541546
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* History or presence of low platelet count, bleeding issues or family history of bleeding disorders
* Paget's disease, parathyroid disease, or thyroid disease
* Fracture of a long bone within 12 weeks of screening
* Regular use of known drugs of abuse and/or positive findings on urinary drug screening
* Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
* Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
* Blood donation within the last month
* Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study or to abide by the clinical research unit restrictions. Note: Average weekly alcohol intake must not exceed 14 units per week
* Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit (CRU) confinement
Treatment of Post Traumatic Asymmetrical Ankle Arthritis Using Low Tibial Osteotomy

Evaluation of joint preserving procedure for asymmetrical ankle arthritis regarding the improvement of alignment and its effect on symptoms

The most common cause of end-stage ankle arthritis is trauma. Post traumatic ankle arthritis is accepted as the most common cause of ankle arthritis,with reports ranging from 70% to 80% of all ankle arthritis. Factors contributing to the development of posttraumatic ankle arthritis are the initial cartilage damage, malreduction ,nonunion, infections, and instability. In a retrospective study,found that 55% of patients with posttraumatic ankle arthritis presented with a varus malalignment, whereas 8% had valgus malalignment 1. Nonoperative treatments, including orthotics, wedges, shoe modifications,anti-inflammatory medications, and activity modification,are usually not successful. Although the gold standard treatment for ankle arthrosis remains ankle arthrodesis, the significant loss of motion in the ankle is limiting and may lead to the development of arthritis in adjacent joints in the hind foot and forefoot . Total ankle replacements (TAR) used only in older, low-demand patients with neutral alignment and intact stabilizing ligaments. Ankle arthroscopy is indicated in acute, recurring-acute, and chronic ankle pain to detect the possible presence of anterior ankle impingement (bony or soft tissue), syndesmotic injury, osteochondral defects and loose bodies . Supramalleolar osteotomy have been used for varus and valgus as well as sagittal and rotational deformities .Fibular osteotomy, Calcaneal slide osteotomy and osteotomies of the medial arch can be also used as joint preserving procedure. Our study is designed for evaluation of the effect of joint preserving procedures in young patient with asymmetrical ankle arthritis.

Eligibility Criteria:
Inclusion Criteria:

* 1-Age 18-60 years. 2-Symptomatic ankle osteoarthritis varus or valgus ankle deformity on X-ray with asymmetrical ankle arthritis.

  3-Patient had failure of conservative treatment. 4-Patient with clinical symptoms,such as pain with walking and limitation of daily and recreational activities.

Exclusion Criteria:

* 1- End-stage arthritis 2- Severe hindfoot instability that cannot be stabilized 3- Severe vascular or neurologic deficiency in the affected extremity 4 - Neuropathic disorders (eg, Charcot foot). 5- Diabetes,chronic liver disease,renal failure 6- Smoking, and rheumatic disease. 7- Condition altered bone quality (due to medication, large cysts,osteoporosis and osteopenia )
Apelin in Willis Ekbom Disease

The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as RLS/WED according to International Classification of Sleep Disorders (ICSD-3) criteria
* Patients with idiopathic RLS/WED
* Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating Scale
* Periodic Leg Movements Index above 5 in polysomnography record
* BMI below 25

Exclusion Criteria:

* Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy)
* Systemic diseases which cause possible oxidative stress status (cardiovascular diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE inhibitors e.g.)
* Another sleep disorder
Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).

At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.

However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.

The investigator propose to conduct a prospective, bi-center, non randomized study.

The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month.

The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
* Patient treated by DMARDs (disease-modifying antirheumatic drug)
* Patient in confirmed remission for less than 6 months

Exclusion Criteria:

* Patient participating simultaneously in another clinical study with blind treatment
* Patient participating simultaneously in another clinical study involving decreasing of drug dose
* Patient in post clinical study exclusion period
* patients subject to legal protection measures
* Patient unable to read French
* Pregnant or breast-feeding women
* patient treated with Rituximab
Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor

This study is a patient registry of people with Desmoplastic Small Round Cell Tumor (DSRCT). A patient registry is a collection of health information about a group of people, and it is usually focused on a specific diagnosis or disease.

The purpose of this registry is to create a database- a collection of information-or better understanding DSRCT. Researchers will use the information from this database to learn more about DSRCT and for current and future research on DSRCT.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of desmoplastic small round cell tumor
* Participants may be of any age as long as the appropriate consent and assent may be obtained
* Willing to provide historical and longitudinal clinical data

Exclusion Criteria:

* Participant unwilling to provide consent or share historical and longitudinal clinical data
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients

Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes.

Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications.

The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome.

Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP).

Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD.

However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI≥35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years old
* Patient must be able to give written informed consent
* Patient affiliated to a social security system
* Patients participating in the standard bariatric surgery care program (bariatric surgery criteria defined with BMI ≥ 40 kg / m² or patients with BMI ≥ 35 kg / m² and at least 1 associated co-morbidity

Exclusion Criteria:

* Patient with presence of ascites
* Patients with exclusion criteria for bariatric surgery
National Survey of Young Adult Nutrition

The purpose of this research is to better understand how people's background, habits, and other factors influence their diets and health.

The purpose of this study is to provide further insight into the correlates and predictors of young adults' eating habits, with particular emphasis on sociodemographics, reproductive health, and food upbringing.

Eligibility Criteria:
Inclusion Criteria:

* U.S. citizens
* Current, full-time, non-institutionalized residents of the United States
* Access to a computer with internet access

Exclusion Criteria:

* Non-U.S. citizens
* Non-resident of the United States
* No access to a computer with internet access