cyrilzakka/clinical-trials huggingface dataset:
Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome

Marfan syndrome (MS) is an autosomal dominant genetic disorder caused by a mutation in the fibrillin-1 gene (FBN1) encoding the protein fibrillin-1. Fibrillin is the main component of microfibrils, elements found in all of the body's tissues, and this pathology is characterized by the multitude of its clinical manifestations. These patients may develop aneurysms in the aortic root and one of the main factors of morbidity in patients with MS is aortic dissection. Prevention mainly involves preventive aortic surgery. However, the repercussions are global and can affect the functioning of other tissues such as skeletal muscle tissue, bone tissue, lung tissue and the eyes. The association of skeletal (scoliosis, hyperlaxity), muscular and ocular disorders is clearly associated with an impairment in the quality of life. These disorders are associated with pain and disability which affect professional activity, leisure and family life.

Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.

The main objective is to show that the quality of life of patients with Marfan syndrome can be improved by personalized training at home. The goal is to be able to offer new non-drug management based on physical activity to these patients.

Improved quality of life; Improvement of muscle strength by a muscle strengthening protocol; Improvement of cardiovascular function parameters. Regular coaching throughout the study.

1. / Assessment of muscular capacities
2. / Assessment of cardiovascular and respiratory capacities
3. / Response to psychometric questionnaires
4. / Participation in a training circuit (training protocol)

Eligibility Criteria:
Inclusion Criteria:

* patient with Marfan syndrome and followed up at Bichat Claude Bernard hospital, Paris. Marfan syndrome should be diagnosed according to the Ghent nosology revised in 2010
* Patient taking protective treatment for the aorta (beta blocker, calcium channel blocker, ACE inhibitor, angiotensin II receptor antagonist).
* Valid patient, able to return to consultation and carry out functional assessments and personalized physical training at home.
* Patients operated prophylactically on the ascending aorta may be included at a distance \> 6 months from their surgery.

Exclusion Criteria:

* Myocardial pathology other than Marfan syndrome.
* Thoracic aorta dissection.
* Aortic diameter \> 45 millimeters.
* Uncontrolled high blood pressure at rest (systolic blood pressure \> 140 Millimeter of mercury and diastolic blood pressure \> 90 Millimeter of mercury)
* Increase in systolic blood pressure \> 160 Millimeter of mercury during exercise.
* Pregnancy at the time of the study
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
* Presence of radiographically measurable disease as defined by RECIST 1.1
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years
* Known central nervous system metastases and/or carcinomatous meningitis
* A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Vitamin D Retrospective Study and Role With Disease

Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Older people, individuals with high skin pigmentation, obese and sedentary individuals have low levels of Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical inactivity are associated with reduced exposure to sunlight, and obesity is associated with the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues that require its metabolic action. These conditions are also associated with heightened risk for developing type 2 diabetes, glucose intolerance, hypertension, and osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in older women who tend to have increased body fat, are more physically inactive and are at high risk for central obesity and its metabolic consequences of diabetes, hypertension and osteoporosis.

The heightened prevalence of obesity in aging especially in postmenopausal women suggests that interventions to raise Vitamin D levels might be preventive of these diseases. Investigators have completed studies of the effects of weight loss and exercise interventions in approximately 400 older women and men over the last 15 years, many of whom are obese. Investigators have data on glucose tolerance, blood pressure and bone density in these studies and stored plasma in which investigators can analyze Vitamin D levels. Vitamin D may be an important risk factor for these metabolic diseases and the availability of these samples for Vitamin D analysis will allow investigators to perform a cross-sectional study to address relationships of Vitamin D levels to glucose intolerance and diabetes, hypertension/blood pressure status, bone mineral density, the degree of obesity, and physical activity status measured as maximal aerobic capacity and accelerometry in these older men and women.

The results of this study have the potential to impact clinical practice in the prevention and treatment of diabetes, hypertension, and osteopenia/osteoporosis. This would circumvent the current dilemma for prevention of these chronic diseases through treatment of obesity, as these data would provide immediate prospects for changing the recommended doses of Vitamin D beneficial for reducing risk for these diseases.

The purpose of this study is to 1) determine the prevalence of Vitamin D deficiency in obese, older men and postmenopausal women and 2) the association of Vitamin D levels to glucose tolerance, blood pressure, bone mineral density, and hyperlipidemia, as well as association with Vitamin D receptor gene polymorphisms affecting metabolic responses to Vitamin D.

Eligibility Criteria:
Inclusion Criteria: 45-85 years of age

Exclusion Criteria: none

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Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging

Exclusion Criteria:

* Patients who formally decline enrolment into the study
Clinical and Radiographic Outcomes of CAD/CAM vs Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders

The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

- Patients' age ranging from 20 to 50 years.

TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:

i. Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion and good oral hygiene. Co-operative patient that should show motivation to follow up.

Exclusion Criteria:

* Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
* Patients showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
* Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
* Any condition that contra-indicates MRI such as patients with pacemakers in heart.
* Patients with removable dental prosthesis
Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.

The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
* Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
* Breathing test ratio (FEV1/FVC) \<0.7
* Amount of exhaled air (FEV1) \<80% predicted after bronchodilator
* Total Lung Capacity (TLC)\>80%
* Matched healthy volunteers without COPD.

Exclusion Criteria:

* FEV1/FVC\>0.7
* Clinical diagnosis of heart disease, hypertension or diabetes
* Use of vasoactive medications (nitrates, Beta blockers)
* Uncontrolled high blood pressure
* Pulmonary hypertension
* Fluid in the lungs
* Sleep apnea
* Thyroid problems
* Anemia
* Raynaud's phenomenon
* Gastrointestinal bleeding
* History of coagulopathies
* History of low platelets
* Gangrene of the digits
* Phenylketonuria
* Pregnant or women attempting to become pregnant
* In lactation
* Individuals who may not be able to read or understand the resveratrol label
Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)

The study is a multi-center, prospective, randomized, controlled, clinical study evaluating the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially available pressure redistribution surfaces compared to standard of care (SOC). The objective of this study is to evaluate if a commercially available pressure redistribution surface when combined with the Skin IQ™ MCM coverlet will significantly reduce pressure ulcer (PU) incidence as compared to use of a commercially available pressure redistribution surface by itself by decreasing the effects of excessive moisture and temperature at the skin and surface interface.

This prospective, randomized, controlled study is designed to capture, evaluate and compare the effects of Skin IQ™ MCM coverlet placed over commercially available pressure redistribution surfaces versus commercially available pressure redistribution surface (SOC) used by itself to manage patients at risk for tissue breakdown.

Anticipation is that 160 Subjects will need to be screened and consented to achieve the desired sample size of 136 Subjects at up to 5 centers. Individual Subject, Standard Time of Observation: Up to 60 days for incidence of PU development; beyond 60 days, only hospital discharge date and disposition will be collected. The safety endpoint is the incidence of device-related serious adverse events (SAEs).

Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years or older
* Deemed at risk for tissue breakdown by clinical staff via an institutional assessment protocol such as the Braden Scale, the Waterlow Scale or the Norton Scale.
* Subject, or their legal representative, is able and willing to sign an informed consent form (ICF) and willing to undergo all study related procedures.

Exclusion Criteria:

* Female Subjects who report being pregnant
* Subjects with any unstable spinal injury
* Subjects with chronic renal failure requiring dialysis at the time of enrollment
* Subjects with body mass index (BMI) \> 39 as estimated at the time of enrollment
* Use of hyperbaric oxygen therapy (HBO) ≤30 days prior to screening
* Use of external warming and/or cooling devices
* Subjects who have been enrolled in this study previously
* Subjects, who in the investigator's opinion, would have any clinically significant condition that would impair the participants' ability to comply with the study procedures
* Diagnosed chronic skin disorder
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient

Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* age between 18 and 70
* Non-specific low back pain - achieved rehabilitation program

Exclusion Criteria:

* inflammatory diseases
* cancer
* infectious diseases
Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients

The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at the age of 20 to 65 years old
* Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with

  * Erythema severity ≥ 1
  * Telangiectasia severity ≥ 1
  * At least 3 papules or pustules in facial region
* IGA score ≥ 2
* Voluntarily signed written informed consent forms for study participation

Exclusion Criteria:

* Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area
* Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area
* Patients who are sensitive to the drug or vehicle
* Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1
* Previous use of estrogen or oral contraceptives within 3 months prior to visit 1
* Previous use of topical retinoids or oral antibiotics (e.g., tetracycline, tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole, trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior to visit 1
* Previous use of topical steroid or topical antibiotics, topical treatment for rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1
* Presently undergoing anti-coagulant therapies
* History of hematologic disease
* Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require systemic antibiotics
* History of laser treatment for rosacea within 6 weeks prior to visit 1
* Alcoholic or drug abuse patients
* Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period
* Renal function impairment with creatinine level higher than twice of maximum normal range
* Hepatic function impairment with AST/ALT higher than twice of maximum normal range
* Pregnant and lactating woman, woman with child-birth potential(should have negative pregnancy test at the baseline visit of the study)
* Participation in another clinical study within 1 month prior to screening
* Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; rosacea due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease
Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.


Eligibility Criteria:
Inclusion criteria:

* Previously untreated, histologically proven classical Hodgkin lymphoma
* Clinical stages III/IV (Ann Arbor)
* Age 18-60
* WHO performance 0-2
* Adequate organ function
* Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
* Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations

Exclusion criteria:

* Pregnancy or lactation
* Specific contraindications to BEACOPPesc therapy, including:
* Poorly controlled diabetes mellitus
* HIV infection,
* Chronic active hepatitis B and/or hepatitis C
* Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for \>5 years
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Smart Gaming in Obesity

Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.

This randomized, controlled study will evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming (BWL+GAMING) on weight loss and maintenance in adults with obesity and executive functioning deficits compared to standard behavioral treatment alone (BWL) at two urban Philadelphia university-based clinics (PCOM \[Philadelphia College of Osteopathic Medicine\] and Temple University). Participants will be recruited from the community. All participants (N = 200) will complete 12 weeks of behavioral weight loss treatment. Intervention participants will also complete 30-minutes (5 days per week for 8 weeks) of a serious gaming program, which will feature online games developed specifically to enhance executive functions. The primary outcomes are weight change and weight change maintenance, which will be measured at 12 and 52 weeks, respectively. Neuropsychological testing will evaluate the proposed mechanism of action, changes in executive functioning, before and after treatment (12 and 52 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Obesity
* Executive functioning deficits
* Internet access

Exclusion Criteria:

* Under 18 years of age
* Over 65 years of age
* Taking weight loss medication
* Pregnant