cyrilzakka/clinical-trials huggingface dataset:
DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)

Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. FD lesions may be isolated in one or more bones or may be associated with endocrinopathies in McCune-Albright syndrome. Bone lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and decreased quality of life. There is no cure for FD lesions and current therapies failed to soothe patients' complaints or to display any effect on progression of the lesions on imaging. However, the RANKL-inhibitor Denosumab demonstrated encouraging results in mouse models and in off-label clinical use, leading to clinical, biochemical and radiographical improvements.

Study's aim is to investigate whether 3-monthly Denosumab will improve the clinical, radiological and biochemical manifestations of FD bone lesions.

Eligible patients will be randomized to treatment with either subcutaneous Dmab 120mg or placebo at baseline and 3 months in a blinded fashion. At 6 months, after 2 injections, patients with pain score \<4 will exit the study to discontinue study medication and proceed in usual care, while patients with pain score ≥4 or lesional growth will be offered Dmab 120 mg at 6 and 9 months in an open-label design.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with established diagnosis of FD/MAS and closed growth plates(\>18 years)
* Pain in the region of an FD localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
* Pain score from FD lesion for maximum or average pain on VAS ≥ 4
* Increased lesional activity defined as increased bone turnover markers (ALP, P1NP or CTX) or increased activity on Na\[18F\]-PET/CT or bone scintigraphy in at least one lesion
* Normal levels of calcium, parathyroid hormone and vitamin D (supplementation is allowed)
* Treated hypophosphatemia (defined as \>0.7 at two separate measures)
* good dental health (last check within the last 12 months)

Exclusion Criteria:

* Active pregnancy wish, pregnancy or nursing
* Pain not related to FD
* Uncontrolled endocrine disease
* Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia
* Previous use of bisphosphonates or Dmab \< 6 months before inclusion ('6 months wash out')
* Previously reported severe side effects on Dmab
* Inability to fulfil study requirements
* Poor untreated dental health without intention to get treatment
* Treatment with other bone influencing drugs, such as high doses corticosteroids
Using Differences in Peripheral Blood Leukocyte Gene Expression to Determine Cardiovascular Disease Risk

Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Although these established risk factors can be helpful in determining people at risk for developing CVD, the addition of novel gene markers for subclinical, or suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease mechanisms. This study will compare specific genes of white blood cells in people with significant SA versus people without SA to improve identification of those at risk for developing CVD and to better understand the biological basis of SA.

CVD is the leading cause of death worldwide and accounts for almost 40% of deaths each year in the United States. In a person with CVD, oxygenated blood is not adequately distributed throughout the body because of impaired function in the heart and blood vessels. This restricted blood flow can eventually lead to organ damage, heart attack, and stroke. Risk prediction for CVD, which is largely associated with SA, relies on the use of certain traditional risk factors. The widely used Framingham risk score (FRS) has provided excellent risk discrimination and reliable estimates of 10-year risk for CVD, but it does not account for the genetics behind SA. Although numerous studies have investigated novel genetic biomarkers to attempt to add predictive value to the FRS, no single biomarker to date has been able to improve risk prediction in a meaningful way. A multi-marker approach that identifies several novel markers unrelated to traditional risk factors may be more effective in improving the identification of those at risk for CVD. This study will first construct a multi-marker approach that is based on patterns of gene expression in peripheral blood leukocytes (PBLs) and that can serve to identify people with substantial SA. The study will then use this approach to determine whether gene expression patterns of PBLs in people with SA are distinct from those in people without SA.

This study will use previously collected data and specimens, including blood samples and SA imaging, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) trial and from healthy female participants from Northwestern University. Blood samples will be used for analysis of patterns of gene expression in PBLs. There will be no new study visits for this study.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
Inclusion Criteria:

* Female participant from the MESA study who has a low Framingham risk score and has either SA or no evidence of SA
* Healthy female below the age of 40 from Northwestern University.

Exclusion Criteria:

- Diabetes
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown).

Rhomboid intercostal and subserratum plane block (RISS) is a nerve block technique in which local anesthetics are injected into the rhomboid-intercostal muscle planes and the serratus anterius-intercostal muscle planes, and the intercostal nerve is blocked by diffusion of local anesthetics. It is confirmed that RISS can provide analgesia not only in the front half of the chest, but also in the upper abdomen. However, the efficacy of RISS in minimally invasive surgery for esophageal cancer has not been proven. The investigators placed catheters on the RISS plane and continuously injected local anesthetics to investigate whether RISS is effective and safe in minimally invasive esophageal cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients received MIE-McKeown surgery and were confirmed by postoperative pathology; Age 18-75 years old
* body mass index (BMI) : 18.5\~23.9kg/m2;
* American Society of Anesthesiologists (ASA) grade: Ⅰ\~Ⅱ;
* Clear consciousness, no cognitive impairment;
* Patients informed to participate in the study and signed informed consent.

Exclusion Criteria:

* Infection of the puncture site, abnormal platelet or coagulation function;
* Patients with drug allergy involved in this study;
* Long-term use of analgesic, sedative drugs or a history of heavy drinking;
* Patients with chronic painful diseases;
* With severe heart, liver, kidney and lung dysfunction;
* Infectious diseases, blood, immune, circulatory system diseases; -Communication barriers, can not cooperate with the scale assessment; -
* Other situations not suitable for this study.
A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.


Eligibility Criteria:
Inclusion Criteria

* Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
* Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m\^2), inclusive, at screening.

Exclusion Criteria

* Participants must not have any significant acute or chronic medical illness as determined by the investigator.
* Participants must not have any current or recent (within 3 months of study intervention administration) GI disease, liver and kidney that could possibly affect drug absorption, distribution, metabolism, and excretion, (e.g., bariatric procedure, Cholecystectomy, and any other GI surgery that could impact upon the absorption of study intervention).
* Participants must not have Gilbert Syndrome.
* Participants must not have a history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias (e.g., long QT syndrome, catecholamine polymorphic ventricular tachycardia).
* Participants must not have exposure to any investigational drug or placebo (other than BMS-986419 or moxifloxacin) within 4 weeks or 5 half-lives (whichever is longer) prior to Day -1 (Day -2 for Part 2) until follow-up phone call.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, male or female;
* The Participants was diagnosed with novel coronavirus pneumonia;
* It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9).
* Participants who voluntarily sign informed consent.
* The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6;

Exclusion Criteria:

* Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
* Participants who have received the following treatments within the specified time window before randomization:

  1. Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
  2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;
* Immune deficiency;
Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test

The 6 Minute Pegboard and Ring Test is a test applicable to the upper extremities. The upper extremity plays an important role in activities of daily living, especially in tasks related to reaching, grasping and holding objects. Various activities of daily living, such as combing hair, brushing teeth and picking up objects, require supported or unsupported upper limb activity. Therefore, evaluation of upper extremity function is important. In addition, it is a simple test, it is also seen as a game, its application is functional, and there is no need for expensive equipment. Its validity and reliability have been demonstrated only for patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy adults. In addition, to the best of our knowledge, the suitability of this test in a virtual environment has not been evaluated in the literature. Therefore, the main aim of this study is to examine the applicability of this test in a virtual environment.

6 Minutes The virtual reality space for the Pegboard Ring Test will be designed in Blender programme. The software and integration that provides the interactive movement of the person in the application will be done by the UNITY programme.

Entry to the prepared training test area will be with OCULUS Quest 2 (virtual reality glasses and console) equipment.

Eligibility Criteria:
Inclusion Criteria:

* No orthopaedic problem or limitation of movement in the upper extremity that would adversely affect the test 6PBRT,
* no diagnosis or history of symptomatic lung and/or heart disease,
* no serious visual and hearing problems,
* no psychological and epileptic illnesses,
* not being diagnosed with migraine before,
* body mass index (BMI \> 20.34, kg/m2 and \< 25.94 kg/m2 for male individuals; BMI \> 14.6 kg/m2 and \< 25.55 kg/m2 for female individuals)

Exclusion Criteria:

* Not completing 18 years of age
* not willing to volunteer to study.
A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Men with erectile dysfunction
* At least 18 years of age

Exclusion Criteria:

* Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
* A history of certain impotence disorders
* History of specified pelvic surgery
* Any significant genital abnormality identified at the start of the study
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder

Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.


Eligibility Criteria:
Inclusion Criteria:

* age \> 65 years
* arterial hypertension (at least dual treatment)
* diabetes mellitus (oral antidiabetics or insulin)

Exclusion Criteria:

* known atrial fibrillation
* ischaemic heart disease
* Current anticoagulation treatment
* Ejection fraction \<45 %
* significant valvular heart disease
* previous stroke/transient ischemic attack
* peripheral arterial disease
* end stage renal disease
* thyreotoxicosis
Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital

The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.

The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.

Eligibility Criteria:
Inclusion Criteria:

* Women with at least one previous caesarean section and suspected PAS disorders by imaging studies

Exclusion Criteria:

* Patients with intraoperative spontaneous placental separation.
* Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
* Any other associated uterine pathology requiring hysterectomy.
* Coagulation disorders.
Enrichment of Day Centers in Community-based Psychiatry

This RCT study addresses the topic of improving the possibilities for people with severe mental illness (SMI) to be engaged in meaningful daily occupations at community-based activity (CBA) centers. Meaningful occupation, which includes not only work-related activities, but also leisure, household and social activities, is assumed to generate health and wellbeing. It is well established that there is a relationship between satisfaction with daily occupations and well-being.

A Swedish mental health care reform stated that the social services should provide meaningful daily occupations to people with SMI. However, evaluations of the effects of the reform conclude that the target group's needs for meaningful daily occupation have not been met.

Thus, on the basis of governmental reports and evaluations, there is an urgent need for improving the quality of the activities and support offered at CBA centers. Therefore, the overarching aim of this project is to develop and implement an intervention method for improving the activities offered and support given at CBA centers, and evaluate the outcomes of that intervention.

Specific aims

* Developing and implementing an intervention that means reorganization of CBA centers in such a way that they become enriched with characteristics that have been identified as rewarding and meaningful in previous research.
* Evaluating the outcome of that intervention on:

  * the unit level, i.e., in terms of changes in the characteristics of the CBA centers,
  * the individual level, in terms of changes among the consumers regarding satisfaction with the activities at the CBA center, perceived control, social interaction, quality of life, etc.

Cluster randomization is used. Day centers are randomized to either giving the new intervention ("enrichment") or continuing with "care as usual" during the study period, which is 14 months. This means that all participants in a day center get the type care their specific day center offers during the study period.


Eligibility Criteria:
Inclusion Criteria:

* severe mental illness \> 2 years
* age 18-65 years
* visiting the day center \> 4 hrs per week

Exclusion Criteria:

* comorbidity of dementia or developmental disorder
* acute psychosis
* primary diagnosis of substance use disorder
* insufficient knowledge of Swedish
Motivational Interviewing for Smoking Cessation

The purpose of this study is to determine whether or not motivational interviewing is effective in smoking cessation at general practice setting in China.

OBJECTIVES:

• To compare the effectiveness of motivational interviewing versus brief advice by conducting a randomized controlled trial in General Practice Setting in China.

OUTLINE:

This is a randomized controlled study. Patients are randomized to either the intervention arm or the control arm.

• Arm I (intervention): Patients will be given a 20 minutes personal talk in the family physician's office during the visit. The family physicians will determine the stage of change in smoking cessation (precontemplative, contemplative, action, maintenance and relapse) and use the motivational interviewing skills during the talk. The motivational interviewing skills include expressing empathy, developing discrepancy, rolling with resistance, supporting self efficacy. Up to six phone calls will be given to the patients during the follow-up, using the motivational interviewing skill.

• Arm II (control): Patients will receive brief advice for smoking cessation, lasting approximately 5 minutes. The risks of smoking and the advantages of quitting will be explained. The information provided during the talk will be standardized. No phone call will be given during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 80 years.
2. Any person who replies "Yes" when asked "Do you smoke?".
3. Agree to participate the trial and be followed for at least one year.

Exclusion Criteria:

1. With severe mental illness, serious drug dependent patients.
2. Cannot understand conversation or cannot communicate, such as deafness or dementia.
3. Cannot be followed up for one year, such as not likely survive for more than one year.
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction

The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged between 18 and 80 years old
2. Able to comprehend, follow, and provide written informed consent.
3. Willingness to comply with study requirements including follow-up visits

Exclusion Criteria:

1. Patients who have a pacemaker
2. Pregnant or breast feeding females.
3. General contraindication for surgery as deemed by the PI (e.g. physically unfit)
4. Patients who smoke
5. Diabetic patients
6. Patients who are receiving permanent analgesics
7. Patients receiving anti-coagulation therapy.
8. Patients with a physical or psychological condition which would impair participation in the study.
9. Participation in any other device or drug study within 90 days prior to enrollment.
10. Planned participation in any other medical device study during the timeframe of this study.
Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery

Machine learning methods potentially provide a highly accurate and detailed assessment of expected individual patient risk before elective cardiac surgery. Correct anticipation of this risk allows for improved counseling of patients and avoidance of possible complications. The investigators therefore investigate the benefit of modern machine learning methods in personalized risk prediction in patients undergoing elective heart valve surgery.

The investigators performe a monocentric retrospective study in patients who underwent elective heart valve surgery between January 1, 2008, and December 31, 2014 at our center. The investigators use random forests, artificial neural networks, and support vector machines to predict the 30-days mortality from a subset of demographic and preoperative parameters. Exclusion criteria were re-operation of the same patient, patients that needed anterograde cerebral perfusion due to aortic arch surgery, and patients with grown up congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

\* Patients who underwent heart valve surgery of any kind between 2008-01-01 and 2014-12-31 were included.

Exclusion Criteria:

* re-operation of the same patient
* patients that needed anterograde cerebral perfusion due to aortic arch surgery
* patients with grown-up congenital heart disease