cyrilzakka/clinical-trials huggingface dataset:
Increased Monitoring of Physical Activity and Calories With Technology

Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.

For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.

Eligibility Criteria:
Inclusion Criteria:

Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet

Exclusion Criteria:

Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism

Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.

The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-60 years old;
* BMI ≥ 28 kg/m2；
* With acanthosis nigricans。

Exclusion Criteria:

* With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in dialysis fistulae.

Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in dialysis fistulae and drug-eluting devices might be beneficial in this field as well.

In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.

The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

* Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Hair Cortisol and Testosterone in Heart Failure

The purpose of this study is to determine whether hair cortisol and testosterone levels correlate with heart failure status in patient with chronic congestive heart failure.

Progression of chronic congestive heart failure (CHF) is associated with abnormal secretion of several hormones including glucocorticoids and testosterone.

A single study of patients with chronic heart failure has demonstrated that higher serum levels of cortisol are independent predictors of increased mortality risk. However, this study included patients with heart failure who were admitted to the hospital due to other causes and it might be speculated that the single serum cortisol measurement taken may have been influenced by the acute illness or by the emotional stress associated with the admission itself.

Currently, there are several modalities for measuring cortisol levels including serum, urinary and salivary techniques. However, all these methods represent indicators of acute cortisol secretion and do not reflect accumulation of the hormone over time. Recently there has been a growing interest in measuring hair cortisol level. Hair grows approximately 1 centimeter per month and therefore hair analysis accurately reflects long-term endogenous production of cortisol. This provides for the first time a reliable mode for the measurement of the accumulation of cortisol over time. We have recently demonstrated higher hair cortisol levels in patients with acute myocardial infarction compared with controls (the manuscript has been submitted for publication). Regarding testosterone, several studies have recently demonstrated lower free serum testosterone levels in patients with heart failure compared with controls. Furthermore, Serum testosterone levels were inversely correlated with heart failure status.

The longitudinal assessment of cortisol and testosterone levels over time using the hair technique may be superior to a single random serum sample for the assessment of chronic heart failure status and prognosis.

If indeed, hair cortisol and testosterone levels would correlate with heart failure status, they may be used as a quantitative mode for clinical follow-up of CHF patients (similar to the role of HbA1C in the follow-up of diabetic patients). However this hypothesis has not yet been evaluated

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age \>18
* Left ventricular (LV) systolic function (EF\<45 per echocardiography)

Exclusion Criteria:

* Any corticosteroid treatment in the last 6 months
* Any treatment with testosterone in the last 6 months
* Diagnosis or Cushing's or Addison's disease
* Any hospital admission within 3 months prior to enrollment
* Inability to sign inform consent
* Patients with moderate or severe aortic stenosis
* Inability to provide 3 cm hair sample from vertex posterior.
* Dyed hair
* Morbid obesity (BMI\>35)
* Any symptomatic chronic lung disease
Effect of Eccentric Exercise on Spasticity, Walking and Balance in Spastic Cerebral Palsy

Our clinical research study is planned as a randomized controlled study and will use a stratified randomization method. The aim of this study is to investigate the effects of eccentric exercise training on spasticity, walking and balance in individuals with spastic Cerebral Palsy (CP). Individuals with spastic unilateral SP (hemiparetic) and bilateral SP (diparetic) diagnosis, Gross Motor Function Classification System (GMFCS) Level I, II and III, aged between 6-18 years will be included in the study.

As a result of the G-power analysis, it was revealed that a total of 42 individuals should be included in the control and study groups. In our study, a control group of 21 people (Neurodevelopmental Treatment Group-NGT/2 days per week, 40 minutes) and an experimental group (Neurodevelopmental Treatment + Eccentric Exercise Group-NGT+EE/2 sessions per week, 20 minutes NGT + 30 minutes eccentric exercise program) will be formed. After the initial evaluations, 2 physiotherapy sessions per week will be applied to both groups for 8 weeks and then the final evaluations will be made and the obtained data will be compared with the initial evaluation data to reveal the statistical effect of eccentric exercises on spasticity, walking and balance parameters.

The hypotheses of the study are as follows:

H1: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on spasticity severity.

H2: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on gait parameters.

H3: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on balance parameters.

H4: Eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on quality of life, activities of daily living (ADL), and participation.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 6-18 and diagnosed with spastic hemiparetic or spastic diparetic CP,
* Being at level I, II or III according to GMFCS,
* Having increased muscle tone in hip flexor, hip adductor, knee flexor, knee extensor or ankle plantar flexor muscles according to MTS,
* Giving informed consent including detailed information prepared for the study (by parent/guardian).

Exclusion Criteria:

* Having received botox or surgery in the last 6 months.
* Not signing the consent form.
* Having limited cooperation regarding perception or performance of exercises required for the study.
* Having a systemic disease in addition to CP.
Reversal of Remimazolam by a Single Dose of Flumazenil

Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.

As ambulatory surgery has been increased last two decades, 'Enhanced Recovery After Surgery (ERAS)' also has become an important issue in clinical fields.

It is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.

Even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.

Common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.

In this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.

Eligibility Criteria:
Inclusion Criteria:

* participants aged over 20 years scheduled for ambulatory gynecologic surgery.

Exclusion Criteria:

* allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
* arrhythmia, myocardial infarction, coronary artery disease
* obstructive sleep apnea
* severe or acute respiratory distress
* tricyclic anti-depressant
* lactose intolerance
* BMI over 30kg/m2
* ASA classification 4 or 5
LFD of Aspergillus Antigen in Paediatrics

Many children and young people are at risk of invasive fungal disease (IFD), such as those who have had a haematopoietic stem cell transplants, those with an immune deficiency or those who are prescribed immunosuppressive drugs, for example, corticosteroids. One type of mould that causes invasive fungal disease is called Aspergillus. There is currently no quick test which can tell us if someone has an invasive fungal disease caused by Aspergillus called Aspergillosis. It is a difficult condition to diagnose and the results from the tests that are involved take days or weeks to come back. These tests including a few different blood tests, a scan of the lungs (CT scans) and taking fluid from inside the lungs/airway.

A new test for Aspergillosis is the lateral flow device (LFD) assay. This is a rapid test which gives a result within minutes. It involves testing a sample of the fluid from the lungs/airway. This fluid can be obtained as part of the routine investigations for Aspergillosis. It has been shown to be a good and safe test in adults but the investigators do not know if it will be a valuable test in children and young people yet. The purpose of this study is to determine whether the LFD test can effectively diagnose Aspergillosis in children and young people.

The overall study design is a prospective, single centre, cohort study in patients who have suspected pulmonary Invasive Aspergillosis (IA)/IFD and hence have a diagnostic BAL as part of their clinical care. A total number of 20 children \<18 years of age undergoing a BAL for suspected IA/IFD at St George's Hospital University Hospitals NHS Foundation Trust (United Kingdom) will be enrolled. No changes in the regular diagnostic pathway or treatment will be done for this study.

If patients are scheduled to have a BAL sample and meet the Inclusion/Exclusion criteria the patients will be approached for consent at the same time as consent for the standard of care BAL procedure. With the patients consent the samples will be retrieved from the BAL fluid, both for the standard of care investigations (fungal culture, GM and fungal PCR in BAL fluid) and for the study sample. The minimal study sample required will be 1 ml. The study samples will be tested directly with the LFD for Aspergillus antigen when possible. Haemorrhagic or too viscous samples will need to be previously treated with a buffer (150 ul BAL with 300 ul buffer). Every individual participant patient will be followed up prospectively at two weeks and 3-months post-BAL to collate information.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients aged less than 18 years who are clinically identified as requiring investigation for pulmonary IA/IFD and hence are undergoing a BAL as part of clinical care
* Written informed consent

Exclusion Criteria:

* Patients who are undergoing a BAL for other indications than suspected invasive fungal lung disease
* Patients ≥ 18 years of age
Evaluating Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the United States

This study better understands the views on shared decision-making among Chinese adults who smoke or who have a spouse who smokes. Lung cancer is the second most common cancer among men and women in the United States and is the number one cause of cancer-related mortality among Asians and Pacific Islanders. Clinicians are recommended to initiate conversations about lung cancer screening with eligible patients, provide information about the benefits and harms, and engage in shared decision-making. However, a patient's cultural background can influence decision-making in many ways. Given this, there is a need to understand the perceptions of shared decision-making among different populations (in this case, Asian populations) in order to inform the design of culturally sensitive decision aids for cancer screening. This study evaluates how Chinese populations in the U.S. who currently smoke or who have partners who smoke perceive the process of shared decision-making, their preferences, the perceived barriers and facilitators, and their perspective on currently-available screening tools.

PRIMARY OBJECTIVES:

I. Understand how Chinese populations in the Unites States who currently smoke or who have partners who smoke perceive the process of shared health-related decision-making and their preferences in terms of role involvement, and the barriers to and facilitators of shared decision-making.

II. Evaluate current publicly available lung cancer screening tools from the perspective of Chinese adults who smoke or who have partners who smoke.

OUTLINE:

Participants attend an interview over 45-60 minutes and/or a focus group over 1.5 to 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who self-identify as Chinese
* Live in the U.S. (either citizens or have lived in the U.S. for at least 5 years or more, i.e. long-term residents)
* Age 50-80
* Currently smokes or partner of a person who smokes
* Speak English and/or Mandarin
Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change

We aim to study the use of a virtual reality device (VRD) in addition to our standardized analgesic care protocol for abdominal bedside VAC dressing change and we hypothesize to decrease pain and anxiety and to increase patients' comfort by this intervention.

Monocentric non-blinded superiority randomized controlled trial: standardized analgesic protocol + virtual reality device vs. standardized analgesic protocol alone for abdominal VAC dressing change.

The day of the procedure, each patient will receive a standardized local and systemic analgesia 30 minutes before starting the procedure. The referring surgeon will explain at this moment every step of the procedure of bedside abdominal VAC dressing change.

Baseline levels of pain and anxiety will be assessed by use of VAS (0-10) and one additional questionnaire (STAI).

Virtual reality device will be activated 15 minutes before the beginning of the procedure and will remain as long as the procedure is going on and for 15minutes after finishing the wound dressing.

15 minutes after removing the VRD and 30minutes after finishing the wound dressing the STAI questionnaire and VAS for anxiety, pain and satisfaction (0-10) will be completed by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a bedside abdominal VAC dressing change
* Patients above 18 years old
* Patients able to give informed consent as documented by signature

Exclusion Criteria:

* Patients under 18 years old
* Patients with impaired cognitive status
* Patients with known psychiatric disorders
* Patients unable to follow the procedures of the study due to language problems
* Not consent provided
* Prior inclusion in the same trial (only 1 VAC dressing change per patient can be studied, the first one)
* Pregnant patients
Belimumab (BENLYSTA®) Pregnancy Registry

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
* Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
* Pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable HCPs if initial reporter is the pregnant woman
* Consent provided by the pregnant woman for her participation and assent for participation of her infant.

Exclusion Criteria:

* Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
Aortic Elongation and Dissection

Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.

Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g. aneurysm) can lead to life-threatening complications such as dissection and/or rupture. In daily practice however (e.g. imaging reports), the investigators often encounter patients with elongation of the ascending aorta. Little is known about the length of the proximal aorta. Furthermore, the clinical implications of an elongated aorta are unknown.

Eligibility Criteria:
Inclusion Criteria:

* Underwent recent (\<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry.

Exclusion Criteria:

* Age \<18 years old.
* Prior thoracic, cardiac or aortic surgery.
* Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease).
* Infectious disease of the aorta.
* Malignant disease with involvement of heart and/or aorta.
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility

The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body vibration (WBV) training in people with generalized joint hypermobility (GJH). The study included 33 participants aged 22-25 years. 12 participants were classified into the GJH group and 21 into the control group (CG). The study included the Beighton score and muscle flexibility tests: straight leg raise test (SLR), popliteal angle test (PA), and the modified Thomas test. These tests were performed before and after the short-term WBV program, which consisted of six sessions (frequency: 15 Hz and 30 Hz, amplitude 3 mm, 3 trials x 3 min.).


Eligibility Criteria:
Inclusion Criteria:

* healthy young adults

Exclusion Criteria:

* rheumatological disease
* orthopaedic disease
* neurological disease
* genetic disease
* cardiovascular system disease
* previous injuries of lower limbs
* surgeries of lower limbs and spine
* pain over 3 months of lower limbs and spine
* pregnancy
* implants
* the benign joint hypermobility syndrome (the Brighton criteria)
* the absence during one or more training day
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥18 years
* Body weight \> 40 kilograms (kg)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
* Participants with advanced and/or metastatic solid tumors
* Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
* Negative serum pregnancy test
* Participants must have adequate cardiovascular, hematological, liver and renal function.

Exclusion Criteria:

* Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
* Active second malignancy within 2 years prior to screening
* History or current clinically significant cardiovascular/cerebrovascular disease
* Active or history of autoimmune disease
* Serious, uncontrolled infection
* Known clinically significant liver disease
* Unresolved acute toxicity \> grade 1 from prior therapy