cyrilzakka/clinical-trials huggingface dataset:
Framingham Children's Study - Food and Exercise Habits in Framingham Study Descendents

To identify early childhood determinants of eating and exercise behaviors that relate to cardiovascular disease.

BACKGROUND:

While dietary and physical activity habits are known to relate to cardiovascular risk, in 1985 little data were available on factors that influence the development of such behaviors early in life. In 1987, 106 families with 3 to 5 year old children were recruited to take part in the Framingham Children's Study. The children and their parents are direct descendents (4th and 3rd generation, respectively) of participants in the Framingham Heart Study. During the initial grant period, the feasibility of collecting relevant data has been demonstrated. Maintenance of the cohort and acceptance of the monitoring procedures have been excellent, due partly to the fact that the families consider themselves a part of the Framingham Heart Study and take pride in long-term compliance with study procedures.

DESIGN NARRATIVE:

The investigators have been following 100 families who are 3rd and 4th generation descendants of the original Framingham Heart Study cohort. The subjects were age 3-5 years at the onset of the study and were ages 11-14 years in 1996. There has been excellent cohort maintenance with over 90 percent of the original families continuing to participate. The study was renewed in FY 1996 to extend the Framingham Children's Study (FCS) to permit the evaluation of the determinants of change in the child's risk behaviors and other risk factors from early childhood through puberty to mid to late teens, a time when the individual's risk profile should better reflect his/her cardiovascular risk status as an adult.

The FCS is a longitudinal source of data on diet, activity and family and environmental factors in children. By 1996, the investigators had collected extensive dietary data with an average of 32 days of diet records and almost 50 days of electronically monitored physical activity data for each subject. Additional data included psychosocial and anthropometric data on children and their parents. The extension of the FCS allows continued monitoring of eating behaviors and physical activity habits of the children and their parents, as well as the personal environmental and behavioral factors influencing changes in the child's physical activity, diet, blood pressure, lipids and obesity from pre-school into the late teen years.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Validation of a Dance As Therapy Program in Co-facilitation

The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.

This present research is a prospective longitudinal monocentric comparative study of an alternative, non-pharmacological therapy. It is a controlled, non-randomized, and experimental study in which half of the participants benefit from an additional program with speech and movement co-therapy via body activity, and the other half only benefit from standard support (e.g. medical, social, and legal assistance, individual psychotherapy).

The effect of this program will be examined across three dimensions:

* A clinical trial of N=80 participants to compare symptom improvement between individuals receiving the standard support for victims of sexual violence (N=40) and those receiving, in addition, the RECREATION program (N=40).
* A longitudinal evaluation of physiological conditions, psychological traits, and social well-being of RECREATION workshop attendees (N=10) versus victims not participating in said workshops (N=10).
* A qualitative analysis of interviews with program participants and their associated professionals (data saturation sample size).

Eligibility Criteria:
Inclusion Criteria:

* French-speaking
* Woman
* Over 18 years old
* Victim of sexual violence

Exclusion Criteria:

* Non-French-speaking person,
* Under 18 years old
* Not woman
* Not victim of sexual violence
Efficacy of the Apollo System for Children With ADHD

To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Eligibility Criteria:
Inclusion Criteria: All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:

1. Participants must be 8 years of age or older and under the age of 18.
2. Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
3. Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
4. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria: The following exclusion criteria exist for all participants:

1. Lack of consent.
2. Participants cannot have started a new treatment within the last 30 days.
3. Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.
4. Participants cannot have previously used the Apollo System.
Stress of Anesthesia Professionals in the Operating Room

The objective of this study was to determine whether there was an association between the resilience of anesthesia professionals in the operating room of the Grenoble University Hospital and perceived work-related stress.

This trial will be conducted at the Grenoble Alpes University Hospital (CHUGA). Volunteer anesthesiologists, anesthesia interns, nurse anesthetists and nurse anesthetist students will answer questionnaires evaluating resilience, perceived stress in the last month, sleep quality, number of hours worked in the month, number of night hours and will evaluate each working day the perceived stress with the visual analogical scale of stress over 3 periods of the working day

The main objective is to determine if there is an association between the resilience (questionnaire: Connord davidson resielience scale: CDRISC10) of the anesthesia professionals in the block of the CHUGA and the perceived stress at work (Perceived stress sacle 10: PSS10).

The secondary objectives are to study the association between:

1. The mean of the two stress VAS (at the beginning and end of the shift) collected and the PSS10 over the same period.
2. The median of the peaks of stress VAS collected and the PSS10 over the same period.
3. The PSS10 and the PSQI (Pittsburgh Sleep Quality Index)
4. The PSS10 and the number of hours worked in the month.
5. The PSS10 and the number of night hours worked in the month.

Eligibility Criteria:
Inclusion Criteria:

* resident in anaesthesiology, Anesthesiologist,anaesthetic nursing student, anaesthetic nurse graduated

Criteria for non-inclusion:

* Professionals objecting to the use of their data in the the research
* Professionals working part-time
* Professionals who had a number of CA \> 3 during the month of the study.
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old at the screening visit (Visit 1)
* Has a diagnosis of FECD at Visit 1
* Meet all other inclusion criteria outlined in the Clinical Study Protocol.

Exclusion Criteria:

* Is a female subject of childbearing potential and any of the following is true:

  1. is pregnant or lactating/breastfeeding, or
  2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
* Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI

On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.

Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.

Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.

A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.

In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients

Eligibility Criteria:
Inclusion Criteria:

* Males diagnosed of abnormal DNA fragmentation index ( \> 19%).
* Males with mild to moderate OTA (oligoteratoasthenozoospermia).
* Male aged 18-60 years.
* Female aged 18-40 years.
* Normo responder ( \> 5 mature oocytes)
* Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval

Exclusion Criteria:

Males with normalDNA fragmentation index (\<19%)at the initial assessment.

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm donation or cryopreserved sperm
* Use of Oocyte donation
* Use of gestational carrier
* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery

the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .

Group OLA: The patients will undergo ARM followed by personalized PEEP.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 18 - 65 years
* BMI between 30-40 kg/m²
* ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery

Exclusion Criteria:

* Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 \< 80% of the predicted value)
* active asthma, acute respiratory distress syndrome
* history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
* significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
Quality Of Life Outcomes Following Treatment for Esophageal Cancer

The goal of this study is to evaluate how treatment for esophageal cancer affects your quality of life. The findings of this study may help us understand how this disease and its treatment affect your lifestyle, diet, exercise, support system and overall quality of life. We hope this study will provide important information that can be used to develop programs to improve the quality of life of patients with esophageal cancer.

In order to determine the impact of esophageal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals, evaluating their physical symptoms, physical and social functioning and overall quality of life. Medical and sociodemographic factors as well as health behaviors that might be predictive of adaptation will be tested. This is a preliminary investigation and it is hoped that we will be able to base future research questions on the results of this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of esophageal cancer.
* Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, McKeown procedure) of esophageal cancer. (Group 1 patients only)
* Underwent esophagectomy for esophageal cancer at least 18 months prior to consent, with no evidence of disease. (Group 2 patients only)
* Ability to speak, read and write English.

Exclusion Criteria:

* Inability to give informed consent.
* Patients anticipated to require a laryngectomy as part of their surgical resection.
Characterizing SAPHO With 68Ga-FAPI PET/CT

68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of SAPHO than 18F-FDG PET/CT.

Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated SAPHO patients;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
The Actuate-CBC Study

The study team will use implementation science to accelerate the uptake of teleconsultationfor burn patients by 1) examining the relationships between clinician perceptions of acceptability, feasibility, intention to use, and actual use of burn teleconsultation 2) identifying the optimal process for burn teleconsultation and the barriers and facilitators for its use during a crisis or prolonged care situation, and 3) designing and testing the effectiveness of a specific, tailored burn teleconsultation toolkit intervention to increase burn teleconsultation use.

The principal investigator's central hypothesis is that a tailored implementation intervention (toolkit) that integrates the known advantages of using telemedicine for burn consultation with new knowledge regarding clinician perceptions and the setting in which they work will improve the feasibility, acceptance, intention to use, and uptake of burn teleconsultation. The implementation intervention will enable rapid burn teleconsultation implementation under crisis circumstances and assist clinicians to virtually connect the person caring for a burn patient anywhere to the entire burn team's expertise. The study results will lead to more robust national crisis, wartime, and disaster response plans, improve quality of burn care, and decrease morbidity and mortality from serious burn injury, regardless of injury location.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and
* are providing burn care to patients at the 4 burn centers and the non-burnhospitals are eligible for inclusion.

Exclusion Criteria:

* do not meet inclusion criteria,
* decline to participate or do not give consent to participate in the study, •
* directly express uneasiness about the participation
Multimodal Physical Activity for the Elderly

Although some authors have observed favorable effects of group physical activity programs, others have reported that the individualized prescription of exercises may be jeopardized by programs that do not allow sufficient consideration of individual characteristics. Therefore, we aim to verify the effects of an elderly-specific multimodal physical activity program on physical parameters after one year of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participate in the Geriatric Revitalization Program for one year
* Be on the waiting list for the Geriatric Revitalization Program

Exclusion Criteria:

* Attend less than 75% of the physical activity program's activities
* Absent any of the three follow-up physical parameter evaluations
Norwegian Constraint-Induced (CI) Therapy Multisite Trial

The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke).
* Modified ranking scale 0-2 before admission
* Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4)
* Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position.
* Able to follow a two step command.
* Mini Mental State examination score of more than 20 (or more than 16 in combination with expressive aphasia)

Exclusion Criteria:

* Modified Rankin Scale \> 4
* Unable to give informed consent
* Large hemispatial neglect (more than two cm on the Line Bisection Test)
* Not expected to survive one year due to other illnesses (eg cardiac, malignancy)
* Injury or condition in the affected upper extremity that limited use prior to the stroke.
* Other neurological condition affecting motor function
Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)

There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. This study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (DLS) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from April 2009 to May 2016. Patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in DLS patients undergoing posterior selective decompression and long segment fixation and fusion. It has guiding significance for clinical operation decision making.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years old;
* The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment;
* Third generation total pedicle screw internal fixation system;
* Follow-up time ≥24 months;
* Complete clinical and imaging data.

Exclusion Criteria:

* Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
* Documented COPD symptoms for more than 2 years
* Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC\<70%

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
* Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
* COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.