cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Tracking--Childhood to Young Adulthood

To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and young adulthood. Data were used from the same cohort of 339 children who had been followed for nine to twelve years in a previous study.

BACKGROUND:

Blood pressure measurements in childhood and young adulthood are less predictive of future levels than those taken in middle age. In part, this may be due to the fact that within-person variability appears to make up a larger proportion of total variability in childhood than adulthood. Previous work on an NHLBI supported grant indicated that repeated blood pressure measurements and visits led to higher childhood tracking correlations over a period of three years.

DESIGN NARRATIVE:

Follow-up data were used as well as multiple visits which reduced the large within-person variability of blood pressure measurements and improved the tracking correlations. In addition, 'true' or 'corrected' tracking correlations were provided by eliminating the effects of random measurement error. The effects were examined of time-varying covariates on both the observed and true tracking correlations. Besides computing tracking correlations, predictive values were computed for young adult blood pressure given childhood levels. This was the probability that a young adult's true blood pressure was above a specific cutpoint conditional on childhood blood pressure. These values were validated using data from the Fels Longitudinal Study, which included serial blood pressure measurements over the age range in the study. The prediction models were also derived including terms for covariates such as age, sex, height and weight. From these models nomograms were constructed which were useful to physicians for prognostic purposes. Thus, because of the unique multiple-visit approach used in these data, the effect of random measurement error was eliminated. These methodologic improvements strengthened the usefulness of blood pressure screening in childhood to detect those at high risk of developing hypertension.

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
Turkish Adaptation, Validity and Reliability of Cravings for Rest and Volitional Energy Expenditure (CRAVE)

The aim of this study is to adapt the Cravings for Rest and Volitional Energy Expenditure (CRAVE) scale to Turkish society and to make its validity and reliability in Turkish. The CRAVE scale developed by Stults-Kolehmainen et al assesses the intrinsic motivation required for sedentary behavior and participation in physical activity. It has 13 questions. CRAVE scale questions and questions in the data collection form will be prepared through the google surveys and will be sent to the participants via Whatsapp, Facebook, Instagram and e-mail. Participants will fill out the survey forms online. 130 participants will be included in the study. In order to evaluate the validity of the CRAVE, the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), which can measure exercise behaviors and intrinsic motivation and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion. The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, miguel blacutt and Stults-Kolehmainen approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a pre-assessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of CRAVE will be able to be modified. RAVE scale questions and questions in the data collection form will be prepared through the google surveys and will be sent to the participants via Whatsapp, Facebook, Instagram and e-mail. Participants will fill out the survey forms online. 130 participants will be included in the study. In order to evaluate the validity of the CRAVE, the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), which can measure exercise behaviors and intrinsic motivation and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-30 years
* Adult individuals who have access to the Internet and agreed to participate in the study. -
* Native language being Turkish

Exclusion Criteria:

* Inability to use a computer, tablet or mobile phone
* Native language not being Turkish
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer
* Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
* No more than one prior treatment for advanced disease
* Her2 positive status
* Adequate liver and kidney function
* No remaining severe harmful effects to prior treatments

Exclusion Criteria:

* Certain heart condition
* Pregnant Women
* History of another cancer except some skin cancers and cervical cancer
* Taking other treatments for your cancer at the time you enter the trial
Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

This is a prospective, single-cluster randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based transnasal laser-assisted surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery (MLS) under general anesthesia.

Patients with benign laryngeal lesions were block-randomized to either TNLS or traditional MLS group. Pre-operative diagnosis and post-operative follow-up were conducted in a multidisciplinary voice clinic. All patients were followed up at 2-week, 6-week, 3-month, 6-month and 1-year post-operation. Primary outcome included functional vocal measures using Voice-Handicap index (VHI-30). Secondary outcomes included length of stay, patient-perceived procedural discomfort, complications, operative time, recurrence rate, reoperation rate, and medical cost.

Eligibility Criteria:
Inclusion Criteria:

* older than 18-year-old
* mentally competent to give an informed consent
* operable benign laryngeal lesions
* able to tolerate transnasal flexible laryngoscopy

Exclusion Criteria:

* under 18-year old
* unable to give an informed consent
* unable to tolerate flexible laryngoscopy under local anesthesia
* allergy to local anesthesia
* unfavourable anatomy precluding adequate visualization
* with extensive lesions with expected difficult operation
* with pathologies suspicious of or confirmed malignancy
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) as an Inflammatory Markers to Predict Length of Hospital Stay After Total Laparoscopic Hysterectomy (TLH) for Benign Indications

Due to short hospital stay, rapid return to work, less pain, and good cosmetic results, laparoscopic hysterectomy ( LH) has substantially increased the era of hysterectomy procedures especially for the last two decades. The main reason for this is probably that LH leads to fewer inflammatory responses when compared to open abdominal hysterectomy. Although the inflammatory response is supposed to be lower with total laparoscopic hysteroscopy (TLH), unpredictable inflammatory response as a result of the operation has been still unenlightened and it can be associated with hospital stay.

IInflammatory response after surgery is an ordinary outcome which ends up with tissue repair. The increase in neutrophil levels accompanied with a decrease in lymphocyte levels is characteristic for the inflammatory response. Therefore, neutrophil to lymphocyte ratio (NLR) comes out as a simple index of inflammation. In the literature, NLR was shown not only to be associated with surgical complications but also the length of hospital stays in certain surgeries. Another inflammatory marker index of hemogram is the platelet to lymphocyte ratio (PLR). As a result of endothelial tissue damage, platelets are gathered in the affected area. Therefore, an increase in the number of platelets is inevitable for inflammation. Hence, PLR appears to be another simple index of inflammation due to the increase of platelets and the decrease of lymphocytes. PLR has also shown to be associated with length of hospital stay in various surgeries. NLR and PLR are both newly recommended inflammatory markers to estimate the prognosis of surgical treatment in clinics. Investigations regarding NLR and PLR concerning prognosis of patients after surgeries including gynecological cancer, cardiac surgeries, and emergency surgeries are available in prior literature. Investigators aimed to investigate the possible effects of inflammatory parameters, that can be easily obtained from complete blood count in the post-operative first day of total laparoscopic hysterectomy, to the length of hospital stay in patients without any complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients whom have undergone TLH

Exclusion Criteria:

* Ureter injury
* Bladder injury,
* Bowel injury,
* Superficial inferior mesenteric artery injury
* Vaginal cuff hematoma
* Vaginal cuff dehiscence
* Endometriosis
* Endometrial cancer
* Cervical cancer
* Chronic lymphocytic leukemia
* Behçet disease
* Electrolyte imbalance
* Thyroid disease
* Using anti-inflammatory medications
* Having severe intraabdominal adhesions
Measurement Properties in People with Hemophilia

The aim of this project is to determine the measurement properties (namely reliability and validity) of a set of clinical assessments, measuring different aspects of physical function.

The medical treatment of hemophilia has advanced greatly in recent years. There are now medications that reduce the physical symptoms of hemophilia. Nevertheless, those affected by hemophilia suffer from restricted mobility, reduced strength, reduced balance and pain as a result of the repeated bleeding. In order to make well-founded decisions regarding possible supportive therapeutic or medical measures, it is important to be able to estimate the extent of such limitations and whether these will change or remain stable.

The study is needed to validate the measurement properties of measurement instruments used to measure the effects of physical training interventions in participants with hemophilia. Clinical questions can only be solved if measuring instruments with sufficient measuring properties are used. These measurement properties must be evaluated in a relevant population. Otherwise, health professionals cannot assess whether measures or treatment are not effective or whether measured changes are not large enough to detect an actual change. Therefore, research is required to ensure that adequately studied measurement instruments are available for clinical assessment of those affected by adult participants with hemophilia.

Some of the tests (such as the Unipedal Stance Test or Four Square Step Test) have already been studied in children with hemophilia or in participants with other diseases. Since hemophilia is a disease with specific effects, the measuring instruments must also be researched in this participant group. There is still a research gap that the investigators would like to close with this study. For the study, the investigators selected tests that are already being used on adult participants with hemophilia and have had good experiences in practice. The tests are safe and can be carried out with little strain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Hemophilia Types A or B
* Adult people ≥ 18 years
* Patients on prophylactic factor or non-factor replacement treatment, or on demand factor replacement treatment.
* Able to walk for 20 meters independently, with or without walking aid
* Signed informed consent to participate in the study

Exclusion Criteria:

* Severe health conditions like severe cardiovascular, pulmonary, neurological or musculoskeletal diseases.
* Unable to perform the assessments due to disability or language problems.
Long-term Effect of Online Mental Health Literacy Training

The purpose of this study is to assess the effectiveness over time of an online mental health in sport module in improving mental health literacy, stigma, and help-seeking behaviors in a sample of Brock student-athletes. Student-athletes will be assigned to one of two conditions, mental health module or the waitlist condition. The mental health module will consist of completing the Supporting Student-Athletes Mental Wellness" online module for the student-athlete by the National Collegiate Athletics Association (NCAA). Participants will complete surveys at pre-intervention, post-intervention, 3-months and 6-month time points.


Eligibility Criteria:
Inclusion Criteria:

* student-athletes

Exclusion Criteria:

* non student-athletes
The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and Minimum Alveolar Concentration (MAC) Hour of Sevoflurane During Thyroidectomy

This study is to evaluate the level of anxiety, and to check the correlation of induction dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* female patients (ASA physical status I and II) aged between 20-65 years and scheduled elective thyroidectomy

Exclusion Criteria:

* cardiovascular, renal, liver disease, or psychiatric disorder
CONNECARE-Assuta-Case Study 1

The European Union's Horizon 2020 project issued a Call for Action \[1\] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries.

The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver.

Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.

The intervention in this study consists of two parts:

1. Integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital.
2. Empowering the patient to self-manage his or her health by using applications for smart devices.

The study protocol:

1. Recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, explanation of the study and signing the consent form.
2. Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
3. Distribution of research kit and related accessories and training.
4. Close monitoring for three months in the community after discharge from the hospital and use of the research kit.
5. Reassessment of the patient at the exit of the study.

Eligibility Criteria:
Inclusion Criteria:

* All Maccabi members who arrive at the ER in an unplanned manner
* Age over 65
* Living in a home and not in a nursing home
* LACE\> 7
* At least three of the following conditions:

  * Multiple drugs - regular use of four or more drugs
  * More than one case of hospitalization or visit to the ER in the past year
  * Malnutrition
  * Elements of low socio-economic status
* The patient and / or the main caregiver speak Hebrew, English or Russian
* The patient or primary caregiver has a password to the Maccabi Online website
* The patient and / or the primary caregiver have basic technological knowledge in the use of the applications
* The patient has wireless Internet access at home (via Wifi or through a cellular connection)

Exclusion Criteria:

* Patients with cognitive or dementia problems
Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint

This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Primary prostate cancer proven by sextant prostate biopsy
* Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
* Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
* In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
* ECOG status of 0 or 1 Pt \> 18 yrs of age

Exclusion Criteria:

* Definitive or concomitant therapeutic intervention within the interval of study intervention
* Prior pelvic therapeutic radiation
* Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
* Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
* Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in gynaecological surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

Eligibility Criteria:
Inclusion Criteria:

* All the hospital wards within the Piemonte Region performing hysterectomy.
* All the patients receiving an elective hysterectomy for benign or malignant tumors of the uterus.

Exclusion Criteria:

* Hospital wards performing less than 20 expected cases per year
* Emergency hysterectomy
* Hysterectomy for pelvic floor disorders
* High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).
New Ways of Doing Magnetic Resonance Imaging in Children and Adults

This study is being done to see how we can prevent problems caused by movement during the MRI scan. Different ways of doing the scan (techniques) will be tested to see if they are practical and can prevent problems related to motion. For example, changes in the timing of the magnetic field and the radio waves will be examined, and at changes in the way a computer is used to process the images. The new techniques will be compared with the techniques that are usually used.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age, including males and females, who are being treated in the Department of Pediatrics and are already scheduled to undergo MRI

Exclusion Criteria:

* Anyone who would normally be excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI (Appendix A). Subjects with pacemakers or aneurysm clips that are MRI conditional or MRI compatible may enroll in the study if the study is clinically indicated.
* Female patients who are pregnant
* Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
* Patients at higher risk due to age, frailty, or the emergent nature of their condition
* Patients who are undergoing MRI only of the head, neck or spine