cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study

Over 20% of the population is reporting on "white coat syndrome", manifested as anxiety symptoms and elevated BP during interaction with medical staff. It is estimated that, throughout the life span of children, approximately 15-20% will suffer from some form of a trauma relating to an interaction with health provider. The proposed study aims is to evaluate the correlation between a single preliminary psychological intervention, including providing knowledge and tools for problems solving, and the anxiety level in female patients arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in comparison to the anxiety in patients arriving to the same test without psychological intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment (performed as part of routine medical care) will be recruited to the study and will be randomized to one of 2 groups. Participants in the intervention group (10 patients) will be required to arrive with their parents an hour prior to the test and will receive a preliminary psychological intervention. The control group will arrive to the ACTH LRH test on the scheduled time and will not receive psychological intervention


Eligibility Criteria:
Inclusion Criteria:

* Girls referred to ACTH LRH or LRH test
* Age 7-12 years old
* Ability to answer questionnaire independently (hebrew language only)

Exclusion Criteria:

* Mental disability
* Girls who were referred to the test in purpose of evaluation of the pituitary adrenal axis after prolong steroids therapy.
* Girls with chronic disease that required frequent hospitalization (over 4 times per year)
UW WELL-FIT Exercise Program for Cancer Patients

The purpose of this project is to help to manage the many cancer treatment side effects through cardiovascular and resistance exercise, and education with the goal of using program outcomes to contribute to current research.

This study is a single group pre-test post-test design.There are 4 optional measures that will be presented to participants from which they can choose to participate or not. These are presented with check boxes in the consent form. After completion of the University of Waterloo (UW) WELL-FIT program, participants will be given an option to continue with an exercise program; they will be offered the Graduate Program. Following consent of Graduate Program, repeated measures would be taken annually. At the time of consent, they will have the option to have their data used in research. At any point in their involvement of the exercise based programs, they can indicate "they no longer want to participate in the program or the data collection". Their medical care or participation in the UW WELL-FIT program will not be affected.

Procedures

1. UW WELL-FIT advertisement for Grand River Regional Cancer Centre
2. UW WELL-FIT brochure
3. Referral Form
4. Participants initial consultation and assessment
5. Obtain consent for UW WELL-FIT
6. Obtain Participant Information
7. Completion of FACIT-F survey
8. Metabolism \& Body Composition - Information sheet for optional measures
9. Physical Activity Survey- Godin Questionnaire
10. Provide 3-Day food diary and Nutritional Assessment
11. Fitness assessment, exercise programming and data entry:

    1. Submaximal cardiovascular cycle ergometer or treadmill graded exercise test
    2. Muscular strength using force transducer
    3. Body composition:

       * Height, weight and waist girth
       * Bioelectrical Impedance Analysis (BIA)
       * Dual Energy X-ray Absorption (Optional)
    4. Range of motion using a goniometer
    5. Blood sampling (Optional)
    6. Design Individualized exercise program
12. UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)
13. Post assessment (repeated pre-test assessments)
14. Pre and post data are entered into database
15. Summary and Feedback Report
16. Graduate Program: participant selects to attend UW WELL-FIT Graduate Program
17. Participants have annual reassessments in the Graduate Program

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)

Exclusion Criteria:

* Physical / health factors that prohibit exercise or lack of medical clearance from physician
Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training

Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim,
* (2) has received HAT pack training,
* (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training,
* (4) patient provides informed consent.

Exclusion Criteria:

-No exclusion criteria for this observational study
Agreement Between Clinician and Instrumented Laxity Assessment

Ankle injuries are the most common acute injury to the active population. It is important to ensure best practices and techniques used in clinics for evaluation are validated and consistent. This study will compare diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries.

Ankle injuries, specifically lateral ankle sprains, are the most common acute injury to the active population (Hootman, Dick, \& Agel, 2007). It is important to insure the use of best practice and ensure that the techniques being utilized in clinics for evaluation are validated and consistent within the techniques. Manual testing and instrumented testing have not yet been tested within the same cohort.

The purpose of this study is to compare the diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries. Participants will be recruited at University of Nebraska at Omahas (UNO) Injury Prevention and Care Clinic and Athletic Training Room in Sapp Fieldhouse. Participants with be members of the UNO Wellness Center or UNO athlete, aged 19-80 years old. During a standard evaluation the participant will have a clinician test manual ligamentous laxity and a blinded clinician testing laxity using an arthrometer. Participation will not alter the normal treatment or care for participants. The author hypothesizes that the diagnostic accuracy for all performed test will be good to excellent when assessed for laxity and moderate to good when assessed for pain.

Eligibility Criteria:
Inclusion Criteria:

* Membership to University of Nebraska at Omahas Wellness Center: a student taking on campus classes or a paying community member. Acute injury occurred within one week of evaluation.

Exclusion Criteria:

* Any condition that is contraindicated for manual test (i.e. fracture).
Task Sharing for Anxiety

This single-arm pilot clinical trial will evaluate the feasibility, acceptability, and engagement of target mechanism, and preliminary impact of a low-intensity behavioral intervention for mild-to-moderate anxiety disorders. Treatment will delivered by trained lay counselors (n = 5) to patient participants (n = 15).

Anxiety is the most common adult mental health condition. Left untreated, it is costly and imparts significant personal and public health burden. Evidence-based psychotherapy (EBP) is an acceptable and effective first-line treatment; however, rural, low-income, and other underserved areas suffer from provider shortages, rendering such treatment largely unavailable. International contexts are beginning to address this problem using provider task sharing, in which low-intensity behavioral health services are delivered by non-specialist health workers (i.e., those with no prior training as a mental health professional). This approach is designed to improve access to care, particularly for those with mild-to-moderate symptoms, and free up limited expert resources. What is lacking is a brief, evidence-based, low-intensity behavioral intervention for mild-to-moderate anxiety disorders as well as an implementation blueprint (e.g., identifying appropriate clinical setting, stakeholder needs, supervision requirements, other counselor and clinic supports) needed to successfully implement and sustain such a novel service model in U.S. contexts. This study will begin to address the above problem in two phases, while creating the foundation for a longterm research program and external funding applications. The primary objective of this work is to develop and preliminarily test a brief intervention for anxiety appropriate for primary care and other non-specialty contexts. Investigators will test the intervention and delivery method via a small, single-arm pilot clinical trial. Non-specialists will be five undergraduate students, each working with three patient participants with anxiety (N = 15) to provide preliminary data on fidelity, feasibility, acceptability, preliminary clinical outcomes, and engagement of the target clinical mechanism of avoidance. The activities of these aims will develop community and clinical partnerships for testing and future implementation of low-intensity treatment paradigms.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years,
* score on Beck Anxiety Inventory (BAI) ≥ 16,
* ability to speak English
* willing and able to attend in-person study visits at UNLV
* community dwelling

Exclusion Criteria:

* other psychological conditions rendering the person unlikely to benefit from a brief treatment, including psychosis, bipolar disorder, cognitive impairment, and substance abuse or dependence (comorbid depression permitted);
* active suicidal ideation or intent;
* concurrent receipt of regular individual psychotherapy;
* use of anxiolytic medication.
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

- Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months.

- Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent boys or girls aged 13 to 18 inclusive
* Weighing more than 40 kg
* Capable of understanding the protocol
* Who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday
* Presenting the diagnostic characteristics of manic, mixed or hypomanic episodes of bipolar disorder established in accordance with the DSM IV, gathered in a semi-structured interview (Mini International Neuropsychiatric Interview - M.I.N.I.)
* With a score on the YMRS scale (Young Mania Rating Scale) \>= 14 for the manic or mixed episode or \>= 10 for the hypomanic episode
* Absence in blood of valproic acid at the inclusion visit
* Willing to use effective contraception in the case of girls of child-bearing potential. In this case the investigator should satisfy him/herself as to the psychological capacity of the patient to understand and undertake use of this contraception.
* Whose physiological test results are normal: hepatic function, blood count, lipid levels, fasting blood glucose level, blood urea, blood ammonia, blood protein, serum creatinine levels and plasma ions

Exclusion Criteria:

* General criteria:

  * Pregnant girls, or those breast-feeding or those for whom a pregnancy test is positive (blood beta HCG test)
  * Simultaneous participation in another study or in the 2 months preceding selection of the patient
* Psychiatric criteria:

  * Established or known mental retardation
  * Autistic disorders
  * Established schizophrenia
  * Schizoaffective disorders
* Somatic criteria:

  * Medical or organic disease of the CNS (epilepsy, tumour etc.)
  * Any known renal, cardiac or haematological disease, or disease of the immune system
  * Endocrine disorders and/or any biochemical abnormality known or existing at the moment of inclusion
* Exclusion criteria linked to the treatment

  * Known hypersensitivity to valproate or to sodium divalproate or to one of the constituents of the drug
  * Hepatic disease: acute hepatitis, chronic hepatitis, past personal or family history of severe hepatitis particularly caused by medicinal products, hepatic porphyria
  * Treatment with lamotrigine, (Lamictal)
  * Treatment with mefloquine, (Lariam)
  * Any treatment based on valproate
  * Treatment with methylphenidate (Ritalin)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Risk Factors for Barrett's Esophagus in Patients With BE, Gastroesophageal Reflux, or Gastrointestinal Bleeding

RATIONALE: A study that evaluates DNA changes and other disease-related health information in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may help doctors learn more about the risk factors for Barrett's esophagus.

PURPOSE: This clinical trial is looking at DNA changes and other disease-related health information as risk factors for Barrett's esophagus in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding.

OBJECTIVES:

* Assess the role of several genetically determined factors that, in combination with CagA status, cigarette smoking, alcohol, and diet to varying degrees, result in an increased risk for Barrett's esophagus.

OUTLINE: This is a controlled study.

Patients complete questionnaires about demographics, medical history, smoking and alcohol history, current medications, frequency and chronicity of gastroesophageal reflux symptoms, and diet history.

Blood and tissue are collected and analyzed by DNA-based assays and enzyme-linked immunosorbent assay for CagA status and polymorphisms in detoxifying enzyme systems, other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4, CYP3A5, NQO, NAT-2), inflammatory gene pathways (e.g., IGF, IGFBF3), and in DNA repair genes or p53 pathways (e.g., XRCC1, p53 gene).

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing elective esophagogastroduodenoscopy for any of the following reasons:

  * Surveillance of Barrett's esophagus
  * Evaluation of severe or refractory gastroesophageal reflux disease or chest pain thought to be due to reflux
  * Gastrointestinal bleeding

PATIENT CHARACTERISTICS:

* Not pregnant

PRIOR CONCURRENT THERAPY:

* Not specified
Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work

Aim is to study the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work. The intervention is compared with inpatient rehabilitation only, and participants will be recruited from the diagnostic groups dominating the sick-leave statistics, namely musculoskeletal disorders, common mental disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic fatigue.

Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal, unspecific and common mental disorders. Research indicates that interventions on the work place might facilitate return to work. The aim of this study is therefore to investigate the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Central Norway
* Sick-listed due to common mental disorders, musculoskeletal pain/problems, unspecific disorders and/or fatigue
* Sick-listed more than 50 %
* Sick-listed longer than 8 weeks
* Has employer and is willing to participate in a work place intervention during the rehabilitation program

Exclusion Criteria:

* is self-employed
* has, or is currently examined for, a serious somatic or psychiatric disorder
* suffers from substance abuse
* has trouble with participating in a group
* is in a rehabilitation process that will interfere with the occupational rehabilitation program
* function level is to weak to participate in the rehabilitation program
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.


Eligibility Criteria:
Inclusion Criteria:

* Patients having a needle biopsy of a breast mass

Exclusion Criteria:

* none
Effect of Nursing Care on Prevention of Dry Eye

Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.

Critically ill patients are at higher risk for dry eye and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years;
* Did not present dry eye at the time of admission;
* Stay in the ICU for at least 24 hours;
* Be in mechanical ventilation therapy;
* Glance less than 5 per minute;
* Comatose, sedated or Glasgow less than or equal to 7;
* Consent to participate in research or have.

Exclusion Criteria:

* Have not the responsabille authorization;
* Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.
Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).


Eligibility Criteria:
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).