cyrilzakka/clinical-trials huggingface dataset:
Emotion Regulation Therapy to Address Distress Among Caregivers

The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Providing care to someone with cancer can be difficult. The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones. Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being. This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.


Eligibility Criteria:
Inclusion Criteria:

* As per self-report, age 18 or over
* As per self-report, a current caregiver to a patient with any site or stage of cancer
* score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
* Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score \> 12 on the Brooding Subscale of the Rumination Response Scale
* In the judgment of the investigators and/or consenting professional, able to read and comprehend English
* In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion Criteria:

* As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
* If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
* As per self-report, is a regular smoker (daily use)
* As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
* As per self- report, engaging in night shift work
* As per self- report, currently engaged in ongoing psychotherapy.
Vigilance and Simulated Driving After a Nap

The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance.

This study also aims to record during nap time, sleep, body temperature and heart rate.

Nap time is one of the most effective means of combating decreased alertness throughout the day and maintaining cognitive and psychomotor performance.

As such, it is recommended for long-haul drivers driving their vehicle. However, these drivers have no alternative but to sleep in their seats. These conditions are not optimal for producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has developed a mini-hotel allowing drivers to find an optimized place to take a nap.

Investigators propose an experimental study to evaluate the effectiveness, on simulator driving performance and on the results obtained during cognitive and motor testing, of a nap taken under three different conditions. The effect of the nap will be assessed by comparison to a rest awake.

This study should include healthy volunteer participants.

Eligibility Criteria:
Inclusion Criteria:

* -Male and female participants, aged 20 to 50 years in good health, good sleepers (\>8h on average), not being extreme chronotypes, without sleep disorders, healthy, unmedicated, not working in shift work, having been licensed for at least 2 years and driving a minimum of 5000 km per year
* The need for the collection of the signature of informed consent
* The need to be affiliated with the social security system
* The need to understand French

Exclusion Criteria:

* participant with a sleep disorder, even if not medicated
* participant with extreme morning or evening chronotype
* pregnancy
* ill or medicated participant
A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control.

At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control (Nimenrix, a tetravalent meningococcal vaccine - Men ACWY).

At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (Nimenrix) (n=60).

As a safety precaution measure, the first 30 sentinel participants will be enrolled into the trial in an open-label fashion according to an age step down scheme.

After sentinel analysis, participants will be enrolled in a blinded, randomized manner into three Trial Arms. Within each treatment arm participants will be stratified into three age strata:

Stratum A: 7 to 11 years -children from their 7th birthday until the day before their 12th birthday.

Stratum B: 3 to 6 years - children from their 3rd birthday until the day before their 7th birthday.

Stratum C: 1 to 2 years - children from their 1st birthday until the day before their 3rd birthday.

Age strata for the VLA1553 treatment arms are targeted to be equal in size, i.e., approximately 40 per age stratum.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination;
2. Written informed consent by the participant's parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to local requirements, and written informed assent of the participant, if applicable;

Exclusion Criteria:

1. Participant who is IgM+/IgG- does not qualify for participation in this trial.
2. Participant is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical trial involving an investigational CHIKV vaccine;
3. Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0)
The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.

The purpose of the study is to compare effects of treatment of patients acutely admitted to a Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior decorations like an ordinary, Norwegian home.

The PICU in Østmarka psychiatric department, St. Olavs Hospital contains 2 identical parts. Each part contains 2 beds. The PICU had a traditional sparsely decorated interior. In cooperation with architects and the county building authorities one of the parts were redecorated to an interior like an ordinary Norwegian home. All patients admitted the the PICU were semi-randomized to either traditional or "Norwegian home" interior decorations. Symptoms, behaviour, and treatment were evaluated at admittance, day 3 and discharge from the PICU

Eligibility Criteria:
Inclusion Criteria:

* All patients acutely admitted to the PICU, St. Olavs Hospital, Østmarka dep.

Exclusion Criteria:

* Patients with dementia or mental retardation to an extensive degree.
* Patients not speaking Norwegian or English
Extracorporeal Photopheresis (ECP) After Lung Transplantation

The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.

The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.

Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing first lung transplantation
* Patient underlying disease COPD
* Male or female be 18 years or older
* Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
* Patients must have a body weight more than 40 kg
* Patients must have a platelet count more than 20.000/cmm
* Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent

Exclusion Criteria:

* Previous organ transplantation
* Women who are pregnant and/or lactating
* Patients with hypersensitivity or allergy to both heparin and citrate products
* Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure
Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed Alzheimer's Disease with MMSE score 1\~12
* Have not been treated by any medication for Alzheimer's Disease in past 3 months
* Live in community or Assisted Living Facility
* Healthy or with chronic diseases that are medically controlled or stabilized
* Able to swallow tablets

Exclusion Criteria:

* Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
* Dementia caused by organic diseases other than Alzheimer's Disease
Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy

Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to treatment, local control, and/or survival in NSCLC.

Locally advanced NSCLC has a poor prognosis with a 5 year overall survival rate of only 15%. Tumour hypoxia may impact the ability to control NSCLC. Using 18F-FAZA PET, this study will assess patients for hypoxic treatment. With this information, we can start individualizing patient treatment to target hypoxia. The relationship between areas of hypoxia (18F-FAZA) and high glucose utilization (18F-FDG) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histological types: squamous cell carcinoma; adenocarcinoma; undifferentiated large cell carcinoma, and non-small cell, not otherwise specified (NOS, diagnosis on cytology alone)
2. Patients with American Joint Committee on Cancer (AJCC) Stage I, II, IIIA, or IIIB with detectable tumour that can be encompassed by radiation therapy fields, including both primary tumour and the involved regional lymph nodes.
3. Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
4. The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
5. Male or female ≥ 18 years of age. If female of child bearing potential and outside the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
6. ECOG/Zubrod status 0-1
7. Patients must have at least one measurable lesion ≥ 1 cm on CT
8. Able and willing to follow instructions and comply with the protocol
9. Provide written informed consent prior to participation in the study

Exclusion Criteria:

1. Patients who have undergone complete or subtotal tumour resection
2. Patients with post-resection intrathoracic tumour recurrence
3. Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
4. No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
5. Evidence of any small cell histology
6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years
7. Inability to lay in supine position for approximately one hour
8. Nursing or pregnant females
9. Aged less than 18 years
Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area

Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement or blood donation. The predominantly used venous for blood withdraw are in the cubital region because in this area venous are most superficial placed and most often visible for the human eye. However, when using the usual blind landmark and palpation method in this region, it often proves exceedingly difficult or even impossible to obtain peripheral venous access on patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various studies have shown that the success rate for establishing a vascular access with ultrasound compared to blind landmark technique is higher in patients with difficult access. When ultrasound is used to establish intravascular access, the prerequisite sterile puncture area can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or blood. A strict sterile procedure is important to reduce complications related to infection.The traditional way of coping with this is by covering the transducer and the wire in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band around the transducer and pulled tightly around the transducer foot to prevent artefacts from appearing on the screen. This is an expensive and time consuming method, and it still leaves the problem with gel in the puncture area.

The investigators have developed a method by where all these problems are solved by using, a slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning technique

The investigators hypothesize that it is possible to perform ultrasound-guided venous puncture with a sterile and dry puncture area and that puncture can be performed proximal and distal to the traditional puncture side.

It is a procedure presenting study that serves to demonstrate the feasibility of the method in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years of age
* mentally competent
* of good health

Exclusion Criteria:

* age below 18 or above 70 years of age
* daily use of blood thinner medication
* suffering from a chronic illness that requires frequent blood withdrawals
* heart conditions or vascular diseases
* People known to experience vasovagal episodes when having blood samples taken
The Use of Lung Ultrasonography in COVID-19 Patients

In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.

In this study, the COVID-19 patients hospitalized in the intensive care unit due to respiratory failure will be evaluated. Participants will be divided into two groups as patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung ultrasonography (Group Control).

While performing lung ultrasonography, each hemithorax will be evaluated using anterior axillary line and posterior axillary line into anterior, lateral and posterior region, and each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with the Lung Ultrasound Score (LUS score).

Participants in both groups will be evaluated by comparing arterial blood gas analyzes before examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and ventilation between Group Ultrasonograpy and Group Control will be evaluated?

Eligibility Criteria:
Inclusion Criteria:

* Patients have been diagnosed with COVID 19
* Patients in the intensive care unit over the age of 18

Exclusion Criteria:

* Patients not diagnosed with COVID 19
* Patients with cardiac problems
* Patients with renal problems
Improving Safety By Computerizing Outpatient Prescribing

Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.

Specific Aim 1: Increase routine identification of outpatient adverse drug events (ADEs) through development of a computerized ADE detection monitor.

Specific Aim 2: Use basic computerized outpatient prescribing to reduce preventable ADEs in a diverse array of outpatient settings.

Specific Aim 3: Use advanced decision-support within computerized prescribing to reduce the frequency of preventable ADEs, medication errors, and potential ADEs.

Eligibility Criteria:
Inclusion Criteria: At Brigham \& Women's Hospital, clinics utilizing the electronic medical record will be included. At Regenstrief, any clinic that has access to their electronic medical record will be utilized.

* For the impact of basic decision support, clinics were not randomized
* For impact of advanced decision support, clinics were randomized to receive the intervention

Exclusion Criteria:

* Clinics not using electronic medical records
the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-50 years old
2. Diagnosed with FAIS according to the Warwick agreement
3. Patients having cam morphology should have an alpha angle of \> 55 degrees on an anterior-posterior radiograph.
4. Patients having pincer should have a lateral centre edge angle of \>39 degrees on an anterior-posterior radiograph.
5. Lateral joint space width should be \>3 mm.
6. Body mass index is below 30.
7. Motivated for participation in a 12 week training program with 8 physical attendances.

Exclusion Criteria:

1. Received physiotherapist-led treatment in the past 3 months,
2. Previous hip surgery in included hip or other major hip injury,
3. Systemic conditions e.g. rheumatoid arthritis, cancer,
4. Chronical pain syndromes,
5. Unable to perform testing procedures,
6. Unable to attend a 12-week treatment program or baseline and follow-up assessments
7. Contraindications to radiographs (e.g. pregnancy)
8. Unable to read or understand questionnaires and/or instructions
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.

The duration of the current study is 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent
2. Confirmed MS diagnosis as defined by the McDonald criteria
3. R-R MS disease course.
4. At least one gadolinium-enhanced lesion on screening MRI
5. Women of child-bearing potential must practice a reliable method of birth control.
6. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

1. Subjects who suffer from any form of progressive MS.
2. Any condition which the investigator feels may interfere with participation in the study.
3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
5. Previous treatment with immunomodulators within two months prior to screening