cyrilzakka/clinical-trials huggingface dataset:
Support for Bereaved Cancer Caregivers

Friend and family caregivers of recently deceased cancer patients experience acute bereavement following the death. Post death bereavement is an intense period of mourning that includes an unfolding of the grief process and is characterized by strong emotions and demands on cognitive resources to those who have put aside their own needs to support the dying patient with cancer. This research will test the feasibility and acceptability of a nature-based healing meditation (NBHM) intervention to support cancer caregivers' during the bereavement process.

Bereaved friend and family caregivers have taken on the burden of end-of-life care for patients with cancer who die in hospice care at home. Bereavement can be emotionally devastating, especially to those who have put aside their own needs to support the dying individual. Supporting bereaved CGs' emotional health and general well-being is a critical need. The proposed pilot study will evaluate the acceptability and feasibility of a 6-week low-tech nature meditation intervention aimed at supporting bereaved caregivers' who are in the first 6 months since the patients' death. The intervention, based on the mutually supportive role that meditation practices and nature have been shown to promote wellbeing, will be developed capitalizing on the strengths of the research team's early intervention work involving patients with advanced cancer and their caregivers. For this single group longitudinal study, Aim 1 will focus on the development of 6 nature-based healing meditation (NBHM) auditory modules available via the study website to facilitate bereavement (grief) recovery and assessed on parameters of directed attention, grief, and QOL (including parameters of depression/anxiety).

The 2nd aim will then evaluate acceptability and feasibility of the 6-week program of both content and delivery methods (numbers eligible vs. number consented; numbers consented vs. numbers completed; number of weeks using the intervention) for the intervention modules. We will then conduct semi-structured interviews with a small diverse representative sample of caregivers to evaluate benefits, satisfaction, and challenges in more depth. Fifty-five home-based cancer caregivers who recently experienced the death of their patient will be recruited from Hospice of Michigan. Testing will occur at baseline (Time 1; study week 0), at the intervention end (Time 2; week 6), and (Time 3; study week 12). This research targets a supportive caregiver intervention that will be flexibly delivered on-line for use at the caregiver's convenience. Once feasibility and acceptability for this new intervention to support bereaved caregivers are addressed, a larger scale randomized control trial will be sought.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older; Able and willing to provide reflexology
* Able to speak and understand English
* Have access to a telephone
* Able to hear normal conversation
* Cognitively oriented to time, place, and person (determined via recruiter)

Exclusion Criteria:

* Unwilling to perform return demonstration with 90% accuracy
A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR with NRCT-202XR Compared to NRCT-202XR Alone in Subjects with Attention-Deficit/Hyperactivity Disorder

A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.

A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD.

Subjects' enrollment will be conducted in two stages.

In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio):

Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR

In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR.

The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.

Eligibility Criteria:
1. Male or female, 13-17 years of age at screening.
2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.
3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.
4. Has side effects identified using SDSE-RS at Screening and Baseline.
5. CGI-S ≥ X (blinded) at Screening and Baseline.
6. Must be fluent in English and communicate effectively with others.
7. Both subject and parent/guardian willing and able to give informed assent/consent.
8. Parent/guardian willing to serve as informant.
The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics

This is a prospective, randomized, open-label, active drug controlled clinical trial that aims to compare the effects of henagliflozin or metformin on myocardial tissue level characteristics in type 2 diabetes patients with obesity. Eligible subjects with type 2 diabetes before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to henagliflozin 10 mg once a day or metformin 1000 mg twice a day and treated for 24 weeks. The study includes five visits.

MRI scanning will be assessed at baseline and at the end of the treatment period in order to to assess the cardiac morphology, cardiac function, and myocardial tissue characteristics. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 2 diabetes newly diagnosed based on the WHO (1999) criteria;
* Hemoglobin A1c levels \>=7.0% and \<=8.0%;
* Females or males ≥18 years up to 75 years of age.

Exclusion Criteria:

* Females or males \<18 years.
* Clinical diagnosis of type 1 diabetes and other types of diabetes.
* Blood pressure at screening that would require a change in blood pressure treatment over the study period.
* History of stroke or other clinically significant cerebrovascular disease.
* Any of the following cardiovascular diseases:

  1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
  2. Unstable heart failure or any heart failure with NYHA class III and IV
  3. Significant valvular disease
  4. Significant peripheral artery disease
* Active malignancy requiring treatment at the time of visit 0.
* Patients with severe hepatic impairment.
* Unstable or rapidly progressing renal disease.
* Ongoing treatment with loop diuretics.
* Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m2.
* Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

* Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
* Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
* The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
* Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
* Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
* The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.


Eligibility Criteria:
Inclusion criteria:

* Newborns or Infants
* less than 7 kg
* Infra-umbilical surgery less than 1 hour
* Spinal anesthesia

Exclusion criteria:

* parental refusal
* Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
* Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery

Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

This study is proposed to explore the effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery.

After ankle or foot arthrodesis patients need a good analgesia. Nevertheless early mobilisation and discharge are important for the healing process after surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. Perineural dexamethasone added to local anesthetic prolongs the duration of analgesia of the perineural nerve block.

The perineural use of dexamethasone is still off-label. There is a ongoing discussion of which has better benefits, intravenous or perineural dexamethasone.

There are multiple research where the intravenous and perineural dexamethasone use has compared, but there is still a limited amount of research of low dose perineural dexamethasone versus intravenous dexamethasone.

In this study investigators compare different doses of perineural dexamethasone added to ropivacaine 2 mg/ml 20ml. After arthrodesis under spinal anaesthesia the patients receive popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. Groups 1 to 4 has dexamethasone doses 0, 2mg, 3mg or 4 mg.

After the popliteal nerve block investigators follow postoperative pain, opiate consumption, mobilisation and long term quality of life.

Investigators goal is to find a dexamethasone dose which is as low as possible but at the same time covers the need for a good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition

Exclusion Criteria:

Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Steroid medication in regular use
Leipzig Adipose Tissue Childhood Cohort

In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. The investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.

The investigators aim to identify how adipose tissue dysfunction in childhood contributes to the development of obesity and related comorbidities and to characterize factors that play a role in the development of adipose dysfunction in children. The investigators will employ a translational approach which is based on the characterization of adipose tissue biology in samples of children to determine alterations leading to adipose tissue dysfunction. These include assessment of the composition (including BAT), remodeling, function, metabolism and inflammation of adipose tissue as well as the adipokine profile. For the assessment of clinical relevance, these experimental data will then be correlated with the clinical phenotype. Finally, we aim to identify factors responsible for early adipose tissue dysfunction and characterize them for their clinical and functional relevance.

Eligibility Criteria:
Inclusion Criteria:

* body weight: 3000 g - 180 kg
* suitable surgical procedure
* signed informed consent by the guardians and the study participant, if older 12 years

Exclusion Criteria:

* severe chronic and inflammatory diseases
* acute or chronic infections
* oncological diseases
* clotting disorders
* complications during surgical procedure
* drug treatment
* nil by mouth
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.


Eligibility Criteria:
Appropriate Patient Criteria:

* Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient Criteria:

* Known sensitivity to paclitaxel.
* Known allergy to stainless steel.
* Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
* Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
* Patients with unresolved vessel thrombus at the lesion site.
* Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.
* Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
* Patients with diffuse disease or poor overflow distal to the identified lesions.
* Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
* Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

Autologous epidermal cell transplantation is based on the principle and technology of skin tissue engineering, and is performed by cutting small pieces of autologous skin from patients, isolating and culturing and expanding them, and then transplanting them to the patient's wounds to repair the damage.

Timely wound repair has been a great challenge in the treatment of patients with large deep burns. The current conventional approach is to use autologous skin grafts, such as micro-skin grafts, stamp skin grafts, and mesh skin grafts. Since there is very little normal skin left after large deep burns and the expansion of autologous skin grafts is limited (3-15 times), repeated skin grafting procedures are needed to repair the wound gradually, resulting in a long course of disease, scar growth and contracture, which seriously affects the quality of survival and even endangers life. Especially for patients with very large deep burns, there is an extreme shortage of normal skin sources, so they face the dilemma of having no rice to cook and unable to repair their wounds.

Based on the principle and technology of skin tissue engineering, autologous epidermal cell transplantation can provide sufficient skin source for patients with large deep burns by cutting very small pieces of autologous skin (about 2-10 cm2) and expanding them by 1000-5000 times after 2-3 weeks of in vitro culture. Autologous epidermal cell membranes combined with a large proportion of expanded autologous dermis (e.g. stamp skin, reticular skin) can significantly shorten the interstitial fusion time, improve the survival rate of autologous dermis transplants, and reduce scar growth after wound healing; autologous epidermal cell membranes combined with allogeneic dermis transplants can repair third-degree burn wounds, thus providing a large number of dermis sources for patients with lack of dermis sources, and has become an important treatment tool for saving the lives of patients with large deep burns. It has become an important treatment tool to save the lives of patients with large deep burns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a body surface trauma of 30% TBSA or more and a wound that requires at least 2 weeks to repair as assessed by the clinician

Exclusion Criteria:

* Patient body surface trauma area less than 30% TBSA
Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU

Hearing impairment affects the ability to communicate, which can adversely affect both mental and physical health. The most common used rehabilitation method in hearing impairment is hearing aid fitting. Even with optimally fitted hearing aids, many struggle to hear in situations with difficult listening conditions. Active Communication Education (ACE) is an interactive group rehabilitation programme aiming to help those with hearing loss communicate more effectively using communication strategies to cope better in everyday life. An Individualised Active Communication Education (I-ACE) distributed digitally could enable those unable to get to the hearing care facility, or don't want to join the group sessions to benefit from the programme.

This project aims to investigate the effects of the swedish digital version of the I-ACE in first time hearing aid users.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>20 years old who have been fitted with hearing aids for the first time (first time users) 6 - 12 months prior.
* Computer experience and access to computer, tablet and/or smartphone with internet access.
* Access to BankID or equivalent.

Exclusion Criteria:

* Those who have participated in Active Communication Education prior.
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.

Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.

Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.

Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

Exclusion Criteria:

* Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.


Eligibility Criteria:
Group A: Receive Intervention

Inclusion Criteria:

-Healthy children aged 6 months to 72 months

Exclusion Criteria:

* Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components
* Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain- Barré syndrome within eight weeks of a previous influenza vaccine
* Use of aspirin or salicylate- containing products within 30 days before enrollment

Group B:

Inclusion Criteria:

* household and extended family members of children in Group A
* extended family is defined as the household members of the grandparents of the children in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants

Group C:

Inclusion Criteria:

* other Hutterite community members that are not in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants