cyrilzakka/clinical-trials huggingface dataset:
Parent Training for Youth With Chronic Symptoms

The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. The investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. The investigators also predict that this group will be acceptable and feasible for parents.


Eligibility Criteria:
Inclusion Criteria:

* Presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic Lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms
* Symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation
* Participants must be proficient or fluent in English
* Children must live with their participating parent(s) at least 50% of the time

Exclusion Criteria:

* Presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition
* Lifetime history of a psychotic disorder, bipolar disorder, Autism, or intellectual disability (Note: this criterion applies to child and parent(s))
* Presence of severe emotional or behavioral problems that require a more immediate treatment
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior

This study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate and skin conductance will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Able to understand the nature of the study and give informed consent

Exclusion Criteria:

* Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
* Currently consuming anti-depressants
* History of seizures
* Metallic implants on the scalp
* Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day
* History of adverse reactions to tDCS
Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy

This is a pilot study designed to assess for relative change in cardiac 18F Florbetapir uptake in patients with AL cardiac amyloidosis after appropriate chemotherapy.

Current research involving \[18F\]-florbetapir in relationship to cardiac amyloid has taken advantage of the ability of the radiopharmaceutical to bind specifically to amyloid fibrils. It has previously been established that the degree of radiotracer uptake correlates with the density of Beta-amyloid plaque. The ability to quantify this uptake makes \[18F\]-florbetapir imaging a potential tool to evaluate cardiac response in patients undergoing therapy for AL amyloidosis. It would provide a much-needed tool to monitor cardiac response to chemotherapy to potentially adjust chemotherapy if response was not adequate. It could also provide a tool by which investigators would be able to evaluate new therapies designed to decrease the burden of formed amyloid fibrils within the heart.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \> 18 years are eligible.
2. Patient must provide informed consent to participate in the study protocol.
3. All patients must have clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or cardiac MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis).
4. Planned plasma cell-directed chemotherapy.
5. A negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted.
6. Patients must be able to undergo PET-CT imaging
7. Patients must be able to complete 6-minute walk test

Exclusion Criteria:

1. Severe claustrophobia
2. Pregnancy
3. Allergy to F-18 florbetapir
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Eligibility Criteria:
Inclusion Criteria:

* Female Subjects able to give consent
* Post partum patients
* Baseline Hbg\< /= 10
* Agree to practice birth control
* Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria:

* Known hypersensitivity reaction to oral or IV iron (VIT-45)
* Documented history of discontinuing oral iron
* Significant bleeding
* History of anemia other that iron deficiency anemia
* Severe Psychiatric disorders
* Active severe infection
* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
* Known HIV antibody
* Received investigational product within 30 days
* Alcohol abuse
* Hemochromatosis or other iron storage disorder
Strengthening Hope After ICU Discharge

The goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (ICU) patients in the rehabilitation phase. The main questions it aims to answer are:

To develop and implement a follow-up service to strengthen hope in ICU patients, and to evaluate the effect on hope in a stepped wedge randomized trial.

To identify possible predictive factors (facilitators and barriers) associated with hope.

Participants will be asked to take part in an ICU follow-up service, a "Hope Intervention" consisting of digital individual- and group conversations. The program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future.

We will compare the level of hope between participants who have completed the "Hope Intervention" to those that have not yet completed the program.

The ICU patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the ICU.

Having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. Hope is scarcely described in ICU patients.

Health care professionals need to learn how to best support ICU patients and promote hope during the rehabilitation period. Therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former ICU patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (SW-CRT). The secondary aim is to identify possible predictive factors associated with hope.

The intervention will start after hospital discharge and will be carried out in group sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years
* ICU patient for \> 48 hours
* must be able to communicate verbally just after their ICU stay and be able to handle digital meetings

Exclusion Criteria:

* Patients with severe cognitive impairment
* Do not understand and speak Norwegian
* Patients with major psychiatric challenges, suicidal attempts as a reason for ICU stay
* Age over 85 years.
Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme

Check your health is a prevention intervention designed to create awareness and action on health condition with focus at physical activity at a population-level to 30-49 years of age. It consists of a behavioural and clinical examination followed by either (I) referral to a health promoting consultation in general practice (II) targeted behavioural programmes at the local Health Centre or (III ) no need for follow-up; stratified after risk-profile. The CORE trial (Check your health) aim to investigate effectiveness on health and social outcomes of the preventive health check and to establish the cost-effectiveness according to life years gained; direct costs and total health costs. A pragmatic cluster randomised controlled trial has been established to meet the aims and in total 10.600 individuals from 35 practices have been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively. The group offered the preventive health check in 2013-14 will constitute the intervention group and the group examined in 2017 - 18 the control group. A follow up of the intervention group in 2017 - 18 will provide data for the intention to treat analysis revealing the effect. Outcome measures are level of physical activity, risk of getting cardiovascular disease, sick leave and labor market attachment.


Eligibility Criteria:
Inclusion Criteria:

* all citizens living in Randers Municipality aged 30-49 on 1 January 2012, identified in the Danish Civil Registers (DCR) and randomised for health check in 2013 or 2017.

Exclusion Criteria:

* Terminal illness, reported by their GP is exclusion criteria for receiving invitation.
Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with leptorrhine noses
* Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep
Exercise Training Post Burn Injury

The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.

Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.

This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.

Eligibility Criteria:
Inclusion Criteria:

* Burns greater than 20% total body surface area
* 18 years of age and over
* English speaking
* Post final grafting procedure

Exclusion Criteria:

* Accompanying anoxic brain injury
* Cardiac disease or injury (American College of Sports medicine ACSM criteria)
* Quadriplegia
* Severe behaviour or cognitive disorders
* Compassionate care only
Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement

Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

The goal of this clinical trial is to compare, the efficacy of

* circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
* endoanal mucosal flap in terms of clinical and radiological healing (combined remission)

in patients with Crohn's rectovaginal fistulas refractory to standard treatment,

Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Crohn's disease
* presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
* The patient has received, understood and signed the informed consent to actively participate in the study.
* The patient is able to understand the conditions of the study and to participate for the whole duration.

Exclusion Criteria:

* presence of oostomy
* Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
* Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
* Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
* Patients with active oncological or lymphoproliferative diseases
* Pregnant or breastfeeding women
Transfer of Microorganisms Between Green Areas and Humans

The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.

Several hypotheses propose that the modern surge in immune disorders is related to diminished contact with nature. Specifically, the Biodiversity hypothesis emphasizes that contact with natural environments enriches the human microbiome and is necessary for promoting immune balance. This project aims to investigate whether visiting green areas can contribute to changes in human microbiome composition. Additionally, the investigators aim to explore the environmental, health and lifestyle factors that can influence these microbiome changes. Adults and/or children will be asked to visit a green space (such as an urban park) and perform specific activities (such as walking or pushing a stroller) for a defined time period. Before and after this visit, swabs of their skin and nose will be collected to analyze microbiome changes. In addition, questionnaires will be administered to the participants, with the goal to align microbiome changes with environmental, health, lifestyle and demographic factors.

Eligibility Criteria:
Inclusion criteria:

Children (min. 4 years old) and adult participants (18+) of any gender in generally good health.

No strict exclusion criteria will be set in advance.
Expanded Access Program for Avapritinib

This record comprises the currently available Expanded Access Programs (EAP) for avapritinib (BLU-285):

1) A Post Trial Access (PTA) program to provide continued access to treatment with avapritinib to BLU-285-1107 participants with solid tumors who are unable to access commercially available avapritinib after trial BLU-285-1107 (NCT04908176) has ended.


Eligibility Criteria:
Inclusion Criteria:

-Participant has received treatment with avapritinib in BLU-285-1107 clinical trial and continues to receive clinical benefit from avapritinib treatment, as assessed by the Investigator.

Exclusion Criteria:

* Participant requires ongoing treatment or has received treatment within 28 days before the start of avapritinib administration with drugs or foods that are strong CYP3A inhibitors or inducers.
* Female participants of childbearing potential who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment.
* Male participants who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment.
* Participant is pregnant, as documented by a serum β-hCG pregnancy test. Participants with β- hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor after pregnancy has been ruled out.
* Female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-hCG test.
* Participant is breastfeeding.
* Participants who require anticoagulants, with the exception of stable doses of prophylactic reversible anticoagulants.
* Participants who are unable to swallow tablets.
tDCS Effects on Associative Learning in Older Adults of Working Age

The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age: older in working age (50-65 years)
* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
Entia Liberty: Accuracy and Precision

This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle
* Blood samples that have been stored in K2-EDTA vacutainers only
* For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
* Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
* Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
* Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: \>400 x 109/L (1-2 samples)
* Haemoglobin Low: \<120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: \>170 g/L (1-2 samples)

Exclusion Criteria:

* History of haematological malignancy
Impact of Self-tonometry on Glaucoma Treatment Decision.

Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.

Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.

As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
* Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
* Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
* Monitoring over at least two days

Exclusion Criteria:

* More than one measurement with iCare Home® tonometer below 5 mmHg
* Missing more than one daily measurement with iCare Home® tonometer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.

This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2 positive early stage or locally advanced breast cancer.

Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Vinorelbine given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1. female patients, 18 years ≤ age ≤ 75 years. 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1. 3. Histologically confirmed invasive breast cancer:early stage or locally advanced,Primary tumour greater than 2 cm diameter 4. HER2 positive (HER2+++ by IHC or FISH+) 5. Subjects received neoadjuvant therapy with trastuzumab 2 weeks post-imaging evaluation Patients with a price of PD or SD. 6. Known hormone receptor status. 7. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male. 8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

- 1. metastatic disease (Stage IV) or inflammatory breast cancer. 2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.

3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. Unable or unwilling to swallow tablets.