cyrilzakka/clinical-trials huggingface dataset:
Supported Exercise Programme for Adults With Congenital Heart Disease

This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

Congenital heart disease (CHD) describes heart defects present from birth. The majority of affected patients will require lifelong care to not only manage their medical condition, but also to offer support and guidance on living with their specific heart condition. Exercise and physical activity is one such area where patients often require support and advice. Recommendations are in place for health care providers to promote physical activity for this patient population. However, many health care providers find it difficult to know what level of exercise is reasonable or how to escalate current exercise programmes.

The benefits of regular exercise are well known and evidence suggests that even a modest increase in physical activity can reduce morbidity, improve psychological wellbeing and protect against cardiovascular disease.

This pilot study will determine the feasibility of introducing a supported exercise programme to clinical practice. The investigators aim to assess if improvements can be made in both physical and psychological well-being for adults with CHD who are living in Scotland. After initial assessment and baseline measurements are obtained, participants will follow a twelve week individualised programme. The investigators will keep in regular contact with the participant throughout and arrange interval and final assessments. The baseline measurements will be repeated during the final assessment at 12 weeks. Investigators anticipate that the study will also help to establish a programme that will help to improve the way adults who were born with a heart condition can be supported with physical activity on a long term basis.

Eligibility Criteria:
Inclusion Criteria:

* Living in Scotland
* Diagnosis of congenital heart disease
* Walks less than 450 metres on a 6 minute walk test (Group 1)
* Walks more than 450 metres on a 6 minute walk test (Group 2)

Exclusion Criteria:

* No access to internet or telephone
* Non English speaking (If the pilot study is successful, we anticipate that materials and programmes could be translated and accessible to non English speakers)
* Vulnerable adults
* Severe aortic stenosis or severe left ventricular outflow tract obstruction (LVOTO)
* Eisenmenger Physiology (ongoing study recruitment with SPVU)
* Currently prescribed Advanced Pulmonary Vasodilator therapy
Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis

The aim of the study is to determine the importance and impact of resistive breathing techniques versus inspiratory hold techniques in patients with chronic bronchitis and specially to find out if there are any changes seen in results measured via the incentive spirometer.

Chronic Bronchitis (CB) is defined as a chronic cough and sputum production for at least 3 months a year for 2 consecutive years. It is covered under the umbrella term of Chronic Obstructive Pulmonary Disease (COPD). Chronic bronchitis is thought to be caused by overproduction and hypersecretion of mucus by goblet cells. Epithelial cells lining the airway response to toxic, infectious stimuli by releasing inflammatory mediators and e.g. pro-inflammatory cytokines. During an acute exacerbation of chronic bronchitis, the bronchial mucous membrane becomes hyperemic and edematous with diminished bronchial mucociliary function. This, in turn, leads to airflow impediment because of

luminal obstruction to small airways. The airways become clogged by debris and this further increases the irritation. The characteristic cough of bronchitis is caused by the copious secretion of mucus in chronic bronchitis. Pseudostratified epithelium, highlighting the pseudostratified epithelial cells, goblets cells (shown in blue), then underlying connective tissue.(3) To determine the importance and impact of resistive breathing techniques versus inspiratory hold techniques in patients with chronic bronchitis and specially to find out if there are any changes seen in results measured via incentive spirometer. There are few studies done over it whereas purpose of this research work is to compare these techniques to get better results.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosed with chronic bronchitis

  * Clinically stable patients.
  * Both genders.
  * Age 45 to 60 years.
  * Pink puffers included in this study
  * Clients that are involved in research are not allowed for other interventional therapies. They can take their regular medications.
  * Patients diagnosed at least 2 years ago with bronchitis.

Exclusion Criteria:

* • Presence of any genetic disorders (cystic fibrosis).

  * Recent spinal / chest surgery
  * Cardiac issues
  * Fractures of vertebra caused by osteoporosis.
Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.

Randomized, controlled, single-centre study with 1x500mg or 1x1000 semi-annual infusions of RTX (Mabthera) as intervention and a follow-up period of 2 years. Patients as well as assessors will be blinded to the type of treatment. Patients in the 1x500mg group who experience a flare as defined by the disease activity score 28-ESR (DAS28) will receive 1x1000mg RTX (Mabthera) at their upcoming scheduled infusion appointment. Patients in the 1x1000mg group whose disease activity reaches DAS28 \>3.2 during the duration of the study will be re-evaluated for a change in biological therapy and will discontinue the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to the 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria
* Current treatment with RTX (at time of inclusion have already received at least 2 cycles of 1000mg RTX) at the Day-Clinic of the Division of Rheumatology of the Medical University of Vienna
* Persistent low disease activity or clinical remission as defined below
* Persistent clinical remission (pREM) will be defined as a simplified disease activity index (CDAI) (12) ≤2.8 measured at two time-points 6 months apart. The CDAI is calculated as follows: tender joint count (TJC) + swollen joint count (SJC) + patient's assessment of general health on a 100 mm visual analogue scale (GH) + evaluator's assessment of general health on a 100 mm visual analogue scale (EGH)
* Persistent low disease activity (pLDA) will be defined as a CDAI ≤10 measured at two timepoints 6 months apart Patients who achieve REM at only either one of the two successive time-points will be considered as having pLDA with regard to the current trial

Exclusion Criteria:

* Patients ≤ 18 yrs
* Patients receiving RTX for a disease other than RA
* Patients who fail to meet criteria for REM or LDA at either one of the two successive timepoints (i.e. having a disease activity \>10 as measured by the clinical disease activity index, (CDAI))
The Effectiveness of Intervention on Insulin Injection

The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).

According to the Transtheoretical Model (TTM) proposed by Prochaska and Diclemente, people will experience different stages of change before the actual behavioral change takes place. Ineffectiveness of intervention to instigate behavioral change is largely due to failure to take into account the stage of change in which individuals are. The TTM suggests that decisional balance, which reflects the relative difference between pros and cons, is important for influencing the stage of change. In order to achieve behavioral change, the perceived pros of changing must be strengthened to outweigh the cons. In addition, individual must be self-convinced that the behavioral change is important for themselves. Furthermore, the process for behavioral change can be provided to facilitate behavioral change in individuals. The theory of TTM has yet been used to improve the behavior of insulin initiation in insulin-naïve patients with T2DM. Thus, this study aims to assess the effectiveness of an intervention for insulin injection initiation based on the TTM in insulin-naïve patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

(1) diagnosed with T2DM for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) HbA1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection.

Exclusion Criteria:

(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment including the impact on survival, compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer.

Who is this study for:

Adults with unresectable oligo-metastatic colorectal who have demonstrated treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.

Study details

Participants will be randomly allocated to either a LAT arm, who will receive metastasis-directed LAT such as radiotherapy or thermal ablation following initial standard first-line systemic treatment, or a control arm who will receive continued first-line systemic treatment alone. Those receiving LAT will return to systemic treatment 16 weeks post-randomisation. Information on progression-free survival and treatment outcomes will be collected.

Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal adenocarcinoma that is not amenable to potentially oncological curative surgery alone.
* Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
* Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
* At least one metastatic lesion detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans, meeting the following criteria:

  1. max of 3 lesions per organ except for the liver and lung
  2. max of 5 lesions in the lung
  3. no limitation to the number of liver lesions provided they are all amenable to LAT
  4. max of 3 involved organs including a lymph node station
  5. only one lymph node station involvement is allowed
  6. for patients with liver metastases, a quadruple phase contrast enhanced CT or MRI liver is required to fully stage the liver; this can be performed prior to or within 4 weeks of commencing first line systemic treatment
  7. staging FDG-PET scan is encouraged and can be performed prior to or within 4 weeks of commencing first line systemic treatment
* All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.

Exclusion Criteria:

* Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high) tumour
* BRAFV600E mutated tumour
* Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a Gleason score ≤6.
* Presence of brain, peritoneal, omental or ovarian metastases
* Malignant pleural effusion or ascites.
Randomized Trial of Follow-up Strategies in Breast Cancer

The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.

see above

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba
* Diagnosed at least 12 months previously (range 9-15 months)
* Without evidence of active disease (i.e., stages IIIB and IV excluded)
* Free from any primary treatment complications

Exclusion Criteria:

* Primary treatment at least 3 months previously, except for continued use of tamoxifen
* Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window)
* Unable to identify an acceptable family physician to provide follow-up
* Language or literacy skills inconsistent with completing questionnaires
* Unable to comply with study protocol including completion of questionnaires
* Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics
* Actively followed at a cancer centre for another primary cancer
Incretin Regulation of Insulin Secretion in Monogenic Diabetes

The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.

Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:

1. Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
2. Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points
3. OGTT during GLP-1 infusion
4. IGI during Exendin-9 infusion

Eligibility Criteria:
Monogenic Diabetes Subjects:

Inclusion Criteria:

* Diagnosis of monogenic diabetes
* Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
* Age: 18 years +

Exclusion Criteria:

* Pregnancy
* Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct \< 36%), or uncontrolled hypertension

Healthy Controls:

Inclusion Criteria:

* Good general health
* Stable weight for 6 months
* Age: 18 years +

Exclusion Criteria:

* Pregnancy
* Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct \< 36%), or uncontrolled hypertension
Quality Assessment in Exposure Therapy

This project will test a measure of treatment quality, Exposure Guide, for therapists using exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of this measure will be able to complete it reliably, find it acceptable, and that the measure will predict patient outcome. This project will include 40 therapists treating 300 anxious youth and young adults ages 5-25 at a large community mental health agency. Results of this study will establish the Exposure Guide as a measure of exposure quality in real world settings.

Empirically supported behavioral treatments cannot be effectively disseminated without understanding key quality components. Mechanism-informed quality measures have extraordinary potential to enhance pragmatism by eliminating unnecessary elements and targeting multiple problems and populations, and to enhance predictive value by detecting mechanism engagement early in treatment. Community Mental Health Agencies (CMHAs), however, are often ill-equipped to use such measures of treatment quality due to burden and limited resources. Exposure therapy for anxiety is an ideal prototype for testing a practical, mechanism-informed quality measure in CMHAs given its potential for public health impact and clear theory of mechanism. The Exposure Guide (EG), a brief quality tool measuring therapist behaviors and mechanism, was developed based on microanalytic coded data showing a strong link between therapist behavior and patient outcome across three RCTs of exposure therapy in youth. Initial psychometrics for the EG using these RCT data are promising showing reliability, construct validity, and predictive validity, and pilot data suggests it may be acceptable and feasible in a community setting. Building upon these findings, we propose to test this novel measure of exposure quality, EG, in a community setting including its reliability and validity, its pragmatism, and which community end-users can become reliable and valid reporters. Therapists at a large local CMHA (N = 40) treating anxious youth and young adults ages 5-25 (N = 300) will participate in this study. The EG will be completed by 1) agency supervisors monthly, 2) therapists per session, 3) patient/families per session, and 4) study raters per session. Results from this study will establish an innovative model for measuring therapeutic elements that trigger mechanism of change in real-world therapy as well as inform future use of EG as a training tool to improve exposure quality in community settings.

Eligibility Criteria:
Inclusion Criteria:

* Patient at a Community Mental Health Agency that is partnering with this study
* Primary or co-primary diagnosis of OCD, Separation Anxiety, Social Anxiety, Panic Disorder, or Specific Phobia.
* Children \< age 12 have a caretaker available to participate in treatment
* Patient and parent/legal guardian are English speaking

Exclusion Criteria:

* Concurrent psychotherapy for treatment of anxiety
* Psychosis, Pervasive Developmental Disorder, or Mental Retardation
§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

§ The goal of this clinical trial is to assess the effect of periarticular procaine injections combined with physical therapy on joint pain in individuals 65 and older suffering from osteoarthritis of the hip or the knee. The main question it aims to answer is: Is procaine effective in decreasing joint pain?

Researchers will compare procaine injections combined with physical therapy to physical therapy only to evaluate whether or not procaine helps decrease joint pain.

Participants will:

Undergo procaine periarticular injections and physical therapy Assess their symptoms and pain using scales and tests provided

This clinical trial aims to evaluate the safety and efficacy of procaine complex injections in managing pain and improving functional capacity in elderly patients with osteoarthritis in the knee and/or hip. The study enrolled 178 patients aged 65 and older, who were randomly assigned to receive either physical therapy combined with periarticular procaine injections or physical therapy alone. Pain levels were assessed using the Visual Analogue Scale (VAS), and functional capacity was evaluated using the Lequesne Index, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), and other geriatric assessment tools. Results indicated significant pain reduction and functional improvement in the procaine group, highlighting a safe alternative treatment to surgery for older adults with osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 and older diagnosed with knee or hip osteoarthritis per the American College of Rheumatology criteria. Must exhibit radiographic evidence of OA and experience persistent joint pain

Exclusion Criteria:

* Individuals with Alzheimer's, severe depression, cancer, or other severe health conditions, and those with allergies to procaine
Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa

This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.

This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 17 years of age (inclusive) at Visit 1.
* Positive sputum culture for P. aeruginosa
* Clinical diagnosis of CF
* FEV1 greater than or equal to 40% predicted normal lung function
* Able to perform spirometry testing reproducibly according to ATS guidelines.

Exclusion Criteria:

* Use of an investigational agent within 30 days prior to Visit 1 (first dosing visit).
* History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit;
* Use of any nebulized or systemic antibiotics within 14 days prior to Visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to Visit 1.
* History of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics
* History of lung transplantation.
* AST, ALT or total bilirubin \> 3 x upper limit of normal at screening.
* History of hemoptysis \> 30 cc per episode during the 28 days prior to Visit 1.
* Other present conditions, abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.