cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation of Syndi

Mental health concerns are a growing global concern, but support can still be difficult to access. Digital health technologies can help people access support, but with over 10,000 mental health apps available, it can be difficult to choose one that is safe, effective, and personalised. Syndi is a digital health platform that uses a machine learning system to provide personalised recommendations of mental health apps. This study aims to examine the impact of Syndi and its recommendations on the mental health and well-being of people with mental health concerns.

The investigators will use the standard National Health Service (NHS) Talking Therapies measures of anxiety and depression, as well as additional measures of wellbeing and functional impairment to look at the impact of Syndi on patients' mental well-being. The investigators will also look at user experience with Syndi using a survey. Users' engagement with Syndi and its recommended apps will be assessed using a short survey and some participants will be randomly selected for an interview so the investigators can get a better understanding of what people liked and disliked about using the platform and why.

The investigators expect that the project will show that using Syndi helps improve mental well-being in people with mental health concerns. If the study shows this positive impact, this will provide evidence to support the use of Syndi to improve the accessibility of mental health support in clinical pathways. The investigators will publish the results of the study in academic journals as well as in more accessible platforms.


Eligibility Criteria:
Inclusion Criteria:

* Based in the UK
* Referred or self-referred to proceed through the standard NHS Talking Therapies care pathway OR people with mental health concerns looking for app recommendations online;
* Willing and able to provide informed consent;
* Aged 18 years or older;
* Able to speak English;
* Have access to the internet and own a smartphone.

Exclusion Criteria:

* Patients with a PHQ-9 score \>=20
* Patients with suicidal ideation measured as an answer of 'YES' to any question in the Columbia Suicide Severity Rating Scale (C-SSRS);
* Incapable of self-consent;
* In a dependent/unequal relationship with the research or care teams or any PPI representatives.
Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

This study is being done to test a new ultrasound method to detect possible stiffness problems within wrist(s). The purpose of this research is to the test the effectiveness of a new ultrasound method to check the nerve and surrounding tissue in both wrist of patient volunteers before and after treatment.

The ultrasound system is FDA approved. The risks associated with this research study are not beyond the normal risk of conventional ultrasound and should not cause you any discomfort. Ultrasound at the intensity levels and duration used in this study has not been shown to present risk to humans. The investigators will conduct the SWE study on the set time point when the patient returns for follow-up after the therapy (surgical decompression or corticosteroid injection).

A set of pictures will be taken of patients wrists by the FDA approved ultrasound system. This system uses a special type of ultrasound for imaging your wrists.

The ultrasound study will be repeated after 3 and 6 months after the treatments.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers.
* Age ≥ 18 years old.
* Having unilateral symptom of wrist pain
* Scheduled for corticosteroid injection or surgery

Exclusion Criteria:

* Individuals less than 18 years of age.
* Prior surgery.
* People considered in "vulnerable" populations.
* Having bilateral symptoms
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Heart failure (HF) with a left ventricular ejection fraction (LVEF) \>0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF \>0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile

Objective: To assess the risk profile associated with the combined endpoint of all-cause mortality and HF hospitalizations in HF patients with LVEF \>0.40.

Study design: Single-center, prospective, study.

Study population: We aim 200 patients with symptomatic heart failure (NYHA class II-III), and a recent HF hospitalization, emergency room visit or symptom relief with diuretics who have a left ventricular ejection fraction \>0.40, echocardiographic evidence of left atrial enlargement or left ventricular hypertrophy, and elevated concentrations of BNP or NT-proBNP.

Study procedures: All patients will undergo echocardiography, cardiac magnetic resonance (CMR) imaging, Holter recording and blood sampling at inclusion. The 99mTc-HDP scan is optional.There is no control group.

Total follow up: Up to five years.

Main study endpoint: incidence of the combined endpoint of all-cause mortality and HF hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

Clinical criteria:

1. Age \>18 years
2. Written informed consent
3. HF with moderate to severe symptoms NYHA II or III
4. Hospitalization or emergency room visit for HF or symptom relief with diuretics
5. Sinus rhythm or AF

Echocardiographic criteria:

1. LVEF \>0.40
2. Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall \<9 cm/s).

Biomarker criteria:

1. BNP \>31ng/L or NT-pro-BNP\>125ng/L if sinus rhythm
2. BNP \>75ng/L or NT-pro-BNP\>300ng/L if atrial fibrillation

Exclusion Criteria:

1. Patients unwilling or unable to sign informed consent
2. Patients with a pacemaker or ICD
3. Indication for ICD therapy according to the ESC guidelines
4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction \< 3 months
6. Complex congenital heart disease
7. Pregnancy
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR\<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two.

The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.

Eligibility Criteria:
Inclusion Criteria

* Informed consent before any study-related activities.
* Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.

Procedures include:

* CABG
* Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
* CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement

Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:

* Valve surgery
* eGFR \< 45 ml/min/1.73m2
* Documented LVEF ≤ 35% within six months before surgery
* Documented history of heart failure
* Insulin-requiring diabetes
* Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)
* Preoperative anemia (hemoglobin \<11g/dl for men and women)
* History of prior CABG
* Age ≥65

Exclusion Criteria

* Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
* Kidney transplant status
* Off-pump cardiac surgery
* ESRD
* Emergent cardiac surgery
* Pregnancy
* Patient enrolled in competing research studies that may affect outcomes
* Patients held in an institution by legal or official order
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.

This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).

With the emergence of species of multi drug resistant P.falciparum across the archipelago the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P. falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern provinces.

This trial sets out to assess two fixed dose artemisinin combination regimens: artekin (DHA-Piperaquine) and coartemether (artemether-lumefantrine) against both P.falciparum and P. vivax and their safety profiles.

Patients who present to an established rural outpatient clinic in Timika, Papua with symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. Drug administration will be supervised once per day. Patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic.

The data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the Timika region. In order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at least one 1year of age and weighing more than 10kg.
* Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
* Fever (axillary temperature \>37.5C) or history of fever in the last 48 hours.
* Able to participate in the trial and comply with the clinical trial protocol
* Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

* Pregnancy or lactation
* Inability to tolerate oral treatment
* Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)
* Known hypersensitivity or allergy to artemisinin derivatives
* Serious underlying disease (cardiac, renal or hepatic)
* Parasitaemia \>4%
Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD

A descriptive study evaluating balance, gait speed, Quadriceps Femoris muscle strength and quality of life in individuals with Chronic obstructive pulmonary disease (COPD) who fell and did not fall.

Falls in the elderly can have devastating consequences. The ability to maintain stability and balance is critical for functional independence, mobility, and avoidance of falls in activities of daily living. An impaired balance is associated with an increased risk of falls and causes a higher mortality rate among older adults. Balance impairment is independently associated with falls in patients with Chronic obstructive pulmonary disease. Well-known risk factors for falls in individuals with Chronic obstructive pulmonary disease include advanced age, increased comorbidities, dyspnea, physical inactivity, muscle weakness, fear and decreased balance confidence, as well as lower extremity muscle weakness. It has been reported that there are functional deficiencies, lack of performance and postural control. According to the results of a recent study, it was found that Chronic obstructive pulmonary disease is in the second place after osteoarthritis in chronic conditions where the prevalence of falls is highest. The prevalence of falls in individuals with Chronic obstructive pulmonary disease is estimated to range from 25% to 46%.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD according to criteria
* Not having had an attack in the last 2 months
* Volunteering to participate in the study
* Being 65 years or older
* Not having any mental or communication problems that prevent filling out the surveys to be used in the research.

Exclusion Criteria:

* Having unstable COPD
* Unstable angina, previous Myocardial Infarction, uncontrolled hypertension, cancer, neurological or musculoskeletal diseases with functional limitations
* Being currently addicted to alcohol or drugs
* Being in the process of COPD exacerbation
* Having severe vision and hearing problems
* Having severe cognitive impairment
* Having had major surgery in the last few months
Effect of Solution-Focused Support Program on Anxiety Levels of Parents During the COVID-19 Pandemic

In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.

The study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. In collecting research data; an introductory information form prepared by researchers and the State-Trait Anxiety Inventory will be used.

Eligibility Criteria:
Inclusion Criteria:

* Parents with children aged 3-6,
* Having internet at home or mobile phone,
* Parents who volunteer to participate in the study

Exclusion Criteria:

* Having communication problems,
* Parents who have not attended at least one session
Protein Intake Associated With Physical Activity Related to Specific Outcomes

This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.

Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life.

The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Age greater than or equal to 18 years old
* Have a tendency to be admitted to the ICU after the surgery
* Fill the eligible criteria to start enteral feeding within 72 hours
* Sign the consent form;

Exclusion Criteria:

* Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) \>60% or positive end expiratory pressure (PEEP) \> 12cm H2O
* Bronchopleural fistula
* Karnofsky \<50
* Participant cannot b enrolled in another study
Periinterventional Outcome Study in the Elderly

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

Elderly population (≥80 years) will increase from 5.3% of the total population in 2015 to 9% in 2040. This implies an increasing number and variety of surgical and non-surgical interventional procedures. Little is known about the in-hospital mortality rates in the overall elderly interventional population. Compared with younger interventional patients, the elderly are at greater risk of peri-interventional mortality and morbidity, because of decline in physiological and cognitive reserve, and frequent comorbidities. Previous data are mostly limited to specific populations, like the elderly hip fracture patient.

The investigators aim to recruit as many as possible centers throughout Europe, to participate in this study. A total sample size of 7500 patients will provide reasonable and valid results for the study aims. The primary endpoint will be analysed by fitting a COX-Regression model to the data of the post-interventional mortality until day 30.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years
* Written informed consent according to the national law requirements
* All consecutive patients undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (done by an anaesthetist) within the selected inclusion period of four weeks
* Elective and emergency procedures
* In-patient and out-patient procedures

Exclusion Criteria:

* People who are institutionalized by court or administrative order
* Patients with re-intervention within the 4 week period, who were already enrolled in this study
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced carcinoma of the pancreas
* Arterial invasion or encasement
* Invasion/encasement of the portomesenteric veins
* Patients who have been previously denied operation
* Obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment.
* White blood cell count \> 3500 per ml and platelet count \> 100,000 per ml
* Serum creatinine ≤ 1.5 mg/dl
* Bilirubin ≤ 1.5
* ECOG performance status \< 2

Exclusion Criteria:

* Prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer
* Evidence of distant metastasis or malignant lymphadenopathy
* Concurrent malignancies
* History of allergic reactions to celecoxib or to sulfa drugs
* No non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments.
* Pregnant women and lactating women
* Uncontrolled or serious intercurrent illness
* HIV-positive patients receiving combination antiretroviral therapy
A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People with Multiple Sclerosis (MS)

PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.

Study participants will undergo fourteen weeks of on-label PoNS therapy and, specifically, two weeks in-clinic PoNS therapy directly supervised by a physical therapist who has been trained on PoNS therapy by Helius Medical and certified as a clinic PoNS trainer (Phase 1) followed by 12 weeks of at-home unsupervised PoNS therapy Once weekly in-clinic PoNS therapy session (Phase 2). Subjects will be then asked to return to the clinic six month after the end of the study Phase 2 to assess maintenance of PoNS therapy effects.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 22 years of age with a diagnosis of MS.
2. EDSS scores \< 6.5 at screening; a demonstrated gait deficit.
3. Can walk at least 10 meters with or without the use of walking aids.
4. Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.

Exclusion Criteria:

1. Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
2. Dementia.
3. Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
4. Subjects who are already functional community ambulators (gait speed\>120cm/s43).
5. Subjects will also be excluded as per the Helius Medical PoNS device indication for usage ("electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper").
Prospective Data Collection of Patients With Diffuse Parenchymal Lung Diseases

The purpose of this study is to generate a prospective database of all patients evaluated for diffuse parenchymal lung diseases to provide much needed data on the various disease aetiologies, incidence and prevalence rates, clinical and radiological presentations, pathologic correlations, disease progression and response to treatment, and final outcomes in this group of patients in Singapore.


Eligibility Criteria:
Inclusion Criteria:

* All patients 21 years old and older diagnosed with suspected diffuse parenchymal lung disease (multi-lobar pulmonary infiltrates)

Exclusion Criteria:

* None