cyrilzakka/clinical-trials huggingface dataset:
Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test

The predictors of objective impaired alertness assessed by Maintenance of Wakefulness Tests (MWT) are poorly understood. Identifying such predictors are essential from a clinical point of view and from a pathophysiological perspective, to better understand the determinants of residual Excessive Daytime Sleepiness (EDS) and the complex link between subjective and objective impairments.

Also, the objective of this study is to describe psychological but also sociological and professional factors associated with Maintenance of Wakefulness Tests results.


Eligibility Criteria:
Inclusion Criteria:

* Adult (i.e. age ≥ 18 y.o)
* referred for Maintenance of Wakefulness test at Lyon University hospital (HCL - Croix Rousse Hospital)

Exclusion Criteria:

* do not consent
* unable to answer the questionary
* cognitive impairments
I Can Move with Purpose Now! a Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients

The goal of this study is to see if patients with myeloproliferative disorders are able to successfully complete the Cardiac Lifestyle Program(CLP). The goal of the CLP is to teach patients how to become more active and eat healthier foods.

The name of the intervention used in this research study is:

Cardiac Lifestyle Program (a 12-week, tailored nutrition and physical activity program)

This is a single-arm, prospective pilot study that will enroll eligible Myeloproliferative Neoplasms (MPN) patients in a 12-week exercise and nutrition-based Cardiac Lifestyle Program (CLP). This research study is a Feasibility Study, which is the first time investigators are examining this exercise program in myeloproliferative disorder patients.

Study procedures include screening for eligibility, an in-clinic visit, questionnaires, program group classes, and blood work.

Participation in this research study is expected to last 12 weeks.

It is expected that about 30 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age

* Diagnosed with an MPN by WHO 2016 criteria,22 including essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic myelofibrosis (pre-MF), myelofibrosis (MF), and MPN not otherwise specified (NOS). Within MF patients, only patients who are low or intermediate-1 risk by the Dynamic International Prognostic Scoring System (DIPSS) are eligible.23 All risk groups are eligible for the remaining MPN subtypes.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Must have at least one cardiovascular risk factor including: Body mass index (BMI) \>25 kg/m2, hypertension, hyperlipidemia, diabetes mellitus or pre-diabetes or metabolic syndrome, or any prior history of cardiovascular disease, transient ischemic attack, stroke, or peripheral vascular disease. Patients not meeting any cardiovascular risk criteria must receive prior approval from the PI to participate in this study.

Exclusion Criteria:

-- MF patients with intermediate-2 or high-risk disease by DIPSS

* ECOG performance status \>2.
* Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491

The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.


Eligibility Criteria:
Key Inclusion Criteria:

* Has stable chronic heart failure with reduced ejection fraction
* Has adequate acoustic windows for echocardiography

Key Exclusion Criteria:

* Any significant structural cardiac abnormalities on Screening TTE
* At Screening, symptomatic hypotension or hypertension or bradycardia.
* Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators \[e.g., nesiritide\], diuretics) or routinely scheduled ultrafiltration.
* Presence of protocol specified laboratory abnormalities at Screening.
Financial Incentives to Improve Medication Adherence

Medication adherence is a challenge in all of medicine and is associated with multiple negative outcomes. Strategies to better measure and enhance adherence to medication are urgent and necessary to minimize unwanted health outcomes, hospitalizations, poorer quality of life and excessive costs for individuals, insurers and caregivers. Recently, behavioral economics-based approaches have emerged as a promising tool to address this unmet need, but its effectiveness in oral antipsychotic treatment remains to be assessed. For this project, investigators will use an app that offers financial incentives to increase compliance for patients with chronic diseases. Investigators intend to enroll 25 patients in a pilot project to assess feasibility of offering financial incentives to improve medication adherence in severe mental illness.


Eligibility Criteria:
Inclusion Criteria:

1. Psychiatric patients with suspected or confirmed poor oral medication adherence.
2. Age 18-80 years old
3. English speaking, since the app being used is only available in English
4. Owning a Smartphone, since the app requires a Smartphone to work
5. Willing and able to participate.

Exclusion Criteria:

1. Acute anger to self or others as per investigator assessment
2. Unwilling or unable to participate
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder

To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.

In this study, a parallel controlled study will be conducted to recruit 60 patients with ADHD, 30 patients in the fNIRS group and 30 patients in the drug group. At the same time, 30 healthy controls will be recruited. 6 weeks, 12 sessions of NIRS feedback will be given for participants in NIRS group and healthy controls. 6 weeks of first or second line medication will be given for participants of drug group. Magnetic resonance imaging will be performed at baseline for all participants. SNAP IV, PSQ, CGI will be evaluated at baseline, week 3, week 6 and week 8 for ADHD participants.

Eligibility Criteria:
For ADHD patients:

Inclusion Criteria:

* diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
* aged 6-12;
* right handed;

Exclusion Criteria:

* full-scale intelligence quotient below 80(measured by Wechsler Intelligence Scale for Children，WISC)
* medical or neurological disorders, psychiatric disorders other than oppositional defiant disorder
* current participation in a psychotherapeutic treatment
Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes

The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
* Low exercise levels
* Smartphone ownership
* English literacy
* Under regular care by a healthcare provider
* Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)

Exclusion Criteria:

* Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
* \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
* A1c ≥10.0%
* Resting blood pressure \>160mmHg systolic or \>100 mmHg diastolic
* Myocardial infarction or angina in past 12 months
* Uncontrolled arrhythmia (e.g., Afib with RVR, new onset Afib, ventricular tachycardia, escape rhythms)
* Congestive heart failure (stage 3 or 4)
* Exercise-induced asthma (not controlled on inhalers)
* Chronic obstructive pulmonary disease (requiring home oxygen)
* Renal failure
* Pregnancy
* Cognitive impairment
* Severe retinopathy or neuropathy.
* Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.

The purpose of this study is to determine whether an omega-3 fatty acid supplementation is effective in the prevention of progressive cognitive decline in elderly people aged 75 years or older.

Participants are residents at three nursing homes in Pamplona (Spain). We assumed that 20% of elderly people have a cognitive decline and we estimated a 5% of cognitive decline in the intervention group. Sample size estimated was 85 participants for each arm, assuming two groups with an alpha of 0.05, 80% power and accounting for 10% of participants lost to follow-up.

Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used for the statistical analysis of data.

Eligibility Criteria:
Inclusion Criteria:

* Elderly people aged 75 years or older
* Global Deterioration Scale \< 4
* Capacity to complete the tests

Exclusion Criteria:

* Neurological, physical or psychiatry conditions, obtained from the medical history, that may have an influence on the cognitive function.
* Dementia
* History of epilepsy, convulsions
Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-75 years
2. Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index \< 0.9
3. Poor distal arterial outflow tract
4. Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
5. Poor physical condition can not tolerate surgery
6. Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
2. Severe or acute organ damage
3. Presence of malignancy
4. Pregnancy or lactating patients
5. HIV positive
6. ABI≧0.9
7. A history of severe allergies related cell therapy
8. Conservative treatment \< 3 months
9. Acute limb ischemia
10. Local obvious infection uncontrolled
11. Alcoholics or drug abusers within a year
12. Severe psychiatric disorder.
13. Patients need surgical treatment
14. Above the ankle gangrene
15. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Have thrush that has not responded to fluconazole treatment.
* Are 18-65 years old.
T Regulatory and Childhood Asthma

This is an epidemiologic study, examining environmental exposures and affect on immune development.

This is an epidemiologic study, examining environmental exposures and affect on immune development. The study has completed enrollment

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe asthma

Exclusion Criteria:

-
Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block on Postoperative Pain After Septoplasty

The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are:

Will the participants' need for painkillers decrease after the operation? Can sphenopalatine ganglion block be used for postoperative pain after septoplasty? The researchers will compare 2 groups with and without sphenopalatine ganglion block to see the effectiveness of sphenopalatine ganglion block.

Participants will:

Read the information Participants have been given about the sphenopalatine ganglion block.

In case of any side effects, please contact participant's doctor.

This randomised controlled study will be conducted in Umraniye Training and Research Hospital operating room between November 2024 and January 2025 after obtaining ethics committee and patient consent. Each patient will be informed about the procedures to be performed during anaesthesia and surgery and signed informed consent will be obtained before the procedure. Patients will undergo septoplasty by the same otolaryngology team.

A total of 50 participants (25 envelopes each with Group 1 and Group 2 written inside) will be kept closed for the patients participating in the study. Upon the patient's fulfilment of the conditions suitable for the study, it will be randomly determined which group he/she will be included in. Thanks to this randomisation, conscious or unconscious manipulations in the selection of patients to the study group will be prevented.

Eligibility Criteria:
Inclusion Criteria:

* Participants who will undergo septoplasty
* 18 to 50 years old
* ASA score 1 or 2

Exclusion Criteria:

* Under 18 or over 50 years of age
* ASA score III and above patient group
* The patient is allergic to any of the drugs used
* The patient has a contraindication to any of the drugs used
* Use of anticoagulant medication
* Failure of the patient to give consent
* Being pregnant
* Those with GCS retardation such as dementia, mental retardation
* Those with diagnosed headache
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients

This single group quasi-experimental study was conducted at Rafsan Neuro Rehab Center, Peshawar from October 2021 to February 2022. The sample size of study was 40 post stroke patients who were diagnosed on physical findings and other investigation like CT and MRI. The inclusion criteria were set as post-stroke patients for more than 3 months with 20 and above score on MAS scale and age of 55 to 65 years, while the exclusion criteria were defined as participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia, patients having recurrent episodes of stroke, stroke patient with dementia and score on MAS scale below 20.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were set as post-stroke patients for more than 3 months
* 20 and above score on MAS scale
* age of 55 to 65 years

Exclusion Criteria:

* The exclusion criteria were defined as
* participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia,
* patients having recurrent episodes of stroke,
* stroke patient with dementia
* score on MAS scale below 20.
The Effect Of Proprioceptive Neuromuscular Facilitation Techniqueson in Patients With Multiple Sclerosis

The aim of this study is to examine the effects of PNF techniques on pain, motor function, fatigue and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of Relapsing-Remitting MS (RRMS) as defined by McDonald criteria
* 18-65 years of age
* an Expanded Disability Status Scale (EDSS) score \< 4
* relapse-free for the last 3 months
* cognitive impairment that was defined with mini mental test.

Exclusion Criteria:

* a history of different neurological diseases
* having any contraindication for exercise
* having orthopedic, vision, hearing, or perception problems.
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark

Background:

Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.

Objective:

The purpose of the Danish IBBIS study is to examine the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark.

Method:

This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is return to work at 12 months.

Results/discussion:

This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.

Eligibility Criteria:
Inclusion Criteria:

* Depression, Generalized Anxiety, Social Phobia or Panic Disorder according to Mini International Neuropsychiatric Interview (MINI)
* On sick leave from work or unemployment and have received sick leave benefit for minimum four weeks OR have started a sick leave benefit case which is estimated to last for minimum eight weeks
* Citizen in one of the following municipalities: Copenhagen City, Gladsaxe Municipality, Lyngby-Taarbæk Municipality or Gentofte Municipality
* Danish-speaking
* Given informed consent

Exclusion Criteria:

* Pregnant
* High degree of suicidal ideation
* Dementia
* Alcohol or substance misuse that hinders the person participating in treatment
* Wish to start or continue psychological therapy
* Need for psychiatric treatment in the secondary psychiatric care system
* Medically unstable to a degree that the patient cannot adhere to treatment
* Participant in the research project Collabri
* Attending stress courses in the stress clinics of Copenhagen City
* Assessed by job center case managers to be dangerous
Effects of Active and PRT on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fascitis

The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks

A single blinded randomized clinical trial will be conducted on 26 subjects diagnosed for planter fasciitis from Jawad Club Faisalabad and Alfatah Sports Club, Faisalabad by looking for symptoms and tenderness at heel as mentioned in inclusion criteria and will confirmed by windlass test. Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks. Pain will be measured by Numerical Pain Rating Scale (NPRS), Foot and ankle disability will be assessed by Foot Function Index (FFI), while gait parameters i.e. walking speed will be measured by 4-meter walking test, and step and stride length will be evaluated by measuring tape by taking foot prints before and after the 4 weeks of treatment period. Data will be analyzed through statistical package for the social sciences (SPSS) version 22.

Eligibility Criteria:
Inclusion Criteria:

* Male runners age between 18-30 years
* Duration of running at least 6 months
* Positive windlass test
* Patients with unilateral or bilateral plantar fasciitis

Exclusion Criteria:

* Recent accidental foot or ankle injury
* Previous lower-body surgical intervention within 6 months
* Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months
* Diagnosed musculoskeletal disorders (rheumatoid arthritis, calcaneal spurs)
* Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial