cyrilzakka/clinical-trials huggingface dataset:
Validity And Reliability of The Incremental Shuttle Walk Test In Type 2 Diabetes Mellitus

The aim of our study was to determine the validity and reliability of the incremental shuttle walk test (ISWT) in patients with type 2 diabetes mellitus.This study involves the evaluation of the validity and test-retest reliability of the ISWT.

The assessments will be performed in two separate time periods. At the first visit, baseline assessments of the patient will be performed. These assessments include the recording of demographic information and the ISWT and 6 minute walk test assessments. Both tests will be performed with a 30-minute interval between them.

A retest will be performed 1 week after the initial assessment.

Diabetes mellitus is a hormonal, metabolic and chronic disease characterised by hyperglycaemia resulting from a partial or complete deficiency of the hormone insulin or a defect in insulin-sensing receptors. Functional capacity is a vital marker for many chronic diseases, including Type 2 diabetes. Many things about the mechanism of decreased functional capacity specific to individuals with type 2 diabetes have not yet been clarified. As a result of the researches, it has been concluded that the deterioration in functional capacity is mostly related to glycaemic control and complications.

The Incremental Shuttle Walk Test (ISWT) is a maximal test that is widely used for the assessment of functional capacity and exercise tolerance because it is low cost and easy to perform. The incremental speed shuttle walk test was first described in 1992 to assess exercise capacity in patients with COPD. Compared to other field tests, ISWT is recommended because it shows high levels of maximum oxygen uptake (peak VO2) and provides physiological results closest to cardiopulmonary exercise testing (CPET), which is considered as the gold standard in the assessment of functional capacity.

The aim of our study was to determine the validity and reliability of the increasing speed shuttle walking test in patients with type 2 diabetes mellitus.

This study involves the evaluation of the validity and test-retest reliability of the ISWT.

The assessments will be performed in two separate time periods. At the first visit, baseline assessments of the patient will be performed. These assessments include the recording of demographic information and the ISWT and 6 minute walk test assessments. Both tests will be performed with a 30-minute interval between them.

A retest will be performed 1 week after the initial assessment.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c between 6.5 and 11
* No mental problems
* Able to walk independently

Exclusion Criteria:

* Lack of co-operation
* Uncontrolled diabetes,
* Patients with uncontrolled hypotension or hypertension
* Unstable cardiovascular and pulmonary conditions
* Having vertigo and various vestibular system disorders
* Those with severe neurological or severe respiratory diseases
* Patients with major musculoskeletal problems
* Pregnant women
Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome

This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.

During the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. The data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months.

During the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (M9, M12) after the therapeutic Education Program (M6). The comparison between the evolution during the two phases, before and after the TEP will allow us to assess the benefits of the TEP.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria
* For minors, no oral opposition from the holders of parental authority and consent of the minor.
* For adults, no oral opposition collected
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability)
* Patient who has already participated in a TEP session for his pathology.
* Protected adult: patient under legal guardianship or curator protection
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.

Eligibility Criteria:
Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
* completed active treatment (surgery, radiation, chemotherapy) at least three months prior
* within 5 years of treatment or still on adjuvant therapy
* Completes informed consent to participate

Exclusion Criteria:

* sleep apnea or restless leg syndrome
* practicing mindfulness techniques \>1/wk
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).

A prospective, placebo controlled, partially blinded and randomized study, comprising two hOMSC200 dose groups (low \& high) and one placebo treated group of DFU patients (3 groups; n=8 / treatment groups and n=6/ control group).

Study employs a 2+2 design for dose escalation. The first two patients recruited were treated with a low dose, in a staggered manner, followed by two patients who were recruited to receive the high dose. The remaining patients (18) are randomized to receive the low dose, high dose, or placebo treatment. The assessors and patients will be blinded to the study treatments.

Following administration of hOMSC200 or placebo patients will attend on-site follow up visits for 6 months. During this period safety profile of the investigational product will be assessed as well as measurement of ulcer size. All patients, irrespective of allocated treatment, will receive routine standard of care.

Patients will be followed for long term safety with a phone call interview 1 year following the 6 months termination visit. Optional on-site follow up visits will be offered to all patients during this time period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks.
* Size of foot ulcer 0.5-13 cm2
* Ulcer graded I by Wager scale
* Ulcer is free of necrotic debris, exhibits no signs of clinical infection
* Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis anterior and posterior arteries in the affected foot; B. ABI range \>0.7 to \<1.3; C. TcPO2\>30mmHg

Exclusion Criteria:

* Ulcer is of non-diabetic pathophysiology
* The ulcer has decreased in size by \>=30% after the screening visit (week -2 to -4 before treatment)
* Severe hepatic deficiency
* Glycated hemoglobin A1C (HbA1C) level of \>12%
* Postprandial blood sugar \> 350mg/dl
* Require antibiotics to treat the target wound infection within 14 days prior to treatment
* Evidence of current wound infection including pus drainage from wound site
* Severe renal failure (GFR\<30) including subject on renal dialysis
* Pregnant or breastfeeding
* Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening
* Patient receiving anticoagulation therapy except for aspirin
* Underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)

This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.


Eligibility Criteria:
Inclusion criteria:

* age\>18yo
* Chronic Low Back Pain as seen on medical history as well as score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions.
* receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider.
* willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider)
* able and willing to perform/tolerate pain procedures (e.g., QST)
* able to communicate fluently in English
* able to use a smartphone or laptop for the virtual therapy program

Exclusion criteria:

* Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants;
* Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition;
* regular meditation practice
* cognitive impairment
* pregnancy
* lack of English fluency
* severe OUD
* inability to provide informed consent.
Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management

This study is a single-center, prospective, observational study. According to the sample size formula, an estimated 40 cases should be collected, all of whom are from the emergency intensive care unit. After successful cardiopulmonary resuscitation, the enrolled patients will be transferred to the emergency intensive care unit for further standardized target temperature management (TTM). They will be divided into 33 ° C hypothermia group and 36 ° C hypothermia group according to the patient's core body temperature. The baseline data of the patients will be collected at the beginning. After admission to the hospital, they were fasted within 24 hours to reach the target temperature, and then 20kcal/kg/d parenteral nutrition will be given. At selected time points (T0: the initial time point before TTM; T1: the core temperature was reduced to 33 ° C or 36 ° C; T2-T4: 33 ° C or 36 ° C was maintained for 24h, 48h, 72h; T5: the end of rewarming; Tend: the last REE measurement before discharge or death) , various observation indicators will be collected, including resting energy expenditure (REE), glucose oxidation rate, fat oxidation rate, protein oxidation rate, and metabolism of three major nutrients Proportion. Neurological outcomes were followed up 28 days after onset according to the Cerebral Performance Categories (CPC) score.


Eligibility Criteria:
Inclusion Criteria:

* Be admitted to the emergency department of Beijing Chao-yang Hospital, Capital Medical University;
* Successfully resuscitated, and are unconscious after restoration of spontaneous circulation (ROSC);
* Be admitted to the intensive care unit (ICU) for advanced life support such as endotracheal intubation after restoration of spontaneous circulation (ROSC);
* Accepted target temperature management (TTM) therapy after restoration of spontaneous circulation (ROSC);

Exclusion Criteria:

* Age \> 18 years old；
* Incomplete clinical data and loss of follow-up;
* Traumatic brain injury or cerebrovascular accident revealed by computed tomography (CT)；
* Severe metabolic abnormalities are known: cachexia, thyroid dysfunction, and cancer；
* Indirect calorimetry measurement is not possible such as sustained oxygen concentration \> 70%；
* There were no signs of resuscitation at the time of admission；
The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world.

The staging of the disease is done by combining blood tests and imaging tests. Ultrasound scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods based on identifying or significant change in the liver.

Those changes are sometimes difficult to identify, especially when there are changes in liver structure resulting from disease, such as cirrhosis of the liver.

In many cases it is also difficult to detect secondary scattering in anatomical tests, such as identifying a disease in normal size lymph nodes or early skeletal dissociation.

Functional imaging is not based on structural changes, but on the ability to detect changes in the function and properties of the tissue, such as a change in the cell's metabolic consumption or the presence of proteins that characterize the tumor tissue.PET scans can show tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see more absorption in PET), detect small tumors and metastases outside the liver (because they do a whole body test). To complete this test, a CT scan is also performed on the same device (PET-CT scanner).

There is a new material called prostate-specific mRNA that is marked with gallium isotope (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients because of the over-expression of the antigen in the blood vessels.

Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a complete picture of the extent of the disease.

Each patient has individual characteristics of the tumor, and according to the results it will be possible to adapt the test to the patient with the appropriate material for the disease and this will be effective for the decision to treat and follow up.

At the end of the study it will be possible to offer the study participant the appropriate functional imaging test.


Eligibility Criteria:
Inclusion Criteria:

* 16 patients diagnosed with HCC.

Exclusion Criteria:

* Minors under the age of 18
* Pregnant women
* People without primary liver cancer
Patient Pathway Pharmacist - Optimal Drug-related Care

Medication errors represent the most common cause of patient injury and one of the most frequently reported health related deviation in Norway. The addition of a dedicated clinical pharmacist throughout the hip fracture patient pathway (patient pathway pharmacist) is believed to improve patient safety and ensure optimal drug-related patient care. The pharmacist will perform medication reconciliation at admission to hospital, medication review after surgery and assist physicians with discharge summary. Six weeks after discharge the patient pathway pharmacist will perform a second drug reconciliation and medication review. This study will assess the pharmacists' place and specific tasks in the patient pathway, describe areas where the pharmacist contribute to increased quality of care and assess the benefits and/or disadvantages experienced with introducing a patient pathway pharmacist. The estimated number of patients included is 60. Current practice will be determined by investigating the last 50 patients' medical record and a questionnaire to health care professionals involved in treatment of hip fracture patients. Data from medication reconciliation and drug review will be collected and compared to current practice. After the inclusion period, focus group surveys and/or semi-structured interviews will be executed to describe the perceived improvement in the quality of care. Primary endpoints are: 1) Medication reconciliation score at admission 2) Number of inappropriate drugs for elderly 3) Discharge summary score 4) Discharge summaries following procedure. Secondary endpoints are readmissions and mortality after 30 and 90 days. Qualitative endpoints: 1) Health care professionals experience of current drug-related practice 2) Experienced advantages and disadvantages of a patient pathway pharmacist.


Eligibility Criteria:
Inclusion Criteria:

* Hip fracture patients in Vestfold county, Norway

Exclusion Criteria:

* Patients under 18 years
* Terminally ill
* Hip fracture patients who do not follow the standardized patient pathway at Vestfold Regional Hospital
* Patients who do not consent to be included in the study
Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder

This project apply curriculum of online programme materials and structure for mindful parenting and caregiving. It will include four modules (introductory mindfulness, mindful parenting, applying mindfulness in challenging moments, and advanced exercises for parents of children with special needs). Each module will include short psychoeducation videos and audio mindfulness exercises that can be used in various web-based or application-based platforms. A set of videos and audio exercises will be produced for the core program materials. One study of online mindful parenting program reported a low completion rate below 30%, showing the significance of weekly video or phone contact by professionals in program engagement. Although web-based or application-based mindfulness intervention have become popular, very limited effort has been developed for applying mindfulness in parenting and caregiving using technology. Only two published studies on online mindfulness-based intervention for parents are identified. Objectives of the study are: 1. Investigate the effects of online mindfulness-based intervention for parents of children with Attention Deficit/Hyperactivity Disorder. 2. Validate the protocol of the programme and explore the needs to make refinements of the programme based on the quantitative outcome and qualitative interview analyses


Eligibility Criteria:
Inclusion Criteria:

* parents whose children are between 6 and 18 years old and diagnosed with Attention Deficit/Hyperactivity Disorder
* parents can understand and speak Cantonese Chinese, and
* participants should be the primary caretaker of the children in the last one year

Exclusion Criteria:

* parents who were diagnosed with psychosis, developmental disabilities, or cognitive impairment, which may present difficulties in comprehending the content of the program,
* parents have had prior experience in any 8-week Mindfulness-Based Stress Reduction/Mindfulness-Based Cognitive Therapy or equivalent program.
Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure

The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)\<35%, Left Bundle Branch Block (LBBB)\>120 ms, New York Heart Association (NYHA) Class II-III).
* Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks

Exclusion Criteria:

* Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.
The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device

The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.

The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.


Eligibility Criteria:
Inclusion Criteria:

* HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
* Heart failure in stable phase without the need for intravenous inotropic therapy.
* Ischemic and non-ischemic cardiomyopathy.

Exclusion Criteria:

* Severe aortic insufficiency.
Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children

To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.

One single operator, Master degree student in the department of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. The survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on EAPD criteria

Eligibility Criteria:
Inclusion Criteria:

1. Children age from eight to twelve years.
2. Medically free.
3. Singed informed consent.
4. Both sexes are included
5. Parent and children cooperation.

Exclusion Criteria:

1. Children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis).
2. Children with orthodontic bands on the first permanent molars preventing adequate clinical examination.
Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2

To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.

See study protocol.

Eligibility Criteria:
Inclusion Criteria:

Speak English or Spanish

Exclusion Criteria:

1) significant eye pain (2) sudden decrease in vision within one week (3) binocular diplopia (4) cognitive impairment (5) pregnancy, or (6) previously declined participation