cyrilzakka/clinical-trials huggingface dataset:
Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).

This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.

AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.

The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.

Descriptive statistics will be used to record and analyse the study data, using SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Ankylosing Spondylitis

Exclusion Criteria:

* Previous spinal surgery
* Spondylolisthesis
* Unwillingness to participate
* Unable to complete self-report questionnaires
* Progressive neurological deficit
* Neurological disease
* Cauda equina syndrome
* Unable to exercise on medical grounds
Evaluation of Immunization Coverage of Premature Infants Leaving CHU d'Angers According to the Recommended Regimen During the First 4 Months (VACCIPREM)

Premature children are particularly vulnerable in terms of infection and vaccinated in a specific, reinforced vaccination schedule. However, the beginning of the vaccination of these children is often postponed and the vaccination schedule little followed.Concerning the vaccination of premature children, the national recommendations of the High Council of Public Health (HCSP) are different from those of the French experts in pediatric vaccinology. The HCSP recommends a vaccination schedule beginning at the age of 8 weeks postnatal, including, as for full-term infants, two injections at 2-month intervals of vaccine against diphtheria, tetanus, poliomyelitis, haemophilus influenzae B type, whooping cough and hepatitis B. Anti-pneumococcal vaccination is recommended at 2, 3 and 4 months of life.

The French experts of the Infectious Pediatric Pathology Group (GPIP) of the French Pediatric Society recommend a primary vaccination against whooping cough, diphtheria, tetanus, poliomyelitis, Haemophilus Influenzae B (DTPCoqHIB) and hepatitis B at 2, 3 and 4 months for children born before 33 weeks of amenorrhea (WA), and at 2 and 4 months for those born between 33 and 36 weeks + 6 days. Primary anti-pneumococcal vaccination is recommended at 2, 3 and 4 months for all children born prematurely before 37WA.

On the other hand, the cocooning vaccination of the parents against whooping cough is recommended in case of birth at term as of premature birth. This cocooning strategy has not been sufficiently applied, justifying a recall in 2008 for all adults who have not received pertussis vaccination during the last ten years.

The investigators seek to evaluate the follow-up of the recommended vaccination schedule of premature children leaving Angers University Hospital and the reasons associated with the non-monitoring of the calendar in order to identify possible lines of work to improve immunization compliance.


Eligibility Criteria:
Inclusion Criteria:

* Child born before 37 weeks of amenorrhea
* Child hospitalized in resuscitation and neonatalogy unity of Angers Hospital

Exclusion Criteria:

* Child transfered to an another unity before to go home
* Child without french parents
Improving Gait in Patients With Spinal Cord Injuries

This study is part of a larger clinical trial that examines the potential of a 12-week treadmill-training program to improve walking in patients with spinal cord injuries (SCIs). Patients in the trial are at least 1 year past their injury. This substudy tests a combination of two strategies to enhance the treadmill training program: electrically stimulating a muscle withdrawal reflex and providing body weight support by partially suspending patients as they walk on the treadmill.

Patients with spastic paresis due to incomplete SCI have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. Among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. If the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring.

Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. Two technologies that may enhance the benefits of treadmill walking are body weight support (BWS) and functional electrical stimulation (FES). Preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. This study will evaluate the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.

During the treadmill training, patients are suspended in an apparatus to provide partial body weight support (BWS). The training effects of BWS locomotion with FES over the course of a multi-session training program will be examined. Study visits will be scheduled 3 days each week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait parameters modified by training will be identified and the nature of these changes will be characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle strength will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury classified as American Spinal Injury Association (ASIA) C
* At least 1 year post injury

Exclusion Criteria:

* Spinal cord injuries of other severities (classified ASIA A, B, D, or E)
Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).

Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (HOMA) value are eligible for the trial. At baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-PET imaging before/after adenosine infusion. Subjects are then given an oral glucose load (75g), followed by PET imaging with F-18-fluoro-2-deoxyglucose (FDG). Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test \& PET imaging is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-II congestive heart failure
* History of Stage C-D heart failure with EF ≤ 40% during the course of the disease
* Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
* Age \> 18 yrs

Exclusion Criteria:

* Cardiomyopathy due to one of the following:

  * Ischemic heart disease
  * Primary valvular lesion
  * Hypertrophic cardiomyopathy
* Cardiac resynchronization within the last 3 months
* Transaminase values \> 2.5 x upper limit of normal or history of liver disease
* Diagnosis of diabetes mellitus by:

  * Diabetes previously diagnosed per patient history
  * 2 or more fasting glucose values \> 125 mg/dl
* Current NYHA class III or IV heart failure
* Serum creatinine \> 1.6 mg/dl
* History of heart transplantation
* Pregnancy or active breast feeding
* Hospitalization for decompensated heart failure within 30 days prior to enrollment.
Ketones Supplementation and Postprandial Lipemia

This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.

Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2
* Between the ages of 25 and 45 years
* Fasting triglyceride levels less than 250 mg/dL

Exclusion Criteria:

* Participates in regular physical activity (≥3 days/week at 30 minutes or more per day)
* Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes)
* Currently following a low carbohydrate (\<100 g/day) diet
* Lost greater than or equal to 5% body weight over the last 2 months
* Alcohol/smoking/antibiotics
Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy

Primary objective of this study is to compare diabetes-related healthcare utilization and costs in patients initiating exenatide once weekly vs insulin glargine.

This retrospective, observational cohort analysis will assess medical and pharmacy claims for adult patients with type 2 diabetes from the Truven Health MarketScan® Commercial and Medicare Supplemental claims databases between 2011 and 2015. Diabetes-related healthcare utilization and costs will be measured as a primary outcome. Secondary outcomes include all-cause healthcare utilization and costs, major adverse cardiovascular event (MACE)-related utilization and costs, and medically attended hypoglycemia events.

Eligibility Criteria:
Inclusion Criteria:

1. One or more outpatient prescription claim for EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) between February 1, 2012, and June 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy).
2. Aged 18 or older as of the index date.
3. Continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.)
4. One or more medical claims with a diagnosis code for T2DM (ICD-9-CM 250.x0 or 250.x2) in the baseline period or on the index date.

Exclusion Criteria:

1. No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).
2. No medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (ICD-9-CM 250.x1 or 250.x3), gestational diabetes (ICD-9-CM 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.
Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven
* locally advanced pancreatic adenocarcinoma stage
* No systemic metastases
* Age between 18-75
* Karnofsky-Performance Status equal to, or greater than 70 %
* At least a 2-dimensionally measurable tumor lesion
* Adequate renal and liver function
* Written consent statement
* Patients' compliance and geographical proximity
* Life expectancy equal to or greater than 3 months

Exclusion Criteria:

* Serious psychological disease
* Pregnancy and inadequate or not secure contraception or breastfeeding women
* Other previous malignant disease in the past two years
* Serious systemic concomitant diseases, excluding participation in a trial
* Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)
* Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial
* Distant metastasis
Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial

This is a randomised controlled study of patients suffering from intermittent claudication (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise levels and quality of life.

IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by narrowing or blockage of the blood vessels in the legs.

The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides estimates of the number of steps taken and the amount of distance covered each day.

This study will be conducted over a period of 18 months at Imperial College Trust's vascular outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to consider participating. Participants will receive routine diagnostic work up with the addition of having their walking distances measured on a lab treadmill. They will also have their functional status and mood assessed using a questionnaire. These assessments will be carried out a total of five times over the course of the study. Patients will not need to make any additional visits to hospital.

Patients will be randomly allocated to either the NFB group or the control group. Patients in the NFB group will be given a FuelBand with instructions on how to use it. All patients will be given routine instructions on maintaining activity and target daily walking distances. Target walking distances will be programmed into the NFB. Patients in the NFB group will be asked to record estimates of how far they have walked each day directly from their band. All patients will be contacted by telephone at a pre-arranged time to collect recordings.

Patients will be followed up at their routine 3-month follow up appointment and additionally at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-80
* Referred to vascular rehabilitation service at St Marys Hospital (UK)
* IC involving the calf muscles
* Clinical and duplex investigations indicate Superficial Femoral Artery stenosis or occlusion

Exclusion Criteria:

* Clinical and duplex investigations indicate iliac disease
* Major joint disease in lower limb or lumbar spine/entrapment syndrome
* Significant cardiopulmonary limitations (NYHA\>1)
* Maximum walking distance \>500m
* Hospital inpatient/ living in a care home
* \*Unfamiliarity with required technology
* History of dementia
* Unable to mobilize independently (does not include walking aids)
* IC not limiting factor of mobilization, limited by other medical problems
* Unable to attend supervised exercise programme
* Patient owns or uses any type of activity monitor
* Uses a walking frame \*Patients should be able to use the NFB technology with minimal assistance
SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.

There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.

Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.

Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).

Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. We hypothesize that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).

The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% \[≥58 mmol/mol\]) for reducing postoperative morbidity and mortality.

The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:

1. Short-term glycemic control group:

   Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.

In both groups, diabetic drugs will be managed per local protocol.

Eligibility Criteria:
Inclusion Criteria:

* all adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is \> 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).

Exclusion Criteria:

* Patients \< 18 years
* Emergency Surgery
* Elective surgery that can be postponed safely till glycemic control
* Hb A1c \< 7.5%
* Pregnant patients
* Patient Refusal
Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)

The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Chronic Granulomatous Disease (CGD). The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.


Eligibility Criteria:
Inclusion Criteria:

* The participant is willing and able to provide written informed consent
* The participant is willing and able to provide appropriate photo identification
* Participants aged 18 to 85
* Participants have been diagnosed with Chronic Granulomatous Disease (CGD)
* Subjects who have a confirmed p47phox CGD mutation or Subjects who have a confirmed X-linked CGD mutation

Exclusion Criteria:

* Participants who are pregnant or are nursing
* Participants with a known history of HIV, hepatitis, or other infectious diseases
* Participants who have taken an investigational product in the last 30 days
* Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months