cyrilzakka/clinical-trials huggingface dataset:
Repetitive Thinking in Fibromyalgia

Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. Distraction would be a more effective strategy to cope with pain. From this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. As with any condition of chronic pain, psychological mechanisms can help maintain discomfort and pain. These mechanisms may hinder the recovery of physical activity. Some patients may use cognitive strategies of emotional regulation that are ineffective to cope with pain and discomfort of everyday activities, such as rumination. The literature suggests that this process is linked to the physical and psychological difficulties of fibromyalgia. However, no study has revealed a causal link between rumination and negative affectivity in a context of physical activity in this population. The investigators want to test this hypothesis by directly manipulating the style of information processing following a relevant activity for these patients: climbing steps. In one group the investigators will induce rumination right after climbing the steps. In the other group the investigators will induce distraction. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales before to climb steps and after experimental induction. The investigators hypothesize that Patients using a rumination strategy after an uncomfortable physical activity will experience a greater subjective discomfort than patients using a distraction strategy.

Eligibility Criteria:
Inclusion Criteria:

* Adults Patients
* Free and informed consent signed.
* French native speaker, writer and reader.
* according 1990 American College of Rheumatology criteria : Patients with diffuse pain for more than three months and with digital palpation pain on more than 11 insertion points.

Exclusion Criteria:

* minor patients
* Adult major under administrative protection
* Patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician
Study of Weekly Radiotherapy for Bladder Cancer

Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.

Radiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.

It is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects.

Aims

In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:

1. whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity
2. the local tumour control rate achieved by hypofractionated weekly radiotherapy
3. the requirement to treat with adaptive planning.

How results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥18 years
* Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological sub-type)
* Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal)
* Expected survival \>6 months
* WHO performance status 0-3
* Willing to undergo post treatment cystoscopy

Exclusion Criteria:

* Nodal or metastatic disease
* Concurrent malignancy
* Previous pelvic radiotherapy
* Urinary catheter in-situ
* Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)
* Unable to attend for post treatment follow up
Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases

This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability.

We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.


Eligibility Criteria:
Inclusion Criteria:

* patients with different burdens of comorbidity who have at least two continuous years of enrollment in the Generations Plus/ Northern Manhattan Health Network between June 2007 to July 2009 and members of a large self insured union trust fund from 2007-2010
Spot Drug-Eluting Stenting for Long Coronary Stenoses

Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.

Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (\>20 mm) lesions and indications for percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.

Exclusion Criteria:

* Unprotected left main coronary artery stenosis,
* Left ventricular ejection fraction \<25%, OR
* Contraindication to aspirin or clopidogrel
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.

The trial will consist of the following periods:

* A screening period of up to 2 weeks,
* A 24-week, open-label treatment period, including a titration period and a maintenance period.
* A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.

Eligibility Criteria:
Inclusion Criteria:

1. Is an adult aged ≥18 years at screening.
2. Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of \>1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period.
3. Has an HbA1c ≥7.5% and ≤10.5% at screening.
4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of \<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.
5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
7. Is capable of understanding the written informed consent, and provides signed written informed consent.
8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
9. Is willing and able to fast without having administered study drug for scheduled site visits.

Exclusion Criteria:

1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
2. Has a body mass index (BMI)\* \>45 kg/m² during the screening period.
3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels).
4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening.
5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Promoting Informed Decision Making Through Advance Care Planning

The purpose of this study is to evaluate the application of a best-practice Advance Care Planning (ACP) model for individuals living with dementia in a sample of nursing homes in Northern Ireland


Eligibility Criteria:
Inclusion Criteria:

1. Family Caregivers

   * Family caregivers of a resident who does not have decision making capacity to participate in ACP discussion
   * Individuals identified by the nursing home manager as the family member who possess power of attorney for personal care and/or viewed by the nursing home staff as most involved in the care of the resident who does not have decision making capacity.
2. Health Care Professionals

Nursing home managers, registered nursing staff and GPs who:

* are employed, or in the case of GPs, care for residents, in the six nursing homes that were part of the intervention group
* were familiar with the intervention to discuss its strengths and weaknesses in an interview
* are able to speak English as they are required to participate in interviews.

Exclusion Criteria:

* Family caregivers and health care professionals who are unable to communicate through written and spoken English.
* Family caregivers who has a family resident considered to have the ability to participate in ACP discussions.
Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)

This is a single-site, open-label, phase II trial of C7, a food supplement or medical food, for the development of treatment outcome measures for glucose transporter type I deficiency (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by changes in comprehensive blood work, including lipid and free fatty acid panels, self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on ketogenic diet, as measured by serial ketone levels during treatment initiation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or suspected diagnosis of glucose transporter type I deficiency (G1D).
* On stable ketogenic diet at a ratio between 1:2.5 and 1:4 OR Stable on no dietary therapy
* Males and females 30 months to 55 years old, inclusive.

Exclusion Criteria:

* Subjects with a history of life-threatening seizure episodes, including but not limited to status epilepticus and cardiac arrest.
* Subjects with a BMI (body mass index) greater than or equal to 30 will be excluded.
* Subjects currently on dietary therapy other than ketogenic diet (i.e., medium chain triglyceride-supplemented diets, Atkins diet, low glycemic index diet, etc.).
* Women who are pregnant or breast-feeding may not participate. Women who plan to become pregnant during the course of the study, or who are unwilling to use birth control to prevent pregnancy (including abstinence) may not participate.
* Allergy/sensitivity to triheptanoin.
* Previous treatment with triheptanoin.
* Treatment with medium chain triglycerides in the last 30 days.
* Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain disorder (such as Alzheimer's disease) that would confound assessment of cognitive changes, in the opinion of the investigator.
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Patients with metal implants, experience claustrophobia, or who are behaviorally unable to be still for MRS (magnetic resonance spectroscopy) imaging (not due to seizures) will be excluded from the imaging portion of the research.
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent, or assent for children age 10-17.
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children

This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children.

Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan Cao,which relieving cold and cough, resolving phlegm in traditional Chinese medicine theory. This prescription was used for a long time in clinical for treatingacute cough caused by common cold as an herb formula. To standardize the quality and make it easier to take, we reproduced it into a patent medicine and design this trial for evaluating it.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as common cold standard, and VAS score of daytime or night-time cough \>= 40mm;
* Diagnosed as wind cold cough syndrome;
* Aged 6-14 ( \< 14) years;
* The course of cough is \<= 48 hours;
* The maximum temperature is \<= 38 degree C within 24 hours before visit;
* The informed consent process complies with the requirement,and the legal representative and the child (\>= 8 years old) sign the informed consent form.

Exclusion Criteria:

* Accompanied by sore throat, obvious fever;
* The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
* With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
* Acute bronchitis, pneumonia have been cured less than 8 weeks;
* With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
* Patients with severe malnutrition;
* Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders;
* Allergic to the experimental drugs;
* Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment;
* The investigator considers it inappropriate to participate in this clinical trial.
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient way to evaluate the biological impact of day-to-day stressors that people encounter as they go about their lives, since saliva is so easy to collect. However, the biological meaning of saliva cortisol measures has never been carefully examined. The goal of this study is to collect saliva from a large group of people as they go about their every-day lives, to measure their cortisol levels, and then study them in the laboratory where Investigators can learn more about how their stress response system (which produces cortisol) is really functioning. Investigators can then determine much more precisely what saliva cortisol levels really mean in terms of stress system biology. This will allow investigators to obtain much more useful information from the next decade of research on naturalistic stress and its biological impact using saliva cortisol measures, helping investigators to understand how stress undermines health and how to combat this effect.


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy volunteers, ages 18 to 50 years

Exclusion Criteria:

* Pregnancy
* Irregular menses, medications or drugs that effect HPA axis
* Most psychiatric disorders
* Medical problems that effect HPA axis or increase risks involved in participation
Rhythmic Stabilization Versus Ball Balancing

Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. These impairments result in changes in muscle growth and hinder the development of motor skills, leading to reduced muscle force generation and decreased flexibility. Spastic cerebral palsy is the most prevalent type, affecting 77% of individuals with CP, and is caused by damage to the motor cortex and pyramidal tracts. The motor cortex is responsible for transmitting voluntary movement signals from the brain to the muscles. Characteristics of spastic cerebral palsy include stiff muscles (hypertonia), which can cause jerky and repetitive limb movements (spasticity). Additionally, individuals with CP often have difficulties in processing somatosensory and proprioceptive information. Proprioceptive training refers to interventions aimed at enhancing proprioceptive function to ultimately improve motor performance, a concept that has been explored in studies focused on sports injuries. In this study, we will utilize two proprioceptive exercises-rhythmic stabilization and ball balancing-to promote functional improvement in the upper extremities of children with spastic CP.

There will be two groups: Group A will consist of 16 patients undergoing rhythmic stabilization, while Group B will also have 16 patients participating in ball balancing activities. Data will be collected both before and after the intervention to determine the most effective approach. Data analysis will be conducted using SPSS version 23.00.

This study will be a randomized clinical trial, with data collected from the University of Lahore Teaching Hospital (ULTH) and the Pakistan Society for the Rehabilitation of the Disabled (PSRD) in Lahore. A total of 32 patients will participate, equally divided into two groups through random allocation. The inclusion criteria will consist of children aged 5-12 with spastic CP, encompassing both genders. Patients with any neurological conditions, other orthopedic issues, a history of spine surgery, severe systemic disorders, psychiatric disorders, or neuromuscular disorders will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Spastic diplegic CP children age 6 to 12 years,
* Each gender included
* Grade 1 of spasticity according to modified Ashworth scale (21)
* With normal I.Q. greater than 70 (assessed by psychologist),
* Can follow commands(

Exclusion Criteria:

* Children with any other neurological impairment
* Children with audio visual impairment