cyrilzakka/clinical-trials huggingface dataset:
GALLANT 5 Tesaglitazar Versus Metformin

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are ³18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)

To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can be found to alter the progression of events thereby significantly impacting the long-term outcomes of children who develop AKI.

This research study is designed to study what happens to the kidneys after they have an injury. There is some evidence that even if there appears to be great improvement of kidney function, an injury can put patients at risk for long-term problems with their kidney function and increase their risk to have high blood pressure. We want to collect information from participants to help explain why this injury can cause future problems, including Chronic Kidney Disease (CKD) which may help us prevent these health problems.

Eligibility Criteria:
Inclusion Criteria:

* Children between age 2-20
* Decrease in renal function by 25% or greater
* Renal function has returned to normal

Exclusion Criteria:

* History of chronic disease
* Cancer
* Congenital heart disease
* Organ Transplantation
* Liver disease
* Pulmonary disease
* Diabetes other primary metabolic condition
* Severe neurologic impairments
* Hypertension
* Auto-immune
* Infectious disease or renal disease
* Smokers
* Renal disease w/primary cause i.e. - HUS or Glomerulonephritis
* severe allergies including allergy to seafood and/or iodine
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients presenting with a solid tumor or a malignant hemopathy,
* Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),
* Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias

Exclusion Criteria:

* Patients presenting with a chronic myeloproliferative syndrome,
* Patients presenting with a myelodysplastic syndrome,
* Patients showing hypersensitivity to any of the ingredients of Nivestim®,
* Patients not receiving chemotherapy,
* Patients who were already included in the study during a previous chemotherapy line
Kidney Recovery After Acute Kidney Injury - Longitudinal Study

The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI).

Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls.

Acute kidney injury (AKI) is a major health problem being both common and costly. It affects \~20% of hospital inpatients and consumes \~1% of the annual NHS budget. AKI occurs following a diverse range of insults, commonly ischaemia-reperfusion injury (IRI) but also sepsis and drug toxicity. Therapies for AKI are currently supportive and short-term mortality remains high, with \~2 million deaths per year worldwide. In those who survive an episode of AKI, 30% are left with chronic kidney disease (CKD). The remaining 70% that recover full renal function are at \~28-fold increased risk of ultimately developing CKD. This risk is even greater in elderly patients. Importantly, CKD is strongly and independently associated with incident cardiovascular disease (CVD), and together these exert a global socioeconomic burden.

The recognition that AKI and CKD are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. Currently, there are no specific treatments that reduce the risk of progressing to CKD after AKI. Thus, there is an unmet need for therapies that will prevent the transition from AKI to CKD and reduce the cardiovascular burden associated with both. Our preliminary investigations (not yet published) in humans and mice suggest that AKI causes sustained activation of the endothelin (ET) system to the long-term detriment of renal and systemic haemodynamic function. These pilot data form the basis of our project that seeks to determine whether the ET system is active in patients with AKI and, thus, represents a potential target for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as:

* Previous (within 3 years) eGFR \>45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND
* Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND
* Increasing creatinine \>= 27μmol/L above index value within 48 hours

The control group (N=50) inclusion criteria are:

(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR \> 60)

This group will be recruited contemporaneously with, and matched to, AKI participants by:

1. Age (± 5 years)
2. Sex
3. AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not

Exclusion Criteria:

1. Inability to provide informed consent
2. Prisoners
3. Pregnancy or breast feeding
4. Evidence of CKD
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety

This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.

This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
2. Age ≤ 28 days
3. Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts)
4. Head circumference at birth within normal range (3rd to 90th percentile of the chart)
5. Chinese, Malay, or Indian ethnicity
6. Written informed consent from parent(s)
7. Currently reside in Singapore and with the intention to reside in Singapore for at least the next 2 years

Exclusion criteria for the pregnant women/parents:

1. Pregnant women / mothers who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation.
2. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
3. Pregnant women / mothers known to have other significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (including, but not limited to: placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement
4. Incapability of the parents to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

   Exclusion criteria for the subjects:
5. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
6. Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
7. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
8. Infants who received any other infant formula, except the infant formula given in between birth and the initial breast-feeding (maximum of 3 consecutive days)
9. Infants with any history of or current participation in any other study involving investigational or marketed products.
Measurement of Autonomic Cardiovascular Integrity in Persons With SCI

People with a spinal cord injury (SCI) have limited ability to move and feel sensation below the level of the SCI. Doctors and researchers have tests which determine the level of function and sensation, this test was developed by the American Spinal Cord Injury Association (ASIA) and has been modified over the years to improve use and sensitivity. Most recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does not include the evaluation of autonomic nervous system (ANS) impairment. However, people with SCI do have impairment of the ANS and this may adversely affect how organ systems in the body function. Specifically, ANS impairment tends to result in changes in heart rate and blood pressure that may relate to the level of the SCI, but this is not fully understood. In this investigation we hope to develop simple tests which will allow doctors and scientist the ability to measure the amount of ANS impairment to the cardiovascular system, specifically the heart. The first part of the study will be to determine the heart rate response to several tests (administration of drugs and physical challenges) which will change heart rate. These tests will be given to people with and without SCI and the heart rate response will be compared between people with and without SCI. The bigger the difference in the heart rate response to these test between people with and without SCI the greater degree of ANS impairment in the people with SCI. Once this heart rate difference is determined, several simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and without SCI to again compare the heart rate response. The second part of this study will be to determine if the heart rate responses to the first set of tests (administration of drugs and physical challenges) can predict the heart rate response to these simple tests (deep breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of tests which can be easily used by doctors and scientists to determine the degree of ANS impairment to the heart in persons with SCI.


Eligibility Criteria:
Inclusion Criteria:

For All Groups:

* Age 18-65 years (18-89 years for Non-Invasive Only SCI Subjects)
* Stable health for \> 6 months
* Non-smoker

  o Subjects with SCI:
* Level of injury - C1-S4
* Duration of injury - ≥ 1 year
* AIS classification - A, B, C

Exclusion Criteria:

For Main Study SCI Group:

* Tachycardia (resting HR ≥ 100 bpm)
* Bradycardia (resting HR ≤ 40 bpm)
* Hypertension
* KNOWN:

Coronary artery disease, Chronic heart failure, Cardiac arrhythmias, Diabetes mellitus, Thyroid disease, Renal insufficiency, Hepatic disease, Autonomic neuropathy, Ulcerative colitis, Benign prostatic hyperplasia, Hiatal hernia, Glaucoma, Parkinson's disease, Stroke, other neuromuscular diseases, Known sulfite allergy or hypersensitivity, Asthma, Active illness or infection, For Non-invasives Only SCI Group

* Diabetes mellitus
* Autonomic neuropathy
* Parkinson's disease
* Active illness or infection
Multimodal Exploration of Patients With Multiple Sclerosis for an Early Detection of Subtle Progression

Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease of the central nervous system (CNS), characterized by a complex interplay of inflammatory demyelination and neuronal damage. The core MS phenotypes defined by clinical course are the relapsing and the progressive forms.Relapsing MS (RMS) is characterized by attacks - also called relapses - defined as new or increasing neurologic dysfunction, followed by periods of partial or complete recovery, without apparent progression of the disease during the periods of remission. In contrast, progressive MS (PMS) is characterized by progressive worsening of neurologic function leading to accumulation of disability over time independent of relapses. Additional descriptors ("active/not-active") serve to better characterize the presence of clinical and/or radiological activity both in relapsing and progressive forms.

In recent years, the concept of a silent progression, also known as smouldering MS, is making its way into the common lexicon of MS experts, challenging the current definitions of MS phenotypes. A growing body of literature suggests that the line between RMS and PMS is not as marked as men thought, and that inflammation and neurodegeneration can represent a single disease continuum coexisting early on in the disease course. Whilst it is established that relapse-associated worsening (RAW) can be accounted for by an acute inflammatory focal damage leading to axonal transection and conduction block, the physiopathology underlying the progression independent of relapse activity (PIRA) remains unclear.

It is becoming apparent that there is an increasing need for a personalized therapeutic approach by considering the individual MS phenotype of each patient, thereby enabling the choice of the molecule best suited to counteract the predominant disease pattern of that individual patient.

There is a limited number of studies combining clinical scores, neurophysiological evaluation and neuroimaging in patients with MS experiencing PIRA. Integrating a multimodal exploration of these patients might allow a step forward in the early recognition, management, and treatment of disability accumulation independent from relapses in patients with MS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18-year-old with diagnosis of RMS according to 2017 McDonald diagnostic criteria
2. Availability in the functional outcome database of at least 3 time-point complete evaluations with a time frame from the first to the last evaluation of minimum 12 months
3. Most recent functional outcome evaluation within 12 months of enrollment
4. Availability of follow-up MRI data during the observational period

Exclusion Criteria:

a) Contraindication to one or more of the paraclinical tests of the prospective multimodal evaluation
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT

The most common and feared complications of total thyroidectomy are vocal cord paralyses and hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important consequences on the quality of life (QoL). It should be taken seriously by all clinicians.

Dysphagia is a possible complication that can be observed in patients undergoing thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN), tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy to be detected. Therefore, a subjective feeling of dysphagia is more common.

Dysphagia has important consequences on the QoL in postoperative period, and should be addressed by the primary surgeon/clinician, regardless of whether it is objective or subjective.

The goal of the present study is to better understand the incidence of postoperative dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme will also be employed and results will be shared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma)
* Patients with total thyroidectomy (TT) indication
* Patients over 17 year-old

Exclusion Criteria:

* Patients without thyroid disease
* Patients with thyroid disorder, but prepared for surgery other than TT
* Healthy volunteers
* Patients below 17 y/o
Motivational Interviewing Training for Medical Students: a Pilot Pre-post Study

Objective is to evaluate the impact of a basic training programme in motivational interviewing (MI) for medical students, by comparing the ability of students to promote behavioural changes through relationship skills and to conduct a motivational interview before and after training.

Design: A pilot pre-post study in 20 students by comparing students' performance before and after MI training session.

Setting: Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, France.

Interventions: Students received three four-hour sessions of a basic MI training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.

Main outcome measures: Global scores by two independent raters who used the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 code, perception of student's empathy by the caregivers (CARE questionnaire), self-efficacy of students to engage in a patient-centred relationship (SEPCQ score), and student's satisfaction with the odds of achieving the target goal.

Eligibility Criteria:
Inclusion Criteria:

* Students in clinical internships (fourth or fifth year of medical courses) in the Immunology-Infection-Inflammation-Endocrinology Division of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris.
* signed consent

Exclusion Criteria:

* participation refused
* prior training in motivational interviewing
rTMS as a Treatment of Visceral Pain Secondary to Malignancy

The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in patients suffering from malignant visceral pain. Thirty four patients were included in the study. They are divided randomly into 2 groups using closed envelop as real rTMS group and sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for ten consecutive days (5 days/week) and the coil elevated and angled away from the head as sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn) level was measured at baseline, 5th and 10th session.


Eligibility Criteria:
Inclusion Criteria:

* All patients within age group 18-65 years with malignant visceral pain resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication was involved in this study.

Exclusion Criteria:

* We excluded patients with intracranial metallic devices or with pacemakers or any other device. We also excluded those with extensive myocardial ischemia, unstable angina and those known to have epilepsy.
Data-driven SDM to Reduce Symptom Burden in AF

This study is a single-group feasibility study evaluating decision aid visualizations which display common post-ablation symptom patterns as a tool for shared decision-making. The specific aim of the clinical trial is to evaluate the feasibility of putting the visualizations into clinical practice (n=75). The hypothesis is that patients will report low decisional conflict and decision regret and high satisfaction with their decision about whether to undergo an ablation or not.

Atrial fibrillation (AF) is the most common heart rhythm disorder, and nearly 90% of patients experience symptoms such as shortness of breath that directly impair their health-related quality of life (HRQoL). Catheter ablation is a minimally invasive, surgical procedure that is routinely performed to treat AF and associated symptoms with the goal of improving HRQOL, but also carries potentially serious risks. Shared decision-making (SDM), in which treatment decisions are aligned based on high quality evidence and patient values and goals of care, is a widely encouraged practice for navigating complex healthcare decisions such as these. However, SDM around rhythm and symptom management does not routinely occur due to a lack of detailed evidence about symptom improvement post-ablation, and a lack of decision aids to communicate evidence to patients. The overarching goal of this award is to create an interactive patient decision aid composed of established evidence from clinical trials together with novel "real world" evidence about symptom improvement post ablation mined from electronic health records (EHRs).

The investigators propose to use "real-world evidence" drawn from electronic health records (EHRs) to characterize post-ablation symptom patterns, and display them in decision-aid visualizations to support shared decision-making (SDM). In this project, the investigators will first use natural language processing (NLP) and machine learning (ML) to extract and analyze symptom data from narrative notes in EHRs. The investigators will also employ a rigorous, user-centered design protocol created during the Principal Investigator's post-doctoral work to develop decision-aid visualizations. In the clinical trial, the investigators will evaluate the feasibility of implementing these interactive decision-aid visualizations in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of paroxysmal AF according to International Classification of Diseases, Tenth Revision (ICD-10)
* Scheduled consultation at NewYork-Presbyterian Hospital (NYP) to discuss catheter ablation
* Symptomatic AF at baseline
* Age 18 years and older
* Able to read and speak English
* Willing/able to provide informed consent

Exclusion Criteria:

* Asymptomatic AF
* Severe cognitive impairment
* Major psychiatric illness
* Concomitant terminal illness that would preclude participation