cyrilzakka/clinical-trials huggingface dataset:
Impact of Physical Activity on Quality of Life for Chronic Hemodialysis Patients

Chronic end-stage renal disease has a significant impact on patients' quality of life. In 2005, a study evaluating the quality of life of patients with end-stage chronic kidney disease using the SF-36 and KDQoL questionnaires showed that the proportion of patients with an altered quality of life varied from 20% to 50% in the physical component dimensions and from 12% to 47% in the mental component dimensions. More than 75% of dialysis patients had at least one of the 8 scores below the threshold that defines impaired quality of life. In 2011, the Quavi-REIN study involved 1251 dialysis patients showed a significant reduction of quality of life assessed using the generic SF36 questionnaire compared with the general population, in the physical and mental dimensions.

Moreover, in France, more than one senior citizens aged between 55 and 74 in three does not comply with the World Health Organisation's recommendations on the minimum level of physical activity required per day. A sedentary lifestyle is a major public health problem. It is the 4thrisk factor for mortality after hypertension, smoking and diabetes. This inactivity increases mortality and morbidity rates in humans, and consequently the risk of diseases such as cancer and type 2 diabetes.

Physical activity is recommended for patients with chronic kidney disease. In a survey of 505 nephrologists, 97% thought that physical activity is beneficial for dialysis patients, given that a sedentary lifestyle increases the death rate among dialysis patients. Data from the international DOPPS registry, involving 20,920 patients, showed that patients who engage in physical activity have a better quality of life (physical, psychological and sleep quality components), as assessed by the KDQoL-SF questionnaire.

The main objective is to study factors associated with the quality of life of hemodialysis patients, including physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis
* Major
* Agreeing to participate in the study

Exclusion Criteria:

* On peritoneal dialysis
* On daily dialysis at home
* Minors
* Protected by law (guardianship, curatorship, safeguarding of justice)
* Refusing to participate in the study
Production of Nonverbal Acoustic Signals and Resulting Physiological Responses

Like many other animals, humans produce nonverbal vocal signals including screams, grunts, roars, cries and laughter across a variety of contexts. However, despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal signals remain little studied and poorly understood in humans.Our studies aim to improve our understanding of the nature and function of non-verbal signals.

Like many other animals, humans produce nonverbal vocal signals including screams, grunts, roars, cries and laughter across a variety of contexts. Many of these signals (such as cries) are already produced at birth and likely serve a number of important biological and social functions. In addition, human speech is characterised by nonlinguistic acoustic parameters (such as pitch, formant frequencies, and nonlinear phenomena) that are known to correlate with biologically important traits of the vocalizer.

However, despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal signals remain little studied and poorly understood in humans.

Theses studies aim to improve the understanding of the nature and function of non-verbal signals. Thus, this study is part of a long-term research project in which investigators are trying to clarify the information contained in the acoustic structure of human non-verbal signals, and to investigate the factors influencing their production.

Eligibility Criteria:
Inclusion Criteria:

- Participant should be affiliated or entitled to a social security scheme

Exclusion Criteria:

* Pregnant women
* Voice production disorders
* Hearing impairment, speech production disorders or major health problems.
* Chronic smoker (more than 10 cigarettes per day)
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.

The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.

The study hypothesis is:

● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.

Eligibility Criteria:
Inclusion Criteria:

* Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
* The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
* The child is between 12-71 months old.
* Fluent Danish skills with parents / guardians.

Exclusion Criteria:

* Known allergy to macrolide antibiotics.
* Known impaired liver function.
* Known renal impairment.
* Known with neurological or psychiatric diseases.
* Known with congenital or documented acquired QT interval.
* Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
* Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\> 50 and / or Fever: temperature\> 39 °C and / or C-reactive protein (CRP)\> 50).
Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with sepsis severity. The pathophysiological mechanisms (increased lactate production vs decreased lactate utilization; tissues involved in sepsis-induced lactate production) remain largely unknown.

In this study, the investigators will assess whole body and regional metabolism in healthy young male subjects on two occasions, once after administration of an intravenous bacterial endotoxin challenge, and once without intervention.

In one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge

* Energy expenditure and net substrate oxidation rates (indirect calorimetry)
* Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)
* Glucose kinetics (measured with 6,6 d2 glucose)
* Hemodynamic parameters and body temperature
* Blood clinical chemistry In one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge
* Energy expenditure and net substrate oxidation rates (indirect calorimetry)
* Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)
* Glucose kinetics (measured with 6,6 d2 glucose)
* Hemodynamic parameters and body temperature
* Blood clinical chemistry

In a second group of subjects, regional muscle lactate metabolism will be measured over 10 hours after the endotoxin challenge by means of muscle microdialysis


Eligibility Criteria:
Inclusion Criteria:

* gender male
* body mass index (BMI) \< 25 kg/m2
* absence of known disease

Exclusion Criteria:

* any known pathology
* abnormal cardio-pulmonary and hemodynamic status
* electrocardiographic alterations
* history of allergy
* current medications
* drug abuse
* consumption of more than 20g/day alcohol
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).

The treatment of perforating Crohn's disease is not codified.

The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.

Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.

Indeed, data are scarce, especially in paediatrics.

Eligibility Criteria:
Inclusion Criteria:

* Minor patients (aged 3 to 18).
* Diagnosed with Crohn's disease.
* fistulizing crohn's disease

Exclusion Criteria:

- perianal crohn disease
Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD)

This is a prospective, open-label, observational study of the efficacy and safety of ECT for BPSD. There is no control or comparison group. Subjects will be compared on outcome measures pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects over three years

The study population are patients whom have a diagnosis of dementia and has behavioural and psychiatric symptoms of dementia (BPSD). In this study, the participants will have already been treated with antipsychotic medications as per usual practice but still do not have adequate symptoms control. One of the options in current clinical practice is to consider Electroconvulsive therapy (ECT) for treatment-resistant BPSD, particularly in those with psychosis and/or substantial aggression. Therefore, the study involves offering ECT to these individuals and measuring the patient's clinical status and severity of symptoms before and after ECT treatments by using standardized rating scales. Further, background information about the patient will be collected, such as their age and medical conditions.

ECT for BPSD has been done previously as reported in the medical literature. It has shown significant benefit for individuals when medication does not provide enough symptomatic relief. This research project is part of a larger multi-site study done in conjunction with Ontario Shores academic research group in Ontario, Canada. Active recruitment began in Ontario since October 2012, but our University of British Columbia (UBC) site is hoping to recruit further subjects to the total of 30 participants between the two sites.

Eligibility Criteria:
Inclusion Criteria:

* Severe BPSD: BPSD of sufficient severity that the safety of the patient or others precludes the possibility of discharge to any non-hospital environment.
* Failed "standard of care for BPSD":

  * Non-pharmacological treatments (see Clinical Practice Guideline) are of insufficient benefit to allow discharge to any non-hospital environment, and
  * Pharmacological treatments are of insufficient benefit to allow discharge to any non-hospital environment. Pharmacological treatments must consist of the following prescribed specifically for BPSD:

    * at least three atypical antipsychotic agents each for at least 4 weeks
    * at least one of the following for at least four weeks: an antidepressant, a cholinesterase inhibitor, and/or and N-methyl-D-aspartate (NMDA) receptor antagonist (i.e. memantine).
* Provided informed (substitute) consent to their attending psychiatrist for off-label treatment of BPSD with ECT as per the Health Care (Consent) and Care Facility (Admission) Act, and institutional policies and procedures.
* Been medically-cleared for ECT by Anaesthesia as per the usual pre-ECT work-up for patients admitted to the Geriatric Psychiatry Units.

Exclusion Criteria:

* Patients that are medically unfit to undergo ECT as per consultation with an anesthetist.
A Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis

Cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids. Both adrenal and non-adrenal (ovarian + testicular) all steroid hormones are primarily synthesized using the LDL-cholesterol in the circulation. Additionally there is 'de novo' cholesterol synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third pathway is the use of circulatory HDL-cholesterol by the adrenal and gonadal tissues for the synthesis of steroids. Since statins both decrease circulatory LDL and inhibit de novo cholesterol synthesis, they are likely to affect the synthesis of steroid hormones. In this study we aim to investigate the effects of lowering LDL levels below 70 mg/dL on steroid hormone synthesis.

Today atherosclerotic diseases are among the most important causes of death in the world. Epidemiological, clinical, genetic, experimental and pathological studies have clearly shown the role of lipoproteins in atherosclerosis. LDL is the major atherogenic lipoprotein and has been defined as the primary target of lipid lowering treatment by NCEP. Although the level of LDL, the primary target in the treatment of dyslipidemia, has been set as below 100mg/dl in coronary heart diseases (CHD) and CHD risk equivalents, this level has been pulled down to below 70mg/dl for the group defined as very high risk group by the ATP (Adult Treatment Panel) guide that has been updated following the new clinical studies. As we already know, cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids, besides being a structural component of the cell membrane. Both adrenal and non-adrenal (ovarian+testicular) all steroid hormones are primarily synthesized using the LDL-cholesterol in the circulation. In addition to this, there is 'de novo' cholesterol synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third pathway, which under normal circumstances has little contribution as compared to the first two, is the use of circulatory HDL-cholesterol by the adrenal and gonadal tissues for the synthesis of steroids. Our knowledge on extremely lowered LDL levels is quite limited. However, since statins both decrease circulatory LDL and inhibit de novo cholesterol synthesis, they are likely to affect the synthesis of steroid hormones.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the very high risk group according to the ATPIII guide.

Exclusion Criteria:

* Patients having a major disease involving hepatic, gastrointestinal and endocrinologic diseases other than diabetes.
* Patients having a known muscle disease
* Pregnancy, breast-feeding
* Patients having a history of allergy to statins or ezetimibe
* Nephropathic patients
4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years old or older
2. Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.
3. Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
4. Patients who have signed the consent form for this study

Exclusion Criteria:

1. Pregnant or breast-feeding women.
2. Patients with severely decreased renal function19-21.
3. Patients with known severe allergic reactions to contrast.
4. Patients who have difficulty lying flat on their back for extended periods of time.
5. Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.
Home-based Circuit Training for People With Intermittent Claudication

The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.

30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ankle/brachial index (ABPI) \< 0.9 at rest or a drop of 20mmHg after exercise testing
* Ability to walk independently
* English speaking
* Able to follow instructions
* ≥ 18 years of age

Exclusion Criteria:

* Unable to provide informed consent
* Walking impairment for a reason that is not PAD
* Critical limb ischaemia
* Asymptomatic PAD
* Active cancer treatment
* Severe mental or physical limitations precluding participation safely in the home environment
PF-06671008 Dose Escalation Study in Advanced Solid Tumors

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC.


Eligibility Criteria:
Key Inclusion Criteria

* Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
* Performance status of 0 or 1
* Adequate bone marrow, kidney and liver function

Key Exclusion Criteria

* Known CNS disease including, but not limited to, metastases
* Current or history of seizure disorder
* History of or active autoimmune disorders
* Active bacterial, fungal or viral infection
* Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment
* Requirement for systemic immune suppressive medication
* Grade 2 or greater peripheral neuropathy
Open-Label, Randomised Parallel-Group Study

An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Screening testosterone level above the lower limit of normal range, globally defined as \> 2.2 ng/mL.
* Screening PSA level of =2 ng/mL. ECOG score of =2.
* Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
* Serum levels of testosterone, LH, FSH, and PSA over time.
* Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
* Plasma levels of degarelix over time.
* Frequency and severity of adverse events.
* Clinically significant changes in laboratory safety parameters.
* Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing

This study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to exercise stress SPECT for detecting obstructive artery disease.


Eligibility Criteria:
Inclusion Criteria:

* any patient referred for stress SPECT
* known or suspected ischemic heart disease
* ability to perform adequate treadmill stress

Exclusion Criteria:

* any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
* renal insufficiency (GFR \< 40)
* known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA (computed tomography angiography) in patients not referred for cath after 2 weeks)
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
* Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria:

* Functionally significant vision loss, or progressive field loss within the last year.
* Contact lens wear at any time during the treatment period.
* Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
* Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
* Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
* Currently on chronic ocular topical medications
* Currently on any ophthalmic or systemic steroid therapy.
* Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
* History of macular edema
* History of chronic/recurrent inflammatory eye disease.
* History of a non-response to topical prostaglandin therapy.
* Subjects who have epiphora.