cyrilzakka/clinical-trials huggingface dataset:
Biological Rhythms Impact of 12 Hours Shift Work

Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.


Eligibility Criteria:
Inclusion Criteria:

* Nurses or nursing assistants working in the Sleep and Respiratory Diseases Department of the Croix-Rousse Hospital with positions in 12 hours for more than 6 months
* informed consent given by the subject

Exclusion Criteria:

* Pregnancy or lactation \<6 months
* Taking treatment modifying the secretion of melatonin (melatoninergic drugs (including antidepressants), beta-blockers)
* Refusal of participate
* Minor or major protected subject
* Not affiliated to a social security scheme
* Participant in another interventional study interfering with sleep / wake rhythm or work schedules (judgment of the investigator)
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma

Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients.

Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results.

The aim of study is to further explore the role of OMT on asthma in a pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* children with asthma age between 5 and 14

Exclusion Criteria:

* associated co-morbities surgical patients
GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations

The obesity epidemic is attributable to dietary and behavioral trends acting on a person's genetic makeup to determine body mass and susceptibility to obesity-related diseases. Furthermore, common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the appetite center in the hypothalamus. Today, GLP-1 receptor agonists are available for the treatment of type 2 diabetes, and their treatment potential in obesity is an area of active research.

The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in people diagnosed with obesity causing genetic disorders and to investigate the physiological role of GLP-1 on food intake and appetite regulation in this group.

* Exploration of the physiological role of GLP-1 concerning food intake and appetite regulation in obese adults diagnosed with obesity related genetic disorders.
* Assessment of the effect of GLP-1 on body composition, bone mineral density, energy expenditure, cardiac function, glucose tolerance, insulin sensitivity, lipid concentrations and neuroendocrine function.
* Assessment of the impact of the leptin induced adaptive thermogenesis response in the weight reduced study participants.
* Investigating the alteration of the composition of gut bacteria as well as subjective ratings of satiety and hunger before after supplement with GLP-1.

Eligibility Criteria:
Inclusion Criteria:

* BMI above 28 (kg/m2)
* age 18-65 years
* otherwise healthy

Exclusion Criteria:

* pregnancy or breastfeeding
* Type 2 Diabetes
* suffering from severe medical conditions

Recruitment for this study finished November 2015
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

A questionnaire composed of items addressing psychological, emotional and social aspects of GERD is developed for Chinese population. We plan to conduct a validation study on this novel disease-specific quality of life (QoL) instrument. This study aims to evaluate various indicators of validity and reliability, which include criterion validity, test-retest reliability, responsiveness, internal consistency reliability and discriminant validity.

After initial pilot testing of face validity and content validity, two hundred GERD patients from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be evaluated using exploratory factor analysis to identify appropriate items and domains and the internal consistency of the domains will be determined and further refinement of questionnaire will follow.

100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale (VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile will repeat GERD QOL two weeks after the first administration for evaluation of test-retest reliability.

Another 26 patients who are receiving maintenance acid suppressive therapy and in remission of symptom will be recruited as controls for comparison with active reflux patients. The ability to distinguish active patients from controls in remission is known as discriminant validity.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with 1 attack of heartburn and/or acid regurgitation per week as chief complaint in recent 6 months

Exclusion Criteria:Patients with

* GERD as GI involvement of systemic disease e.g. scleroderma, SLE, thyrotoxicosis, chronic intestinal pseudo-obstruction
* Cause of esophagitis other than GERD e.g. drug induced, infection, nasogastric tube injury
* Previous gastrointestinal or hepatobiliary surgery (including cholecystectomy)
* Organic pathology of upper GI tract that may present as reflux / dyspeptic symptom e.g. peptic ulcer, gastric cancer, gastric outlet obstruction
* Presence of alarm symptom that does not suggest functional GI disorder
* Use of NSAID in recent 4 weeks (Low dose aspirin \< 300 mg is allowed)
* Pregnant woman or lactating female
* Illiterate patient (who cannot administer questionnaire)
* Known hypersensitivity to PPI
Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients

The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.

The mechanisms by which carbon monoxide exerts its effects in preventing damage of the graft appear to vary among the models and organs with the common theme of carbon monoxide acting as a potent anti-inflammatory molecule. Carbon monoxide affects several intracellular signaling pathways. In addition, carbon monoxide generates increased levels of anti-inflammatory molecules.

Evaluate the safety and tolerability of three carbon monoxide dose levels consisting of a single 0.7 mg/kg dose and a single 2.0 mg/kg dose when administered post-operatively and a single 2.0 mg/kg dose, a single 3.0mg/kg dose and a 3.5 mg/kg dose when administered intra-operatively as an inhaled gas for 1 hour, by assessment of adverse events (AEs), vital signs, laboratory variables, serum carboxyhemoglobin (COHb), oxygenation, electrocardiography (ECG), and neurocognitive status in patients receiving kidney transplants.

Eligibility Criteria:
Inclusion Criteria:

* Male or female receiving a kidney transplant from any donor type
* BMI between 16 and 36 inclusive
* Spontaneously breathing (non-intubated) with supplemental oxygen standardized at 2 liters via nasal cannula
* Hemodynamically stable with a systolic arterial pressure \> 90 mmHg and a heart rate \< 120 beats/min
* Acceptable transplantation candidate as judged by medical history, physical exam, ECG, vital signs, clinical chemistry, hematology, and urinalysis
* Given written and verbal information and had the opportunity to ask questions about the study
* Signed informed consent to participate in the study

Exclusion Criteria:

* Exposure to any carbon monoxide source (e.g., fire, gas, or heavily polluted air) during the 48 hours prior to the study day
* Baseline blood level of COHb \>2%
* Baseline hemoglobin (Hb) \<10.0 g/dL
* Patients with significant underlying lung disease such as moderate or severe asthma, COPD, and interstitial lung disease
* Baseline oxygen saturation \<95%
* Pregnancy or breastfeeding
* Participation in other clinical trial within 2 months prior to study drug treatment
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients

The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia diagnosis
* Provision of written informed consent before initiation of any study

Exclusion Criteria:

* AIDS and hepatitis B
* History of seizure disorder
* Hospitalisation for schizophrenic more than 1 month immediately before enter into study
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients

Patients with Inflammatory Bowel Disease (IBD) have poorer quality of life than healthy people. Despite the high prevalence of psychological issues and its profound influence on quality of life, most IBD patients have limited access to mental health support. As well, many may decline support if it is offered because mental health is often not thought of as part of IBD care. Patients may be able to access cognitive behavioural therapy (CBT) through a psychologist, however this intervention is costly and requires considerable commitment on the part of person with IBD. There is a need for new methods of reaching IBD patients to provide information on their psychological needs, and normalize the psychological effects of IBD. These new methods should integrate medical issues with psychosocial issues while being effective, scalable, and low cost to the health care system. 90SecondIBD is a novel way of delivering health information about IBD using Persuasive Design technology embedded in a planned behavior model. This project will investigate the effect of the intervention "90SecondIBD", a weekly online health letter, on IBD patients' quality of life and self efficacy. Regression modelling will be performed to explore the ability of clinical and demographic factors to predict quality of life and self efficacy scores following receipt of 90SecondIBD educational health letters weekly for 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone

Exclusion Criteria:

* N/A
Effect of Fatigue on Regional Anaesthesia Task

The adverse effects of sleep related fatigue are significant, impacting on doctors' health, wellbeing, performance and ultimately their safety and that of their patients'.

Trainees are at an increased risk of fatigue because they routinely, and are increasingly, working long hours, and exposed to excessive and high intensity workloads. With increasing numbers of patient consultations, there is a higher risk of making poorer quality clinical decisions (i.e. decision fatigue). The excessive workloads experienced by doctors can cause fatigue through the requirement for sustained attention over long periods of time, particularly when performing complex and mentally demanding tasks. Our main objective is to study the difference between the fatigued and non-fatigued state of anaesthetists and on their ability to perform an ultrasound-guided peripheral nerve blockade task. We hypothesise that fatigue will result in a clinically significant reduction in the objective structured assessment scores of anaesthetists who are performing an ultrasound-guided peripheral nerve blockade task compared to their scores when they are non-fatigued.


Eligibility Criteria:
Inclusion Criteria:

1. Anaesthetists of ST3 grade and above with previous experience of performing an ultrasound guided peripheral nerve block.

Exclusion Criteria:

1. Previous experience of gaze control training or eye-tracking software applied to medical interventions.
2. No previous experience of performing an ultrasound guided peripheral nerve block.
Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team

The purpose of the proposed study is to evaluate the impact of a behavioral intervention team (BIT) on 2 adult units: a general medical (8N); a cardiac/medical stepdown (8S) at Vanderbilt University Medical Center (VUMC) with a higher proportion of patients with behavioral health comorbidities.

The BIT will provide a proactive psychiatric team that will screen all patients on admission, provide consultation to those meeting established criteria, and recommend interventions to the primary care team for consideration. BIT will also serve to model therapeutics tactics in communication and goal setting to the clinical staff.

Research Questions for the proposed study:

Considering that behavioral health co-morbidity is common among hospitalized medical inpatients and is associated with higher costs of care and staff dissatisfaction, we will ascertain whether the addition of dedicated, trained behavioral intervention team, compared to nursing staff training on trauma informed care and de-escalation techniques provides:

1. meaningful, measureable improvement in the prevention and management of disruptive behavior in the healthcare setting at VUMC, and
2. Improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

Specifically, using a pragmatic, cluster cross-over trial design where the BIT crosses between 8N and 8S, we will test the hypothesis that presence of the BIT results in:

1. Improvement in the prevention and management of patients exhibiting disruptive, threatening or acting out behavior
2. Improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to two adult medical surgical units (8N/8S) at Vanderbilt University Medical Center during the study period.
* All clinical nurses and staff on 8N/8S employed during the study period.

Exclusion Criteria:

* Patients admitted to the floor before the BIT team has begun the crossover period on the unit.
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

Eligibility Criteria:
Inclusion Criteria:

* The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
* The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.
* The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Music Listening for Cataract Surgery

The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.

Cataract surgery is the most frequent surgical procedure performed in Europe, usually done under topical anaesthesia. Restlessness and hypertension are the most frequent medical complications during surgery, potentially leading to surgical complications. Since the surgery is ambulatory and requires the patient's cooperation, heavy intravenous sedation should be avoided. However, this procedure is stressful, with patients experiencing high anxiety due to being awake and aware of the procedure on their eye and equipment. Music therapy may be considered as a non-pharmacologic and non-invasive mean to reduce anxiety and therefore intra-operative hypertension. To assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures under topical anaesthesia, investigators intend to perform a randomized controlled trial. Depending on the results of the study, music therapy may subsequently be replacing the usual premedication before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cataract surgery performed under topical anaesthesia

Exclusion Criteria:

* Non topical anaesthesia
* Non ambulatory surgery
* Communication difficulties including language barrier, and mental disorders
* Age\<18yo
* Hearing impairment
* Uncontrolled hypertension
Fertility and the Microbiome

With this study, the investigators want to investigate the microbiome and human papilloma virus (HPV) status of couples with subfertility. The investigators want to gain information about association of female and male microbiome and its impact on fertility. HPV prevalence is high, and its impact on fertility has not been studied intensively. The investigators want to find out whether there is an association between HPV status and subfertility, vaginal and seminal microbiome and HPV status and the prevalence among our subfertile couples.

As part of this study, the investigators will perform a randomized placebo controlled double blind pilot study to investigate the association between altered sperm quality (impaired motility and elevated DNA fragmentation index), the seminal microbiome and whether intake of probiotics alters these parameters.

Observational study:

The investigators will include 150 couples within 24 months and will take samples of oral, urinary, stool, vaginal, uterine and seminal microbiome and cervical as well as seminal samples for HPV analysis. Further, the investigators will test for other sexually transmittable diseases, hormone status and metabolic status. Time to pregnancy, pregnancy rate and live birth rate will be evaluated.

Placebo controlled double blind randomized controlled trial:

30 subfertile men (Asthenozoospermia, elevated DNA fragmentation index) will be randomized in to two groups: Placebo or Probiotics for 3 months daily. Before and after these 3 months, sperm count microbiome analysis and HPV analysis will be performed to find possible associations with intake of probiotics.

Eligibility Criteria:
Inclusion Criteria:

* Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss.

Exclusion Criteria:

* unable to consent
* diseases or conditions that might impact investigation
* intake of probiotics, antibiotics within last 3 months
* intake of nutritional supplements
* chemo therapy or radiation therapy
* excess alcohol intake
* smoking
Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.
Fast Stepping in Stroke Patients for Fall Prediction and Prevention:Control Mechanisms and Clinical Implications

The purpose of this study was to compare the balance strategy, as well as center of pressure (COP) trajectory and parameters between healthy adults and patients with hemiplegia in response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and backward directions.

The ability to quickly respond to external perturbations is an important capacity of stroke patients to maintain dynamic balance in activities of daily living. The purpose of this study was to compare the balance strategy, as well as center of pressure (COP) trajectory and parameters between healthy adults and patients with hemiplegia in response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and backward directions.

Eligibility Criteria:
Inclusion Criteria:

Healthy adults

* Age ang Sex are correspond with the stroke subjects(between 40 and 75 years old)
* being willing to accept one-year follow-up examination
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital Stroke patients
* between 40 and 75 years old
* stroke confirmed by ICD-10-CM (including I60, I61, I62, I63, I67, and I69)
* first stroke with single side hemiplegia and received acute treatment at NTUH
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
* able to step forward, laterally and backward independently without assistive device

Excursion criteria:

Healthy adults

* - having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability Stroke patients
* having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke