cyrilzakka/clinical-trials huggingface dataset:
Protection of Arteritic Patients by Remote Preconditioning

Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.

Patients will be screened amongst arteritic patients who have undergone a positive treadmill test in Angers University Hospital, defined by a premature test stop caused by muscular pain associated to trans-cutaneous pressure of oxygen (TCPO2) drop.

After signing the informed consent, patients will take two treadmill tests in a week-span. According to randomization, patients will undergo the "remote preconditioning" procedure or the "control" procedure before the first treadmill test. The following week, in respect to a cross-over strategy patients will undergo the other procedure before the second treadmill test.

Only the study nurse will be advised of the procedure to do. Investigators will not be informed about the allocated procedure. Patients will not be informed about the procedure supposed to have a beneficial effect.

The treadmill test will be run according to a calibrated protocol. After a 2-minute stand-up resting period, the treadmill will progressively speed up to a 3.2km/h during one minute. This stage will be maintained with a 10% slope for 14 minutes. Then, the treadmill's slope and speed will increase progressively every minute according to a calibrated protocol. The test duration will be measured from the start of the walk to the patient's request to stop because of pain in the lower limbs.

TCPO2 will be measured before and during the test on the glutei and the legs. Tissue oxygenation on both lower limbs will be measured by Near Infra-Red Spectroscopy (NIRO-200NX system). Oxygen consumption will be analysed throughout the test.

A blood sample will be drawn just before the start of the test, that is 5 minutes after the end of the last cuff deflation. A second blood sample will be drawn 2 minutes after the patient's request to stop walking. These blood samples are composed of one 3ml tube to measure out blood lactate level, one 6ml ethylene diamine tetraacetic acid (EDTA) tube and a 5ml plain tube. These two last tubes will be centrifuged and subsampled to build up a bio-collection stored at the local Biological Resources Center.

Eligibility Criteria:
Inclusion Criteria:

* Positive treadmill test (maximum walking distance \< 750m because of lower limbs muscular pain)
* Resting systolic pressure index \< 0,9 (uni- or bilateral)
* Resting systolic blood pressure \<200mmHg
* Written informed consent
* Affiliation to a Social Security scheme

Exclusion Criteria:

* Effort hypoxemia during the selection treadmill test
* Patient treated with metformin during the 7 days preceding the treadmill tests
* Person who is not affiliated to a Social Security scheme or benefiting from such a scheme
* Person in an exclusion period related to another biomedical study
* Patient refusal / patient not having provided written informed consent
The Influence of Fictitious Peers in a Social Media Intervention for Downsizing Portions: The Smart Snacking Studies

The 2 interventions aimed to examine whether peer-led nudging on social media may be a way of influencing young adults and adolescents to reduce their self-reported ideal portion sizes of high energy-dense snacks and sugar-sweetened beverages.

Two pilot interventions were conducted which examined the influence of peer-led nudging on social media as a way of influencing self-reported ideal portions of high energy-dense snacks and sugar-sweetened beverages. In both interventions the peers posted images of 'their' snacks and beverages, which constituted the recommended portion, onto an Instagram account. The peers also posted images relating to portion sizes, calories and other information related to health but not specifically portion size. It was hypothesised that viewing images of peers' snacks would influence the participants to reduce their own snack and beverage ideal portion sizes.

Intervention 1 lasted for 2 weeks and recruited young adults and used a within-subjects design. Intervention 2 lasted for 4 weeks and recruited adolescents and used a between-subjects design. In intervention 2, participants were randomly assigned to either the intervention or the control condition. This protocol focusses on intervention 2.

In both interventions, participants in the intervention condition were added to an Instagram account and were required to visit Instagram daily and to like all posts. All participants (intervention and control) completed a survey at baseline and at the end of the intervention, and completed quizzes at the end of each week.

Eligibility Criteria:
Inclusion Criteria:

13-16 years old (intervention 2)

Exclusion Criteria:

* Younger than 13 or older than 16 (intervention 2).
* History of or current eating disorder
Extravascular Lung Water Index in Severe Sepsis

To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.


Eligibility Criteria:
Inclusion Criteria:

* All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis.

Exclusion Criteria:

* Pregnancy,
* Age less than 18 years old, and
* Uncontrolled malignancy.
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study

The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is of legal age to participate in the study per the laws of their respective geography;
2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject does not have mitral stenosis or a mechanical heart valve);the subject has not been diagnosed with rheumatic mitral valvular heart disease);
3. The subject is deemed by the treating physician to be suitable for the protocol defined pharmacologic regimens;
4. The subject has a calculated CHA2DS2-VASc score of 2 or greater;
5. The subject is able to undergo ICE examinations;The subject is able to undergo ICE(which will be used during the index procedure) and TEE (which will be performed at 45 days and may also be performed at baseline);
6. The subject is able to understand and willing to provide written informed consent to participate in the trial;
7. The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

1. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed;
2. The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoaguable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic warfarin therapy);
3. The subject has a history of atrial septal repair or has an ASD/PFO device;
4. The subject has an implanted mechanical valve prosthesis in any position;
5. The subject currently or has had any documented history of, New York Heart Association Class IV Congestive Heart Failure;
6. The subject is of childbearing potential and is or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes.

These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option.

Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 60 years;
* Fulfilling the ROME IV criteria for Irritable bowel syndrome (IBS);
* Moderate symptom severity as defined by a IBS-Symptom Severity Scale \> 175;
* Sedentary lifestyle defined as SIT-Q-7D \> 8h/day;
* Physically inactive defined as \< 150min/week on the IPAQ score

Exclusion Criteria:

* Cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (SKA) questionnaire.
* Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
* Known inflammatory bowel disorder;
* Known intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of appendectomy or cholecystectomy more than 6 months ago);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 8 weeks;
* Change in diet in the past 8 weeks;
* Dietary supplements unless taken at a stable dose for more than 8 weeks;
* Antibiotics, pre-, pro-, post-biotics or any combination during the past 8 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
* Treatment with spasmolytic agents, opioids, loperamide, gelatine tannate or mucoprotect-ants during the past 8 weeks.
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents

The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from patient and parent(s)/legal representative.
* Male or female patient from 12 to 17 years.
* Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
* Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
* Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
* Spirometry with best FEV1 \> 80% of predicted FEV1.

Exclusion Criteria:

* Patient with a nasal or oral disease that could interfere with the safety assessments
* Patient has undergone recent nasal surgery
* Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
* Patient with partially controlled or uncontrolled asthma
* Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
* Female patient pregnant or breast-feeding/lactating.
* Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
* patient with a history of anaphylaxis
* patient having participated in any clinical study within the 12 weeks before visit 1
Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression

A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version B on symptoms of depression and negative interpretation bias.

Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM (active version) will result in superior treatment outcomes as indexed by a standardized clinical battery compared to iCBT + CBM (control version).

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder
* Internet and printer access
* Australian resident
* Fluent in written and spoken English

Exclusion Criteria:

* Current substance abuse/dependence
* Psychotic mental illness (Bipolar or Schizophrenia)
* Change in medication or psychological treatment during last 1 month or intended change during study duration
* Use of Benzodiazepines
* Severe depression (PHQ9\> 23)
* Suicidal
The Impact of Multimedia Childbirth Prediction on Parturients and Their Spouses

Multimedia birth prediction intervention helps mothers and their spouses reduce the number of trips to the hospital, reduce anxiety, and increase self-confidence. A total of 83 couples were accepted for cases, with a 10% attrition rate. so, A total of 95 couples were admitted and divided into the experimental group and the intervention measures were implemented Experimental group. Fill out basic demographic and obstetric variables, self-confidence visual analog scale, situational-trait anxiety scale-situational anxiety part at 37 weeks of pregnancy, at the first visit to the hospital, and one hour after admission to the hospital for delivery

More than 90% of pregnant women are prone to anxiety and fear due to unexpected and uncontrollable birth signs before delivery and because they cannot control their own condition.

Pregnant women who receive prenatal education can reduce their fear, depression, anxiety and stress about childbirth, increase their self-confidence during childbirth, and thus gain a positive childbirth experience. As a quasi-experimental study, cases were accepted using a random method. The number of cases admitted was 83 couples, with a 10% attrition rate. Therefore, a total of 95 couples were admitted and divided into an experimental group and a control group. The experimental group received intervention measures, and the control group received intervention measures.

At 37 weeks of pregnancy, at the first visit to the hospital for examination, and one hour after admission, basic demographic and obstetric variables, self-confidence visual analogy scale, and situational-trait anxiety scale-situational anxiety were filled in, and statistical analysis was performed. The methods were descriptive statistics, independent t test, chi-square test, analysis of variance, generalized estimating equations, and linear regression between the experimental and control groups.

Eligibility Criteria:
1. Low-risk first-time mothers over 20 years old and their spouses
2. Pregnancy \>37 weeks, pregnancy \<40 weeks
3. Single birth, head position
4. Vaginal producers
5. Those who can listen, speak, read and write Chinese

4. Diagnosed by a doctor as prenatal mental illness 5. The fetus' condition requires admission to a moderate or severe ward or intensive care unit.
Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

Primary Objectives:

To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG \& PPBG) from baseline to the end of the study.

Secondary Objectives:

To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + Basal insulin or Premix (Type I) or by either a basal insulin + OAD or basal + RHI/other short acting analogue insulin or Premix (Type II) with HbA1c \>7%.
* Adequate hepatic and renal functions
* Ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home.

Exclusion Criteria:

* Pregnant or lactating women or women of childbearing potential not using adequate contraception.
* Patients with hypersensitivity to insulin glulisine or to any of the excipients.
* History of diabetic ketoacidosis.
* Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
* Alcohol abuse or drug abuse.
* Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult.
* Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. Mental retardation or language barrier such that the patient is unable to give informed consent.
* Participation in an investigational trial within 30 days of study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia

The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.
* All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.
* Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.
* Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.
* History of any other brain surgery or surgery for the treatment of PD.
* Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
* A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).
* A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.
* Clinically significant abnormal laboratory data at screening.
* Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP1.
* History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.
* History of serotonin syndrome.
* Breast feeding or pregnant women.
Exercise Treatment of Dental Anxiety

A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.

The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure.

Primary efficacy endpoint:

Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior to the elective minor dental procedure

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years of age or older
* A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations
* Scheduled appointment for an elective minor dental procedure
* Informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Current diagnosis of any other DSM-IV, with the exception of other phobic disorders, social anxiety disorder or dysthymia
* Serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% VO2max