cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.


Eligibility Criteria:
Inclusion Criteria:

• Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs.

Exclusion Criteria:

* Pacemaker dependent
* Prisoners
* Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
* Not capable of informed consent
* Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
* ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
* Recent myocardial infarction (4 weeks or less)
* Maintenance dialysis
* Epilepsy
* Patients on labetalol (labetalol will interfere with catecholamine measurements)
* Patients with diabetes
* At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.
An Intervention to Protect Young Children From Tobacco Smoke Exposure

The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children

The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.

This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.

Eligibility Criteria:
Inclusion Criteria for RCT :

1. - Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week
2. - Parents willing to provide child hair samples
3. - Hebrew speaking participants
4. - Parents are willing to participate from time of entry for the coming 8 months .

Exclusion Criteria:

There are no additional exclusion criteria

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Study of Neurocognitive Therapeutic Exercise in the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise

It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography.

Exclusion Criteria:

* Rotator cuff and/or subscapularis tendon partial/full-thickness tears,
* capsulolabral pathology responsive to surgical repair,
* congenital abnormalities of the acromion,
* previous surgery on the affected shoulder,
* inflammatory or neurological (systemic or local) diseases involving shoulder girdles,
* cognitive or psychiatric disorders,
* local tumor metastasis or application of radiotherapy,
* acute infections or osseous tuberculosis.
Lactate Kinetics in Septic Shock

Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

Adult septic patients admitted to the Intensive Care Unit (ICU) or Intermediary Medical Unit in Karolinska University Hospital will be recruited within 72 hours from start of symptoms.

Other than fulfilling the definition for sepsis-3, patients need to be equipped with an arterial catheter to be eligible for inclusion. After informed consent (from next of kin when applicable) baseline blood samples are drawn from existing catheter and the subject is given a bolus dose of 20umol/kg 13C-labeled lactate in 20 ml isotonic saline. After this a total of 14 blood samples á 2 ml is drawn in the following 120 minutes. All blood samples are centrifuged and stored in -800 C until analysis. After all subjects have been included sampled are thawed and analyzed for content of endogenous and labeled lactate. Through analysis between their relationship the lactate production and consumption can be quantified.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* Age \>17 years
* Arterial catheter
* Lactate \> 2 mmol at any time point prior to inclusion

Exclusion Criteria:

* Mitochondrial defect
* Degenerative muscle disease
* Terminal liver failure
Autologous Cell Therapy for Treatment of Fecal Incontinence

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

This study is designed to test the safety and feasibility of iltamiocel (Autologous Muscle Derived Cells, AMDC) as a treatment for fecal incontinence in men and women. Iltamiocel therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects or a generalized weakening of the external anal sphincter.

Eligibility Criteria:
Inclusion Criteria:

* Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
* Wexner (Cleveland Clinic Incontinence Severity (CCIS)) score ≥ 9
* Etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction
* Failed conservative treatment

Exclusion Criteria:

* Gracilis sling repair or insertion of an artificial sphincter
* Inflammatory Bowel Disease
* Significant rectocele or rectal prolapse
* History of radiation treatment to the anal sphincter or adjacent structures
* Less than 18 years of age
* Pregnant, breastfeeding, or plans to become pregnant during the course of the study
* Neuromuscular disorder
* History of neoplasia within 5 years prior to enrollment, except for basal cell carcinoma, or is receiving or planning to receive anti-cancer medications
* Known bleeding diathesis or uncorrected coagulopathy
* Medical condition that would preclude treatment due to contraindications and/or warnings of concomitant medications or listed in the experimental product labeling
* Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
* Participating in another investigational drug or device study
* Unable or unwilling to provide informed consent
* Unable or unwilling to commit to the follow-up procedures
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.

The incidence of maternal hypotension during spinal anaesthesia for Caesarean delivery is reported to be as high as 70-90%. The potential adverse effects resulting from maternal hypotension are nausea, vomiting, cardiac dysfunction, foetal acidosis and hypoxia.

Hypotension during spinal anaesthesia is currently detected using an intermittent blood pressure (BP) monitor cycling and reactive administration of vasopressors upon detection. The use of conventional non-invasive BP monitoring is limited by the time required to inflate and to deflate the cuffs commonly applied to the arm, which subsequently leads to a failure to react in a timely manner to BP changes when they occur.

The DIVA system (double-intravenous vasopressor automated system) previously developed helped tackle the limitations associated with the conventional management of hypotension in Caesarean sections under spinal anaesthesia. In a recent randomized controlled trial the DIVA system achieved less incidence of maternal hypotension compared to conventional management, however the side effects in mother and baby were still not fully eliminated.

In this proposed study a new algorithm for an advanced DIVA (ADIVA) system will be developed to control BP more rigorously by detecting BP with more stable haemodynamic profiles and thereby improve patient outcomes. The clinical trial will be conducted in 2 phases. The first phase included the use of ADIVA in 76 subjects who undergo spinal anaesthesia for Caesarean delivery to test its safety and efficacy. The second phase was a randomised controlled trial to investigate the use of ADIVA in comparison to the existing DIVA system in 97 patients undergoing spinal anaesthesia for Caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients;
* With singleton full-term pregnancy;
* The indication for an elective cesarean delivery;
* The use of spinal anaesthesia for cesarean delivery;
* Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm.

Exclusion Criteria:

* Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
* Contraindication to spinal anaesthesia and/or allergy to opioids.
Effect of High Intensity Laser Versus Plus Exercises

High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of musculoskeletal pain management. This study is conducted to find out the effect of high intensity laser therapy only versus high intensity laser pulse exercises on level of wrist pain, function and Joint position sense in girls Gymnasts

Effect of high intensity laser plus exercises on wrist pain ..three groups of gymnastics girls suffer from non specific wrist is allocating ..the first group will receive exercises only , the second will receive laser only while the third will receive exercises plus laser

Eligibility Criteria:
Inclusion Criteria:

* All girls diagnosed with generalized chronic wrist pain and referred by orthopaedic physician.
* Their age between 10-16 years old
* They will be able to follow instructions.
* All are medically stable

Exclusion Criteria:

* • Bone fractures and tumors.

  * Cases after plastic surgery.
  * Hypertension (due to secondary vasoconstriction)
  * Diabetes mellitus
  * Pacemakers
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glioblastoma multiforme WHO Grade IV
* The patient is a surgical candidate, with the surgical intent for a \> 80% resection of the lesion
* Negative pregnancy test
* ECOG status \<= 2
* Tumor volume \<= 3.5 cm
* Adequate organ function
* Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus, Hepatitis C Virus, tubercolosis)

Exclusion Criteria:

* Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, bilateral cerebral hemisphere involvement ("butterfly" gliomas)
* Patients at increased risk of neurologic decompensation
* Continued use of high dose intravenous or oral corticosteroids, or \> 8milligrams per day of systemic dexamethasone
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Uncontrolled or symptomatic hypercalcemia
* History of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Significant cardiovascular disease
* History of other malignancy within 1 year prior to screening
* Severe infection within 4 weeks prior to initiation of study treatment
* History of allogeneic stem cell or organ transplant
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies
* Treatment with systemic immunostimulatory agents
* Treatment with systemic immunosuppressive medication
Effect of Telephone Follow-up on Repeated Suicide Attempt in Patients

Attempted suicide is a major public health problem, and the efficacies of current postvention protocols vary. The investigators evaluated the effectiveness of telephone follow-up of patients referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year.

In a single-center, controlled study with intent to treat, they evaluated the efficacy of a protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated for attempted suicide. For comparison, they evaluated as controls patients with similar social and demographic characteristics referred to their emergency psychiatric unit in the year prior to the study who did not receive telephone follow-up after their initial hospitalization. Data were analyzed using logistic regression.

The importance of suicide and suicidal attempts recurrence is a major public health problem. Indeed, the suicide attempt is one of the most important predictors of suicide, as well as suicidal relapse is considered a suicide risk factor. It is therefore essential to establish the suicidal relapse prevention devices.

Moreover, the consensus conference on suicidal crisis (6) in particular stresses the importance of organizing continuity of care and foster a therapeutic alliance to avoid a break in continuity of care.

This study aims to evaluate the effectiveness of telephone Callback patients on suicide rate of recurrence at 6 months of suicidal gesture. A secondary objective is to assess and promote compliance.

Patients were included after a psychiatric interview following a suicide attempt in the North hospital's emergency unit no emergency hospitalization or indication in the interview before the release of the psychiatric emergency service. The interview provides an assessment of suicide risk and oral information about the protocol. A map showing the coordinates of the psychiatric emergency service and a reminder of the protocol is given. A consent form is signed. This protocol does not replace the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Patient who have attempted suicide regardless of the medium
* Patient falling 4 psychiatric sectors covered by the CHU of Saint-Etienne
* Major and minor Patient (with parental permission)
* Patient for which there is no evidence of psychiatric hospitalization sector or clinic immediately after switching to the suicidal act

Exclusion Criteria:

* Homeless Patient
* Patients for whom Callback is not possible (no phone, incarceration ...)
* Patient who do not speak French
* Patient admitted sector or clinic following the psychiatric interview inclusion
* Patient Refusal
* Medical Reason
* Deleterious character of recontact by a doctor of the psychiatric emergency after passing the act
The SPIRO-MOTE Study

Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry


Eligibility Criteria:
Inclusion Criteria:

* Male and female children aged 5 to 16 years old
* Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
* Child able to perform reliable spirometry
* Family have access to a smartphone or tablet and a second device for video consultation

Exclusion Criteria:

* Significant learning difficulties
* Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
* Informed consent/assent has not been provided
* No English speaking member of the family
* Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)
Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women with Overweight or Obesity

The aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.

The growing rate of obesity is a major public health problem in the West, where 28% of pregnant women are overweight and 11% are obese. Worldwide, 50% of pregnant women are obese or overweight.

One of the problems directly related to obesity is gestational diabetes. In fact, its prevalence is increasing as the prevalence of obesity increases, as well as other complications of pregnancy. The prevalence of gestational diabetes in our environment is 6-12%.

Compared with pregnant women with BMI \<25 kg/m2, pregnancies among women with obesity are at increased risk of several adverse outcomes, including early pregnancy loss, congenital anomalies, stillbirth, pregnancy-associated hypertension, preterm birth and postterm, gestational diabetes mellitus, multiple gestation, cesarean delivery, and birth of a macrosome.

The consequences of obesity in pregnant women can be decreased through physical activity. This hypothesis is due to several mechanisms: reduction of blood pressure, improvement of the lipid profile, reduction of oxidative stress and the proinflammatory state.

In recent years, scientific societies have published new recommendations on physical exercise in pregnant women with clear guidelines. Even this, less than 15% of patients do the recommended exercise. Usually the recommended exercise is aerobic and in the group of obese and overweight patients this type of exercise requires more effort and time, with the consequent worse adherence.

In non-pregnant patients, exercise has been shown to be related to a decrease in cardiovascular risk and DM2. However, in pregnant patients, a meta-review of systematic reviews has shown that although lifestyle interventions decrease weight gain, they do not have a clear benefit in terms of maternal-fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* BMI≥25 kg/m2
* Singleton pregnancies

Exclusion Criteria:

* Chronic hypertension
* Pre-pregnancy DM (type I or 2 diabetes mellitus)
* Cardiovascular disease
* History of preterm delivery
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke

A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.

To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups. The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients. Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged \< 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* 35 years of age or older, and gender not limited;
* Between 2 and 4 weeks onset of ischemic stroke;
* The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
* Understand and voluntarily signed informed consent.

Exclusion Criteria:

* Known severe liver or kidney dysfunction;
* Known allergies for ingredients in the investigational product;
* Known medical condition likely to limit survival to less than 3 months;
* Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;
* Hemorrhage transformation after infarction, or bleeding tendency;
* Pregnancy or breastfeeding;
* Known lower extremity venous thrombosis;
* Having participated in others clinical trial within 1 month before randomization.