cyrilzakka/clinical-trials huggingface dataset:
The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.


Eligibility Criteria:
Inclusion Criteria:

* Elective open heart surgery.

Exclusion Criteria:

* Significant cardiac arrhythmias, including atrial fibrillation.
* Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.
* Recent myocardial infarction (\< 3 mnd, troponine \> 50 ug/l).
The Fruit and Vegetable Study

The main aim of this study is to determine if persons can increase fruit and vegetable intakes if they make a specific plan to do so.

The conduct of cancer prevention trials through community settings and/or national networks of clinical sites requires the development of appropriate interventions. One promising behavioral strategy that is very simple to administer is that of the formulation of implementation intentions. The premise of this intervention is that once persons formulate a plan of action, automatic behavior follows. Use of this intervention in primary care is an innovative approach to eliciting preventive behaviors with minimal staff time. The goal in this study will be to increase fruit and vegetable consumption by 2 servings/day without a change in overall energy intakes by decreasing consumption of a less nutritious food. Substitution of foods is critical for prevention of weight gain. This feasibility study aims conduct a randomized, controlled clinical trial to test whether formulation of implementation intentions, either alone or with telephone support, can increase fruit and vegetable consumption without an increase in overall energy intakes. Recruitment success in a family medicine clinic in Ypsilanti Michigan will be documented with emphasis on the extent of minority participation. Dietary assessment will be the main outcome variable. Other assessments will include demographics, self-assessment of behaviors targeted by the intervention and levels of carotenoids in plasma. We will enroll 105 subjects to retain 28/arm, and power is good to detect small differences in fruit and vegetable intakes among the three study arms. This will generate useful data for the design of larger dietary intervention trials that are cost-effective and which will utilize multiple clinical sites to optimize enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 and older
* Give informed consent
* In general good health
* Less than 5.5 servings/day of fruits and vegetables

Exclusion Criteria:

* On medically prescribed diets that the study would not be consistent with
* Evidence of eating disorders
* Health problems that affect energy needs (eg. broken leg can interfere with normal activities and affect energy needs).
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes

Benign paroxysmal positional vertigo (BPPV) is one of the most common types of vertigo, especially in elderly. Therefore the investigators have set the goal to evaluate the prevalence of BPPV and its therapy using the Rotundum device in elderly living in retirement homes. Furthermore the investigators use a questionnaire to evaluate possible predictive signs to improve the diagnosis of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Lives in retirement home/has vertigo/has signed the informed consent

Exclusion Criteria:

* severe heart failure
* untreated cardiac arrythmia
* severe autonomic Dysregulation
* untreated epilepsy
* untreated cervical vertebral body fracture
* inability to follow the test
* weight over 150kg or under 40kg
* height below 140cm or over 200cm
* bedridden
* already participated this study
* participant is connected to the study team
Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants

The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.

This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.

If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation


Eligibility Criteria:
Inclusion Criteria:

* Infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours,
* Affiliate or beneficiary of a social security scheme,
* With informed consent of the 2 legal representatives.

Exclusion Criteria:

* Known allergy to silicone.
Resistant Starch and Satiety

Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-64 years
* Non-smoking
* Not taking medication
* Non dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to ingredients found in the study products
* BMI \<18 or \>27
* Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus
* Cancer in previous 5 years
* Any gastrointestinal disease or condition
* Recent bacterial infection (\< 3months)
* Recent or concurrent participation in an intervention research study
* History of drug or alcohol abuse in prior 6 months
* Use of lipid lowering, anti-hypertensive, or anti-inflammatory steroid medication
* Eating disorder
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day
* Women who are pregnant or lactating
* Women with irregular menstrual cycles
Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce

Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce. Upadacitinib mechanism of action JAK-STAT pathways are composed of four JAK kinases and seven STATs (STAT1-6, including homologs STAT5a and STAT5b). A cytokine binding to its receptor initiates the signaling cascade as well as the subsequent association/rearrangement of the receptor subunits. This rearrangement enables JAK activation by transphosphorylation and, upon activation, JAKs phosphorylate the receptors.

Eligibility Criteria:
Inclusion Criteria:

* all patients are systemic sclerosis disease duration more than 3 years limited and diffuse types ground glass at HRCT DLCO\< 80% decline in FVC \>10% in last 12months

Exclusion Criteria:

* associated other CT diseases disease duration \< 3 years kidney disease
Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation

The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke

Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.

In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.

However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.

With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Ischaemic acute stroke
* Informed consent

Exclusion Criteria:

* 25 ≤ National Institute of Health Stroke Scale ≤ 32
* Rankim ≥ 5
* Mini Mental State Examination ≤ 24
* tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists

The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.

This is a national multicenter randomized open-label superiority study of the use of Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing cardiovascular disease. Patients will be stratified based on baseline endothelial function and presence prostate cancer metastasis.

Study population: Subjects with pre-existing cardiovascular disease with locally advanced or metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT). Patients already on ADT will be excluded. subjects will receive either two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months EndoPAT2000 measurements will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
* Scheduled to start ADT for a period of at least one year.
* Subject has a history of one or more of the following:

  1. Myocardial infarction
  2. Ischaemic or Haemorrhagic cerebrovascular conditions
  3. Arterial embolic and thrombotic events,
  4. Ischaemic heart disease
  5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
  6. Peripheral vascular disease (e.g. significant stenosis (ABPI\<0.9), claudication, prior vascular surgery/intervention)
* Life expectancy of over 12 months.
* WHO performance status of 0-2
* Subject is able and has agreed to sign a consent form.

Exclusion Criteria:

* Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed.
* Prior use of dutasteride/finasteride in past 6 months
* Known allergic reaction to Degarelix.
* Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Aggreguide A-100 ADP Assay Evaluation

The study is to characterize the AggreGuide ADP Assay's performance.


Eligibility Criteria:
Inclusion Criteria:

* 18-75

Exclusion Criteria:

* less than 60 kg
* on antiplatelet meds other than aspirin
* antiplatelet drugs contraindicated
A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age related.
* Other protocol-defined exclusion criteria may apply.
Low-dose Naltrexone for Bladder Pain Syndrome

Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions.

The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with non-Hunner and Hunner lesion disease
* Meeting AUA definition of BPS: An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder associated with lower urinary tract symptoms of greater than 6 weeks duration in the absence of infection or other identifiable cause.
* Stable treatment for 1 month
* 7-day maximum of pain scores at least 4/10 on the numerical rating scale of pain in the bladder/pelvic area. Urinary frequency 8 or higher while awake. Nocturia 2 or higher. BPIC-SS 19.
* Agreement to not take opioids through the duration of the trial

Exclusion Criteria:

* Substance Use Disorder Diagnosis including Opioid Use Disorder Diagnosis
* Known allergy to naltrexone or naloxone
* Participation in another clinical trial
* Current or planned pregnancy, or breastfeeding
* Chronic pain in another location of the body that is more severe than that related to BPS.
* Any intravesical instillation in last 8 weeks
* If on Elmiron, stable dose for last 3 months
* If on amitriptyline, stable dose for last 3 months
* Any botox within last 6 months
* Treatment for Hunners in the last 6 months
* Any new Interstim settings within last 3 months
* Any new pelvic floor physical therapy in last 12 weeks
* Any change in or new OTC meds over last 2 months.
* Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks)
* Opioids chronically for IC/BPS in the past unless have been off for 1 year
* Recent short-term (within one week of enrollment) opioid use for flairs
* No documented cystoscopy in the last 5 years
Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.

This study intends to observe the effect of intravenous hydrocortisone combined with vitamin C and vitamin B1 infusion on the prognosis and sublingual microcirculation in patients with sepsis or septic shock through a prospective randomized controlled study method.

Shock is a common pathophysiological state in critical care medicine and occupies an important position. In recent years, some studies have had uesd metabolic resuscitation agent -- namely hydrocortisone + vitamin C + vitamin B1 cocktail therapy in the treatment of sepsis patients, studies found that this method may reduce the lactate level, improve renal failure and circulatory failure, and then improve the prognosis of such patients. There are also study groups that do not significantly prolong the survival of septic shock, suggesting that we need to screen out the use of metabolic resuscitation agents. Given the important role of vitamins in shock, uncontrolled inflammatory response, capillary leakage, and microcirculation dysfunction, whether the improved prognosis may be related to the patients' own vitamin levels. Vitamin deficiency is often present in the elderly.

This study aims to observe the effect of precision treatment of metabolic resuscitation agent on mortality and sublingual microcirculation in the follow-up prognosis of elderly septic patients on the basis of monitoring vitamin B1 and C levels in elderly septic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 and ≤85 years old;
* Diagnosis of sepsis or septic shock;
* Clinical judgment for hydrocortisone treatment;
* Signing Informed Consent.

Exclusion Criteria:

* patients in palliative care;
* uncontrolled malignancy with multiple metastases;
* ineffective surgical intervention for the infectious agent;
* estimated death within 24 hours;
* glucocorticoids used in the last 7 days;
* allergy to hydrocortisone, vitamin c or vitamin B1;
* inability to measure sublingual microcirculation.
The Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section

We aim to investigate the value of vitamin B (B1, B6, B9, B12) on post-cesarean section analgesia in addition to the standard opioid-sparing multimodal regimen to achieve more robust analgesia with minimal side effects.

Optimum analgesia is an essential component in enhanced recovery after elective and emergency Caesarean section. Opioid-based analgesia negatively affects maternal functional recovery. Unlike other types of surgeries, the performance and the quality of postoperative recovery in caesarean section affects two individuals: the patient and their infant, hence it is recommended to use Opioid-sparing medications post-caesarean section.

Multimodal analgesia is recommended for post-caesarean section pain control. The main properties of its components are to promote return of (i) Mobility (ii) Oral intake (iii) Normal bowel function (iv) Micturition: Trial without urinary catheter (v) Activities of daily living, with Few adverse effects: inactive metabolites (no nausea, vomiting, sedation, pruritus, constipation or respiratory depression), Readily available after discharge home, Little risk of dependency (especially long-term opioids), Minimal risk of hyperalgesia or chronic pain and cost-efficient with minimally invasive technique and no side-effects on the neonate.

The morbidity of critically ill obstetrics can increase due to inadequate control of pain and also due to the consumption of opioid analgesia due to associated respiratory depression, sedation, and nausea. Multimodal analgesia is strongly recommended.

An immune-histochemistry study found that B vitamins potentiate acute morphine antinociception. In other studies, the value of vitamin B complex on postoperative analgesia was discussed and investigated in different combinations Another study reported the value of folic acid in decreasing gastric hypersensitivity in maternal stress in rats. Other studies explained the benefit of folic acid in analgesia through modulating gut microbiota, reducing inflammation, modulating purinergic signaling, and promoting nerve repair (6)This is the first study to investigate the effect of vitamin B9 (folic acid ) and other vitamin B (B1, B6, B12) beside the standard opioid sparing analgesics on post-caesarean section pain in critically ill obstetrics.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia.

Exclusion Criteria:

1. Patient's Refusal to participate
2. Known allergy to one or more of the given components.
3. Disturbed conscious level.
4. Prolonged or complicated surgery; defined by operative time of more than 90 min.
5. Severe liver dysfunction or failure
6. Severe renal dysfunction or failure.
7. Severe thrombocytopenia; platelets less than 50