cyrilzakka/clinical-trials huggingface dataset:
The Effect of Auditory Cues on Mood and Gait

The objective of this study is to identify the influence of positive and negative auditory cues, music and a placebo (silence) on mood and gait during 30 minutes of free walking. Participants will be required to walk for a total of 30 minutes with mood being measured every 5 minutes and gait measured throughout the 30 minute protocol.


Eligibility Criteria:
Inclusion criteria:

* Able to stand without an assistive device

  * This study requires subjects to stand and to walk with the Delsys monitors, thus we are unable to use subjects who cannot stand without assistive devices.
  * Delsys monitors are a wearable device that allows for comprehensive analysis of gait and balance. The sensors will be attached to the subject and they will be instructed to perform the gait test by walking for 5 minute intervals over the duration of 63 minutes. The Delsys will generate a report automatically that will then be analyzed.
* Able to walk in 5-minute intervals over the duration of 63 minutes without assistive devices.

  * The objective of this study is to measure gait. Assistive devices change gait and limit our ability to measure gait.

    • Subjects must be within the age of 18-45

Exclusion criteria:

* Impairment or inability to perform physical activity (e.g. walking) independently.
* Inability to walk for 2 minutes without pain or discomfort.
* Neurological conditions (i.e. stroke or Parkinson's disease)

  ○ Many neurological conditions can potentially alter gait. Therefore, we are eliminating individuals in this group.
* Recent (within 6 months) orthopedic surgery that impacts walking ability and balance, e.g. total joint replacement

  ○ The objective of this study is to measure gait and people with lower extremity injuries may have excessive variation in gait. Hence we will be eliminating them from this study.
* Wound or absent sensation on plantar surface (bottom) of the subject's feet.

  ○ Subjects with this issue will have alterations and variations in gait due to sensory deficits and/or pain. They will not eligible for this study.
* Visual Impairment ○ Subjects must be able to read and visually recognize words. Therefore, subjects must have 20/40 (corrected) vision. Subjects who are blind cannot participate.

Day of testing eligibility

* Subjects must not have consumed caffeine within the last 12 hours
* Subjects must have slept \>2 hours of their normal reported sleep time .
Study of Patients Hospitalized in Specialized Cognitive-behavioral Unit (UCC)

The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.

The purpose of specialized cognitive-behavioral unit is to take care of patients demented, valid and with disruptive behavior disorders. The hypothesis is that analyzing the healthcare of these discharged patients might provide a view of the benefices of these units.

The study will be explained to the eligible subjects if they are able to understand it, or to their trusted person, primary caregiver or legal representative.

Medical information will be collected during and after the hospitalization in the specialized cognitive-behavioral unit. The investigator will call the medical staff and the primary caregiver at 3, 6, and 12 months after the patient's discharge, in order to collect study data.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient at the UCC of Toulon

Exclusion Criteria:

* Patient already included in the study ( a patient cannot be included twice during the study)
* Non-affiliated to a social security regimen
* Objection of the patient, the trusted person, the legal representative, the relative or the member of the family (depending on the overall condition of the patient)
Effects of Plant Polar Lipids on Glucose Tolerance

In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women
* non-smokers
* between 20-40 years of age
* BMI between 18,5-30 kg/m2
* No known metabolic disorders or food allergies.
* The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion Criteria:

* Fasting blood glucose ≥6.1 mmol/L
* Use of antibiotics or probiotics in the last three months or during the study period.
* Smoking
* Blood donation during the last two months and during the study.
* Food allergies or food intolerances
* Cardiovascular diseases
* Metabolic diseases
* Inflammatory bowel diseases.
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

At the completion of the Week-12 visit of the pivotal study (Baseline \[Day 1\] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);
2. Male and female subjects
3. Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance while on the study, and for at least 4 weeks after the last exposure to study treatment
4. Capable of giving written informed consent

Exclusion Criteria:

1. Used a prohibited concomitant product or procedure to treat psoriasis during parent study
2. Had a serious adverse event (SAE) that was potentially related to treatment or experienced an adverse event (AE) that led to permanent discontinuation of treatment in the parent study
3. History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's completion of the study
4. Known hypersensitivity to tapinarof
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.

Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.

Therefore we want to investigate mechanistic relations between the three hormones.


Eligibility Criteria:
Inclusion Criteria:

* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Exclusion Criteria:

* Diabetes
* Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Inflammatory bowels disease
* Bowels surgery
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 24h
Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial

Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.


Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke on brain MRI
* NIHSS 6-22
* thrombolysis

Exclusion Criteria:

* Previous SAS
* Previous stroke
* Auto-adaptative Servo-Ventilation Contraindication
Thoracic Paravertebral Block Versus IV Fentanyl Infusion

High-quality analgesia during and following cardiac surgery is infrequently obtained, Sternotomy and thoracotomy is associated with significant pain that resulte in hypoventilation, atelectasis, and hypoxemia,Pain management is rarley a priority in the immediate postoperative care of these patients, who frequently require mechanical ventilation in an intensive care environment

Paravertebral nerve blocks (PVBs) can provide excellent intraoperative anaesthetic and postoperative analgesic conditions with less side effects and fewer contraindications than central neural blocks,Bilateral PVB has been successfully used in the thoracic, abdominal, and pelvic regions(12). Paravertebral analgesia is produced by placing local anaesthetic (LA) alongside the vertebral column, close to the exit of the spinal nerves(13)..

Traditionally, profound intraoperative analgesia has been provided by using high doses of opioids to suppress hormonal and metabolic stress responses to surgical stimuli. This regimen resulted in improved morbidity and mortality after cardiac surgery(14).

Eligibility Criteria:
Inclusion Criteria:

* males and females patients scheduled for elective open heart surgery

Exclusion Criteria:

* Patients with chest trauma, injuries to peripheries, unstable hemodynamics, sensitivity to local anesthetic drugs, infection at the operation site, renal or hepatic dysfunction, left ventricular dysfunction, coagulation abnormalities and patients on opioids
BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns

In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction.

In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction.

500 patients who were planned to undergo elective surgery and under general anesthesia as anesthesia method were included in the study. Demographic data of patients, their three biggest fears of anesthesia and APAIS scores were recorded. The patients were divided into two groups, they underwent BATHE anamnesis or standard anamnesis methods according to their groups, then their APAIS and patient satisfaction scores were recorded.

Eligibility Criteria:
Inclusion Criteria: A) ASA I-II patients

Exclusion Criteria:

A) ASA III-IV B) illiterate patients C) patients with known psychiatric disorders D) patients with chronic sedative E) antipsychotic drug use F) patients with a history of going to psychiatry in the last year G) patients with any cancer diagnosis were not included in the study.
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.


Eligibility Criteria:
Inclusion Criteria:

* Females, 18 years of age or older, of child-bearing potential.
* Subject has at least one myoma \>= 3 cm.

Exclusion Criteria:

* Pregnant or lactating females.
* Females undergoing prior open or closed myomectomy for treatment of myomas.
* Evidence of current active endometriosis or infection
* History of or active inflammatory bowel disease or pelvic inflammatory disease.
* Presence of a frozen pelvis, or hydrosalpinges.
"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas

Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site for hyperacute treatment and transfer to the most appropriate target hospital. The effects on reduction delays until different stroke treatments will be assessed. First estimations of cost-effectiveness will also be performed.

Stroke is a medical emergency for which "time-is-brain". Indeed, a huge body of animal experimental and clinical evidence exists that demonstrates that reducing the time to thrombolytic therapy is the most important variable in prevention of the disability. However, most stroke patients arrive to hospital too late for any type of acute stroke treatment: Only an estimated 19-60% of stroke patients present within 3 hours after symptom onset. Today, for stroke patients 3 different treatment options exist.

1. Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.
2. More recently, mechanical clot removal via catheters has been developed. There is currently increasing evidence that in obstruction of large brain vessels such endovascular treatment is superior to systemic thrombolysis in regard to recanalization rates and outcome.
3. Patients with intracranial hemorrhage can profit if transferred to hospitals with neurosurgical treatment options such as ventricular drainage or hematoma removal.

However, each of these treatment are highly time sensitive and due the availability of endovascular and neurosurgical treatment options only in very few highly specialized neurovascular centres decision in which institution the patient should be transported is of high medical and financial relevance. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site and its role in decision regarding transfer to appropriate target institution, thus potentially allowing reduction of time until treatment and delays until specialized treatment also in remote regions. First estimations of cost-effectiveness will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of acute stroke reported to the EMS dispatcher office (extended FAST Score, Table I) and verified by the EMS (after glucose testing)
* Reported onset of symptoms until call ≤ 8 hours
* Patients with "wake up stroke"
* Age older than 18 years
* Patient (or representative) is willing to participate voluntarily and to sign a written informed consent.

Exclusion Criteria:

* Cardiopulmonary unstable medical conditions requiring immediate treatment in an intensive care unit
* Patients with preexisting severe functional impairment and disease
* Known allergy or contraindications to contrast agents
Gabapentin in Patients at Clinical Risk for Psychosis

The purpose of this study is to test the effects of the drug gabapentin on brain function thought to be important in the development of schizophrenia. Researchers think that treating a brain region with gabapentin (the hippocampus) may reduce the risk for developing schizophrenia.

Six week, single site, proof-of concept, randomized double-blind placebo-controlled pilot study to examine the effects of moderate dose gabapentin (3600mg) in n= 100 putatively prodromal patients on hippocampal activity.

Eligibility Criteria:
Inclusion Criteria:

1. COPE patient between age of 18-30
2. Capacity to give informed consent
3. Currently using a reliable method of birth control (female) (condom plus spermicide, diaphragm plus spermicide, IUD, birth control pills, norplant, vasectomy in partner)

Exclusion Criteria:

1. Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium
2. Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
3. Lifetime diagnosis of renal failure/disease
4. Acute neurological, neuroendocrine,or medical disorder including renal insufficiency
5. Lifetime diagnosis of hypertension or diabetes
6. Intelligence Quotient (IQ) \< 70
7. Acute risk for suicide and/or violence
8. Pregnant, lactating
9. Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
10. Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also Depakote, lithium, lamotrigine, pregabalin or any med with a mechanism of action like gabapentin)
11. The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6
HIT Training in the Frail Elderly.

This pilot study aims to investigate whether high intensity interval training can result in rapid improvements in physical fitness amongst the frail elderly (over 70 years old). Participants will undergo a wide range of physical fitness measures followed by a four week exercise protocol. Determination of improvement will be by repeated testing of the physical measures taken for baseline. The primary outcome measure will be anaerobic threshold. There will also be a subgroup of participants who will undergo muscle biopsy and D2O ingestion to allow an insight into the mechanistic basis behind exercise training response in this age group.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 70 years.
* Sufficient mobility to be able to exercise on a static exercise bike.
* Availability for the entire trial period.
* Sufficient capacity to consent for the trial.

Exclusion Criteria:

* Participants under the age of 70 years.

Participants with a significant past medical history of:

* Myocardial infarction (within last 6 months)
* Unstable Angina
* Heart failure (NYHA class III/IV)
* Uncontrolled Hypertension (BP\>160/100)
* Previous stroke/TIA
* Severe respiratory disease inc. known pulmonary hypertension(\>25 mmHg), Forced -Expiratory Volume in 1 second \<1.5l.
* Brittle asthma / exercise induced asthma
* Known cerebral aneurysm or abdominal aortic aneurysm.
* Cognitive impairment, which may reduce individuals' ability to provide informed consent.
* Inclusion in a recent study which included any form of exercise, taking a drug or ionising radiation.

Exclusion criteria pertaining specifically to muscle biopsies:

* Current use of anticoagulation (i.e. Warfarin/Clopidogrel/Rivaroxaban)
* Any pre-existing clotting disorders known to the patient (i.e. haemophilia).
* Family history of severe bleeding requiring medical intervention.
* Any musculoskeletal deformity or skin conditions making the taking of a biopsy unsuitable as deemed by the medical practitioner taking that sample.
* Lack of capacity to fully consent for the procedure.
Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes

The management of ARDS, which is one of the important problems of intensive care patients, has gained popularity with the pandemic. Mechanical ventilation is an important life-saving treatment in ARDS patients. However, when not used correctly, it can cause Ventilator-Induced Lung Injury (VILI). Therefore, lung protective ventilation should be applied to minimize VILI in ARDS patients. Mechanical power is one of the parameters that guides intensivist in predicting VILI.

The goal of mechanical ventilation in ARDS patients is to improve oxygenation by reducing the work of breathing . With this aim, the orientation towards sensitive ventilation strategies has increased in the light of experience and scientific data from the past to the present. Today, the concept of Mechanical Power (MP) has been developed, which combines different variables, such as tidal volume, drive pressure, gas flow, respiratory rate, and PEEP, which have been associated with VILI in various studies, into a single parameter. In this study, the investigators used the simplified MP equation (MPvcv (simpl)) developed by Gattinoni et al. for power calculation in volume control mode and the simplified MP equation (MPpcv(simpl)) developed by Becher et al. for power calculation in pressure control mode. Thus, the investigators aimed to compare the volume control and pressure control modes over the concept of MP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed Covid-19 diagnosis in intensive care unit (ICU) and diagnosed with ARDS according to Berlin criteria
* Intubated patients which treated in the supine position on the second day of ICU admission

Exclusion Criteria:

* Patients with a known diagnosis of COPD
* Patients experiencing hemodynamic instability during ventilation
* Prone pozisyonda olan hastalar
* Patients receiving inotropic support
* Patients with missing data
Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia

This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.

This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 3 months of clinically diagnosed insomnia
* Body mass index ≤35 kg/m2
* Insomnia Severity Index (ISI) \> 7 arbitrary units (i.e., mild-to-severe insomnia)
* Pre-menopausal women must have regular menstrual cycles (\~26-30 day cycles) and will be scheduled for microneurography 2-7 days after menstruation to consistently test during the early follicular phase (or low-hormone phase in women on contraceptives)

Exclusion Criteria:

* Current or prior treatment of Suvorexant.
* Obstructive sleep apnea defined as an apnea-hypopnea index \> 30 using an FDA approved home sleep apnea screening devices as used in routine clinical practice.
* Participants without evidence of clinically significant obstructive sleep apnea on the screening test will undergo an overnight in-laboratory polysomnography to confirm absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per hour)
* Circadian rhythm sleep disorders
* History of meeting DSM-V criteria of major psychiatric disorder
* Have been clinically-diagnosed with diabetes, cardiovascular disease, or any other unstable or serious medical condition.
* Current, or use within past month, of psychoactive (other than stable treatment with antidepressant or antianxiety), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics)
* Shift work or other types of self-imposed irregular sleep schedules
* Habitual smoking (6 or more cigarettes per week)
* Habitual alcohol consumption (more than 2 alcoholic drinks per day)
* Breastfeeding or pregnancy