cyrilzakka/clinical-trials huggingface dataset:
Early PP Monitored by EIT in Patients With ARDS

Acute Respiratory Distress Syndrome (ARDS) is a syndrome characterized by respiratory distress and refractory hypoxemia caused by pulmonary and extra-pulmonary factors. Despite improvements in diagnosis and treatment in recent years, the mortality rate of severe ARDS is still around 40%. The distribution of lung lesions in ARDS patients is significantly gravity-dependent. Even with lung-protective ventilation strategies, tidal volume is concentrated in the ventral lung region, leading to ventilator-associated lung injury. Prone position ventilation can increase ventilation to the dorsal lung tissue and improve the ventilation-perfusion ratio, thus improving oxygenation. During prone position ventilation in ARDS patients, lung-protective ventilation strategies should be maintained, but with different respiratory mechanics from the supine position, requiring adjustment of ventilator parameters. Electrical Impedance Tomography (EIT) technology can be used for bedside monitoring of mechanically ventilated patients, providing real-time feedback on the patient's ventilation status and having great potential for clinical applications. Investigators believes that EIT monitoring during prone position ventilation in ARDS patients can individualize lung-protective ventilation strategies, minimize alveolar overdistension and collapse, improve the weaning success rate of invasive ventilation, and ultimately improve patient prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old；
2. Meets the diagnostic criteria for ARDS according to the 2012 Berlin definition；
3. Intubation with invasive mechanical ventilation time \< 36 hours；
4. PaO2/FiO2 \< 150mmHg.

Exclusion Criteria:

1. Contraindication to the prone position;
2. Contraindication to the EIT;
3. Patients have received extracorporeal membrane oxygenation treatment.
Effect of Olive Leaves as Hypoglycemic Agents in Diabetic Subjects

Background: Animal studies indicate that olive leaf extract normalizes blood glucose. We hypothesized that olive leaf extract might be of benefit in human subjects.

Methods: A total of 79 adults with diabetes were randomly assigned to treatment with olive leaf extract capsules or matched placebo. Measures of glucose homeostasis including glucose, insulin and HbA1c were measured and compared by treatment group.

The present study is a randomized, double blind, placebo controlled, clinical trial with a 14 week duration. Patients were randomized to treatment with a tablet of olive leaves or matching placebo in 1:1 ratio.

Patients were instructed to consume a diet consistent with ADA recommendations and an exercise training program was prescribed.

Weight, height, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in all subjects at the beginning and at the end of the study. Venous blood samples were drawn after an overnight fast of not less than 12 hours. Laboratory tests included fasting blood glucose (FBG), HbA1c, insulin, lipid panel and liver and renal function.

A total of 79 subjects (51 men, 28 women) aged 18-79 years with type 2 diabetes mellitus, were recruited from and followed up at an outpatient clinic. The subjects were selected from a series of 93 consecutive diabetic patients. Eligible patients had been diagnosed with T2DM for at least 1 year.

Subjects were randomized to treatment with olive leaf extract pills (1 500 mg pill daily taken orally) or matching placebo. The intervention was prepared as follows: olive leaves were picked from the Barnea cultivar in the Jezreel Valley region of Israel and immediately freeze-dried on dry ice. After the leaves were thoroughly rinsed with sterile distilled water to remove dust, insecticides, and contaminating material, the leaves were ground and successively Soxhlet extracted with hexane for 3 h and 80% aqueous ethanol for 6 h. The alcoholic extract was concentrated under reduced pressure at 25 °C, and reconstituted with 30% ethanol in water.

Olive leaves or placebo tablet was taken once daily orally throughout the study. All subjects continue their stable treatment to diabetes.

Data were analyzed using SPSS v10.0 (SPSS Inc., Chicago, USA). Continuous data were described a mean ± standard deviation and compared by treatment assignment using the t-test for independent samples. Associations between continuous variables were described by calculating the Pearson's correlation coefficients. Nominal variables such as sex and treatment assignment are described using frequency counts and compared by treatment assignment using the chi square test (exact as appropriate). All tests are two-sided and considered significant at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* adults
* type 2 diabetes

Exclusion Criteria:

* type 1 diabetes
Botox vs Occlusal Splint for Masseter Pain

This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years old;
* at least 20 teeth in the mouth;
* occlusal stability;
* presenting pain in face muscles.

Exclusion Criteria:

* Angle's Class III
* Kennedy's Class II or I removable partial denture wearer;
* Complete denture wearer;
* Individuals that have taken any anti inflammatory drugs in the last 3 months;
* Individuals with temporomandibular joint disorders.
HIV and Hepatitis Care Coordination in Methadone Treatment

This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).

In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age
* be able to provide informed consent
* agree to participate in hepatitis/HIV intervention
* expect to be available to participate in the study for the entire duration of the study
* HCV negative, of unknown HCV status, or have not received any previous medical care for HCV

Exclusion Criteria:

* have already had a formal hepatitis C evaluation
* are obtaining medical care for hepatitis C
* not interested in obtaining medical care for hepatitis
Naltrexone for Overdose Prevention

The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are:

What are the challenges for implementing naltrexone as an overdose prevention strategy?

Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants?

How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids?

Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other.

Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

This pilot randomized controlled trial aims to evaluate the efficacy of IM naltrexone for opioid overdose prevention among individuals living with HIV (PWH) and those at risk for HIV who use stimulants. The study will concurrently collect data on the feasibility, acceptability, and preliminary effectiveness of the intervention, along with epidemiological data on the prevalence of both intentional and unintentional fentanyl exposure in this population.

Participants will be randomly assigned in a 1:1 fashion to either the intervention group, which will receive IM naltrexone, or the usual care group, which will be provided with safe consumption supplies and intranasal naloxone.

Monthly assessments over a 24-week period post-intake (followed by a final study visit at 32 weeks) will be conducted to measure participants' exposure to fentanyl/opioids, utilizing both short-term (urine) and long-term (hair) biomarkers, as well as self-reported data. Adherence to the monthly IM naltrexone injections and the safety profile of the 'opioid PrEP' will also be rigorously evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. at-risk for HIV or living with HIV
2. stimulant use disorder (by DSM-V) or positive urine drug test for cocaine, amphetamine, or methamphetamine in last 6 months AND report at least 10 days of stimulant use/month,
3. able to provide informed consent,
4. English-speaking,
5. age 18 years old or greater.

Exclusion Criteria:

1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by DSM-V),
2. receipt of long-acting injectable naltrexone for other indications in past 30 days,
3. planned surgery in next 6 months,
4. moderate, severe or chronic liver disease (AST, ALT ≥ 5 times the upper limit of normal or symptoms of current liver disease),
5. persons who are pregnant or breastfeeding,
6. increased risk of bleeding (thrombocytopenia \<50 x 109/L, coagulopathy, or therapeutic anticoagulation), or
7. known hypersensitivity to naltrexone or its diluents.
Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block

The goal of this observational study is to assess the size and location of cutaneous sensory block area after dual laparoscopic assisted transverse abdominis plane block (L-TAP) with ropivacaine in patients undergoing laparoscopic cholecystectomy.

L-TAP is applied as a medial subcostal infiltration between midclavicular and central sternal lines and a lateral subcostal infiltration between midclavicular and anterior axillary line bilaterally.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective laparoscopic cholecystectomy in a day surgery setting
* able to give oral and written consent

Exclusion Criteria:

* prior surgery to the upper abdominal wall
* known sensory deficits of the abdominal wall or thorax
* allergy to local anesthetics
* pregnancy
Sleep, Awake & Move - Part II

Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by Parkinson's Disease (PD) after sleep and before taking their first dose of dopaminergic medications. The aim of this study is to test the hypothesis that objective and/or subjective improvement of motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at awakening from this sleep phase.

The "Awake \& Move" study is the second part of the Sleep, Awake \& Move project. This study will be conducted in a subgroup of unselected, consecutive patients having completed the part I of the Sleep, Awake \& Move project (i.e. the "Sleep \& Move" study). The investigators plan to explore the carry-over effect of REM sleep on motor function in a subgroup of PD subjects p. In this interventional study the investigators expect to induce SB by awakening the subjects from nocturnal REM sleep in a sleep laboratory setting, but not from Non-Rapid Eye Movements (NREM) sleep (control intervention).

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria of idiopathic Parkinson's disease (UKPDBB)
* Mild to moderate disease (Hoehn \& Yahr score ≥ 1 and \< 3)
* Mentally and physically capable to give informed consent
* Stable antiparkinsonian and psychotropic therapy for the last 30 days

Exclusion Criteria:

* Atypical parkinsonian syndrome
* Cognitive impairment (MMSE ≥ 26)
* Deep brain stimulation
* History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
* Psychiatric disorders, excepting mild depression
* Alcohol abuse
* Other clinically significant severe concomitant disease states
* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.)
* Participation in another study with investigational drug within the 60 days preceding and during the present project.
* subjects with (a) sleep-disordered breathing \[Respiratory Disorder Index (RDI)≥ 5\] and (b) with no clear-cut distinction of REM and NREM sleep, based on a video-polysomongraphical recording.
Study of Treatment and Metabolism in Patients With Urea Cycle Disorders

RATIONALE: The urea cycle is the process in which nitrogen is removed from the blood and converted into urea, a waste product found in urine . Urea cycle disorders are inherited disorders caused by the lack of an enzyme that removes ammonia from the bloodstream. Gene therapy is treatment given to change a gene so that it functions normally. Studying the treatment and metabolism of patients with urea cycle disorders may be helpful in developing new treatments for these disorders.

PURPOSE: Two-part clinical trial to study the treatment and metabolism of patients who have urea cycle disorders.

PROTOCOL OUTLINE: This protocol involves 2 clinical studies. Part A is a metabolic study of glutamine conversion to urea at different levels of protein intake, while on and off medications. Part B is a dose escalation study of a first-generation adenoviral vector with an E1 deletion and an E3 deletion substitution (d1309) expressing ornithine transcarbamylase (OTC).

In Part A, diet is controlled for protein and calories. Intravenous glutamine and urea are administered. Controls are given intravenous arginine, phenylacetate, and benzoate.

In Part B, groups of 3 patients are given a single low, intermediate, or high dose of intravenous OTC vector. Allopurinol is administered every 12 hours for 12 days. As of 12/10/1999, Part B of the study is closed.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Part A. Patients at least 6 months old with ornithine transcarbamylase deficiency (OTC), i.e.: Hemizygous OTC or homozygous autosomal recessive disorder with evidence of complete enzyme deficiency Hemizygous OTC male with late presentation and presumed evidence for residual enzyme activity OTC heterozygotes (molecular diagnosis) with severely symptomatic to asymptomatic disease Obligate heterozygotes for autosomal recessive disorder (parent or genotyped sibling) Normal adult volunteers and genotyped siblings entered as controls Part B. Metabolically stable heterozygous OTC females aged 18 to under 65 Orotic acid level at least 5 times normal on allopurinol Symptoms ranging from severe to asymptomatic acceptable No prior hospitalization for hyperammonemia Exclusion criteria (Parts A and B): Acute or chronic intercurrent illness Pregnancy Acute hyperammonemia
DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function

The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 years of age or older
* Have a documented EF value ranging from 25% to 40%
* Have been scheduled to undergo or have undergone a cardiac MRI study

Exclusion Criteria:

* Severe valvular dysfunction
* Inability to remain supine for 30 minutes
Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site

The aim was to compare the rate of teeth movement into fresh and old extraction sites.

Trial design: Randomized controlled clinical trial with a split mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.

Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper.

The rate of extraction space closure in the lower arch was assessed monthly.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years
* Proclined upper and lower incisors (Ui/max \>115 o, Li/mand \>99o)
* Mild upper and lower arch crowding (\<4mm) or no crowding
* Need for upper and lower first premolars extraction
* Skeletal I malocclusion (1\<ANB \<5)
* Average lower facial height and maxillomandibular plane angle (22 o \<MM\<32 o)
* Class I canine relationship
* Good oral hygiene and healthy periodontium

Exclusion Criteria:

* Poor oral hygiene
* Diseases and medications that were likely to affect bone biology
* Previous orthodontic treatment
* Evidence of bone loss
* Active periodontal disease
* Smoking
Spinal and Supraspinal Control in Chronic Ankle Instability

Ankle sprains are common sports injuries that often lead to chronic ankle instability (CAI). Patients with CAI experience deficits in neuromuscular control (NMC), including proprioception and strength. It is believed that damage to the ankle's ligament mechanoreceptors and the peroneal nerve after the initial ankle sprain can cause alterations in NMC, resulting in postural control and dynamic joint stability dysfunction. Inflammation related to recurrent ankle sprains may also contribute to neuromuscular impairments. Evidence suggests that bilateral postural control deficits occur after an ankle sprain, suggesting alterations in the central nervous system (CNS). Rehabilitation for CAI has been shown to lead to bilateral improvements in NMC, potentially due to neural alterations at both the spinal and supraspinal levels. Cross-education, which refers to the muscular crossed effect of unilateral training, has also been proposed as a mechanism for improving contralateral strength in neurologically healthy individuals. While the exact mechanisms underlying cross-education are not yet fully understood, evidence suggests that it involves neural adaptations at both spinal and supraspinal levels. This study aims to investigate the cross-education effect of a 6-week, unilateral balance training on corticomotor excitability, motor neuron pool excitability, and static and dynamic balance in athletes with chronic ankle instability.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being an athlete between the ages of 18-25,
* Being a player in a field team sport such as basketball, volleyball, and handball,
* Having a history of at least 2 significant grade II LAS diagnosed by a physician,
* Related inflammatory symptoms, "giving away" sensation, obtaining a score ≤25 from the Cumberland Ankle Instability Tool (CAIT),
* A score \<90% for the activities of daily living subscale and \<80% for the sport subscale from the Foot and Ankle Ability Measure,
* Recurrent episodes of LAS of the injured ankle which occurred within at least 12 months.

Exclusion Criteria:

* Acute injury of lower extremity musculoskeletal structures in the last three months,
* Orthopedic surgery in any of the lower extremities,
* Bilateral ankle instability,
* Vestibular or balance disorder
Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control, patterns of recurrence, freedom from treatment failure and overall survival. Correlations of physicians- and patients-assessed functional outcomes are planned.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven anal cancer without distant metastases
* indication for definitive chemoradiation therapy based on multidisciplinary evaluation
* age \>=18 years
* written informed consent
* ability to answer the standardized questionaires according to the treating physician

Exclusion Criteria:

* age \< 18 years
* prior systemic therapy with regard to anal cancer
* distant metastases
* second malignancy
Neural Correlates of Self

Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. This study aims to identify the neural correlates of self-consciousness in meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy participants combined with detailed first-person experiential accounts and behavioural tasks. This study will provide important clues about the widely reported effects of mindfulness meditation and hypnosis and shed light on the neural correlates of the conscious experience of self.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70
* Body mass index between 18.5 and 30
* Covered by health insurance
* motivated to participate
* signed informed consent
* normal or corrected-to-normal eyesight
* sufficient command of French to be able to follow the instructions

Exclusion Criteria:

* history of neurological or psychiatric conditions
* chronic pain or another medical condition altering pain perception
* use of medication that affects the central nervous system
* use of opioids or antidepressant medication
* severe auditory loss
* consumption of alcohol or intoxicants on the day of the experiments and the day preceding the experiments
* pregnancy, breastfeeding or having given birth \<6months ago
* any contra-indication to Magnetic Resonance Imaging (metal implants or foreign bodies), agitation, claustrophobia