cyrilzakka/clinical-trials huggingface dataset:
CoolSculpting the Upper Arm Study

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.

This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form.

Exclusion Criteria

* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
* History of prior surgery in the arms.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 5 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements.
* Currently enrolled in a clinical study of any other unapproved investigational drug or device. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial

Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.


Eligibility Criteria:
Inclusion Criteria:

* ureteral or renal stones \< 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
* stone-free procedure and absence of intraprocedural complications
* WHO performance status 0-2

Exclusion Criteria:

* significant residual fragments at the end of the procedure
* intraprocedural complications (e.g. ureteral damage or stricture)
* indwelling double J stent
* acute kidney failure
* urinary tract infection
* urinary tract abnormalities
* pathologies or medications potentially influencing voiding pattern and pain perception
Outcomes of Acute Kidney Injury in Critically Ill Patients

this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units.

Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill . Depending on severity, Acute kidney injury (AKI) contributes to short-perimortality rates between 40% and 70% , and survivors are at increased risk for chronic kidney disease (CKD) and late death.

The diagnosis of Acute kidney injury (AKI) is only considered after achieving an adequate status of hydration and after excluding urinary obstruction; Acute kidney injury (AKI) is defined by the sudden decrease (in 48 h) of renal function, defined by an increase in absolute serum creatinine of at least (0.3 mg/dL) or by a percentage increase in serum creatinine ≥50% (1.5× baseline value), or by a decrease in the urinary output (documented oliguria \<0.5 mL/kg/h for more than 6hours).

The purpose of this study was to benchmark the outcomes of acute kidney injury in a critically ill surgical patients.We hypothesized that renal dysfunction in this population is common and is associated with a significantly higher burden of morbidity, mortality, and resource utilization

Eligibility Criteria:
Inclusion Criteria:

• All patient with acute kidney injury in critical care units in Luxor international hospital

Exclusion Criteria:

* Patients on chronic dialysis
* Previous acute kidney injury
* Nephrectomy
* Organ transplant
* Chronic kidney disease
Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

This is a randomized controlled clinical trial performed in urban primary care centers in Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age in the improvement of lifestyles, body composition, quality of life, cognitive performance and daily life activities.

* Objective: To evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age.
* Design and setting: A randomized clinical trial of two parallel groups. Population: 140 participants over 65 years of age will be included, selected by consecutive sampling in primary care centers of Salamanca (Spain.
* Measurements and intervention: Lifestyles (physical activity, sedentarism and mediterranean diet), body composition, health-related quality of life, cognitive performance and daily life activities will be evaluated at 3 months. The advice on healthy diet and physical activity recommendations will be common to both groups. The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Age between 65 and 80 years

Exclusion Criteria:

* Cardiovascular disease
* Moderate or severe chronic obstructive pulmonary disease.
* Musculoskeletal disease that limits ambulation.
* Severe mental illness
* Score in the Mini-mental \<24 points.
* Oncological disease in treatment.
Glutaminergic Transmission in Autism : Molecular Imaging Exploration

Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Male
* Between 18 years-old and 45 years-old
* Informed, written consent obtained from patient or his representant
* Subject with an affiliation to French social security
* For autistic patient : patient with diagnosis of ASD (Autistic Spectrum Disorders) following DSM-IV or DSM-5 criteria with recommended tools (ADI-R and/or ADOS)
* For FXS patient : diagnosis of FXS and confirmation of total mutation of FMR1

Exclusion Criteria:

* Contraindications to MRI
* Excessive use of alcohol or drug, or addiction to alcohol or drug during last 6 months
* Any unstable or uncontrolled disease, clinically significant
* Participation to an other experimental protocol with drug or irradiant exam
* Person under exclusion period because of previous participation to an other experimental protocol
* Person under temporary guardianship
* Forbidden treatments : any psychotropic treatment for 4 last weeks before PET exam and changing durably glutaminergic transmission directly or undirectly
* For healthy subjects : adult under guardianship, medical history of central nervous system disease, medical history of attention deficit hyperactivity disorder, past or present psychiatric or neurologic disorder (MINI DSM-IV)
Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

In recent years, fasting or the use of special diets (ketogenic, high protein, etc.), whether or not associated with food supplements, have increased substantially, particularly in oncology with the idea of improving for some of them, the tolerance of the proposed treatments, in particular emetogenic chemotherapy, or even to improve the prognosis. Although there are preclinical data on cell cultures and in rats, the clinical data supporting these practices are very fragmented, with few trials carried out and only including small cohorts, mainly in the context of breast cancers. It is therefore very difficult to respond objectively to patients asking the question of the merits of these changes in dietary practices in the management of their cancer.

The investigators want to carry out an inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. This semi-quantitative self-administered survey (answers in never / sometimes / regularly / systematically) was developed by the nutrition and radiotherapy team of the Georges-Pompidou European Hospital because there was no validated medical questionnaire on fasting or the use of special diets in oncology


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented inoperable stage III non-small cell lung carcinoma (no metastasis)
* Treatment with curative intent including thoracic radiotherapy and at least one cycle of concomitant chemotherapy
* Patient informed and having signed the consent

Exclusion Criteria:

* Sequential radiochemotherapy
* Metastatic forms from the outset
* Ear, nose, and throat (ENT) or digestive pathologies interfering with normal oral nutrition
* Other concurrent or pre-existing cancer for less than 5 years at the diagnosis of bronchial cancer
* Patient under guardianship or curatorship
* Patient with cognitive impairment
* Patient not affiliated with a social security
* Patient under state medical help from french government
* Radiotherapy performed outside the AP-HP for cohort A and outside the HEGP for cohort B
Articaine Efficacy and Safety for Children Below Age of 4-years

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

* The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0804 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients, ages 18 years or older
* Is expected to require ≥4 days of IV antibiotic therapy
* Has an acute complicated skin and skin structure infection with findings of systemic inflammatory response
* Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Has received an investigational drug within past 1 month
* Has been previously enrolled in this protocol
* Has received \>24 hr of a potentially effective systemic antibiotic immediately prior to study drug
* Is nursing
Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging

Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (\>70 years) and has been recently recognized as a geriatric syndrome. The main features of OD are: a high prevalence and severe complications either related with the decreased swallowing efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50% prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of mortality rate. However, there is no specific pharmacologic treatment for OD in older patients yet. Treatments are now evolving from compensation to active treatments aiming to restore the swallowing dysfunction and some groups have been looking for new therapeutic strategies. The main goal of this study is to evaluate the effect of administering menthol in bolus on the swallowing response in elderly and neurogenic patients with OD. In addition, this study will also assess the side effects of this pharmacological strategy.


Eligibility Criteria:
Inclusion Criteria:

* patients with suspicion of OD associated with aging (\>70 years), neurodegenerative diseases or stroke.

Exclusion Criteria:

* Patients with suspicion that they will not be able to compliment the protocol, patients participating or have participated in a clinical study the last 4 weeks and patients with alcoholic or drugs dependence
Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Spin-lock MRI for Steatohepatitis Assessment

Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age.
* Non-alcoholic fatty liver disease (NAFLD) patients at stage of either Non-alcoholic steatohepatitis (NASH) or simple steatosis
* NAFLD patients scheduled to undergo liver biopsy.
* No abnormal lesions detected at baseline MRI exam for healthy volunteers.

Exclusion Criteria:

* Evidence of hepatocarcinoma (HCC) or any other types of neoplasm.
* Patients who had undergone liver transplantation.
* Any contraindications to either liver biopsy or MRI scan.
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain

This study is to see if applying green and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

It is the goal of this single (active) group study to evaluate the efficacy of the Erchonia® GVL which simultaneously emits both green (520 nano-meter (nm)) and violet (405 nm) diodes, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Eligibility Criteria:
Inclusion Criteria:

* Subject presents with one or more of chronic neck or shoulder pain.
* Subject is diagnosed with of one or more of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain.
* Pain is chronic, having persisted for longer than the past 30 days
* Self-reported Pain rating on the 0-100 Visual Analog Scale (VAS) of 50 or greater.
* Willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation.
* Willing and able to refrain from engaging in any non-study procedure therapies throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture
* 18 years of age or older

Exclusion Criteria:

* Current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia
* Use of analgesics or muscle relaxants within 7 days prior to study procedure administration.
* Use of systemic corticosteroid therapy (inhaled and topical corticosteroids permitted), narcotics or Botulinum toxin (Botox®) injection in the neck/shoulder region within 30 days prior to study procedure administration.
* Active cancer or treatment for cancer within the last 6 months.
* Unstable cardiac disease, such as recent cardiac arrhythmia, congestive heart failure or myocardial infarction.
* Prior surgery to the neck/shoulder region.
* Known herniated disc injury.
* Active infection, would or other external trauma to the areas to be treated with the laser Medical, physical or other contraindications for or sensitivity to light therapy.
* Serious known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
* Pregnant or breast feeding.
* Participation in a research study within the past 30 days.
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.


Eligibility Criteria:
Inclusion Criteria:

1. Severe motor impairment
2. Able to give consent
3. Appropriate candidate for neurointerventional procedure
4. Able and willing to access all clinical testing and not impeded by geographical location
5. Proficient in English
6. Have a study partner

Exclusion Criteria:

1. Active condition resulting in immunosuppression
2. Unsuitable for general anaesthetic
3. Anaphylactic allergy to contrast media
4. Allergy to nickel
5. History of pulmonary embolism
6. History of recent deep vein thrombosis
7. Psychiatric or psychological disorder
8. No study partner or caregiver
9. Unable to provide evidence of COVID vaccination
Effectiveness Study of Individual Online Treatment for Cybersex Addiction/Online Sexual Compulsive Behavior Disorder

Cybersex addiction, understood as a subtype of Internet addiction or a manifestation of Compulsive Sexual Behavior Disorder, is a growing phenomenon. Recent studies developed by our research group have revealed that about 10% of young people in Spain could be at risk of suffering or already suffer from this problem, which can lead to consequences beyond the addiction or compulsive behavior itself, such as low self-esteem, emotional problems, sexual dysfunction, infidelity, breakups, social isolation, development of paraphilias, increase of risky sexual behavior, problems with the law, etc.. Although some studies have been carried out so far, especially on the prevalence and characterization of the sociodemographic and psychological profile of people with this disorder, psychological intervention programs for this problem have hardly been developed, and studies on the effectiveness of such programs are very scarce. Furthermore, seeking psychological help for people with this type of problem is infrequent due in part to the stigma associated with sexual addictions. In this sense, e-health approaches can reach a potential audience of users who would not access treatment if they had to physically visit a clinic. For this reason, the present project seeks to evaluate the efficacy of an online intervention aimed at the treatment of cybersex addiction or online sexual compulsive behavior disorder in the general population. For this purpose, a sample of 100 patients with a risk or pathological profile will be randomly assigned to an experimental (n=50) or control group (n=50) with similar characteristics. All of them will undergo an online assessment. The experimental group will receive an individualized online program of twelve one-hour sessions. The study will be based on an experimental design of comparison between groups (experimental-control) with pretest-posttest-follow-up evaluation at 1 month, 3 months, 6 months and 12 months, to evaluate the efficacy of the intervention. For this purpose, descriptive and differential statistical analyses (t-tests and repeated measures ANOVA), Cohen's d test for effect size and regression analysis will be performed.

Principal Investigator: Rafael Ballester-Arnal (Universitat Jaume I of Castellón, Spain)

Eligibility Criteria:
Inclusion Criteria:

* online sexual compulsive behaviors, and may or may not also have other offline sexual compulsive behaviors
* any gender or sexual orientation
* minimum score of 9-18 points on the Internet Sex Screening Test (ISST) of Delmonico (1997) in the Spanish adaptation of Ballester, Gil, Gómez and Gil (2010)

Exclusion Criteria:

* coocurrence of psychotic symptoms, cognitive impairment, or other serious mental conditions