cyrilzakka/clinical-trials huggingface dataset:
Influence of Microfiltered-seawater Supplementation and Variable Resistance Training in Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women

This study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women.

This study was a 32 weeks, double-blinded, randomized, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* (i) women aged ≥65years
* (ii) able to climb 10 stairs without pause and walk 100m without a walker
* (iii) score above 23 points in the mini-mental state examination
* (iv) \<1h of physical activity per week throughout the six months before the study
* (v) possess a medical certificate of aptitude to carry out physical activity

Exclusion Criteria:

Participants who had suffered:

* (i) any type of musculoskeletal, cardiovascular, hepatic, renal, pulmonary, neurological, or neuromuscular injury or disorder and/or
* (ii) taking any type of drug/supplement that may alter the results of the study (e.g., vitamin C, vitamin E, estrogens, beta-blockers, calcitonin, steroid hormones, etc.)
* (iii) changes in body weight of more than 10% in the year prior to the study
* (iv) have a severe hearing or visual impairment
* (v) participate in another research project (within the last six months) involving an exercise, dietetic and/or pharmaceutical intervention
Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer

The main objective of this study is to determine the feasibility of optimizing the IMRT treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the dental fillings to reduce such dose to \< 35 Gy without compromising tumor coverage and/or increasing the dose to the remaining oral cavity or nearby parotid glands.

Using radiation dosimeter, we will perform measurement of the doses received by the mucosa adjacent to the dental fillings in patients receiving IMRT for head and neck cancer. If the mucosa dose is estimated to be greater than 35 Gy for the entire radiation course, we will generate and implement a "filling" optimized IMRT plan, provided that this new plan does not compromise tumor coverage or increase dose to the rest of the oral mucosa or parotid glands. Dosimeter will be used to measure the mucosal dose delivered by this new IMRT plan. Patient's mucositis grade, narcotic use and self-reported mouth and throat soreness scores will be recorded and correlated to mucosal dose. We hypothesize that modulation of an IMRT plan to reduce the dose delivered to adjacent normal mucosa surrounding the dental filling can decrease the severity and duration of radiation-related oral mucositis. Here we propose to use thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT plan that is normally delivered in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HNC undergoing radiation therapy +/- chemotherapy at Stanford University
* At least 18 years old
* Metallic filling present
* Planned radiation dose to the tumor \> 60 Gy at 1.8 to 2.2 Gy/fx
* Able to understand and sign a written informed consent document.

Exclusion Criteria:

* Pregnant
* Nursing
Cognitive Enhancement in Bipolar Disorder

The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.

To address the primary aim, the study is an eight-week, randomized, double-blind, placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder (BPD) patients, who demonstrate cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and confirmed in the diagnostic consensus conference will be included.
* Subjects must also meet criteria for euthymia described above.
* All subjects must be taking a standard mood stabilizer at a stable therapeutic dose (i.e. lithium, carbamazepine, valproate, lamotrigine).

Exclusion Criteria:

* Subjects with a history of central nervous system (CNS) trauma, neurological disorder, Attention Deficit Hyperactivity Disorder (ADHD), or learning disability will be excluded.
* Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence (in the previous 1 month) will be excluded.
* Moreover, subjects with rapid-cycling during the past year will be excluded (based on SCID).
* Any subject with an active, unstable medical problem that may interfere with cognition will be excluded based on the investigator's judgment.
* While medication status is an important consideration in any study of bipolar disorder, the exclusion of patients taking any medication is not practical, given the high prevalence of combination pharmacotherapy for bipolar disorder. To help control for medication effects on cognition, we plan to limit the types of medications allowed by excluding certain medications with a known impact on cognitive performance.

  * Subjects taking clozapine will be excluded due to it's potential overlapping mechanisms of action with pramipexole.
  * Subjects taking prescription or over-the counter medications may also be excluded if these medications have been shown to impact cognition (i.e. diphenhydramine).
  * The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of neurocognitive testing will not be allowed. In addition, patients taking topiramate, tricyclic antidepressants, or anticholinergic medications that are known to impact cognition will be excluded from participation.
  * Subjects taking any medications that are known to interact with pramipexole (i.e. Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan, quinidine, selegiline, verapamil, and any other medication with a known interaction) will also be excluded.
App-based Intervention to Promote Mental Health Help-seeking Among University Students

It is estimated that approximately one in three university students has a mental health problem and between 5-10% have active suicidal ideation. Most college students do not receive professional treatment, which has been associated with structural and attitudinal barriers to help-seeking. Given that young people regularly use the internet to seek information about health problems, internet and digital technology-based interventions could represent an effective approach to overcome attitudinal barriers.

The goal of this study is to evaluate the feasibility of a mobile app-based intervention for the promotion of help-seeking in mental health services for university students at risk of suicide. The main questions it aims to answer are:

* Is it feasible to implement a mobile app-based intervention for the promotion of mental health help-seeking in a university context?
* Is it possible to increase the likelihood of help-seeking in mental health services among university students at risk of suicide through an app-based intervention?

Participants will receive a brief contact intervention (via phone call or chat) where they will be assessed by a clinical psychologist, receive information on available support services and instructions to download and use a mobile app called "Take Care of Your Mood". In addition, the participants can request a counseling session with a clinical psychologist. Participants will also receive reminder messages (by email and chat) motivating them to use the app or request a counseling session with a psychologist if they deem it necessary.

Researchers will compare this intervention with a brief contact intervention (control group) where participants will be assessed by a clinical psychologist, will receive instructions to download and use the app, but will not receive reminder messages or be able to access a counseling session with a psychologist.


Eligibility Criteria:
Inclusion Criteria:

* University students who have completed the Longitudinal Survey of University Student Mental Health (ELSAM), based on The WHO World Mental Health International College Student (WMH-ICS) initiative
* Suicidal ideation during the last 12 months
* Have access to Internet, email and Smartphone
* Agree to participate in the research through informed consent.

Exclusion Criteria:

* Currently undergoing mental health treatment (psychological or psychiatric)
* High suicidal risk during the last 30 days and/or 3 months \[answer "yes" to questions 4 and 5 (last 30 days) and/or question 6 (last 3 months) of the C-SSRS\]
A Prospective Study to Monitor Liver Diseases Dynamically by Ultrasound Viscoelasticity

The accuracy of ultrasound elastography for assessing liver fibrosis by measuring liver stiffness (elastic modulus) is better than traditional method. Elastography has certain advantage such as non-invasive, simple, real-time and it has been recommended by clinical guidelines.

However, some chanllenging scientific problems showed up with further research and clinical practice. Firstly, present elastography machines can only calculate liver stiffness from shear wave speed or elastic modulus but ignore other physical characteristics such as tissue viscosity. So far, present technique simply assume liver as an idealized model with isotropic elasticity to assess liver fibrosis while liver is actually anisotropic and viscoelastic. What's more, theoretically, there are not only different solid state structures such as cell organization and vessel but also flowing liquid such as blood and bile. Thus, ignoring viscosity and evaluating elasticity only is unreasonable. In the other hand, a number of confounding factors have been found to influence liver stiffness measurement by elastography. Different pathological chang of liver including inflammation, necrosis, cholestasis and inhomogeneity among the individuals such as obesity, ascites, et,al. will decrease the accuracy of liver stiffness measurement and liver fibrosis staging by elastography.

In fact, liver fibrosis is a dynamic process. Liver fibrosis is a reaction of compensation and repair for inflammation and necrosis as well as a contributing factor for liver damage. This dynamic process constitutes the common characteristic of chronic liver disease and result in the complicated biological mechanical characteristics of liver. In consequence, how to measure liver viscosity and elasticity respectively, and to evaluate liver fibrosis stage and Inflammation degree accurately during the complicated and dynamic pathological process is the key scientific problem demanding solution, which is also the urgent requirement of related fundamental research and clinical practice.

Therefore, this project plan to apply LOGIQ E viscoelastography machine as research tool, rat liver fibrosis model and rat liver failure model as research object to investigate the correlation between liver viscoelastography measurement and liver fibrosis stage and Inflammation degree. The investigators also aim to assess the feasibility of using ulstrasound viscoelastography to evaluate liver fibrosis stage and Inflammation degree dynamically.


Eligibility Criteria:
Inclusion Criteria:

* agree to have liver biopsy in later therapy
* agree to participate in our study

Exclusion Criteria:

* Hepatic malignant mass lesion
* After liver transplantation
* Pregnant patients
* Liver biopsy specimens do not meet the requirements: speciments length \<15mm, or numbers of the portal ducts \<6.
Transient Elastography and Variceal Bleeding

Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed
* Social security affiliation
* Variceal bleeding with hematemesis or melena within 24 hours of inclusion
* Age \> 18 years
* Scheduled to undergo endoscopy within 24 hours of hospital admission

Exclusion Criteria:

* Hepatocarcinoma
* Upper Gastro Intestinal bleeding for other causes than variceal bleeding
* Concomitant disease with a life expectancy of less than 45 days
* Rebleeding within 24 hours after first endoscopy
* Technical failure of transient elastography
Neutrophil Side Fluorescent Light (NEU-SFL) in COVID-19 Patients

Recently, a study showed that markers of neutrophil extracellular traps formation, a mechanism corresponding to neutrophil activation, were increased in patients who died of COVID 19 compared with survivors.

The investigators propose to analyze the NEU-SFL parameter, obtained automatically on the Sysmex™ blood count machine (Sysmex Corporation, Kobe, Japan) and which is considered as a reflect of neutrophil extracellular traps formation, in these two groups of patients. The aim was to evaluate whether this parameter could be used to predict the risk of death related to COVID 19.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for COVID 19 in 2021

Exclusion Criteria:

* Patients who refused the use of their data
Understanding Visual Confusion Using Stereoscopic Displays

In this research study we want to test how people understand a visual scene when the same image is presented to both the eyes, but portions of these images are altered in terms of contrast, depth or in some cases motion.


Eligibility Criteria:
Inclusion Criteria:

* Better than 20/40 visual acuity in the worse eye
* No restrictions of the peripheral visual field: (at least 60 degrees vertically and 40 degrees horizontally)
* At least 14 years of age (no upper age limit)
* Able to give voluntary, informed consent
* Able to understand English
* Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)

Exclusion criteria:

* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
* Being unable to complete sessions lasting 2-3 hours
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
* Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
* A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

* A history of asthma at or after 18 years of age
* A history of allergic rhinitis at or after 18 years of age
* Subjects taking oral steroids
* Any significant disease or disorder that may jeopardize a subject's safety
Compassionate Use of Vidutolimod

Provide Compassionate Use of Vidutolimob

Compassionate use is only available to patients who transitioned from a previous vidutolimod (CMP-001) study.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.


Eligibility Criteria:
Inclusion Criteria:

* Out-patients with Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria

Exclusion Criteria:

* Based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
* Based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
* Disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined criteria.
* Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
* Night shift workers and individuals who nap 3 or more times per week
* Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.

The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.

Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.

The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight 500 - 1,250 g
* On mechanical ventilation before 7 days of age
* First extubation before 14 days of age

Exclusion Criteria:

* Presence of lethal anomalies or upper airway abnormalities
* IVH, grade 3 or 4
* Neuromuscular disorders
* Receiving muscle relaxation at time of extubation
* Congenital heart disease, except for PDA
* GI problems resulting in a need to avoid gastric distension
The Effects of Virtual Colonoscopy on Intraocular Pressure

Our trial examined the intraocular pressure measurements differences, before and after virtual colonoscopy examination.

Glaucoma is a complicated disease in which damage to the optic nerve leads to progressive, irreversible vision loss. Glaucoma is the second leading cause of blindness and associated with elevated intraocular pressure (IOP) as a major risk factor.

IOP is influenced by many factors, including ethnicity, heredity, various chemical substances (existing body and external body like drugs), physical changes (postures, neural and vascular autoregulation) and more.

Virtual colonoscopy is a common screening test for the early detection and diagnosis of colon cancer. The test is performed by computed tomography (CT) after inflating the colon with carbon dioxide (CO2) gas. The procedure is performed by inserting a Foley catheter through the anus. As a result of gas inflating of the bowel, consequently, there is an increase in the abdominal pressure.

Raising intra-abdominal pressure may cause a rise in intraocular pressure. The aim of this research is to examine the changes in IOP before and after the virtual colonoscopy, with the aim to improve the understanding of the relationship between intra-abdominal pressure and IOP.

The study will include 100 patients, men and women, that are scheduled for virtual colonoscopy test both in a hospital and in ambulatory.

Eligibility Criteria:
Inclusion Criteria:

* Participants: men and women.
* Age ≥ 18 years.
* directed by a gastroenterologist to examine colonoscopy for diagnosing colon pathology (either screening, follow-up routine or after surgery).
* patients who want to participate which are able to understand and sign, an informed consent to participate in research.

Exclusion Criteria:

* Exclusion recruitment criteria:
* Family History of Glaucoma first-degree relatives.
* patients suffering from known eye diseases, except for refractive disorders, strabismus or amblyopia, and do not take any eye care on a regular basis.
* patients with a known allergy for Localin drops.
* patients who do not want to participate or are unable to understand or sign an informed consent to participate in research.

Exclusion criteria from the study:

* The researcher doctor may remove a participant from the study if he impressed, of strong health impairments resulting from the research.
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome

The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without androgen, has on growth.

Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal development, and increased learning problems. This study is designed to (1) examine the effects of sex steroids (androgen and estrogen) on multiple variables including growth rate, GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination versus each alone, on the above variables.

Eligibility Criteria:
* Karyotype diagnosis compatible with Turner syndrome, but no presence of any Y material in the peripheral karyotype unless a gonadectomy has been performed;
* Chronological age between 10.0 and 14.9 years;
* Bone age less than or equal to 12 years; and
* No treatment with estrogen, androgen, growth hormone, or any other growth-promoting agents exceeding 12 months, and no treatment with any of these agents in the previous 3 months.