cyrilzakka/clinical-trials huggingface dataset:
The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes

The aims of this study are two fold: To show whether there is an increased environmental or genetic susceptibility to stress in patients with T1D and whether it influences diabetes management. And to develop a strategy for the assessment and treatment of patients with T1D and an increased risk for development of psychopathology under stress.

Lately, a marked increase in the incidence and earlier age of onset of type 1 diabetes (T1D) has been noted. These observations could also be connected to an increased prevalence of stressful experiences and a lowered stress tolerance in some children.

The way a person responds to stress is determined by the interplay of genetic and environmental factors. Environmental experiences at specific times of development have been shown to shape individual's hypothalamic-pituitary-adrenal axis (HPA axis) stress response. It is known, that early development of central nervous system is critically dependent on child's interaction with the environment (experience dependent maturation), especially to the attachment to caregivers (most often the mother). Appropriate caregiving is connected to lower basal cortisol levels in children and a more stable HPA axis response after the exposure to stress. Any circumstances that disturbed the formation of the attachment to the primary caregiver (e.g. complications at delivery, psychosocial stressors affecting the mother or mother's postpartum depression) resulted in higher HPA axis responsiveness to stress in the affected children.

Changes in individual genes have also been shown to influence a person's susceptibility to stress and risk for the development of stress-induced psychopathology.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry
* Diagnosed with Type 1 DM prior to signature of Patient Informed Consent (PIC) (for the T1D group).
* Age between 8-15 years old (inclusive) at signature of PIC
* Treated by the investigator's centre prior signature of PIC (For the T1D group).
* Willing to undergo all study procedures

Exclusion Criteria:

* Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease)
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability).
Brain Imaging Technology to Examine the Effects of Meditation

The purpose of this study is to use brain imaging technology to identify the parts of the brain that are activated during meditation and to compare these parts to those activated during other activities. This study will also determine the effects of meditation on involuntary functions, such as breathing.

Meditation and relaxation-based interventions are becoming more widely accepted in clinical settings because of their low cost, low risk, and proven effectiveness as a complementary intervention in a wide range of diseases. Despite the success and growing use of relaxation-based treatments, few studies have addressed the basic mechanism by which these treatments work. This study will use functional magnetic resonance imaging (fMRI) to define the brain mechanisms underlying the meditative state, to differentiate this state from other states, and to determine how meditation-induced brain changes affect autonomic function.

Participants in this study will have an fMRI brain scan. Brain activity, breathing rate, and heart rate will be measured while the participant engages in three different activities: lying quietly, meditating, and mentally generating numbers.

Eligibility Criteria:
Inclusion Criteria:

* Daily practice of Vipassana or Kundalini meditation for at least 1 year and participation in at least one 1-week meditation retreat

Exclusion Criteria:

* Current medical or psychological illness
* Use of antidepressants, antianxiolytics, or compounds that alter cerebral blood flow
* Claustrophobia
* Pregnancy
Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, newborn to age 3 months
* Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of \>60 mEq/L or the identification of two detectable mutations associated with CF
* Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic
* Parent/guardian provides informed consent to participate in the study

Exclusion Criteria:

* Contraindications for obtaining oropharyngeal swabs
Estimation of Standard Liver Volume in the Indian Population

Estimation of liver volume is important for live donor liver transplant as well as extended liver resections. Computed tomography (CT) volumetry which is currently a gold standard for liver volumetry , is a time consuming process. A quicker method to estimate liver volume is essential. The aim of the present study is to try and formulate an equation based on patients height, weight etc to estimate liver volume.


Eligibility Criteria:
Inclusion Criteria: Patients undergoing CT scans

* Autopsy cases

Exclusion Criteria:

* Patients with hepatobiliary disorders Autopsy cases with liver disease or trauma
Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

The purpose of this study is to evaluate the efficacy and safety of Canadá association in the treatment of chronic pain


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
* Chronic pain during at least 3 months.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnacy and lactating participants;
* Known hypersensitivity to any of the formula compounds.
Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)

Surgery still remains the main treatment option for Non-Small Cell Lung Cancer (NSCLC) which is limited within the lung parenchyma and possibly invades the intrapulmonary or hilar nodes. The role of surgery in locally advanced NSCLC with the form of invasion of adjacent strictures or mediastinal nodes is a 30-year point of discussion and debate among thoracic surgeons, clinical and radiation oncologists, chest physicians and other related specialties. Despite the continuous debate the management of locally advanced NSCLC varies between different countries and different institutions.We try to investigate the short and long term outcomes of surgery after induction treatment performed for locally advanced NSCLC.

All patients who underwent surgery with curative intent or salvage after induction treatment during a 8-year time period (2011-2019). Induction treatment with the form either of chemotherapy or chemoradiotherapy was delivered according to the thoracic multidisciplinary team decision which it was based on primary tumor histology and stage. Patients with Pancoast tumors were excluded from the study design, because these tumors have different clinical characteristics and represent a separate category of NSCLC with a well recognized specific treatment plan worldwide.

Overall 42 patients are included in the study and the recorded parameters in each patient are:

1. Age, gender, comorbidities, histology, location in the lung and stage of tumor at presentation, tools used for preoperative staging in each case, any previous surgical procedures of other treatments performed before elsewhere, type of induction treatment, tools used for tumor restaging.
2. In each patient were recorded any specific technical details concerning the applied surgical procedures, time of surgery and one-lung ventilation (OLV), postoperative complications and their management, mortality, pos-resection staging (ypTNM), the number of resected lymph nodes in each patient.
3. Concerning the long term outcomes, overall and disease-free survival, kind of recurrence (local, distant, combination) and treatment of recurrences were recorded.

Interpretation fo the results will include the correlation of surgical details, kind and dose of induction treatment with postoperative complications, especially infectious complications and prolonged air leaks. Radicality of the resection and response of the tumor to induction treatment (ypTNM stage) as it is recorded in histology reports are the two important clinical parameters to be studied for their effect on long term survival and recurrences.

Surgery was applied as salvage surgery in not well responded tumors or as resection of downstaged tumors.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent surgery for NSCLC after induction treatment

Exclusion Criteria:

Patients who underwent surgery fo NSCLC located in the superior sulcus and Pancoast syndrome.
Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea

Excess drooling, or sialorrhea, is a chronic problem seen in pediatric patients with oral-motor dysfunction or neurodevelopmental abnormalities. Despite significant social and physical detriment from sialorrhea, an effective and safe treatment remains elusive.

The investigator's objective is to study the effect of sublingual ipratropium (an anticholinergic aerosol spray) on sialorrhea in the pediatric population

Method: A double-blind, randomized, placebo-controlled cross-over trial of sublingual ipratropium bromide application in pediatric patients with inappropriate drooling. Patients are recruited from the sialorrhea clinic and informed consent is obtained. Patients are randomized to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micrograms per metered dose) or matching placebo, every 6 hours up to a maximum of 4 times per day, in a double-blind, cross-over design using randomization tables. Total treatment length is two weeks for each limb of the study with a 2 week washout period. The primary outcome measure is the reporting of sialorrhea using a validated scales. Secondary outcome includes global assessment of treatment, patient satisfaction, and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 5-18 with a history of excessive drooling

Exclusion Criteria:

* known hypersensitivity to ipratropium bromide
* surgery for sialorrhea within one year
* the concurrent use of acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents
* botulinum toxin for drooling within the preceding six months
* a history of glaucoma
* the presence of clinically significant urinary retention or outflow obstruction as evidenced by patient history or documented urodynamic studies
Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation

Exclusion Criteria:

1. Previous spinal fusion surgery.
2. Morbid obesity (BMI \> 40)
3. Diagnosis of spinal metastatic cancer
4. Allergy to an amide local anesthetic or morphine sulfate
5. History of renal dysfunction, liver dysfunction or congestive heart failure
6. History of substance abuse disorder.
7. Chronic opioid use.
Rapid Renal Sympathetic Denervation for Resistant Hypertension II

This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
* Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion Criteria:

* Renal anatomy unsuitable for treatment
* Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
* Patient has Type I diabetes
* Has scheduled or planned surgery within the next 6 months
* Individual is pregnant nursing or plans to be pregnant
Decision Making in Video Games

The purpose of this study is to determine whether anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex induces approach motivation, and whether anodal tDCS applied to the right dorsolateral prefrontal cortex induces avoidance motivation. This study consists of three experiments: one in which an approach/avoidance video game is validated, one in which the effect of anger and fear on approach/avoidance is studied, and one in which the effect of tDCS is studied. Only the experiment in which the effect of tDCS is studied involves tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Normal hearing and vision

Exclusion Criteria:

* Left-handedness
* History of seizure, head injury (including neurosurgery), brain injury, diagnosis or a neurological or psychiatric disorder, metal in the head, sensitive scalp
* History of anxiolytic and/or antidepressant medications
* Participation in Experiment #1 or Experiment #2 of the larger study
Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease

Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98% of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors that may predispose to acquisition of LD are well known. Some studies suggest that genetic factor may also enhance susceptibility to LD.

The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and therapeutic management of patients. Few prospective studies have assessed the factors associated with LD outcomes, particularly death, and most of them involved a limited number of patients.

In a multicentre cohort study, the investigators recently identified risk factors associated with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein level (PMID: 22005914). Other factors are suspected but their involvement has not been formally demonstrated including a high infectious bacterial load, particular virulence of Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics. Disease progression is highly variable from one patient to another, and usually remains unpredictable. There are no objective criteria to predict the prognosis of these patients.

The clinical course of patients with LD remains difficult to predict because no predictive biomarkers have yet been characterized and the demonstration of the presence of mutants to antibiotics in vivo has never been done.

The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ Dysfunction).

Secondary objectives are to identify new host and bacterial biomarkers associated with poor outcome of LD.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with medical and biological signs of legionnaires' disease.
* Pediatric patients regardless of age but with a minimum weight of 7.5 kg with medical and biological signs of legionnaires' disease.
* Patient and/or his/her legal representative have reviewed the patient information/informed consent form and have given written informed consent.

Exclusion Criteria:

* None Legionella pneumophila Legionnaires' disease.
* Patients for whom respiratory secretions can't be obtained.
* Cases diagnosed only by serology.
* Outpatients.
BiomeBakery Project

This study aims to investigate the chronic effects of prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy adults aged 60-75 years with mild to moderate subjective cognitive complaints.

This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of an 12 week prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints.

Seventy four participants will be randomised (1:1 ratio, matched by age, sex, and fibre intake) to Intervention or Placebo groups where they will be consuming a prebiotic fibre-fortified functional bakery product (containing 10g prebiotic fibre/day) or a regular bakery product (containing 0g prebiotic fibre/day), respectively, for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, immediate and delayed verbal memory, executive functions; affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; inflammatory measure of high sensitivity C-reactive protein (hs-CRP); metabolic measures of lipid profiles (total-C, LDL-C, HDL-C, triglycerides), Hemoglobin A1c (HbA1c) and systolic and diastolic blood pressure; and anthropometric measures of height, weight, hip and waist circumference.

Eligibility Criteria:
Inclusion Criteria:

* Aging between 60-75 years old
* Having normal vision and hearing
* Having a normal body mass index (BMI\<30)
* Having mild to moderate subjective cognitive complaints
* Consuming bread (5 or more times a week)

Exclusion Criteria:

* Smoking
* Having food allergies
* Following restrictive and/or unbalanced diets
* Changing dietary intake majorly in past month
* Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
* Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
* Being anaemic
* Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
* Currently consuming prebiotic or probiotic supplements
* Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
* Continuous use of weight-loss drug for \> 1 month before screening
* Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
* Having a high fibre intake defined as \> 20g of fibre/day
* Wheat and/or gluten intolerance and having coeliac disease
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:

1. To determine whether the use of electronic reminder system increases adherence to topical agents.
2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
4. To obtain subjects' feedback on the adherence monitoring and reminder system.

We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Capable of giving informed consent
* Have a cellular phone capable of receiving text messages.
* Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Non-English speaking individuals