louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00282139: Aripiprazole in the Treatment of Tourette's Syndrome
Official title: Aripiprazole in the Treatment of Tourette's Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tourette's Syndrome
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.

Detailed description: This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.

Eligibility criteria: Inclusion Criteria:

DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder;

"Moderate" severity as reflected on the CGI or the YGTSS;

Normal ECG; and,

Written informed consent/assent.

Exclusion Criteria:

Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence);

Subjects who are pregnant or nursing women;

Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold;

Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified;

Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months);

Subjects with known allergy or hypersensitivity to aripiprazole;

Subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication;

Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG, or laboratory tests; and,

Subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.

Primary outcomes:
measure: Global improvement in severity of symptoms (tic behaviors)
Secondary outcomes:
measure: Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Tanya K Murphy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276039: Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus
Official title: Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Alcoholic Fatty Liver Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 adult Egyptian patients collected from Gastroenterology Unit, Internal Medicine, and Tropical Medicine Departments, were included. Additionally, 20 apparently healthy subjects were included as the control group. They were classified into three groups: Group I: included 25 patients with NAFLD diagnosed by radiological features and by exclusion of other causes of fatty liver.

Group II: included 25 patients with radiological features of NAFLD and laboratory evidence of chronic hepatitis C viral infection (positive PCR).

Group III: included 20 apparently healthy control subjects with negative medical history, normal physical examination, and normal laboratory and radiological examination.

Brief summary: This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.


Eligibility criteria: Inclusion Criteria:

* Patients with NAFLD.
* Patients with NAFLD and chronic hepatitis C viral infection.

Exclusion Criteria:

* Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively.
* Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids.
* Patients who take statins as it has lowering effect on plasma PTX3.
* Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal.
* Patients with heart failure.
* Patients with autoimmune rheumatic disease.
* Patients with chronic kidney diseases.
* Patients with sepsis.

Primary outcomes:
measure: Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06125639: Effects of Sauna Bathing on Sleep, Mood and Stress
Official title: Effects of Sauna Bathing on Sleep, Mood and Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2023-11-09
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sauna bathing is a popular, low-cost, and easily accessible type of whole-body thermotherapy that has been used for social, religious, health, and hygienic reasons for thousands of years. There is strong evidence to support the various physiological and psychological benefits of sauna bathing. The positive effects of regular sauna use have been explained by a number of mechanisms of action, including increased cardiac output, reduced peripheral vascular resistance and other physiological changes in cardiovascular parameters such as decreased systolic and/or diastolic blood pressure. Additionally, the psychological impact of sauna bathing may occur due to a combination of factors that include the release of endorphins, relaxation, placebo effects, and psychological and social interactions that likely occur around frequent sauna activity. Taken together, it is possible that acute and regular sauna bathing may impact sleep quality.


Eligibility criteria: Inclusion Criteria:

* good general health assessed by physician
* written consent to participate

Exclusion Criteria:

* medication or dietary supplements, which could potentially impact the study outcomes
* history of sleep or neurological disorders
* regular sauna use
* professional athlete
* shift worker

Primary outcomes:
measure: Objective Sleep - Time in bed
timeFrame: 5 weeks
measure: Objective Sleep - Sleep-onset latency
timeFrame: 5 weeks
measure: Objective Sleep - Total sleep time
timeFrame: 5 weeks
measure: Objective Sleep - Light sleep
timeFrame: 5 weeks
measure: Objective Sleep - Deep sleep
timeFrame: 5 weeks
measure: Objective Sleep - REM sleep
timeFrame: 5 weeks
measure: Objective Sleep - Sleep efficiency
timeFrame: 5 weeks
Secondary outcomes:
measure: Subjective Sleep Quality assessed by Karolinska Sleep Diary
timeFrame: 5 weeks
measure: Stress level assessed by VAS scale
timeFrame: 5 weeks
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: baseline, after 1,3,6,9 sauna bathing, after 5 weeks
measure: Mood
timeFrame: baseline, after 1,3,6,9 sauna bathing, after 5 weeks
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University School of Physical Education in Cracow
city: Kraków
country: Poland
facility: University School of Physical Education in Cracow
Study officials:
References:
Clinical trial NCT05302739: The Effects of Facial Cooling on Fencing Performance
Official title: The Effects of Facial Cooling on Physiological and Perceptual Responses During Simulated Competition in Male Epee Fencers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperthermia
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Fencing competitions can last between nine and eleven hours, during which athletes wear layers of protective equipment that impair evaporative heat transfer and spend a large amount of time at exercise intensities \> 85% maximum heart rate. Fencing performance can potentially contribute to heat stress due to increases in core temperature. Elevated core temperatures could hamper performance, and therefore the implementation of a strategy to reduce core temperature increases could lead to augmented fencing performance. Cooling methods are limited for use between fencing matches and during short breaks within a direct elimination match. Furthermore, due to multiple layers of thick protective equipment cooling method applications are limited primarily to the facial area. A potential cooling strategy, during fencing competition, includes the utilization of a water facial mist spray combined with fanning of the face. Therefore, the aim of this study is to investigate the novel use of facial cooling on core temperature, relevant physiological parameters, perceived exertion and thermal comfort and sensation during a simulated fencing competition performance, in male epee fencers.


Eligibility criteria: Inclusion Criteria:

* Trained fencers

Exclusion Criteria:

* Injured or a contraindicative medical condition

Primary outcomes:
measure: Tympanic temperature
timeFrame: From baseline to completion, up to 31 days
measure: Heart rate
timeFrame: From baseline to completion, up to 31 days
measure: Blood lactate concentration
timeFrame: From baseline to completion, up to 31 days
measure: Thermal comfort
timeFrame: From baseline to completion, up to 31 days
measure: Thermal sensation
timeFrame: From baseline to completion, up to 31 days
measure: Rating of perceived exertion of the dominant arm
timeFrame: From baseline to completion, up to 31 days
measure: Rating of perceived exertion of the legs
timeFrame: From baseline to completion, up to 31 days
measure: Rating of whole body perceived exertion
timeFrame: From baseline to completion, up to 31 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04479839: Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.
Official title: Senior Atending Anesthesiologist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube
Cricoid Cartilage
Ultrasound
Lead sponsor: Sidra Medicine
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 71
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 children from birth to 7 years, scheduled for the surgery requiring endotracheal intubation

Brief summary: Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.

Detailed description: Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing general anesthesia requiring endotracheal intubation

Exclusion Criteria:

* Patients with any anatomical airway deformity or mass

Primary outcomes:
measure: Visualize the saline-filled cuff of the endotracheal tube
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Sidra Medicine
Study officials:
affiliation: Attending physician
name: Tariq Wani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06561139: Mindfulness as an add-on Intervention in Treatment for Problem Gambling in Clinical Settings in Sweden
Official title: Mindfulness as an add-on Intervention in Treatment for Problem Gambling - a Randomized Control Trial and a Qualitative Analysis in Clinical Settings in Sweden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problem Gambling
Keywords: Problem gambling
Mindfulness
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2024-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial, and subsequently a qualitative study
Primary purpose: TREATMENT

Brief summary: This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. The study will primarily aim to decrease gambling behaviour compared to the control condition which receives the intervention later, after two months, and secondarily to decrease symptoms of depressive and anxiety symptoms. In addition, patients who have undergone the mindfulness intervention will be offered participation in a qualitative interview study aiming to deepen the understanding of feasibility and challenges of a mindfulness add-on intervention against gambling problems.


Eligibility criteria: Inclusion Criteria:

* Enrolled in any kind of treatment for problem gambling at a regional health care unit for problem gambling or at any municipal social service unit for problem gambling, and who provides informed consent

Exclusion Criteria:

* Inability to provide informed consent due to language difficulties or due to severe mental health problems, or because of mental health problems requiring urgent psychiatric management (such as suicidal, homicidal, delirious or psychotic behavior)

Primary outcomes:
measure: Change in past 30-day gambling (NODS 30 days)
timeFrame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Secondary outcomes:
measure: Change in past-2-week depressive symptoms
timeFrame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
measure: Change in past-2-week anxiety symptoms
timeFrame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Center
Study officials:
References:
Clinical trial NCT01749839: Pain Relief by Platelet-rich Plasma (PRP) Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sciatica
Lead sponsor: Saint Bernard Mission University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Athlete community

Brief summary: Past PRP therapy is not sufficient for some part of patients.In this clinical research, The integrated application of PRP with extracellurar matrix and some type of stem cell technique.


Eligibility criteria: Inclusion Criteria:

* Injury by professional sports and non professional sports

Exclusion Criteria:

* Other basic disease holder

Primary outcomes:
measure: The Changes of Amounts of Pain Killer Consumed for Scheduled Term Before and After PRP treatment.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02310139: Failed/Difficult Colonoscopy Outcomes
Official title: Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For a small proportion of patients a complete colonoscopy is unsuccessful due to technical and physical reasons. This will be the study population which will be invited to participate in this study.

Brief summary: Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this removal is also known as polypectomy.

Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a tertiary centre with extensive experience in difficult colonoscopy or have an alternative test such as CT scan. The investigators unit has accumulated significant experience related to previously failed colonoscopy and anecdotally appears to have a high success rate in completing the procedure.

The purpose of this project is to describe the investigators technical approach to management of patients with previously failed colonoscopy. There is no additional intervention and the project is observational in nature. The investigators will collect data on patient characteristics, the reason for the failure and what technique was used to overcome the difficulty. The investigators will also note whether the final outcome of the technique had any impact on the overall management of the patient.


Eligibility criteria: Inclusion Criteria:

* Previously failed colonoscopy
* Referred to Westmead Endoscopy Unit for a complete colonoscopy
* 18 years or older

Exclusion Criteria:

* Younger than 18 years
* Previously successful colonoscopy
* No previous colonoscopy attempted

Primary outcomes:
measure: Description of reasons for failure of colonoscopy.
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917939: Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
Official title: Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Hippocampal Sclerosis
Keywords: Epilepsy
Hippocampal Sclerosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epilepsy patients with or without hippocampal sclerosis.

Brief summary: Epilepsy is a common neurological disease, manifested in the sudden abnormal discharge of neurons leading to short-term brain dysfunction, has become the neurology after headache the second most common disease. In China, the prevalence of epilepsy is about 4.7-8.5 per 1,000, and more than 400,000 new cases of epilepsy are developed each year. Of these, 30% of patients were treated with ineffective medication, developing into a drug-incurable epilepsy that required surgery and other treatments. The most common type of epilepsy is temporal lobe epilepsy, while the common complication in temporal lobe epilepsy is hippocampal sclerosis, which often requires surgical removal. The incidence of inner temporal lobe epilepsy associated with hippocampal sclerosis is increasing, but its exact cause and specific pathogenesis are still unclear, so clarifying its pathogenesis will contribute to the understanding of temporal lobe epilepsy and the improvement of surgical procedures. This study is intended to get single-cell transcriptome as well as spatial transcriptome data of temporal lobe and hippocampus samples. By studying gene expression change associated with epilepsy and hippocampus sclerosis, we intended to find possible prognostic-related molecules and to deepen understanding of pathological changes in epilepsy at the molecular level.


Eligibility criteria: Inclusion Criteria:

* Patients confirmed in our hospital as having temporal lobe epilepsy and intending surgery to remove temporal lobe and hippocampal tissue;
* Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign an informed consent form.

Exclusion Criteria:

* Chronic diseases of the central nervous system other than temporal lobe epilepsy;
* Other patients that are not suitable for this clinical trial determined by the researchers;

Primary outcomes:
measure: RNA sequencing data
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: 2nd Affiliated Hospital
role: STUDY_CHAIR
References: