louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02025686: Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
Official title: Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Inflammation
Hyperalgesia
Keywords: Pain
Inflammation
Hyperalgesia
burn injury
Hyperbaric Oxygen
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in humans induced by tonic heat stimulation. It has been shown in animal studies with rats that HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat stimulation in healthy subjects and promote future research and understanding of the anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary hyperalgesia after HBO.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yr Approved physical health examination Healthy Male

Exclusion Criteria:

* Arterial hypertension Chronic pain Claustrophobic tendency History of substance abuse Impaired cognitive abilities Inability to participate in quantitative sensory testing Incomplete understanding of Danish Neurological deficits Previous barotrauma or pneumothorax Previous head trauma Unable to equilibrate pressure in middle ear and/or sinuses

Primary outcomes:
measure: The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain on Pain Scores on the Visual Analog Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References:
Clinical trial NCT03258086: Vitamin D in Diabetic Children
Official title: Assessment of Vitamin D in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back, or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.

Vitamin D supplement is recommended in all infants until enough formula, milk, or other food sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type 1 diabetes is an autoimmune disease, and the self immune system plays a central role in the destruction of the beta cell of pancrease.


Eligibility criteria: Inclusion Criteria:

* Age (5 years - 15 years ).
* Type 1 diabetes patients.

Exclusion Criteria:

* Patients aged more than 15 years, less than 2 years.
* Type 2 diabetes.
* Neonatal diabetes.
* Patients with any complications from diabetes.

Primary outcomes:
measure: Assessment of vitamin D level (ng/ml)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT03280186: Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention
Official title: Measurement of Bladder Function Change In Patients With Spinal Vascular Malformations Before and After Surgical Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Vascular Disorder Nos
Neurogenic Bladder Dysfunction Nos
Keywords: Spinal Vascular Malformations
Bladder
Surgical intervention
Urodynamics
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators goal is to create a better understanding of patient with SVMs reported outcomes for bladder management strategies before and after surgery.

Detailed description: Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. However, no study show the relationship of the SVMs and bladder function. The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies before and after surgery.

Eligibility criteria: Inclusion Criteria:

- patient diagnosed with spinal vascular diseases including intradural arteriovenous malformation, intradural arteriovenous fistula, dural arteriovenous fistula, extradural arteriovenous malformation, paravertebral arteriovenous malformation, paravertebral arteriovenous fistula, cobbs' syndrome, other spinal arteriovenous metameric syndromes involve the spinal cord. patient not received surgical or interventional treatment before patient with normal cardiac, renal and hepatic function patient capable of understanding the content of the patient information / Informed Consent Form patient willing and able to participate in the registry

Exclusion Criteria:

- patient received surgical treatment or interventional treatment before patient is pregnant patient allergic to iodine patient unable to complete follow-up patient with cerebral lesions patient with other spinal lesions patient with cardiac, renal or hepatic dysfunction

Primary outcomes:
measure: bladder function change in urodynamics
timeFrame: postoperative 3 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Tongwen Ou, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04763486: Prophylactic Antibiotic After Perineal Tear
Official title: Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Puerperal Infection
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parturition
Primary purpose: PREVENTION

Brief summary: Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.

Detailed description: The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.

Eligibility criteria: Inclusion Criteria:

* age 18-45
* perineal tear 2nd and 1st degree( episiotomy)

Exclusion Criteria:

* 3rd and 4 th degree perineal tear
* antibiotic indication during delivery
* cesarian section delivery

Primary outcomes:
measure: Number of participants with a fever after delivery
timeFrame: 6 weeks of delivery
Secondary outcomes:
measure: Way of delivery
timeFrame: 6 weeks of delivery
Other outcomes:
Locations:
city: Kfar Saba,
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center , Tel Aviv University
name: Gil Shechter, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04002986: Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Official title: Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
Keywords: increased risk of breast cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 116
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.


Eligibility criteria: Inclusion Criteria:

* Women participating in IRB:18-010601
* Aged 35 and over with a negative routine mammogram within 3 months.
* Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
* Have an active email address for survey completion

Exclusion Criteria:

* Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
* Known genetic cancer syndrome with test results available for review in Mayo EMR
* Known breast cancer
* Unable to understand or sign informed consent

Primary outcomes:
measure: Genetic mutations
timeFrame: One year
measure: Study Participants
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: N. Jewel Samadder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019586: Helicobacter Pylori Resistance
Official title: Helicobacter Pylori Resistance. A Study of Morbidity, Immunological and Clinical Phenotypes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Resistance
Keywords: Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients referred to Gastrointestinal (GI) unite in the time periode from 1990 to 2010 and defined as resistant to triple Helicobacter pylori (HP) treatment
2. Patients referred to GI unite in the time periode from 2010 to 2012 due to opper GI complaints. Included were patients a) newly diagnosed HP, b) previously successful triple HP therapy, and c) never HP infected

Brief summary: The main goal of the study was to characterize the morbidity, immunological, microbiolical and clinical phenotypes of patients with treated- resistance to Helicobacter pylori (HP) infection, and the effect of triple therapy including the levofloxacin. Control groups were newly diagnosed, previously infected and never infected HP patients

Detailed description: See Nestegard O, et al. PLOS ONE \| https://doi.org/10.1371/journal.pone.0238944 September 23, 2020

Eligibility criteria: Inclusion Criteria:

Patients referred to a GI- unite with upper GI complains and performing an upper endoscopy -

Exclusion Criteria:

Patients with severe chronic diseases and not willing to participate

Primary outcomes:
measure: Characterization of patients with chronic HP infection resistant to previous conventional triple therapy
timeFrame: 2010-2012
measure: Endoscopy
timeFrame: 2010-2012
measure: Histology
timeFrame: 2010-2012
measure: Immunology
timeFrame: 2010-2012
measure: HP microbiology
timeFrame: 2010-2012
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, Norwegian Artic University/Universiuty of Tromsø, Norway
name: Jon Florholmen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nestegard O, Moayeri B, Halvorsen FA, Tonnesen T, Sorbye SW, Paulssen E, Johnsen KM, Goll R, Florholmen JR, Melby KK. Helicobacter pylori resistance to antibiotics before and after treatment: Incidence of eradication failure. PLoS One. 2022 Apr 20;17(4):e0265322. doi: 10.1371/journal.pone.0265322. eCollection 2022.
Clinical trial NCT04117386: Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
Official title: Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Pterygium
Keywords: HPV infection
Pterygium
Cytokine
VEGF
auto-inoculation
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population:Patients diagnosed with primary pterygium and recurrent pterygium Target Population: Patients diagnosed with primary pterygium at out-patient clinic, Department of Ophthalmology, King Chulalongkorn Memorial Hospital Control Population: participants without any ocular diseases

Brief summary: Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

Detailed description: The main purpose of this study is to evaluate the prevalence of HPV infection in primary and recurrent pterygium and the association of HPV types collecting from conjunctiva swab and urine. The second purpose is to compare a quantity of cytokines including IL-6, IL-18 and growth factor including VEGF found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease Primary hypothesis

- The prevalence of HPV infection in primary pterygium is difference with prevalence in recurrent pterygium patients.

Secondary hypothesis

* Ocular HPV infection has association with HPV genitalia infection.
* Tears cytokine and growth factor level (IL-6, IL-18 and VEGF) are higher in pterygium HPV infection than non-HPV infection and also more than normal population

Eligibility criteria: Participants as primary and secondary pterygium group

Inclusion Criteria:

* Age above 18 years old
* presence of pterygium invading the cornea

Exclusion Criteria:

* Other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons

Participant without ocular disease Inclusion criteria

* Age above 18 years old Exclusion criteria
* Presence of any ocular inflammation diseases

Primary outcomes:
measure: HPV prevalence
timeFrame: 1 hour per participants which is on a day for collecting sample
Secondary outcomes:
measure: HPV autoinoculation
timeFrame: 1 hour per participants which is on a day for collecting sample
measure: cytokine IL-6, IL-18 and VEGF levels
timeFrame: 1 hour per participants which is on a day for collecting sample
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, Chulalongkorn university
Study officials:
affiliation: Department of Ophthalmology, Chulalongkorn University
name: Ngamjit Kasetsuwan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608486: Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
Official title: Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial (CO-STAR)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.

Detailed description: This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol.

Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs.

Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA).

Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.

Eligibility criteria: Inclusion Criteria:

1. The subject completed study SOM-029 (SUPRA).
2. The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.
3. In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.

Exclusion Criteria:

1. The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.
2. Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.
3. The subject is pregnant or plans to become pregnant during the course of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Kingman P. Strohl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184686: Effects of Electromagnetic Field and Noise on Resting Electroencephalogram of Health Subjects
Official title: Effects of Electromagnetic Field and Noise on Alpha Band and Functional Connections of Human Resting Electroencephalogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroencephalography
Electromagnetic
Noise Exposure
Keywords: Electroencephalography
Noise Exposure
electromagnetic Exposure
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: With the development of science and technology, there are more and more electromagnetic and noise factors in the working and living environment. These two factors often exist together, and their impact on people may interact. Scalp EEG is a classic nerve detection technology, which can reflect the functional state of the brain in a non-invasive and real-time manner. This project intends to use EEG technology to study the effects of electromagnetism and noise on human brain function.


Eligibility criteria: Inclusion Criteria:

* Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;

Exclusion Criteria:

* Have history of smoking, alcohol abuse, no history of neurological or psychiatric disorders (e.g., epilepsy), no relevant family history, and no recent medication use;
* Have history of surgery for head injury, no metal implants in the body (including braces);
* Sleep-wake time irregular， with sleep disturbance;
* Have history of noise allergy;
* Participate in similar psychological experiments during 2 months.

Primary outcomes:
measure: alpha band power of the EEG spectral
timeFrame: Procedure (record EEG during the noise and RF expose, and then compute the alpha band power of the EEG )
measure: theta band power/beta band power of the EEG spectral
timeFrame: Procedure (record EEG during the noise and RF expose, and then compute theta/beta of the EEG )
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Air Force Military Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT03336086: Effect of Weight Reduction on Immunity
Official title: Reduction of Natural Killer Cell (CD16/56) and T-lymphocyte (CD3) Subset Counts After a Weight Loss Program Using Anti-obesity Drugs in Obese Women: a Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphocytes
Weight Loss
Viral Diseases
Immunity
Anti-obesity Agents
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mashhad University of Medical Sciences
First posted: 2017-11-08
Enrollment: 29
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. At baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.

Detailed description: TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity

Eligibility criteria: Inclusion Criteria:

* BMI \>=30
* female
* healthy
* no smoking
* not lactating
* not pregnant
* no medication use

Exclusion Criteria:

* pregnancy
* any disease
* any medication use
* iron and zinc deficiency
* any supplement use

Primary outcomes:
measure: lymphocyte subgroups
timeFrame: 6 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 6 months
measure: Biomarkers
timeFrame: 6 months
measure: Systolic blood pressure
timeFrame: 6 months
measure: diastolic blood pressure
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Fat Mass
timeFrame: 6 months
measure: Fat Free Mass
timeFrame: 6 months
measure: Trunk Fat
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: