louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02625805: Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD
Official title: Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Brainmarc Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.

Detailed description: The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.

The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged 18 -45 years.
* Able and willing to comply with all study requirements.

Diagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:

* Adult ADHD Self-Report Scale (ASRS)
* Wender-Utah Rating Scale
* Positive And Negative Affect Schedule (PANAS)

Exclusion Criteria:

Diagnosed with Psychotic or bipolar disorder.

* Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
* A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
* Cognitive impairment.
* Hearing disorder and/or known ear drum impairment.

Primary outcomes:
measure: Measurements of brain electrical signal in Micro volt.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Hospital
Study officials:
affiliation: Shalvata Hospital
name: Yuval Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181205: Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Official title: Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postdural Puncture Headache
Sphenopalatine Ganglion Block
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists assigned class I-III
* age \>/= 18 years
* experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated \>3/10 pain score

Exclusion Criteria:

* allergy to study medications \<18 years of age pain score on presentation \</=3/10 for headache

Primary outcomes:
measure: verbal pain score
timeFrame: 1 hour
Secondary outcomes:
measure: epidural blood patch
timeFrame: 7 days
measure: patient satisfaction
timeFrame: 1 hour
measure: pain score
timeFrame: 30 minutes
measure: pain score
timeFrame: 7 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest School of Medicine-Anesthesiology
name: Peter H Pan, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745705: Cervical Spine Manipulation Affects on Balance and Proprioception
Official title: Immediate Effects of Cervical Spine Manipulation on Balance and Joint Proprioception in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Headache
Keywords: Manipulation
Balance
Proprioception
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cervical spine manipulation (CSM) is utilized by many health care practitioners in the management of patients with neck pain and headache. How CSM works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects. This study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following CSM.

Detailed description: Consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a Neurocom Balancemaster. Following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.

Eligibility criteria: Inclusion Criteria:

* healthy individuals between the ages of 18 and 60

Exclusion Criteria:

* current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.

Primary outcomes:
measure: Cervical joint proprioception
timeFrame: 1 day (Immediately after the intervention)
Secondary outcomes:
Other outcomes:
measure: SMART Neurocom Balance Master
timeFrame: 1 day (Immediately after the intervention)
Locations:
city: Las Vegas
country: United States
facility: Department of Physical Therapy, University of Nevada Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT04695405: Pharmacogenetics Associated With IV Ketamine
Official title: Genetic Markers Associated With Response to Intravenous Ketamine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Resistant Depression
Lead sponsor: Brain and Cognition Discovery Foundation
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will have received IV ketamine previously for treatment resistant depression, as defined by the DSM-5

Brief summary: The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.


Eligibility criteria: Inclusion Criteria:

1. Must have received IV ketamine previously to treat Treatment-Resistant Depression
2. Between the ages of 18-65 years old.
3. Clinical diagnosis of MDD
4. Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
5. Ability to provide informed consent

Exclusion Criteria:

1. Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
2. Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
3. Individuals who are unable to consent to the procedure.
4. Individuals who are unable to adhere to the protocol in its totality

Primary outcomes:
measure: Genetic Biomarkers
timeFrame: 1 month
measure: Quick Inventory of Depressive Symptomatology Self Report 16-Item
timeFrame: Over 1-2 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: Over 1-2 weeks
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Over 1-2 weeks
measure: Sheehan Disability Scale
timeFrame: Over 4 initial infusions
measure: Clinician Administered Dissociative States Scale
timeFrame: Over 1-2 weeks
Secondary outcomes:
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 1 month
measure: Mystical Experience Questionnaire (MEQ)
timeFrame: 1 month
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 1 month
measure: UCLA Loneliness Scale (UCLA)
timeFrame: 1 month
measure: Diet Screener Questionnaire
timeFrame: 1 month
measure: Quality of Life Questionnaire (EQ-3D-5L)
timeFrame: 1 month
measure: Perceived Health Questionnaire (PHQ)
timeFrame: 1 month
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Canadian Rapid Treatment Centre of Excellence
state: Ontario
Study officials:
affiliation: Canadian Rapid Treatment Center of Excellence
name: Joshua D Rosenblat, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197505: Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
Official title: Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.

Detailed description: Human subjects will be enrolled into the study from NYU Langone Health and Bellevue Hospital Center. When orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. The collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. If any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. No obtunded or unresponsive patients will be enrolled into the study. The goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. Age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 to 95
* Have fracture injury

Exclusion Criteria:

* Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness
* Those with a concomitant fracture
* Subjects with no specific medical history or surgical history
* Subjects who cannot provide informed consent

Primary outcomes:
measure: Comparison of thermal imaging of extremity with and without fracture
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Change in thermal imaging predicting non-union
timeFrame: through study completion, an average of 18 months
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone
name: Philipp Leucht
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03794505: Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis
Official title: Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shoulder Arthritis
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2019-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis

Detailed description: To describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis

Eligibility criteria: Inclusion Criteria:

* IMSS affiliated
* Glenohumeral arthritis diagnosed

Exclusion Criteria:

* Previusly treatment for the same disease
* No follow up
* Dead

Primary outcomes:
measure: Pain before
timeFrame: VAS before intervention
measure: Pain 2 months after
timeFrame: VAS 2 months after
measure: Pain 6 months after
timeFrame: VAS 6 months after
Secondary outcomes:
measure: Quality of life before procedure
timeFrame: SF12v2 before procedure
measure: Quality of life 2 months after procedure
timeFrame: SF12v2 2 months after
measure: Quality of life 6 months after procedure
timeFrame: SF12v2 6 months after
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Department of Orthopedics, UMAE "Dr. Victorio de la Fuente Narváez" IMSS-UNAM. Ciudad de México, México
state: Gustavo A Madero
Study officials:
affiliation: IMSS
name: Luis Alonso Calderon Cordova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06555705: Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children
Official title: Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children, a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (HRV) measures, all of which may be indicators of cardiovascular health.As a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.

Detailed description: This is a two-armed study , the interventional group will be given omega 3 and the control group will be given a placebo and both will be examined for the heart rate variability

Eligibility criteria: Inclusion Criteria:

* Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study
* Obese Children (Simple obesity )
* Both males and females

Exclusion Criteria:

* Patients are known to have cardiac disease
* Patients with associated chronic systemic illness
* Patients with 2ry obesity : (endocrine /metabolic/genetics/drug intake)
* Patients on medications affecting heart rate :structural or arrhythmic

Primary outcomes:
measure: The effect of omega-3 on heart rate variability that is represented in the root mean square of successive differences of the heart rates ( RMSSD ) in obese children
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hoda Atef Abdelsattar Ibrahim
Study officials:
affiliation: Professor of Pediatrics
name: Rodina Sobhy
role: STUDY_DIRECTOR
References:
Clinical trial NCT00067405: Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Official title: Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Intravenous micronutrient therapy
IVMT
alternative medicine
complementary medicine
vitamins
vitamin supplements
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is effective in the treatment of fibromyalgia, as assessed by validated functional and pain measures.

Detailed description: As per Brief Summary

Eligibility criteria: Inclusion criteria:

* Meet the American College of Rheumatology criteria for Fibromyalgia diagnosis;
* On no medication for Fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study

  * Willing to stop all FMS medication for the duration of the study or be on a stable dose of such medication for at least 3 months

Exclusion criteria:

* Other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding problems

  * Allergy to thiamin
* Unwilling to stop vitamin supplementation for the duration of the study

  * PLEASE NOTE: Travel to and accomodations at the study site can NOT be compensated. Anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ali A, Njike VY, Northrup V, Sabina AB, Williams AL, Liberti LS, Perlman AI, Adelson H, Katz DL. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med. 2009 Mar;15(3):247-57. doi: 10.1089/acm.2008.0410.
Clinical trial NCT05392205: Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer
Official title: Evaluating the Potential Usefulness of 68Ga-FAP-2286 PET/CT in Patients With Various Types of Cancer and Compared With 18F-FDG PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor, Solid
Positron-Emission Tomography
Keywords: Tumor
Solid
Positron-Emission Tomography
diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-FAP-2286 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.

Detailed description: Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years or order);
* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled both 18F-FDG and 68Ga-FAP-2286 PET/CT scans;
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* patients with non-malignant lesions;
* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent;

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 90 days
Secondary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
measure: Number of lesions
timeFrame: 90 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First affiliated hospital of xiamen university
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Long Sun, PhD
role: STUDY_DIRECTOR
References: