louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00928772: Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety
Official title: The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anxiety
Keywords: Cranial Electro Stimulation
First Eye Cataract Surgery
Preoperative sedation
Perioperative sedation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 115
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

Detailed description: CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
* ASA classification I II and III

Exclusion Criteria:

* ASA classification IV (patients with a chronic or severe disease).
* Hypersensitivity to midazolam or benzodiazepines
* acute narrow-angle glaucoma
* untreated open-angle glaucoma
* Patients with any sort of psychiatric or neurological disorder
* Patients on anti-anxiety medication
* Patients who have demand-type pacemakers installed before 1999\* \*Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.

Primary outcomes:
measure: Anxiety During Cataract Surgery Under Topical Anesthesia
timeFrame: during the cataract surgery up to30 minutes
Secondary outcomes:
measure: Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia
timeFrame: during cataract surgery up to 30 minutes
measure: Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
timeFrame: during cataract surgery up to 30 minutes
measure: Heart Rate During Cataract Surgery Under Topical Anesthesia
timeFrame: during cataract surgery up to 30 minutes
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
Study officials:
affiliation: Oklahoma City VAMC
name: Grigory Chernyak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04895072: Injection Rate and Erector Spinae Plane Block
Official title: Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Surgery
Keywords: Erector spinae plane (ESP) block
Postoperative Pain
Breast Surgery
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of injection rate on the block sensory level in the ESP block.

Detailed description: Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.

Eligibility criteria: Inclusion Criteria:

* aged between eighteen and sixty-five
* ASA I-III
* undergo elective breast cancer surgery

Exclusion Criteria:

* under 18 years of age or over 65 years of age
* ASA IV and above
* declined to give written informed consent
* contraindications of peripheral blocks or local anesthetic infiltration
* history of allergy against local anesthetics
* chronic pain history
* history of hepatic, neuromuscular, cardiac and/or renal failure
* infection at the injection site

Primary outcomes:
measure: Block sensory level
timeFrame: 12 hours
Secondary outcomes:
measure: Postoperative tramadol consumption
timeFrame: 24 hours
measure: Assesment of postoperative analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya TRH
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
Clinical trial NCT01343472: Evaluation of the Washington Intensive Supervision Program
Official title: Evaluation of the Washington Intensive Supervision Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Drug Users
Keywords: Behavior
Drug users
Lead sponsor: Pepperdine University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The purpose of the evaluation is to test whether subjects assigned to WISP perform better than those assigned to parole-as-usual (PAU).

Detailed description: This study entails an evaluation of the Washington Intensive Supervision Program (WISP). WISP is a program targeting high-risk parolees in Seattle, and is modeled after the HOPE program in Hawaii. The purpose of the evaluation is to test whether subjects assigned to WISP perform better than those assigned to parole-as-usual (PAU) on a number of outcomes, including drug use, missed appointments, recidivism, prison and jail stays, and parole revocations. WISP uses regular random drug testing and close community supervision, paired with swift and certain, but modest sanctions for every detected violation.

Eligibility criteria: Inclusion Criteria:

* Inmates released by DOC to community corrections supervision
* Supervised out of the Seattle CJC (Community Justice Center) to include field offices and offenders from the downtown "Metro" unit, Southeast Seattle unit, Northgate (north Seattle) and West Seattle.
* Have a parole supervision discharge date at least one year from the date of release from entry into WISP

Exclusion Criteria:

* Level III Sex Offenders
* Existing assignment to supervision that precludes WISP. These include: Drug Offender Sentencing Alternative (DOSA)and Special Sex Offender Sentencing Alternative (SSOSA).
* Dangerously Mentally Ill (DMIO)

Primary outcomes:
measure: Revocation rate
timeFrame: 12 months
Secondary outcomes:
measure: % positive drug tests
timeFrame: 12 months
measure: Days incarcerated
timeFrame: 12 months
measure: % Missed appointments
timeFrame: 12 months
measure: New arrests
timeFrame: 12 months
measure: Assessed risk
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Community Justice Center
state: Washington
Study officials:
affiliation: Pepperdine University
name: Angela Hawken, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02621372: Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis
Official title: Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Hypertension
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2015-12-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 110 cirrhotic patients were included

Brief summary: Portal hypertension is a common complication of liver cirrhosis that can lead to development of esophageal varices (EV). They are abnormally dilated veins within the wall of the esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV at some point, and about third of these patients will have at least one bleeding episode because of rupture of a varix . For this reason, screening endoscopy for detection of the presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is a very important preventive step for identification of those patients with variceal bleeding risk and furthermore, identification of patients in urgent need for prophylactic treatment.

All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients with portal hypertension. However this approach is limited by its invasiveness and cost effectiveness issues of screening endoscopy .

Detailed description: Recent research has focused on the use of noninvasive methods to detect patients with the intention of avoiding endoscopy in low-risk cases . Thrombocytopenia (platelet count \< 150,000/μl) is a common complication in patients of chronic liver disease (CLD) . So, the investigators in this research formulated this study to determine whether platelet count can predict the presence of EV or varices which need prophylactic therapy (medium or large size EV) in a cohort of Egyptian patients with liver cirrhosis and can identify patients with the intention of avoiding endoscopy in low-risk cases.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion.

Exclusion Criteria:

* Hepatocellular carcinoma.
* Portal vein thrombosis.
* Parenteral drug addiction.

Primary outcomes:
measure: Number of patients with esophageal varices and have low platelet count
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tropical medicine dept.-Tanta university hospital
Study officials:
affiliation: Tanta university hospital
name: Sherief Abd-Elsalam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484872: Has Inflammation a Significant Implication in Lung Cancer Evolution?
Official title: L'Inflammation A-t-elle Une Implication Significative Dans l'évolution du Cancer Bronchique?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Keywords: Inflammation
Glasgow score
Intensive Care Unit
Emergency
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
Collaborators: name: Jules Bordet Institute
First posted: 2015-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed untreated lung neoplasms

Brief summary: Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to ICU admission and the risk of death.

Detailed description: Patients with newly diagnosed lung cancer will be eligible. All patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.

Eligibility criteria: Inclusion Criteria:

* Lung neoplasms irrespective of stage, histology

Exclusion Criteria:

* Previously treated lung neoplasms
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)

Primary outcomes:
measure: Survival
timeFrame: Measured from diagnosis until death or last date known to be alive, or at least 48 months
Secondary outcomes:
measure: Complications leading to emergency/ICU
timeFrame: From inclusion until death, or a least 48 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Study officials:
affiliation: Jules Bordet Institute
name: Anne-Pascale Meert, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05685368: Acceptance and Commitment Therapy (ACT) for Combating the Effects of Race-Related Stress Among Black Adolescents
Official title: The Healing Power of Acceptance: Evaluating the Efficacy of Acceptance and Commitment Therapy (ACT) in Combating the Effects of Race-Related Stress Among Black Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Race-related Stress
Depression, Anxiety
Quality of Life
Stress Reaction
Keywords: Black
African American
Adolescents
Acceptance and Commitment Therapy
race-related stress
racial trauma
coping
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.


Eligibility criteria: Inclusion Criteria:

* Identify as Black/African American
* English-speaking

Exclusion Criteria:

* Prisoners or youth in detention centers will be excluded.
* Not capable of participating meaningfully in the assent/consent process.
* Being at significant risk for suicide and self-injury
* Currently experiencing psychosis
* Having severe health concerns that will impact study participation or attendance

Primary outcomes:
measure: Total Score on Index of Race-Related Stress (IRRS)-Brief Version
timeFrame: 12 weeks
Secondary outcomes:
measure: Total Scores on Acceptance and Action Questionnaire-2
timeFrame: 12 weeks
measure: Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t)
timeFrame: 12 weeks
measure: Total Score on Patient Health Questionaire-9
timeFrame: 12 weeks
measure: Total Score on General Anxiety Disorder-7
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Xzania Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03159468: Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
Official title: Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Aggression
Heavy Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Arizona State University
First posted: 2017-05-18
Enrollment: 209
Sex: MALE
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. Previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. Despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. Thus, this study evaluates the effects of two brief online ER interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. Additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment.


Eligibility criteria: Inclusion Criteria:

* Single
* Male
* Age 21-30
* Heterosexually active within past year
* Heavy episodic drinker
* Self-reported history of sexual aggression

Exclusion Criteria:

* History of alcohol problems
* Medical condition or medications that contraindicate alcohol consumption

Primary outcomes:
measure: Sexual Aggression Intentions
timeFrame: Within one hour after receiving the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT02162368: Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients
Official title: Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Spine Surgery
Prone Position
Keywords: laryngeal mask, prone position, spine surgery
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent scheduled spine surgery in prone position

Brief summary: Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. The aim of our retrospective study is to describe our experience in the laryngeal mask use for airway management in patient submitted to spine surgery in neurosurgery

Detailed description: Retrospective analysis of our experience in the last 8 years with the airway management in spine surgery in prone position. A total of 358 cases were reviewed from 2008 to 2013.

Airway management (need for LM repositioning, orotracheal intubation because of failed LM insertion), anticipated difficult airway, and airway complications were registered. Statistics were compared between groups with the t test or the χ test, as appropriate.

Eligibility criteria: Inclusion Criteria:

* elective spinal surgery

Exclusion Criteria:

* emergency cases
* complex spine surgery

Primary outcomes:
measure: safety in the use of laryngeal mask in knee chest position in spine surgery
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Anesthesia department, Hospital Clínic de Barcelona
Study officials:
affiliation: Head of neuroanesthesia
name: Ricard Valero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06935968: Effect of Levonorgestrel Intrauterine System on Hemoglobin Level
Official title: Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemoglobin; Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.

Detailed description: Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level

Eligibility criteria: Inclusion Criteria:

1. The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
2. Age between 18 and 45 years
3. Women who choose LNG_IUS for contraception
4. Any parity including nulliparous

Exclusion Criteria:

* 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery

Primary outcomes:
measure: Change of blood haemoglobin level from time of insertion to 6 months after insertion
timeFrame: 6 months
Secondary outcomes:
measure: Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: