louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03952208: Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Official title: Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.

Detailed description: All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.

Eligibility criteria: Inclusion Criteria:

* Male or Female \>16 years of age with a recent concussion (\<10 weeks) from planned procedure under anesthesia.

Exclusion Criteria:

* Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.

Primary outcomes:
measure: Wide Range Achievement Test Fourth Edition, WRAT-4
timeFrame: Pre-anesthetic to one week Post-anesthetic
Secondary outcomes:
measure: Numeric Pain Scale 0-10
timeFrame: Post-operatively to hospital discharge, up to 10 days.
measure: Oral morphine equivalent of consumed opioids
timeFrame: Post-operatively to hospital discharge, up to 10 days.
measure: Length of hospital stay
timeFrame: Post-operatively to hospital discharge, up to 30 days.
measure: Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
timeFrame: Pre-anesthetic to one week Post-anesthetic
measure: Sport Concussion Assessment Tool - 5th edition, SCAT-5
timeFrame: Pre-anesthetic to one week Post-anesthetic
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Arnoley S Abcejo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00290108: The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Official title: The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Surgery
Healthy
Keywords: BIS
Propofol
hemodynamic
pharmacokinetic
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.

Detailed description: The clinical daily routine indicates that slowing the rate of administration of propofol can lead to a reduction of up to 50% in the dose of propofol required to achieve the onset of a clinical endpoint of anesthesia (i.e. loss of consciousness) when titrating to effect. Therefore, it has been concluded that a slow injection requires a smaller dose of propofol as the graded effect is weakened by fast injection. This conclusion contradicts pharmacologic considerations, that a fast injection would lead to a higher peak concentration and in consequence, to a higher peak effect at the effect side, the brain.

The present study was designed to measure the Electroencephalogram (EEG) peak effect of a propofol bolus (2 mg/kg) injected with different infusion rates.

Although it is known that propofol has cardiovascular effects, the influence of injection rate on these cardiovascular changes is less clear. Others found that faster injection rates of propofol caused greater reductions in blood pressure. Other similar studies have shown no difference in blood pressure for different injection rates. An additional aim of this study was therefore to investigate the influence of different injection rates on hemodynamic parameters.

Eligibility criteria: Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* scheduled for elective surgery under general anesthesia.

Exclusion criteria:

* emergency surgery
* obesity
* indication for rapid sequence induction
* drugs that affect the central nervous system
* history of alcohol or drug abuse
* neurological or psychiatric diseases
* contraindications against the use of propofol

Primary outcomes:
measure: maximum hypnotic effect as indicated by the minimum BIS value.
Secondary outcomes:
measure: time to loss of consciousness
measure: time to loss of eye lash reflex
measure: time to BISmin
measure: BIS at LOC
measure: BIS at LOL
measure: BIS 30 seconds after LOC
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
state: Bavaria
Study officials:
name: Eberhard Kochs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02726308: Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
Official title: Dexamethasone Alone Versus in Combination With Intra-operative Super-hydration for Prevention of Postoperative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea and Vomiting, Postoperative
Keywords: Dexamethasone
Super-hydration
Laparoscopic Cholecystectomy
Nausea
Vomiting
Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy

Detailed description: In the operating room, standard monitors included electrocardiogram, noninvasive arterial blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. All patients received standardized anesthetic technique. At the end of surgery, gastric contents were suctioned via an orogastric tube before extubation. Atropine and neostigmine (1/2.5 mg) was given slowly I.V. to antagonize the residual neuromuscular block. Then, the trachea was extubated. Then, patients were transferred to the post-anesthesia care unit in a stable condition. Patients were allowed to drink liquids as soon as requested.

Eligibility criteria: Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy

Exclusion Criteria:

Steroids use within the last 3 days before surgery Antiemetic use within the last 3 days before surgery Opioids use within the last 3 days before surgery. Patients with liver, cardiac or renal diseases Patients with Pregnancy Patients with Bmi ˃ 30kg/m2 Patients with Delayed wound healing Open surgery

Primary outcomes:
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: Within the first 24 hours postoperatively
Secondary outcomes:
measure: Total number of patients who had nausea, vomiting or retching
timeFrame: Within the first 24 hours postoperatively
measure: Antiemetic usage
timeFrame: Within the first 24 hours postoperatively
measure: Pain Score
timeFrame: Within the first 24 hours postoperatively
measure: Total analgesic consumption
timeFrame: Within the first 24 hours postoperatively
measure: Incidence of wound infection
timeFrame: Within the first week postoperatively
measure: Incidence of delayed wound healing
timeFrame: Within the first week postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor of anesthesia and critical care
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219323: Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.
Official title: Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma, IgE, Omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2005-09-22
Enrollment: 133
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility criteria: Inclusion Criteria:

* Allergic asthma patients
* Inadequately controlled patients

Exclusion Criteria:

* - History of severe anaphylactoid or anaphylactic reactions
* Previous treatment with omalizumab
* History of cancer or cancer

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Safety of omalizumab
Secondary outcomes:
measure: Pulmonary function parameters measured by spirometer
measure: Morning and evening peak expiratory flow (PEF)
measure: Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: This study is not being conducted in the United States
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT00000523: Optimal Exercise Regimens for Persons at Increased Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. Also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.

Detailed description: BACKGROUND:

Regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed. This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting.

DESIGN NARRATIVE:

Following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. The intervention program was conducted for one year followed by a one-year maintenance program. Main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. Variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

Eligibility criteria: Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: King AC, Haskell WL, Taylor CB, Kraemer HC, DeBusk RF. Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial. JAMA. 1991 Sep 18;266(11):1535-42.
Clinical trial NCT06790823: Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder
Official title: Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depressive Disorder
Depressive Disorder, Major Depressive Disorder
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the potential of probiotics as a therapeutic intervention for Substance-Induced Depressive Disorder (SIDD). The primary question the study aims to answer is: Can a four-week course of probiotics improve depressive symptoms and alter immune markers in patients diagnosed with SIDD, compared to a placebo?

The study uses a double-blind, placebo-controlled, randomized clinical trial design with 40 participants to explore this question by measuring clinical outcomes using BDI and HAM-A and immunological markers.


Eligibility criteria: Inclusion Criteria:

* Males and females, aged between 18 and 70 years
* Diagnosis of Substance-Induced Depressive Disorder as per DSM-5 criteria
* Absence of significant internal diseases as per exclusion criteria

Exclusion Criteria:

* Pregnant or lactating
* Patients who for any reason cannot comply with adequate follow-up

Primary outcomes:
measure: The Beck Depression Severity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences, Shiraz, Iran
state: Fars
Study officials:
References:
Clinical trial NCT00111423: Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI) in Subjects With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Inflammation
Pegsunercept, PEG sTNF-RI
Autoimmune, Amgen
Clinical Trials
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-23
Enrollment: 216
Sex: ALL
Minimum age (years): 18
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 evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.


Eligibility criteria: Inclusion Criteria: - Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - The subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed Exclusion Criteria: - Greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study - Any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent - Concurrent treatment with an investigational agent

Primary outcomes:
measure: Treatment-emergent adverse events
Secondary outcomes:
measure: Description of RA assessment outcomes
measure: Assessment of Compliance
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06273423: Feasibility Evaluation of a Dance Fitness Program
Official title: A Feasibility Randomized Controlled Evaluation of a Mind-Body Dance Fitness Program for Improving Symptoms of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum
Depression
Mind-body
Physical activity
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).

Detailed description: The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.

Eligibility criteria: Inclusion Criteria:

* Ages 20-39 years
* Have an infant 0-12 months old
* Self-report clearance from provider to engage in physical activity following birth
* Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
* Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
* English speaking
* OULA-naïve
* If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks

Exclusion Criteria:

* Unable to be physically active
* Current pregnancy
* SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
* Active suicidal attempt or plan identified on the SCID-5-RV
* Suicide attempt in the past 6 months
* Concurrent participation in another group dance fitness format
* No access to Internet via computer, tablet, or smart phone

Primary outcomes:
measure: Feasibility and acceptability
timeFrame: 7 months
Secondary outcomes:
measure: Changes in postpartum depression
timeFrame: 7 months
measure: Changes in postpartum anxiety
timeFrame: 7 months
Other outcomes:
Locations:
Study officials:
affiliation: Montana State University
name: Tracy Hellem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099723: The Effect of a Probiotic on Hepatic Steatosis
Official title: The Effect of a Probiotic on Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fatty Liver
Keywords: Hepatic steatosis
adult-onset diabetes
Non-alcoholic fatty liver disease
Lead sponsor: VSL Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.


Eligibility criteria: Inclusion Criteria:

* Adult-onset diabetes
* Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3

Exclusion Criteria:

* There are multiple exclusion criteria.

Primary outcomes:
measure: MRI
measure: Liver biopsy
measure: Blood work
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steve Solga, MD
role: PRINCIPAL_INVESTIGATOR
References: