louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02171923: Multicenter Comparative Study of the Activity of the Medial Prefrontal Cortex in Vulnerability to Depression
Official title: Medial Prefrontal Cortex and Vulnerability for Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Keywords: depression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Formerly depressed patients and healthy controls matched for age and sex

Brief summary: To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls


Eligibility criteria: Inclusion criteria (patients)

* History of at least one major depressive episode
* In clinical remission for at least 6 months (BDI-21 ≤ 10 \& Montgomery and Asberg Depression Rating Scale ≤ 7)
* Aged 20-65

Exclusion criteria :

* first depressive episode after the age of 59
* last episode treated by cognitive behavior therapy
* currently receiving a antipsychotic or mood-stabilizing drug
* personal history of: major depressive episode with psychotic features, other axis-I disorder (except generalized anxiety disorder), substance-related disorder (except nicotine dependence), bipolar disorder
* first-degree familial history of bipolar disorder
* cognitive impairment due to another central nervous system disease
* contra-indication to MRI
* pregnancy
* refusal to be informed of abnormal findings during the MRI

Primary outcomes:
measure: BOLD signal in the medial prefrontal cortex
timeFrame: 18 month
Secondary outcomes:
measure: depression relapse
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: URC - HEGP, 20 rue Leblanc
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Cédric Lemogne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemogne C, Delaveau P, Freton M, Guionnet S, Fossati P. Medial prefrontal cortex and the self in major depression. J Affect Disord. 2012 Jan;136(1-2):e1-e11. doi: 10.1016/j.jad.2010.11.034. Epub 2010 Dec 23.
Clinical trial NCT06961123: Establishment of a Longitudinal Cohort for Newborns With Low Apgar Scores at Birth
Official title: Establishment of a Longitudinal Cohort for Newborns With Low Apgar Scores at Birth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Apgar Scores
Keywords: Low Apgar scores, neonatal, birth cohort
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns born at Peking University Third Hospital with Apgar scores ≤ 7 at any time point within 1 minute, 5 minutes, or 10 minutes after birth

Brief summary: The objective of this study is to identify high-risk factors associated with low Apgar scores, implement proactive interventions to reduce their occurrence, and analyze neonatal resuscitation procedures and systemic treatment during hospitalization. This aims to provide evidence-based references for improving the resuscitation and medical management of newborns with low Apgar scores, thereby enhancing clinical care capabilities. Additionally, continuous follow-up management and timely intervention guidance will be provided to these infants to optimize their long-term prognosis.

Detailed description: This is a prospective and retrospective biphasic cohort study.Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.

Prospective cohort inclusion criteria: Newborns born in our hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.

Eligibility criteria: Inclusion Criteria:

* Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.

Prospective cohort inclusion criteria: Newborns born at Peking University Third Hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.

Exclusion Criteria:

* There are serious congenital malformations that affect physical and neurological development, and family members refuse to participate in the study

Primary outcomes:
measure: Physical development indicators, Neurodevelopmental outcome
timeFrame: 6 months old, 1 year old, 2 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT00929123: Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
Official title: Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carpal Tunnel Syndrome
Keywords: manual therapy
carpal tunnel syndrome
central sensitization
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. The investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years of age
* signs and symptoms of carpal tunnel syndrome for greater than 12 weeks

Exclusion Criteria:

* non english speaking
* prior surgery for carpal tunnel syndrome
* systemic condition known to affect sensation
* chronic pain condition other than carpal tunnel syndrome

Primary outcomes:
measure: thermal and pressure pain sensitivity
timeFrame: immediate effect
Secondary outcomes:
measure: grip strength
timeFrame: 3 weeks
measure: wrist range of motion
timeFrame: 3 weeks
measure: clinical pain
timeFrame: 3 weeks
measure: self report of disability
timeFrame: 3 weeks
measure: median nerve function
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida Department of Physical Therapy
name: Steven Z George, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.3117.
citation: Bialosky JE, Bishop MD, Robinson ME, Price DD, George SZ. Heightened pain sensitivity in individuals with signs and symptoms of carpal tunnel syndrome and the relationship to clinical outcomes following a manual therapy intervention. Man Ther. 2011 Dec;16(6):602-8. doi: 10.1016/j.math.2011.06.003. Epub 2011 Jul 20.
citation: Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
Clinical trial NCT05038423: The 5R Shared Leadership Program in Older Adult Walking Groups
Official title: The 5R Shared Leadership Program in Older Adult Walking Groups: A Clustered Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leadership
Identification
Empowerment
Keywords: 5RS
group identification
social identification
peer leadership
identity leadership
elderly
physical activity
well-being
cohesion
walking group
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 503
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clustered randomised controlled trial
Primary purpose: TREATMENT

Brief summary: To test the efficacy of the 5R Shared Leadership program in older adults on participants' identification with their walking group, group cohesion, walking activity, and well-being, compared to a regular group walking program, the investigators conducted a cluster randomised trial.

Detailed description: All walking groups participated in a 12-week structured group walking program. Half of these walking groups were randomly assigned to the intervention condition and received additionally the 5R Shared Leadership Program

Eligibility criteria: Inclusion Criteria:

* Being part of a community-based OKRA SPORT+ meeting point that engages in the 12-week walking program

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Identity leadership
timeFrame: 12 weeks
measure: Group identification scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Group cohesion
timeFrame: 12 weeks
measure: Well-being
timeFrame: 12 weeks
measure: Walking activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Katrien Fransen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fransen, K., Haslam, S. A., Steffens, N. K., Mallett, C. J., Peters, K., Mertens, N., & Boen, F. (2020). All for us and us for all: Introducing the 5R Shared Leadership Program. Psychology of Sport and Exercise, 51, 101762. https://doi.org/10.1016/j.psychsport.2020.101762
citation: Fransen K, Cruwys T, Haslam C, Iserbyt P, Seghers J, Vanderlinden J, van Uffelen J, Verbaanderd E, Boen F. Leading the way together: a cluster randomised controlled trial of the 5R Shared Leadership Program in older adult walking groups. Int J Behav Nutr Phys Act. 2022 Jun 3;19(1):63. doi: 10.1186/s12966-022-01297-x.
Clinical trial NCT00566423: Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)
Official title: Biomarkers in the Diagnosis and Assessment of PAH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Biomarkers
MIF
BNP
6 Minute Walk (6MW)
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization.
* Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization.

Exclusion Criteria:

* Significant left heart disease or renal insufficiency (serum creatinine \> 1.5 mg%).

Primary outcomes:
measure: Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH.
timeFrame: 2 year
Secondary outcomes:
measure: To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs
timeFrame: 2 year
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: North Shore-Long Island Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Arunabh Talwar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647123: Evaluation of Biomarker Levels in Blood, Saliva and Gingival Fluid in Periodontitis
Official title: Evaluation of Ischemic Modified Albumin, Catalase, Reduced Glutathione, Malondialdehyde, Adenosine Deaminase Levels in Blood, Saliva and Gingival Fluid in Periodontitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: periodontitis
catalase
malondialdehide
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Systemically healhty ,non-smokers,non-pregnants will be included in the study

Brief summary: The aim of this study was to compare IMA, MDA, CAT, GSH and ADA levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.

Detailed description: The research methodology was approved by the Van Yuzuncu Yıl University Clinical Research Ethics Committee. (Decision number: 06.06.2018/09).

The aim of this study is to compare Ischemia-modified albumin (IMA), malondialdehyde (MDA), Catalase (CAT), Glutathione (GSH) and Adenosine deaminase (ADA) levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.

In this study, 25 periodontally healthy individuals (control group) and 25 individuals with various levels of periodontal disease in different teeth will be included.

Gingival crevicular fluid, saliva and blood samples will be taken from patients with periodontally healthy teeth without any treatment.

In patients diagnosed with periodontal disease, teeth will be divided into 3 subgroups as hopeless, periodontitis and gingivitis. In patients with a diagnosis of periodontal disease, saliva and blood samples will be taken twice, before and after the training of scaling and root planing, desperate tooth extraction, oral hygiene motivation.

Eligibility criteria: Inclusion Criteria:

Systemically healhty non-smokers non-pregnants -

Exclusion Criteria:

- Patients with systemic disease smokers pregnants

Primary outcomes:
measure: adenosine deaminase
timeFrame: 1 year
measure: catalase
timeFrame: 1 year
measure: Ischemia-modified albumin
timeFrame: 1 year
measure: malondialdehide
timeFrame: 1 year
measure: glutathione
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yuzuncu yil university
Study officials:
affiliation: Yuzuncu Yıl University
name: hacer sahin aydınyurtt, assoc. prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584723: Microsurgery in the Elderly in a Private Practice Setting
Official title: Outcomes of Microsurgical Reconstruction in the Elderly Patient in a Private Practice Setting in México City: Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged
Microsurgery
Lead sponsor: Hospital Angeles del Pedregal
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients more than 65 years old, with indications for a free flap reconstruction.

Brief summary: This study reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Investigator will answer the question about the age as the variable of interest in this series in which age was not a factor in deciding reconstructive methods, and examine complication rates.

Detailed description: Investigators will evaluate the outcomes of 17 flaps in 14 patients who required microsurgical reconstruction with free flaps and microvascular vessels anastomosis. All patients more than 65 years old. Demographic data will be reported as: obesity, American Society of Anesthesiology (asa) level, radiotherapy, combined surgery. And the results of investigation will include: Flap survival, local complications, systemic complications, re-interventions, 30-day mortality.

Eligibility criteria: Inclusion Criteria:

* Elderly population, defined as more than 65 years old
* Patients underwent to free flap microsurgical procedures.
* Complete files
* Patient acceptance to participate

Exclusion Criteria:

* Lost follow up

Primary outcomes:
measure: Flap survival
timeFrame: 1 month
measure: Complications
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital Angeles Pedregal
state: Cdmx
Study officials:
References:
Clinical trial NCT06170723: A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants
Official title: A Phase 1, 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Itraconazole, Food, and pH, on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986368
Itraconazole
Famotidine
Food Effect
Healthy Volunteers
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) to 33.0 kg/m\^2, inclusive.

Exclusion Criteria:

* Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
* Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
* Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 11 days
measure: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 11 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 11 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 41 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 17 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 17 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 17 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 17 days
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Local Institution - 0001
state: Arizona
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02483923: Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: serratus anterior block
ultrasound
breast cancer
postoperative pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.


Eligibility criteria: Inclusion Criteria:

1. ASA 1\~3
2. Age 20\~80
3. Breast cancer patient twho are scheduled for elective mastectomy

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Severe cardiovascular disease
4. Renal failure
5. Liver failure
6. Neurologic and psychologic disease
7. Chronic treatment with analgesics
8. Previous history of mastectomy or thoracic surgery.

Primary outcomes:
measure: Total opioid consumption
timeFrame: within 24 hrs after mastectomy
Secondary outcomes:
measure: Postoperative pain scale (Numeric rating scale 0-10) at PACU
timeFrame: chang from 3,6,12,24 to 48hrs after operation end
measure: Total intraoperative remifentanil consumption(mcg)
timeFrame: within 24 hrs after mastectomy
measure: Additional analgesics requirements (dose/number)
timeFrame: within 24 hrs after mastectomy
measure: incidence and intensity of postoperative nausea and vomiting(NRS:0-10)
timeFrame: within 24 hrs after mastectomy
measure: Total hospital staying time
timeFrame: within 24 hrs after mastectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: