louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00692692: Use of Dermal Matrix in Breast Reconstruction
Official title: The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

Detailed description: We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Eligibility criteria: Inclusion Criteria:

* All women who are candidates for breast reconstruction using tissue expanders after mastectomy

Exclusion Criteria:

* Other forms of breast reconstruction after mastectomy

Primary outcomes:
measure: Patient Satisfaction With the Procedure
timeFrame: one year from time of operation
measure: Post Surgical Infection
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jason Wendel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06952192: Virtual Reality During Skin Prick Test
Official title: Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: virtual reality
skin prick test
pediatric allergy
anxiety
pain
compliance
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.

To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.


Eligibility criteria: Inclusion Criteria:

* a confirmed history of allergic symptoms related to either environmental or food allergens
* between 4 and 18 years of age

Exclusion Criteria:

* history of seizure disorders,
* motion sickness,
* severe developmental delay,
* non-Italian-speaking patients
* Participants who had used systemic antihistamines or corticosteroids within the past seven days

Primary outcomes:
measure: change of procedural anxiety in pediatric patients undergoing skin prick test
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Univeristy of Naples Federico II
Study officials:
References:
Clinical trial NCT02870192: Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Official title: Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Prolapse
Keywords: Rectal Prolapse
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.

Detailed description: Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.

Eligibility criteria: Inclusion Criteria:

* all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse

Exclusion Criteria:

* other condition than rectal prolapse

Primary outcomes:
measure: intra-operative complications
timeFrame: 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rome Tor Vergata
name: Pierpaolo Sileri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06501092: To Assess the Utility of the Point Mini in a Clinical Take-home Study
Official title: To Assess the Utility of the Point Mini in a Clinical Take-home Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation; Traumatic, Hand
Amputation, Congenital
Lead sponsor: Point Designs
Sponsor class: INDUSTRY
Collaborators: name: Children's Healthcare of Atlanta
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-15
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.


Eligibility criteria: Inclusion Criteria:

* Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
* Intact thumb with full range of motion
* Fluent in English
* Age between 5 and 15 years

Exclusion Criteria:

* Patients with a residual limb that is unhealed from the amputation surgery
* Unhealed wounds
* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist

Primary outcomes:
measure: ABILHAND-Kids
timeFrame: Baseline (pre-fitting)
measure: DISABKIDS
timeFrame: Baseline (pre-fitting)
measure: ABILHAND-Kids
timeFrame: Immediately post-fitting
measure: DISABKIDS
timeFrame: Immediately post-fitting
measure: ABILHAND-Kids
timeFrame: 30 days post-fitting
measure: DISABKIDS
timeFrame: 30 days post-fitting
measure: ABILHAND-Kids
timeFrame: 60 days post-fitting
measure: DISABKIDS
timeFrame: 60 days post-fitting
Secondary outcomes:
measure: Weekly Diary Entries
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Point Designs
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Point Designs
name: Levin Sliker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04865692: Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Official title: Effects of Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis.

A single blinded randomized controlled trial conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Defense Road, Lahore.

Total 60 participants were randomly assigned in to two groups, with 30 in each group The intervention group received routine physiotherapy program combined with Low Intensity Blood Flow Restriction Technique (LI-BFR. While control group were treated with only routine physiotherapy.

Dynamometer was used to assess the knee extensor strength while Knee injury and osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on SPSS version 23.

Detailed description: nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test was used for comparison between groups.

Randomization had done through the sealed envelope method. After allocation subjects had received their treatment protocals.

Eligibility criteria: Inclusion Criteria:

* Diagnosed patients of grade II knee osteoarthritis
* Patient's age 45-65

Exclusion Criteria:

* Bilateral knee replacement
* Lower limb surgery in the last six months
* Diagnosis of inflammatory joint or muscle disease
* Chest pain during exercise or at rest; or need for supplemental oxygen
* Pregnancy
* Any systemic disease

Primary outcomes:
measure: Quadriceps muscle strength
timeFrame: 12 Weeks
measure: thigh muscle size
timeFrame: 12 weeks
measure: Pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Activities of daily living
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: zoya Mujahid, DPT
role: STUDY_CHAIR
References:
Clinical trial NCT05334992: Reducing Mental Health in Informal Caregivers
Official title: Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Grief
Burden, Caregiver
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia

Detailed description: Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients.

Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.

Eligibility criteria: Inclusion Criteria:

* Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia
* Informal caregivers can be family members or close friends
* Adults (18 to 89 years old) who read, write, and speak in English
* Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder

Exclusion Criteria:

* Formal caregivers (who are being paid to take care of the patient)
* Any informal caregivers with cognitive impairment is identified during the assessment.

Primary outcomes:
measure: Prolonged Grief Scale-12 (measuring pre-death grief)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Zarit Burden Inventory (ZBI)
timeFrame: through study completion, an average of 6 months
measure: Perceived Stress Scale
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: jonsinge@ttu.edu
name: Jonathan D Singer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120692: Treatment for Patients Suffering From Anemia Due to Chemotherapy
Official title: An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Anemia
Keywords: breast cancer
darbepoetin alfa
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-19
Sex: FEMALE
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 validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility criteria: Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Anemia correction
Secondary outcomes:
measure: Activities of daily living, patient preference
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Senecal FM, Yee L, Gabrail N, Charu V, Tomita D, Rossi G, Schwartzberg L. Treatment of chemotherapy-induced anemia in breast cancer: results of a randomized controlled trial of darbepoetin alfa 200 microg every 2 weeks versus epoetin alfa 40,000 U weekly. Clin Breast Cancer. 2005 Dec;6(5):446-54. doi: 10.3816/cbc.2005.n.050.
Clinical trial NCT05862792: Liposomal Bupivacaine and Transoral Robotic Surgery
Official title: Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Cancer
Dysphagia, Oropharyngeal
Post Operative Pain
Transoral Robotic Surgery
Keywords: oropharyngeal cancer
squamous cell carcinoma
postoperative pain
transoral robotic surgery
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 80
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: Adult patients undergoing TORS

Brief summary: This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.


Eligibility criteria: Inclusion Criteria:

* Adult patients, greater than or equal to 18 years of age; Patients of all genders; Patients undergoing transoral robotic surgery; Patient who are able and willing to give consent

Exclusion Criteria:

* Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency

Primary outcomes:
measure: Postoperative Pain Control
timeFrame: 3 months
measure: Postoperative Dysphagia with Endoscopic Swallow Study
timeFrame: 3 months
measure: Postoperative Dysphagia with Dysphagia Survey
timeFrame: 3 months
Secondary outcomes:
measure: Postoperative Pain Medication Usage
timeFrame: 3 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06624592: Sevoflurane/Dexmedetomidine Vs. Isoflurane for Pediatric Emergence Delirium
Official title: Sevoflurane/Dexmedetomidine Vs. Isoflurane and Their Effects on Pediatric Emergence Delirium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Delirium on Emergence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 2-7 years.
* Surgeries include ENT cases (i.e., tonsillectomy/adenoidectomy), ophthalmology cases (i.e., strabismus), and urology cases.
* Can be outpatient or General Care inpatient procedures.
* All cases must include an IV and an endotracheal tube (ETT).

Exclusion Criteria:

* Severe developmental/cognitive delay (unable to make eye contact, nonverbal, or inability to interact with providers for PAED scale assessment requirements)
* TIVA cases.
* No PIV in place during the case, planned PICU admission postoperatively.
* Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated).

Primary outcomes:
measure: Number of subjects with emergence delirium
timeFrame: Within 1 hour after dropped off by anesthesiology team
Secondary outcomes:
measure: Post Anesthesia Care Unit (PACU) length of stay
timeFrame: Post-procedural (0-4 hours after anesthesiology drop off)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lindsay Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372292: Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
Official title: Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorenal Syndrome
Keywords: cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Although the traditional determinant of renal dysfunction in heart failure was suggested as decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the association of persistent systemic venous congestion and kidney dysfunction. Relief of the congestion has demonstrated to improve renal functions in decompensated heart failure. The current trial was set up to investigate the changes of renal venous impedance and renal arteriolar resistivity indices with diuretic therapy, in patients with congestive renal failure. The investigators asked whether measurement of renal venous impedance index or renal arteriolar resistivity index can guide the practice of diuretic therapy.


Eligibility criteria: Inclusion Criteria:

* Decompensated heart failure
* Elevated serum creatinine levels on admission

Exclusion Criteria:

* Atrial fibrillation
* Obstructive uropathy
* Patients with ascites
* Patients who exposed the potential nephrotoxic drugs in the previous week (metformin, antibiotics, chemotherapeutics, iodinated contrast agents and non-steroidal anti-inflammatory agents)
* Patients who needed positive inotropic agents

Primary outcomes:
measure: Alterations in the renal arterial resistivity index
timeFrame: during hospitalization, an expected average of 4 weeks.
Secondary outcomes:
measure: Alterations in the renal venous impedance index
timeFrame: during hospitalization, an expected average of 4 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine, Department of Cardiology
Study officials:
References: