louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03107039: Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Official title: Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 50
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 group
Primary purpose: TREATMENT

Brief summary: This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.


Eligibility criteria: Inclusion Criteria:

* Experiencing depression symptoms and generally healthy.

Exclusion Criteria:

* Anyone assessed to be unsafe to be enrolled.

Primary outcomes:
measure: Depression symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Blood lipids
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College
name: Joseph Ciccolo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciccolo JT, Louie ME, SantaBarbara NJ, Webster CT, Whitworth JW, Nosrat S, Chrastek M, Dunsiger SI, Carey MP, Busch AM. Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy. BMC Psychiatry. 2022 Apr 21;22(1):283. doi: 10.1186/s12888-022-03935-x.
citation: Busch AM, Louie ME, SantaBarbara NJ, Ajayi AA, Gleason N, Dunsiger SI, Carey MP, Ciccolo JT. Effects of resistance training on depression and cardiovascular disease risk in Black men: Protocol for a randomized controlled trial. Ment Health Phys Act. 2019 Oct;17:100299. doi: 10.1016/j.mhpa.2019.100299. Epub 2019 Sep 12.
Clinical trial NCT02026739: The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy
Official title: The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxygenation Index
Keywords: minimally invasive esophagectomy; pulmonary function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study hypothesized that a relative low oxygen concentration (40%) supplemental would be advantageous to protect the pulmonary function of patients, comparied with conventional high oxygen concentration (80%). Therefore we raise this prospective randomized controlled research.

Detailed description: Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be randomizedly assigned to low oxygen concentration (40%) supplemental or high oxygen concentration(80%) supplemental group. Intra-operative and post-operative pressure of Oxygen in Arterial Blood will be examined, and the surgical outcome will be recorded in the two groups.

Eligibility criteria: Inclusion Criteria:

1. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.
2. Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).

Exclusion Criteria:

1. Patients with previous thoracic surgery history.
2. Patients with severe Co-morbidity.
3. Pulmonary function is abnormal in the examination before surgery.

Primary outcomes:
measure: The change of oxygenation index
timeFrame: Change from Baseline at post-operative Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Lijie Tan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05708339: Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects
Official title: Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Deformity External
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: : patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.


Eligibility criteria: Inclusion Criteria:

* Patients with missing or severely deformed ears.
* Patients with failed autogenous reconstruction.
* Compliant and cooperative patients.
* Patients committed to maintain the prosthesis.
* Patients willing to attend the follow up appointments.

Exclusion Criteria:

* Patients undergoing radiotherapy or chemotherapy treatment.
* Patients taking corticosteroids or bisphosphonates.
* Patients with contraindications for CT scanning.
* Patients with any debilitating medical condition.
* Patients with any type of psychosomatic disorder.
* Patients allergic to any of the materials used.

Primary outcomes:
measure: Prosthesis adaptation using Silicon replica measuring technique.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01415739: Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer
Official title: Evaluation of a Novel Molecular NSCLC Classification System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer registered on CALGB 9761

Brief summary: This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.

SECONDARY OBJECTIVES:

I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).

OUTLINE:

Previously collected tissue samples are analyzed via hematoxylin and eosin (H\&E) staining and immunohistochemistry (IHC).

Eligibility criteria: Inclusion Criteria:

* Patients must have been registered on CALGB-9761

  * Stage I disease
  * Treatment-naive patients
* A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
* A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
* Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required

Primary outcomes:
measure: Validation of a novel 4-protein signature's ability to subtype NSCLC
timeFrame: 1 month
Secondary outcomes:
measure: NSCLC misclassification rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Alliance for Clinical Trials in Oncology
state: Massachusetts
Study officials:
affiliation: Smilow Cancer Hospital at Yale-New Haven
name: Daniel J. Boffa, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03806439: Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
Official title: Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Delirium
Radical Cystectomy
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing radical cystectomy.

Brief summary: Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.

Detailed description: Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.

Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done.

Discussion Results of the study will be discussed compared to other studies.

Eligibility criteria: Inclusion Criteria:Adult patients undergoing radical cystectomy. -

Exclusion Criteria: Patient refusal.

-

Primary outcomes:
measure: Delirium
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Alexandria University
name: Mohammad Hazem I Ahmad Sabry, MB,ChB MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.
Clinical trial NCT00178139: Music Therapy for Patients Being Weaned From Mechanical Ventilation
Official title: Music Therapy as an Adjunctive Treatment in the Management of Stress for Patients Being Weaned From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Insufficiency
Keywords: Music Therapy
Mechanical ventilation
Weaning from mechanical ventilation
complementary and alternative therapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Arthur Flager Fultz Research Fund
First posted: 2005-09-15
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether Music Therapy interventions can be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management.Music used is varied according to subject's preferences.

Detailed description: Music therapy interventions will be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management. The intervention will consist of 40 - 50 minutes of active music therapy and improvisation in which the music is used as a distraction from the hospital setting and the procedure taking place. The intervention will end with 5 to 10 minutes of discussion of music activities/selections to be used between music therapy sessions. The intervention is individualized and can be modified accordingly to the subject's preferences.

Eligibility criteria: Inclusion Criteria:

* Anxiety
* weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours

-

Primary outcomes:
measure: Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects.
timeFrame: prospective
Secondary outcomes:
measure: Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures
timeFrame: prospective
measure: - decreased use of anxiolytic, antidepressant and antipsychotic agents.
timeFrame: prospective
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Olle Jane Z Sahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliva R, Hunter BC, Sahler OJZ, Gaisser D, Salipante DM. (2009). The Use of Music Therapy for Patients Being Weaned from Mechanical Ventilation: A Pilot Study. In Azoulay R & Loewy J (eds). Music, the Breath and Health: Advances in Integrative Music Therapy. New York: Satchnote Press.
Clinical trial NCT01384539: Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Official title: Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arterial Dysfunction
Chronic Kidney Disease
Keywords: chronic kidney disease
vitamin D deficiency
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-06-29
Enrollment: 128
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: The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate \[GFR\] 44-15 ml/min/1.73m2)
* Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level \< 30 ng/mL
* Corrected serum calcium \< 10.2 mg/dL
* Serum phosphate \< 4.6 mg/dL
* Serum albumin \> 3.0 g/dL
* Body mass index \< 40 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Expected to undergo living related kidney transplant in next 6 months
* Pregnant, breastfeeding, or unwilling to use adequate birth control
* History of severe liver disease
* Nephrotic range proteinuria (\> 3.5 gm/day)
* Use of active vitamin D analogs within 30 days of randomization

Primary outcomes:
measure: Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
timeFrame: 6 months
measure: Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920139: Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
Official title: Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus: Breast Cancer With Axillary Node Metastasis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Suros Surgical (now Hologic )
First posted: 2013-08-09
Enrollment: 105
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast.

Detailed description: Women with suspected or recently diagnosed breast cancer and ipsilateral abnormal appearing axillary lymph nodes underwent fine needle aspiration immediately followed by core biopsy of the same lymph node.Cytology results from the fine needle aspiration (FNA)and histology from the core biopsy were compared to surgical pathology from axillary node excision to determine if either method of percutaneous node sampling was more sensitive in detecting metastasis. Pain during each procedure was also compared.

Eligibility criteria: Inclusion Criteria:

* Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography.

Exclusion Criteria:

* Inability to understand consent form.
* Emotionally unprepared to discuss possibility of axillary metastasis
* Node not amenable to core biopsy

Primary outcomes:
measure: Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy
timeFrame: 1 week to 10 months
Secondary outcomes:
Other outcomes:
measure: Pain associated with each type of percutaneous biopsy procedure
timeFrame: immediate at time of biopsy
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
References:
citation: Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.