louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02543073: MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
Official title: Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lung Diseases, Interstitial
Hematopoietic Stem Cell Transplantation
Bronchiolitis Obliterans
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2015-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality. At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as the treatment of ILD will be evaluated in the recipients of allo-HSCT.

Detailed description: ILD is a group of diseases involving pulmonary interstitial, alveolar and (or) bronchioles. In the patients receiving allo-HSCT, ILD mainly present as bronchiolitis obliterans syndrome (BOS). ILD after HSCT is characterized by non-responsiveness to treatment, leading to high morbidity and mortality. MSC has been considered as an effective treatment for refractory acute graft-versus-host disease (aGVHD), but the response to treat chronic GVHD (cGVHD), especially refractory BOS, is rarely reported.

Eligibility criteria: Inclusion Criteria:

* Receiving allo-HSCT
* Diagnosed with ILD after allo-HSCT

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: Response rate of ILD
timeFrame: 4 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olivieri A, Locatelli F, Zecca M, Sanna A, Cimminiello M, Raimondi R, Gini G, Mordini N, Balduzzi A, Leoni P, Gabrielli A, Bacigalupo A. Imatinib for refractory chronic graft-versus-host disease with fibrotic features. Blood. 2009 Jul 16;114(3):709-18. doi: 10.1182/blood-2009-02-204156. Epub 2009 Apr 29.
citation: Chen S, Zhao K, Lin R, Wang S, Fan Z, Huang F, Chen X, Nie D, Du X, Guo Z, Lin D, Xuan L, Xu N, Sun J, Peng Xiang A, Liu Q. The efficacy of mesenchymal stem cells in bronchiolitis obliterans syndrome after allogeneic HSCT: A multicenter prospective cohort study. EBioMedicine. 2019 Nov;49:213-222. doi: 10.1016/j.ebiom.2019.09.039. Epub 2019 Oct 23.
Clinical trial NCT06504173: Diced Cartilage in Breast Reconstruction
Official title: Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mammaplasty
Microsurgery
Rip Reconstruction Cartilage
Lead sponsor: ISAR Klinikum
Sponsor class: OTHER
Collaborators: name: Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany
First posted: 2024-07-16
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of women who received autologous free flap breast reconstruction using internal mammary vessels as recipient vessels.

Brief summary: Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

Detailed description: This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; \> 6 months post-op) and photographic documentation (6-month follow-up).

Eligibility criteria: Inclusion Criteria:

* Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
* MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

Exclusion Criteria:

* Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
* Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023

Primary outcomes:
measure: Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area
timeFrame: October 2021 to June 2023
Secondary outcomes:
measure: Visual contour deficit of the recipient vessels area
timeFrame: October 2021 to June 2023
Other outcomes:
Locations:
city: Munich
country: Germany
facility: ISAR Klinikum - Department Plastic Surgery
state: Bavaria
city: Munich
country: Germany
facility: ISAR Klinikum
state: Bavaria
Study officials:
affiliation: Head of Department plastic and reconstructive surgery ISAR Klinikum
name: Ulf Dornseifer, MD/PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00474773: Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery
Official title: Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Management
Function
Minimally Invasive Total Knee Arthroplasty
Celecoxib
Lead sponsor: St. Louis Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Zimmer Biomet
First posted: 2007-05-17
Enrollment: 107
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: total knee canidates

Brief summary: This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day.

This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.


Eligibility criteria: Inclusion Criteria:

* having undergone a minimally invasive total knee by select surgeon
* voluntarily enrolled
* independent community ambulators
* only patients being discharged directly home

Exclusion Criteria:

* celecoxib allergy or intolerence
* Renal insufficiency (defined as serum creatine level \>1.5 mg/dL or BUN level \>22mg/dL
* History of bleeding gastic or duodenal ulceration
* New York Heart Association Class III or IV Congestive Heart Failure
* Previous myocardial infarction or cerebralvascular event
* Severe inflammatory bowel disease
* Known coagulation abnormality or hepatic disease
* Chronic coumadin administration
* Refusal by primary or cardiac physician

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: DePaul Health Center
state: Missouri
Study officials:
affiliation: St. Louis Joint Replacement Institute
name: William C Schroer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05604573: DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer
Official title: DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Circulating Tumor DNA
DNA mutation
DNA methylation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GENECAST Co., Ltd.
First posted: 2022-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 or older who diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins

Brief summary: Based on the cell free nucleic acid analysis information of blood samples and genetic mutation profile of EUS-FNB tissue from pancreatic cancer, the concordance between them is evaluated. And based on this information, biomarkers for diagnosis, treatment, and prognosis of pancreatic cancer are explored.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
* Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
* Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group

Exclusion Criteria:

* Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
* If a laboratory test is impossible due to a qualitative problem with the collected blood sample
* Where the collected tissue does not contain tissue of the desired malignant or benign disease

Primary outcomes:
measure: correlation of genetic mutation
timeFrame: the day of study enrollment (baseline)
measure: detection sensitivity of genetic mutation by mmADPS
timeFrame: the day of study enrollment (baseline)
Secondary outcomes:
measure: correlation of genetic mutation and prognosis
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05075473: SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
Official title: SEGMENTAL STABILIZATION AND GENERAL LUMBER STABILIZATION EXERCISE IN CHRONIC LOW BACK PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Segmental Stabilization
Generalized Segmental Stabilization Exercises
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 44 patients with chronic low back pain, distributed randomly in to two groups.
Primary purpose: TREATMENT

Brief summary: Chronic low back pain effects more than 50% of general population. It's prevalence is higher is young adults that are economically active adults.

Its significance is often underestimated because usually young adults ignore these initial episodes of low back pain due to their busy life style or life full of commitments. Approximately 70% of adults have at least one episode of low back pain during their lifetimes.

Detailed description: It will be randomized control trial with 60 patients with chronic low back pain divided into 2 groups. One group will be given segmental stabilization whose purpose is to achieve segmental control over primary stabilizers. Second group will be given just generalized lumber stabilization exercises as it includes close chain exercises with low velocity as well as low load. This study will be conducted in Rehabilitation setup of Benazir Bhutto hospital Rawalpindi and IIRS that is Rehabilitation dept. at Al Nafees medical college and hospital, Islamabad. Non probability Convenience Sampling technique will be utilized

Eligibility criteria: Inclusion Criteria:

* Both males and females will be included in the study

Exclusion Criteria:

* Age limits of subjects will be between 15 to 60

Primary outcomes:
measure: VAS
timeFrame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
measure: Oswestry disability Index
timeFrame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
measure: International physical activity questionnaire
timeFrame: Only one reading is required that is the baseline reading.
Secondary outcomes:
Other outcomes:
measure: ROM
timeFrame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
Locations:
city: Islamabad
country: Pakistan
facility: Isra institute of rehabilitation sciences
Study officials:
affiliation: Isra Institute of rehabilitation
name: Dr. Summaiya Zaman, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538173: Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
Official title: Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Side Infections After Breast Reduction
Keywords: surgical side infection
breast reduction
reduction mammaplasty
prospective trial
microcirculation
breast surgery
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: University of Rostock
First posted: 2012-02-23
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.

Detailed description: Many studies identifying risk factors for surgical side infections (SSI) after breast surgery included a large percentage of breast conserving therapies and risk factors for patients undergoing more extensive procedures like breast reduction (BR) are underrepresented and risk factors for more extensive breast surgeries might not be identified. Our approach to decrease SSI after BR was the application of an i.v. isotonic crystalloid solution, 6% hydroxyethylstaerke (HES) as a diminished peripheral blood flow and impaired vasculogenesis are characteristics of poorly healing wounds. HES causes a medium- to long-term increase in blood volume, blood flow and improved blood oxygen transport. Blood flow and tissue oxygenation are parts of regulating the healing process by utilizing molecular oxygen as a terminal oxidant. This antioxidant capacity can influence the wound healing process positively, as a characteristic feature of the inflammatory phase is the oxidative burst. HES additionally decreases haematocrite, blood viscosity and aggregation of erythrocytes positively influencing the complex components regulating wound healing. These characteristics and the increase in blood circulation might influence the postoperative healing and regeneration process.

Eligibility criteria: Inclusion Criteria:

* Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.

Exclusion Criteria:

* Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery

Primary outcomes:
measure: Surgical side infection
timeFrame: 4 weeks
Secondary outcomes:
measure: Risk factors
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock, Department of Obstetrics and Gynecology
state: MV
Study officials:
affiliation: University of Rostock
name: Max Dieterich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01237873: Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Official title: A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Aliskiren
Amlodipine
Essential hypertension
Long term
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.


Eligibility criteria: Inclusion Criteria:

* Patients that complete CSPA100A1301 study
* Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria:

* Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
* Presence of major protocol violation in CSPA100A1301 study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
timeFrame: 52 weeks
Secondary outcomes:
measure: Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
timeFrame: 52 weeks
measure: The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshigaya city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kunitachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05087173: Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination
Official title: Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients.


Eligibility criteria: Inclusion Criteria:

* Individuals aged over 18 years who have been resident in the selected study district for more than six months;
* Willing to participate the study and provide informed consent.

Exclusion Criteria:

* Having ocular, hearing or mental disorders precluding reading or telephone interview.

Primary outcomes:
measure: Informed choice about COVID-19 vaccination (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
timeFrame: 2 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yingfeng Zheng, MD, PhD
state: Guangdong
Study officials:
References: