louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01409954: Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
Official title: Defining the Osteogenic Potential of Mesenchymal Stem Cells and Their Progenitors During Spinal Decompression and Posterolateral Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pseudarthrosis After Fusion or Arthrodesis
Keywords: Fusion
Spine
Decompression
Pseudarthrosis
bone harvest
Instrumented posterolateral fusion
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialty clinic, University of Utah Orthopaedic Center

Brief summary: The purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. Patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. By using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. This will help reduce the need for revision surgeries and improve patient recovery.

Detailed description: This study requests using your additional bone tissue (the extra tissue not needed after your back surgery is complete).

This tissue will be measured for total volume (amount), labeled with your age, gender, date and time the tissue was removed (date and time of surgery), and taken to a lab for analysis. You will not be billed for the collection of your additional tissue or the lab analysis. All routine procedures (surgery and all follow-up care relating to your back surgery) will still be paid for by you or your insurance.

Once your extra tissue sample has been collected, measured, labeled, and sent to the lab for testing, no further participation is required from you in this research study. The investigators will use your sample in our research to enhance bone healing.

Eligibility criteria: Inclusion Criteria:

* Patients electing to undergo spinal decompression with an instrumented posterolateral fusion

Exclusion Criteria:

* Patients not undergoing spinal decompression with an instrumented posterolateral fusion

Primary outcomes:
measure: Osteogenic Potential of Mesenchymal Stem Cells
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah Department of Orthopaedics
name: Brandon Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02595554: Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
Official title: Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Carcinoma Stage IIB
Keywords: Cervical cancer, Stage IIB, Neoadjuvant chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Detailed description: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).

Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma
* Original clinical stage must be IIB （FIGO 2009）
* Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
* Age between 18-65
* Patients must give signed informed consent

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Investigator consider the patients can't finish the whole study
* With normal liver function test (ALT、AST\>2.5×ULN)
* With normal renal function test (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm3

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Ph. D
role: STUDY_DIRECTOR
References:
citation: Tu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9.
Clinical trial NCT02720354: A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Official title: A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: Synektik S.A.
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2016-03-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: \[11C\]-dimethyl-diphenyl ammonium (\[11C\]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) between 18.0 and 30.0 kg/m2
* good health
* written informed consent

Exclusion Criteria:

* smokers
* subject receiving medication
* a blood transfusion in the 4 weeks prior to screening
* positive alcohol blood test
* Subjects who suffer from claustrophobia
* Subjects who have had a clinically significant illness
* Subjects exposed to radiation within 12 months prior to screening

Primary outcomes:
measure: Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second).
timeFrame: within 80 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01758354: Newborn Screening Assay of Pompe's Disease
Official title: Newborn Screening Assay of Pompe's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pompe Disease
Keywords: Pompe disease
alpha glucosidase deficiency
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 236536
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to test the feasibility of a newborn screen assay for Pompe disease

Detailed description: DBS from newborn will be tested for acid alpha-glucosidase (GAA) activity. Babies with low GAA activity will be confirmed for Pompe disease.

Eligibility criteria: Inclusion Criteria:

* newborns receiving newborn screening in Newborn Screening center of National Taiwan Univeristy Hospital
* parents signed inform consent for this study

Exclusion Criteria:

-

Primary outcomes:
measure: detect patients with infantile onset Pompe disease
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Whu-Liang Hwu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715554: Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients
Official title: Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients: Results of a Pilot, Pragmatic, Randomized, Open Label, Controlled Trial Investigating Acceptability and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID Syndrome
Keywords: Rehabilitation
Homeopathy
Post-COVID Syndrome
Lead sponsor: Innowage Limited
Sponsor class: INDUSTRY
Collaborators: name: Gyansanjeevani India
name: Collaborative Homeopathy Research Network
First posted: 2023-02-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A growing number of studies identify a spectrum of persistent symptoms experienced by COVID-19 patients for months after recovery. Symptoms include cough, fatigue, dyspnea, pain, and brain fog (cognitive impairment, including confusion and memory loss), which have a negative impact on daily activities. Homoeopathic practitioners from around the world have documented a number of successful cases of Post COVID treatment. Even though evidence from practice-based research is limited, the purpose of the current study was to evaluate the effect of individualized homoeopathy treatment on post-COVID syndrome.


Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 history
* Persistent respiratory symptoms for more than three months after COVID-19
* Able to provide informed consent

Exclusion Criteria:

* Presence of respiratory issues without COVID-19 diagnosis
* On complementary and Alternative Treatment
* Symptoms of infection
* Pregnancy or Breastfeeding
* Cognitive impairment

Primary outcomes:
measure: Cough severity
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in dyspnea
timeFrame: 8 weeks
measure: Change in Fatigue
timeFrame: 8 weeks
measure: change in Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dausa
country: India
facility: Gyansanjeevani India
state: Rajasthan
city: Jaipur
country: India
facility: Gyansanjeevani India
state: Rajasthan
city: Mandawa
country: India
facility: Gyansanjeevani India
state: Rajasthan
city: Sawai Madhopur
country: India
facility: Gyansanjeevani India
state: Rajasthan
city: Sīkar
country: India
facility: Gyansanjeevani India
state: Rajasthan
Study officials:
affiliation: Gyansanjeevani India
name: Sadhana Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Collaborative Homeopathy Research Network
name: Vesna Marinković
role: STUDY_DIRECTOR
affiliation: Innowage Limited
name: Neha Sharma
role: STUDY_CHAIR
References:
Clinical trial NCT06720454: Study on Single-cell Regulons Atlas of Pancreatic Ductal Adenocarcinoma
Official title: Multiplex Immunofluorescence Staining of Pathological Tissue Microarray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Molecular Prognostic Model
Regulons
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 68

Brief summary: The first purpose of this study is to reveal the gene regulatory network of pancreatic cancer by analyzing single-cell transcriptome sequencing data and to draw a pancreatic cancer regulator map. In addition, bulk transcriptome sequencing data are combined to construct and verify the genetic prognostic model of pancreatic cancer regulators, providing clinical tools for accurate prognostic stratification and personalized treatment of pancreatic cancer patients. The second purpose of this study is to explore the molecular mechanism by which the key oncogene in the gene prognostic model promotes pancreatic cancer advance. New ideas and scientific basis are provided for finding potential molecular targets for the treatment of pancreatic cancer. Thus, the investigators included a Tissue Microarray (TMA)-based cohort of 68 PDAC patient tissue samples. TMA was obtained from OUTDO BIOTECH (Shanghai, China). The study was approved by the institutional review board, and ethics document number is YB M-05-01.


Eligibility criteria: Inclusion Criteria:

* Pancreatic ductal adenocarcinoma
* With post-operative paraffin specimens

Exclusion Criteria:

* Other types of pancreatic cancer other than pancreatic ductal adenocarcinoma
* Without post-operative paraffin specimens or less than 20% of the paraffin sections contain cancerous tissue

Primary outcomes:
measure: Intensity of immunofluorescence staining
timeFrame: From January 2019 to January 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00611754: Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: Phase II Study of Oxaliplatin in Combination With 5-Fluorouracil (5-FU) in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)


Eligibility criteria: Inclusion Criteria:

Patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage III-IV) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used \< or=to 300 mg/m² or carboplatinum total dose used \< or=to 200mg/m²), at least 1 target lesion (measurable in 2 dimensions \> or=to 20 mm on computed tomography (CT) or magnetic resonance imaging (MRI) evaluated \< 15 days before start of study treatment, outside of irradiated fields),performance status (PS) \< or =to 2 World Health Organization (WHO), weight loss \< 5% normal weight,hemoglobin \> or =to 10 g/dL, neutrophils \> or =to 2000/mm3, platelets \> or =to 100,000/mm3 , creatinine \< or =to 1.5 x upper limit of normal (ULN), bilirubin \< or =to .5 x ULN, alanine amino-transferase (ALT)/aspartate amino-transferase (AST)\< or =to 2.5 x ULN (5 x ULN if liver metastases), clotting: prothrombin time (PT) \> or =to 60%. Written informed consent signed by patient and doctor prior to all study procedures -

Exclusion Criteria:

-

Primary outcomes:
measure: To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer.
Secondary outcomes:
measure: To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Nathalie Billon
role: STUDY_DIRECTOR
References:
Clinical trial NCT01191554: Dose-ranging Study of Tranexamic Acid in Valve Surgery
Official title: Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Valvular Heart Surgery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 175
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: Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.


Eligibility criteria: Inclusion Criteria:

* valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

* a history of bleeding disorders
* active chronic hepatitis or cirrhosis
* chronic renal insufficiency (serum creatinine \> 2 mg/dl)
* preoperative anemia (Hb \< 10 g/dl)
* previous cardiac surgery
* urgent and emergency surgery

Primary outcomes:
measure: Frequency of allogeneic red blood cells transfused
timeFrame: 7 days post-operation
Secondary outcomes:
measure: Chest tube drainage
timeFrame: 6 hours post-operation
measure: Chest tube drainage
timeFrame: 24 hours post-operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
Study officials:
affiliation: Fuwai Hospital & Cardiovascular Institute
name: Lihuan Li, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04882254: Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
Official title: Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Kidney Transplant Failure
Chronic Kidney Failure
Keywords: Normothermic kidney machine perfusion
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
Primary purpose: TREATMENT

Brief summary: This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* kidney-only transplant
* renal replacement therapy at time of transplant
* receiving standard immunosuppression regimen post-transplant.
* Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.

Exclusion Criteria:

* pre-emptive at time of transplant
* receive a multi-organ or dual kidney transplant
* age donor or recipient below 18 years
* Maastricht type I and II DCD
* donor kidneys preserved on static cold storage (SCS)
* kidneys retrieved after normothermic regional perfusion (NRP)
* Recipient virtual panel reactive antibodies ≥85%
* Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria

Primary outcomes:
measure: Number of patients with immediate graft function
timeFrame: 3 months
Secondary outcomes:
measure: Duration of delayed graft function
timeFrame: 3 months
measure: estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant
timeFrame: 1 year
measure: Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant
timeFrame: 1 year
measure: all-cause and death-censored graft survival up to 5 years
timeFrame: 5 years
measure: patient survival up to 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC Transplant Institute
Study officials:
References:
citation: Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.