louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03645187: Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
Official title: Evaluation of Anticancer Effect of Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Colon Cancer Stage
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 50
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: The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Detailed description: The primary aim of the study is to evaluate the anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Eligibility criteria: Inclusion Criteria:

* advanced colorectal cancer

Exclusion Criteria:

* cerebral metastases
* other malignancy
* H pylori infection
* thromboembolism

Primary outcomes:
measure: number of patients with improved radiology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Amira Roushdy
state: Elgharbia
Study officials:
affiliation: Clinical pharmacy Department- Tanta University
name: Tarek M Mostafa, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Oncology - Tanta University
name: Mohamed Alm El-din, prof
role: STUDY_DIRECTOR
affiliation: Clinical pharmacy Department- Tanta University
name: Amira Roushdy, Msc
role: STUDY_DIRECTOR
References:
citation: Mostafa TM, Alm El-Din MA, Rashdan AR. Celecoxib as an adjuvant to chemotherapy for patients with metastatic colorectal cancer: A randomized controlled clinical study. Saudi Med J. 2022 Jan;43(1):37-44. doi: 10.15537/smj.2022.43.1.20210574.
Clinical trial NCT02740387: Open Label Study of OTO-104 in Subjects With Meniere's Disease
Official title: A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Meniere's Disease
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject has a diagnosis of definite unilateral Meniere's disease.
* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

* Subject has an infection in the ear, sinuses, or upper respiratory system.
* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.

Primary outcomes:
measure: Evaluation of adverse events as a measure of safety and tolerability
timeFrame: Up to 1 Year
Secondary outcomes:
measure: Change in hearing from baseline as assessed by audiometry
timeFrame: Up to 1 Year
measure: Changes in patient condition assessed by otoscopy
timeFrame: Up to 1 Year
measure: Changes in patient condition assessed by tympanometry
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: London
country: Canada
facility: Call Otonomy call center for trial locations
state: Ontario
Study officials:
affiliation: Otonomy, Inc.
name: Kathie Bishop, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT07005687: Using MSCs for Chronic Active Antibody Mediated Rejection
Official title: Using MSCs for Chronic Active Antibody Mediated Rejection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant Rejection
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cell (MSCs) therapy has already been studied in kidney transplant recipients (KTRs), and the available data showed that it is safe and well tolerated. The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR received treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and were followed for up to 12 months. The primary endpoints were safety by assessment of adverse events. Secondary endpoints included assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts. A total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. We found that AMR did not improve in any of the patients after treatment with MSCs. In addition, serious adverse events were observed in one case when autologous MSCs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.

Detailed description: The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR will receive treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and will be followed for up to 12 months. The primary endpoints are safety by adverse events. Secondary endpoints include assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts.

Eligibility criteria: Inclusion Criteria:

* chronic active antibody mediated rejection in kidney transplanted recipients

Exclusion Criteria:

-

Primary outcomes:
measure: progression of chronicity index
timeFrame: one year after administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03229187: Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer
Official title: Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasms
Cervical Cancer
Uterine Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Wuhan Central Hospital
First posted: 2017-07-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed Ib\~ IIb cervical carcinoma underwent Neoadjuvant Chemotherapy

Brief summary: Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.

However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.

This study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Untreated cervical cancer with FIGO stage Ib-IIb
* Measurable lesions
* Possible to radical hysterectomy
* Age: 18 and older
* Karnofsky Performance Status≥ 70.
* WBC \> 3,000/mm³, Hb \> 9.0g/dl, Platelet \> 100,000 /mm³, SGOT/SGPT \< 60 IU/L, T-Bil \< 1.5 mg/dL, Cr \< 1.2 mg/dL, PaO2 \> 80 torr, normal ECG
* Written informed consent

Exclusion Criteria:

* Previous history of cancer
* Patients with previous treatment
* Patients without information of clinical risk factors
* Patients who have active infection

Primary outcomes:
measure: The clinical response to neoadjuvant chemotherapy
timeFrame: 1 to 3 months
Secondary outcomes:
measure: The pathological response to neoadjuvant chemotherapy
timeFrame: 1 to 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT06666387: The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.
Official title: The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: The Evaluation of a New MD - Combined PET-MR System
Lead sponsor: Siemens Healthcare A/S
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical investigation is used to evaluate the novel PET-MR scanner and it is a clinical investigation under MDR.

The focus is on the evaluation of the diagnostic image quality in a clinical setting, considering the speed of the examination and the new functionalities to minimize the patient's lying times. Based on the assessment, the defined protocols and measurement sequences are further improved as necessary to optimize the clinical value of the sequences and user interface components.


Eligibility criteria: Inclusion Criteria:

* Adult test subjects for whom a PET-MR examination is indicated and will be performed, or
* Test subjects for whom a PET-CT examination is indicated and will be performed
* Test subjects of legal age who have given their written informed consent to participate in the clinical investigation
* Written consent of the test subject to be informed in the event of suspected clinically relevant incidental findings
* Written consent to the disclosure of a clinically relevant incidental finding to a subsequent physician (release from the duty of confidentiality)
* The test subject´s written consent that the recorded image data may be made available to Siemens Healthcare A/S in pseudonymized form
* Test subjects whose weight does not exceed the permissible weight limit of the patient table (200 kg).

Exclusion Criteria:

* Metal in and on the body that causes stress to the test subject during an examination in the FoV of the combined PET-MR system
* All pacemakers and other implants
* Pregnancy: The exclusion of test subjects of childbearing potential is carried out based on a positive pregnancy test
* Test subjects who indicate an increased sensitivity to loud noises
* Test subjects who are incapable of giving consent.

Primary outcomes:
measure: Evaluation of the diagnostic image quality (software and hardware) of the novel combined PET-MR system NextGen PET-MR in the clinical setting.
timeFrame: Estimated 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04167787: Intelligent Operating Room (InOR) for Orthopaedic Surgery
Official title: Intelligent Operating Room (InOR) for Orthopaedic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Replacement
Musculoskeletal
Keywords: Surgery
Lead sponsor: Digital Surgery Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University College London Hospitals
First posted: 2019-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Adult patients undergoing elective total and unicondylar knee replacement.

Brief summary: The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.


Eligibility criteria: * Inclusion Criteria:
* Adult patients 18-99 years.
* All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
* Exclusion Criteria:
* Patients/staff who are unwilling to participate in the study
* Patients/staff that withdraw from the study
* Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities,
* Single stage revision procedures with the need for special instruments and modified steps
* Patients with cognitive impairment/ special cognitive needs.
* \<18 years old

Primary outcomes:
measure: Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).
timeFrame: 14 months
Secondary outcomes:
measure: Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.
timeFrame: 14 months
measure: To provide automatic post-operative analytics after each surgical operation (up to 150 cases).
timeFrame: 14 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital NHS Trust
Study officials:
References:
Clinical trial NCT01428687: Short Term Effects of Increasing Sleep Duration
Official title: Increasing Sleep Duration: A Novel Approach to Weight Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: Weight loss
Sleep duration
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.

Detailed description: Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.

Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.

Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.

Eligibility criteria: Inclusion Criteria:

* age 25 to 45;
* BMI 25 to 50;
* healthy;
* sleep 6.5 hours or less per night

Exclusion Criteria:

* use of sleep medications;
* sleep apnea;
* third shift worker

Primary outcomes:
measure: Sleep Duration
timeFrame: 4 weeks
Secondary outcomes:
measure: Eating Behavior
timeFrame: 4 weeks
measure: Physical Activity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R. Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914987: Determining Individualized Cancer Therapy in Pancreatic Cancer
Official title: Profile-Related Evidence Determining Individualized Cancer Therapy in Pancreatic Cancer (PREDICT-PANC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasms
Keywords: Mutation
Genomics
Targeted Therapy
Cancer
Pancreas
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from individuals seeking treatment for pancreatic cancer who have had next generation genomic sequencing of their tumors.

Brief summary: This is a non-therapeutic exploratory observational precision oncology study designed to collect and analyze data that demonstrate the clinical efficacy and tolerability of personalized treatments based on molecular tumor profiling assessments (i.e., matched therapy) in adult pancreatic cancer patients. Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well molecular testing might predicts response to therapy. Patient demographic and outcome parameters to be evaluated include, but are not limited to, tumor response, time to treatment failure, patient survival, and toxicity.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Pathologically confirmed pancreatic cancer.
* Ability to understand a written informed consent document and the willingness to sign it

Exclusion Criteria:

* Age \<18 years.
* Primary cancer diagnosis other than pancreatic cancer.

Primary outcomes:
measure: Number of Subjects Receiving Targeted Therapy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mandana Kamgar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06607887: The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy
Official title: The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infection Wound
Antibiotic Resistant Infection
Keywords: antibiotic
prophylaxis
cholecystectomy
postoperative
Lead sponsor: Minia University Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection.


Eligibility criteria: Inclusion Criteria:

* Adult patients (aged above 18 years) undergoing laparoscopic cholecystectomy.

Exclusion Criteria:

* patients with comorbidities (Diabetes, malignancies, Immunosuppressed). Lost of follow-up. Patients received antibiotics within 72 hr before admission. Complicated cases involved, gangrenous and perforated cholecystitis and abscess.

Primary outcomes:
measure: Surgical site infection
timeFrame: 4 weeks
Secondary outcomes:
measure: Fever
timeFrame: 4 weeks
measure: Length of the hospital stay
timeFrame: 4 weeks
measure: Hematoma and Seroma formation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Sohag University
name: Asmaa A Elsayed, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04555187: Cardiovascular Risk Stratification in Covid-19
Official title: Cardiovascular Risk Stratification in Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cardiovascular Risk Factor
Keywords: Covid19
cardiovascular risk factor
electrocardiogram
risk stratification
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 1355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Records of patients who had Covid19 test performed

Brief summary: This retrospective double-cohort study seeks to:

1. Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and
2. Develop a method of cardiovascular risk stratification in COVID-19


Eligibility criteria: Inclusion Criteria:

* age \>=18y
* available data on Covid19 test in the electronic medical record (either positive or negative)

Exclusion Criteria:

* no data of Covid19 test

Primary outcomes:
measure: Number and rate of persons with cardiovascular composite outcome
timeFrame: 6 months after Covid19 test
Secondary outcomes:
measure: Rate of all-cause death outcome
timeFrame: 6 months after covid19 test
measure: Rate of cardiac arrhythmia
timeFrame: 6 months after covid19 test
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Larisa G Tereshchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tereshchenko LG, Bishop A, Fisher-Campbell N, Levene J, Morris CC, Patel H, Beeson E, Blank JA, Bradner JN, Coblens M, Corpron JW, Davison JM, Denny K, Earp MS, Florea S, Freeman H, Fuson O, Guillot FH, Haq KT, Kim M, Kolseth C, Krol O, Lin L, Litwin L, Malik A, Mitchell E, Mohapatra A, Mullen C, Nix CD, Oyeyemi A, Rutlen C, Tam AE, Van Buren I, Wallace J, Khan A. Risk of Cardiovascular Events After COVID-19. Am J Cardiol. 2022 Sep 15;179:102-109. doi: 10.1016/j.amjcard.2022.06.023. Epub 2022 Jul 15.
Clinical trial NCT04607187: Ultrasound B Mode Imaging and Elastography
Official title: Ultrasound B Mode Imaging and Elastography During Administration of Xiaflex (Collagenase Clostridium Histolyticum) for Dupuytren's Contracture: A Pilot Study (The UBIEX-DC Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Contractures
Lead sponsor: Arthritis & Rheumatism Associates, P.C.
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2020-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three groups of people will take part in the research:

5-Normal subjects without a Dupuytren's contracture 5-Subjects that have a hand Dupuytren's contracture that will not receive tx 10-Subjects that have a hand Dupuytren's contracture that will receive tx

Brief summary: A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture.

Detailed description: Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture

Eligibility criteria: Inclusion Criteria:

* Normal Hand or Hand Dupuytren's contracture

Exclusion Criteria:

* Previous treatment of Dupuytren's cord

Primary outcomes:
measure: Ultrasound B mode Imaging and Elastography
timeFrame: 30 day trial
Secondary outcomes:
Other outcomes:
Locations:
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
state: Maryland
Study officials:
References: