louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00284258: Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Official title: Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2006-01-31
Enrollment: 426
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival of IRIS in comparison with FOLFIRI.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed colorectal cancer
* Locally advanced and/or metastatic colorectal cancer
* Have prior chemotherapy as first line treatment
* No prior irinotecan administration
* Able to take oral medication
* Age 20 to 75
* Performance status 0 or 1 (ECOG)
* WBC 3,000-12,000 / mm\^3
* Platelet ≥100,000 / mm\^3
* AST and ALT ≤ 100 IU/L
* Creatinine ≤ 1.2 mg/dL
* Bilirubin ≤ 1.5 mg/dL

Exclusion Criteria:

* Prior radio therapy for colorectal cancer
* Other malignancies in the past 5 years
* Serious illness or medical condition

Primary outcomes:
measure: Progression free survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Over all survival, Response rate, Adverse event, Medical economy
timeFrame: adverse events will be collected during treatment
Other outcomes:
Locations:
city: Saku City
country: Japan
facility: Saku Central Hospital
state: Nagano
Study officials:
affiliation: Tokyo Medical and Dental University Hospital
name: Kenichi Sugihara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muro K, Boku N, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Takiuchi H, Esaki T, Tokunaga S, Kuwano H, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol. 2010 Sep;11(9):853-60. doi: 10.1016/S1470-2045(10)70181-9. Epub 2010 Aug 12.
citation: Yasui H, Muro K, Shimada Y, Tsuji A, Sameshima S, Baba H, Satoh T, Denda T, Ina K, Nishina T, Yamaguchi K, Esaki T, Tokunaga S, Kuwano H, Boku N, Komatsu Y, Watanabe M, Hyodo I, Morita S, Sugihara K. A phase 3 non-inferiority study of 5-FU/l-leucovorin/irinotecan (FOLFIRI) versus irinotecan/S-1 (IRIS) as second-line chemotherapy for metastatic colorectal cancer: updated results of the FIRIS study. J Cancer Res Clin Oncol. 2015 Jan;141(1):153-60. doi: 10.1007/s00432-014-1783-3. Epub 2014 Aug 9.
Clinical trial NCT02440958: Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
* Refractory or progress to Gemcitabine based 1st line chemotherapy
* Older than 19 years old and younger than 75 years old
* Life expectancy\> 3 months
* ECOG Performance status ≤2
* Only patients with measurable lesions in imaging study
* Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
* Adequete liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
* Adequete renal function (serum creatinine \< 1.5 mg/dl)
* Adequete cardiopulmonary function

Exclusion Criteria:

* Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
* Metastatic adenocarcinoma of originating at other organs
* Evidence with CNS metastasis
* Active infection
* Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
* Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
* Participation in any other investigational drug study within 1 month
* No signed informed consent

Primary outcomes:
measure: True response rate
timeFrame: within 16 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 6, 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04346758: Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
Official title: Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2020-04-15
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.

Detailed description: A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing orthopedic trauma operations of the lower extremeties
* Age \>70 years old

Exclusion Criteria:

* Preexisting neuropathy of Lumbar plexus
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Allergy to local anaesthetics
* Prior surgery at the lumbar region

Primary outcomes:
measure: Time required to localize the lumbar plexus
timeFrame: 10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus)
measure: Complications from lumbar plexus blockade
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative pain
timeFrame: 4 hours (visual analogue scale 0-10 at 4 hours postoperatively)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon Hospital
Study officials:
References:
Clinical trial NCT00160758: Physical Characteristics of Retrieved Massive Allografts
Official title: Physical Characteristics of Retrieved Massive Allografts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic clinic

Brief summary: This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.

Detailed description: Allograft bone is the primary source of graft material for large skeletal defects resulting from trauma, disease, oncological resection, or reconstruction of failed total joint arthroplasties. The physical characteristics of such grafts after various intervals of remodeling and incorporation in vivo have never been studied.

The purpose of this study is to obtain tissue from allografts retrieved at autopsy, at amputation for oncological complications and from patients undergoing revision procedures for failed allograft transplantation. We will evaluate the mechanical properties, histomorphometric indices and presence of microfractures.

Our hypotheses are:

* histomorphometric parameters of porosity and microfracture density will predict allograft strength,
* microfracture density will be correlated with time in vivo and allograft strength,
* the rate of host-allograft nonunion and fracture will correlate with radiation therapy and chemotherapy.

The retrieved tissue will be processed using standard undecalcified histology and quantitatively assessed for degree of incorporation, allograft porosity, and microfracture density. The biomechanical characteristics of the bulk allograft and allograft-host junction will be quantified and compared to allograft bone prior to transplantation.

Eligibility criteria: Inclusion Criteria:

* failed allograft bone
* removal of allograft due to oncological complications
* amputation due to oncological complications

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Mark T. Scarborough, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264835: Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Excisional Hemorrhoidectomy
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2010-12-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.


Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age
* Are willing to give consent and comply with evaluation and treatment schedule
* Meet institutional criteria for excisional hemorrhoidectomy
* Are able to understand and complete study questionnaires.

Exclusion Criteria:

* Previous Hemorrhoid surgery
* Chronic daily narcotic use
* Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
* Internal hemorrhoids that may be suitable for office management (surgeon discretion)
* Fecal or urinary incontinence
* Inflammatory Bowel Disease (Crohns, ulcerative colitis)
* Acutely thrombosed hemorrhoids (surgeon discretion)
* Evidence of acute sepsis or the presence of a fistula
* Anal stricture.

Primary outcomes:
measure: Procedure Duration (Surgery Time)
timeFrame: Time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00609635: Association Between Cytokines and Severity of Respiratory Syncytial Virus (RSV)-Induced Illness in the Elderly
Official title: The Association Between Cytokine Genotype Polymorphisms and Severity of RSV-Induced Illness in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory
RSV-induced respiratory illness
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: American Academy of Allergy, Asthma, and Immunology
First posted: 2008-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatient or outpatient subjects with respiratory illnesses potentially caused by RSV

Brief summary: This research study involves studying the genes that may affect how ill you become during respiratory infection with respiratory syncytial virus (RSV). RSV is a virus that often causes common colds.

Cytokines are chemicals that are naturally made by your body. Cytokine levels are increased in some people when they have common colds or wheezing caused by respiratory syncytial virus (RSV). The purpose of this study is to study the genes that may control cytokine levels during infection with RSV in the elderly population.


Eligibility criteria: Inclusion Criteria:

* Subjects \> 65 years of age diagnosed with RSV-induced respiratory illness
* Diagnosis (based upon ICD-9-CM codes) for pneumonia, upper respiratory illness, bronchitis, COPD, asthma, viral illness, or congestive heart failure (CHF)
* Willing to sign informed consent.

Exclusion Criteria:

* Not willing to sign informed consent.
* Subjects less that 65 years of age
* Subjects not diagnosed with a respiratory illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Ritu Pabby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531635: Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
Official title: Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
Keywords: Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil


Eligibility criteria: Inclusion Criteria:

* Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil.

Exclusion Criteria:

* Uncontrolled major medical illnesses

Primary outcomes:
measure: Efficacy
timeFrame: 2001-2012
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Mahmoud Aljurf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889935: Investigating the Effect of Respiratory Exercise Diary on Pain in Cardiovascular Surgery
Official title: The Effect of Respiratory Exercise Diary Use on Postoperative Pain in Patients Undergoing Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Surgery
Keywords: Cardiovascular surgery
exercise diary
nursing care
pain
postoperative pain
postoperative period
respiratory exercise
spirometer
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a conventional therapy control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was carried out to evaluate the effect of respiratory exercise diary use on postoperative pain in patients undergoing elective cardiovascular surgery in a training and research hospital in Istanbul.

Detailed description: The randomised controlled experimental study was conducted between 11 July 2024 and 11 January 2025 in the cardiovascular surgery inpatient wards of a training and research hospital in Istanbul. The study was conducted with a total of 74 patients, 37 in the control group and 37 in the intervention group. Data were collected by the researcher through face-to-face interviews with the patients. 'Patient Identification Form', "Visual Analogue Scale (VAS)", "Respiratory Exercise Diary" were used.

Eligibility criteria: Inclusion Criteria:

* No barriers to verbal communication (mental, physiological and psychological)
* Patients undergoing elective cardiovascular surgery,
* Individuals who agreed to participate in the study,
* Patients whose haemodynamics are suitable for respiratory exercise

Exclusion Criteria:

* Being in the intensive care unit after surgical intervention,
* Patients undergoing re-operation after surgical intervention,
* Those who do not accept the study or who want to leave during the study.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: four days
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara Univesity
state: Maltepe
Study officials:
affiliation: Marmara University
name: Melisa KÖSE TUNÇ, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Hamdiye B. KATRAN, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Siyami Ersek Training and Research Hospital Department of Cardiovascular Surgery
name: Mehmet E. MEMETOĞLU, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01240135: Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
Official title: Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Fit
Myopia
Keywords: Contact Lens Wear
Contact Lens Solution
Multi-purpose disinfecting solution
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
* Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
* History of intolerance or known sensitivity to any component of the treatments.
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Lens Fit
timeFrame: Day 14 of lens wear
Secondary outcomes:
measure: Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
timeFrame: Day 14 of lens wear
Other outcomes:
Locations:
Study officials:
References: