louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00320294: ILF With/Without Cisplatin for Advanced Gastric Cancer
Official title: A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasm
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Detailed description: Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen \[Pozzo C, et al. Ann Oncol 2004\]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Histologically proven gastric adenocarcinoma
* Advanced, metastatic or recurrent
* ECOG performance status 0 to 2
* No prior chemotherapy
* Measurable or evaluable indicator lesion(s)
* Normal marrow, hepatic and renal functions
* Provision of written informed consent

Exclusion Criteria:

* Active infection, bleeding or severe comorbidities
* Pregnant or breastfed women
* Active CNS metastasis

Primary outcomes:
measure: Objective response rate
measure: Safety
Secondary outcomes:
measure: Progression-free survival
measure: Overall survival
measure: Quality of life
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SH, Nam E, Park J, Cho EK, Shin DB, Lee JH, Lee WK, Chung M, Lee SI. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol. 2008 Apr;19(4):729-33. doi: 10.1093/annonc/mdm502. Epub 2007 Dec 13.
Clinical trial NCT00617994: Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Official title: An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 25
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: This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Subjects must have psoriatic lesions measuring protocol specific BSA

Exclusion Criteria:

* Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
* Pustular psoriasis or erythroderma

Primary outcomes:
measure: Number of Treatment of Emergent Adverse Events
timeFrame: Approximately 3 months
measure: Pharmacokinetics Parameter : Skin Flux of INCB018424
timeFrame: Days 1, 4, 8, 15, 22, and 28-30
measure: Pharmacokinetics Parameter: Bioavailability of INCB018424
timeFrame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
measure: Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
timeFrame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
Secondary outcomes:
measure: Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
timeFrame: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
measure: Mean Change in Psoriatic Lesion Area
timeFrame: Days 1 and 28
measure: Mean Change in Physicians Global Assessment Score
timeFrame: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later
Other outcomes:
Locations:
city: Fridley
country: United States
state: Minnesota
city: Rochester
country: United States
state: New York
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: William Williams, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01152294: Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Official title: Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Decision making
Decision aids
Decision quality instrument
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
name: Massachusetts General Hospital
First posted: 2010-06-29
Enrollment: 401
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of menopause. In particular, we will examine whether the decision aid increases knowledge about menopause/managing menopause symptoms and concordance between goals and treatment choices.


Eligibility criteria: Inclusion Criteria:

* Female, aged 40-60
* Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year

Exclusion Criteria:

* Prior diagnosis of breast cancer
* Surgical or medically induced menopause (ovaries removed)

Primary outcomes:
measure: Menopause Knowledge
timeFrame: 2 weeks, on average
Secondary outcomes:
measure: Value Concordance
timeFrame: 2 weeks, on average
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Survey Research - University of Massachusetts Boston
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Boston
name: Patricia M Gallagher, PhD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815394: 177Lu-labeled NY108 SPECT Imaging in Patients
Official title: 177Lu-labeled NY108 SPECT Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male;
3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;
4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;
6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;
7. An ECOG score of 0-2

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with severe systemic or localized infections or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;
4. Patients with autoimmune diseases, including rheumatoid, etc;
5. Inadequately controlled arrhythmias, including atrial fibrillation:
6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
7. Uncontrolled hypertension;
8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;
9. Subjects positive for syphilis, HBV, HCV, FIIV;
10. Subjects of childbearing age who are unable to use effective contraceptive devices:
11. Patients with a history of mental illness or related medical conditions;
12. Patients who are unable or unavailable for SPECT/CT scanning;
13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.

Primary outcomes:
measure: Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
timeFrame: 1 year
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: Chunjing Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636194: Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
Official title: Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of Contact Lens Solution
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution


Eligibility criteria: Inclusion Criteria:

* Subjects are adapted wearers of silicone hydrogel contact lenses
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* wear a monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings

Primary outcomes:
measure: Subjective Assessment of Comfort and Cleanliness
timeFrame: 7 days
Secondary outcomes:
measure: Symptoms and Complaints
timeFrame: 2 weeks
measure: Graded Slit Lamp Findings > Grade 2
timeFrame: 2 week follow-up visit
Other outcomes:
Locations:
city: Jalan Kuning, Tamn Pelangi
country: Malaysia
facility: Laser Focus Sdn Bhd, Vision Correction Centre
state: Johor Bahru
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Mohinder Merchea, OD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04899362: The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
Official title: The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Ischemic Conditioning
Keywords: Remote Ischemic Conditioning
Dynamic Cerebral Autoregulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

Detailed description: Remote ischemic conditioning(RIC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIC provides neuro-protection by means of improving dCA.

Eligibility criteria: Inclusion Criteria:

* age from 18 to 50,both genders
* willing to participate in follow-up visits

Exclusion Criteria:

* current or having a history of chronic physical diseases or mental diseases
* suffering from infectious diseases in late one month
* pregnant and lactating women#
* smoking or drinking#
* inability to cooperate sufficiently to complete the dCA examination

Primary outcomes:
measure: Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree
timeFrame: 36 days
Secondary outcomes:
measure: Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg
timeFrame: 36 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT00563862: Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)
Official title: Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nasopharyngeal Neoplasms
Carcinoma, Squamous Cell
Keywords: Nasopharyngeal Carcinoma
T3-4N0-1M0
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The Hong Kong Nasopharyngeal Cancer Study Group
First posted: 2007-11-26
Enrollment: 465
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Undifferentiated or non-keratinizing carcinoma
* Tumor staged as T3-4 AND N0-1
* No evidence of distant metastasis (M0)
* Performance status: 0-2
* Marrow: WBC \>= 4 and platelet = 100
* Renal: creatinine clearance = 60
* Informed consent

Exclusion Criteria:

* WHO type I squamous cell carcinoma or adenocarcinoma
* Age \>= 70
* Palliative intent or tumor extent mandating AP opposing facio-cervical fields
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
* Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
* Previous chemotherapy
* Patient is pregnant or lactating

Primary outcomes:
measure: Failure free survival rate
timeFrame: 5-year
Secondary outcomes:
measure: Overall survival rate
timeFrame: 5-year
measure: Disease-specific survival rate
timeFrame: 5-year
measure: Complication-free rates
timeFrame: 5-year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
name: Anne WM Lee, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06708962: Effect of Mulligan's Mobilization on Shoulder Joint Range of Motion and Subacromial Space in Paraplegic Patients
Official title: Shoulder Joint Range of Motion and Subacromial Space Changes After Mulligan's Mobilization for Paraplegic Patients with Subacromial Impingement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia, Incomplete
Keywords: Range of motion
subacromial impingement
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (A) and Group (B)

Detailed description: 30 patients will be randomly assigned to two groups Group (A): will receive Mulligan's mobilization plus steroid injection for rotator cuff tendinopathy Group (B): will receive Steroid injection for rotator cuff tendinopathy only

Outcome measures will be:

* shoulder joint range of motion will be measured by laser goniometer
* Subacromial joint space will be measured by 3D ultrasonography

Eligibility criteria: Inclusion Criteria:

* More than one year after traumatic spinal cord injury
* The injury is at the second thoracic level or below.
* No cognitive impairment
* Relying on manual wheelchair for main movement.

Exclusion Criteria:

* No frozen shoulder
* No subluxation

Primary outcomes:
measure: Shoulder joint range of motion
timeFrame: Two months
Secondary outcomes:
measure: Subacromial joint space
timeFrame: Two months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Modern University for Technology and Information
Study officials:
References:
Clinical trial NCT00005362: Dose Estimation for Studies of Acute Respiratory Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a new model to estimate tracheobronchial dose of an active agent for each subject in a study of acute respiratory health effects.

Detailed description: BACKGROUND:

Epidemiologic analysis of acute, reversible respiratory health effects is uncommonly performed, yet these are important health outcomes because acute responses by the respiratory defense system appear to represent one end of the continuum toward progressive, chronic and potentially disabling physiologic changes. Repeatable epidemiologic studies of dose-response relationships necessitate accurate measures of 'dose'. However, in occupational and environmental settings, exposure to a toxin is seldom found at identical concentrations and/or particle sizes among persons with the same activity patterns. In addition, air concentration does not account for factors such as clearance or metabolism which may alter the biologically effective tissue dose. These factors cause the target tissue dose of the toxin to vary greatly despite exposure to similar air concentrations.

DESIGN NARRATIVE:

The results of these toxicokinetic models were individual measures of tissue dose used in a 2-stage epidemiologic analysis which placed special emphasis on the definition of individual dose-response curves for exposure to an irritant dust, sodium borate, and the reversible effects of peak expiratory flow and irritant symptoms. A primary advantage of the two stage epidemiologic approach was that it permitted particular attention to be focused on the factors which determined the sensitivity (threshold) and reactivity (slope) for an individual. The use of tissue dose estimates were also compared to simple exposure measurements in the epidemiologic analysis to evaluate the efficacy of using dosimetric methods in epidemiologic studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Woskie SR, Eisen EE, Wegman DH, Hu X, Kriebel D. Worker sensitivity and reactivity: indicators of worker susceptibility to nasal irritation. Am J Ind Med. 1998 Dec;34(6):614-22. doi: 10.1002/(sici)1097-0274(199812)34:63.0.co;2-s.
Clinical trial NCT00154362: The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
Official title: A Multi-center, Randomized, Double-blind, Cross-over, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o. (300-1200 mg/Day) as Adjuvant Therapy for Impulsivity and Aggressive Behavior in Conduct Disorders in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conduct Disorder
Keywords: Oxcarbazepine, conduct disorder, adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.


Eligibility criteria: Inclusion Criteria:

* History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
* Score \>8 on the Impulsivity Rating Scale

Exclusion Criteria:

* Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
* Treatment with antiepileptic medications

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage reduction on Impulsivity Rating Scale (IRS)
Secondary outcomes:
measure: Percent reduction in the Modified Overt Aggression Scale (MOAS)
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Gregorio Marañón,Madrid, Spain
name: Celso Arango, MD
role: PRINCIPAL_INVESTIGATOR
References: