louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02737631: Human Repeat Insult Patch Test to Evaluate Personal Lubricants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Edema
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.


Eligibility criteria: Inclusion Criteria:

* good health as determined from screener
* signed and dated informed consent
* signed and dated HIPAA Form

Exclusion Criteria:

* subjects on test at any other research laboratory or clinic
* known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
* pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
* pre-existing other medical conditions (e.g. adult asthma, diabetes).
* treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
* chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs \[except for therapeutic maintenance dosage of aspirin\], antibiotics, steroid inhalers, etc.)
* known pregnant or nursing women

Primary outcomes:
measure: Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
timeFrame: 24, 48 and 72 hours after patch application
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
facility: Harrison Research Laboratories, Inc.
state: New Jersey
Study officials:
affiliation: Harrison Research Laboratories, Inc.
name: Lynne B Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104831: The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Official title: The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Proximal Tibia Fracture
Keywords: Tibial Plateau Fracture
AO/OTA 41
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
name: Orthopedic Trauma Association
First posted: 2010-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.

Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement


Eligibility criteria: Inclusion Criteria:

* Skeletally mature
* Trauma patients with single-system musculoskeletal injuries.
* Proximal tibia fractures treated with open reduction and internal fixation.
* Unilateral proximal tibial injuries.

Exclusion Criteria:

* Previous ipsilateral knee surgery
* Upper extremity injuries impairing mobilization
* Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
* Associated injuries impairing mobilization
* Suspected or confirmed compartment syndrome
* Open fractures
* Patients previously on narcotics
* Patients with impaired sensorium Concurrent head injury Intoxication

Primary outcomes:
measure: Cost
timeFrame: 3 months
Secondary outcomes:
measure: VAS Pain Score
timeFrame: 2 weeks
measure: Narcotic Requirements
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jesse A Shantz, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167631: Can VI-RADS/ADC Accurately Stage Bladder Cancer??
Official title: Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MRI Contrast Media Adverse Reaction
Bladder Cancer
Bladder Disease
Bladder Neoplasm
Bladder Urothelial Carcinoma
Bladder Cancer Stage
Diagnoses Disease
Keywords: VI-RADS
Multiparametric MRI
Non-muscle invasive bladder cancer (NMIBC)
Muscle invasive bladder cancer (MIBC)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 150
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: Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

Detailed description: Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour

Exclusion Criteria:

* fungating lesions
* beyond the scope of enbloc resection

Primary outcomes:
measure: Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed Mosbah, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Mohammed Aboelghar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04978831: The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs
Official title: The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs, Fatigue and Pulmonary Function Parameters in Patients With COPD Who Followed Up by Wearable Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Breath Shortness
Keywords: COPD
Fatigue
Breath exercise
Reading aloud
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 131
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: Purpose of the research; To determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with COPD. This research will be conducted using a randomized controlled trial model. "Personal Description Form", "COPD and Asthma Fatigue Scale", Visual Analog Scale and pulmonary function tests will be used in data collection.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with COPD for at least 6 months or before
* Not having a respiratory system defect caused by diseases other than COPD
* Not in the GOLD-4 COPD stage
* Being able to read and write Turkish
* Have no problems communicating or speaking
* Being able to use basic information technologies
* Using a smartphone
* Having an active internet connection

Exclusion Criteria:

* Having non-COPD pulmonary problems and diagnosed cardiovascular disease
* Not volunteering to participate in the study
* Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process

Primary outcomes:
measure: Pulmonary Function Parameters
timeFrame: 2 month
measure: Fatigue
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnönü University
Study officials:
References:
citation: McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Dec 19;12(12):CD012296. doi: 10.1002/14651858.CD012296.pub2.
citation: Wang YT, Green JR, Nip IS, Kent RD, Kent JF. Breath group analysis for reading and spontaneous speech in healthy adults. Folia Phoniatr Logop. 2010;62(6):297-302. doi: 10.1159/000316976. Epub 2010 Jun 28.
Clinical trial NCT03704831: Comparison of Analgesic Efficiency Between IPACK Block and Surgical Infiltration After Total Knee Arthroplasty
Official title: Comparison of Analgesic Efficiency Between IPACK Block (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) and Surgical Infiltration After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Keywords: Locoregional anesthesia
IPACK block
surgical infiltration
Total knee arthroplasty
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults patients after a total knee arthroplasty

Brief summary: The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.

Detailed description: After patient agreement, data will be collected on patient records and will be compared into 2 groups.

Data will be :

* cumulative consumption of morphine during the first 24 hours after surgery
* pain scores during the first 24 hours after surgery
* amount of analgesics during the first 24 hours after surgery
* maximal pain score during the first 24 hours after surgery

Eligibility criteria: Inclusion criteria:

- All adults patients after a total knee arthroplasty since november 2015

Exclusion criteria:

- Child, non primitive surgery

Primary outcomes:
measure: Analgesic need
timeFrame: 24 hours
Secondary outcomes:
measure: Pain scores in the recovery room
timeFrame: 24 hours
measure: maximal pain score
timeFrame: 24 hours
measure: Description of the analgesics administered
timeFrame: 24 hours
measure: amount other analgesics
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Xavier Capdevila, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00725231: Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
Official title: Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral T Cell Lymphoma, Unspecified
Angioimmunoblastic Lymphadenopathy
Extranodal NK/T-cell Lymphoma
Keywords: T cell lymphoma
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: German High-Grade Non-Hodgkin's Lymphoma Study Group
name: Nordic Lymphoma Group
First posted: 2008-07-30
Enrollment: 274
Sex: ALL
Minimum age (years): 61
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* all risk groups of peripheral T cell lymphoma
* performance status ECOG 0-2
* written consent
* measurable disease

Exclusion Criteria:

* stage I N without bulky disease
* already initiated treatment
* serious accompanying disorder or impaired organ function
* bone marrow involvement \>25%
* HIV positivity
* leukemic manifestation of lymphoma
* simultaneous participation in another trial
* platelets \< 100 000/ mm, leukocytes \< 2500 /mm

Primary outcomes:
measure: Event free survival
timeFrame: 3 years
Secondary outcomes:
measure: Rate of complete and partial remissions
timeFrame: 4 months after inclusion
measure: treatment related deaths
timeFrame: time of occurence
measure: Overall survival
timeFrame: @ 3 years
measure: protocol adherence
timeFrame: 4 months of treatment
measure: immune reconstitution after alemtuzumab CHOP
timeFrame: 3 years
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University of Göttingen
state: Lower Saxony
Study officials:
affiliation: University of Göttingen
name: Lorenz H Trümper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04829331: Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Official title: Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Acera Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function


Eligibility criteria: Inclusion Criteria:

1. All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
2. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria:

1. Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
2. Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
3. Morbid obesity (BMI \>40).
4. Inability to maintain wrist immobilization for full planned period.
5. Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight).
6. Other conditions felt to significantly impair wound healing per surgeon discretion.

Primary outcomes:
measure: Tendon Exposure
timeFrame: 4 weeks post-operatively
measure: Surface Area of Split-thickness Skin Graft Incorporation
timeFrame: 4 weeks post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
Study officials:
References:
Clinical trial NCT06674031: Knowledge of Cardiovascular Risk Factors in Chronic Kidney Disease Patients
Official title: Investigation of Knowledge of Cardiovascular Risk Factors and Perception of Benefits and Barriers to Exercise in Patients with Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease(CKD)
Renal Transplantation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic kidney disease patients and healthy individuals will be included in the study.

Brief summary: The aim of this study is to assess knowledge of cardiovascular risk factors, physical activity levels, health literacy and perceptions of benefits and barriers to exercise in patients with chronic kidney disease and compare them with healthy people.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease
* Being aged 18-65
* Voluntary participation in the study

Exclusion Criteria:

* Having cognitive problems
* Being illiterate

Primary outcomes:
measure: Knowledge of cardiovascular risk factors
timeFrame: 10 minutes
measure: Exercise benefits/barriers
timeFrame: 10 minutes
measure: Physical activity
timeFrame: 5 minutes
Secondary outcomes:
measure: Health literacy
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT00031031: Kanglaite Injection Phase I Study
Official title: Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors Refractory To Standard Therapy
Neoplasms
Keywords: MTD
Safety
Pharmacokinetics
Efficacy
Lead sponsor: KangLaiTe USA
Sponsor class: INDUSTRY
First posted: 2002-02-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.


Eligibility criteria: * Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist.
* Patients with an estimated life-expectancy of at least 3 months
* Patients with a Karnofsky Performance Score of at least 60%
* Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography
* Patients with adequate renal and hepatic function
* Patients with adequate bone marrow status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institue
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Richard H Wheeler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543231: A Phase I Study of G3139 Subcutaneous in Solid Tumors
Official title: A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: ECOG
MRT
NCI CTC
SAE
Short Intravenous Infusion to Patients with Solid Tumors
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. The route of administration limits the convenience of treatment, and catheter-related complications have been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139 administered by subcutaneuous injection.


Eligibility criteria: Inclusion Criteria:

* A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. Patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids.
* Adequate organ function as determined \< 7 days prior to starting study medication
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* At least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy

Exclusion Criteria:

* Significant medical diesese
* History of leptomeningeal disease
* Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function.
* Use of any investigational drug within 3 weeks prior to starting study medication
* Known hypersensitivity to phosphorothioate-containing oligonucleotides
* Pregnancy/Lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Research Institute for Drug Development
state: Texas
Study officials:
References: