louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00115414: Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)
Official title: A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Fever
Neutropenia
Keywords: Neulasta®
Chemotherapy
TAC
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.


Eligibility criteria: Inclusion Criteria: - Breast cancer, previously untreated Exclusion Criteria: - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents

Primary outcomes:
measure: Neutropenia
Secondary outcomes:
measure: Neutropenia
measure: Disease Response
measure: Adverse Events
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00547014: First Safety Study in Humans of a Single Dose of CPG 52364
Official title: Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.


Eligibility criteria: Inclusion Criteria:

* Normal body mass index and weight
* No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion Criteria:

* Current illness or history of medical condition affecting the body's function
* Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
* Use of any medications during the study
* Positive TB test
* Smoking within 6 months
* Pregnancy or risk of Pregnancy
* Alcohol or drug misuse within 60 days
* Sensitivity to quinazolines

Primary outcomes:
measure: Clinical Assessment of Adverse Events
timeFrame: 28 days/subject
Secondary outcomes:
measure: Pharmacokinetic Parameters
timeFrame: 28 days/subject
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03072914: Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome
Official title: Effects of Remote Ischemic Preconditioning With Postconditioning in Patients Undergoing Superficial Temporal Artery-middle Cerebral Artery (STA-MCA) Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moyamoya Disease
Remote Ischemic Preconditioning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, we evaluated whether RIPC with RIPostC reduce the major neurocomplication in patients undergoing STA-MCA anastomosis.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists
2. Adults 18 to 65 years of age
3. In patients with planned MCA-STA anastomosis under general anesthesia
4. Patients who pre-agreed to the study

Exclusion Criteria:

1. If there is a history of peripheral vascular arterial or venous disease
2. If there is a previous history of peripheral nerve disease
3. Other brain or cerebrovascular disease
4. In case of serious cardiovascular disease, pulmonary disease, kidney disease
5. Patients who do not agree with the test

Primary outcomes:
measure: Number of major adverse event
timeFrame: postoperative one month
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospita
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06913114: Relationship Between Hip Extensor Strength and Gait Speed in Diplegic Cerebral Palsy
Official title: Exploring the Relationship Between Hip Extensor Strength and Gait Speed in Diplegic Cerebral Palsy: A Feasibility Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diplegic Spastic Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with diplegic CP who can walk

Brief summary: The hip extensors are essential for upright posture and forward propulsion during gait. Children with diplegic CP often demonstrate reduced muscle strength, which impacts their gait speed and overall mobility. Understanding the relationship between hip extensor strength and gait speed could provide a basis for targeted interventions. This feasibility study will establish whether the handheld dynamometer can reliably measure hip extensor strength and if this strength correlates with gait speed in children with diplegic CP.


Eligibility criteria: Inclusion Criteria:

* • Diagnosed with diplegic CP

  * Ages 6 - 8 years
  * GMFCS Levels I-II (indicating they are ambulatory)
  * Able to follow instructions and participate in strength and gait assessments

Exclusion Criteria:

* • Severe cognitive or behavioral impairments affecting participation

  * Musculoskeletal conditions or recent orthopedic surgery that could interfere with hip function
  * Use of assistive devices for ambulation

Primary outcomes:
measure: Hip Extensor Strength
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University, Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT05026814: Clitoral Reconstruction (CR) in FGM/C Patients
Official title: Clitoral Reconstruction (CR) in FGM/C Patients: Assessment of Multidisciplinary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Genital Mutilation / Cutting (FGM/C)
Keywords: Clitoral Reconstruction (CR)
Psychosexual care (PC)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FGM/C patients of the FGM/C outpatient clinic of HUG within the time frame of 01/2013 until 04/2021

Brief summary: Surgical interventions to reconstruct the vulva together with psychosexual care have been proposed as a multidisciplinary care concept for women who have undergone female genital mutilation/cutting (FGM/C).

This cross-sectional study is to assess the experiences of multidisciplinary care of women who request CR at Geneva University Hospital (HUG) in order to analyze the expectations and motivations for clitoral reconstruction, to study the reasons for deciding against or in favor of CR and to study the outcome of the care received (CR+ psychosexual care versus psychosexual care alone) in sexual response, eventual dyspareunia, genital self-image and overall satisfaction through questionnaires.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent of the present study
* French and / or English speaking

Exclusion Criteria:

* Insufficient knowledge of project language (French/English)
* No informed consent
* Inability to sign consent

Primary outcomes:
measure: General satisfaction with multidisciplinary care
timeFrame: one time assessment at baseline
Secondary outcomes:
measure: General satisfaction with subdomain CR and psychosexual care
timeFrame: one time assessment at baseline
measure: General satisfaction with subdomain CR alone
timeFrame: one time assessment at baseline
measure: General satisfaction with subdomain psychosexual care
timeFrame: one time assessment at baseline
measure: General satisfaction after CR with sexual response
timeFrame: one time assessment at baseline
measure: General satisfaction after CR with genital image
timeFrame: one time assessment at baseline
measure: General satisfaction after CR with pain
timeFrame: one time assessment at baseline
measure: General satisfaction after CR with female identity
timeFrame: one time assessment at baseline
measure: Female Genital Self Image Scale (FGSIS)
timeFrame: one time assessment at baseline
measure: World Health Organization (WHO)-Five Well-Being Index
timeFrame: one time assessment at baseline
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: University Hospital of Geneva (HUG), Department of Obstetrics and Gynecology
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital of Geneva (HUG)
name: Jasmine Abdulcadir, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04551014: Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm
Official title: Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Polyp of Colon
Adenomatous Polyp of Colon
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.

Detailed description: The details of the proposed study are as follows:

1. Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
2. Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
3. Methods:

   1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
   2. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
   3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
   4. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Polyps 4-9mm

Exclusion Criteria:

* Pregnant
* Inflammatory bowel disease
* Polyposis syndromes

Primary outcomes:
measure: Number of Polyps With Complete Resection
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to Resection
timeFrame: During the procedure
measure: Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
timeFrame: During the procedure (up to 10 minutes)
measure: Number of Patients With Procedural Complications
timeFrame: 4 weeks (from procedure through 30 day follow-up)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Shai Friedland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536014: Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Robotic Surgery
Keywords: Dexmedetomidine
pneumoperitoneum
trendelenburg position
QTc interval
Tp-e interval
robotic prostatectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum.

Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.

Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.


Eligibility criteria: Inclusion Criteria:

1. ASA class I-II
2. Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy

Exclusion Criteria:

1. Emergency operation
2. Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
3. Ventricular conduction abnormality
4. Prior pacemaker insertion
5. Abnormal electrolyte values
6. Patients who take antiarrythmic agent
7. Hepatic or renal failure
8. Drug hyperactivity
9. Neurological or psychiatric illnesses

Primary outcomes:
measure: Dexmedetomidine on heart-rate corrected QT(QTc) interval
timeFrame: From pre-induciton until 60 min after the end of pneumoperitoneum
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT00950014: Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms
Official title: Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Communication
Keywords: Numeracy
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Attorney General Consumer & Prescriber Education Grant
First posted: 2009-07-31
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test comprehension of five numeric formats used to present data about treatment benefits and harms.


Eligibility criteria: Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Primary outcomes:
measure: Comprehension questions (e.g., overall direction of effect and specific numeric data)
timeFrame: 0 weeks (assessed during intervention)
Secondary outcomes:
measure: Risk perceptions (e.g., how big or small is the benefit)and preferences (e.g., did the box help subjects understand the benefits) assessed via Internet surveys.
timeFrame: 0 weeks (assessed during intervention)
Other outcomes:
Locations:
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Lisa M Schwartz, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009 Apr 21;150(8):516-27. doi: 10.7326/0003-4819-150-8-200904210-00106. Epub 2009 Feb 16.
citation: Schwartz LM, Woloshin S, Welch HG. The drug facts box: providing consumers with simple tabular data on drug benefit and harm. Med Decis Making. 2007 Sep-Oct;27(5):655-62. doi: 10.1177/0272989X07306786. Epub 2007 Sep 14.
citation: Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med. 2011 Jul 19;155(2):87-96. doi: 10.7326/0003-4819-155-2-201107190-00004.
Clinical trial NCT02226614: Development of a Head Cooling Device
Official title: Development of a Head-cooling Device for Brain Injury: Healthy Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature Changes
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is testing a head-cooling device on volunteers to assess temperature reduction.


Eligibility criteria: Inclusion Criteria:

* healthy humans

Exclusion Criteria:

* pregnant
* refusal of consent for registration with The Over-volunteering Protection Scheme

Primary outcomes:
measure: Temperature change
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Peter Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538714: Interval Training and Cardio-metabolic Health in Overweight/Obese Girls
Official title: Impact of Different Interval Training Protocols on Physical, Cardio-metabolic, Lipidomic, Hematological and Psychological Parameters in Young Overweight/Obese Girls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Overtraining
Enjoyment
Cardiometabolic Syndrome
Obesity
Keywords: interval training
obesity
overweight
childhood
cardiometabolic risk
enjoyement
lipidomics
body composition
physical fitness
Lead sponsor: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 45
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.


Eligibility criteria: Inclusion Criteria:

* Female gender,
* Overweight or obese according to the BMI classification,
* Age, 12 to 15 years,
* Personal or parental/guardian written consent

Exclusion Criteria:

* Severe infectious or inﬂammatory diseases,
* Irregular menstrual cycles
* Participation in organized exercise training in the last 6 months or additional physical -
* recreational activities, except physical education classes.
* Using medications, hormone therapy or dietary supplements

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: 12 weeks
measure: Changes in plasma triglycerides
timeFrame: 12 weeks
measure: Enjoyment
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Changes in Aerobic velocity
timeFrame: 6 and 12 weeks
measure: Changes in lipidomic profile
timeFrame: 12 weeks
measure: Changes in hematological parameters
timeFrame: 12 weeks
measure: Change in Heart rate
timeFrame: 12 weeks
measure: Change in sprint performance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
city: Tunis
country: Tunisia
facility: Rabta Hospital
Study officials:
References:
Clinical trial NCT04489914: Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement
Official title: Observational Study on the Application of High-Flow Therapy in the Postinterventional Follow-up Care of Patients With Percutaneous Interventional Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University hospital

Brief summary: Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with high perioperative risk has become a standard method in recent years. In addition to the detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on the monitoring of respiratory parameters after an operation under intubation anesthesia or deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients with a warmed and humidified air-oxygen mixture and to independently control the oxygen content in the inhaled air and the flow in the pharyngeal area.

The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen therapy as a measure of weaning success in postinterventional patients after TAVI.


Eligibility criteria: Inclusion Criteria:

* High-flow oxygen therapy after TAVI

Exclusion Criteria:

* patients without consent
* age \< 18 years

Primary outcomes:
measure: Change of Horovitz index
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Tobias Graf, Dr
role: PRINCIPAL_INVESTIGATOR
References: