louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193349: Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
Official title: Phase II Evaluation of Gleevec Combined With Camptosar Plus Paraplatin in Patients With Previously Untreated Extensive Stage SCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Novartis
name: Pharmacia and Upjohn
First posted: 2005-09-19
Enrollment: 60
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: This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.

Detailed description: Upon determination of eligibility, all patients will be receive:

* Irinotecan + Carboplatin + Imatinib

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Small cell lung cancer with extensive stage disease confirmed by biopsy
* Measurable or evaluable disease
* Ability to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney
* No active brain metastasis.
* No previous chemotherapy or radiation therapy
* Give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Limited stage disease (includes IA, IB, IIA, IIB, and IIIA)
* Active brain metastasis
* Age \< 18 years old
* History of a prior malignancy within three years
* Women pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
measure: Response duration
Secondary outcomes:
measure: Time to progression
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Anthony Greco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Hainsworth JD, Simons L, Meng C, Burris HA 3rd, Yardley DA, Grapski R, Schreeder M, Mallidi PV, Greco FA; Minnie Pearl Cancer Research Network. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol. 2007 Sep;2(9):854-61. doi: 10.1097/JTO.0b013e31814617b7.
Clinical trial NCT03557749: Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
Official title: Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Immune and Microbial Reconstitution
Systemic Viral Infection
Acute-graft-versus-host Disease
Chronic Graft-versus-host-disease
Recurrent Malignancy
Cytokine Release Syndrome
Allogenic Related Donors
Cell Therapy/Immunotherapy Patients
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program

Brief summary: This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).


Eligibility criteria: Inclusion Criteria:

* Patients planning to undergo HCT or other cellular therapy/immunotherapy
* Allogeneic related donors
* Aged 0-80
* Willing and able to sign voluntary written consent

Exclusion Criteria:

* Patients whose medical record indicates that they have opted out of research

Primary outcomes:
measure: Immune Function after HCT
timeFrame: 7 Years
measure: Immune Function after HCT
timeFrame: 7 Years
measure: Immune Function after HCT
timeFrame: 7 Years
measure: Immune Function after HCT
timeFrame: 7 Years
measure: Immune Function after Cell Therapy/Immunotherapy
timeFrame: 7 Years
measure: Immune Function after Cell Therapy/Immunotherapy
timeFrame: 7 Years
measure: Immune Function after Cell Therapy/Immunotherapy
timeFrame: 7 Years
measure: Correlate Immune Parameters
timeFrame: 7 Years
measure: Correlate microbiota changes and their interactions with the host with outcomes of HCT
timeFrame: 7 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
References:
Clinical trial NCT02537249: Effects of Dexmedetomidine on Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Video-assisted Thoracoscopic Surgery
Keywords: dexmedetomidine
quality of recovery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics, anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial of intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be enrolled. Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours post op. They will also complete clinically significant pains score and oxygenation from the postanesthetic recovery unit (PACU).


Eligibility criteria: Inclusion Criteria:

1. The inclusion criteria included patients scheduled video-assisted thoracoscopic surgery for lung cancer
2. Adults above 20 years of age and providing informed consent.
3. American Society of Anesthesiologists (ASA) Physical class II, \& III patients

Exclusion Criteria:

1. severe functional liver or kidney disease
2. history of chronic pain requiring opioid treatment
3. arrhythmia or received treatment with antiarrythmic drug .
4. severe bradycardia (HR \< 45 bpm) and AV block
5. pathologic esophageal lesion (esophageal stricture or varix )
6. pregnancy
7. psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire
8. History of alcohol or drug abuse

Primary outcomes:
measure: quality of recovery measured by QoR-40 questionnaire
timeFrame: 24 hr after operation
measure: pulmonary function test
timeFrame: 24 hr after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02333149: Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Official title: Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Attention Deficit/Hyperactivity Disorder
Initial Insomnia
Keywords: Melatonin
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: The University of Queensland
First posted: 2015-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial insomnia in children with attention-deficit disorder.


Eligibility criteria: Inclusion Criteria:

* School-aged children and adolescents between the ages of 6 to 17 years
* Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

Exclusion Criteria:

* Co-morbid psychiatric/neurological diagnoses that may affect sleep
* Co-morbid seizure disorder
* Co-morbid sleep disorder
* Concurrent use of immunosuppressive drugs, blood pressure drugs, selective serotonin re-uptake inhibitors or anticoagulant drugs;
* Pregnancy or breastfeeding

Primary outcomes:
measure: Mean change in sleep onset latency (minutes)
timeFrame: Daily, up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Punja S, Nikles CJ, Senior H, Mitchell G, Schmid CH, Heussler H, Witmans M, Vohra S. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:375. doi: 10.1186/s13063-016-1499-6.
Clinical trial NCT03083249: Gardasil Knowledge
Official title: Gardasil Anonymous Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females age 18-26 of all ethnic background

Brief summary: Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of women and men who are sexually active will be exposed to a strain or strains of the virus. While there are hundreds of viral strains, high risk strains are associated cervical and oral cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were 38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to prevent infection from the most common high risks strains of HPV. Gardasil/HPV-9 was created to help prevent HPV related cancers and warts. The HPV-9 vaccine includes protection from 7 strains of HPV associated with 74% of HPV related cancers. While Gardasil was approved and released in 2006, many men and women have not been vaccinated. A national immunization survey in 2011 of teens 13-17 years old noted that only 60% of girls and 40% of boys have received at least one vaccination in the series. While complete vaccination series is recommended, a recent study found that a single dose of Gardasil when compared to placebo created a higher level of serum antibodies in uninfected females.

Detailed description: All patients seen at a single clinic will be offered participation in the anonymous survey. The survey will ask a series of questions regarding basic demographics, sexual history, smoking status, and Gardasil vaccine knowledge. The survey will serve as evidence of the vaccine utility by highlighting patient risk factors for HPV and patient knowledge about the vaccine series.

Eligibility criteria: Inclusion Criteria:

* All patients 18-26 will be offered participation

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: knowledge about HPV risk factors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Sarah Hostetter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240249: Constructive Self Assertiveness Via the Internet
Official title: Constructive Self Assertiveness Via the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problems With Self-assertiveness
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with three groups.
Primary purpose: TREATMENT

Brief summary: Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.

In a randomized controlled trial three groups will be compared:

1. constructive self-assertiveness with guidance
2. constructive self-assertiveness without guidance
3. Waitlist control

Detailed description: Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.

In a randomized controlled trial three groups will be compared:

1. constructive self-assertiveness with guidance
2. constructive self-assertiveness without guidance
3. Waitlist control

The treatment (and wait) will be 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Human,
* At least 18 years old,
* Able to speak and read Swedish,
* Informed consent.

Exclusion Criteria:

* Severe depression (as defined by a PHQ9 score of 15 points or higher),
* If on medication the dosage has been stable for at least the past 3 months,
* No ongoing psychotherapy.

Primary outcomes:
measure: Adaptive and Aggressive Assertiveness Scale
timeFrame: Up to 12 months
Secondary outcomes:
measure: Patient Health Questionnaire 9-item
timeFrame: Up to 12 months
measure: Generalized Anxiety Disorder 7
timeFrame: Up to 12 months
measure: Liebowitz Social Anxiety Scale , self-report
timeFrame: Up to 12 months
measure: Rathus Assertiveness Schedule
timeFrame: Up to 12 months
measure: Well-being scale
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Psychology
Study officials:
References:
citation: Hagberg T, Manhem P, Oscarsson M, Michel F, Andersson G, Carlbring P. Efficacy of transdiagnostic cognitive-behavioral therapy for assertiveness: A randomized controlled trial. Internet Interv. 2023 May 13;32:100629. doi: 10.1016/j.invent.2023.100629. eCollection 2023 Apr.
Clinical trial NCT07022249: Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
Official title: Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 150
Sex: ALL
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: The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

* Patient must be 18-75 years of age at the time of screening.
* Patient must have a single ruptured or unruptured IA requiring treatment.
* Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

* Patient had an IA with characteristics unsuitable for endovascular treatment.
* Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
* Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
* Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
* Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
* Patient was pregnant.

Primary outcomes:
measure: The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.
timeFrame: 12 months
measure: Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01026649: The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematoma
Keywords: hematoma formation
success rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 334
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.


Eligibility criteria: Inclusion Criteria:

* Patients who require a central venous catheter for their thoracic surgery

Exclusion Criteria:

* Refuse to enroll
* Infection at insertion site
* Carotid artery disease
* Anomaly of central vasculature
* Hypertrophied thyroid
* History of recent neck surgery

Primary outcomes:
measure: hematoma formation
timeFrame: immediately after catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04961749: Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy
Official title: Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CP
Gait Disorders, Neurologic
Locomotion Disorder, Neurologic
Keywords: Cerebral Palsy
Locomotion
Pediatrics
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the retention effects of a four-week whole-body vibration training intervention in children with Cerebral Palsy. The primary outcomes for this study are gait function, including Timed Up and Go and the two-minute walk test. Secondary outcomes of this study include lower extremity gait function, coordination, and gait variability. For this study, a total of 10 children with Cerebral Palsy (CP) will be recruited with 5 being randomly placed into an experimental group and 5 being randomly placed into a control group. Each participant, regardless of group, will complete pre-, post-, and retention testing, with a four-week whole-body vibration training intervention between the pre- and post-testing. The four-week whole-body vibration training will include three visits per week, with the experimental group receiving a vibration stimulus while standing on a vibration platform. Vibration sessions will consist of three-minutes of vibration, followed by three minutes rest, completing this cycle three separate times. The control group will follow a similar pattern, but rather than experiencing vibration, they will hear a sound of the vibration platform through a speaker. Once the four-week training session is finished, participants will return after a three-month retention period to determine whether ambulation function was retained.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Cerebral Palsy
* Ability to walk independently

Exclusion Criteria:

* Musculoskeletal injuries or conditions (other than Cerebral Palsy) which alter their independent walking ability

Primary outcomes:
measure: Timed up and go test
timeFrame: 16 weeks
measure: Two-minute walk test
timeFrame: 16 weeks
Secondary outcomes:
measure: Lower extremity gait function
timeFrame: 16 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: The University of Texas at El Paso
state: Texas
Study officials:
affiliation: The University of Texas at El Paso
name: Jeffrey D Eggleston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277249: Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion
Official title: Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Current practice for the provision of late second trimester abortion (dilation and evacuation, or D\&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Singleton viable gestation
* Identifying as primarily English-speaking
* Body mass index less than 40 kilograms/meters squared
* Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site
* No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)

Primary outcomes:
measure: Patient Discomfort With Digoxin Injection (Pain Score)
timeFrame: At time of study (immediate)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: