louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00047801: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer
Official title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2002-10-21
Enrollment: 28
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 purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.


Eligibility criteria: Inclusion criteria include:

* Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
* Stage IV or Stage IIIB
* Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal, and bone marrow function

Exclusion criteria include:

* Pregnant or lactating women
* Treatment with more than one cytotoxic therapy
* Prior radiation to the whole pelvis
* Unstable medical conditions such as uncontrolled cardiac arrhythmia
* Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cancer Institute Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT04668001: Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Official title: Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Down Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.

Detailed description: This study will compare the effect of tPBM to sham tPBM on gamma neural oscillations in the brain as assessed by EEG, and on language, attention and memory as assessed by neuropsychological testing. Participants will be randomized to either tPBM with near-infrared light (tPBM-NIR) or tPBM-Sham and will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term and long- term follow up visits.

Eligibility criteria: Inclusion criteria for this study include:

1. adult men and women between the ages of 16 and 35
2. diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)

Exclusion criteria for this study include:

1. diagnosis of seizure disorder
2. diagnosis of dementia
3. inability to complete study procedures
4. English as a second language
5. speech as the secondary mode of communication
6. speech of less than two-word utterances
7. changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
8. untreated obstructive sleep apnea (OSA)
9. Participation in other clinical research trials that may influence affect primary outcomes or adherence to the proposed study, as assessed by the PI and the Co-Is
10. candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
11. history of migraine with an aura in the past 6 months
12. current pregnancy

Primary outcomes:
measure: Change in EEG
timeFrame: Baseline to Post-Treatment (~6 weeks)
measure: Change in Wordless Picture Book
timeFrame: Baseline to Post-Treatment (~6 weeks)
measure: Change in Cambridge Neuropsychological Test Automated Battery
timeFrame: Baseline to Post-Treatment (~6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital at the Charlestown Navy Yard
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Paolo Cassano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05132101: Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
Official title: Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Keywords: Hormone receptor positive (HR+)
Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
Metastatic Breast Cancer (MBC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: BC patients who were prescribed with Palbociclib in combination with AI for at least 1 cycle during the index period will be selected as the study population.

Brief summary: The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea.


Eligibility criteria: Inclusion Criteria:

* Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period
* Patients who were diagnosed with BC during the index period

Exclusion Criteria:

* Male
* Prescribed with palbociclib during 12-month period preceding the index date

Primary outcomes:
measure: Total treatment duration and cycle for Palbociclib
timeFrame: From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)
Secondary outcomes:
measure: Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting.
timeFrame: From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 2020)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05845801: Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer
Official title: Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is represented by individuals who have received a pathological diagnosis of pancreatic cancer before the age of 55 years old (namely, EO-PDAC patients). No subject will be financially compensated for their participation.

Brief summary: The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.


Eligibility criteria: Inclusion Criteria:

* Age ≤55 years old at the time of diagnosis of pancreatic cancer
* Age ≥ 18 years
* Written informed consent obtained.

Exclusion Criteria:

* Any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor)
* Absence of informed consent.
* Age \< 18 years or \> 55 years old at the time of diagnosis of pancreatic cancer

Primary outcomes:
measure: Register of young PDAC patients
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
References:
Clinical trial NCT02091401: A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
Official title: A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: magnesium sulfate
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.


Eligibility criteria: Inclusion Criteria:

Exhibit systolic blood pressure \> 160mm Hg OR a diastolic pressure \> 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).

Exhibit proteinuria \> 1+; Have not given birth, or be \<24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be \> 18 years of age Give informed consent for study participation

Exclusion Criteria:

Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine \>1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if \>1.2 mg/dL in order to have a proper dose adjustment.

Primary outcomes:
measure: Magnesium concentration
timeFrame: 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby Maternity Hospital
city: Cairo
country: Egypt
facility: El Galaa Teaching Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: STUDY_DIRECTOR
References:
citation: Easterling T, Hebert M, Bracken H, Darwish E, Ramadan MC, Shaarawy S, Charles D, Abdel-Aziz T, Nasr AS, Safwal SM, Winikoff B. A randomized trial comparing the pharmacology of magnesium sulfate when used to treat severe preeclampsia with serial intravenous boluses versus a continuous intravenous infusion. BMC Pregnancy Childbirth. 2018 Jul 6;18(1):290. doi: 10.1186/s12884-018-1919-6.
Clinical trial NCT06924801: Integration of Real-Time Motion Tracking and Pediatric Rehabilitation
Official title: Evaluating the Feasibility, Usability, and Integration of the OptiTrack Motion Capture System in Inpatient Physical Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Keywords: motion capture technology
Total translational movement
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emerging technologies that utilize motion capture integrated with engaging software offer new methods for increasing engagement and movement in patients admitted to the hospital. Hospitalized patients are often limited to sedentary activities, spending the majority of their time in bed, which can contribute to deconditioning and functional mobility deficits. This study seeks to explore the feasibility of a tool designed to promote movement through engaging gameplay that is acceptable to both clinicians and families.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 6-17 years.
* Receiving physical therapy at Stanford Children's Hospital.
* Medically cleared for standing and upper-body movement.
* Ability to follow simple instructions and engage in standing gameplay

Exclusion Criteria:

* Orthopedic or medical conditions contraindicating physical activity.
* Legal guardian not present to obtain consent
* Child with a significant neurological condition or major developmental disability
* Child with active infection of the face or hand
* A history of severe motion sickness A history of seizures caused by flashing light Major surgery within the last 48 hours

Primary outcomes:
measure: Evaluate the ease of use of Optitrack system measured by System Usability Scale (SUS)
timeFrame: Post-simulation (5 minutes)]
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM) survey
timeFrame: immediately after the intervention
measure: Intervention Appropriateness Measure (IAM) survey
timeFrame: immediately after the intervention
measure: Feasibility of Intervention Measure (FIM) survey
timeFrame: immediately after the intervention
measure: ISO 9241-400
timeFrame: immediately after intervention
measure: Setup time required for system use
timeFrame: Before intervention
measure: Duration of gameplay-driven physical activity
timeFrame: immediately at the start of intervention, immediately after intervention
measure: Evaluation parent's perception of patient's engagement.
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT03873701: Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
Official title: Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydronephrosis
Pyelonephritis
Urosepsis
Keywords: bedside ultrasonography
emergency department
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
First posted: 2019-03-13
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single-center population collected from patients with contact to the emergency department (ED) at Odense University Hospital (OUH). Convenience sample.

Brief summary: The aim of this study is to evaluate the accuracy and implications of the diagnoses and treatment determined by bedside ultrasonography (b-US) of the kidneys compared to current clinical assessment. Potentially diagnosing patients faster and avoiding missing conditions leading to readmission or unnecessary radiation from computed tomography (CT).

This study evaluates the use of b-US as a supplement to clinical evaluation, in an unselected group of patients in the emergency department (ED) with signs of kidney involvement. The b-US of the kidneys is performed by a medical student certified in this technique. The evaluation will be based on data collected from a Danish hospital (Odense University Hospital, OUH) in autumn 2018.


Eligibility criteria: Inclusion Criteria:

* Suspicion of urinary tract infection and one or more of the following:
* Flank pain
* Fever
* Symptoms when voiding
* Creatinine elevation or 20% elevation from known creatinine level elevation

Exclusion Criteria:

* Age \< 18 years
* Radiological ultrasonographic examination already performed
* Patients who are not able to consent

Primary outcomes:
measure: Ultrasonographic hydronephrosis
timeFrame: All included patient undergo bedside ultrasonography within 4 hours after admission
Secondary outcomes:
measure: Clinical consequence of bedside ultrasonographic result
timeFrame: Within 4 hours after admission
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense Universitetshospital
Study officials:
affiliation: Forskningsenheden FAM OUH
name: Annmarie T Lassen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01830101: A Phase III Study of Re-Irradiation in Recurrent Glioblastoma
Official title: A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Recurrent Glioblastoma
Keywords: recurrent glioblastoma
re-irradiation
continuous low-dose temozolomide
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.

Detailed description: This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.

Eligibility criteria: Inclusion Criteria:

* histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
* radiographic evidence of tumour progression or recurrence
* 18 years or older
* ECOG 0 - 2
* signed informed consent form

Exclusion Criteria:

* tumour progression or recurrence within 3 months of initial concurrent chemoradiation
* 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
* more than one prior course of salvage chemo for recurrent disease
* prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
* prior head or neck RT except for T1 glottic cancer

Primary outcomes:
measure: To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
timeFrame: 2 months
Secondary outcomes:
measure: To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.
timeFrame: 2 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Samir Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tom Baker Cancer Centre
name: Gerald Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271201: Exercise Intensity for Down Syndrome Children
Official title: Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 34
Sex: MALE
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: The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

Detailed description: Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.

Eligibility criteria: Inclusion Criteria:

* independent walking
* Intelligence quotient range from 40 to 70
* right dominant foot
* body mass index from 50 to 75

Exclusion Criteria:

* chronic diseases
* congenital anomalies
* involved in any competitive sport
* previous injury to the lower limb

Primary outcomes:
measure: knee extensor peak torque
timeFrame: three months
measure: ankle plantar fexors peak torque
timeFrame: three months
measure: functional mobility
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Ta'if
country: Saudi Arabia
facility: College of Applied Medical Sciemces
state: Mecca
Study officials:
affiliation: Taif University
name: Hatem H Allam, ass. prof.
role: PRINCIPAL_INVESTIGATOR
References: