louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00201812: Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
Official title: Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Advanced Solid Tumors
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Immunex Corporation
First posted: 2005-09-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of the combination of Etanercept and Docetaxel in patients with advanced solid tumors for which there is no standard treatment.


Eligibility criteria: Inclusion Criteria:

* Must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists.
* Solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option:

  * Non-Small Cell Lung
  * Breast
  * Head and Neck
  * Esophageal
  * Stomach
  * Ovarian carcinomas
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Life expectancy of at least 12 weeks.
* Must have adequate organ function
* Peripheral Neuropathy must be less than Grade 2

Primary outcomes:
measure: Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.
timeFrame: up to 4 years
Secondary outcomes:
measure: Characterize toxicities of weekly docetaxel when administered weekly to patients with solid malignancies to determine if co-administration of etanercept can result in higher tolerated doses of docetaxel.
timeFrame: up to 4 years
measure: Determine if weekly docetaxel administration is associated with increased expression of TNF and if inactivation of TNF by etanercept is associated with a decrease in the rate of moderate to severe asthenia.
timeFrame: up to 4 years
measure: Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Miguel Villalona
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monk JP, Phillips G, Waite R, Kuhn J, Schaaf LJ, Otterson GA, Guttridge D, Rhoades C, Shah M, Criswell T, Caligiuri MA, Villalona-Calero MA. Assessment of tumor necrosis factor alpha blockade as an intervention to improve tolerability of dose-intensive chemotherapy in cancer patients. J Clin Oncol. 2006 Apr 20;24(12):1852-9. doi: 10.1200/JCO.2005.04.2838.
Clinical trial NCT05599412: Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic ALK+ Non Small Cell Lung Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patient who has a disease for which Lorlatinib is indicated

Brief summary: The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Patients to whom Lorviqua® is contraindicated as per the local labeling. A. Hypersensitivity to Lorviqua® or to any of the excipients of this product B. Lorviqua® is contraindicated in patients taking concomitant use of strong CYP3A4/5 inducers C. This medicinal product contains lactose as an excipient. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product.
2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information

Primary outcomes:
measure: Incidence of the adverse events from baseline
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: Up to 2 years
measure: Partial Response (PR)
timeFrame: Up to 2 years
measure: Stable Disease (SD)
timeFrame: Up to 2 years
measure: Progressive Disease (PD)
timeFrame: Up to 2 years
measure: Complete Response (CR)
timeFrame: Up to 2 Years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06318312: Effects of Hypoxia on Cognitive Performance
Official title: Effects of Different Hypoxia Exposures on Cognitive Performance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: cognitive
anticipation
memory
attention
reaction time
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:

* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?
* Which hypoxia exposure causes the greatest detriments in cognitive function?

Detailed description: Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).

Eligibility criteria: Inclusion Criteria:

* Physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity)
* Non-smokers
* Individuals without serious and undiagnosed health problems

Exclusion Criteria:

* Pregnancy and/or breastfeeding
* Residing at an altitude of more than 1300 m
* Having been exposed to an altitude of more than 900 m in the last 8 months
* Having performed a study with hypoxia in the last 8 months
* Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.

Primary outcomes:
measure: Memory
timeFrame: During each hypoxic condition
measure: Attention
timeFrame: During each hypoxic condition
measure: Anticipation
timeFrame: During each hypoxic condition
measure: Reaction time
timeFrame: During each hypoxic condition
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Performance and Sport Rehabilitation Laobratory. University of Castilla-La Mancha
Study officials:
References:
Clinical trial NCT01002612: Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community
Official title: Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community: 6 Months After Nutrition Care Support by the Thai-Australian Collaboration HIV-Nutrition (TACHIN) Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
HIV Infections
Keywords: Nutritional status
Thai HIV-infected children
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: South Eastern Area Health Service
First posted: 2009-10-27
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai HIV-infected children living in a family style community located in rural central region of Thailand

Brief summary: To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

Detailed description: The first assessment indicated that improving dietary intake, either energy or micronutrient intakes, to meet the recommended for HIV-infected children (CLHIV) would be able to improve growth of these children. We implemented the nutrition support program through the two strategies aiming to increase dietary intake for all children to meet the current World Health Organization (WHO) recommendations which the recommended energy requirements are increased by10% for asymptomatic CLHIV and increased by 20 to 50% for children who require catch up growth or experiencing opportunistic infections. The nutrition support program composed two strategies. Firstly is providing nutrition education to caregivers and also children. Secondly, revision food menus by caregivers with assisting from the nutritionists of the project. After this program have been implemented for 6 months, reassessment is needed to evaluate the changes of nutritional status and health outcomes in this children aiming to further providing support and applying to other settings.

Eligibility criteria: Inclusion Criteria:

* Children age 4-15 years old
* Confirmed HIV-1 diagnosis
* Reside at the community
* The guardian must be able and willing to provide written informed consent. Oral consent in the presence of witness is acceptable in the case of illiteracy

Exclusion Criteria:

* non-HIV infected children
* Age 0-3 years

Primary outcomes:
measure: Growth parameters (weight and height), blood lipid levels and dietary intakes
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children
timeFrame: 6 months
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
affiliation: The Thai Red Cross AIDS Research Centre
name: Praphan Phanuphak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01624012: Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
Official title: Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome (RDS) of Neonate
Keywords: NIV NAVA
non-invasive ventilation
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.

The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.


Eligibility criteria: Inclusion Criteria:

* postconceptional age 28+0 - 36+6
* need of ncpap treatment and inspired oxygen for at least 60 minutes

Exclusion Criteria:

* severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
* any condition which prevents insertion of naso/orogastric tube

Primary outcomes:
measure: Duration of inspired oxygen supply
timeFrame: 30minutes- 3weeks
Secondary outcomes:
measure: Duration of noninvasive ventilation
timeFrame: 30 minutes - 3 weeks
measure: Fraction of inspired oxygen
timeFrame: 0, 1, 3 and 6hours, after which every 6 hours
measure: Blood gas analyses
timeFrame: 3 weeks
measure: Duration of parenteral nutrition
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University hospital
Study officials:
References:
Clinical trial NCT05378412: Effect of the 3C Model in Students and Teachers From Vaupés, Boyacá and Amazonas
Official title: Efecto Del Modelo "Conmigo, Contigo y Con Todos" (3Cs) en Niños, Niñas y Adolescentes y Sus Profesores en Vaupés, Boyacá y Amazonas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resilience, Compassion
Lead sponsor: Fundación Saldarriaga Concha
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
name: Ministerio de Ciencia, Tecnología e Innovación
First posted: 2022-05-18
Enrollment: 6000
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is based on a mixed-methods experimental design and concurrent triangulation
Primary purpose: OTHER

Brief summary: This study will evaluate the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion in students and teachers from three regions from Colombia: Vaupés, Amazonas and Boyacá. It will also evaluate its relevance in the design of programs aimed at mental health in educational settings.

Detailed description: Colombia has experienced a long-lasting internal armed conflict that has impacted society at all levels and on people of all ages. This has led to changes in behavior and the way people cope with psychosocial distress. Focusing on children and adolescents, this study aims to assess the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion. The changes in the scores of the CD-RISC and ECOM instruments will be evaluated through a mixed methods analysis that will evaluate the pre and post intervention results and the perception of all the actors involved in the development and implementation of the 3Cs program.

Eligibility criteria: Inclusion Criteria:

* Students and teachers from public institutions

Exclusion Criteria:

-

Primary outcomes:
measure: CD-RISC
timeFrame: 36 months
measure: ECOM
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00959712: Computer Agents to Promote Walking in the Elderly
Official title: Computer Agents to Promote Walking in Older Adults With Low Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: Stanford University
First posted: 2009-08-17
Enrollment: 263
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This proposal is a randomized control trial using innovative interactive health technologies to promote and sustain walking behavior among elderly patients. The technology uses an Embodied Conversational Agent (ECA), a computer character that simulates face-to-face conversation. The trial will be block randomized by literacy status and include an intensive two-month, daily contact intervention via a Tablet PC ECA in the subject's home, an automated telephone program, and then an in-clinic, kiosk-based ECA for an additional 10 months, to promote maintenance of walking behavior. The study will occur in 2 phases, a pilot phase in which 20 subjects will be enrolled for the purpose of pre- testing the intervention and all data collection instruments, and a main study phase in which an additional 264 subjects will be enrolled.


Eligibility criteria: Inclusion Criteria:

1. 65 years old or greater
2. English-speaking
3. Actively being cared for by a primary care provider at Boston Medical Center

Exclusion Criteria:

1. Non-ambulatory
2. Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, complex cardiac arrhythmias or significant left ventricular dysfunction, and major functional disabilities relating to gait or balance
3. Medications that would compromise patient's ability to participate
4. Had more than 2 falls in the past year (i.e. fall risk)
5. Moderate to severe dementia
6. Severe depression
7. Currently exercising, i.e., engaged regularly in moderate-intensity or more vigorous physical activity 3 or more days per week for at least 20 minutes per day

Primary outcomes:
measure: Increase in physical activity (measured as step counts from pedometer)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Rebecca A Silliman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06948812: Foot Positions Affect Basketball Players With Flatfoot
Official title: Effect of Various Initial Foot Positions on Proprioception, Balance, Jump, and Electromyographical Muscle Activity in Basketball Players With Flatfoot and Chronic Ankle Instability: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balance
Proprioception
Jumping Performance
EMG
Keywords: basket ball players
balance
flatfoot
electromyography
propioception
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Basketball players with chronic ankle instability

Brief summary: This study investigated the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.

Detailed description: Objective: To investigate the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.

Methods: Eighty-four basketball players with chronic ankle instability were distributed to three groups (28 with flexible FF, 28 with rigid FF, and 28 without FF). The outcome measures will include static and dynamic balance, knee and ankle proprioception, vertical jump, and electromyography (EMG) of ankle muscles (including gastrocnemius (GE), soleus (SOL), tibialis anterior (TA), and peroneus longus (PL) muscles)

Eligibility criteria: Inclusion Criteria:

* The presence of flatfoot in the dominant leg.
* The presence of chonic ankle instability

Exclusion Criteria:

* The exclusion criteria were the existence of limited hallux dorsiflexion
* previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies;
* Had any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance

Primary outcomes:
measure: Knee proprioception with repositioning error test
timeFrame: 3 months
measure: Ankle proprioception with angular error measurement test
timeFrame: 3 months
measure: Static balance with The Y-Balance test
timeFrame: 3 months
measure: Dynamic balance with Biodex Balance device
timeFrame: 3 months
measure: Vertical jump height with vertical jump tester
timeFrame: 3 months
measure: Electromyographical activity (EMG) during one-leg standing
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Nahda University
state: Beni Suef
Study officials:
References:
Clinical trial NCT00000212: IV Cocaine Abuse: A Laboratory Model - 1
Official title: IV Cocaine Abuse: A Laboratory Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: crack cocaine
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Columbia University
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of desipramine DMI maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Amount cocaine self-administered
measure: Direct cocaine effects (cardiovascular, subjective
measure: Interaction of cocaine and DMI on cardio measures
measure: Interaction of cocaine/DMI on coc's subjective
measure: Effects of DMI on cocaine craving
measure: Drug use during outpatient DMI maintenance
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Richard Foltin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischman MW, Foltin RW, Nestadt G, Pearlson GD. Effects of desipramine maintenance on cocaine self-administration by humans. J Pharmacol Exp Ther. 1990 May;253(2):760-70.