louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03277768: Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Official title: Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant
Patent Ductus Arteriosus
Hemodynamic Instability
Keywords: Premature infant
Tissue Oxygenation
Patent Ductus Arteriosus
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2017-09-11
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants born \<30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.

Brief summary: The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \< 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.


Eligibility criteria: Inclusion Criteria:

* Infants \< 30 weeks estimated gestational age

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants \>34 weeks post-menstrual age

Primary outcomes:
measure: Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
timeFrame: Up to a maximum of 14 data collection times
Secondary outcomes:
measure: Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
timeFrame: Up to a maximum of 14 data collection times
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: University of Florida
name: J Lauren Ruoss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170768: Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Official title: Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: Darifenacin, oxybutynin, cognition, memory
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 60 and over
* United States English as a primary language
* Given written informed consent by signing and dating an informed consent form prior to study entry

Exclusion Criteria:

* Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
* Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator

Other protocol defined inclusion/exclusion criteria may apply.

- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary outcomes:
measure: Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
measure: Effects on other cognitive domains measured by various tests at week 1,2 and 3.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Neuropsychological Institute LLC Georgetown
state: District of Columbia
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT00468468: Mentor Integration Study
Official title: Mentor Integration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CHESS and Cancer Mentor
CHESS Only
Mentor Only
Control (Internet Only)
Keywords: breast cancer
Internet
computer
support
information
education
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-02
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Mentor Integration Project

This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.

Primary Aims:

* Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
* Determine which of the above conditions is most effective
* Determine which of the above conditions is most cost efficient


Eligibility criteria: Inclusion Criteria:

Eligibility for this protocol is as follows:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age,
* All subjects must be able to read and write English at the 6th-grade level
* Not homeless

Primary outcomes:
measure: Patient quality of life
timeFrame: throughout study
Secondary outcomes:
measure: Self efficacy
timeFrame: throughout study
measure: Emotional well being
timeFrame: throughout study
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Houston
country: United States
facility: M.D. Anderson
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Hawkins, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538068: The Psychology of Physical Activity
Official title: Meaning and Purpose as Predictors of Physical Activity Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Purpose in Life
Self-determination
Physical activity
Self-monitoring
Behavior change
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study plans to learn more about psychosocial factors that contribute to adopting physical activity. The goal of this study is to improve upon existing theories of behavior change in order to help other people become more physically active.

Detailed description: The purpose of this study is to examine the relationship between personal life meaning and purpose and physical activity maintenance in a group of previously sedentary adults starting new exercise programs. Participants complete questionnaires at baseline, 4 weeks, and 12 weeks after starting an exercise program. Participants are randomly assigned to complete questionnaires about daily meaning, mood, and activity for the first 4 weeks or to complete 8 random questionnaires about daily activities over the first 4 weeks. It is hypothesized that personal life meaning and purpose will be related to greater exercise participation at 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 30-89 years old
* Joining or already a member of the Anschutz Health and Wellness Fitness Center
* Able to read and understand English
* Sedentary (\< 60 minutes of moderate-vigorous physical activity a week) for the past 3 months
* Planning to start a new exercise program

Exclusion Criteria:

* Physical contraindications to participate in physical activity (as defined as a positive PAR-Q score)
* Existing diagnosis of cardiovascular disease
* Currently pregnant

Primary outcomes:
measure: Changes in Physical Activity as measured by the International Physical Activity Questionnaire - Short Form
timeFrame: Baseline, 4 weeks, and 12 weeks
Secondary outcomes:
measure: Frequency of Fitness Center Attendance measured by number of check-ins at fitness center
timeFrame: Daily for 12 weeks
measure: Changes in Physical Fitness, as measured by a combined scores on objective cardiovascular fitness, flexibility, and strength.
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Changes in the Satisfaction with Life assessed by Satisfaction of Life Scale
timeFrame: Baseline, 4 weeks, and 12 weeks
measure: Changes in Vitality assessed by Subjective Vitality Scale
timeFrame: Baseline, 4 weeks, and 12 weeks
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Stephanie A Hooker, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooker SA, Masters KS. Daily meaning salience and physical activity in previously inactive exercise initiates. Health Psychol. 2018 Apr;37(4):344-354. doi: 10.1037/hea0000599. Epub 2018 Jan 25.
Clinical trial NCT01396668: Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer
Official title: Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: locally advanced
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 35
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: This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Detailed description: The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

* unresectable locally advanced pancreatic cancer
* no distant metastasis
* histologically confirmed adenocarcinoma of pancreas
* 18-75 of age
* ECOG performance status 0-2
* normal marrow function :

  * WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
  * Platelet count at least 100,000/mm3
* normal liver function :

  --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)
* normal renal function :

  --Creatinine no greater than 1.5 times ULN
* signed informed consent

Primary outcomes:
measure: Time to progression
timeFrame: 12 months
Secondary outcomes:
measure: safety
timeFrame: 12 months
measure: 1 year survival rate
timeFrame: 1 year
measure: response rate
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
measure: clinical benefit rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seock-Ah Im, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02297568: Vitamin D Supplementation During Lactation
Official title: Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency, Vitamin D
Keywords: Breast-fed infant
vitamin D supplementation
Lactation
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Queen Sirikit National Institute of Child Health
First posted: 2014-11-21
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.

Detailed description: Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.

Eligibility criteria: Inclusion Criteria:

* Pregnant Thai women and intends to deliver at Rajavithi Hospital
* Insufficient Vitamin D levels (25(OH)D \< 30ng/ml)
* Gestational age at birth and no complications

Exclusion Criteria:

* Age \< 18 years old
* Unintended to deliver at Rajavithi Hospital
* Insufficient Vitamin D levels (25(OH)D \< 10ng/ml)

Primary outcomes:
measure: Comparison serum 25OHD levels from breastfed infants
timeFrame: 6 weeks after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Sathit Niramitmahapanya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02444468: Preoperative Treatment of Malleolar Fractures
Official title: A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Intermittent Pneumatic Compression
Comparative Study
Preoperative Care
Lead sponsor: Hospital of Southern Jutland
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 96
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: This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling.

The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.

Detailed description: Malleolar fractures are often complicated by tissue swelling due to soft tissue injury, haemorrhage and secondary inflammation.

This can lead to severe oedema which can compromise the ability to perform surgery due to blister formation or the inability to close the skin after surgery. Studies have shown that the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from diagnosis to surgery as well as reduce length of hospital stay.

Purpose of the study is in a randomized study to investigate whether patients requiring surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC than patients not using IPC.

All patients age 18 or above admitted to our hospital with malleolar fractures (AO type 44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of surgery(time of incision) will be the primary outcome. Patients will be seen in a postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.

Eligibility criteria: Inclusion Criteria:

* Malleolar fracture requiring surgery.

Exclusion Criteria:

* Severe arteriosclerosis.
* Known or suspected acute DVT or flebit.
* Severe decompensated heart failure.
* Pulmonary embolism.
* Acute skin conditions as dermatitis, infected wounds or recent skintransplant.
* Open fracture.
* Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.
* Pregnancy.

Primary outcomes:
measure: Time from diagnosis-to-surgery
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Åbenrå
country: Denmark
facility: Jesper O. Schønnemann
Study officials:
affiliation: Hospital southern Jutland
name: Jesper O Schønnemann, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230068: ExBRAC - the Pilot Study
Official title: ExBRAC - Expressive Writing in Breast Cancer - The Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Keywords: breast cancer
quality of life
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The EXBRAC pilot study will investigate the quality of life of patients with breast cancer, and the effect of an intervention with expressive writing. This is a pilot study with two purposes, the first is to create a questionnaire specifically developed for the ExBRAC study, and the second to evaluate the feasibility of the expressive writing.

Detailed description: In the first stage of the study, patients newly diagnosed with breast cancer will be interviewed using a semi-structured method. Based on the transcriptions from the interviews, themes will be gathered and transformed into questions. The questions will be compiled into a questionnaire and an expert group will review the questionnaire to ensure no topic is lacking and an adequate number of response options is present. Lastly, the questionnaire will be face-to-face validated, meaning a patient completes it with a research nurse present to apprehend any ambiguities or questions needing clarification.

In the second part of the pilot study, patients will be included to test the feasibility of the interventions consisting of expressive writing. The intervention consists of expressive writing during 20 minutes. The writing should be of the breast cancer, the treatment or other related topics. The patient is invited to write once every week in a separate place. The intervention ends after four weeks. The written text is not collected. In the pilot study, the intervention will be followed by a telephone call about five weeks after inclusion. To test the feasibility of the intervention, 20 to 25 included patient is considered sufficient.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed breast cancer

Exclusion Criteria:

* Does not understand swedish

Primary outcomes:
measure: Number of included patients that completed the intervention
timeFrame: Five weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Skane
Study officials:
affiliation: Region Skane
name: Linnea Huss, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070368: Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Official title: Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wheat Allergy
Keywords: skin test
open wheat challenge
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for wheat allergy. However, commercial wheat extracted for skin prick test have less precise test result compared to extract from omega-5 gliadin, which is one of the major allergen with immediate wheat allergy.


Eligibility criteria: Inclusion Criteria:

* A patient with the age of 1-15 year old
* A history of symptoms that suspected of type 1 hypersensitivity (eg. Urticaria, angioedema, wheezing, anaphylaxis) occur within 4 hours after wheat ingestion.
* Patients attend in allergy clinic, pediatric department, Siriraj hospital since 2007-2012

Exclusion Criteria:

* First sign and symptom happens more than 4 hours since wheat ingestion
* Have underlying disease such as heart disease, epilepsy etc.
* Have contraindication for performed skin prick test

Primary outcomes:
measure: correlation skin test result and food challenge result
timeFrame: 3 year
Secondary outcomes:
measure: comparison of skin test result and specific IgE to challenge result
timeFrame: 3 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
Study officials:
References: