louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02164149: Length of Tumour Feeding Artery After Colon Cancer Surgery
Official title: Length of Tumour Feeding Artery After Colon Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Keywords: Colon cancer
Quality of surgery
Length of tumour feeding artery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 65
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: All patients over 18 years with primary colon cancer, who are to have surgery at Randers Regional Hospital, Denmark.

Brief summary: The quality of colon cancer surgery is highly debated these years since the mortality of the disease is not declining markedly. Surgery is the main treatment of colon cancer and during surgery it is very important for the surgeon to remove the tumour and all potential ways of tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along the tumour feeding artery the surgeon aims to cut the vessel as central as possible. This means that all of the tumour feeding artery should have been removed after surgery.

In this study the investigators want to measure the length of the tumour feeding artery after surgery as a quality control of the surgery. The investigators hypothesize that the artery will be shorter than 5 mm.

The investigators wish to CT scan all patients two days after colon cancer surgery and afterwards measure then length of the artery on the images. This study will not inflict with the normal routine for patient information and treatment.


Eligibility criteria: Inclusion Criteria:

* Primary colon cancer

Exclusion Criteria:

* Kidney failure, allergy to contrast, pregnancy

Primary outcomes:
measure: CT scan after colon cancer surgery. The length of the tumour feeding artery will be measured on the images.
timeFrame: 6 to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Soren Laurberg, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01280149: Reduction of IgE Antibody in Human Allergic Subjects
Official title: Reduction of IgE Antibody in Human Allergic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Allergic Rhinitis
Keywords: substance P
allergic rhinitis
allergen immunotherapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.

Detailed description: Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.

Eligibility criteria: Inclusion Criteria:

* positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive
* volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period

Exclusion Criteria:

* volunteer is pregnant or lactating
* abnormal electrocardiogram for subjects over 50 years of age
* use of beta adrenergic antagonists or tricyclic antidepressants

Primary outcomes:
measure: CBER ID50 skin test result
timeFrame: 1 to 6 months after completing injections
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Paul A Greenberger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349749: The Use of LiDCOplus in Fluid Resuscitation Decision-Making
Official title: Does the Use of LiDCOplus Alter Decision-making in Fluid Prescription During Resuscitation in the Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Keywords: intensive care units
resuscitation
fluid therapy
Vascular Access Devices
cardiac output
monitoring, physiologic
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients in the Intensive Care Unit (ICU) undergoing fluid resuscitation guided by fluid challenges monitored by a LiDCOplus haemodynamic monitor.

Brief summary: Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be given into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be harmful. It can sometimes be difficult to tell whether or not a patient will benefit from extra fluids so they are given a "fluid challenge", whereby a small volume of fluid is given quickly into the cannula and the change in their status is noted. If the patient's condition improves, this suggests that the patient is "fluid responsive" and needs more fluid.

A LiDCOplus haemodynamic monitor is a device used in the ICU to estimate the amount of blood ejected from the heart on each heartbeat using pressure readings obtained from a tube placed in one of the patient's arteries (arterial line).

The investigators aim to determine whether or not the use of this device called makes a difference to the judgement of "fluid responsiveness" when the patient is given a fluid challenge when compared to simply using measurements of pulse and blood pressure and assessing the circulation in the patient's limbs. This will allow the investigators to determine whether or not the LiDCOplus alters the decisions made by doctors and nurses about how much fluid to give their patients and hence if it is of any benefit.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Admitted to Intensive Care Unit (ICU)
* Undergoing fluid resuscitation guided by fluid challenges
* Monitored by a LiDCOplus haemodynamic monitor attached to an arterial line

Exclusion Criteria:

* Poor arterial line trace
* Moribund state
* Patient / relative refusal
* Contra-indication to fluid bolus

Primary outcomes:
measure: Fluid responsiveness decisions changed by use of LiDCOplus
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: James A Patterson, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113749: Improving Decision Making About Feeding Options for Dementia
Official title: Improving Decision Making About Feeding Options for Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Nutrition
Feeding
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-04-30
Enrollment: 256
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.

Detailed description: This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.

Eligibility criteria: Inclusion Criteria:

* dementia diagnosis
* advanced cognitive impairment
* feeding problem
* age \>= 65
* surrogate decision maker

Exclusion Criteria:

* feeding tube decision made
* hospice
* BMI \> 26
* major psychosis or developmental delay

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: 3 months
Secondary outcomes:
measure: Percent With Treatment Decisions
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura C Hanson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19.
citation: Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15.
citation: Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20.
Clinical trial NCT03617549: Stress and Breast Milk Study In the Neonatal Intensive Care Unit
Official title: A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Breast Milk Expression
Stress
Keywords: neonatal intensive care
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of singleton moderate preterm appropriate for Gestational Age (AGA) infants (29-32+6 weeks gestation29) will be approached during the enrollment period and screened for eligibility.

Brief summary: The overall goal of this research is to clarify the relationship between reported maternal stress, biological measures of maternal stress, breast milk biomarkers and milk quantity. Our primary hypothesis is that measures of maternal stress are associated with cortisol, cytokines, and other stress markers in the blood, which impacts breast milk quantity and composition and which may impact infant health.


Eligibility criteria: Inclusion Criteria:

* Baby will remain in mom's legal custody
* Intends to exclusively breastfeed during the NICU stay
* Has kept a daily log of milk expression (pump or hand expression) with date/time/quantity since birth of their child
* Less than 7 days postpartum

Exclusion Criteria:

* Baby and mother are to be separated due to legal custody issues
* Medical contraindication to breastfeeding
* Non-English speaking
* Unable to answer a written survey in English
* More than 50% of infant intake is not mother's own milk at 4 weeks postpartum

Primary outcomes:
measure: Correlation between secretory IgA levels in mother's serum and reported stress
timeFrame: baseline
measure: Correlation between secretory IgA levels in mother's serum and reported stress
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center NICU
state: New York
Study officials:
References:
Clinical trial NCT00136149: Study on Immediate Placement to Evaluate Astra Tech Osseospeed Implants in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges
Official title: An Open, Prospective, Controlled Study on Immediate Placement to Evaluate Clinical Outcome of Astra Tech Implants, Fixture Microthread Osseospeed in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2005-08-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate immediate implants.

Detailed description: Solitary replacement of teeth by implants in upper maxilla - immediate implants

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Smoking
* Medical risk patients

Primary outcomes:
measure: Implant survival after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
timeFrame: after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618149: Use Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
Official title: Use Dual-energy X-ray Absorptiometry and Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periprosthetic Bone Loss in Total Knee Replacement
Keywords: osteoarthritis
periprosthetic bone loss
dual energy x-ray absorptiometry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who are indicated for total knee arthroplasty and are post menopausal women. The patients who had history of immune disease , fracture of the femur and end stage of renal disease will be excluded

Brief summary: The investigators hypothesized that the microarchitecture of bone influence the degree of periprosthetic bone loss after total knee arthroplasty surgery. The investigators collected the bone fragment at the distal femur while performing total knee replacement and take quantitative radiography analysis . Before and after the surgery(6 month ,12 month) , the investigators check the BMD at identical location of the distal femur by using dual energy absorptiometry. The investigators will use linear regression to evaluate the relationship between the microarchitecture and the degree of bone loss.


Eligibility criteria: Inclusion Criteria:

* severe knee osteoarthritis
* post menopausal women

Exclusion Criteria:

* immune disease
* end stage of renal disease who receive dialysis
* history of fracture at ipsilateral distal femur

Primary outcomes:
measure: change in bone mineral density
timeFrame: before the surgery and after the sugery (6month ,12month)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National taiwan university hospital
Study officials:
affiliation: National Taiwan University Hospital
name: ching chuan Jiang, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00779649: MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial
Official title: MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Colonoscopy,
Prep
MoviPrep
HalfLytely
The effectiveness of colonoscopy preps
Lead sponsor: Research Associates of New York, LLP
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.

Detailed description: To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing colonoscopy

Eligibility criteria: Inclusion Criteria:

1. Has provided written informed consent.
2. Is scheduled for colonoscopy within 30 days of screening
3. Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
4. Is able to communicate effectively with study personnel.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
2. Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
3. History of renal insufficiency

Primary outcomes:
measure: The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire.
timeFrame: one year from the trial start date
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York Gastroenterology Associates, L.L.P
name: Lawrence B Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03011749: Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients
Official title: Value of FLT PET/CT in Radium-223 Therapy of Patients With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Prostate Carcinoma
Keywords: Radium-223 therapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 6
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of hematological toxicity


Eligibility criteria: Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Eligible for Radium-223 therapy
* Informed consent

Exclusion Criteria:

* Inability to understand study protocol
* Extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)

Primary outcomes:
measure: Uptake of FLT in hematological bone marrow
timeFrame: 3 months
Secondary outcomes:
measure: Occurrence of hematological toxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04792749: Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Official title: Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometrial Cancer Stage I
Keywords: Endometrial cancer
Metformin
Progestin
Fertility-sparing treatment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effects of metformin in addition to the conventional progestin therapy in the fertility-sparing treatment of early stage endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Endometrial cancer radiologic International Federation of Obstetrics and Gynecology (FIGO) stage IA patients
* Endometrioid endometrial cancer patients
* FIGO cellular differentiation grade 1 patients
* Patients who wish to preserve fertility
* Patients who understand that the recommended treatment of endometrial cancer is surgical treatment even in early stages, but still wish to preserve fertility and avoid surgical treatment
* Patients who have good performance status (Eastern Cooperation Oncology Group (ECOG) performance score equal to or greater than 3)
* Patients who are not contraindicated to the progestin therapy
* Patients who are not contraindicated to the use of metformin

Exclusion Criteria:

* Patients who have already received chemotherapeutic or radiotherapeutic treatments for endometrial cancer
* Patients whose disease is already advanced and not indicated for fertility-sparing treatment
* Patients whose tumor cellular differentiation grade is greater than FIGO grade 1

Primary outcomes:
measure: Treatment response rates
timeFrame: 3 months after the initiation of the treatment
measure: Treatment response rates
timeFrame: 6 months after the initiation of the treatment
measure: Treatment response rates
timeFrame: 9 months after the initiation of the treatment
measure: Treatment response rates
timeFrame: 12 months after the initiation of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong-Won Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: