louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000111: Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mouth Diseases
Keywords: mouth mucosa
transplants
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-01-19
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 purpose of this study is to see if we can develop a good graft for oral mucosal tissue that is like the top of the mouth in a "test tube" that could be used successfully in humans. We have already done this successfully mice. The next step is to take a small piece of tissue from a human volunteer and see if we can grow a larger piece of tissue from it outside the human body and graft it back into the same person successfully. We expect that this technique will work. It has already been tried in patients with burns of the skin who have had similar procedures where the skin is grafted back to them. The significance of this research is that oral tissue taken from the top of the mouth or palate is in limited supply and leaves the patient with a painful and uncomfortable post surgery experience. If we are successful with our technique the patient will experience less pain and discomfort from the site that we are using to grow our tissue outside the body than if we had taken it from the top of the mouth or palate. In addition, by waiting longer periods to grow the patient's cells we can make larger pieces of oral tissue than we could have gotten directly from the patient's mouth. Patients who will participate in this study will need to require a soft tissue graft from the mouth to an area that needs additional attached or keratinized mucosa. This will most likely be either in preparation for patients who have or will have dental implants placed. Another subset of patients are those who need scar tissue released or the vestibule of their mouth (area that turns from the gums to the lip) released.


Eligibility criteria: Inclusion Criteria:

* Lack sufficient attached keratinized tissue at recipient surgical site in question

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00554411: Assessing Ocular Surface Changes After Changing Glaucoma Medications
Official title: Assessing Changes at the Ocular Surface Following the Switch From Xalatan to Travatan Z.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Monotherapy With Xalatan From 1 to 18 Months
Ocular Surface Disease
Keywords: Travatan Z
glaucoma
tear film break up time
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients will be selected from the ophthalmology clinic of the principal investigator

Brief summary: Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects on Xalatan therapy presenting with ocular surface disease.

Detailed description: Patients who have been taking Xalatan monotherapy to treat their glaucoma and presenting with ocular surface disease will be advised to switch their medication to Travatan Z. Test results will be recorded at the day that the medication was changed and at follow-up to determine if there is a measurable change in tear film break up, corneal staining and in the Ocular Surface Disease Index.

Eligibility criteria: Inclusion Criteria:

* on Xalatan monotherapy from 1 to 18 months
* 18 years of age or older
* has been diagnosed with ocular surface disease

Exclusion Criteria:

* special populations such as children, pregnant females, prisoners, etc.

Primary outcomes:
measure: Change in Signs and Symptoms of Ocular Surface Disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
Study officials:
affiliation: Rocky mountain Lions Eye Institute
name: Malik Y Kahook, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266211: Antitetanus Vaccination for People Older Than 65 Years.
Official title: Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetanus
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be all patients older than 65 years who are consulting their general practitioner and accepting to participate to the study. And their general practitioner.

Brief summary: In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.

Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.


Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years consulting their attending physician in and who agreed to participate in the study.
* The doctors included are general practitioners located in a liberal office in the "Auvergne Rhône Alpes" region for which the URPS ("Union régional des Professionnels de Santé") has an email address.

Exclusion Criteria:

* None

Primary outcomes:
measure: Tetanus vaccination coverage
timeFrame: About 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Urgence et Réanimation Pédiatrique Hôpital Femme Mère Enfant Groupement Hospitalier Est
Study officials:
References:
Clinical trial NCT00735111: Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?
Official title: Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: QOL
Quality of Life
KPS
Karnofsky Performance Status
Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.

Detailed description: The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of brain or spinal tumor.
* Receiving medical care under the supervision of the Principal Investigator.
* Written informed consent.

Exclusion Criteria:

None.

Primary outcomes:
measure: To determine the correlation between self-rated and health-care-provider-rated Karnofsky Performance Status scores.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Erin M Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080611: Smart Textile Technology for Scoliosis
Official title: Smart Textile Technology for Scoliosis: Aim 1
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Deformities
Scoliosis
Kyphosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Moai Technologies
First posted: 2014-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers will be used, recruited from the university community.

Brief summary: The investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. The investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. Concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3D space.

The motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. Because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. Healthy adult volunteers provide an adequate input to the sensing signal.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Under age 18 or over age 65
* Any medical condition that impairs movement or makes movement painful or difficult.

Primary outcomes:
measure: Body movement
timeFrame: Participants will be assessed during a 1-2 hour visit. Visits will be scheduled over a period of approximately one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lynne Dunn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577211: Hypocaloric Enteral Nutrition in the Critically Ill Patient
Official title: Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critically Ill
Keywords: Critically ill
Enteral nutrition
Lead sponsor: Lafrancol S.A.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario San Ignacio
name: Pontificia Universidad Javeriana
First posted: 2015-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

Detailed description: The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will \>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.

The SOFA score will be assessed every two days until discharge from ICU.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* Estimated fasting period of at least 96 hours
* ICU patients

Exclusion Criteria:

* Parenteral nutrition
* Pregnancy
* Diabetes
* Liver failure
* Transplantation or in transplant protocol
* Previous nutrition support
* Chronic Renal failure

Primary outcomes:
measure: Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
timeFrame: 48 hours after the onset of nutrition
Secondary outcomes:
measure: Units of insulin require in a day
timeFrame: Within the first 4 days after the onset of nutrition
measure: Number of days the patient requires mechanical ventilation.
timeFrame: Within the first 28 days after the onset of nutrition
measure: Number of days in the intensive care unit
timeFrame: Within the first 28 days after the onset of nutrition
measure: Mortality to 28 days
timeFrame: 28 days after the onset of nutrition
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Saul J Rugeles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670811: Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects
Official title: Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Fermented Milk
Clinical Study
Randomized
Double-blind
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present work was to evaluate the antihypertensive effect associated with the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on prehypertensive subjects.

Detailed description: A double-blind randomized controlled clinical study of an 8-week intervention with 36 hypertensive subjects was carried out to evaluate the antihypertensive effect of fermented milk with Lactococcus lactis NRRL-B50571. Once obtained the informed consent; volunteers were randomized into two groups (n=18) to either receive 150 mL daily: fermented milk with Lactococcus lactis NRRL-B50571 (intervention group) or artificially acidified milk as control (placebo). Both drinks were consumed daily. Participants were asked not to change their diet or lifestyle during the intervention. We applied intention to treat for those participants who did not have good adherence and those who withdraw the study. The outcomes between groups were analyzed using an independent sample Student t test, with a P value of 0.05 or less (two sided) when there was statistical significance; using statistical software.

Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure \>130 mmHg
* Diastolic blood pressure \> 85 mmHg

Exclusion Criteria:

* Pregnant women
* Cardiovascular diseases
* Diabetes
* Cancer
* Dairy allergy
* Lactose intolerance
* Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy

Primary outcomes:
measure: Systolic Blood Pressure Measurements
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Diastolic Blood Pressure Measurements
timeFrame: Baseline to 10 weeks
measure: Total Cholesterol Measurements
timeFrame: Baseline and 8th week
measure: Low Density Lipoproteins Measurements
timeFrame: Baseline and 8th week
measure: High Density Lipoproteins
timeFrame: Baseline and 8th week
measure: Triglycerides Measurements
timeFrame: Baseline and 8th week
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Investigación en Alimentación y Desarrollo A.C.
name: Belinda Vallejo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194311: Human Papillomavirus (HPV) Infection in Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Pregnancy Complications
Keywords: HPV
Pregnancy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-19
Enrollment: 620
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine if maternal infection with human papillomavirus (HPV) is associated with pregnancy complications including spontaneous preterm delivery (sPTD), severe preeclampsia (PE), and poor fetal growth.


Eligibility criteria: Inclusion Criteria:

* All women presenting for prenatal care at the Hospital of the University of Pennsylvania or affiliated clinics

Exclusion Criteria:

* Multiple gestations
* Medical conditions such as diabetes, chronic hypertension, renal disease
* Fetal malformations or chromosomal anomalies
* Fetal death

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Samuel Parry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204828: T Regulatory and Childhood Asthma
Official title: T Regulatory and Childhood Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Asthma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6-7 yo children of either gender

Brief summary: This is an epidemiologic study, examining environmental exposures and affect on immune development.

Detailed description: This is an epidemiologic study, examining environmental exposures and affect on immune development. The study has completed enrollment

Eligibility criteria: Inclusion Criteria:

* moderate to severe asthma

Exclusion Criteria:

-

Primary outcomes:
measure: Childhood asthma
timeFrame: 3 years
measure: Allergic sensitization
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: James Gern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02448628: A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
Official title: A Multi-center, Open Label, Dose Titration, Exploratory Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Hypertension
moderate renal impairment
mineralocorticoid receptor antagonist
CS-3150
Japanese
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.


Eligibility criteria: Inclusion Criteria:

* Men and women Aged 20 years or older and 80 years or younger at informed consent
* Subjects with hypertension (Sitting systolic blood pressure SBP \>= 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP \>= 80 mmHg and \< 110 mmHg)
* estimated glomerular filtration rate eGFR \>= 30 mL/min/1.73 m2 and \< 60 mL/min/1.73 m2

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or \>= 5.1 mEq/L
* Subjects under Insulin treatment
* Subjects under or pre-planned for hemodialysis

Primary outcomes:
measure: Change from baseline in sitting systolic and diastolic blood pressure
timeFrame: Baseline to end of Week 12
Secondary outcomes:
measure: Change from baseline in UACR
timeFrame: Baseline to end of Week 12
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
References: