louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01459055: Long-term Follow-up in Patients Affected With Acrofacial Vitiligo
Official title: Long-term Ten Years Follow-up in Patients Affected With Acrofacial Vitiligo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Lead sponsor: Irmandade da Santa Casa de Misericordia de Curitiba
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 100
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 of both genders affected by acrofacial vitiligo diagnosed by one single dermatologist.

Brief summary: Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal digits, periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies vitiligo as generalized or localized; generalized vitiligo may be further sub-divided into acrofacial, vulgaris and universalis, and localized vitiligo, into segmental and focal. Some authors do not believe that acrofacial is a real vitiligo clinical form, considering it as an initial form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed acrofacial patients during ten years in order to define if these patients will maintain this clinical form or will evolute to a more severe clinical form.


Eligibility criteria: Inclusion Criteria:

1. Patients of both genders, aged older than years, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
2. Presence of acrofacial vitiligo;
3. Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.

Exclusion Criteria:

1- Subjects assessed as not suitable for the study in the opinion of the investigator

2 -Inability to complete survey

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Curitiba
state: Parana
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de Curitiba
name: Caio C Silva de Castro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463255: Diet and the Aging Brain
Official title: Phase IV Interventional Study: Effect of Diet on Brain Function in Elderly Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Diet
elderly
age-related diseases
prevention
cognitive decline
Clinical study
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.

Detailed description: The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with potentially devastating effects.

Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* 50-80 years old
* moderate to heavy weight
* must be able to change diet at home

Exclusion Criteria:

* diabetes
* younger than 50 years
* BMI \< 23
* already participating in other studys
* MMSE \> 26
* eating disorders

Primary outcomes:
measure: implicit visual-motor learning of a finger sequence of the hand.
Secondary outcomes:
measure: implicit learning of an artificial language
measure: several plasma levels related to cognitive functions
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster, Department of Neurology
state: NRW
Study officials:
affiliation: University Hospital Muenster
name: Stefan Knecht, MD, Prof.
role: STUDY_CHAIR
affiliation: University Hopsital Muenster
name: Bernd E Ringelstein, MD, Prof
role: STUDY_CHAIR
affiliation: University Hospital Muenster
name: Agnes Floeel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00871455: Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
Official title: Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Baclofen
Growth Hormone, Pituitary
Insulin-Like Growth Factor I
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Kessler Foundation
First posted: 2009-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce growth hormone. Growth hormone is important for muscle tissue as well as many other tissues in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I levels. IGF-I levels will be determined before and after treatment with baclofen. In this study, the investigators will determine the minimum dose of baclofen at which improvements in GH and IGF-1 levels occur.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic SCI (injury greater than 6 months) who have been screened and found to have depressed plasma IGF-1 levels and who are not taking baclofen.

Exclusion Criteria:

* Acute illness of any etiology,
* Patients with chronic renal, liver, lung, or cardiac disease,
* Patients receiving any of the following medications: narcotics, or L-DOPA, and
* Alcoholics.

Primary outcomes:
measure: Determine the threshold dose 20 or 40 mg/d of baclofen and the dose-response curve of the medication for its effect to raise plasma IGF-1 levels
timeFrame: 20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy
Secondary outcomes:
measure: Assessment of the adverse side effects, if any, of low dose baclofen therapy
timeFrame: 20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: William Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01655355: Revision of the Hip Joint - Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Revision of the Hip Joint
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-08-01
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent a revision of the hip replacement without removing the acetabular implant.

Brief summary: Between the years 1999-2011 70 patients went through a revision of the hip joint(revision after not successful Total or Partial Hip Replacement). During the revision the Acetabular implant was found to be stable and it was decided not to replace it. The polyethylene insert was replaced and was fixated using a cement. Our purpose is to evaluate the physical condition of these patients.


Eligibility criteria: Inclusion Criteria:

1. Patients that underwent a revision of the hip replacement without removing the acetabular implant
2. Insert polyethylene with cement

Primary outcomes:
measure: Quality of life
Secondary outcomes:
measure: Function
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT04293055: Phone Coaching for Weight Loss Maintenance
Official title: Examination of Phone Coaching as a Weight Loss Maintenance Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Phone coaching
Diet
Exercise
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine whether 4 consecutive weeks of phone coaching aids in recovery from weight regain during weight loss maintenance. Individuals who previously achieved and maintained a \>=5% weight loss in a 1-year behavioral weight loss program were provided with a low-intensity maintenance intervention (monthly newsletters and smart scale). At baseline, participants were randomized to the coaching group or the control group (no coaching). If participants regained \>1.5% of their weight, randomization was "triggered." At this point, participants randomized to the coaching condition received 4 brief weekly coaching calls; participants randomized to the control condition received no additional intervention contact. Short-term and long-term weight change was assessed and compared between treatment groups.


Eligibility criteria: Inclusion Criteria:

* 18-72 years of age
* Recent completion of a 1-year behavioral weight loss program
* Achievement of \>=5% weight loss at the end of the 1-year weight loss program

Exclusion Criteria:

* Not currently enrolled in another weight management program

Primary outcomes:
measure: Percent Change in Body Weight From Baseline to Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent Weight Change Over the Coaching Period
timeFrame: Trigger date and 40 days post-trigger date
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital's Weight Control and Diabetes Research Center
name: Jessica L Unick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730855: Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
Official title: Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Potentially Malignant Lesions
Oral Lichen Planus
Leukoplakia, Oral
Keywords: lncRNA DQ786243
saliva
oral potentially malignant lesions
miRNA146a
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian Population

Brief summary: The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.


Eligibility criteria: Inclusion Criteria:

* participants will be divided into 3 groups:

Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria:

* Subjects taking any drugs inducing any changes that could affect the salivary flow.
* Pregnant females.
* Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
* Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.

Primary outcomes:
measure: salivary expression of lncDQ786243 in OLP, Leukoplakia, control
timeFrame: 2 months
Secondary outcomes:
measure: salivary expression of miRNA146a in OLP, Leukoplakia, control
timeFrame: 2 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT00520455: Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Official title: Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-08-24
Enrollment: 177
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.


Eligibility criteria: Inclusion Criteria:

Non-contracepting women \>15 years of age who were reported to Public Health Seattle \& King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification

Exclusion Criteria:

* Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age \<15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.

Primary outcomes:
measure: Pregnancy
timeFrame: 1 year - measured via interview every 3 months
Secondary outcomes:
measure: Abortion
timeFrame: 1 year - measured via interview every 3 months
measure: Condom use
timeFrame: Measured every 3 months for one year
measure: Use of hormonal contraception
timeFrame: Measured via interview every 3 months for one year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Public Health - Seattle & King County STD Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Matthew R Golden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872755: Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)
Official title: Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Barrett's Esophagus
Esophagitis
Dysphagia
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Indications for surgical treatment of GERD
* ASA I, II

Exclusion Criteria:

* ASA III, IV
* Previous gastric procedures
* Conversion to open procedure

Primary outcomes:
measure: Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
timeFrame: 9-94 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: G. Hatzikosta General Hospital Department of Surgery
state: Epirus
Study officials:
affiliation: G. Hatzikosta General Hospital, Ioannina, Greece
name: Evangelos C. Tsimoyiannis, M.D. chairman
role: STUDY_CHAIR
References:
citation: Tsimogiannis KE, Pappas-Gogos GK, Benetatos N, Tsironis D, Farantos C, Tsimoyiannis EC. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc. 2010 Jun;24(6):1303-9. doi: 10.1007/s00464-009-0764-0. Epub 2009 Dec 4.
Clinical trial NCT01667055: The Diagnosis of Beta-lactam Hypersensitivity in Thailand
Official title: The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penicillin Allergy
Aminopenicillin Allergy
Beta Lactam Adverse Reaction
Keywords: drug allergy
drug hypersensitivity
beta-lactam allergy
penicillin allergy
adverse drug reaction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of beta-lactam hypersensitivity

Brief summary: The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.

Detailed description: Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .

Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.

The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.

Eligibility criteria: Inclusion Criteria:

* Patients with a history of beta-lactam hypersensitivity

Exclusion Criteria:

* Being pregnant
* Having serious medical illnesses

Primary outcomes:
measure: The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity
timeFrame: 1 year
Secondary outcomes:
measure: Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chongpison Y, Palapinyo S, Mongkolpathumrat P, Buranapraditkun S, Thantiworasit P, Klaewsongkram J. Beta-lactam hypersensitivity diagnosis in ambulatory and hospitalized settings require different approaches. Ann Allergy Asthma Immunol. 2023 Jan;130(1):84-92.e1. doi: 10.1016/j.anai.2022.09.011. Epub 2022 Sep 16.
Clinical trial NCT01890655: Extension Study of MT-1303
Official title: A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: relapsing-remitting multiple sclerosis
RRMS
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).


Eligibility criteria: Inclusion Criteria:

* Completion of the 24-week treatment period in MT-1303-E04 as per protocol
* Able to provide written informed consent and to comply with the requirements of the protocol
* For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

Exclusion Criteria:

* Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
* Newly diagnosed diabetes mellitus during MT-1303-E04

Primary outcomes:
measure: Safety assessments
timeFrame: Month 18
Secondary outcomes:
measure: Clinical efficacy
timeFrame: Month 18
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Month 18
Other outcomes:
Locations:
city: City name
country: Belgium
facility: Research Site
city: City name
country: Bulgaria
facility: Research Site
city: City name
country: Canada
facility: Research Site
city: City name
country: Croatia
facility: Research Site
city: City name
country: Czech Republic
facility: Research Site
city: City name
country: Finland
facility: Research Site
city: City name
country: Germany
facility: Research Site
city: City name
country: Hungary
facility: Research Site
city: City name
country: Italy
facility: Research Site
city: City name
country: Lithuania
facility: Research Site
city: City name
country: Poland
facility: Research Site
city: City name
country: Russian Federation
facility: Research Site
city: City name
country: Serbia
facility: Research Site
city: City name
country: Spain
facility: Research Site
city: City name
country: Turkey
facility: Research Site
city: City name
country: Ukraine
facility: Research Site
city: City name
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Ludwig Kappos, MD
role: STUDY_DIRECTOR
References: