louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00280995: Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
Official title: A Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia, Familial
Keywords: LDL-cholesterol
apoB-100
Homozygous Familial Hypercholesterolemia
Lead sponsor: Kastle Therapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Ionis Pharmaceuticals, Inc.
First posted: 2006-01-24
Enrollment: 12
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 aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as add-on therapy in subjects with Homozygous Familial Hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Weight ≥ 40 kg for Cohorts A, B, \& C; Weight ≥ 50 kg for Cohort D
* Diagnosis of Homozygous Familial Hypercholesterolemia.
* Female must be non-pregnant and non-lactating.
* On stable lipid lowering therapy for at least 4 weeks.
* Lipid values that meet the pre-specified criteria.

Exclusion Criteria:

* Subject had heart problems in the prior 6 months.
* Subject has elevated ALT, AST, or CPK.
* History of renal disease, liver disease, or malignancy.
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

Primary outcomes:
measure: Percent reduction in LDL-cholesterol from baseline
timeFrame: Week 7 (Cohorts A-C), Week 15 (Cohort D)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: New York City
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05871255: Natural Topical Treatment for Vulvar and Vaginal Atrophy
Official title: Natural Topical Treatment for Vulvar and Vaginal Atrophy: a Single-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2023-05-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Same as the inclusion/exclusion criteria

Brief summary: Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

Detailed description: The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).

Eligibility criteria: Inclusion Criteria:

* Age between 45-65 years
* Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria)
* No previous treatment for VVA
* Informed written consent signed

Exclusion Criteria:

* Pregnancy
* Previous or concurrent neoplasms
* Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
* Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.

Primary outcomes:
measure: Change in vaginal health index score
timeFrame: 5.5 months
measure: Change in Female Sexual Distress Scale (FSD)
timeFrame: 5.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Maternal-Fetal Medicine at Policlinico Umberto
Study officials:
References:
Clinical trial NCT00894855: Skin Cancer Screening and Education at Beaches
Official title: Skin Cancer Screening and Education Program at Beaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: skin cancer prevention
SHADE
Beach
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: The Shilling SHADE Foundation of America
name: University of Massachusetts, Amherst
name: Harvard Medical School (HMS and HSDM)
name: Brigham and Women's Hospital
First posted: 2009-05-07
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center Van's existing skin cancer screening and education program. This program occurred over 2 summers. This study will fill a critical gap in the investigators' knowledge about how best to address the high-risk behaviors that regularly occur during the summertime at beaches. The investigators randomized beaches to receive different combinations of the van program components in order to determine how services should optimally be configured to maximize impact. The investigators hypothesized that providing all three components (1-Skin cancer prevention education; 2-Biometric feedback using a Dermascan Analyzer that illustrates skin damage due to sun exposure and Ultra Violet (UV) Reflectance Photography; and 3-Dermatologist skin exam) will maximize knowledge and behavior change, relative to education alone.


Eligibility criteria: Inclusion Criteria:

* Beachgoers eligible to participate in the study included:

  * those who were 18 years and older
  * Caucasian
  * able to understand, speak and read English
  * ability to give informed consent
  * had not already enrolled in the study at another participating beach

Primary outcomes:
measure: sun protection behaviors
timeFrame: 4-6 months post-intervention
measure: sun burns
timeFrame: 4-6 months post-intervention
measure: skin self-exams
timeFrame: 4-6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Karen M Emmons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05127655: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA
Official title: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children Below 5 Years Old (A Before and After Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: Rehabilitation
full mouth rehabilitation
Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers paired with their children attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt

Brief summary: To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children below 5 years


Eligibility criteria: Inclusion Criteria:

* Age range 2 to 5 years .
* Children with untreated early childhood caries .
* Children who will undergo dental treatment under general anesthesia.

Exclusion Criteria:

* Participation in any other concurrent clinical trials.
* The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
* Children with special healthcare needs.
* Children whose parents had no home or mobile phone to enable postoperative contact.
* Parent that will not sign the consent.

Primary outcomes:
measure: Oral health related quality of life (OHRQOL)
timeFrame: change from baseline oral health related quality of life at 6 months
Secondary outcomes:
measure: Body mass index
timeFrame: change of baseline body mass at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Fatima Korany, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04580355: Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome
Official title: Impact of Non-surgical Periodontal Therapy With or Without Antibiotics on Oral and Gut Microbiome in Patients With Stage III/IV and Grade C Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Microbial Colonization
Periodontal Diseases
Periodontal Inflammation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Stage III/IV and grade C Periodontitis
* Presence of at least 20 teeth
* Good general health

Exclusion Criteria:

* Pregnant or lactating
* Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes)
* Received antimicrobials in the previous 6 months
* Received a course of periodontal treatment within the last 6 months
* Were taking long-term anti-inflammatory drugs
* Smoking habits

Primary outcomes:
measure: Change in the oral-gut axis microbiome at 3 months
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Change of biofilm gene expression on oral microbiome at 3 months
timeFrame: Baseline and 90 days
measure: Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples
timeFrame: Baseline and 90 days
measure: Change of the baseline relative clinical attachment level at 3 months
timeFrame: Baseline, 30 days and 90 days
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: University of Campinas, UNICAMP
state: Sao Paulo
Study officials:
References:
Clinical trial NCT05786755: Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis
Official title: Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Microbiome Taxonomic Profiling was performed on 240 stool samples (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). All 142 patients were classified in six groups based on compilation: only cirrhosis, cirrhosis with hepatocellular carcinoma (HCC), cirrhosis with varices, cirrhosis with ascites, cirrhosis with 2 complications and cirrhosis with 3 or more complication.

Brief summary: Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.

Detailed description: Stool samples were collected prospectively from 240 participants (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). 16S rRNA (ribosomal ribonucleic acid) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship,16S-based Microbiome Taxonomic Profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.

Eligibility criteria: Inclusion Criteria:

1. Registered in the Hallym University Hospital
2. Presented initially sign of liver cirrhosis
3. Patients must have the following laboratory parameters at screening:

   1. Alanine aminotransferase (ALT) ≤10 × upper limit of normal (ULN)
   2. Aspartate aminotransferase (AST) ≤10 × ULN
   3. Hemoglobin ≥12 g/dL for male, ≥11 g/dL for female patients
   4. Platelets ≥ 50,000/mm3
   5. International normalized ratio (INR) ≤1.5 × ULN unless patient has known haemophilia or is stable on an anticoagulant regimen affecting INR.
   6. Albumin ≥3g/dL.
   7. Direct bilirubin ≤1.5 × ULN h) HbA1c ≤10.0%

   i) Creatinine clearance (CLcr) ≥60 mL/min, as calculated by the Cockcroft-Gault equation.

   -

   Exclusion Criteria:
   * Pregnant Female

Primary outcomes:
measure: Gut microbial compositional signature in liver cirrhosis and liver cirrhosis complications.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
state: Gangwondo
Study officials:
affiliation: Chuncheon Sacred Hallym hospital
name: Ki Tae Suk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150955: Potential Beneficial Effects of Resveratrol
Official title: Potential Beneficial Effects of Resveratrol on Obesity, Metabolic Syndrome and Inflammation - Emphasis on Description of the Molecular Biology Underpinning the Interplay Between Calorie Restriction, SIRT1, STAT5 and the GH/IGF-I Axis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: Resveratrol
Diabetes
SIRT1
STAT5
IGF-I
Growth hormone
NAFLD
Longevity
Substrate metabolism
Calorie restriction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2010-06-25
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.

Detailed description: The aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. We hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. Of special interest is the potential connection between resveratrol, calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg/m2
* Otherwise healthy
* Written informed consent

Exclusion Criteria:

* Any disease
* Alcohol dependency
* Allergy to trial medication
* Present or previous malignancy
* Participation in other clinical trials within three months before randomization

Primary outcomes:
measure: Metabolic parameters
timeFrame: Five weeks
Secondary outcomes:
measure: Pathways of substrate metabolism.
timeFrame: Five weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Endocrinology, MEA
Study officials:
affiliation: Aarhus University Hospital
name: Jens Otto L Jørgensen, Professor,MD
role: STUDY_CHAIR
References:
citation: Clasen BF, Poulsen MM, Escande C, Pedersen SB, Moller N, Chini EN, Jessen N, Jorgensen JO. Growth hormone signaling in muscle and adipose tissue of obese human subjects: associations with measures of body composition and interaction with resveratrol treatment. J Clin Endocrinol Metab. 2014 Dec;99(12):E2565-73. doi: 10.1210/jc.2014-2215.
citation: Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stodkilde-Jorgensen H, Moller N, Jessen N, Pedersen SB, Jorgensen JO. High-dose resveratrol supplementation in obese men: an investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition. Diabetes. 2013 Apr;62(4):1186-95. doi: 10.2337/db12-0975. Epub 2012 Nov 28.
Clinical trial NCT02597855: Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polypoidal Choroidal Vasculopathy
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 29
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients were recruited from the retinal clinic of the Yeungnam university hospital. Recruitment started on October 01 2015 to March 31 2016.

Brief summary: To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy

Detailed description: The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.

Eligibility criteria: Inclusion Criteria:

1. symptomatic typical PCV accompanying branch vascular network involving subfoveal area
2. signed informed consent; and
3. over 6 months follow-up period after enrollment.

Exclusion Criteria:

1. retinal diseases other than PCV
2. extrafoveal PCV not involving subfoveal area
3. massive subretinal hemorrhage blocking polypoidal lesion on ICGA
4. severe media opacity such as senile cataract
5. previous history of intravitreal injection
6. previous intraocular surgery history except cataract surgery which was done more than 3 months.

Primary outcomes:
measure: Regression Rate of Polyp on Indocyanine Green Angiography
timeFrame: 3 months
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: baseline, 3 months, and 6 monthsc
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University College of Medicine
Study officials:
References:
citation: Jeong S, Sagong M. Short-term efficacy of intravitreal aflibercept depending on angiographic classification of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2017 Jun;101(6):758-763. doi: 10.1136/bjophthalmol-2016-309144. Epub 2016 Sep 5.
Clinical trial NCT01643655: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avascular Necrosis of the Femoral Head
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2012-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.


Eligibility criteria: Inclusion Criteria:

* Age :18-70, males and females.
* Subjects who understand and sign the consent form for this study.
* Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
* Steinberg stage I, II, ⅢA
* Patients whose lesion is more than 30% (by Kim's Method)

Exclusion Criteria:

* Patients who have collapsed femoral head
* Patient has had a Core Decompression or Multiple Drilling in the affected hip
* Patients who received osteoporosis medicines and parathyroid hormone drugs
* Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
* Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
* Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Positive serology for HIV and hepatitis
* Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Primary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: 96 weeks
Secondary outcomes:
measure: SPECT/CT
timeFrame: 96 weeks
measure: Hip X-ray
timeFrame: 96 weeks
measure: HHS (Harris Hip Score)
timeFrame: 96 weeks
measure: WOMAC (Western Ontario and McMaster Universities) Index
timeFrame: 96 weeks
measure: UCLA (University of California Los Angeles) hip questionnaire
timeFrame: 96 weeks
measure: Safety evaluation
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Kang-Sup Yoon, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: