louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00335179: Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream
Official title: Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic keratosis
AK
imiquimod
confocal microscopy
gene microarray
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.

Detailed description: The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.

Eligibility criteria: Inclusion Criteria:

* Have actinic keratoses on balding scalp
* Discontinuation of tanning bed use
* Discontinuation of moisturizers
* Avoidance of retinol products

Exclusion Criteria:

* Uncontrolled, clinically significant medical condition
* Dermatologic disease other than actinic keratosis in treatment area

Primary outcomes:
measure: Gene expression profiling of treated lesions
timeFrame: weeks 1, 2, and 4, and at 4 weeks post-treatment
Secondary outcomes:
measure: Confocal microscopic evaluation before, during and post treatment
timeFrame: weeks 1, 2, 4 and at 4 weeks post-treatment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Graceway Pharmaceuticals
name: TC Meng, MD
role: STUDY_DIRECTOR
References:
citation: Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. Br J Dermatol. 2007 Dec;157(6):1132-47. doi: 10.1111/j.1365-2133.2007.08218.x. Epub 2007 Oct 18.
citation: Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.
Clinical trial NCT04050579: OPIE in the Thin Interventricular Septum
Official title: A Single Center Trial of On-pump Intracardiac Echocardiography (OPIE) in the Thin Interventricular Septum
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.


Eligibility criteria: Inclusion Criteria:

* All hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm.

Exclusion Criteria:

* Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.

Primary outcomes:
measure: correlations
timeFrame: at the conclusion of all data collection; approximately 6 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Daniel Swistel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams DM, Nampi RG, Saric M, Grossi EA, Sherrid MV, Swistel DG. A novel imaging modality to guide septal myectomy for hypertrophic cardiomyopathy. Podium presentation at the Western Thoracic Surgical Society Association Annual Meeting. Squaw Valley, CA. June 28, 2019.
Clinical trial NCT00414479: Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
Official title: Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia
Schistosomiasis Infection
Malaria
Iron Deficiency
Keywords: schistosomiasis
anaemia
malaria
iron deficiency
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children 9-12 years of age

Brief summary: The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

Detailed description: The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.

Eligibility criteria: Inclusion Criteria:

* school children between 9 to 12 year

Primary outcomes:
measure: hemoglobin level
Secondary outcomes:
measure: Schistosomiasis infection
measure: malaria infection
measure: iron deficiency
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Kenya Medical Research Institute
name: Diana Karanja, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218579: Endoscopic Assessment and Prediction of Microbiome-modifying Interventions
Official title: Endoscopic Assessment and Prediction of Microbiome-modifying Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gut Microbiome
Antibiotic Side Effect
Keywords: microbiome
intestinal bacteria
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2017-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics.

Outcomes of probiotic treatment versus bacteriotherapy will be compared.

Detailed description: The investigators would like to examine the extent of rehabilitation of the composition and functioning of the intestinal bacteria in healthy people after the consumption of antibiotics.

Since the digestive mocus enables the connection between the host and the bacteria that live within it, the investigators would like to characterize the microbiome in the different areas along the digestive system - before antibiotic treatment and after rehabilitation by probiotic treatment versus bacteriotherapy.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age: 18 years and up
* Gender: women and men

Exclusion Criteria:

* Pregnancy
* Age under 18 years
* antibiotic treatment 3 months prior to enrollment
* Viral Hepatitis
* HIV positive

Primary outcomes:
measure: Microbiome composition
timeFrame: 1 year
Secondary outcomes:
measure: Microbiome composition
timeFrame: 1 month
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Zamir Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198379: Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients
Official title: Efficacy of Monitoring of Aspirin Responsiveness in the Prevention of Cardiovascular Events and Decrease in Bleeding Complications in Patients With End-Stage Kidney Disease Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: End-Stage Renal Disease
Keywords: aspirin
aspirin resistance
hemodialysis
cardiovascular
Prevalence of aspirin resistance, cardiovascular events, and safety profile
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2010-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.


Eligibility criteria: Inclusion Criteria:

* patients with end-stage renal disease who are undergoing long-term hemodialysis.

Exclusion Criteria:

Patients will be excluded if there is evidence of

* a recent history of acute uremia,
* previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema),
* concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs,
* high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or
* life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).

Primary outcomes:
measure: the prevalence of aspirin resistance
timeFrame: 3 years
Secondary outcomes:
measure: the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)
timeFrame: 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Der-Cherng Tarng, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Clinical trial NCT02993679: Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction
Official title: Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cruciate Ligament Rupture
Lead sponsor: Hospital Znojmo
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

Detailed description: Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

Eligibility criteria: Inclusion Criteria:

* The isolated ACL lesion
* The absence of the previous surgery on the knee joint
* The body mass index (BMI) less than 30.

Exclusion Criteria:

* Associated injuries of the tissue around the knee joint

Primary outcomes:
measure: Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
timeFrame: 24 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04350879: Diabetes Mellitus and Pregnancy : Knowledge Assessment
Official title: Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
pregnancy
contraception
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 40 years old, consulting in diabetology department of Reims Universitary Hospital and Charleville Mézières General Hospital

Brief summary: Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia.

Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment.

The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

Detailed description: The aim of the study is to describe the knowledge of the patients with diabetes concerning contraception and pregnancy planning.

Eligibility criteria: inclusion criteria :

* Patients Aged between 18 and 40 years old
* With type 1 or type 2 diabetes mellitus
* Consulting in the department of diabetology in Reims and Charleville Mezieres hospitals
* Accepting to participate in the study

exclusion criteria :

* Patients With secondary diabetes (endocrine, pancreatic or genetical origin)
* With postmenopausal status
* Without capacity to have a pregnancy (uterine aplasia, hysterectomy)

Primary outcomes:
measure: Risk of unplanned pregnancy
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Feutry L, Barbe C, Marquet-Dupont A, Fevre A, Lukas-Croisier C, Vitellius G, Delemer B, Barraud S. Contraception use and knowledge related to pregnancy in diabetic women. Ann Endocrinol (Paris). 2022 Apr;83(2):88-94. doi: 10.1016/j.ando.2022.01.007. Epub 2022 Feb 7.
Clinical trial NCT02090179: Evaluation of Blood Brain Barrier Integrity and Structural Abnormalities in MPS IIIB Patients Using Multimodal Magnetic Resonance Imaging
Official title: Evaluation of Blood Brain Barrier Integrity and Relationship to Structural Brain Abnormalities in MPS IIIB Patients Using Cerebrospinal Fluid/Serum Albumin Index (CSF-AI) and Multimodal Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MPS IIIB (Sanfilippo B Syndrome)
Keywords: MPS IIIB
Mucopolysaccharidosis
Mucopolysaccharidosis type IIIB
Sanfilippo Syndrome
Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to six subjects with MPS IIIB. An attempt will be made to enroll equal numbers (three) of MPS IIIB subjects with a classic (severe) disease presentation, and MPS IIIB subjects with an attenuated phenotype.

Brief summary: The purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS IIIB).


Eligibility criteria: Inclusion Criteria:

* Subject and/or subject's parent or legal guardian provides informed consent
* Subject is ≥5 years of age.
* Subject has a definitive diagnosis of MPS IIIB, as determined by either a documented deficiency in alpha-N-acetylglucosaminidase (NAGLU) enzyme activity or documented functionally-relevant mutations in both alleles of the NAGLU gene.

Exclusion Criteria:

* The subject has any internal or non-removable external metal items that may present a safety risk (for MRI), or any other medical condition or circumstance in which an MRI is contraindicated.
* The subject has a known or suspected hypersensitivity to anaesthesia, a bleeding disorder, or any other medical condition or circumstance in which a lumbar puncture (for collection of CSF) is contraindicated.
* Previous allergic reaction to gadolinium-based MRI contrast media.

Primary outcomes:
measure: Blood Brain Barrier integrity in MPS IIIB subjects
timeFrame: Day 0
measure: Blood Brain Barrier transfer coefficient
timeFrame: Day 0
Secondary outcomes:
measure: Structural brain abnormalities in MPS IIIB
timeFrame: Day 0
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT02250079: Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks
Official title: Features and Differences Between Neonates Undergoing Body Bag With Polyethylene and Conventional Drying During Neonatal Adaptation in Maternal and Child Headquarters Hospital and the Victoria Hospital Engativá, Bogotá, 2013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Adaptation
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 29
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in the basic technology for neonatal adaptation may not be available. Polyethylene bags may be an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the differences between babies undergoing body bag with polyethylene or conventional drying during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá, Colombia, 2013.

MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag body and / or radiant heat lamp was removed. Environment temperature and humidity, temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of the outcome. The study was approved by the hospital ethics committee of victory.


Eligibility criteria: Inclusion Criteria:

* Inborn neonates with both a gestational age \>29 weeks

Exclusion Criteria:

* Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin disorder

Primary outcomes:
measure: Temperature
timeFrame: 10 minutes
measure: Humidity
timeFrame: 10 minutes
Secondary outcomes:
measure: Both, Hypothermia or Hyperthermia
timeFrame: 10 minutes
Other outcomes:
measure: Baseline Charasteristics
timeFrame: 10 minutes
Locations:
city: Bogota
country: Colombia
facility: Hospital de la Victoria
Study officials:
References: