louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00654056: Severe Insulin Resistance in Patients With Type 2 Diabetes
Official title: Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
Severe insulin resistance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
First posted: 2008-04-07
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.

Detailed description: Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. Our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. Moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.

Eligibility criteria: Inclusion Criteria:

* Age 25-75 years old
* BMI between 25 and 42

Exclusion Criteria:

* Severe diseases

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 8 hours
Secondary outcomes:
measure: Changes in insulin signaling proteins?
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
name: Niels Moeller, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00176956: Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Official title: Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dermatitis
Keywords: Post Pediatric Heart Transplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.

Detailed description: We want to determine whether pediatric heart transplant patients with an atopic dermatitis-like rash report a personal and/or family history of atopy (asthma, allergies and atopic dermatitis). In addition comparisons will be made between the presence of atopy between patients with and without the skin rash. Comparisons will be made of systemic immunosuppressive therapies between patients with and without the atopic dermatitis-like rash. Determination will be made as to whether histologic characterization of a skin biopsy specimen is consistent with AD. Thorough evaluations will be made of patients in the clinic with this rash and the presence of bacterial superinfection will be ruled out.

Eligibility criteria: Inclusion Criteria:

* Patients must have had a heart transplant.
* Patients must be less than 16 years of age.

Exclusion Criteria:

* Patients who have not had a heart transplant.
* Patients who are greater than 16 years of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995356: Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Keywords: Ectopic pregnancy
Axonemal Dynein Heavy Chain 5
Creatine Kinase
Cervical fluid
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have doubt for ectopic pregnancy will be selected for study group and patients who have intrauterine pregnancy will be selected for control group.

Brief summary: Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.


Eligibility criteria: Inclusion Criteria:

* Doubted ectopic pregnancy
* Without any finding about intrauterine pregnancy in ultrasonography results
* Without any vaginal bleeding
* Having irregular pregnancy test results
* Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)
* Having fist trimester pregnancy for intrauterine pregnancy group
* Without any emergency findings

Exclusion Criteria:

* Doubted incomplete abortion
* Having vaginal bleeding
* Having ultrasound results which include intrauterine embryo report
* Having lower than 100 mIU/ml beta-HCG results
* Without fetal heart rate in intrauterine pregnancy group
* Having older than fist trimester pregnancy for intrauterine pregnancy group
* Having emergency findings

Primary outcomes:
measure: Concentration of Axonemal Dynein Heavy Chain 5
timeFrame: 1 year
measure: Concentration of creatine kinase
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University, Medicine Faculty, Department of Obstetrics and Gynecology
Study officials:
References:
citation: Sahin C, Uygun ZO, Hortu I, Akdemir A, Kocamanoglu M, Ergenoglu AM, Akcay Y. Using dynein heavy chain 5 and creatine kinase levels in cervical fluid and blood for early diagnosing of ectopic pregnancy. J Obstet Gynaecol Res. 2021 Mar;47(3):921-927. doi: 10.1111/jog.14616. Epub 2020 Dec 17.
Clinical trial NCT04918056: Genetic Variants Affecting the Clinical Severity of Beta Thalassemia
Official title: Screening and Identification of Genetic Modifiers Which Affecting the Phenotype Severity of Beta Thalassemia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Beta Thalassemia
Keywords: beta thalassemia
Hb F
Onset age
Genetic Modifier
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: 303rd Hospital of the People's Liberation Army
name: Liuzhou Municipal Maternity and Child Healthcare Hospital
name: Zhuhai Municipal Maternal and Child Healthcare Hospital
name: Dong Guan Maternal and Child Health Hospital
First posted: 2021-06-08
Enrollment: 1300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: beta thalassemia patients from Southern China.

Brief summary: β-thalassemia is one of the most common single gene disorder in Southern China. The phenotypic severity of beta thalassemia widely varies from mild to severe forms. Patients with the same beta thalassemia genotype show wide phenotypic variability that ranges from moderate to severe disease due to various genetic modifiers of disease severity. The aim of this study is to looking for the genetic factors which could affect the severity of beta thalassemia.

Detailed description: The understanding of the genotype-phenotype correlation is a very important issue to the precise diagnosis of beta thalassemia. However, the genotype-phenotype correlation of Beta thalassemia is so complex that the pathogenesis of some patients remains uncertain and cannot be explained by known mechanisms. The study of the role of the genetic variants in modulating beta thalassemia phenotype could brought us considerable novel and interesting information in this area. We will collecting more than 1000 beta thalassemia patients , analyzing their clinical data and genome data, and association study will be conducted to screen the positive genetic variants which exert a significant effect on both the HbF levels and onset ages of beta thalassemia patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with β-thalassemia

Exclusion Criteria:

* Iron Deficiency Anemia

Primary outcomes:
measure: Genetic variants which could influence the phenotype of beta thalassemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03157856: Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
Official title: Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer Prostate
Keywords: Fluorescence imaging technique
Biopsies from resected prostate
Medical device
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-05-17
Enrollment: 8
Sex: MALE
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: Patient with indication for radical prostatectomy

Brief summary: In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

1. / the FEMTO-ST institute medical device,
2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Detailed description: For this protocol, 12 patients will be included.

Eligibility criteria: Inclusion Criteria:

* male patient over 18 years old
* patient with indication for radical prostatectomy
* patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.

  * patient affiliated to French social security system or equivalent
  * patient who have signed a non-opposition form

Exclusion Criteria:

* patient with contraindication to radical prostatectomy
* patient with remedial prostatectomy
* patient with normal preoperative MRI or with absence of tumoral area
* patient with history of hormonal therapy
* person deprived of freedom by judicial or administrative decision
* person under legal protection
* person hospitalized for psychiatric care.

Primary outcomes:
measure: Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
timeFrame: 14 months
Secondary outcomes:
measure: Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).
timeFrame: 14 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital - Urology department
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Jean Luc Descotes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229956: Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia
Official title: Promoter Methylation in MLL-Rearranged Childhood AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-28
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Acute Myeloid Leukemia.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.

OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.

PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Available cryopreserved cells from diagnosis

  * At least 2 x 10\^7 viably cryopreserved cells
* One of the following biologically defined cytogenetics/molecular cohorts:

  * t(9;11)
  * t(11;19)
  * Other 11q23 translocations
  * Normal cytogenetics

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre
name: Patrick N. Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00880256: Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Official title: Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel
mindfulness
stress
meditation
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.

Detailed description: Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.

Eligibility criteria: Inclusion Criteria:

* All patient who enroll in a MBSR course

Exclusion Criteria:

* Psychosis, borderline personality, active substance abuse

Primary outcomes:
measure: IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)
timeFrame: 6 months
Secondary outcomes:
measure: Irritable Bowel Syndrome (IBS) Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Heatlh Care System
name: David Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05302856: CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Official title: CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Keywords: sperm
blood testis barrier
cmv antibody
unexplained infertility
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.

Detailed description: Prospective cohort study performed in the artificial reproductive technology (ART) unit.

The study will evaluate semen and serum samples from the following groups:

1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
2. Subfertile/infertile male patients with abnormal semen analysis.
3. Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.

Eligibility criteria: Inclusion Criteria:

* All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure

Exclusion Criteria:

* Refusal to participate
* Male partner utilizing pre cycle frozen sperm sample
* Donor sperm cycles
* Surgically retrieved sperm

Primary outcomes:
measure: CMV antibody ratio serum/semen
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Haverfield JT, Meachem SJ, Nicholls PK, Rainczuk KE, Simpson ER, Stanton PG. Differential permeability of the blood-testis barrier during reinitiation of spermatogenesis in adult male rats. Endocrinology. 2014 Mar;155(3):1131-44. doi: 10.1210/en.2013-1878. Epub 2013 Jan 1.
citation: Stanton PG. Regulation of the blood-testis barrier. Semin Cell Dev Biol. 2016 Nov;59:166-173. doi: 10.1016/j.semcdb.2016.06.018. Epub 2016 Jun 25.