louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00464139: Prevalence of Endometriosis in a Well Defined Group of Infertile Women
Official title: High Prevalence of Endometriosis in Infertile Women With Normal Ovulation and Normospermic Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Infertility
Keywords: endometriosis
prevalence
fertility
pain
ultrasound
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Brief summary: At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.

Detailed description: In this study, the electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Eligibility criteria: Inclusion Criteria:

* all patients who consulted the LUFC since 2003
* with at least 1 year of infertility,
* a regular cycle (variation 21 - 35 days),
* whose partner had normal sperm according to World Health Organization (WHO) criteria.

Exclusion Criteria:

* a previous laparoscopic diagnosis of endometriosis before referral to our centre

Primary outcomes:
measure: The diagnosis of endometriosis was made by the fertility surgeon of the LUFC.
timeFrame: 2003 - 2006
Secondary outcomes:
measure: The diagnosis of endometriosis was always confirmed by histological examination.
timeFrame: 2003 - 2006
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
affiliation: University Hospital Gasthuisberg, Leuven, Belgium
name: Christel LC Meuleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, Leuven, Belgium
name: Thomas D'Hooghe, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02635139: Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions
Official title: Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal skipping
isocaloric diet
macronutrient oxidation
glucose homeostasis
arterial stiffness
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping) on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch, dinner) serves as a control.

Detailed description: The duration of the study is 7 days including 3 days with controlled diet and 4 days (including 5 nights) in a metabolic chamber at the Institute of Nutritional Medicine at the University of Hohenheim.

The study phase in the metabolic chamber consists of (i) 1 day with 3 meals/day = baseline day, (ii) 1 day with breakfast skipping, (iii) 1 day with dinner skipping, (iv) 1 washout day where the subjects leave the chamber between 7 a.m. until 7 p.m..

Beginning on the 3rd study day macronutrient and energy intake as well as the fasting periods are kept constant. To achieve comparable conditions the washout day is setted before the baseline day.

Eligibility criteria: Inclusion Criteria:

* healthy
* not obese (BMI\<30)

Exclusion Criteria:

* food allergy
* smoking
* alternative nutrition habits
* chronic disease
* regular medication intake
* claustrophobia

Primary outcomes:
measure: Regulation of glucose metabolism (substrate oxidation and insulin sensitivity)
timeFrame: 1 day
Secondary outcomes:
measure: Actigraphy-assessed sleep quality
timeFrame: 1 day
measure: cardio vascular risk (lipid profile, arterial stiffness, autonomic function)
timeFrame: 1 day
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Anja Bosy-Westphal, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.
Clinical trial NCT02551939: Breast Fat Grafting Augmentation in Chinese Women
Official title: Magnetic Resonance Imaging and Breast-Q Evaluation After Breast Autologous Fat Grafting Augmentation in Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Implantation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.

Detailed description: Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses were blindly performed by examiner independently preoperatively and 1 year postoperatively. Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q scores of 1 through 4 or 5 to scores of 0 to 100.

Eligibility criteria: Inclusion Criteria:

* Healthy women agreed to participate in the study

Exclusion Criteria:

* Patients who had breast surgery previously
* Women on the lactation or gestation period

Primary outcomes:
measure: Breast volumes were measured by magnetic resonance imaging
timeFrame: one year
measure: BREAST-Questionaire was used to analyze the satisfaction and well-being of patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00149539: Abuse Potential of Buprenorphine/Naloxone
Official title: Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2005-09-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Detailed description: Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone.

Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Eligibility criteria: Inclusion Criteria:

* Actively abusing illegal opioids
* Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry
* Meets DSM-IV criteria for opioid dependence

Exclusion Criteria:

* Significant medical problems (e.g., insulin dependent diabetes mellitus)
* Non-substance use psychiatric disorders (e.g., schizophrenia)
* Seeking substance abuse treatment

Primary outcomes:
measure: Opiate withdrawal
timeFrame: up to one day
measure: opiate agonist symptoms
timeFrame: up to one day
measure: physiologic measures
timeFrame: up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03400839: Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
Official title: Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung disease
prognosis
clinical endpoints
association
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Universidade Norte do Paraná
First posted: 2018-01-17
Enrollment: 105
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.

Brief summary: This prospective cohort study will investigate whether progression of the interstitial lung diseases is related to specific clinical endpoints and their changes over time. Longitudinal data of patients will be compared to an age-matched control group during a follow-up of at least two years.


Eligibility criteria: Inclusion Criteria:

1. Patients with interstitial lung disease:

   * Age between 40 and 75 years old upon inclusion;
   * Diagnosis of interstitial lung disease;
   * Clinical stability for at least 4 weeks prior to inclusion;
   * Absence of any comorbidity that interferes with the performance of tests;
2. Age-matched control group:

   * Age between 40 and 75 years old upon inclusion;
   * Absence of any comorbidity that interferes with the performance of tests;

Exclusion Criteria (both groups):

* Participants that present severe or unstable cardiac disease identified during the cardiopulmonary exercise testing;
* Participants with cognitive deficit that interfere with any of the tests;

Primary outcomes:
measure: Changes of daily steps over time
timeFrame: from date of inclusion until the date of study completion or until the documented date of death from any cause, whichever came first, up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Estadual de Londrina
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Carlos A Camillo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834339: EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection
Official title: A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mandibular Injuries
Keywords: vestibuloplasty
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 1
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 compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.


Eligibility criteria: Inclusion Criteria:

* Be an adult over 18 years of age
* Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
* Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function

Exclusion Criteria:

* Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
* A history of syphilis, HIV, Hepatitis B or Hepatitis C
* Pregnancy or planning to become pregnant
* Known or suspected allergy to bovine (cow) protein
* Receiving radiation
* Currently smoking or using tobacco products
* Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
* Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
* Allergy to Polysorbate 20

Primary outcomes:
measure: Percent Graft Contracture
timeFrame: 2-24 weeks
Secondary outcomes:
measure: Degree of Epithelialized Tissue
timeFrame: 4 weeks after surgery
measure: Laser Doppler Flowmetry (LDF)
timeFrame: Visit 1 and 2 and 4 weeks after surgery
Other outcomes:
measure: Graft Color
timeFrame: 4 weeks after surgery
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Faculty
name: Stephen Feinberg, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037239: Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
Official title: Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cutaneous T-cell Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono therapy in PTCL. The combination of duvelisib and romidepsin is highly active against relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.


Eligibility criteria: Inclusion Criteria:

* Ages 18-75;
* Mycosis fungoides and Sezary syndrome confirmed by histopathology;
* Patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage IIB-IVB;
* No remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.);
* ECOG score of 0-2;
* Adequate bone marrow hematopoietic function: neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
* Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT\<2.5UNL, TBil\<1.5ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);

Exclusion Criteria:

* Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (\> 450ms in men and \> 470ms in women) within 6 months;
* Uncontrolled active infections;
* Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded)
* Pregnant or lactating women;
* Investigators judged that they were not suitable to participate in the study

Primary outcomes:
measure: Recommended phase 2 dose (RP2D)（Phase 1）
timeFrame: 4 weeks since the date of first dose
measure: Objective response rate (ORR)（Phase 2）
timeFrame: evaluated every 3 months (up to 24 months）
Secondary outcomes:
measure: Progression-free survival
timeFrame: Baseline up to data cut-off (up to 5 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to 5 years)
measure: complete remission (CR) rate
timeFrame: evaluated every 3 months (up to 24 months）
measure: adverse events
timeFrame: evaluated every treatment cycle (up to 24 months）
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01363739: Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab
Official title: Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: VEGF polymorphism Bevacizumab
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 265
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment

Brief summary: -1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of metastatic colorectal cancer patients. The present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma;
* Measurable metastatic disease according to RECIST criteria;
* Patients receiving BV plus FOLFIRI as first-line treatment;
* Written informed consent;
* Availability of blood samples for genetic analysis.-

Exclusion Criteria:

Primary outcomes:
measure: Progression-Free Survival
Secondary outcomes:
measure: Response Rate
measure: Overal survival
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Polo Oncologico Azienda Ospedaliero, Universitaria Pisana
Study officials:
References:
Clinical trial NCT01144039: Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair
Official title: Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertrophy, Left Ventricular
Aortic Stenosis
Myocardial Ischemia
Cardiopulmonary Bypass
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy .

Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.


Eligibility criteria: Inclusion Criteria:

* severe aortic stenosis
* left ventricular hypertrophy of more than 10mm IVS thickness
* normal ejection fraction
* SR

Exclusion Criteria:

* moderately or severely reduced systolic left ventricular function (ejection fraction \<30%)
* atrial fibrillation or flutter
* intolerance to glutamate.

Primary outcomes:
measure: flow propagational velocity
measure: Isovolumic relaxation time
measure: E-velocity
measure: A-velocity
measure: E/A ratio
Secondary outcomes:
measure: ejection fraction
measure: cardiac output
measure: mitral ring motion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital
Study officials:
References: