louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02448459: COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
Official title: COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the number of oocytes retrieved.


Eligibility criteria: Inclusion Criteria:

* Women scheduled to controlled ovarian stimulation for oocyte retrieval.
* Body mass index between 18 and 35 Kg/m2.
* Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/L).
* Signing an informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 20 days
Secondary outcomes:
measure: Number of embryos
timeFrame: 25 days
measure: Ovarian hyperstimulation syndrome
timeFrame: 2 months
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Setor de Reprodução Humana - HC-FMRP-USP
state: SP
Study officials:
References:
citation: Figueiredo JB, Nastri CO, Vieira AD, Martins WP. Clomiphene combined with gonadotropins and GnRH antagonist versus conventional controlled ovarian hyperstimulation without clomiphene in women undergoing assisted reproductive techniques: systematic review and meta-analysis. Arch Gynecol Obstet. 2013 Apr;287(4):779-90. doi: 10.1007/s00404-012-2672-0. Epub 2012 Dec 19.
citation: Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013.
citation: Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.
citation: Seko LM, Moroni RM, Leitao VM, Teixeira DM, Nastri CO, Martins WP. Melatonin supplementation during controlled ovarian stimulation for women undergoing assisted reproductive technology: systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014 Jan;101(1):154-161.e4. doi: 10.1016/j.fertnstert.2013.09.036. Epub 2013 Oct 29.
citation: Nastri CO, Teixeira DM, Moroni RM, Leitao VM, Martins WP. Ovarian hyperstimulation syndrome: pathophysiology, staging, prediction and prevention. Ultrasound Obstet Gynecol. 2015 Apr;45(4):377-93. doi: 10.1002/uog.14684. Epub 2015 Mar 1.
Clinical trial NCT04079959: Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET
Official title: Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in Vitro Fertilization- Embryo Transfer (IVF-ET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing frozen embryo transfer.

Brief summary: Uterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. Serval studies showed an increased uNK cell density in the endometrium of women with reproductive failure. In this study, we wish to investigate the density and clustering of four different immune cells.

Detailed description: Implantation is a process whereby the embryo attaches itself to the endometrium. In humans, the endometrium has a specific period of uterine receptivity, which occurs 5-7 days after ovulation and remains receptive for \~4 days (cycle days 20-24), when embryo implantation starts. Implantation failure refers to the failure of the embryo to reach a stage when intrauterine gestational sac is recognized by ultrasonography. It occurs when the embryo is abnormal or when endometrial function is impaired.

Uterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. They comprise 70-80% of the total leukocyte population in the endometrium during implantation and early pregnancy. Several studies showed an increased uNK cell density in the endometrium of women with reproductive failure. To better understand the contribution of various immune factors to endometrial function and future pregnancy, it is proposed to examine the major immune cells in the same specimen to measure the relative magnitude of the cell density changes and the degree of clustering between two immune cell types.

The aim of this study is to investigate the endometrial leucocytes profile around the time of embryo implantation.

Eligibility criteria: Inclusion Criteria:

* Women undergoing frozen embryo transfer.

Exclusion Criteria:

* Women older than 40 years
* Women who have any uterine anomaly or intrauterine pathology such as:

Endometrial polyp or/ and Large fibroid with a diameter \>4 cm

* Visible hydrosalpinx on transvaginal ultrasound scans
* BMI \>35

Primary outcomes:
measure: immune cell counting
timeFrame: up to 2 months
measure: Quantification of endometrial immune cells spatial distribution
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Xiaoyan Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05383859: Diet and Physical Activity Program for Type 2 Diabetes Mellitus
Official title: Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Oviedo
Sponsor class: OTHER
Collaborators: name: Servicio de Salud del Principado de Asturias. Área Sanitaria III
First posted: 2022-05-20
Enrollment: 208
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: An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.


Eligibility criteria: Inclusion Criteria:

* Be cared for by one of the nurses participating in the research team
* Ability to complete the questionnaire
* Sign the informed consent
* Keep the Primary care health center during till the end of the research

Primary outcomes:
measure: Change in Diet recommendations (mean)
timeFrame: Change from Baseline dietary recommendations at 6 months
measure: Change in Physical activity recommendations (mean)
timeFrame: Change from Baseline physical activity recommendations at 6 months
Secondary outcomes:
measure: Change in HbA1c (Mean percentage)
timeFrame: Change from Baseline % of HbA1c at 6 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: University of Oviedo
name: Ruben Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01095159: TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Official title: Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Keywords: TVTO
TVTSecur
Mini sling
stress urinary incontinence
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2010-03-30
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.


Eligibility criteria: Inclusion Criteria:

* Clinical and urodynamic for stress urinary

Exclusion Criteria:

* Detrusor overactivity (urodynamic study)
* Urodynamic changes suggesting reduced vesical capacity
* Associated neurological diseases
* Coagulopathies
* Pregnancy
* Foreign matter sensitiveness history
* Acute urinary tract infection
* Sequel from high ionizing radiation exposure
* Use of drugs that may result in high surgical risk and/or significant postoperative complication
* Anesthetic procedure contraindication
* Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported

Primary outcomes:
measure: Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Unifesp
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Ana Maria HM BIANCHI, FELLOW
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girao MJ. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J. 2014 Oct;25(10):1343-8. doi: 10.1007/s00192-014-2352-7. Epub 2014 Mar 19.
citation: Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, Bortolini MA, Sartori MG, Girao MJ. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013 Sep;24(9):1459-65. doi: 10.1007/s00192-012-1998-2. Epub 2012 Dec 4.
Clinical trial NCT05031559: Episodic Future Thinking and Compassion
Official title: Episodic Future Thinking and Compassion Reduce Public Health Guideline Noncompliance Urges: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliant Behavior
Self-Control
Impulsive Behavior
Keywords: Episodic future thinking
Compassion
Impulsivity
Self-control
Pandemic
Public Health
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Martin & Loreto Hosking's Three Springs Foundation
name: Australian Research Council
First posted: 2021-09-02
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During the COVID-19 (Coronavirus Disease 2019) pandemic, public health departments have issued guidelines to limit viral transmission. In this environment, people will feel urges to engage in activities that violate these guidelines, but research on guideline adherence has been reliant on surveys asking people to self-report their typical behaviour, which may fail to capture these urges as they unfold. Guideline adherence could be improved through behaviour change interventions, but considering the wide range of behaviours that COVID-19 guidelines prescribe, there are few methods that allow observing changes of aggregate guideline adherence in the 'wild'. In order to administer interventions and to obtain contemporaneous data on a wide range of behaviours, the researchers use ecological momentary assessment. In this preregistered parallel randomised trial, 95 participants aged 18-65 from the United Kingdom were assigned to three conditions using blinded block randomisation, and engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1, max. 10) and their ability to control them. The researchers investigate whether state impulsivity and vaccine attitudes predict guideline adherence, while assessing through which mechanism these predictors affect behaviour.


Eligibility criteria: Inclusion Criteria:

* Resides in the United Kingdom
* Fluent in English
* Must pass attention check in eligibility survey

Exclusion Criteria:

* Less than 50% compliance with ecological momentary assessment surveys

Primary outcomes:
measure: Average strength of urges in ecological momentary assessment surveys
timeFrame: Multiple times per day, for one week.
measure: Average probability of controlling urges in ecological momentary assessment surveys
timeFrame: Multiple times per day, for one week.
Secondary outcomes:
measure: Average number of resisted urges
timeFrame: Multiple times per day, for one week.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Prolific online participant recruitment platform
Study officials:
References:
Clinical trial NCT00170859: Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
Official title: A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Keywords: everolimus
cyclosporine microemulsion
renal function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.


Eligibility criteria: Inclusion Criteria:

* Recipients of primary heart transplant
* Reduced renal function (serum creatinine \> 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
* Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil

Exclusion Criteria:

* Patients who are recipients of multiple organ transplants
* Patients who have previously received an organ transplant
* Patients with serum creatinine \> 3.5 mg/dl

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Various Cities
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Bara C, Dengler T, Hack MA, Ladenburger S, Lehmkuhl HB. A 1-year randomized controlled study of everolimus versus mycophenolate mofetil with reduced-dose cyclosporine in maintenance heart transplant recipients. Transplant Proc. 2013 Jul-Aug;45(6):2387-92. doi: 10.1016/j.transproceed.2013.03.032.
Clinical trial NCT04815759: Dental Anxiety Among Children Pre and Post COVID 19 Pandemic
Official title: Dental Anxiety Among Egyptian Children Pre and Post COVID 19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Anxiety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 82
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with an age range 4-6 years attending the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University

Brief summary: Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention


Eligibility criteria: Inclusion Criteria:

* parental consent
* no previous dental experience
* medically free children

Exclusion Criteria:

* children with negative behavior according to Frankl Rating Scale
* children require general anesthesia

Primary outcomes:
measure: Dental anxiety level
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05181059: DLSCT for Breast Cancer Detection in Women With Dense Breasts
Official title: Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Breast Density
Radiographic Image Interpretation, Computer-Assisted
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Secondary care clinic

Brief summary: The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.

Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of histopathologically proven locoregional advanced primary breast cancer:

  1. Tumors \> 5 cm (= T3) or
  2. Tumors with invasion of the skin or chest wall (= T4) or
  3. Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
* Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon

Exclusion Criteria:

* History of allergic reactions to iodinated contrast agents
* Pregnancy or breast feeding
* Treatment of thyroid disease with radioactive iodine
* Use of metformin
* Creatinine clearance \< 45 ml/min
* Chronic or acutely worsening renal disease
* Patients who are declared incompetent

Primary outcomes:
measure: Visual tumor conspicuity
timeFrame: On the same 1 day as the regular PET-CT scan was performed
measure: BI-RADS score
timeFrame: On the same 1 day as the regular PET-CT scan was performed
Secondary outcomes:
measure: Iodine enhancement
timeFrame: On the same 1 day as the regular PET-CT scan was performed
measure: Iodine content
timeFrame: On the same 1 day as the regular PET-CT scan was performed
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: Laura N Deden
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate Hospital
name: Maxime V.P. Schyns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681759: An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
Official title: A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Low Dose Aspirin (LDA)
Cardiovascular disease
Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 1836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.

Brief summary: The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin


Eligibility criteria: Inclusion Criteria:

* Provision of signed written inform consent.
* Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.
* Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events

Exclusion Criteria:

* Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.

Primary outcomes:
measure: Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P
timeFrame: Once at enrollment
Secondary outcomes:
measure: EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization
timeFrame: Four times daily for three months
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Research Site
state: Tennessee
city: St. Laurent
country: Canada
facility: Research Site
state: Quebec
city: Paris
country: France
facility: Research Site
Study officials:
References:
citation: Bytzer P, Pratt S, Elkin E, Naesdal J, Sorstadius E. Burden of upper gastrointestinal symptoms in patients receiving low-dose acetylsalicylic acid for cardiovascular risk management: a prospective observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):27-35. doi: 10.1007/s40256-012-0001-4.
citation: Pratt S, Thompson VJ, Elkin EP, Naesdal J, Sorstadius E. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs. 2010;10(5):281-8. doi: 10.2165/11584410-000000000-00000.