louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02614781: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
Official title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Termination of Pregnancy
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 892
Sex: FEMALE
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: women asking for medical abortion

Brief summary: This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.


Eligibility criteria: Inclusion Criteria:

* Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy
* Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion
* Patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet
* Informed patients accepting the computer processing of their medical data and their right of access and correction

Exclusion Criteria:

* Patients with known hypersensitivity to mifepristone
* Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost).
* Patients with severe and progressive disease
* Patients with ectopic pregnancy

Primary outcomes:
measure: success rate of the protocol Mifegyne and prostaglandin analogue
timeFrame: At the follow-up at 2-3 weeks after inclusion
Secondary outcomes:
measure: Success rate of the protocol Mifegyne and misoprostol per os.
timeFrame: at the follow up at 2-3 weeks after the inclusion
measure: rate of ongoing pregnancy by term.
timeFrame: at the follow up at 2-3 weeks after the inclusion
measure: rate of patients requiring any additional procedures by term.
timeFrame: at the follow up at 2-3 weeks after the inclusion
measure: Number of medical abortion using misoprostol
timeFrame: at the follow up at 2-3 weeks after the inclusion
measure: Evaluation by patients of pain using a 5 level verbal rating scale
timeFrame: at the follow up at 2-3 weeks after the inclusion
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Conception
Study officials:
affiliation: NORDIC PHARMA
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02006381: Oxytocin Levels in Typically Developing Boys
Official title: Ontogenic Measurement of Plasma Oxytocin in Typically Developing Boys Using Extracted and Unextracted EIA Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Boys
Keywords: healthy boys
plasma oxytocin
pediatric
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 60
Sex: MALE
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This population will be a community sample representative of the community of the area.

Brief summary: Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.

Detailed description: Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods. This study is necessary since there is great variability in reported plasma oxytocin in typically developing children from other studies as well as up to 1000 fold variability in such levels using different assay procedures. Further existing studies have not clearly described variation in levels with age. all samples will be taken in the afternoon.

Eligibility criteria: Inclusion Criteria:

* Between 3 and 17 years old, inclusive
* Consent of parent or guardian.

Exclusion Criteria:

* Exclusion Criteria for Healthy Control Participants:
* Female gender
* Evidence of a mental health diagnosis
* Evidence of significant medical condition (ie: renal, cardiovascular or genetic disease)
* First degree family member with an ASD diagnosis

Primary outcomes:
measure: Plasma Oxytocin Levels
timeFrame: Baseline oxytocin level at visit 1 (time zero)
Secondary outcomes:
measure: Inflammatory markers
timeFrame: at single time point
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Linmarie Sikich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06343181: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer
Official title: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of metastatic breast cancer treated at European Institute of Oncology

Brief summary: Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.

Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project."

Detailed description: The aim of this research project is to assess the barriers and resources (both individual and environmental), as well as the psychological, clinical, and contextual factors that may influence adherence to pharmacological therapy in patients with actively treated metastatic breast cancer.

This will be achieved through a qualitative analysis focused on pharmacological therapy and its administration methods.

For this study, 4 focus groups will be conducted to identify the needs, barriers, and psychological, clinical, and contextual factors that may influence adherence to pharmacological treatment in patients with metastatic breast cancer, as well as their preferences regarding these treatments.

The number of focus groups was determined in accordance with recommendations from the literature for identifying relevant themes, which suggest that to achieve an adequate level of saturation, four or more focus groups are necessary.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old;
* Diagnosis of metastatic breast cancer;
* Availability of an internet connection and a PC or Tablet (for remote focus groups);
* Signing of the informed consent.

Exclusion Criteria:

* Presence of psychiatric or neurological conditions impairing the ability to comprehend the questions in Focus Groups or to express free consent to participate in the study;
* Presence of medical or oncological conditions other than metastatic breast cancer;
* Refusal to sign the informed consent.

Primary outcomes:
measure: Evaluation of factors influencing patients' adherence to medical therapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02553681: Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D
Official title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hartwig Research Center
First posted: 2015-09-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.


Eligibility criteria: Inclusion Criteria:

* Willing and able to sign the informed consent form
* Aged ≥18 years old
* Experienced wearer of rigid gas permeable contact lenses
* Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Corneal astigmatism ≤2.00 D

Exclusion Criteria:• Eye injury or surgery within 3 months immediately prior to enrolment for this trial

* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Current wearers of multifocal contact lenses
* Current wearers of toric contact lenses (front surface design)
* Current wearers of astigmatic contact lenses (posterior surface design)
* Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
* Unacceptable fit of habitual lenses
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Primary outcomes:
measure: questionnaire addressing subjective comfort and wear time
timeFrame: subjects will be followed-up for one month
measure: conjunctival redness - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
measure: corneal staining - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
Secondary outcomes:
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Siehste
Study officials:
affiliation: Hartwig Research Center
name: Andreas Hartwig, PhD, FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937781: Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690
Official title: Molecular Prognostic Factor Analysis in Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: stage III melanoma
recurrent melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-13
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E1690

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial EST-1690.

Detailed description: OBJECTIVES:

* To validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the outcome associated with melanoma in the EST-1690 cohort using IHC analysis.
* To examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy.
* To analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups.
* To examine the prognostic role of these biomarkers on the outcome associated with melanoma in the EST-1690 cohort using quantitative-PCR.
* To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g., NCOA3, SPP1, and RGS1) as prognostic or predictive markers.

OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated from the specimens to assess gene expression via quantitative PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * No metastatic disease at diagnosis
* Treated on protocol EST-1690
* Primary tumor tissue specimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Prognostic role of several biomarkers on the outcome associated with melanoma using IHC
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Mohammed Kashani-Sabet, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02860481: FSH-R : Diagnostic Application for Localized Tumors in Cancerology
Official title: FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the diagnosis of cancer.

A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will include n=10 patients per histological type except for breast cancer (n=50). 100 patients are expected in this cohort.

A second cohort will explore the more promising histological type (if any) in term of incidence of detection. 100 patients are expected for this second cohort.


Eligibility criteria: Inclusion criteria

1. Patient diagnosed with localized cancer and corresponding to the different types explored. The cancer can be already diagnosed or not (strong suspicion)
2. Age\> 18
3. Written informed consent

Exclusion criteria

1. Previous treatment for the tumoral disease
2. Personal history of cancer diagnosis in the last 10 years
3. Pregnant and/or breastfeeding women
4. Person deprived of liberty or under guardianship (including curatorship)
5. psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements

Primary outcomes:
measure: sensitivity of blood FSH R detection in cancer patients
timeFrame: end of the study, up to two years
Secondary outcomes:
measure: variability of blood FSH-R in the same tumoral type and between different tumoral types
timeFrame: end of the study, up to two years
measure: comparison of blood FSH-R with blood from healthy donor
timeFrame: end of the study, up to two years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Saint Cloud
country: France
facility: Centre René Huguenin
Study officials:
affiliation: Institut Curie
name: François Clément Bidard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352481: Early Intervention in Very Preterm Children
Official title: Early Intervention for Speech Sound Disorder in Very Preterm Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prematurity
Speech Sound Disorder
Keywords: Speech sound development
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 25
Sex: ALL
Minimum age (years): 24
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a Speech Sound Disorder (SSD) at 2 years of age.
* The hypothesis of this study is that early intervention on speech development is effective in improving the speech development in preterm children with SSD at 2 years of age compared to a no treatment group (usual care at this age).


Eligibility criteria: Inclusion Criteria:

* birth weight \< 1500 grams or gestational age \< 32 weeks
* singleton birth
* no major neurodevelopmental disabilities, and
* Dutch speaking family background

Primary outcomes:
measure: Number of acquired consonants produced by the child
timeFrame: 12 months after the onset of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical University Center
Study officials:
References:
Clinical trial NCT04304781: Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
Official title: Phase 1 In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Biliary Intra-epithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cholangiocarcinoma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets that are specific for biliary intra-epithelial neoplasia. A dimer is needed because cancer in the biliary tract is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects having a medical condition requiring an ERCP to diagnose a potential biliary disorder. The Phase 1A first-in-human studies of safety with topical administration by ingestion of KSP/QRH dimer (HUM00141420) has been completed.


Eligibility criteria: Inclusion Criteria:

Subject meets all of the following criteria:

* Scheduled for an outpatient ERCP to diagnose a potential biliary disorder (such as an indeterminate biliary stricture)
* Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
* Age 18 to 100 years
* Willing and able to sign informed consent

Exclusion Criteria:

* Subjects with known allergy or negative reaction to any components of the study drug (list these)
* Subjects on active chemotherapy or radiation treatment
* Pregnant or trying to conceive
* Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Primary outcomes:
measure: Contrast in Cell Fluorescence
timeFrame: During and immediately after procedure, generally no more than 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Danielle Kim Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02760381: Acetic Acid for Optical Characterization of Colonic Polyps
Official title: Acetic Acid for Optical Characterization of Colonic Polyps: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyps
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the colon. Currently all polyps should be resected endoscopically, however adenomas have the potential to develop into colorectal cancer whereas hyperplastic polyps do not. This approach enables the lesions to be evaluated under the microscope. Currently only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Acetic acid (AA) chromoendoscopy is already widely used in order to improve optical determination of mucosal lesions in the upper gastrointestinal tract. In the colon only few studies investigated the impact of AA in differentiating normal mucosa from suspicious mucosa. The aim of the present study is to evaluate the value of spraying acetic acid as an adjunct for optical characterization of colon polyps. Using AA may be beneficial for determining optical diagnoses of colon polyps during real time colonoscopy. This is a single-arm proof of principle study. If colon polyps are found during colonoscopy a 1.5 percent AA solution will be used for chromoendoscopy. Endoscopists are encouraged to use the Narrow Band Imaging (NBI) function of the endoscope prior to the use of AA. After AA is sprayed endoscopists will diagnose the polyp optically. Endoscopists have to predict adenomatous or non-adenomatous histology based upon optical features of the polyp. All polyps will be resected endoscopically so that histopathological diagnoses can be determined. After completing the trial the investigators aim to compare optical and histopathological-based diagnoses of polyps. Histopathological diagnoses will serve as the gold standard. Based upon this information the accuracy of the optical diagnoses will be calculated. The investigators hypothesis is, that optical-based diagnosis using NBI and AA will be accurate in \> 75% of all polyp cases.


Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy

Exclusion Criteria:

* pregnant women
* emergency investigation
* history of inflammatory bowel disease
* contraindication for polyp resection

Primary outcomes:
measure: Diagnostic test: Optical characterization of colon polyps
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany
state: Bayern
Study officials:
References: