louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04674995: Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
Official title: Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Stenosis
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We collected clinical, endoscopic and radiological data of patients with benign tracheal stenosis admitted in two operative Units of the University Hospital of Modena (Italy): The Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B) from November 2012 to November 2017

Brief summary: This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.


Eligibility criteria: Inclusion Criteria:

* age \>18 years,
* exclusion from resection-anastomosis surgery after multidisciplinary evaluation,
* Cotton Meyer \> grade II,
* follow-up of at least 3 years after endoscopic surgery,
* no previous tracheal surgery.

Exclusion Criteria:

* age \> 80,
* stent intolerance which requires removal in the first year after endoscopic treatment,
* performance status \> 2,
* end-stage chronic pulmonary disease,
* life-threatening stenosis that needs urgent endoscopic treatments,
* any neoplastic stenosis of the airways,
* dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).

Primary outcomes:
measure: Re-stenosis rate over time
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01764295: Clinical Study for Patients With Hypertension Associated With Dyslipidemia
Official title: Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of DWJ1276


Eligibility criteria: Inclusion Criteria:

* Adult male and female in between ages of 20 and 80 at the time of screening
* Subject who can understand information provided and who can sign written consent voluntarily

Exclusion Criteria:

* Patients with hypersensitivity to olmesartan and rosuvastatin
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* Patient with history of drug or alcohol abuse

Primary outcomes:
measure: LDL-C percent change of DWJ1276 from baseline
timeFrame: 8weeks
measure: DBP change of DWJ1276 from baseline
timeFrame: 8weeks
Secondary outcomes:
measure: Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline
timeFrame: 8weeks
measure: Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report
timeFrame: 8weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05935995: Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
Official title: Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Basal Cell Carcinoma of Skin
Keywords: margin surgical
confocal microscopy
conventional histopathology (H&E)
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck


Eligibility criteria: Inclusion Criteria:

* Adult patient ≥18 years old
* Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin.
* Patient whose surgical indication has been validated in a consultation meeting
* Patients with scheduled surgery
* WHO\< or =2
* ASA \< 3
* Patient affiliated to the social security system
* Patient has understood, signed and dated the consent form.

Exclusion Criteria:

* History of irradiation in the surgical area
* Women who are pregnant or who are breast-feeding.
* Persons deprived of their liberty or under guardianship (including curators)

Primary outcomes:
measure: Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Gilles Dolivet
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: GILLES DOLIVET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329795: Image-derived Prediction of Response to Chemo-radiation in Glioblastoma
Official title: Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 16
Sex: ALL
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: Patients with primary glioblastoma, eligible for chemoradiotherapy.

Brief summary: This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.

Detailed description: Generally, response prediction models seeks to predict time to an event, e.g. time-to-progression and/or overall survival. The aim of this study is to explore the feasibility of establishing an individualized response model, that, based on several morphologic, physiologic and metabolic parameters extracted from computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI), is able to predict the tumor response at the level of an imaging voxel, using machine learning techniques.

Imaging modalities include MRI, PET/CT with 18F-fluroethyltyrosine (18F-FET), and PET/MRI with 64Cu-diacetyl-bis(N4-methylthiosemicarbazone) (64Cu-ATSM).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, primary supratentorial glioblastoma (WHO grade IV).

Exclusion Criteria:

* No informed consent can be obtained
* Inability to undergo MRI examination, due to metal implants, pacemaker etc.
* Not eligible for Stupp-regimen

Primary outcomes:
measure: Sensitivity and specificity of predicted response
timeFrame: 3 months post radiotherapy
Secondary outcomes:
measure: DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI
timeFrame: 3 months post radiotherapy
measure: Correlation (volume and maximum values) between lactate and hypoxia
timeFrame: 1 week before start of chemoradiotherapy
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Section for Radiotherapy, Rigshospitalet
Study officials:
References:
Clinical trial NCT03629795: Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays
Official title: Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trisomy 21 in Fetus
Trisomy 18 in Fetus
Trisomy 13 in Fetus
Lead sponsor: Axis Shield Diagnostics Ltd
Sponsor class: INDUSTRY
Collaborators: name: The Clinical Trial Company
First posted: 2018-08-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First trimester pregnancy

Brief summary: Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Detailed description: Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Eligibility criteria: Inclusion Criteria:

* A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:

  1. Subject is ≥ 18 years of age
  2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
  3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm

Exclusion Criteria:

* A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:

  1. Subject is unable to give consent
  2. Subject has already participated in the study

Primary outcomes:
measure: Sample handling
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle University
state: UK
Study officials:
affiliation: Professor of Fetal Medicine
name: Stephen Robson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06991881: Eosinophilic Esophagitis: Towards Improved Management
Official title: Eosinophilic Esophagitis: Towards Improved Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Esophagitis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse-Bergen HF
First posted: 2025-05-28
Enrollment: 80
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with newly diagnosed or previously confirmed eosinophilic esophagitis.

Brief summary: The current project aims to improve the care for children and adolescents with eosinophilic esophagitis in a collaborative effort involving pediatric units at Oslo Unversity Hospital and Helse Bergen, Norway. Existing and new non-invasive biomarkers will be explored systematically, aiming to reduce the number of endoscopies and time on restricted diet.

Detailed description: The overall aim of the current proposal is to improve the care for children and adolescents with EoE and reduce the need for complex elimination diets and repeated endoscopies.

Our objectives are to determine whether

1. at diagnosis the following are predictive for response to food elimination:

   1. history of atopy, symptoms after food intake
   2. eosinophil counts in biopsies and peripheral blood
   3. total IgE, specific IgE, eosinophilic granula proteins, eosinophil progenitor cells in blood
   4. key cytokines (Eotaxin-3, IL-5, IL-13)
   5. eosinophil derived neurotoxin/EDN in oesophageal aspirates, blood samples and feces
   6. circulating microRNAs
2. at follow-up biomarkers collected by non-invasive methods can predict endoscopic and histologic healing

   1. eosinophil counts in esophageal brushes and peripheral blood
   2. total IgE, specific IgE, eosinophilic granula protein, eosinophil progenitor cells
   3. circulating cytokines like eotaxin-3, IL-5, IL-13
   4. eosinophil derived neurotoxin/EDN in esophageal brushes, blood samples and feces
   5. circulating microRNAs

Eligibility criteria: Inclusion Criteria:

* a diagnosis of eosinophilic esophagitis
* suspected but not yet confirmed eosinophilic esophagitis

Exclusion Criteria:

* chronic severe conditions that preclude general anaestesia
* lack of consent

Primary outcomes:
measure: Active eosinophilic esophagitis (>15 eosinophils per high-power field)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: OsloUH
Study officials:
affiliation: University of Oslo
name: Ketil Størdal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02443181: Demand-driven Management of Essential Tremor
Official title: The Application of DBS Technologies for Demand-driven Management of Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: Essential tremor; closed-loop DBS
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effectiveness of tremor control using various strategies for implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor. Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or thalamic electrodes.

Detailed description: Essential tremor is effectively treated with deep brain stimulation of the ventralis intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a kinetic tremor that is present or worsened with movement. However, DBS therapy is currently continuous, and thus, stimulation occurs when the patient will not benefit symptomatically from treatment. This exposes the patient to unnecessary stimulation, which can lead to unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can possibly contribute to tolerance to DBS therapy.

One possible solution is selective stimulation when movement is required. This study will determine signals predictive of motor activity using external sensors such as EMG, and cortical biomarkers of real and imaginary movement that are well-characterized.

The primary aim is to demonstrate successful initiation and modulation of DBS therapy using the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements in battery usage related to stimulation on-time and definition of coupling signals between thalamus and cortex that characterize tremor state are secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Appropriate candidates for DBS with essential tremor

Exclusion Criteria:

* Not meeting inclusion criteria based on tremor amplitude, neuropsychological testing, etc.
* Prior trauma to the brain on side of putative implantation of stimulator

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 18 months
Secondary outcomes:
measure: Battery usage using demand-driven strategies for tremor control
timeFrame: 18 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Department of Neurological Surgery
state: Washington
Study officials:
affiliation: University of Washington
name: Andrew Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556381: Efficacy of Trans Abdominis Plane Block for Post Cesarean Delivery Analgesia
Official title: The Efficacy of Ultrasound-guided Transversus Abdominis Plane ( TAP) Block Versus Standard Analgesic Protocol for Postoperative Analgesia After Elective, Cesarean- Section Delivery- A Randomize Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Keywords: Pain
cesarean delivery
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Relief from pain is part of the fundamental human right to health. (1) However, available evidence indicates an increasingly detailed understanding of the pathophysiology of pain and general inadequacy of its treatment.

Detailed description: Background: Relief from pain is part of the fundamental human right to health. (1) However, available evidence indicates an increasingly detailed understanding of the pathophysiology of pain and general inadequacy of its treatment.

Rationale: Assessment and Improving the Pain Management Modality

Study objectives: In this study, determined the efficacy of TAP block in patients undergoing cesarean section.

Methods:

This study is a cross-sectional study. It is a multi-centric study as it was conducted in different Governmental hospitals.

Eligibility criteria: Inclusion Criteria:

1. Age: 20-50 years
2. Patients of \>50 kg or \<100 kg weight.
3. Urgency: Elective, Emergent and Urgent cases

Exclusion Criteria:

1. Patients of \<50 kg or \>100 kg weight
2. Any contraindication to any of anesthesia medications
3. Patient unable to understand numeric rating scale (NRS)

Primary outcomes:
measure: Pain Score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Qassim University Medical City
state: Qassim
Study officials:
affiliation: Qassim University
name: Mohammed Abaalkhayl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873481: Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Official title: Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
name: Southern Nursing Research Society
First posted: 2016-08-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will provide the necessary preliminary data to fuel an appropriately powered randomized controlled trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress resilience, and improving maternal-child outcomes among overweight/obese diverse women. Because increasing physical activity has been found to have important mental health effects and maternal-child outcomes, it stands to reason that this innovative intervention has the potential to impact the way prenatal care is delivered in high risk populations.


Eligibility criteria: Inclusion Criteria:

* pregnant women age 18 years or older
* currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District

Exclusion Criteria:

* current physical conditions preventing participation in physical activity (ACOG guidelines: restrictive lung disease, hemodynamically significant heart disease, incompetent cervix, multiple gestation at risk of premature labor, persistent 2nd or 3rd trimester bleeding, placenta previa after 26 weeks gestation, premature labor, ruptured membranes, preeclampsia, severe anemia)

Primary outcomes:
measure: Feasibility of Retention/ Adherence
timeFrame: through study completion, an average of 20 weeks
Secondary outcomes:
measure: Self-efficacy for Physical Activity
timeFrame: baseline (early pregnancy), end of pregnancy (approx 10 months)
measure: Salivary Biomarkers (α-amylase)
timeFrame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
measure: Depressive Symptoms
timeFrame: baseline (early pregnancy), end of pregnancy (approx 10 months)
measure: Stress
timeFrame: baseline (early pregnancy), end of pregnancy (approx 10 months)
measure: Number of Subjects Participating in Focus Group
timeFrame: at intervention completion, an average of 20 weeks
measure: Recruitment Feasibility
timeFrame: at intervention completion, an average of 20 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Nursing
state: Virginia
Study officials:
affiliation: VCU
name: Patricia Kinser, PhD
role: PRINCIPAL_INVESTIGATOR
References: