louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00798980: Scandinavian Mirena Insertion Nulliparous Trial.
Official title: Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nulliparous
Keywords: Mirena
Nulliparous
Intrauterine Devices
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 224
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic Patients

Brief summary: In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.


Eligibility criteria: Inclusion Criteria:

* Nulliparous women Mirena insertion planned as contraceptive method

Exclusion Criteria:

* Ongoing or suspected pregnancy;
* Ongoing or recidivating genital infection;
* Cervicitis;
* Cervical dysplasia;
* Malignancy in uterus or cervix;
* Confirmed or suspected hormone sensitive neoplasia including breast cancer
* Undiagnosed abnormal uterine bleeding;
* Uterine anomaly including myoma if the cavity of the uterus is restricted;
* Conditions that cause increased risk of infections;
* Acute liver disease or liver tumour;
* Allergy to the active substance or any component of the IUD

Primary outcomes:
measure: Evaluation of the insertion procedure of Mirena in nulliparous women
timeFrame: At the insertion time point
Secondary outcomes:
measure: Pain
timeFrame: At the insertion time point
measure: Continuation rate
timeFrame: 12-16 weeks post insertion
measure: Bleeding Pattern
timeFrame: 12-16 weeks post insertion
measure: Satisfaction
timeFrame: 12-16 weeks post insertion
Other outcomes:
Locations:
city: Many Locations
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Marions L, Lovkvist L, Taube A, Johansson M, Dalvik H, Overlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/13625187.2011.558222.
Clinical trial NCT02661880: The Role of Music in Palliative Care: A Proposal for a Rural Based Initiative in Music Based Interventions
Official title: The Role of Music in Palliative Care: A Proposal for a Rural Based Initiative in Music Based Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improved Emotional Regulation
Improvement in Quality of Life
Symptom Relief
Preservation of Dignity
Existential Solace
Relief of Suffering
Emotional Regulation
Quality of Life
Dignity
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Current practice in larger palliative care centers offer many supportive service modalities, which are often unavailable in the rural setting. Music Therapy by experienced registered Music Therapists is an example of such a modality. The current evidence continues to grow, identifying Music Therapy's benefits to help with symptom relief as well as to improve Quality of Life in many aspects of medicine, but especially in the context of palliative care. This proposal outlines an initiative to provide music-based interventions in a rural community palliative care unit where there is limited availability to a registered Music Therapist.

Detailed description: Study participants in the pilot phase will include patients admitted to the Aberdeen Hospital Palliative Care Unit. Patients excluded from participating would include those unwilling to participate for any reason. All patients will be invited to complete the McGill Quality of Life Questionnaire - Revised (McGill QOL-R) upon admission to the unit. The Questionnaire will not be part of the permanent medical record and the participants will remain anonymous. Afterwards participants will be asked if they would like to listen to music during their stay in the hospital. Music will be selected according to their choices from an i-Tunes playlist. Participants will be invited to listen to music at their own discretion. Prior to discharge from the hospital or after 3 days all willing patients will be again invited to complete the McGill QOL-R questionnaire. The participants will remain anonymous, but will be identified as to whether they listened or did not listen to music during their hospitalization.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the Aberdeen Hospital Palliative Care Unit.

Exclusion Criteria:

* those patients unwilling to participate for any reason

Primary outcomes:
measure: Quality of Life-using the McGill QOL-revised questionnaire
timeFrame: within 3 months of data collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dalhousie University
name: Anne M Kwasnik-Krawczyk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909180: Clinical Evaluation for General Electric (GE) CT System
Official title: Clinical Evaluation for GE CT System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CT Scanners X Ray
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An external evaluation to obtain clinical data to create sample clinical images.

The data will also be used for product and technology development, marketing materials, and inclusion in publications.

Detailed description: The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.

Eligibility criteria: Inclusion Criteria:

* Subjects who voluntarily signed the Informed Consent Form (ICF).
* Male subjects 18 years of age or older.
* Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history.

Exclusion Criteria:

* • Subjects previously enrolled in this Evaluation.

  * Subjects who are not able or not willing to give written Informed Consent.
  * For IV contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma.
  * For IV contrast-enhanced CT exams, per the institution's guidelines on risk stratification and prophylaxis for Contrast Induced Neuropathy, subjects will be pre-screened via medical history review by qualified medical personnel for suspected renal function impairment and high risk subjects will undergo a serum creatinine lab test. Any subject with proven renal insufficiency will be excluded.
  * Known pregnancy and nursing (lactating) females.
  * Any subject with urgent medical condition requiring acute care.
  * Any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject.
  * Subjects who do not agree to allow GEHC personnel to be present during the scan.

Primary outcomes:
measure: Image Quality
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist South Florida Hospital
state: Florida
Study officials:
affiliation: Baptist South Hospital
name: Ricardo Curry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00727480: Finger Imaging to Detect Blood Flow in the Fingertips
Official title: Finger Imaging and Biometric System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Capillary Permeability
Keywords: vascularity
fingertips
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a small, easily used device to detect a person's blood flow in their fingertips.

Detailed description: To develop a hand held touch-pad device for identification of individuals, to help with banking and, possibly for detection of anxiety. This is done by their fingerprint and, other digital anatomy and vascular biometrics.

Eligibility criteria: Inclusion Criteria:

* Adult male and female who can give informed consent

Exclusion Criteria:

* Under the age of 18

Primary outcomes:
measure: To develop a new type of electronic hand held device, that will demonstrate the image quality comparable to existing devices based on optical techniques.
timeFrame: 2002-2011
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul L. Carson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302780: BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
Official title: Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of healthy volunteers. Note that this study will also enroll spinal cord injury patients, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.


Eligibility criteria: Inclusion Criteria:

* between 18 and 75 years
* male and female subjects
* healthy subjects (i.e., no recent injuries or pain)

Exclusion Criteria:

* recent injuries or pain
* have a pacemaker, or other metal and/or implanted devices
* have amputation in their arm(s)
* have spinal cord injury (SCI) involving impairment of arms
* have cognitive impairment from brain injury or are not able to follow commands, or to give consent
* have asthma or other pulmonary disease
* are not medically stable
* have preexisting psychiatric disorders
* alcohol or drug abuse
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
* Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.

Primary outcomes:
measure: Electrical Pain Threshold (EPT)
timeFrame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
measure: Electrical Sensation Threshold (EST)
timeFrame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772780: MP-3 Biofeedback Training and Central Vision Loss
Official title: The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this investigation are:

* evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing;
* compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.


Eligibility criteria: Inclusion Criteria:

* Age related macular degeneration

Exclusion Criteria:

* Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days

Primary outcomes:
measure: Fixation stability
timeFrame: 6 months
measure: Reading speed
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02408380: Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)
Official title: Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: biomarker
disease progression
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2015-04-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Gilenya compared with age-matched healthy controls

Brief summary: This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Detailed description: Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.

Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.

Eligibility criteria: Inclusion Criteria:

* Treatment with Gilenya

Exclusion Criteria:

* Subject is under 18 or over 65.
* Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
* Subject cannot communicate reliably with investigator.
* Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.

Primary outcomes:
measure: Change in expression of a biomarker signature
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: MUHC research institute
name: David Haegert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06929780: A Prediction Model of Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery
Official title: Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery: Risk Factor Analysis, Impact on Clinical Outcomes and Development of Prediction Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Type A Aortic Dissection
Keywords: Acute type A aortic dissection
Prolonged mechanical ventilation
mechanical ventilation time
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ATAAD postoperative patients admitted to SICU

Brief summary: The goal of this observational study is to develop and validate a predictive model for prolonged mechanical ventilation (PMV) following acute type A aortic dissection (ATAAD) surgery.

The main questions it aims to answer are:

1. To validate the predictive performance of the model for PMV after ATAAD surgery
2. To assess the proportion of PMV among patients undergoing ATAAD surgery
3. To evaluate the ICU length of stay and operative mortality in patients with PMV following ATAAD surgery


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years;
* Diagnosis of acute type A aortic dissection (ATAAD) confirmed by computed tomography angiography and echocardiography;
* Patients who underwent aortic surgery requiring cardiopulmonary bypass (CPB), were admitted to the surgical intensive care unit (SICU), and received mechanical ventilation.

Exclusion Criteria:

* Reintubation;
* Intraoperative death or failure to survive beyond 72 hours postoperatively;
* Pregnancy;
* Severe comorbidities (e.g., lung cancer);
* Missing critical outcome data (e.g., short-term mortality, mechanical ventilation duration, reintubation).

Primary outcomes:
measure: The predictive performance of the model for prolonged mechanical ventilation (PMV) following acute type A aortic dissection (ATAAD) surgery
timeFrame: 72 hours after ATAAD surgery
measure: The proportion of patients with PMV
timeFrame: 72 hours after ATAAD surgery
Secondary outcomes:
measure: ICU length of stay (ICU-LOS)
timeFrame: From surgery to discharge or death, whichever came first, assessed up to 6 months
measure: surgery-related mortality
timeFrame: 30 days after ATAAD surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06344780: Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
Official title: A Multi-center Study of the Clinical Outcomes of Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer in Real World Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Abemaciclib
Palbociclib
Dalpiciclib
HR Positive
HER2 Negative
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023.

Brief summary: A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer.


Eligibility criteria: Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
3. Received CDK4/6 inhibitors(Abemaciclib, Palbociclib or Dalpiciclib) as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: OS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05355480: Handwriting Analysis in Movement Disorders
Official title: Advanced Machine Learning Analysis of Handwriting in Patients With Movement Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Movement Disorders
Parkinson Disease
Writing Disorder
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and patients with idiopathic PD

Brief summary: Handwriting is a complex cognitive prowess that deteriorates in patients affected by neurodegenerative diseases, including movement disorders. More in detail, patients with Parkinson's disease (PD) may manifest prominent handwriting abnormalities which have been collectively identified as parkinsonian micrographia. MIcrographia may manifest at the onset of the disease and then worsens progressively with time. Previous techniques released to investigate micrographia in PD relied on perceptual analysis of simple tasks or were based on expensive technological tools, including tablets. However, handwriting can be promptly collected in an ecological scenario, through safe, cheap, and largely available tools. Also, the objective handwriting analysis through artificial intelligence would represent an innovative strategy even superior to previous techniques, since it allows for the analysis of large amounts of data. In this experimental project, the investigators apply a specific machine learning algorithm to analyze handwriting samples recorded in healthy controls and PD patients. The study aims to verify whether the technique proposed by the investigators would be able to detect parkinsonian micrographia objectively, monitor the evolution of handwriting abnormalities and assess the symptomatic improvement of handwriting following L-Dopa administration in PD patients.


Eligibility criteria: Inclusion Criteria:

* Healthy conditions
* clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* cognitive decline

Primary outcomes:
measure: Stroke size of handwriting characters
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
References: