louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01789996: The Six Minute Walk Test: Influence of Instruction on Results
Official title: Alternative Instruction in Six Minute Walk Test (6MWT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: 6 minute walk test
idiopathic pulmonary fibrosis
pulmonary arterial hypertension
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-02-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. One was coached to walk at the patients normal walking pace. One was coached to walk at the patient's leisure walking pace.

Detailed description: Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which is walk as far as you can in 6 minutes.

Eligibility criteria: Inclusion Criteria:

* advanced lung disease such as COPD, ILD, IPF, or PAH

Exclusion Criteria:

* inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT

Primary outcomes:
measure: distance meters
timeFrame: 1 day
Secondary outcomes:
measure: oxygen saturation
timeFrame: 1 day
measure: dyspnea score
timeFrame: 1 day
measure: heart rate response
timeFrame: 1 day
Other outcomes:
measure: heart rate recovery at one minute
timeFrame: 1 day
Locations:
city: Falls Church
country: United States
facility: Inova Advanced Lung Disease and Transplant Program
state: Virginia
Study officials:
affiliation: Inova Advanced Lung Disease and Transplant Program
name: Steven D Nathan, MD
role: STUDY_DIRECTOR
References:
citation: Weir NA, Brown AW, Shlobin OA, Smith MA, Reffett T, Battle E, Ahmad S, Nathan SD. The influence of alternative instruction on 6-min walk test distance. Chest. 2013 Dec;144(6):1900-1905. doi: 10.1378/chest.13-0287.
Clinical trial NCT05769296: Australian UCSF Concussion in Athletes
Official title: Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Mild
Keywords: mild traumatic brain injury
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recently concussed athletes playing Australian rules football. Controls are athletes of Australian Football or other sports without concussion for more than 1 year.

Brief summary: Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

Detailed description: Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data will be used to confirm prior models of analysis and produce a tool to be confirmed in a future study.

Eligibility criteria: Concussion Subjects:

Inclusion Criteria:

* Diagnosed with sport related concussion
* first recording obtained within one week
* willingness to have multiple recordings in the month following concussion

Exclusions:

- head laceration

Control subjects:

Inclusion Criteria:

* athletes without concussion over the last year
* willingness to have single or multiple recordings

Exclusion Criteria:

- head laceration

Primary outcomes:
measure: Sensitivity of headpulse measurements to detect subjects with concussion
timeFrame: 1 month
Secondary outcomes:
measure: Feasibility of subject recruitment
timeFrame: 2.5 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wade S Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06118996: Breast 3DUS ABUS System Comparison
Official title: Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Diseases
Keywords: 3D Ultrasound
Intervention
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
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: This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.


Eligibility criteria: Inclusion Criteria:

* Adult Patients who are scheduled for screening ABUS
* Adults Patients who are scheduled for short term follow-up with ABUS.
* Must be at least 18 years of age or older.
* Must be proficient in English (reading/writing).

Exclusion Criteria:

* Patients with breast implants.
* Patients with contraindication for ABUS.
* Patients who cannot tolerate ABUS.

Primary outcomes:
measure: Breast Images
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT05929196: Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.
Official title: Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test microwave metamaterial glucose sensor on blood samples. It means to compare the results of glucose values obtained by microwave metamaterial sensor and by standard biochemical analyzer.

Detailed description: Participants will include physiological and pathological populations. Participants donate approximately 5 ml of blood sample. Three sample tubes will be collected from ten adult participants. In the first test tube, the blood glucose content will be determined by a validated biochemical analyzer (Roche, Switzerland). In the remaining volume of the blood sample, the dielectric parameters (relative permittivity and conductivity) will be estimated using a coaxial probe (Keysight, USA). Microwave metamaterial sensors with 5, 7 and 9 unit cells will be loaded with blood samples and the specific scattering matrices will be obtained using a vector network analyzer. The main monitored outcome measure will be the phase of parameter S21.

Eligibility criteria: Inclusion Criteria:

* blood glucose can be measured with standard biochemical analyzer

Exclusion Criteria:

* minimum age limit 18 years

Primary outcomes:
measure: Phase shift of scattering parameter S21
timeFrame: When blood sample is filled into sensor chamber within 24 hours from blood collection.
measure: Blood glucose concentration
timeFrame: When blood sample is processed in biochemical analyzer within 24 hours from blood collection.
measure: Blood sample specific electrical conductivity
timeFrame: When blood sample is presented into the co-axial probe container within 24 hours from blood collection.
measure: Blood sample relative permittivity
timeFrame: When blood sample is presented into the co-axial probe container within 24 hours from blood collection.
Secondary outcomes:
measure: Sensor sensitivity
timeFrame: After primary data acqiusition.
measure: Mathematical model of blood glucose dependence on blood dielectric parameters
timeFrame: After primary data acqiusition.
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Oblastní nemocnice Kladno, a.s.
state: Středočeský
Study officials:
affiliation: Regional hospital in Kladno
name: Luděk Šprongl, Ing.
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Lukáš Malena, Ing.
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: David Vrba, doc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500496: Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy
Official title: Vaginal Dinoprostone Versus Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Bleeding
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label randomized controlled study
Primary purpose: PREVENTION

Brief summary: To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed description: hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* Nulliparous patients
* patients with cervical pathology
* retroverted uterus (detected by transvaginal ultrasound)
* previous cervical surgery
* patients with severe vaginal bleeding
* allergy or contraindications to dinoprostone or INH therapy

Primary outcomes:
measure: Intensity of pain
timeFrame: 10 minutes
Secondary outcomes:
measure: Operative time
timeFrame: 15 minutes
measure: Pain intensity will be assessed by visual analogue scale
timeFrame: 30 minutes after the procedure
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT03877796: Clinical Pre-screening Protocol for Ovarian Cancer
Official title: Clinical Pre-screening Protocol for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Allarity Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Amarex Clinical Research
First posted: 2019-03-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified at their already planned treatment and or at control visits at the oncology department

Brief summary: The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.


Eligibility criteria: Inclusion Criteria:

* Patients with histological confirmed epithelia ovarian cancer
* Relapse after 2 or more chemotherapies for ovarian cancer
* FFPE tumor tissue available

Exclusion Criteria:

* Other primary malignancy within the last 5 years prior to enrolment

Primary outcomes:
measure: Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug
timeFrame: up to 2 years
Secondary outcomes:
measure: Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Seattle
country: United States
facility: Swedish Center for Research and Innovation
state: Washington
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Scotland
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
Study officials:
References:
Clinical trial NCT04447196: Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in CCHS Patients
Official title: Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in Patients With Congenital Central Hypoventilation Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CCHS
Congenital Central Hypoventilation Syndrome
Dyspnea
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 20
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: Adults with CCHS who already require long terme NIV but not phrenic nerve stimulation

Brief summary: Congenital central hypoventilation syndrome (CCHS) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of CO2/H+ chemosensitivity. This suggests cortical activity during awakening to maintain breathing. Cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (NIV) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. This can suggest that CCHS may be breathless at rest and this discomfort could be reduced by NIV.

The objective is to evaluate dyspnea with a multi dimensional score, MDP, in CCHS patient at rest in every day life and during 1H session of NIV.

The investigators will perform a prospective, including 20 CCHS patients. MDP scores will be measure before and after 1H-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after NIV.

The investigators expect that CCHS patients don't have rest dyspnea but NIV would improve breathing discomfort that would mean they have latent rest dyspnea.


Eligibility criteria: Inclusion Criteria:

* patients with CCHS confirmed by genetic test
* patients with long term non invasive ventilation
* no recent condition that could impact breathing sensations such as infection, pulmonary embolism, heart failure

Exclusion Criteria:

* pregnancy
* phrenic nerve stimulation

Primary outcomes:
measure: "Immediate unpleasantness" corresponding to A.1 item of the multidimensional dyspnea profile
timeFrame: Change in MDP score between baseline and after 1 hour of NIV
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
Study officials:
References:
Clinical trial NCT05214196: The Efficacy of Oral Antiseptics Against COVID-19
Official title: The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Keywords: COVID-19
Viral load
Antiseptic
Povidone-iodine
Hypochlorous acid
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a study conducted on 75 COVID-19 patients, the effect of SARS-CoV-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.

Detailed description: Before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. The sample was sputtered into a sterile plastic container. The participants were grouped according to the type of oral antiseptics used. The effectiveness of SARS-CoV-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. Viral load was analyzed by RT-PCR analysis. The results were evaluated by statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Positive SARS-CoV-2 RT-PCR result,
* Adult hospitalized patient,
* The participants have the physical and psychological ability to follow the instructions in the study.

Exclusion Criteria:

* Patients intubated and supported by a mechanical respirator,
* Severe acute or chronic medical or psychiatric condition,
* History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
* Active uncontrolled thyroid disease,
* Developmental/cognitive disability,
* Pregnancy,
* Undergoing radioactive iodine therapy.

Primary outcomes:
measure: RT-PCR analysis
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Faculty of Dentistry
Study officials:
affiliation: Atatürk University, Faculty of Dentistry
name: Alparslan Dilsiz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06559696: Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
Official title: Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Internal mammary nodal
Radiation
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 722
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

Detailed description: This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer
* Underwent neoadjuvant chemotherapy
* Eastern Cooperative Oncology Group Performance Status Scale 0-2
* ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
* No distant metastases
* No internal mammary nodes metastases based on images before system therapy
* Willing to follow up
* Written,informed consent

Exclusion Criteria:

* Without neoadjuvant chemotherapy
* Distant metastases
* Simultaneous bilateral breast cancer
* Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
* Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Distant metastasis-free survival
timeFrame: 5 years
measure: Local-regional recurrence-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Yong Yang, M.S
role: PRINCIPAL_INVESTIGATOR
References: