louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03113877: Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS)
Official title: Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS), a Pilot Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cornelia de Lange Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CDLS reached through national distribution list through the CdLS Foundation with an invitation to volunteer.

Brief summary: Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience symptoms of autonomic dysfunction however there are no reported studies in which these patients have had objective testing of the autonomic nervous system. This is a pilot study in which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction with a autonomic reflex screen and thermoregulatory sweat test.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (aged 8-17 years of age) with Cornelia de Lange syndrome.
* Consent obtained from responsible guardian.

Exclusion Criteria:

* Patients less than age 8 or 18 and older
* Female patients known to be pregnant
* Individuals not thought to be able to tolerate the testing.
* Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study

Primary outcomes:
measure: Number of patients who tolerated 70 degree head up tilt table test
timeFrame: 1 year
measure: Number of patients who show evidence of dysautonomia
timeFrame: 1 year
measure: Number of patients who tolerated thermoregulatory sweat test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amie E Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00331877: A Communication Strategy for Families of Patients Dying in the ICU
Official title: A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Family of Dying Patient in the ICU
Keywords: family
end-of-life
intensive care unit
Lead sponsor: Famirea Study Group
Sponsor class: OTHER
First posted: 2006-05-31
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.


Eligibility criteria: Inclusion Criteria:

* family of dying patient

Exclusion Criteria:

* family having no enough knowledge of French to respond to telephone interview
* patient alive on day 90

Primary outcomes:
measure: symptoms related to posttraumatic stress disorder
Secondary outcomes:
measure: symptoms of anxiety and depression
Other outcomes:
Locations:
Study officials:
affiliation: Famirea Study Group
name: Elie Azoulay, Md, PhD
role: STUDY_DIRECTOR
References:
citation: Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
citation: Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
Clinical trial NCT05765877: Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
Official title: Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer(NSCLC)
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer (NSCLC).
* ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.
* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
* ECOG Performance Status of 0-1.
* At least one measurable lesion according to RECIST 1.1.
* Adequate organ and marrow function.

Exclusion Criteria:

* Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
* Prior treatment with ALK TKI or ROS1 TKI.
* Prior treatment with local radiotherapy.
* Mixed small cell and NSCLC histology.
* Patients who are candidates to undergo only segmentectomies or wedge resections.

Primary outcomes:
measure: Major Pathologic Response (MPR) Rate
timeFrame: At time of surgery
Secondary outcomes:
measure: Pathologic Complete Response (pCR) Rate
timeFrame: At time of surgery
measure: Resectability rate
timeFrame: At time of surgery
measure: R0 Resection rate
timeFrame: At time of surgery
measure: Objective Response Rate (ORR)
timeFrame: Prior to surgery
measure: Disease Control Rate (DCR)
timeFrame: Prior to surgery
measure: Event-free survival (EFS)
timeFrame: 3 years postoperatively
measure: Disease-free survival (DFS)
timeFrame: 3 years postoperatively
measure: Overall Survival (OS)
timeFrame: 3 years postoperatively
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
References:
Clinical trial NCT05308277: Leo Study Unstable Asthma
Official title: Engineering Validation of Leo Device to Assess Clinical Control of Children Recovering From Acute Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma in Children
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Engineering validation of a lung function monitoring device
Primary purpose: OTHER

Brief summary: This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.

This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.


Eligibility criteria: Inclusion Criteria:

* Children aged ≥2 years old and \<18 years old at time of consent
* Children with a legal guardian able to sign consent for study participation
* Children and caregivers able to read and understand English or Spanish
* Children who are currently hospitalized with acute exacerbation of asthma
* Child's caregiver is able to communicate using SMS
* Child has an asthma inhaler

Exclusion Criteria:

* Children with complex medical conditions which may hinder their ability to complete protocol assessments
* Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
* Children with any implanted medical devices, E.g. cardiac pacemaker
* Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device

Primary outcomes:
measure: Airway resistance through oscillometry test
timeFrame: Baseline visit and 7 days post hospital/ED discharge
measure: Asthma Flare-up diary
timeFrame: Follow-up for 7 days post hospital/ED discharge
measure: CASI questionnaire
timeFrame: Baseline visit and 7 days post hospital/ED discharge
Secondary outcomes:
measure: Inhaler usage
timeFrame: Follow-up for 7 days post hospital/ED discharge
measure: Tidal breathing from PNT device
timeFrame: 7 days post hospital/ED discharge
Other outcomes:
measure: Frequency and severity of localized skin reaction including redness and irritation / itchiness / discomfort.
timeFrame: 7 days post hospital/ED discharge
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT03847077: Trial of a Patient Education Tool For Leiomyoma
Official title: Randomized Trial of a Patient Education Tool For Leiomyoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Leiomyoma
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.

Detailed description: Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive either standard counseling or multimedia counseling using the drawMD OB/GYN iPad application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and then completed a post-counseling questionnaire.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant
* English speaking
* Women aged 18-60 years
* presence of fibroids confirmed on imaging
* no confirmed or suspicion of malignancy

Exclusion Criteria:

-

Primary outcomes:
measure: Change in patient knowledge scores
timeFrame: Day 1
measure: Patient satisfaction post-counseling
timeFrame: Day 1
measure: Patient anxiety pre-couseling
timeFrame: Day 1
measure: Patient anxiety post-couseling
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04715477: Intensive Care Anxiety in SARS-CoV-2 Patients
Official title: Intensive Care Anxiety in SARS-CoV-2 (COVID 19) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Co-operative patients over 18 years of age, with COVID PCR + admission to intensive care unit, will be included in the study.

Brief summary: It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.


Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* COVID PCR +,
* admitted to intensive care,
* conscious, cooperative patients

Exclusion Criteria:

* Having hearing and speaking problems,
* Can't speak Turkish or English,
* who do not have the cognitive level to understand and answer the questions,
* Communication problems such as dementia and Alzheimer's,
* patients receiving sedation

Primary outcomes:
measure: intensive care Anxiety
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇zmi̇t
country: Turkey
facility: İlke Küpeli
state: Kocaeli̇
Study officials:
affiliation: Derince Training and Research Hospital
name: ilke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.
citation: Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, Zandi MS, Lewis G, David AS. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul;7(7):611-627. doi: 10.1016/S2215-0366(20)30203-0. Epub 2020 May 18.
citation: 3. Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlik Güvenilirlik Çalışması. Türk Psikiyatri Dergisi 1997;8:280-287.
citation: Kupeli I, Kara MY, Yakin I, Caglayan AC. Anxiety and depression in the first 24 h in COVID-19 patients who underwent non-invasive mechanical ventilation in the intensive care unit. Ir J Med Sci. 2022 Oct;191(5):2291-2295. doi: 10.1007/s11845-021-02808-8. Epub 2021 Oct 19.
Clinical trial NCT04438577: Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery
Official title: Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast conserving surgery; fluorescence-guided surgery
Lead sponsor: Shantou Central Hospital
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.


Eligibility criteria: Inclusion Criteria:

* Female at least 18 years old
* Histologically or cytologically confirmed breast carcinoma
* Patients planned to receive a breast-conserving surgery
* Patients received a preoperative breast magnetic resonance imaging
* Informed consent form understood and signed
* Patient agrees to all follow-up visits
* Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery

Exclusion Criteria:

* Psychiatric or other condition that may interfere with the study
* Known allergy or contraindication to any study drug
* Patients received neoadjuvant therapies
* Patients received an excision biopsy of the tumor
* Breast feeding period
* Pregnant (female of childbearing potential only)

Primary outcomes:
measure: Margin width
timeFrame: 7 days
measure: Positive margin rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
Study officials:
affiliation: Shantou Central Hospital
name: Si-Qi Qiu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520477: Watershift - Pilot Study
Official title: Watershift - Pilot Study: Observing the Interindividual Effects and Mechanims of the Uptake, Storage and Excretion of Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Body Water
Nocturnal Polyuria
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this pilot was to study how body water behaves between the different internal water pools of the human body, what the role and influence of the interstitium is and what the effect is of body position on the distribution and allocation of BW between different body parts (trunk, legs, arms). To study this, 2 techniques that have not been used before in urological research were tested on their usefulness:

* The first technique is a recent BIA device, which distinguishes itself from earlier devices by measuring impedance at different electrical currencies in different body parts (arm/limb/trunk). This technique made it possible to observe the influence of body position on the distribution of BW in these body compartments. Rationale for this research question is mainly the link between NP and edema that was found in earlier research and the fact that body position seemed to have an impact on the size of edema. For this reason, it can be suggested that body position and thus edema will have an impact on whether or not NP occurs.
* The second technique uses deuterium as a biological marker. With this technique the distribution, storage, allocation and excretion of BW was examined among the urological most relevant water pools (blood, urine and interstitium).


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Ages between 18 and 30
* BMI between 18 and 24.9

Exclusion Criteria:

* Intake of medications except of OAC
* Patients with pacemaker or neurostimulator

Primary outcomes:
measure: Observing the absorption time, and the lay over time from deuterated water from the gast of deuterated water in the blood
timeFrame: 3 hours
measure: Observing impedance changes linked with position switch
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Department of Urology, Ghent University
Study officials:
References:
Clinical trial NCT02504177: Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 433
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.


Eligibility criteria: Inclusion Criteria:

1. Patients who consent with study
2. Patients with Atrial fibrillation (20-80 years old)
3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
4. Patients possible to NOAC

Exclusion Criteria:

1. Patients who do not agree with study inclusion
2. eGRF \< 30ml/min
3. Impossible to NOAC
4. Structural cardiac disease
5. Major hemorrhagic complication
6. CHA2DS2-VASc score \> 5
7. Patients who have experienced Ischemic cerebellar infarction more than 2times

Primary outcomes:
measure: incidence of major bleeding complications
timeFrame: during 30 days post-AF ablation.
Secondary outcomes:
measure: incidence of thromboembolism
timeFrame: during 30 days post-AF ablation.
measure: incidence of minor bleeding
timeFrame: during 30 days post-AF ablation.
measure: Re-admission rate related procedure
timeFrame: during 30 days post-AF ablation.
measure: length of hospital stay
timeFrame: during 30 days post-AF ablation.
measure: incidence of vascular complications
timeFrame: during 30 days post-AF ablation.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT03928977: Functional Imaging in the Acute Phase of Transient Ischemic Attacks
Official title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Ischemic Attack
Keywords: Transient Ischemic Attack
Stroke
functional Magnetic Resonance Imaging
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.


Eligibility criteria: Inclusion Criteria:

* Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
* Prescription for conventionnal MRI

Exclusion Criteria:

* Contraindication to MRI
* Previous neurological disease (with lesions)
* Severe psychiatric disease

Primary outcomes:
measure: Blood-Oxygen-Level Dependent signal
timeFrame: 24 hours after symptoms onset
Secondary outcomes:
measure: Resting state
timeFrame: 24 hours after symptoms onset
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: