louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04629989: Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19
Official title: The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Hypoxemia
Keywords: Double-Trunk Mask
Surgical Mask
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 27
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: This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).

Detailed description: Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.

Eligibility criteria: Inclusion Criteria:

* COVID-19 positive
* SpO2 between 92 and 96% with low-flow oxygen therapy
* Oxygen output at baseline between 3 and 7 L/min.

Exclusion Criteria:

* Pulmonary disease with hypercapnia
* Confusion
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Primary outcomes:
measure: Changes in PaO2
timeFrame: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Secondary outcomes:
measure: Change in PaCO2
timeFrame: At baseline and 30 minutes after wearing the randomized oxygen delivery system
measure: Change in pH
timeFrame: At baseline and 30 minutes after wearing the randomized oxygen delivery system
measure: Change in respiratory rate
timeFrame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
measure: Change in dyspnea
timeFrame: At baseline and 60 minutes after wearing the randomized oxygen delivery system
measure: Change in O2 output
timeFrame: At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT03976167: Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
Official title: Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
Keywords: Children
Desaturations
Bronchoscopy
Oxygen
High flow oxygen
Lead sponsor: Hospital Son Espases
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 108
Sex: ALL
Minimum age (years): 29
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.


Eligibility criteria: Inclusion Criteria:

* elective flexible bronchoscopy

Exclusion Criteria:

* admitted in Neonatal intensive care
* previous respiratory support: oxygen any device, non invasive or invasive ventilation
* patient who may benefit with continuous positive pressure during procedure

Primary outcomes:
measure: Oxygen desaturation
timeFrame: Trough study completion, an average of 2 years
Secondary outcomes:
measure: Moderate oxygen desaturations
timeFrame: Trough study completion, an average of 2 years
measure: Severe oxygen desaturations
timeFrame: Trough study completion, an average of 2 years
measure: Tachypnea
timeFrame: Trough study completion, an average of 2 years
measure: Apnea
timeFrame: Trough study completion, an average of 2 years
measure: Bradycardia
timeFrame: Trough study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ib-salut
name: Artur sharluyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ib-salud
name: Sebastian Sailer, MD
role: STUDY_DIRECTOR
affiliation: Ib-salud
name: Francisco de Borja Osona Rodriguez, PhD
role: STUDY_CHAIR
References:
citation: Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.
Clinical trial NCT01208467: Prognostic Biomarkers in Patients With Endometrial Cancer
Official title: Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Stage I Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-09-24
Enrollment: 2824
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with endometrial cancer

Brief summary: This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.

OUTLINE: This is a multicenter study.

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Eligibility criteria: Inclusion Criteria:

* Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer

  * Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
  * Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed
* Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
* Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
* Women who consented to allow their specimens and clinical data to be used for future cancer research
* Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR

Primary outcomes:
measure: ATR mutation status
timeFrame: 1 month
measure: Microsatellite instability (MSI)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Israel Zighelboim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825967: Acute Diverticulitis and C-Reactive Protein as a Prognostic Marker
Official title: Predictive Value of C-Reactive Protein in Acute Diverticulitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Diverticulitis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients with Acute Diverticulitis

Brief summary: The management of acute diverticulitis maybe better if we have prognostic markers of evolution.

Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute diverticulitis.

The investigators need to know the values of C-reactive protein to predict evolution of acute diverticulitis.

Detailed description: A prospective observational study. All the patients with TC-diagnosis of acute diverticulitis (AD) had a C-reactive protein (PCR) in the initial blood test.

The investigators will predict evolution of AD with the PCR initial.

Eligibility criteria: Inclusion Criteria:

* Acute Diverticulitis

Exclusion Criteria:

* Other Abdominal Pathologies

Primary outcomes:
measure: C-Reactive Protein
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacion parc tauli
state: Sabadell-Barcelona
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Sabadell/barcelona
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Sabadell/barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: MORA LAURA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03159767: A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis
Official title: Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Axial Spondyloarthritis
Lead sponsor: Western Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2017-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.

Detailed description: One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.

The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).

Eligibility criteria: Inclusion Criteria:

-Confirmed diagnosis of axSpA according to the ASAS criteria

Exclusion Criteria:

* Severe joint or spinal pain at the time of the study
* Severely restricted hip movement
* History of previous vertebral fracture
* History of previous spinal surgery
* Major scoliosis deformity
* Pregnancy

Primary outcomes:
measure: Inter-rater reliability for measurement of lumbar spine range of movement
timeFrame: 2 weeks
Secondary outcomes:
measure: Inter-rater reliability for measurement of lumbar spine rotational range of movement
timeFrame: 2 weeks
measure: Reliability of IMU metrology index non-inferior to reliability of BASMI
timeFrame: 2 weeks
measure: Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI
timeFrame: 2 weeks
measure: Inter-rater reliability for measurement of cervical rotation range of movement
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Londonderry
country: United Kingdom
facility: Department of Rheumatology, Altnagelvin Hospital
state: N.Ireland
Study officials:
affiliation: Western HSCT
name: Philip Gardiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551767: Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
Official title: Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neck Cancer
Lead sponsor: City Clinical Oncology Hospital No 1
Sponsor class: OTHER_GOV
Collaborators: name: Moscow City Oncology Hospital No. 62
name: Moscow Clinical Scientific Center
First posted: 2022-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation.
Primary purpose: TREATMENT

Brief summary: patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.

Detailed description: patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.

Eligibility criteria: Inclusion Criteria:

* Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;
* Tumor is morphlogically confirmed;
* CPS\>1 (22C3 clone);
* ECOG 0-2;
* Age above 18 years;
* Signed Informed consent form.

Exclusion Criteria:

* Cancer of nasopharynx;
* Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
* Stages I or II;
* ECOG\>=3.

Primary outcomes:
measure: complete response rate
timeFrame: through study completion, an average of 3 years
measure: progression-free survival
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: overall survival
timeFrame: through study completion, an average of 3 years
measure: objective response rate
timeFrame: through study completion, an average of 3 years
measure: Organ-preserving treatment rate
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center named after Loginov
city: Moscow
country: Russian Federation
facility: City clinical oncology hospital 1
city: Moscow
country: Russian Federation
facility: Moscow City Oncology Hospital No 62
Study officials:
affiliation: City Clinical Oncology Hospital No 1
name: Vsevolod N Galkin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02817867: Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients
Official title: Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery.

The aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery after stroke.


Eligibility criteria: Inclusion Criteria:

* Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition);
* Ability to reach 60 degrees in the shoulder flexion
* Ability to completely extend the fingers in the affected upper limb;
* Minimal cognitive ability to understand commands;
* No current use of antiepileptic drugs for seizures.

Exclusion Criteria:

* Painful shoulder, adhesive capsulitis or glenohumeral subluxation;
* Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;

Primary outcomes:
measure: Motor Function by means of the Wolf Motor Function Test
timeFrame: change from pre to post (at least 10 days)
Secondary outcomes:
measure: Grip strength via hand dynamometer
timeFrame: change from pre to post (at least 10 days)
measure: Manual Dexterity by means of the Box and Block Test
timeFrame: change from pre to post (at least 10 days)
measure: Quality of Life by means of the Stroke Impact Scale
timeFrame: change from pre to post (at least 10 days)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT02990767: Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester
Official title: Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twin pregnancies were recruited prospectively from women attending their routine first hospital visit in Shanghai First Maternity and Infant Hospital between December 2016 and December 2018.

Brief summary: The aims of this study are to develop algorithms based on a combination of maternal factors, uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.

Detailed description: Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the disease is still unknown but it is likely to be multifactorial.Clinical risk factors traditionally have been used to identify women at high risk of developing preeclampsia,and biophysical factors that may help predict hypertensive disorders of pregnancy.In addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are implied in the pathogenesis of PE and have possible relevance in the diagnosis of the disease.

Eligibility criteria: Inclusion Criteria:

* twins pregnancies delivering a phenotypically normal stillbirth or live birth at or after 24 weeks of gestation.
* twins pregnancies at at 11-14 weeks of gestation

Exclusion Criteria:

* pregnancies with major fetal abnormalities and those ending in termination, miscarriage or fetal death before 24 weeks

Primary outcomes:
measure: Early preeclampsia
timeFrame: 1 year
Secondary outcomes:
measure: Selective intrauterine fetal growth restriction
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03318367: Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy
Official title: A Pilot Study to Determine if the Use of a Virtual Reality Education Module Reduces Anxiety and Increases Comprehension in Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 23
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies a virtual reality education module in reducing anxiety and increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual reality education module may be useful in helping patients understand what they can expect to happen during their radiation treatments and help reduce stress relating to the radiation treatments.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if a virtual reality education module for prostate cancer patients is effective in increasing patient comprehension and decreasing patient anxiety related to radiation treatments.

SECONDARY OBJECTIVES:

I. This pilot study could have implications for a broader patient base undergoing radiation therapy.

Eligibility criteria: Inclusion Criteria:

* English speaking males capable of giving informed consent
* Must be able to read English language
* Receiving pre-treatment cone beam and volumetric modulated arc therapy (VMAT) for prostate cancer on the "A" or "B" treatment machines at the Bodine Center
* Must be able to walk two city blocks
* Must not have any auditory or visual deficits

Exclusion Criteria:

* If inclusion criteria are not met
* Previous radiation therapy treatment
* Employment in radiation oncology

Primary outcomes:
measure: Standard deviation for difference in questionnaire response from pre-education to post-education
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Robert Den, MD
role: PRINCIPAL_INVESTIGATOR
References: