louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04456010: COVID-19 in ART: Perception and Experience
Official title: Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Fertility Issues
ART
Keywords: fertility
risk perception
emotional experience
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile couple (male and female) who had a fertility treatment prescribed during the past 9 months (prescription after October 1st, 2019) in the fertility department of Montpellier Hospital

Brief summary: Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.

This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .


Eligibility criteria: Inclusion criteria:

- Men and women who had a fertility treatment prescribed during the past 9 months in our Fertility department

Exclusion criteria:

* Patient attending for a fertility preservation
* Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)
* Patient not fluent in French

Primary outcomes:
measure: Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation
timeFrame: 1 day
Secondary outcomes:
measure: Risk assessment
timeFrame: 1 day
measure: Patients'expectations regarding the management of an abrupt closure of the fertility center
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Noémie Ranisavljevic, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00731510: MEDEX Hidden Valley 2008
Official title: MEDEX Hidden Valley 2008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: Acute mountain sickness
Body composition,Hypoxia
Carbohydrate supplementation
Expedition,
Hydration,
Hypoxia
Performance
Lead sponsor: Medical Expeditions Ltd
Sponsor class: OTHER
Collaborators: name: Bangor University
name: Science in Sport
name: Plans Branch of Headquarters Army Recruiting and Training Division
First posted: 2008-08-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: During a multi-week expedition to the Himalaya, we aim to investigate i) whether dietary supplementation with carbohydrate drinks and gels can improve physical performance; and ii) the underlying mechanisms for any observed changes in performance.

We hypothesise that i) carbohydrate supplementation will improve physical performance; and ii) the underlying mechanism of this improvement in performance will include maintenance of body glycogen (sugar) stores, prevention of dehydration and decrease in the incidence of acute mountain sickness.


Eligibility criteria: Inclusion Criteria:

* a healthy enthusiasm for the outdoors and/or a passion for research in remote and difficult circumstances

Exclusion Criteria:

* Persons with Phenylketonuria

Primary outcomes:
measure: Performance (time to complete a physical performance task)
timeFrame: Mid study
Secondary outcomes:
measure: Body composition
timeFrame: Pre, mid and post study
measure: Hydration status
timeFrame: Pre, mid and post study
measure: Body glucose stores
timeFrame: Pre, mid and post study
measure: Oxygen delivery
timeFrame: Pre, mid and post study
measure: Acute mountain sickness
timeFrame: Every day
measure: Spontaneous physical activity level
timeFrame: Pre, mid and post study
measure: Rating of perceived exertion during a stepping task
timeFrame: Pre, mid and post study
Other outcomes:
Locations:
city: Pinfold, Hyssington, Montgomery
country: United Kingdom
facility: Medical Expeditions Ltd
state: Powys
Study officials:
affiliation: Bangor University
name: Jamie H Macdonald, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangor University
name: Samuel J Oliver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macdonald JH, Oliver SJ, Hillyer K, Sanders S, Smith Z, Williams C, Yates D, Ginnever H, Scanlon E, Roberts E, Murphy D, Lawley J, Chichester E. Body composition at high altitude: a randomized placebo-controlled trial of dietary carbohydrate supplementation. Am J Clin Nutr. 2009 Nov;90(5):1193-202. doi: 10.3945/ajcn.2009.28075. Epub 2009 Sep 30.
Clinical trial NCT03869710: Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain
Official title: Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain by Active and Latent Myofascial Trigger Points.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neck Pain
Head Pain
Keywords: Pain
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain.

Detailed description: The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain by myofascial active and latent trigger point.

The myofascial pain control will be assessed for the superficial and deep posterolateral muscle complex of neck. The analgesic request, Range Of Motion (ROM), Motion Related Pain (MRP) and the quality of life, will be also assessed.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain
* Chronic head pain

Exclusion Criteria:

* previous surgery of neck and head
* Body Mass Index \> 39,99
* politrauma patients
* pregnancy
* neck and head infections

Primary outcomes:
measure: Trigger Point
timeFrame: The first hour of the treatment
Secondary outcomes:
measure: Analgesic request
timeFrame: 3 months trom treatment
measure: Karnofsky Performance Status
timeFrame: 3 months from treatment
measure: Range Of Motion (ROM)
timeFrame: 3 months after treatment
measure: Motion Related Pain
timeFrame: 3 months after treatment
measure: Perception
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Coppito
country: Italy
facility: San Salvatore Academic Hospital
state: L'Aquila
Study officials:
affiliation: San Salvatore Academic Hospital
name: Pierfrancesco Fusco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04992910: Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke
Official title: Study of the Effectiveness of Functional Electrical Stimulation Through the "Fesia Grasp" Device in the Rehabilitative Treatment of Patients With Affected Upper Limbs After a Stroke.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: Stroke
Upper Extremity Paresis
Functional Electrical Stimulation
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: FESIA Technology
First posted: 2021-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Fesia Grasp, a Functional Electrical Stimulation device for the rehabilitation of upper limb in post-stroke patients. Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.

* Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation)
* Control group - patients will receive standard care.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
* Unilateral paresis
* Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment

Exclusion Criteria:

* Very severe proximal spasticity: Ashworth \> 3.
* Psychiatric illness (including post-stroke depression).
* Cognitive impairment.
* Inability to provide informed consent.
* Other severe medical problems.
* Severe hemi-spatial neglect or anosognosia involving the affected arm.
* Pacemakers
* Pregnant women.
* Skin ulcers.
* Peripheral neuropathies.
* Edema of the affected forearm and / or hand.
* Severe pain.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA) scale
timeFrame: Change from Baseline FMA scale at 6 weeks and 3 months
Secondary outcomes:
measure: Medical Research Council (MRC)
timeFrame: Baseline; 6 weeks; 3 months
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline; 6 weeks; 3 months
measure: Box & Blocks Test
timeFrame: Baseline; 6 weeks; 3 months
measure: Motor Activity Log (MAL)
timeFrame: Baseline; 6 weeks; 3 months
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: 6 weeks
measure: Euroqol-5d
timeFrame: 6 weeks; 3 months
measure: Usability questionnaire specifically designed for this study
timeFrame: 6 weeks
measure: Adverse events
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Fernando Mayordomo Riera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661710: Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction
Official title: Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Adherence, Medication
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after acute myocardial infarction requiring dual platelet inhibition

Brief summary: The aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction
* Willingness to participate

Exclusion Criteria:

* Inclusion in an interventional study interfering with standard of care medication

Primary outcomes:
measure: Cardiovascular Event
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT06153810: Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
Official title: Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Bruxism
Lead sponsor: Aesyra SA
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years, in good general health.
* Presence of at least one of the following:

  * sleeping partner's report of tooth grinding sounds during sleep for at least three nights per week within the last 6 months,
  * hypertrophy of the masseter muscle upon digital palpation.
* Presence of at least one of the following:

  * signs of tooth attrition or shiny spots on dental restorations,
  * self-report of masticatory muscle fatigue or pain at awakening.
* Previous prescription of a night splint for bruxism.
* Able to understand and follow the protocol and complete the self-administered paper questionnaires.
* Able to provide written informed consent to study participation and storage and processing of study data

Exclusion Criteria:

* Allergic to Ethylene-Vinyl Acetate (EVA) copolymer.
* With more than two missing molars (excluding third molars).
* Ongoing orthodontic treatment (e.g. teeth alignment).
* With major neurological or psychiatric disorders including substance dependence.
* Using a removable dental prosthesis.
* Using a medication with known effects on sleep or motor behavior.
* Suffering from periodontal disease.
* With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint.
* Participants with pacemakers.

Primary outcomes:
measure: Reduction of the bruxism activity
timeFrame: 1 month
Secondary outcomes:
measure: Reduction of the bruxism index
timeFrame: 1 month
measure: Reduction of the mean duration of sleep bruxism episode
timeFrame: 1 month
measure: Relative change in average intensity of bruxism episodes
timeFrame: 1 month
measure: Change in self-reported sleep quality marked on a visual analogue scale
timeFrame: 1 month
measure: Change in self-reported pain marked on a visual analogue scale
timeFrame: 1 month
measure: Change in self-reported comfort marked on a visual analogue scale
timeFrame: 1 month
measure: Change in self-reported retention marked on a visual analogue scale
timeFrame: 1 month
measure: Change in self-reported ease of breathing marked on a visual analogue scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione Irccs San Gerardo Dei Tintori
state: Monza E Brianza
Study officials:
affiliation: Fondazione IRCCS San Gerardo dei Tintori
name: Marcello Maddalone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713010: Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury
Official title: Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Weaning Failure
Mechanical Ventilation Complication
Keywords: Keywords provided by Atlantic Health System:
Rapid Shallow Breathing Index
Mechanical Ventilation
Additional relevant MeSH terms:
Respiration Disorders
Traumatic Brain Injury
Weaning Failure
Mechanical ventilation complication
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit with brain trauma in the process of weaning from mechanical ventilation.

Brief summary: The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.

Detailed description: The aim of this study is to evaluate the effectiveness of integrated pressure index of airway occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure of weaning from mechanical ventilation in patients with traumatic brain injury.

Eligibility criteria: Inclusion Criteria:

* Traumatic Brain Injury (TBI)
* Patients using artificial airway (intubation and / or tracheostomy)
* Recovery from the acute phase of the disease underlying
* Both sexes
* Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a tidal volume (VT) = 6 to 8 ml / kg
* Age over 18 years
* Hemoglobin \> 7 g/dL
* Duration of mechanical ventilation longer than 24 hours
* Body temperature \< 38 degrees
* pH ≥ 7.30
* PaO2 ≥ 60 mmHg with FiO2 ≤ 0.4 and PEEP ≤ 8 cmH2O
* Glasgow Coma Scale ≥ 8 or tracheostomized
* Sedative agents minimum dosages to to maintain values of 2 or 3 on the Ramsay Scale

Exclusion Criteria:

* Admitted to the ICU with artificial airways held in other institutions
* Surgery scheduled for the next 72 hours
* Withdrawal of consent from parents at any stage of the research

Primary outcomes:
measure: Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Camila Marques Dias
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Uberlandia
name: Célia Regina Lopes
role: STUDY_CHAIR
References:
Clinical trial NCT04097210: Decision-making - the Benefit of Bedside CRP Within Ambulance Care
Official title: When Triage is Insufficient - the Benefit of Bedside CRP Within Ambulance Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Q-CRP
lactate
suPAR
POC
ambulance
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 104
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degreased condition (DGC) over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Brief summary: Patients with degreased (DGC) for ambiguous reasons receive low triage priority. Their death risk is triple. Tools are needed to identify the critically ill patients from this group. The triage used today is not effective. The bedside point-of-care measurements are CRP, lactate acid and suPAR (Soluble Urokinase Plasminogen Activator Receptor). Elevated values associate with the probability of critical illness and predict a risk of death.

Detailed description: Purpose: To improve identification and proper prioritization of patients with non-specific symptoms prehospitally, we intend to investigate whether Q-CRP, a rapid test for CRP, correlates with time-critical states in the above-mentioned patient group alone or together with CRP, lactate and suPAR. The primary endpoint is need for hospital care.

Material: Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Method: In patients with unspecified conditions, defined according to the inclusion template, a venous blood sample was taken prehospitally at the scene by the EMS.

Analysis: Significance tests and regression analyzes with 95% CI were used. The diagnostic accuracy of Q-CRP, lactate, suPAR and combinations thereof were compared with optimal boundary values.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Exclusion Criteria:

* Abnormal vitals

Primary outcomes:
measure: Number of patients with high suPAR level
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Maaret Castrén, Professor
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Johanna Kaartinen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424210: The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
Official title: The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Metastatic Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 163
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolled a cohort of patients diagnosed with stage IV esophageal cancer who had tumor metastasis to distant organs, including lymph node metastasis detected in the retroperitoneum, which could not be eradicated by surgery, from April 2002 to June 2021 in a tertiary medical center.

Brief summary: Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. We sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients.

A retrospective review of esophageal cancer patients with M1 disease treated at National Taiwan University Hospital was performed from April 2002 to June 2021. Patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. Univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. Propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.


Eligibility criteria: Inclusion Criteria:

* Stage IV Esophageal Cancer patients
* Patients were treated with chemoradiation therapy (CCRT)

Exclusion Criteria:

* Not Stage IV Esophageal Cancer patients
* Patients were not treated with chemoradiation therapy (CCRT)

Primary outcomes:
measure: Overall survival and progression-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
Study officials:
affiliation: National Taiwan University Hospital
name: Jang-Ming Lee
role: PRINCIPAL_INVESTIGATOR
References: