louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886548: Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit
Official title: Echocardiographic Examination Performed by Nurses in Cardiac Intensive Care Unit. Is it Clinical Useful?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Myocardial Infarction
Pleural Effusion
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at Cardiac Intensive Care Unit at Levanger Hospital

Brief summary: The purpose of this study is:

* To study the clinical usefulness of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
* To study reproducibility of nurse-performed ultrasound and echocardiographic examinations in a cardiac intensive care unit.
* To study which ultrasound measure that best correlate with the amount of pleural effusion.

Detailed description: For a period of 1 year patients in our cardiac intensive care unit will be recruited to nurse-drive ultrasound and echocardiographic examinations, after informed consent. Nurses underwent a training programme and their skills are approved by cardiologist. Our department does not always have a cardiologist on duty and indication for nurse-driven ultrasound examination is decided by the doctor responsible for the treatment, who not always are trained in echocardiography/ultrasound. We aim to study the described hypothesis.

Eligibility criteria: Inclusion Criteria:

* Patient at Cardiac intensive care unit, Levanger Hospital
* Doctor responsible for treatment finds echocardiographic/ultrasound examination indicated.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change of diagnosis
timeFrame: 6-12 months
Secondary outcomes:
measure: Change of treatment
timeFrame: 6-12 months
measure: Quantification of pleural effusion
timeFrame: 6-12 months
measure: Reproducibility of nurse-performed examinations
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Medicine, Hospital of Levanger
Study officials:
affiliation: Levanger Hospital, Nord-Trøndelag Health Trust
name: Håvard Dalen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06363448: Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia
Official title: Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia, Postcataract
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique.

Detailed description: Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.

The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.

All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.

Aim of

Eligibility criteria: Inclusion Criteria:

* patients aged 40 years
* aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).

Exclusion Criteria:

* Corneal decompensation.
* Jeopardized specular microscopy
* retinal or choroidal detachment
* retained Intraocular foreign body
* uveitis, Scleromalacia
* Reubeosis irides
* previous anti-glaucoma surgery.

Primary outcomes:
measure: Best corrected visual acuity (BCVA) in LogMAR
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ophthalmology department, Sohag University
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
affiliation: Assistant professor of ophthalmology, Sohag University
name: Elshimaa A.Mateen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06503848: Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I
Official title: Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (The MAMBO Study) Phase I
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine Disorders
Keywords: migraine
triptan
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2024-07-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Otherwise healthy episodic migraine patients.

Brief summary: The goal of this observational study is to identify differential traits in spontaneous migraine attacks that can help us predict the response to treatment with sumatriptan.

Participants will be asked to register the headache characteristics before and after taking sumatriptan and whether the treatment was effective or not during four migraine attacks.

Detailed description: There is still an unmet need in acute migraine treatment, some patients don't respond properly to acute medication.

There are some interindividual differences in clinical characteristics of migraine attacks. These differences may determine the response to acute treatment. Describing the phenotypical differences between patients who are responders and patients non-responders will allow us to offer a personalized treatment.

The aim of the study is to determine which characteristics are associated with a response or a non-response to acute treatment with sumatriptan.

Participants will be asked to register the headache characteristics and accompanying symptoms during 4 spontaneous migraine attacks and its response to treatment with sumatriptan.

Eligibility criteria: Inclusion Criteria:

* Migraine with or without aura diagnosis according to ICHD-3 criteria
* \<8 migraine days per month
* Be able to read, write and understand instructions.
* Have internet access and mail address
* Signing of the informed consent

Exclusion Criteria:

* Active preventive treatment for migraine
* Active medication with an effect over the central nervous system
* Serious physical or psychiatric condition
* Cardiovascular or hepatic disease
* Pregnant or breastfeeding women
* Any triptan contraindication
* Severe migraine attacks without previous response to triptans or NSAIDs

Primary outcomes:
measure: Response to sumatriptan
timeFrame: 24 hours
Secondary outcomes:
measure: Migraine characteristics
timeFrame: 24 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron, Headache & Neurological Pain Research Group
name: Marta Torres-Ferrús, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107248: Supine Sleeping After Total Hip Replacement
Official title: The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Hip Dislocation
Keywords: Arthroplasty
Replacement
Hip
Posterolateral surgery
Precautions
Lead sponsor: Orthopedisch Centrum Oost Nederland
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 456
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the current study is to test the non-inferiority hypothesis of differences in early hip dislocation between a group of patients who will be restricted to sleep in supine position and a group without restricted sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach

Detailed description: stratified block randomized controlled trial

Eligibility criteria: Inclusion Criteria:

* Placement of a primary total hip replacement via the posterolateral approach by a high volume orthopaedic surgeon
* Patients with a ASA-classification of I or II

Exclusion Criteria:

* Blindness
* Replacement of 2nd total hip within six months after the1st total hip replacement surgery
* Insufficient knowledge of the Dutch language
* Collum fracture
* Infection of total hip replacement
* Cognitive dysfunction
* Wheelchair dependability
* Hypermobility
* Alcohol abuse
* Neurological disorders such as Parkinson and stroke

Primary outcomes:
measure: Percentage early hip dislocations
timeFrame: in first eight weeks after THP
Secondary outcomes:
measure: HOOS
timeFrame: eight weeks and six months post-operative
measure: VHS
timeFrame: eight weeks and six months post-operative
measure: EQ-5D
timeFrame: eight weeks and six months post-operative
measure: VAS/NRS hip
timeFrame: eight weeks and six months post-operative
measure: Compliance anti-dislocation instructions
timeFrame: eight weeks post-operative
Other outcomes:
measure: Sleeping position preference
timeFrame: baseline
Locations:
city: Hengelo
country: Netherlands
facility: Orthopedisch Centrum Oost Nederland
state: Overijssel
Study officials:
affiliation: Orthopedisch Centrum Oost Nederland
name: Anil Peters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters A, Manning F, Tijink M, Vollenbroek-Hutten M, Huis In 't Veld R. Patient compliance with postoperative precautions in an unrestricted and a supine sleeping position following posterolateral total hip arthroplasty: a randomized controlled trial. Disabil Rehabil. 2022 Dec;44(26):8303-8310. doi: 10.1080/09638288.2021.2012606. Epub 2021 Dec 21.
citation: Peters A, Tijink M, Veldhuijzen A, Huis in 't Veld R. Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial. Trials. 2015 Aug 18;16:360. doi: 10.1186/s13063-015-0901-0.
Clinical trial NCT04373148: Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19
Official title: Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Keywords: Immunity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Cancer Institute (NCI)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2020-05-04
Enrollment: 316
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years and older) and children diagnosed and not diagnosed (controls) with COVID-19

Brief summary: The purpose of this study is to test over time immunity to SARS-CoV-2, a recently identified coronavirus responsible for the 2019 world-wide pneumonia outbreak known as COVID-19. Adults and children diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older) and children with confirmed COVID-19 (RT-PCR diagnosis).
* Adults (18 years and older) and children without COVID-19 for controls (who test negative for COVID-19 but may have viral symptoms)

Exclusion Criteria:

* Patients with special risks attendant to venipuncture will be excluded.

Primary outcomes:
measure: Testing Immunity to SARS-CoV-2 over time
timeFrame: 1 year
Secondary outcomes:
measure: Testing the virus over time
timeFrame: 1 year
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Stanford Health Care - ValleyCare
state: California
city: Stanford
country: United States
facility: Stanford University, Hospital, and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kari Nadeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jia X, Cao S, Lee AS, Manohar M, Sindher SB, Ahuja N, Artandi M, Blish CA, Blomkalns AL, Chang I, Collins WJ, Desai M, Din HN, Do E, Fernandes A, Geng LN, Rosenberg-Hasson Y, Mahoney MR, Glascock AL, Chan LY, Fong SY; CLIAHUB Consortium; Chan Zuckerberg Biohub; Phelps M, Raeber O; Stanford COVID-19 Biobank Study Group; Purington N, Roltgen K, Rogers AJ, Snow T, Wang TT, Solis D, Vaughan L, Verghese M, Maecker H, Wittman R, Puri R, Kistler A, Yang S, Boyd SD, Pinsky BA, Chinthrajah S, Nadeau KC. Anti-nucleocapsid antibody levels and pulmonary comorbid conditions are linked to post-COVID-19 syndrome. JCI Insight. 2022 Jul 8;7(13):e156713. doi: 10.1172/jci.insight.156713.
Clinical trial NCT06834048: Albanian Berg Balance Scale
Official title: Validity - Reliability of Berg Balance Scale in Albanian Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Balance Assessment
Balance Control in Elderly
Balance Changes
Geriatric Assessment
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: geriatric people with postural compensations

Brief summary: Cross-cultural adaptation, validity and Reliability of Berg Balance Scale in Albanian population

Detailed description: The cross-cultural adaptation will be carried out in accordance with the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.

Eligibility criteria: Inclusion Criteria:

* Postural pain
* muscular contractions

Exclusion Criteria:

* mixed fractures
* trauma
* luxation
* tumor

Primary outcomes:
measure: Albanian Berg Balance Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00900848: Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock
Official title: Traumatic Disruption of Iliofemoral Arterial Segment is Often Associated With Multiple Injuries, Massive Hemorrhage, State of Shock, and Loss of Blood Supply to the Ipsilateral Lower Extremity, as Well as With High Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iliofemoral Artery Injury
Shock
Keywords: Posterior tibial artery bypass
Iliofemoral artery injury
Shock
Reconstruction
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 8 patients

Brief summary: Traumatic disruption of iliofemoral arterial segment is often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral lower extremity, as well as with high mortality.

The investigators describe a bypass technique. It can provide adequate blood supply to the lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a low risk procedure for salvage of the extremity and even patient's life.

Detailed description: Patients were selected on the basis of the following: (1) closed injuries to the lower abdomen and/or pelvis; (2) serious hemorrhagic shock; (3) loss of blood supply to the ipsilateral lower extremity; (4) high-risk emergency artery reconstruction.

The instruments used to measure sensibility of the foot were the Semmes-Weinstein (SW) monofilament test 24 and the static two-point discrimination (2PD) test 25. The weight-bearing area of the first metatarsal head and the dorsum of the first metatarsal head were assessed. Active range of motion (ROM) of the hip, knee, and ankle joints was measured with a goniometer. The muscle strength was test using Medical Research Council (MRC) Scale. The cold intolerance of the leg was measured using the self-administered Cold Intolerance Severity Score (CISS) questionnaire 26. The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100) corresponding to mild, moderate, severe, and extreme severity, respectively.

Eligibility criteria: Inclusion Criteria:

1. closed injuries to the lower abdomen and/or pelvis;
2. serious hemorrhagic shock;
3. loss of blood supply to the ipsilateral lower extremity;
4. high-risk emergency artery reconstruction.

Exclusion Criteria:

1. bleeding can be easily control through an open wound;
2. mild shock without life threatening conditions;
3. good blood supply to the ipsilateral lower extremity;
4. low-risk emergency artery reconstruction.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Qinhuangdao
name: Xu Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04889248: Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
Official title: Inspiratory Muscle Training in Respiratory Capacity, Heart Rate Variability, Life Quality and Emotional State in Patients With Amyotrophic Lateral Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Maximum Inspiratory Pressure
Diaphragm
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Abstract:

Context/background: people affected by Amyotrophic Lateral Sclerosis (ALS) see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.

Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, heart rate variability (HRV), quality of life and mood in patients with ALS.

Methods: 20 volunteer patients, male and female, with ALS, bulbar or spinal will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 10) and a control group (n = 10). The Maximum Inspiratory Pressure (PIM), the HRV, the quality of life and mood will be measured. The participants of experimental group will conduct 30 inspirations per day, 15 in the morning and 15 in the evening, 5 days per week, through 8 weeks. The resistance of the training in the experimental group will be increase acording to the PIM measured at the first visit. During the first week, the resistance will be at 30% of PImax, weeks 2 and 3 at 40%, weeks 4 and 5 at 50% and the last 3 weeks at 60%. After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.


Eligibility criteria: Inclusion Criteria:

- Subjects with ALS

Exclusion Criteria:

* PImax more than 30mmH2O
* Score higher than 2 in GDS Reisberg scale
* Using already respiratory devices during the day (except night CPAPs support) more than 14h/day.
* Unstable medical disease for the last 3 years.
* Use of IMT contraindicated for medical reasons.

Primary outcomes:
measure: PImax
timeFrame: 8 weeks
Secondary outcomes:
measure: HRV
timeFrame: 8 weeks
measure: HR
timeFrame: 8 weeks
measure: ALSAQ-40
timeFrame: 8 weeks
measure: ALSFRS-R
timeFrame: 8 weeks
measure: Beck scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Davinia Vicente Campos, PhD
role: PRINCIPAL_INVESTIGATOR
References: