louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02901522: Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Telemedicine in Asthma
Official title: Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: telemedicine
asthma control test
Primary Health care
spirometry
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Prefeitura Municipal de Porto Alegre
name: Ministry of Health, Brazil
First posted: 2016-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with asthma.

Detailed description: This study is a randomized clinical trial for patients with asthma from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of asthma symptoms.

Eligibility criteria: Inclusion Criteria:

* individual with diagnosis asthma, Asthma Control Test \<20, spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster)

Exclusion Criteria:

-low quality spirometries (inadequate)

Primary outcomes:
measure: Symptoms control
timeFrame: 20 to 22 weeks
Secondary outcomes:
measure: Spirometry FVC
timeFrame: 20 to 22 weeks
measure: Spirometry FEV1
timeFrame: 20 to 22 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: TelessaudeRS-Universidade Federal do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Erno Harzheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239122: Recovery Therapy Trial
Official title: Applicability of CBT to Unselected Mental Health Service Clients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychotic Disorders
Mood Disorders
Keywords: Cognitive Therapy
Psychotic Disorders
Treatment Outcome
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: William Buckland Foundation
First posted: 2005-10-14
Enrollment: 94
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.


Eligibility criteria: Inclusion Criteria:

* acceptance by the participating Community Mental Health Services for case management
* a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder
* a recovery "need" in one of the areas addressed by the therapy

Exclusion Criteria:

* a preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, PTSD) even where psychotic features are/have been present
* non-English speaking
* comorbid intellectual disability

Primary outcomes:
measure: To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services
Secondary outcomes:
measure: To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service
measure: To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions)
measure: To identify factors predicting uptake and effectiveness
Other outcomes:
Locations:
city: Epping
country: Australia
facility: Whittlesea Community Mental Health Service
state: Victoria
city: Preston
country: Australia
facility: Darebin Community Mental Health Service
state: Victoria
Study officials:
affiliation: LaTrobe University, NorthWestern Mental Health
name: John Farhall, BA(Hons), MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197222: Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Official title: Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Abdominal Surgery
Keywords: Laparoscopic
EndoClear
Lens Cleaning Device
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

Detailed description: The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.

Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.

Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Patients undergoing laparoscopic abdominal surgery

Exclusion Criteria:

1. Patients with known coagulopathy or bleeding tendencies
2. Intra-abdominal abscesses
3. Pregnancy
4. Non-elective laparoscopic surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Good Samaritan
state: Oregon
Study officials:
affiliation: The Oregon Clinic
name: Lee L Swanstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456222: Impact of Sleep Disruption on the Menstrual Cycle
Official title: Impact of Sleep Disruption on the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Circadian Rhythm
Menstrual Cycle
Keywords: Sleep
Circadian rhythms
Menstrual cycle
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-04-04
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women with regular menstrual cycles

Brief summary: The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing

Detailed description: Menstrual cycle dynamics were studied after sleep disruption

Eligibility criteria: Inclusion Criteria:

* Healthy
* Regular menstrual cycles

Exclusion Criteria:

* No medications affecting the menstrual cycle or sleep

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Janet E Hall, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05015322: Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
Official title: Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Impingement
Ultrasound Guided Injection
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized controlled, single blind
Primary purpose: TREATMENT

Brief summary: Shoulder pain, which is the third most common cause of musculoskeletal pain, has different etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders, tendinitis and tears, is one of the most common pathologies of shoulder pain.

Detailed description: The hypothesis of this study was that injection types including ACJ would increase treatment efficacy.Therefore, this study investigated the six-month follow-up results of patients undergoing SA injection and SSNB and those receiving SA and ACJ injection.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-65,
* who were suffering from shoulder pain for more than three months and
* who were diagnosed with IS.
* All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.

Exclusion Criteria:

* the presence of cervical radiculopathy;
* undergoing shoulder operation before;
* the presence of central nervous system or
* the presence of rheumatological disease, and polyneuropathy;
* receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
* receiving any injection therapy in the past.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: six month
Secondary outcomes:
measure: Shoulder pain and disability index (SPADI)
timeFrame: six month
measure: Short-Form 12 (SF-12)
timeFrame: six month
Other outcomes:
Locations:
Study officials:
affiliation: University of Health Sciences, Yuksek Ihtisas Training and Research Hospital
name: Burcu Metin Ökmen, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün M Ökmen, Assoc. Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05496322: Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
Official title: Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure Determination
Hemodynamic Monitoring
Postoperative Complications
Keywords: Volume clamp
Continuous non invasive blood pressure monitoring
Lead sponsor: University of Messina
Sponsor class: OTHER
Collaborators: name: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
First posted: 2022-08-11
Enrollment: 1265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question


Eligibility criteria: Inclusion Criteria:

* All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
* Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.

Exclusion Criteria:

* Missing of preoperative serum creatinine during 30 days prior surgery
* Preoperative dialysis
* Chronic kidney disease (eGFR \< 60ml/min Cockcroft-Gault equation)
* Surgical procedure lasting less than 60 min
* Planned use of permissive hypotension
* Urological procedures (including nephrectomy and renal transplantation)
* Refusal to give informed consent

Primary outcomes:
measure: Post operative myocardial injury
timeFrame: 1 week
Secondary outcomes:
measure: Post operative Acute kidney injury
timeFrame: 1 week
measure: Post operative death
timeFrame: 28 day after surgery
measure: Events 30d post surgery
timeFrame: 30 days after surgery
measure: Events 90d post surgery
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Messina
country: Italy
facility: A.O.U. G.Martino - University of Messina
Study officials:
References:
Clinical trial NCT04833322: Galactose Supplementation for the Treatment of MOGHE
Official title: Galactose Supplementation for the Treatment of Patients With Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE): a Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Epilepsy
SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
Lead sponsor: Hospital Ruber Internacional
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 8
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-and-after pilot clinical trial with a single group
Primary purpose: TREATMENT

Brief summary: Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.


Eligibility criteria: Inclusion Criteria:

* MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue.
* Epilepsy refractoriness or ongoing epileptiform activity at EEG.

Exclusion Criteria:

* Allergy to galactose or supplement components.

Primary outcomes:
measure: Seizure frequency
timeFrame: 6 months
measure: Epileptiform activity at EEG
timeFrame: 6 months
Secondary outcomes:
measure: Behavioral assessment
timeFrame: 6 months
measure: Cognitive assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
state: Madrid, Comunidad De
Study officials:
affiliation: Hospital Ruber Internacional
name: Angel Aledo-Serrano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05618522: Omnigen in Acute Chemical Eye Injuries
Official title: Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Chemical Eye Injuries
Keywords: amniotic membrane
chemical eye injury
Lead sponsor: Farwaniya Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective
Primary purpose: TREATMENT

Brief summary: evaluation of the role of Omnigen in acute chemical eye injuries

Detailed description: prospective interventional study included patients with different degrees of acute chemical eye injuries were treated by Omnigen and followed up for one month

Eligibility criteria: Inclusion Criteria:

* acute chemical eye injury

Exclusion Criteria:

* absent or shallow fornices
* symblepharon interfering with lens placement

Primary outcomes:
measure: Epithelial healing
timeFrame: 1 week
measure: limbal ischaemia
timeFrame: 1 week
Secondary outcomes:
measure: omnigen tolerability
timeFrame: 1 week
Other outcomes:
Locations:
city: Al Farwānīyah
country: Kuwait
facility: Farwanyia Hospital
state: Farwanyia
Study officials:
References:
Clinical trial NCT02047422: A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart failure, diuretics, kidney, glomerular filtration rate
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients


Eligibility criteria: Inclusion Criteria:

1. dyspnea at rest or minimal activity
2. tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

1. hospitalization for acute heart failure decompensation
2. cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
4. serum creatine level \> 2.5mg/dl
5. serum potassium (K+) \> 5.5mg/dl
6. Age \> 80 years old or poor compliance patients
7. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
8. life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
9. pregnancy or women at age of childbearing potential

Primary outcomes:
measure: urine output change
timeFrame: from admission to Hospital Day (HOD)#4
Secondary outcomes:
measure: serum creatinine change
timeFrame: from admission to HOD#4
Other outcomes:
measure: body weight change
timeFrame: from admission to HOD#4
measure: urine creatinine change
timeFrame: from admission to HOD#4
measure: clinical outcomes
timeFrame: at 90 days after discharge
Locations:
Study officials:
References:
Clinical trial NCT05036122: Estimating Blood [Lactate] Non-Invasively
Official title: Validation of a Non-Invasive Instrument to Estimate Blood Lactate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: High intensity exercise
Stress Testing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].


Eligibility criteria: Inclusion Criteria - Aim 1:

* Subjects must be able to provide written consent.
* Adults 18 years of age and older.
* Nonsmokers.
* No recent hospitalization (\< 60 days).
* Ability to perform high-intensity exercise.

Inclusion Criteria - Aim 2:

* Subjects must be able to provide written consent to be included in the research study.
* Adults 18 years of age and older.
* Nonsmokers.
* Current ICU patient.
* Have regular blood samples taken for \[lactate\] measurements.
* Have one or more risk factors for sepsis.

Exclusion Criteria - Aims 1 and 2:

* History of, or active malignancy.
* History of HIV with antiretroviral treatment.
* Smokers.
* Pregnancy.

Primary outcomes:
measure: Blood [lactate] during incremental exercise
timeFrame: 1 day
measure: Blood [lactate] measurements in ICU patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213122: Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: alpha-glucosidase inhibitor,Insulin
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin.


Eligibility criteria: Inclusion Criteria:

* type2 diabetes
* postprandial plasma glucose levels ≧180mg/dl

Exclusion Criteria:

* type1 diabetes
* AST(GOT) or ALT(GPT) ≧100IU/l
* creatinine ≧2.0mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ibaraki
country: Japan
Study officials:
affiliation: Sanwa Kagaku Kenkyusho Co., Ltd.
name: Clinical Promotiom Group
role: STUDY_DIRECTOR
References: