louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02439853: Communication Bridge Speech Therapy Research Study
Official title: Communication Bridge Speech Therapy Research Study: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Frontotemporal Dementia
Keywords: primary progressive aphasia
progressive nonfluent aphasia
progressive aphasia
frontotemporal dementia
frontotemporal lobar degeneration
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: The Association for Frontotemporal Degeneration
name: Illinois Department of Public Health
name: National Institutes of Health (NIH)
First posted: 2015-05-12
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study on Internet-based video-practice speech and language therapy for persons with primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or related conditions.

Detailed description: The purpose of this study is:

1. To evaluate the effectiveness of speech and language therapy on a person's ability to communicate immediately after treatment, 6-months after treatment, and 12-months after treatment.
2. To identify the most effective speech and language therapy strategies for persons with these conditions.
3. To determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions.

The study will involve 12 to 15 session over the course of 12 months. Some of these sessions will be in-person at the Northwestern Cognitive Neurology and Alzheimer's Disease Center (Chicago, IL), while others will take place over the Internet, using an online study portal.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia with language as a primary symptom (i.e. aphasia)
* An informant who knows the participant well and can answer questions the participant's communication ability
* Adequate hearing to follow conversation (correction permitted)
* Adequate vision (correction permitted)

Primary outcomes:
measure: Assessment of Functional Communication Abilities
timeFrame: Change from baseline assessment at 2-months, 6-months and 12-months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emily J Rogalski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217853: 24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry
Official title: Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: Schlossparkklinik
First posted: 2010-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.

Brief summary: A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent for the investigation
* Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio \> 0,5)
* Age 40-70 years at inclusion
* Not more than 4 diopters spherical equivalent on the study eye
* Not more than 2 diopters cylinder equivalent on the study eye
* For women of childbearing potential, adequate contraception
* Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation

Exclusion Criteria:

* Patients not able to understand the character and individual consequences of the investigation
* Patients committed to an institution by virtue of an order issued either by the courts or by an authority
* Absence of or withdrawn informed consent
* Patients with contraindications for silicone contact lens wear
* Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
* Eye disorders including severe dry eye
* Eye disorders secondary to POAG
* Patient who have had ocular surgery within the last 3 months
* Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
* Pregnancy and lactation
* Allergy to oxybuprocaine (ocular anesthesia)
* Simultaneous participation in other clinical research

Primary outcomes:
measure: SENSIMED Triggerfish output values
timeFrame: During 24 hours
measure: Goldmann applanation tonometry values
timeFrame: During 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitätsklinik Mainz
Study officials:
affiliation: Schlosspark-Klinik Berlin
name: Carl Erb, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04189653: Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward.
Official title: Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Deterioration
Keywords: Early Warning Scores
Continuous Vital Sign Monitoring
Escalation of Care
ICU-Transfer
Deterioration prevention
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 3896
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult general ward patients of the GE-surgery and Internal Medicine wards of a Dutch tertiary academic hospital.

Brief summary: In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.

The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.


Eligibility criteria: Inclusion Criteria:

* Admission on Inclusion ward.

Exclusion Criteria:

* Opt out of file study

Primary outcomes:
measure: Unexpected Intensive Care Unit Admissions
timeFrame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
measure: Rapid Response Team Activations
timeFrame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Secondary outcomes:
measure: Length of Stay
timeFrame: During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References:
Clinical trial NCT06486753: LSTR in Chevron Osteotomy
Official title: Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bunion
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 200
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 goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:

How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.

Participants will:

* Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
* Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
* Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years old
* Have mild to moderate bunions that are determined to benefit from Chevron osteotomies

Exclusion Criteria:

* Under the age of 18
* Connective tissue disease
* Juvenile bunions
* Severe bunions
* Revision surgery

Primary outcomes:
measure: Hallux valgus alpha angle correction
timeFrame: Pre-surgery, 6 weeks post surgery
Secondary outcomes:
measure: Intermetasarsal angle (IMA) degrees of correction
timeFrame: 3 months, 6 months, and 12 months post surgery
measure: Recurrence of hallux valgus deformity
timeFrame: 3 months, 6 months, and 12 months post surgery
measure: Complications following surgery
timeFrame: 3 months, 6 months, and 12 months post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT01291953: Effectiveness of Early Detection of Atrial Fibrillation
Official title: Effectiveness of Early Detection of Atrial Fibrillation in People 65 Years or More bt Physicians and Nurse in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
screening
prevention
case finding
primary care
Lead sponsor: Hospital Universitario Reina Sofia de Cordoba
Sponsor class: OTHER_GOV
Collaborators: name: Spanish Society of Family and Community Medicine
First posted: 2011-02-09
Enrollment: 6990
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the measurement of the arterial peripheral pulse is more effective than the habitual practice for the early detection of AF in 65-year-old who come to Primary care


Eligibility criteria: Inclusion Criteria:

* Patients that come to his center of health for any motive.

  * That give his assent informed to take part in the study.

Exclusion Criteria:

* FA previous Diagnosis

Primary outcomes:
measure: efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Andalusian Health Service
name: Luis A Perula, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez Blanco V, Perula de Torres LA, Martin Rioboo E, Martinez Adell MA, Parras Rejano JM, Gonzalez Lama J, Ruiz Moruno J, Martin Alvarez R, Fernandez Garcia JA, Ruiz de Castroviejo J, Roldan Villalobos A, Ruiz Moral R; grupo de estudio colaborativo DOFA-AP. Opportunistic screening for atrial fibrillation versus detecting symptomatic patients aged 65 years and older: A cluster-controlled clinical trial. Med Clin (Barc). 2017 Jan 6;148(1):8-15. doi: 10.1016/j.medcli.2016.07.036. Epub 2016 Oct 26. English, Spanish.
citation: Perula-de-Torres LA, Martinez-Adell MA, Gonzalez-Blanco V, Baena-Diez JM, Martin-Rioboo E, Parras-Rejano JM, Gonzalez-Lama J, Martin-Alvarez R, Ruiz-Moral R, Fernandez-Garcia JA, Perez-Diaz M, Ruiz-de-Castroviejo J, Perula-de-Torres C, Valero-Martin A, Roldan-Villalobos A, Criado-Larumbe M, Burdoy-Joaquin E, Coma-Sole M, Cervera-Leon M, Cuixart-Costa L; Collaborative Group DOFA-AP. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol. BMC Fam Pract. 2012 Oct 30;13:106. doi: 10.1186/1471-2296-13-106.
Clinical trial NCT03804151: Long-term Evaluation of the FitSpirit Intervention
Official title: The Impact of the FitSpirit Physical Activity Approach on Different Health Parameters of Canadian Adolescent Girls: the Protocol of a Large, Longitudinal Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Keywords: Exercise
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: FitSpirit
name: Public Health Agency of Canada (PHAC)
First posted: 2019-01-15
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.


Eligibility criteria: Inclusion Criteria:

* Attend high-school registered to FitSpirit

Exclusion Criteria:

-

Primary outcomes:
measure: Physical activity participation
timeFrame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
measure: Eating habits
timeFrame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
measure: Sleep habits
timeFrame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
measure: Physical self-efficacy
timeFrame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
measure: Physical self-perception
timeFrame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Marie-Eve Mathieu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leduc G, Gilbert JA, Ayotte A, Moreau N, Drapeau V, Lemoyne J, Monthuy-Blanc J, Tremblay J, Mathieu ME. The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study. BMC Public Health. 2021 Jan 28;21(1):229. doi: 10.1186/s12889-021-10200-5.
Clinical trial NCT02138851: The Effects of a Ficus Carica in Subjects With Functional Constipation
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Functional Constipation
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fig paste on functional constipation. The investigators measured colon transit time, frequency of defecation, defecation time, stool type, and abdominal discomfort.


Eligibility criteria: Inclusion Criteria:

* age between 19 and 39 years,
* diagnosis of functional constipation by ROME III criteria,
* Colon transit time (CTT) ≥ 36 h,
* subjects giving written informed consent

Exclusion Criteria:

* allergic or hypersensitive response to any of the ingredients in the test products,
* having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,
* diagnosis of irritable bowel syndrome by ROME III criteria, etc,.

Primary outcomes:
measure: Changes in colon transit time
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in frequency of defecation
timeFrame: 8 week
measure: Changes in defecation time
timeFrame: 8 week
measure: Changes in stool type
timeFrame: 8 week
measure: Changes in abdominal discomfort
timeFrame: 8 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT00805051: Acquired Von Willebrand Syndrome in Severe Aortic Stenosis
Official title: Does an Acquired Von Willebrand Syndrome Influence Perioperative Blood Loss in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Von Willebrand Disease
Aortic Stenosis
Keywords: Aortic stenosis
aortic valve replacement
von Willebrand disease
blood loss
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for aortic valve replacement for severe aortic stenosis

Brief summary: Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.

Detailed description: Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. After written consent and an extended anamnesis of existing coagulopathy, we take three blood samples in these patients: before surgery, on the day after surgery and 4 weeks after surgery. We determine von Willebrand factor in lab and by a point-of-care platelet function analyzer (Multiplate TM). We measure amount of mediastinal drainage after 24 hours and blood product consumption in these patients.

Eligibility criteria: Inclusion Criteria:

* Severe aortic stenosis (Orifice area \< 1 cm2)

Exclusion Criteria:

* missing consent
* severe hepatic or renal disfunction

Primary outcomes:
measure: Amount of mediastinal drainage in the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Amount of given blood products in the first 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesia, University of Basel Hospital
Study officials:
affiliation: Department of Anaesthesia, University of Basel Hospital
name: Miodrag Filipovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03081351: Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy
Official title: Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head in a Chinese Population:A Multicenter, Open-label, Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreaticoduodenectomy
Keywords: Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Changhai Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiangsu Provincial People's Hospital
name: Second Affiliated Hospital, Sun Yat-Sen University
First posted: 2017-03-16
Enrollment: 480
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: This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.

Detailed description: The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.

Eligibility criteria: Inclusion Criteria:

* 18-70 years; Karnofsky performance\>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.

Exclusion Criteria:

* also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 100 months
Secondary outcomes:
measure: Disease free survival
timeFrame: From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384.