louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05621889: Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer
Official title: Impacts of an Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model to Prevent Swallowing Disorders in Patients Treated With Chemoradiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dysphagia
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Université du Québec à Trois-Rivières
First posted: 2022-11-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project aims to study an innovative intervention, the eG2 Intervention, developed by speech-language pathologists at the Centre hospitalier de l'Université de Montréal to improve therapeutic adherence and prevent dysphagia in patients treated with chemoradiotherapy for head and neck cancer.

The innovation consists in offering a speech therapy intervention that is 1) virtual, 2) group-based (whereas it is usually individual) and 3) involves a patient partner. This intervention has the potential to improve quality of care, accessibility to services and optimize health care resources.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age with a diagnosis of head or neck cancer
* Chemoradiotherapy treatments planned for curative purposes
* Planned external radiation therapy dose of at least ≥60 Grays
* Sufficient proficiency in French to complete self-reported questionnaires

Exclusion Criteria:

* Remote metastases
* Previous or planned total laryngectomy
* Previous moderate/severe dysphagia known and/or evaluated by speech therapy
* Diagnosis of a second synchronous cancer at the time of study enrollment
* History of prior radiation therapy to the head and neck area
* Have a cognitive impairment (diagnosed or suspected) that may significantly interfere with participation in the intervention and various measurement procedures.

Primary outcomes:
measure: Rate of nasogastric tube
timeFrame: within 6 weeks post radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT01508689: Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women
Official title: Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcium Deficiency
Keywords: Cereal bar
Calcium-fortified
Calcium intake
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.

Detailed description: The average intake of calcium in women in the United States from the diet (about 800 mg/day) is below the Recommended Dietary Allowance (1000 mg/day for ages 18 to 50 years, 1200 mg/day for age above 50 years), which increases their risk of developing osteoporosis. Consumption of two calcium-fortified cereal bars per day may be a feasible way to increase the dietary intake of calcium. This study will use Kellogg's Nutri-Grain® cereal bars, which provide 200 mg of calcium per bar, or a total of 400 mg/day.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Able to speak, read, and understand English
* Able to consume Kellogg's Nutri-Grain® cereal bars

Exclusion Criteria:

* Consumption of calcium supplements or calcium-containing medications
* Regular consumption of 2 Kellogg's Nutri-Grain® cereal bars per month
* Currently pregnant or planning to become pregnant during the course of the study
* Liver disease
* Kidney disease
* Gastrointestinal disease (celiac disease, ulcerative colitis, or Crohn's disease)
* Have a history of bariatric surgery
* Had a major cardiovascular event (stroke or myocardial infarction)
* Undergoing treatment of cancer with the exception of non-melanoma cancer
* Following a weight control diet, a disease specific diet, or a vegan diet
* Have a diagnosed eating disorder
* Allergic to any of the ingredients in the study bar

Primary outcomes:
measure: Dietary calcium intake
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Jennifer Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JT, Moore CE, Radcliffe JD. Consumption of calcium-fortified cereal bars to improve dietary calcium intake of healthy women: randomized controlled feasibility study. PLoS One. 2015 May 5;10(5):e0125207. doi: 10.1371/journal.pone.0125207. eCollection 2015.
Clinical trial NCT06901089: Hip Manipulation in Basketball Players
Official title: Assessment of the Impact of Hip Manipulation on Muscle Strength and Stiffness as Well as Motor Functionality of Basketball Players During Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Manual Therapy
Manipulation
Muscles
Musculoskeletal System
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Currently, it is difficult to find studies in the literature assessing the impact of manual therapy on preventing lower limb injuries in basketball players, which may later translate into improved strength and balance in athletes, when planning training or therapy programming, e.g. in patients after ankle sprains.


Eligibility criteria: Inclusion Criteria:

* healthy persons aged 18,
* first league competitor,
* competitor who regularly competes in the league,
* expressing informed consent to participate in the study and undertakes to comply with track regulations and wear a helmet.

Exclusion Criteria:

* lack of volunteer consent,
* previous surgeries of the upper, lower limb and spine,
* other lower limb injuries in the last 6 months,
* pain limiting participation in the study,
* neurological diseases,
* connective tissue diseases.

Primary outcomes:
measure: Assessment of MVC.
timeFrame: The study will be conducted 3 times during one training session (before the intervention, after the intervention and after training). Each isometric muscle test lasts 3 seconds.
measure: Assessment of MVC.
timeFrame: The study will be conducted 4 times during one training session (before the intervention, after the intervention and after training).Each isometric muscle test lasts 3 seconds.
Secondary outcomes:
measure: Assessment of proprioception.
timeFrame: The test will be performed three times during one training session (before the intervention, after the intervention, after the training). Each joint measurement will be performed at three settings: 15, 30, 45 degrees.
measure: Y balance test
timeFrame: The test will be conducted three times during one training session (before the intervention, after the intervention, after training).
measure: Standing Long Jump Test
timeFrame: The test will be conducted 3 times during one training session (before the intervention, after the intervention, after the training). Each test is repeated 3 times.
Other outcomes:
Locations:
city: Starogard Gdański
country: Poland
facility: OSIR przy ul. Olimpijczyków Starogardzkich 1
Study officials:
References:
Clinical trial NCT02331589: Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Official title: Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fatigue
Keywords: Fatigue
Panax ginseng
Chronic hepatitis
Non-alcoholic Fatty Liver Disease
Adiponectin
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.

Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.

Detailed description: Fatigue Severity Scale

We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.

Eligibility criteria: Inclusion Criteria:

* aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

Exclusion Criteria:

* viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer

Primary outcomes:
measure: Liver Enzymes
timeFrame: 3 weeks of KRG
Secondary outcomes:
measure: Fatigue as Measured by KRUPP's Fatigue Severity Scale
timeFrame: 3 weeks of KRG
measure: Pro-inflammatory Cytokine
timeFrame: 3 weeks of KRG
measure: Adiponectin
timeFrame: 3 weeks of KRG
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03857789: Social Robot Support for Healthcare Professionals
Official title: Supporting Health Care Professionals With a Social Robot in an Integrated Care Pathway: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty at Older Adults
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Delft University of Technology
First posted: 2019-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step.

Detailed description: There is a worldwide increasing shortage of adequately trained healthcare personnel, leading to the challenge for society to prevent a future "lack of care". At the same time the number of people requiring healthcare is expanding rapidly, amongst others due to the growing percentage of older adults in the population. New means of supporting the available healthcare professionals are therefore urgently required.

Modern healthcare is often implemented through "integrated care pathways". Certain steps in these pathways involve dialogues with patients. Speaking social robots are increasingly being advertised as supportive for healthcare professionals and may handle certain structured dialogue types, such as questionnaires. Based on previous positive preclinical experiences with social robots interviewing community-dwelling older subjects, the researchers want to investigate the implementation of a social robot in an integrated care pathway in the outpatient clinic.

Eligibility criteria: Inclusion Criteria:

* Suspicion of need for quality of life support

Exclusion Criteria:

* Psychiatric Disorders

Primary outcomes:
measure: Consumer Quality index (CQ-index)
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References:
citation: Boumans R, van Meulen F, van Aalst W, Albers J, Janssen M, Peters-Kop M, Huisman-de Waal G, van de Poll A, Hindriks K, Neerincx M, Olde Rikkert M. Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial. J Med Internet Res. 2020 Sep 9;22(9):e18787. doi: 10.2196/18787.
Clinical trial NCT03705689: Validation BITSS Brussels Infant Stool Scale
Official title: Validation BITSS Brussels Infant Stool Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation of BITTS
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all children who are non-toilet trained

Brief summary: validation of stool scale in toddlers

Detailed description: objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children.

The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS.

Method :

In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic.

What is known :

* reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders.
* the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers

To get validation of the BITTS :

* a non-toilet trained child makes stool in diaper
* caregiver scores the aspect of the stool according to the BITTS
* caregiver takes a picture of the diaper
* after 1 monts she rescores the picture according to the BITTS

Eligibility criteria: Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained

-

Exclusion Criteria:

* none

Primary outcomes:
measure: to evaluate the inter-observer reliability of stool consistency
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT02353689: The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
Official title: Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Enteral Nutrition
Lead sponsor: Dong-A University
Sponsor class: OTHER
Collaborators: name: Dong-A University
First posted: 2015-02-03
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.

Detailed description: A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .

Eligibility criteria: Inclusion Criteria:

* tube-feeding patients

Exclusion Criteria:

* EN prohibited
* renal dysfunction (i.e. serum creatinine \> 1.5 mg/dl or blood urea nitrogen \> 25 mg/ml)
* liver dysfunction (i.e. serum aspartate aminotransferase \> 40 U/L or alanine aminotransferase \> 40 U/L)
* uncontrollable diabetes mellitus
* pregnancy, breast-feeding etc.
* severe diarrhea

Primary outcomes:
measure: diarrhea
timeFrame: 14-day follow-up
Secondary outcomes:
measure: prealbumin
timeFrame: 14-day follow-up
measure: body mass index
timeFrame: 14-day follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Dong-A Univeristy
name: Oh Yoen Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02796989: The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Obese
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years old
* BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
* Regular diet
* Not dieting

Exclusion Criteria:

* Use of antibiotics in the month preceding the study
* Diabetes Type 1 or 2
* Abdominal surgery (except from appendectomy)
* Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
* Use of pre- or probiotic supplements in the month preceding the study
* Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
* Pregnancy or lactation
* Blood donation in the last 3 months
* Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
* Participation in clinical studies involving radiation exposure in the past year

Primary outcomes:
measure: The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
timeFrame: 1 month
Secondary outcomes:
measure: Changes in glucose levels (mg/dL)
timeFrame: 1 month
measure: Changes in insulin levels (pmol/L)
timeFrame: 1 month
measure: Changes in cholesterol levels (mg/dL)
timeFrame: 1 month
measure: Changes in free fatty acids levels (mmol/L)
timeFrame: 1 month
measure: Changes in triglyceride levels (mg/dL)
timeFrame: 1 month
measure: Gut permeability using 51-Cr-EDTA
timeFrame: 1 month
measure: Total gastrointestinal transit time
timeFrame: 1 month
measure: Changes in gut microbiota before and after the intervention using 16S rRNA sequencing
timeFrame: 1 month
measure: Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry
timeFrame: 1 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT04700189: A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
Official title: A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Open Angle Glaucoma
Keywords: Intraocular Pressure
Glaucoma
Glaucoma Surgery
Ab interno
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 42
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

Detailed description: This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all the following criteria in order to be eligible for participation in this study:

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.

Exclusion Criteria:

* Subjects are ineligible for participation in this study if s/he meets any of the following criteria:

  1. Patients who could not be washed-out of IOP-lowering medications. .

Primary outcomes:
measure: Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
timeFrame: From Baseline at Month 12
Secondary outcomes:
measure: Changes from baseline in intraocular pressure (IOP)
timeFrame: From Baseline at Month 12
measure: Changes from baseline in number of IOP lowering medications
timeFrame: From Baseline at Month 12
Other outcomes:
Locations:
city: Puerto Mexico
country: Mexico
facility: Dr. Gabriel S. Lazcano Gomez
Study officials:
affiliation: Puebla, Mexico
name: Gabriel Lozcano, MD
role: PRINCIPAL_INVESTIGATOR
References: