louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06947798: The Effect of Motivational Interviewing on Anthropometric Measurements, Eating Attitudes, and Cardiometabolic Index in Overweight and Obese Patients
Official title: The Effect of Motivational Interviewing on Anthropometric Measurements, Eating Attitudes, and Cardiometabolic Index in Overweight and Obese Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motivational Interviewing
Cardiometabolic Index
Obesity
Overweight (BMI &gt; 25)
Anthropometric Measurements
Eating Behavior Disorders
Lead sponsor: Saltuklu Aile Sağlığı Merkezi
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Effect of Motivational Interviewing on Anthropometric Measurements, Eating Attitudes, and Cardiometabolic Index in Overweight and Obese Patients

Detailed description: Participants were randomly assigned into two groups-an Intervention Group (n = 40) and a Control Group (n = 40)-using block randomization through the website "random.org." Data were collected using a Personal Information Form, the Eating Behavior Disorder Scale, Anthropometric Measurements (body weight, body mass index, waist circumference, waist/hip ratio), and the Cardiometabolic Index. Both groups received routine recommendations, which included a daily caloric restriction of 500 kcal and moderate-intensity aerobic exercise for 30 minutes, five days a week.Motivational interviewing was administered to the intervention group through individual sessions, held once every two weeks, for a total of four sessions, each lasting 15 minutes. The interviews were conducted in the Education Room of the Saltuklu Family Health Center. After the motivational interviewing intervention was completed, post-tests (Eating Behavior Disorder Scale, Anthropometric Measurements, and Cardiometabolic Index) were administered to both groups. All participants were followed for a period of three months.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) in the range of 25 to 34.9 kg/m² was considered as an inclusion criterion
* Being between 20 and 40 years of age (corresponding to the young adulthood period according to Erikson)

  -- Participants were required to be registered with the Saltuklu Family Health Center.
* Willingness to participate in the study and provision of informed consent were required

Exclusion Criteria:

* Current use of medications known to induce weight gain or loss
* Presence of a diagnosed chronic illness
* Pregnancy or being in the lactation period."

Primary outcomes:
measure: CMI
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06035198: Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin
Official title: Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients receiving treatment at four hospitals in Korea

Brief summary: The purpose of this study is to realize customized precision medicine for stroke patients and the visual digitization of patient medical information required in the era of digital transformation.

This study will collect large-scale, high-quality clinical data and daily life exercise pattern data covering the subacute to chronic stages of stroke patients. Based on this, we will use artificial intelligence analysis technology to predict the functional status of stroke patients in the chronic stage after their disability is fixed. We aim to develop the next generation of personalized digital twins by creating a prognostic prediction model.


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years of age with a history of stroke onset between 2018.01.01 to 2023.07.31.
* Patients who exist rehabilitation medical evaluation after stroke onset
* Patients who voluntarily decide to participate in this study

Exclusion Criteria:

* Those who have severe internal diseases such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc. and are in poor overall condition.
* Those who have impaired ability to consent (MMSE score less than 10 points) and not accompanied by a care-giver.
* In any other cases where the researcher determines that participation in this study is not appropriate.

Primary outcomes:
measure: Modified Barthel Index (MBI)
timeFrame: minimum 6 months to maximum 6 years
Secondary outcomes:
measure: Mini Mental Status Examination (MMSE)
timeFrame: minimum 6 months to maximum 6 years
measure: Functional Ambulatory Category (FAC)
timeFrame: minimum 6 months to maximum 6 years
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang CHA Medical Center
Study officials:
affiliation: CHA University
name: Seyoung Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512598: HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
Official title: Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Generalized Pustular Psoriasis
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).

Detailed description: This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.

Eligibility criteria: Inclusion Criteria:

* Male or female patients, aged 18 to 75 years at screening
* A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
* Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
* Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.

Exclusion Criteria:

* Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
* Ongoing use of prohibited psoriasis treatments
* Further exclusions criteria apply

Primary outcomes:
measure: Number of patients with drug related adverse events
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
timeFrame: 12 weeks
measure: Cmax
timeFrame: 12 weeks
measure: AUC0-infinity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shandong
country: China
facility: Dermatology Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong Provincial Dermatology Hospital
name: Zhang Furen, Doc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02458898: Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
Official title: Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a prospective randomized controlled trial investigating the impact of educational bidirectional text message reminders on gluten free diet adherence among adolescents and young adults with celiac disease age 12-24. Participants will complete a series of online questionnaires assessing quality of life, patient activation, celiac symptoms, and self reported dietary adherence at the beginning and end of the study. Participants will also have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done locally, and are at no cost to the participant. Patients are randomized to the intervention or control group based on enrollment TTG IgA. Intervention group receives 45 unique text messages over the 3 month study. A gift card is provided for participation in the study.


Eligibility criteria: Inclusion Criteria:

* Age 12-24
* Celiac disease diagnosed by a gastroenterologist at least 1 year prior to enrollment
* Participant with ability to read email and text messages in English
* Access to a mobile phone
* Unlimited text messaging plan or agreement to receive 45 text messages for the study

Exclusion Criteria:

* Participant inability to answer survey questions and text prompts in English

Primary outcomes:
measure: Tissue Transglutaminase IgA (TTG IgA)
timeFrame: 3 months
Secondary outcomes:
measure: Deamidated Gliadin Peptide IgA (DGP IgA)
timeFrame: 3 months
measure: NIH-PROMIS quality of life score
timeFrame: 3 months
measure: Patient Activation Measure (PAM) score
timeFrame: 3 months
measure: Patient-reported dietary adherence (CDAT) score
timeFrame: 3 months
measure: Patient-reported celiac disease symptom measure (CDI) score
timeFrame: 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Pediatric Gastroenterology Department
state: California
Study officials:
affiliation: Stanford Pediatric Gastroenterology
name: Kelly B Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas K, Martin A, Park KT. Text Message Intervention (TEACH) Improves Quality of Life and Patient Activation in Celiac Disease: A Randomized Clinical Trial. J Pediatr. 2017 Jun;185:62-67.e2. doi: 10.1016/j.jpeds.2017.02.062. Epub 2017 Mar 23.
Clinical trial NCT01147198: Ready to Use Supplementary Food in Moderate Childhood Malnutrition
Official title: Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition
Keywords: Moderate
Wasting
Malnutrition
Ready to Use Food
Fortified Blended Flour
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Nutriset
name: United Nations World Food Programme (WFP)
First posted: 2010-06-22
Enrollment: 570
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.

The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.

Compare the longer term effect on nutritional status and morbidity (relapse?).


Eligibility criteria: Inclusion Criteria:

* all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
* WHM between 70-79% (1977 NCHS/WHO standard) without edema
* approval from the caretaker

Exclusion Criteria:

* presence of the following signs: bilateral edema, MUAC\<110 mm , WHM\< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
* refusal to participate from caretaker

Primary outcomes:
measure: Recovery
timeFrame: 112 days
Secondary outcomes:
measure: average weight gain
timeFrame: 112 days
measure: Duration of treatment
timeFrame: 112 days
measure: Morbidity
timeFrame: 11 months
Other outcomes:
Locations:
city: Bo
country: Sierra Leone
facility: Health Centers run by MSF and MOH
Study officials:
affiliation: Medecins Sans Frontieres, Netherlands
name: Pascale Delchevalerie, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06539598: Respiratory Training in Friedreich's Ataxia
Official title: Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With Friedreich's Ataxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Friedreich Ataxia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.


Eligibility criteria: Inclusion Criteria:

* confirmed genetic testing of Friedreich's Ataxia
* have an overall DIGEST score of 1 or higher based on FEES screening
* are able to perform pulmonary function testing

Exclusion Criteria:

* have been on antibiotics within 15 days prior to baseline screening.
* have been prescribed systemic corticosteroids or neuromuscular blocking agents within 15 days of the baseline screening
* have an allergy or contraindication to topical lidocaine or oxymetazoline
* have any other concurrent medical condition which, in the opinion of the investigators, would make the subject inappropriate to participate in testing or respiratory exercise

Primary outcomes:
measure: Force Vital Capacity
timeFrame: Through study completion (4 months)
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Through study completion (4 months)
measure: Maximal Expiratory Pressure (MEP)
timeFrame: Through study completion (4 months)
measure: Sniff Nasal Inspiratory Pressure (SNIP)
timeFrame: Through study completion (4 months)
measure: Swallowing
timeFrame: Through study completion (4 months)
measure: Surface Electromyography (sEMG)
timeFrame: Through study completion (4 months)
measure: Diaphragm Ultrasound
timeFrame: Through study completion (4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Carmen Leon Astudillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920998: Effect of Food Intake on Pharmacokinetic Profiles of Z-338
Official title: A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Z-338
YM443
healthy volunteers
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Detailed description: The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Eligibility criteria: Inclusion Criteria:

* Healthy subject
* Body weight: 50.0 - 80.0 kg
* BMI: 17.6 - 26.4

Exclusion Criteria:

* Receiving an investigational new drug within 120 days of the study
* Receiving medical treatment drugs within 7 days of the study
* Blood donation before the study

Primary outcomes:
measure: Pharmacokinetics of Z-338
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT01860898: A Phase I Study of iPS Cell Generation From Patients With COPD
Official title: A Phase I Study of iPS Cell Generation From Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Diseases
Respiratory Tract Diseases
Cancer of Lung
Cancer of the Lung
Lung Cancer
Lung Diseases, Obstructive
COPD
Pulmonary Emphysema
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Keywords: lung
cancer
thoracic
chest
pulmonary
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.


Eligibility criteria: Inclusion Criteria:

* Undergoing Thoracic Surgery at the Mayo Clinic Rochester
* Presence of a Thoracic Disease

Primary outcomes:
measure: Feasibility
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis A Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03640598: Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block in Children Undergoing Inguinal Surgeries
Official title: Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators aim to compare the efﬁcacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia

Detailed description: regarding patient registry; a prior G power analysis was done. 24 per group was determined to achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25 patients were included per group to replace any dropouts.

- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Eligibility criteria: Inclusion Criteria:

* : American Society of Anesthesiologists physical status I - II

Exclusion Criteria:

* History of clinically significant cardiac disease.
* History of clinically significant hepatic disease.
* History of clinically significant renal disease.
* History of clinically significant neurological disease.
* Known allergy to local anaesthetics

Primary outcomes:
measure: Postoperative CHEOPS scale
timeFrame: for 6 hours after surgery
Secondary outcomes:
measure: Time to first analgesic request
timeFrame: during first 24 hours
measure: number of patients requiring rescue analgesic
timeFrame: during first 24 hours
measure: incidence of postoperative nausea and vomiting
timeFrame: during first 24 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Enas A Abd el Motlb
state: DK
Study officials:
affiliation: Assistant Professor, Anesthesia Department
name: Enas A Abd el Motlb, MD
role: STUDY_CHAIR
References: