louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05950373: Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
Official title: Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition
Keywords: Older adults
Diseases-related malnutrition
Educational video
Lead sponsor: Nord University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 276
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.


Eligibility criteria: Inclusion Criteria:

* Surgical patients embedded in a regional hospital.
* Home-living in one of nine selected municipalities.
* Be able to read and understand Norwegian.
* Have a consent competence.
* Have a body mass index \< 24.
* Have access to a digital solution such as a tablet or phone.

Exclusion Criteria:

* Persons given only a liquid diet.
* Persons in a terminally ill phase.

Primary outcomes:
measure: Health related quality of life Using Rand 36 questionaire
timeFrame: Change in Health related quality of life Using Rand 36 questionaire after 3 months
Secondary outcomes:
measure: Body fat
timeFrame: Change in Body mass index after 3 months.
measure: Readmissions to hospital after discharge from the hospital
timeFrame: Registration of Readmissions 3 months after
measure: Muscle strength
timeFrame: Change in Hand Grip Strength (muscle strength) after 3 months
measure: The mid-arm circumferences
timeFrame: Change in the mid-arm cirumferences after three months.
measure: Subcutaneous fat
timeFrame: Change in Subcutaneous fat after three months.
measure: Muscle protein mass
timeFrame: Change in Muscle protein mass after 3 months
measure: Knowledge about nutrition
timeFrame: Registration in a questionaire three months after discharge from the hospital.
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Monica Christin Hansen
Study officials:
References:
Clinical trial NCT01267773: Treatment of Conduct Problems and Depression
Official title: Treatment of Youth Comorbid Conduct Problems and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Depression
Oppositional Defiant Disorder
Conduct Disorder
Keywords: depression
conduct problems
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2010-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.


Eligibility criteria: Inclusion Criteria:

* 8-14 years old
* Diagnosis of ODD or CD
* Diagnosis of Depression
* Speaks English

Exclusion Criteria:

* Developmental/cognitive delays
* Substance dependence
* Psychotic disorder or symptoms

Primary outcomes:
measure: Depression Symptoms
timeFrame: baseline to week 24
measure: oppositional symptoms
timeFrame: baseline to week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital/Brown University
name: Jennifer C Wolff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Anthony Spirito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196973: Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Official title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 493
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE


Eligibility criteria: Inclusion Criteria:

* Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
* Brighton Grading of II or III
* Culture-based diagnosis of acute bacterial otitis externa
* Willingness to refrain from swimming through end of the study

Exclusion Criteria:

* Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
* Tympanic membrane perforation
* Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
* Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study

Primary outcomes:
measure: Therapeutic Cure (Clinical + Microbiological Cure)
timeFrame: End of Treatment (Day 8+2)
Secondary outcomes:
measure: Time to End of Pain
timeFrame: From baseline to End of Study (Day 15+2)
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Laboratorios SALVAT
Study officials:
affiliation: Salvat
name: Enrique Jiménez
role: STUDY_DIRECTOR
References:
citation: Chu L, Acosta AM, Aazami H, Dennis P, De Valle O, Ehmer D Jr, Hedrick JA, Ansley JF. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221699. doi: 10.1001/jamanetworkopen.2022.21699.
Clinical trial NCT00221273: Use of Graft Tensioner Device in ACL (Knee) Repair
Official title: Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning in Hamstring ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Torn Anterior Cruciate Ligament (Knee)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.


Eligibility criteria: Inclusion Criteria:

Torn ACL amenable to surgery

Exclusion Criteria:

Primary outcomes:
measure: Endpoints Measured at 6, 12, 18 months post op compared to pre-op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: J Leith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04987073: Vitamin D Analog in Vitamin D 24-hydroxylase Deficiency
Official title: Preclinic Evaluation of a Vitamin D Analog in Vitamin D 24-hydroxylase Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Infantile Hypercalcemia - Severe Form
Keywords: CYP24A1
vitamin D
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 30
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: Preclinical evaluation of a vitamin D analog for the treatment of vitamin D 24-hydroxylase using fibroblast from patients with CYP24A1 mutation.


Eligibility criteria: Inclusion Criteria:

* biallelic mutation in CYP24A1
* consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Effects of the analog on vitamin D induced genes' expression
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Arnaud Molin
state: Normandy
Study officials:
References:
Clinical trial NCT06938373: Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression
Official title: Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with breast cancer

Brief summary: This study is a prospective, observational clinical research aimed at establishing a multimodal database encompassing clinical information and gut microbiome data from a sample of over 1,000 breast cancer patients comorbid with depression. The research involves collecting cohort sample information from breast cancer patients with comorbid depression, as well as fecal, blood, and saliva specimens for metagenomic sequencing, untargeted metabolite detection, and cortisol level analysis, respectively. Based on the collected multimodal data, diagnostic, efficacy prediction, and prognostic survival prediction models for breast cancer with comorbid depression will be developed. Additionally, a precision prediction cloud platform will be designed and deployed to support data upload, model prediction, and result visualization.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed primary breast cancer; Aged 18-80 years; No prior history of malignancy other than breast cancer; Awareness of their breast cancer diagnosis; Karnofsky Performance Status (KPS) score \>70; Willing to provide blood, fecal, and saliva samples with signed informed consent.

Exclusion Criteria:

* Physician-diagnosed mental disorders before or after breast cancer diagnosis; Severe chronic somatic diseases (e.g., central nervous system disorders, severe head trauma, substance abuse/dependence, intellectual disability, diabetes, gynecological diseases, cardiovascular diseases, thyroid disorders, etc.); Presence of two or more primary malignancies of different tissue origins; Central nervous system (CNS) metastasis of breast cancer; Clinically diagnosed digestive system diseases (e.g., enteritis, gastritis); Use of antidepressant or anxiolytic therapy during the study; Use of medications that alter gut function or metabolism during the study; Pregnant or lactating women; Radiotherapy or chemotherapy within the past 21 days; Use of antibiotics, probiotics, prebiotics, or synbiotics within 3 months prior to the study; Other reasons deemed unsuitable for participation by investigators.

Primary outcomes:
measure: objective response rate，ORR
timeFrame: 2025-03-11 to 2027-03-01
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03198273: The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Official title: The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: clinical pilates
exercise
lumbar disc herniation
chronic low back pain
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effects of clinical Pilates Exercises on the level of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles and quality of life in patients with lumbar disc herniation.


Eligibility criteria: Inclusion Criteria:

* Individuals, between the ages of 30-60,
* Have been diagnosed according to Magnetic Resonance Imaging results, in one or several of the levels of L3-L4 / L4-L5 / L5-S1 in the case of Bulging and Protuberance lumbar disc hernia,
* At least 6 weeks with back and leg pain,
* Those who will be able to participate in the exercise program regularly,
* Those who are not included in the physiotherapy program in the last 6 months,,
* With mental, auditory and visual problems that will prevent communication will be included in the study.

Exclusion Criteria:

* Individuals, with spinal stenosis,
* Having previously described lumbar spine surgery,
* Having severe neurological deficits,
* Having primary or metastatic spinal malignancy,
* Having vascular problem at a later stage in the lower extremity,
* Diagnosed with osteoporosis,
* Those who are pregnant,
* Having uncontrolled hypertension,
* With anger-dependent anguish will not be included in the study.

Primary outcomes:
measure: Pain Severity
timeFrame: nine weeks
Secondary outcomes:
measure: Functional Level Status
timeFrame: nine weeks
measure: Quality of Life Level
timeFrame: nine weeks
Other outcomes:
Locations:
city: Kyrenia
country: Cyprus
facility: Kyrenia 7/24 Orthopedics and Traumatology Clinic
state: Karakum
Study officials:
References:
Clinical trial NCT03300973: Urodynamic Study and Stress Incontinence
Official title: Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Keywords: urodynamic study
stress urinary incontinence
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 125
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Detailed description: group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Eligibility criteria: Inclusion Criteria:

* stress urinary incontinence

Exclusion Criteria:

* mixed incontinence
* recurrent cases

Primary outcomes:
measure: cure of stress incontinence
timeFrame: 1 week after surgery
Secondary outcomes:
measure: cure of stress incontinence
timeFrame: one month after surgery
measure: cure of stress incontinence
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT00174473: A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
Official title: An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neutropenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 49
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children


Eligibility criteria: Inclusion Criteria:

* Children who require a systemic antifungal agent for the prevention of systemic fungal infection

Exclusion Criteria:

* Children who are receiving medications which cannot be taken concomitantly with voriconazole.

Primary outcomes:
measure: The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.
Secondary outcomes:
measure: The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection.
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01207973: Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of Multiple Rising Oral Doses (50, 100, 200 and 350 mg qd and 100 mg Bid for 12 Days) of BI 113823 as Tablet in Male and Female Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.


Eligibility criteria: Inclusion criteria patients with osteoarthritis

Exclusion criteria

Primary outcomes:
measure: Safety (Physical examination)
timeFrame: 15 days
measure: Safety (Vital signs)
timeFrame: 15 days
measure: Safety (12-lead ECG)
timeFrame: 15 days
measure: Safety (Clinical laboratory tests)
timeFrame: 15 days
measure: Safety (Adverse Events)
timeFrame: 15 days
measure: Tolerability (Assessment of tolerability by investigator)
timeFrame: 15 days
Secondary outcomes:
measure: Measures of pharmacodynamic effects
timeFrame: 15 days
measure: Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed
timeFrame: 15 days
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: 1272.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05598073: Racial Differences in Yoga-Induced Responses
Official title: Racial Differences in Yoga-Induced Cardiovascular and Immune Responses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular and Immune Responses to Yoga
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to 1) determine whether racial differences are evident in resting arterial stiffness and ambulatory blood pressure between African Americans and Caucasians 2) compare heart rate, blood pressure and cytokine production responses to exercise (yoga) between African Americans and Caucasians; 3) compare isokinetic muscular strength between racial groups; and 4) determine if correlations exist between these measures.


Eligibility criteria: Inclusion Criteria:

* Men between the ages of 18 and 39 (25 African American and 25 Caucasian) that are not professional or collegiate athletes
* Must exercise at least 3 days per week and have no more than 1 month of yoga practice.

Exclusion Criteria:

* Having stage 2 hypertension (\>130 mmHg for systolic / \>90 mmHg for diastolic) or higher or having taken BP medications within the 3 months prior to testing
* Infection within the previous 4 weeks
* Known renal disease
* Prior myocardial infarction
* Known coronary artery disease
* Personal history of stroke
* Heart failure
* Cardiac arrhythmias
* Chronic obstructive pulmonary disease
* Recent chest pain or dyspnea
* Orthopedic limitations that preclude the execution of yoga postures
* Current insulin dependence
* Chronic inflammatory conditions
* Blindness or deafness as participants will need to follow a yoga DVD in order to complete the session
* Having practiced yoga for more than 1 month
* Having parents of mixed racial backgrounds (i.e. both parents must be Caucasian or African American)
* Not being African American or Caucasian
* Being a professional or collegiate athlete
* Being insulin-dependent

Primary outcomes:
measure: Arterial stiffness
timeFrame: Once at baseline
measure: Ambulatory blood pressure
timeFrame: Once at baseline
measure: Isokinetic strength
timeFrame: Once at baseline
measure: Inflammatory markers
timeFrame: Once at baseline
measure: Inflammatory markers
timeFrame: Once 30 minutes into the 1-hour yoga session
measure: Inflammatory markers
timeFrame: Once immediately after the 1-hour yoga session
Secondary outcomes:
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Stacy Hunter
state: Texas
Study officials:
References: