louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03330314: Molar Potency Study of HM12460A in Healthy Subjects
Official title: An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Females must be non-pregnant and non-lactating
* Males must be surgically sterile or using an acceptable contraceptive method

Exclusion Criteria:

* History of any major surgery within 6 months prior to screening
* Use of any new prescription or non-prescription drug in the last 30 days

Primary outcomes:
measure: Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period
timeFrame: 1 month
Secondary outcomes:
measure: Cmax of HM12460A
timeFrame: 1 month
measure: AUC of HM12460A
timeFrame: 1 month
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Hanmi Investigative Site
state: California
Study officials:
References:
Clinical trial NCT06928714: Pediatric Feeding Disorder Evolution in Amiens University Hospital
Official title: Pediatric Feeding Disorder Evolution in Amiens University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Feeding Disorders
Eating Behaviors
Dysphagia
Nutritional Status
Malnutrition
Children
Keywords: feeding disorders
eating behavior
dysphagia
nutritional status
malnutrition
artificial nutrition
children
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 33
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \<18 years old with at least two pediatric gastroenterology PFDs consultations at CHUAP , with an inapropriate oral intakes for at least 2 weeks, Association with medical, nutritional, psychosocial or eating-skills dysfunction.

Brief summary: Pediatric feeding disorders (PFDss) affect children with age-inappropriate oral intakes lasting at least 2 weeks, associated with medical, nutritional, psychosocial or feeding skills dysfunction. Feeding is a complex function involving the digestive tract, and different structures. It evolves throughout the child's development. It involves the caregiver-child relationship. Dysfunction of one or more of these systems may be the cause of pediatric feeding disorders. PFDs affect 25% of children, 5% with severe forms. PFDs can have severe nutritional consequences. They often cause malnutrition, even undernutrition, and sometimes overweight.


Eligibility criteria: Inclusion Criteria:

* Children \<18 years old
* with at least two pediatric gastroenterology PFDs consultations at CHUAP ,
* with an inapropriate oral intakes for at least 2 weeks,
* Association with medical, nutritional, psychosocial or eating-skills dysfunction.

Exclusion Criteria:

* anorexia nervosa

Primary outcomes:
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 1 year
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 2 years
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 3 years
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 5 years
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 8 years
measure: Frequency of children with Pediatric feeding disorders disappearance
timeFrame: 10 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT00180414: MODULA Modul 7 VRR
Official title: MODULA-Study: Modul 7 VRR: Correlation Between Ventricular Rate Regulation (VRR) and the Percentage of Biventricular Pacing as Well as Subjective Quality of Life and Level of Physical Ability in CRT Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: heart failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2005-09-16
Enrollment: 8
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: This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.

Detailed description: To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.

Eligibility criteria: Inclusion Criteria:

* Patients with CRT system with the VRR algorithm
* Patients with permanent atrial fibrillation
* Occasional conducted atrial fibrillation resulting in ventricular rates \> 70 beats per minute (bpm)
* QRS complex \> 120 ms

Exclusion Criteria:

* Patients with third degree atrioventricular (AV) block

Primary outcomes:
measure: Percentage of Biventricular Pacing
timeFrame: 6 month
Secondary outcomes:
measure: Correlation Between VRR and the Subjective Quality of Life
timeFrame: 6 Month
measure: Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
timeFrame: 6 months
measure: Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
timeFrame: 6 months
Other outcomes:
Locations:
city: Luedenscheid
country: Germany
facility: Klinikum Lüdenscheid / Kardiologie
Study officials:
affiliation: Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
name: Bernd Lemke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04462614: Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA
Official title: Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hemolysis
VKA
Anticoagulants / Administration & Dosage
Coated Materials
Biocompatible
Heparin / Administration & Dosage
Membranes Artificial
Prospective Studies
Renal Dialysis / Methods
Renal Insufficiency / Therapy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 49
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: Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions, with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA, without addition of heparin perdialytic.

Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™ membrane and treated by long-term anticoagulation with VKA

Detailed description: The aim will be to study possibility of hemodialysis sessions success, without perdialytic anticoagulation but with adequate dialysis parameters (defined by the patient's Kt / V machine), in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane.

Eligibility criteria: inclusion criteria :

* 18 years old and older
* chronic hemodialysis for at least 3 months
* treated by long-term anticoagulation with VKA
* hemodialysis with the HeprAN® membrane
* per dialytic heparin therapy (UFH or LMWH)
* dialyzed at Reims University Hospital
* agreeing to participate in the study

Exclusion criteria

* chronic hemodialysis without per dialytic heparin
* Patient dialized with single lumen catheter for vascular access
* less than 18 years old
* pregnant or lactating women
* protected by law

Primary outcomes:
measure: Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03538314: UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
Official title: A Phase I, Open-label, Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in First-line Malignant Melanoma Patients Planned for Treatment With Pembrolizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Melanoma
Lead sponsor: Ultimovacs ASA
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UV1/GM-CSF
Primary purpose: TREATMENT

Brief summary: UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.


Eligibility criteria: Key Inclusion Criteria:

1. Stage IIIB, IIIC or IV melanoma
2. Previously untreated and eligible for pembrolizumab treatment (prior treatment with BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4) Consent to undergo tumor biopsies during the study

Exclusion Criteria:

1. Uveal or ocular malignant melanoma
2. History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed
3. Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed.
4. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus.
5. Known hypersensitivity to GM-CSF
6. Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
7. Men who plan to become a father during the study through 4 months after the last dose of study medication
8. Known history of, or any evidence of active, non-infectious pneumonitis
9. History of cardiac disease

Primary outcomes:
measure: Number of patients with treatment-related adverse events
timeFrame: Up to week 29
Secondary outcomes:
measure: Tumor response
timeFrame: Up to week 52
measure: The length of time from the start of treatment that patients are still alive.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Center
state: California
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine
state: Iowa
city: Easton
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
References:
Clinical trial NCT04079114: Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
Official title: Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Hip
Fracture of Hip
Avascular Necrosis of Hip
Dislocated Hip
Osteonecrosis
Post-traumatic; Arthrosis
Rheumatoid Arthritis
Subluxation Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Brief summary: This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Detailed description: The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.

The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
* 18 years minimum
* Patients able to participate in a follow-up program based upon physical examination and medical history
* Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Exclusion Criteria:

* Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
* Known pregnancy
* Revision hip arthroplasty

Primary outcomes:
measure: Implant Survival
timeFrame: 3 years postoperatively, due to early study termination
measure: Dislocation Rate
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
timeFrame: 3 years postoperatively, due to early study termination
measure: Confirmation of Safety Based on Complications
timeFrame: 3 years postoperatively, due to early study termination
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References:
Clinical trial NCT05613114: Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia
Official title: Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Spastic Paraplegia
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are limited but encouraging results supporting the use of dalfampridine in patients with hereditary spastic paraplegia. The investigators aimed to investigate the effects of dalfampridine on walking speed, muscle length, spasticity, functional strength, and functional mobility in patients with hereditary spastic paraplegia. In this triple-blinded, randomized, placebo-controlled trial, 4 patients with hereditary spastic paraplegia received dalfampridine (10 mg twice daily) plus physiotherapy (2 times per week), and 4 patients received placebo plus physiotherapy for a total duration of 8 weeks. The assessor and treating physiotherapists, and patients were masked to the group allocation. The primary outcome was Timed 25-foot Walk Test at the end of the 8-week treatment. The secondary outcome measures were functional mobility, functional muscle strength, muscle length, and spasticity.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hereditary Spastic Paraplegia at least 1 year ago

Exclusion Criteria:

* Having another neurological disorder
* An orthopedic deformity in the lower extremity
* Having a serious cognitive impairment

Primary outcomes:
measure: Timed 25-foot Walk Test
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Sit to Stand Test
timeFrame: Change from baseline to week 8
measure: Timed Up and Go test
timeFrame: Change from baseline to week 8
measure: Modified Ashworth Scale
timeFrame: Change from baseline to week 8
measure: Muscle Length Measurement
timeFrame: Change from baseline to week 8
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Dr. Burhan Nalbantoğlu State Hospital
Study officials:
affiliation: European University of Lefke
name: Ferda Selcuk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06794814: Program of Community Oral Function Enhancement
Official title: Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hypofunction
Keywords: Oral exercises, community-dwelling elderly, oral function, prevention of chewing and swallowing disorders
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 77
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study examined the effects of oral exercise on oral function among older adults in Taiwan, focusing on gender-related outcome differences.

Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal.

After six-week, the participants were examed the salivary secretion, swallowing ability (RSST), oral diadochokinesis, bite force, quality of life (assessed by OHIP-14) and EAT-10.

Detailed description: Objective: Elderly individuals with systemic diseases and disabilities face an elevated mortality risk, with oral functional decline further contributing to both oral and systemic health challenges. Given the rising prevalence of reduced oral function in older adults, this study aims to evaluate the effectiveness of oral exercise training on improving oral function and preventing functional decline. Additionally, the study examines potential gender differences in response to the intervention.

Methods: Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. The study measured changes in oral function post-intervention.

Eligibility criteria: Inclusion Criteria:

* over the age of 65

Exclusion Criteria:

* incomplete data
* failed to perform the assigned daily exercise
* unable to adhere to the protocol and steps outline in the oral exercise video

Primary outcomes:
measure: Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ming-Lun Hsu, Distinguished professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04374214: Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars
Official title: Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reversible Pulpitis
Keywords: Permanent teeth
Complete pulpotomy
Simvastatin -alpha tricalcium phosphate
Mineral Trioxide Aggregate
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 56
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent

Detailed description: After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. Clinical diagnosis of reversible pulpitis will be established. Complete pulpotomy will be done in both groups. Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.

Eligibility criteria: Inclusion Criteria:

1. Patient willing to participate in the study.
2. Age group of 15 to 40 years
3. Mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth)
4. Teeth exhibiting occlusal pulp exposure from primary dental caries.
5. Absence of periapical lesions assessed by radiographic examination.
6. Tooth demonstrating no mobility or swelling and no tenderness to percussion or palpation

Exclusion Criteria:

1. Primary teeth.
2. Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency.
3. Immune-compromised, pregnant and patients with any systemic disorder.
4. Patients taking statin medication.
5. Failure to obtain authorization from the patient.

Primary outcomes:
measure: Clinical success
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Pain analysis
timeFrame: Baseline to 7 days
measure: Radiographic success
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS, Rohtak
name: Sudeepender Gehlot
role: PRINCIPAL_INVESTIGATOR
References: