louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01917266: Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
Official title: Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients indicated for a Cardiac Resynchronization Therapy (CRT) device

Brief summary: The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.


Eligibility criteria: Inclusion Criteria:

* Be scheduled to undergo implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement
* Be in sinus rhythm at the time of enrollment
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Be in New York Heart Association (NYHA) IV functional class
* Have prior left ventricular (LV) lead implant
* Be pacemaker-dependent
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Exhibit Cheyne-Stokes respiration
* Be less than 18 years of age
* Be pregnant or planning to become pregnant during the duration of the investigation
* Be currently participating in any other clinical investigation

Primary outcomes:
measure: Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation
timeFrame: This outcome measure will be assessed after an off-line analysis immediately after implant
Secondary outcomes:
measure: Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline.
timeFrame: 6 months after implant
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
References:
Clinical trial NCT02498366: Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Official title: Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhabdomyolysis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-15
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In order to determine norm values for skeleton muscle disassembly due to physical exertion in healthy and trained population, and developing a prediction test for approval for rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of different physical tests.

Detailed description: 50 healthy civilians volunteers will be recruited for this study. Each subject will undergo the physical tests: anthropometric measurements, wingate test, VO2max test, step test and running on the anaerobic threshold, on separate days. Blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test.

Eligibility criteria: Inclusion Criteria:

* healthy civilians ages 18-30.
* above average aerobic and anaerobic fitness.
* Without heart, cardiovascular, metabolic or respiratory illnesses.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* existence of any of undesired conditions detailed in the inclusion criteria.
* the physician decision.

Primary outcomes:
measure: creatine phosphokinase (CPK)
timeFrame: 5 experiment days for each subject
measure: oxygen consumption (VO2)
timeFrame: 5 experiment days for each subject
Secondary outcomes:
measure: lactic acid
timeFrame: 5 experiment days for each subject
measure: Myoglobin
timeFrame: 5 experiment days for each subject
measure: Heart rate
timeFrame: 5 experiment days for each subject
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03955666: A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
Official title: PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Lead sponsor: Provention Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Double-blind, placebo-controlled, multiple ascending dose study
Primary purpose: TREATMENT

Brief summary: This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects

Detailed description: PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.

Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
2. Body mass index (BMI) 18 to 32 kg/m2, inclusive.
3. Male or female 18 to 50 years of age, inclusive.
4. Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Evidence of active or chronic infections.
3. Previous exposure to PRV-3279.
4. Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: 85 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Clinical site
state: Maryland
Study officials:
affiliation: Provention Bio, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00102466: Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Official title: Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility criteria: Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 52 weeks
timeFrame: 52 weeks
Secondary outcomes:
measure: Adverse event profile after 52 weeks of treatment
timeFrame: 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
timeFrame: 52 weeks
measure: Patients with endpoint HbA1c <7% at 52 weeks
timeFrame: 52 weeks
measure: Patients with reduction in HbA1c >/= 0.7% after 52 weeks
timeFrame: 52 weeks
measure: Patients with reduction in HbA1c >/= 0.5% after 52 weeks
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nurnberg
country: Germany
facility: Investigative Centers
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06871566: AI-Supported Occupational Therapy for Handwriting
Official title: Artificial Intelligence-Supported Occupational Therapy Program on Handwriting Skills in Children at Risk for Developmental Coordination Disorder: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Therapy
Keywords: Artifical intellegence
occupational therapy
developmental coordination disorders
handwriting
rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).

Method: A randomized controlled trial was conducted with 42 children aged 8-12 years, identified as being at risk for DCD using the Developmental Coordination Disorder Questionnaire (DCDQ). Participants were randomized into an intervention group (n=21) and a control group (n=21). The intervention group received an AI-supported occupational therapy program twice weekly for 8 weeks. Handwriting performance was assessed pre- and post-intervention using the Minnesota Handwriting Assessment (MHA).

Keywords: artificial intelligence, occupational


Eligibility criteria: Inclusion Criteria:

1. being between the ages of 8-12 years
2. being at risk for DCD according to the Developmental Coordination Disorder Questionnaire (DCDQ)
3. having the ability to understand the questionnaires
4. continuing formal education
5. having similar motor skill performance (having similar results from the Bruininks-Oseretsky Motor Proficiency Test 2 Brief Form (BOT2-BF)) and having similar visual perception level (having similar results from the Motor-Free Visual Perception Test-3(MVPT-3)

Exclusion Criteria:

(1) having another neurodevelopmental, orthopedic and chronic problem (2) continuing any rehabilitation program

-

Primary outcomes:
measure: Minnesota Handwriting Assessment
timeFrame: Two assessments, one week before the intervention and one week after the intervention was completed
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Güleser Güney Yılmaz
Study officials:
References:
Clinical trial NCT00839566: PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)
Official title: Permanent Atrial Fibrillation in Heart Failure Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Heart Failure
Keywords: Atrial Fibrillation
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2009-02-09
Enrollment: 12
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: Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time


Eligibility criteria: Inclusion Criteria:

* LVEF \<35%
* QRS time ≥150ms LBB
* NYHA classification ≥ NYHA III
* permanent (\> 6 months) Atrial Fibrillation
* sinus rhythm (control group)
* Condition after Implantation of a Medtronic CRT device
* written informed consent

Exclusion Criteria:

* exchange of the current CRT device
* mitral incompetence (2. degree)
* no compliance
* participation in another study
* pregnancy
* patients with AV node
* patients after heart transplant or those who are on the transplant list

Primary outcomes:
measure: End systolic left ventricular diameter
timeFrame: 12 months
Secondary outcomes:
measure: NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test
timeFrame: 12 months
Other outcomes:
Locations:
city: Luenen
country: Germany
facility: Professor Dr. med. Christian Perings
Study officials:
affiliation: marien Hospital Luenen
name: Christian Perings, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06655766: Socket Preservation Using Socket-plug Technique With Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket With Buccal Dehiscence.
Official title: Socket Preservation Using Socket-plug Technique With Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket With Buccal Dehiscence: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Socket Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Socket Preservation Using Socket-plug Technique with Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket with Buccal Dehiscence: A Randomized Controlled Clinical Trial.

Detailed description: this randomized controlled clinical trial evaluates the effect of using alloplastic putty bone with socket-plug technique versus ice-cream cone technique regarding dimensional changes in bone width

Eligibility criteria: Inclusion Criteria:

* Single or double rooted teeth indicated for extraction.
* Systemically free patient
* Presence of small buccal dehiscence not exceeding 1/3 of the root.
* Maxillary and Mandibular Arches
* Non-smoker
* Adults or above the age of 21.
* Able to tolerate surgical periodontal procedures.
* Full mouth plaque and bleeding scores less than 15%.
* Compliance with the maintenance program.
* Provide informed consent

Exclusion Criteria:

* Systemic conditions/disease that contraindicate surgical procedure.
* Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
* Extraction socket with intact walls with no buccal dehiscence
* Patients with large distinct pre-apical pathology
* Heavy Smokers more than 10 cigarettes a day
* Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.
* Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.

Primary outcomes:
measure: Quantitative volumetric changes
timeFrame: day 0 - month 6
Secondary outcomes:
measure: Horizontal alveolar ridge width
timeFrame: day 0 - month 6
measure: Vertical alveolar ridge height
timeFrame: day 0 - month 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01878266: Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Official title: Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Brain Stem Glioma
Keywords: Diffuse Intrinsic Pontine Glioma (DIPG)
Hypofractionated Radiotherapy
Radiotherapy
Median survival
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 119
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.

Detailed description: In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma
2. Aged 2-18years,
3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
4. No performance criteria were required for entry onto the study.

Exclusion Criteria:

* Children were not eligible if they had received any prior therapy other than steroids Treatment

Primary outcomes:
measure: Median overall-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
Study officials:
References:
Clinical trial NCT02356666: Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
Official title: Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Disease
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuromuscular disease

Brief summary: Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.

Detailed description: Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.

Eligibility criteria: Inclusion Criteria:

* Neuromuscular disease
* Age ≥18 years
* Non mechanically ventilated

Exclusion Criteria:

* Long-term oxygen therapy

Primary outcomes:
measure: Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions
timeFrame: Baseline (Day 1)
Secondary outcomes:
measure: Concordance between the diagnostic criteria
timeFrame: Baseline (Day 1)
measure: sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)
timeFrame: Baseine (Day 1)
measure: Prognostic value of the different definitions of nocturnal hypoventilation
timeFrame: 5 years
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Adam Ogna, PhD
role: PRINCIPAL_INVESTIGATOR
References: