louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03063775: Proof of Concept: Socket Seal
Official title: Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tissue Preservation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.

Detailed description: In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:

1. Mucograft® Seal + Bio-Oss®
2. Free Gingival Graft (FGG) + Bio-Oss®
3. Free Gingival Graft + Gelatine sponge (Spongostan®)
4. Spongostan®+ Mucograft® Seal
5. Spongostan®

Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.

Eligibility criteria: Inclusion Criteria:

• Planned extraction in the upper front or premolar region

Exclusion Criteria:

* General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases)
* Acute gingivitis
* Deep pockets (\>5.5mm)
* Apical periodontitis on neighboring teeth
* Heavy smoker (\>10/d)

Primary outcomes:
measure: Soft tissue volume
timeFrame: 2 weeks
measure: Soft tissue volume
timeFrame: 4 weeks
measure: Soft tissue volume
timeFrame: 8 weeks
Secondary outcomes:
measure: Bone volume
timeFrame: 3 months
measure: Bone volume
timeFrame: 6 months
measure: Bone volume
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
References:
Clinical trial NCT00983775: Pharmacology of Insulin Injected With Jet-Injection
Official title: Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Pharmacokinetic profile
Pharmacodynamic profile
insulin
jet injector
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.


Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Body-mass index 18-28 kg/m2
* Blood pressure \<160/90 mmHg
* Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
* Duration of diabetes \>1 year (for patients with type 1 diabetes mellitus)

Exclusion Criteria:

* Inability to provide informed consent
* Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
* Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
* Type 2 diabetes in first-degree relatives (for healthy subjects)
* History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
* Pregnancy
* Macroalbuminuria, i.e. urinary albumin excretion \>200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio \>300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
* Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)
* Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)

Primary outcomes:
measure: (time to) maximal glucose infusion rate
timeFrame: 0-8 hours after insulin injection
Secondary outcomes:
measure: (time to) maximal insulin concentration
timeFrame: 0-8 hours after insulin injection
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: P.O. Box 9101
Study officials:
affiliation: Radboud University Medical Center
name: Cees J Tack, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00358475: Study Of Perennial Allergic Rhinitis
Official title: Study of Perennial Allergic Rhinitis -Long Term Treatment Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Keywords: perennial allergic rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.


Eligibility criteria: Inclusion criteria:

* Informed consent.
* Outpatient.
* Diagnosis of perennial allergic rhinitis with symptoms.
* Able to comply with study procedures.

Exclusion criteria:

* Significant concomitant medical condition.
* Use of corticosteroids/allergy medications.
* Laboratory abnormality.
* Positive pregnancy test.

Primary outcomes:
measure: Adverse events and laboratory blood test
Secondary outcomes:
measure: Change of nasal symptom score
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01629875: Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line
Official title: Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Glabellar Line
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 268
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.



Primary outcomes:
measure: At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
timeFrame: At 4 weeks
Secondary outcomes:
measure: At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
timeFrame: At 8, 12, 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT00063375: Interactive Computer Treatment for Panic Disorder
Official title: Interactive Computer Treatment for Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Panic Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop an interactive computer-based version of cognitive behavioral therapy (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.

Detailed description: Panic disorder (PD) is a highly prevalent and debilitating condition. Unfortunately, many people with PD go untreated because of the high cost and low availability of treatment. Research shows that CBT is an effective treatment for PD. When administered as a self-help, computer based treatment, CBT may provide a less expensive, more engaging treatment for PD.

Participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks. After these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of panic disorder, with or without agoraphobia

Exclusion Criteria:

* Change in medication type or dose 12 weeks prior to study entry
* Suicidal
* Current substance abuse
* Current or past schizophrenia, bipolar disorder, or organic mental disorder. Patients on medications must meet stability requirements such that initial administration of the medication and dose has been maintained for at least 3 months prior to treatment and will be maintained until post-treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT04457375: Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema
Official title: Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema, Secondary
Keywords: tissue dielectric constant
head and neck lymphedema
lymphedema
reference values
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed description: Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Eligibility criteria: Inclusion Criteria:

* Healthy with no current or past skin conditions affecting neck or arms

Exclusion Criteria:

1. Known to have diabetes of any type.
2. Having facial or neck hair that prohibits accurate measurements

Primary outcomes:
measure: Neck-to-Arm TDC ratio
timeFrame: one year
measure: Sub-Mental-to-Arm TDC ratio
timeFrame: one year
Secondary outcomes:
measure: Bilateral values and Variability in TDC values
timeFrame: one year
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
References:
Clinical trial NCT01274975: Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
Official title: Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2011-01-12
Enrollment: 8
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

Detailed description: Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

Eligibility criteria: Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :19-60, males
* Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
* Duration of injury : \> 2 months

Exclusion Criteria:

* Subjects who must put on a respirator
* Subjects who had malignant tumor within 5 years
* Subjects with a infectious disease include HIV and hepatitis
* Subjects who injured brain or spinal cord before spinal cord injury
* Subjects who has high body temperature more than 38℃ or acute disorder
* Subjects with anemia or thrombocytopenia
* Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
* Subjects with congenital or acquired immunodeficiency disorders
* Subjects with muscular dystrophy or articular rigidity
* Patients with clouded consciousness or speech disorder
* treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
* participating another clinical trials within 3 months
* other serious disease or disorder that could seriously affect ability to participate in the study

Primary outcomes:
measure: safety evaluation
timeFrame: 12weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anyang Sam Hospital
name: SangHan Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Clinical trial NCT01456975: Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
Official title: Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ascending Aorta Aneurism
Aortic Insufficiency
Keywords: Ascending aorta aneurism
Aortic insufficiency
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-10-21
Enrollment: 60
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: The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.


Eligibility criteria: Inclusion Criteria:

1. Aortic insufficiency 2+
2. Ascending aorta size more than 5 cm
3. Ascending aorta size more than 4,5 cm (Marfan syndrome)
4. Good conditions of aortic cusps

Exclusion Criteria:

1. Aortic annulus more than 30 mm
2. Aortic cusps destruction
3. Critical aortic cusps elongation
4. Aortic root dissection

Primary outcomes:
measure: all causes of aortic valve replacement
timeFrame: before discharging (average of 2 weeks after surgery)
Secondary outcomes:
measure: all causes of death after procedure
timeFrame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Dmitry A. Sirota
Study officials:
References:
Clinical trial NCT01901575: Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia
Official title: Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia, Ventricular
Keywords: idiopathic ventricular tachycardia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 16
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: TREATMENT

Brief summary: Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin

Detailed description: The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped.

You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin
* Patients between 18 and 65
* ASA 1-3

Exclusion Criteria:

* ASA 4 and 5
* Age 18 and 65

Primary outcomes:
measure: Inhibition of Idiopathic Ventricular Tachycardia
timeFrame: duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours
measure: PVC Suppression With Remifentanil Sedation
timeFrame: duration of the operative procedure, average 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Misha Kogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garofalo NA, Teixeira-Neto FJ, Schwartz DS, Vailati Mdo C, Steagall PV. Effects of the opioid remifentanil on the arrhythmogenicity of epinephrine in halothane-anesthetized dogs. Can J Vet Res. 2008 Jul;72(4):362-6.
Clinical trial NCT05757375: Mulligan Ankle Taping on Volleyball Players
Official title: Effects of Mulligan Ankle Taping in Volleyball Players With or Without Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ankle Instability
Mulligan
Keywords: Chronic ankle instability
Mulligan fibular taping
muscle elasticity
muscle stiffness
muscle tone
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 34
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 34 volunteer professional volleyball players with (n=12) and without (n=22) CAI will include in the study. Mulligan ankle taping will apply. Measurements will take before and after the intervention. Muscle tone, stiffness, and elasticity will measure with MyotonPRO hand-held device. The static balance will measure with single leg stance test(SLST) while the eyes-closed, dynamic balance will measure with the Y balance test(YBT). Single leg hopping test(SLHT) will evaluate performance and an active position sense test will use for JPS. During the static and dynamic balance and performance tests, the ankle's confidence will be evaluated with the Visual Analog Scale (VAS). The study aimed to determine the effect of Mulligan fibular taping over the Tibialis Anterior(TA), Peroneus Longus(PL), Gastrocnemius Lateralis(GCL), and Medialis(GCM) muscles on muscle tone, stiffness, elasticity, as well as the performance, joint position sense(JPS), static and dynamic balance in female volleyball players with and without chronic ankle instability(CAI).


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 15-24,
* Being a professional volleyball player,
* Training for 90 minutes at least 3 days a week,
* Turkish native speakers,
* For participants with chronic ankle instability, those with a Foot and Ankle Disability Index score below 90% and a Foot and Ankle Disability Index-Sport survey score below 75% were included.

Exclusion Criteria:

* An ankle sprain history in the last 6 weeks,
* Having a previous history of fracture in the lower extremity,
* Having bilateral chronic ankle instability,
* Pregnant athletes were excluded from the study.

Primary outcomes:
measure: Myotonometric Measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Single Leg Stand Test with Eyes Closed
timeFrame: 4 weeks
measure: Y Balance Test
timeFrame: 4 weeks
measure: Single Leg Hop Test
timeFrame: 4 weeks
measure: Joint Position Test
timeFrame: 4 weeks
measure: Confidence in the Ankle
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
state: Zeytinburnu
Study officials:
affiliation: İSTİNYE UNIVERSITY
name: ÖZGE ECEM E ŞENEL, PT
role: PRINCIPAL_INVESTIGATOR
References: