louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01138592: Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations
Official title: Pilot Study to Evaluate the Clinical Utility of 3M Littmann Scope-to-Scope Software for Real-time Assessment of Patients at Remote Clinic Locations by Centrally-located Medical Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Auscultation of Heart and Lungs
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2010-06-07
Enrollment: 150
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: Primary Care Patients Hepatitis C Patients

Brief summary: Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.

Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects who are at least 18 years of age
2. Subjects who are scheduled to undergo examination in a telemedicine setting
3. Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.

Exclusion Criteria:

1. Subjects who are unwilling to undergo additional examination in a telemedicine setting,
2. Any subject requiring time-critical medical intervention.
3. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.

Primary outcomes:
measure: Confirmation of hub (remote) observations with satellite (local) observations
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: North Country Health Care
state: Arizona
Study officials:
affiliation: North Country Health Care, Flagstaff, AZ
name: Eric Henley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310492: Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* Positive specific IgE to house dust mites
* Atopic dermatitis according to Hanifin/Rajka
* Chronic course of Atopic dermatitis
* SCORAD larger than 25 points

Exclusion Criteria:

* Erythrodermia
* Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
* History of specific immunotherapy with mites
* UV radiation
* Group 4 topical corticosteroids (European classification)

Primary outcomes:
measure: Changes from baseline in SCORAD and topical medication consumption
timeFrame: 1 year
Secondary outcomes:
measure: Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption
timeFrame: 1 year
Other outcomes:
measure: SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire
timeFrame: 1 year
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
Study officials:
affiliation: ALK-SCHERAX Arzneimittel GmbH
name: Hendrik Wolf, PhD
role: STUDY_DIRECTOR
affiliation: Hannover Medical School
name: Alexander Kapp, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05288192: Changes After Suprachoroidal Injection.
Official title: Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retina; Change
Intraocular Pressure
Cataract
Macular Edema
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Changes after suprachoroidal injection are analyzed for statistical analysis.

Detailed description: Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.
* Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.

Exclusion Criteria:

* Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.
* Choroidal neovascularization that require anti-vascular endothelial growth factors.
* Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.

Primary outcomes:
measure: Changes in visual acuity
timeFrame: Monthly after injection till six months of follow up
measure: Changes in central foveal thickness
timeFrame: Monthly after injection till six months of follow up
Secondary outcomes:
measure: Changes in intraocular pressure
timeFrame: Monthly after injection till six months of follow up
measure: Changes in lens
timeFrame: Monthly after injection till six months of follow up
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Tabl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280292: Central Hypothyroidism, a Novel Laboratory Measurement
Official title: Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Hypothyroidism
Keywords: central hypothyroidism, hypopituitarism, eltroxin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.


Eligibility criteria: Inclusion Criteria:

* Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH

Exclusion Criteria:

* Primary hypothyroidism

Primary outcomes:
measure: free T4 levels
timeFrame: a year
Secondary outcomes:
measure: Symptoms of hypothyroidism
timeFrame: a year
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Ruth Percik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991692: A Multisite Trial of ACQUIREc Therapy
Official title: A Multisite Trial of ACQUIREc Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparetic Cerebral Palsy
Keywords: Pediatric CI Therapy
ACQUIREc Therapy
Dosage
Occupational Therapy
Physical Therapy
Cerebral Palsy
Hemiparesis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.


Eligibility criteria: Inclusion Criteria:

* Children 3-6 years of age
* Hemiparetic CP

Exclusion Criteria:

* No prior CI therapy treatments
* No Botox for 6-months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Stephanie C DeLuca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: effects of therapeutic dosage. J Pediatr Rehabil Med. 2012;5(2):133-42. doi: 10.3233/PRM-2012-0206.
Clinical trial NCT00435292: Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee
Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-02-14
Enrollment: 350
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Detailed description: This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks.

Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis.

Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* OA of the Knee
* K-L Grade 2-3
* Positive response to NSAIDS

Exclusion Criteria:

* K-L grade 1 0r 4 OA of the knee
* History of GI Bleed within past 5 years
* Chronic bleeding disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Primus Pharmaceuticals, Inc
state: Arizona
Study officials:
affiliation: Primus Pharmaceuticals,Inc
name: Robert M Levy, MD
role: STUDY_DIRECTOR
affiliation: Private Practice
name: Alan Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537692: Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol
Official title: A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Male or female subjects 18-45 years of age
* General good health

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
* Participation in any investigational drug study 30 days preceding Screening Visit
* History of respiratory infection/disorder with 28 days preceding Screening Visit

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hours post dose
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hours post dose
measure: Safety and tolerability of BDP HFA nasal aerosol
timeFrame: 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Teva Global Respiratory Research
name: Sudeesh Tantry, PhD
role: STUDY_DIRECTOR
References:
citation: Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22.
Clinical trial NCT01232192: Study of Antenatal Model to Prevent Preterm Delivery
Official title: Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Delivery
Pregnant Women
Antenatal Care Model
Lead sponsor: Showa University
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2010-11-02
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery

Detailed description: The standard antenatal care nowadays can not answer for preterm delivery problems. Thus, comprehensive and proactive approach is needed for preventing preterm delivery. This antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered pH check

Eligibility criteria: Inclusion Criteria:

* 14- 18 week gestation pregnant women with or without any vaginal discharge
* singleton pregnancy, without any fetal or uterine anomaly

Exclusion Criteria:

* Any complication in pregnancy
* Any history of disease in pregnancy

Primary outcomes:
measure: all preterm delivery
timeFrame: 37 weeks
Secondary outcomes:
measure: knowledge of midwife about preterm
timeFrame: one year
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
Study officials:
affiliation: Dept Obstetrics Gynecology, Indonesia University
name: Ali Sungkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sungkar A, Purwosunu Y, Aziz MF, Pratomo H, Sutrisna B, Sekizawa A. Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate. Int J Gynaecol Obstet. 2012 Jun;117(3):264-7. doi: 10.1016/j.ijgo.2012.01.007. Epub 2012 Mar 23.
Clinical trial NCT05488392: Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy
Official title: Safety and Tolerability of Intrajugular Cooling in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
hypothermia
thrombectomy
intrajugular cooling
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years;
2. Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion;
3. In line with the indications for mechanical thrombectomy without contraindications;
4. Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography;
5. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

1. Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia;
2. Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure;
3. Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation;
4. Difficulty in reaching the designated position of the device used for intrajugular cooling;
5. Difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.

Primary outcomes:
measure: Number of participants with major response
timeFrame: Within 24 hours after hypothermia with intrajugular cooling
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06165692: The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.
Official title: The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Swelling
Tooth Position Anomalies
Tooth, Impacted
Tooth Extraction Status Nos
Tooth Avulsion
Keywords: third molar surgery
facial swelling
3D facial swelling evaluation
PRF
tooth impacted
platelet rich fibrin
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

Detailed description: The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 32 years who required both M3M extractions were recruited
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion Criteria:

* Person under the age of 18 or over 32
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease

Primary outcomes:
measure: Facial swelling qualitative analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - volumetric differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - linear differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes:
measure: Trismus analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Pain analysis with Visual analogue scale (VAS)
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University of Catanzaro
Study officials:
References:
Clinical trial NCT01059292: TIPE2 Associated With Kidney Transplant
Official title: Department of Renal Transplantation, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Renal Transplant
Keywords: we have complieted party research
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: kidney transplant patients and healty Volunteers

Brief summary: TIPE2, a negative regulator of innate and adaptive immunity that maintains immune homeostasis. The investigators want to know whether TIPE2 is a risk factor for graft loss and gives rise to the immune dysfunction in renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* long-term surival(\>5year),AR and CR kidney transplant patients and healty Volunteers as control

Exclusion Criteria:

* without hepatitis , tumor and infections

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: