louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06123585: Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes
Official title: Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The aim of the present study is to assess the predictability of Invisalign® SmileView™ for digital AI smile simulation in comparison to actual smile treatment outcomes, using various smile assessment parameters.


Eligibility criteria: Inclusion Criteria:

* healthy systemic condition with no chronic diseases
* no previous orthodontic treatment
* adequate oral hygiene
* a healthy periodontium.

Exclusion Criteria:

* chronic diseases
* previous orthodontic treatment
* poor oral hygiene
* periodontal diseases

Primary outcomes:
measure: Smile line
timeFrame: through study completion, an average of 1 year
measure: Smile arc
timeFrame: through study completion, an average of 1 year
measure: The most posterior teeth displayed
timeFrame: through study completion, an average of 1 year
measure: The philtrum height
timeFrame: through study completion, an average of 1 year
measure: Commissure height
timeFrame: through study completion, an average of 1 year
measure: Smile width/Inter-commissure width
timeFrame: through study completion, an average of 1 year
measure: Smile index
timeFrame: through study completion, an average of 1 year
measure: Maxillary inter-canine width
timeFrame: through study completion, an average of 1 year
measure: Buccal corridor
timeFrame: through study completion, an average of 1 year
measure: Amount of lower incisor show
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Private orthodontic offices of Invisalign Diamond Plus Elite
Study officials:
affiliation: Alexandria University
name: Samar M Adel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, University of British Columbia, Vancouver, Canada
name: Yashodhan M Bichu, DSATP
role: STUDY_CHAIR
affiliation: Saveetha Dental College, Saveetha Insitute of Medical and Technical Sciences, Chennai, India.
name: Srirengalakshmi Muthuswamy Pandian, PhD
role: STUDY_CHAIR
affiliation: Private Practice, Invisalign Centre Dubai United Arab Emirates.
name: Waddah Sabouni
role: STUDY_CHAIR
affiliation: Private practice, Mumbai, India
name: Chandani Shah
role: STUDY_CHAIR
affiliation: Saveetha Dental College, Saveetha Insitute of Medical and Technical Sciences, Chennai, India.
name: Nikhillesh Vaid, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03273985: Effectiveness of Dry Needling in Shortened Triceps Surae Muscle
Official title: Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Myofascial Pain Syndrome
Lead sponsor: Universidad de León
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2017-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion.

Exclusion Criteria:

* Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.

Primary outcomes:
measure: Range of motion
timeFrame: Change from Baseline Range of motion at 25 minutes
Secondary outcomes:
measure: Plantar pressures
timeFrame: Change from Baseline Plantar pressures at 25 minutes
measure: Temperature
timeFrame: Change from Baseline Temperature at 25 minutes
measure: Superficial muscle activity
timeFrame: Change from Baseline Superficial muscle activity at 25 minutes
measure: Pressure pain threshold
timeFrame: Change from Baseline Pressure pain threshold at 25 minutes
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Fisiofuenla
state: Madrid
Study officials:
References:
citation: Benito-de-Pedro M, Becerro-de-Bengoa-Vallejo R, Elena Losa-Iglesias M, Rodriguez-Sanz D, Lopez-Lopez D, Palomo-Lopez P, Mazoteras-Pardo V, Calvo-Lobo AC. Effectiveness of Deep Dry Needling vs Ischemic Compression in the Latent Myofascial Trigger Points of the Shortened Triceps Surae from Triathletes on Ankle Dorsiflexion, Dynamic, and Static Plantar Pressure Distribution: A Clinical Trial. Pain Med. 2020 Feb 1;21(2):e172-e181. doi: 10.1093/pm/pnz222.
Clinical trial NCT01572285: Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
Official title: Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: Hemiplegic
Shoulder Pain
Transforaminal
Treatment
Interventional
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.

Detailed description: Shoulder pain is the most common complication in hemiplegia after Stroke (CVA). Almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. Because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. Although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. TF was never investigated to treat Hemiplegic Shoulder Pain (HSP). The investigators hypothesize that injecting the epidural space at the C6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder.

To test this hypothesis, the investigators developed a treatment protocol consisting of two C6 transforaminal epidural steroid injection with dexamethasone (TF with 0.5mL of lidocaine 1% and 1.5mL of Dexamethasone 10mg/ml). This procedure was compared to a sham intervention.

Eligibility criteria: Inclusion Criteria:

* 3 months of shoulder pain following a stroke
* hemiplegia or paresis after a cerebral stroke for at least 6 months
* Shoulder pain greater than 4 in a visual analogue scale
* 50 to 65 years old

Exclusion Criteria:

* inability to understand or answer the tools in the study
* local inflammation or infection
* History of malignancy
* use of cardiac pacemaker
* allergy to lidocaine or dexamethasone
* disorders of coagulation

Primary outcomes:
measure: Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)
timeFrame: 1 week and 3 months after treatment
Secondary outcomes:
measure: Algometry in shoulder muscles
timeFrame: 1 week and 3 months after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
state: SP
Study officials:
affiliation: University of São Paulo General Hospital
name: Joao D Amadera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229385: Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Official title: Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Obsessive Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia and OCD for at least 6 months
* Minimum score of 14 on YBOCS
* Minimum score of 60 on PANSS
* Diagnosis of Schizophrenia without OC symptoms

Exclusion Criteria:

* Patients who are already being treated with ziprasidone
* Diagnosis of schizophreniform disorder
* Organic brain syndrome, mental retardation and pervasive developmental disorder
* Patients having any significantly cardiovascular illness or electrolyte imbalance

Primary outcomes:
measure: YBOCS
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03459885: PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
Official title: Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Validia Rehabilitation Centre
First posted: 2018-03-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1,2). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and investigate its effectiveness for lower extremity rehabilitation.


Eligibility criteria: Inclusion Criteria:

* cervical incomplete SCI

Exclusion Criteria:

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure

Primary outcomes:
measure: Daniels and Worthingham's Muscle Testing
timeFrame: 2 days after the last stimulation session
measure: Daniels and Worthingham's Muscle Testing
timeFrame: 1 month after the last stimulation session
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: BioMag laboratory, Helsinki University Central Hospital
state: Uusimaa
Study officials:
References:
citation: Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016.
citation: Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Makela JP, Shulga A. Long-Term Paired Associative Stimulation Enhances Motor Output of the Tetraplegic Hand. J Neurotrauma. 2017 Sep 15;34(18):2668-2674. doi: 10.1089/neu.2017.4996. Epub 2017 Jul 21.
citation: Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Effects of Long-Term Paired Associative Stimulation on Strength of Leg Muscles and Walking in Chronic Tetraplegia: A Proof-of-Concept Pilot Study. Front Neurol. 2020 May 20;11:397. doi: 10.3389/fneur.2020.00397. eCollection 2020.
Clinical trial NCT02302885: Healthy Human Control Blood Collection for Validation of Biomarker Assay
Official title: Human Blood Collection to Serve as Negative Control for Validation of Circulating Tumor Cell Assay
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Keywords: cancer-free 18-60 year old men and women
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer-free 18-60 year old men and women

Brief summary: Human blood will be collected to serve as control in validating clinical studies studying the detection and levels of circulating tumor cells and microvesicles in cancer patients. Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort, bruising) to the volunteer.


Eligibility criteria: Inclusion Criteria:

* Age range: 18-60 years old Gender: Male and Female

Exclusion Criteria:

* No previously diagnosed malignancy Age: It is important to obtain a healthy, cancer-free volunteer population to serve as negative controls for this detection assay.

Primary outcomes:
measure: blood count
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Jay Dorsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02600585: Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults
Official title: Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults 18 Years of Age and Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Influenza
Lead sponsor: Protein Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2015-11-09
Enrollment: 254648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include adults 18 years of age and older who are vaccinated with either Flublok or IIV within the same time period, e.g. month of the year.

Brief summary: The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).

Detailed description: The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.

Eligibility criteria: Inclusion Criteria:

Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.

Exclusion Criteria:

Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.

Primary outcomes:
measure: Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)
timeFrame: Five months post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Roger Baxter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992485: Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Official title: A Phase I Dose Escalation Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn's Fistula
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 9
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: Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Prior diagnosis of Crohn's disease
* patients who have Crohn's fistula
* negative for urine beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* patients who have allergy to bovine-derived materials or an anesthetic
* patients with a diagnosis of auto immune disease except for Crohn's disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients who have a symptom of septicemia
* Patients with a diagnosis of active Tuberculosis
* Patients who are pregnant or breast-feeding
* Patients who are unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
* Patients who is sensitive to Fibrin glue
* Patients who have a clinically relevant history of abuse of alcohol or drugs
* Insufficient adipose tissue for manufacturing of ADIPOPLUS
* Patients who are considered not suitable for the study by investigator
* Patients who have history of surgery for malignant cancer in the past 5 years

Primary outcomes:
measure: Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events
Secondary outcomes:
measure: Closure of fistula
timeFrame: week 4
measure: Investigator satisfaction
timeFrame: week 4 and week 8
measure: Patient satisfaction
timeFrame: week 4 and week 8
measure: Digital photography
timeFrame: day 1, week 4 and week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
References:
Clinical trial NCT00342485: In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients
Official title: In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cell Function
Keywords: Cellular Immunity
HIV-infected
Immune Deficiency
Cancer
Transplantation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.

Detailed description: Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.

Eligibility criteria: * INCLUSION CRITERIA:

Greater than or equal to 18 years old.

Documented HIV infection by current DoD criteria (1 ELISA, 2 Confirmatory Western Blot) or by one of the following tests; DNA PCR, RNA PCR, p24 antigen test, viral culture assay.

CD4 lymphocyte cell count greater than 300 mm(3).

EXCLUSION CRITERIA:

Unable to provide informed consent.

Unable to meet the minimum (150 days) and maximum (395 days) research visit interval requirements.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Willford Hall USAF Medical Center
state: Texas
Study officials:
References: