louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01874899: Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Official title: Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Refractory Low Back and Leg Pain
Lead sponsor: Justin Parker Neurological Institute
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chronic refractory back and leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions.

Brief summary: The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

Detailed description: A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature adults between 18 and 70 years old
* Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
* \> 50% pain reduction during the trail period
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing to sign a study specific informed consent

Exclusion Criteria:

* Previous SCS treatment
* Surgically remediable spinal condition
* Active local or systemic infection

Primary outcomes:
measure: Stimulation amplitude changes in response to postural changes
timeFrame: 6 months
Secondary outcomes:
measure: Sleep quality improvement
timeFrame: 6 months
Other outcomes:
measure: Disability score improvement
timeFrame: 6 months
measure: Pain scores
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Locations:
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
Study officials:
affiliation: Boulder Neurosurgical Associates
name: Kara Beasley, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786199: Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging
Official title: Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplastic Disease
Pathology
Keywords: Hepatocellular Carcinoma(HCC)
Ultrasound
Backscatter
Differentiation grade
Survival
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCC who have received surgical resection

Brief summary: Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor affecting patient survival. It has been divided into four grades from I to IV on the basis of histological differentiation. Grade I is the best differentiated consisting of small tumor cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated with hyperchromatic nuclei and loss of trabecular pattern.

Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot replace liver biopsy for the evaluation of HCC.

This study is aimed to quantify the image characters of B-mode image and the scatterer properties using Nakagami distribution. Nakagami parameter is a general model to describe the distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter may also reflect the histological changes in different grades of HCC.

In this study, the resected HCC tumor samples will be collected from the participants who are going to receive surgical resection, and the tumor US images and Nakagami values will be obtained via the single-element ultrasound system. The correlation between the ultrasound backscatter parameter and the differentiation grade will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Age 21 to 75
* Patients with HCC who underwent surgery
* The resected tumor was measured larger than 3 cm

Exclusion Criteria:

* Patients who have received other treatment in 6 months
* Patients who couldn't regular follow-up

Primary outcomes:
measure: Recurrence-free survival
timeFrame: within two years after surgery
measure: Liver-related mortality
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Surgery, National Taiwan University Hospital
name: Ming-Chih Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691699: A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
Official title: A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: ABBV-903
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is =\> 18.0 to \<= 32 kg/m2 after rounded to the nearest tenth, at Screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline to Day 36
measure: Time to Cmax (Tmax)
timeFrame: Baseline to Day 36
measure: Apparent Terminal Phase Elimination Constant (β)
timeFrame: Baseline to Day 36
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: Baseline to Day 36
measure: Area Under the Plasma Concentration-time Curve (AUC)
timeFrame: Baseline to Day 36
measure: Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)
timeFrame: Baseline to Day 36
measure: Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
timeFrame: Baseline to Day 36
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 66
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 251279
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04671199: Collection of Anonymized Data for Improvement of Domestic Patient Monitor System
Official title: Data Collection for Improvement of Domestic Patient Monitor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: surgical patients

Brief summary: Collection of anonymized data for improvement of domestic patient monitor system comparison of commercial patient monitor

Detailed description: the data from the patient will be collected as the baseline data for improvement of the domestic patient monitor system

Eligibility criteria: Inclusion Criteria:

* surgical patients

Exclusion Criteria:

* problem to monitor

Primary outcomes:
measure: anoymized data collection
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongnogu
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05339399: 4 Versus 6 cm Active Phase of Labour
Official title: 4 Versus 6 cm Cervical os Dilatation to Demarcate Active Phase of Labour: Comparative Cross Ectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Complication
Cervix; Open
Keywords: active labour
4 and 6 cm
low risk women
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low risk pregnant women who delivers in our centre

Brief summary: A study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy.

Detailed description: Low risk women with singleton pregnancy are recruited. There are two groups which are 4 and 6 cm cervical os dilatation. The intrapartum management and labour outcomes are documented.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* no medical disorders
* no antenatal complications such as hypertension and diabetes

Exclusion Criteria:

* fetal anomaly
* one previous caesarean section
* other uterine scars

Primary outcomes:
measure: Caesarean section rate
timeFrame: from recruitment up to birth of neonate
Secondary outcomes:
measure: duration from amniotomy until delivery
timeFrame: from recruitment until up to delivery of neonate
measure: oxytocin augmentation
timeFrame: from recruitment until up to delivery of neonate
measure: Percentage of women with complications
timeFrame: from recruitment until up to 6 weeks post delivery
measure: Percentage of neonates with complications
timeFrame: from birth of neonate up tom 7 days
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Rahana Abd Rahman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05549999: Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment
Official title: Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Ambulation Difficulty
Ambulation Disorder, Neurologic
Keywords: Duchenne Muscular Dystrophy
Ambulation
reliability
validity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 86
Sex: MALE
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population include just ambulatory patients with Duchenne Muscular Dystrophy

Brief summary: The aim of this study is to translate the "North Star Ambulatory Assessment (NSAA)" scale into Turkish and make its cultural adaptation and to demonstrate the reliability and validity of the Turkish version in patients with ambulatory DMD. For the translation into Turkish, validity and reliability of the NSAA, necessary permission was obtained from the developer of the questionnaire, Prof. Dr. Francesco Muntoni, via e-mail. In the study, first of all, the translation and cultural adaptation process will be completed, and then reliability-validity studies will be carried out.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with DMD
* Ambulatory
* Being between the ages of 4-18
* Agreeing to participate in the research voluntarily

Exclusion Criteria:

* Insufficient cooperation with the physiotherapist,
* Have had any injury and/or surgery of the lower extremities in the last 6 months,
* Having neurological problems in addition to DMD. -

Primary outcomes:
measure: North Star Ambulatory Assessment
timeFrame: 10 minutes
Secondary outcomes:
measure: Motor Function Measure (MFM)
timeFrame: 20-30 minutes
measure: 6 meter walking test (6MWT)
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Güllü Aydın Yağcıoğlu
Study officials:
affiliation: Hacettepe University
name: Güllü Aydın Yağcıoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277599: Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain
Official title: Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Nerve Block
Ultrasound
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized,single blind
Primary purpose: TREATMENT

Brief summary: Analgesia following tympanomastoid surgery is critical for the prevention of postoperative . There are very few regional anesthesia methods used to achieve this goal.

Detailed description: In this study, it was aimed to investigate the effect of Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for on postoperative tympanomastoid surgery analgesia.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery.

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: tramadol consumption
timeFrame: Postoperative 24 hour
measure: side effect profile
timeFrame: Postoperative 24 hour
measure: additional analgesic use
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
Study officials:
affiliation: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita
name: Korgün Ökmen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050799: US Post-Market Surveillance Study of the Surfacer System
Official title: US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Disease
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 30
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: Patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods and who meet requirements in the labeling of the IFU.

Brief summary: Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.

Detailed description: Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.

Eligibility criteria: Inclusion Criteria:

1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
3. Subjects are willing and able to give written informed consent

Exclusion Criteria:

1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava
2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
3. Occlusion within the arterial system
4. Occlusion within the coronary or cerebral vasculature

Primary outcomes:
measure: Central Venous Access operational
timeFrame: 24 hours
measure: Incidence of adverse events through 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Dallas
country: United States
facility: Baylor Scott & White Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Pasadena
country: United States
facility: Flow Vascular Institute
state: Texas
city: Millcreek
country: United States
facility: St. Mark's Hospital
state: Utah
Study officials:
References:
Clinical trial NCT02662699: Clinical Signs and Symptoms of Anemia in Patients Over 75 Years
Official title: Clinical Signs and Symptoms of Anemia in Patients Over 75 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Keywords: Anemia
Hematologic Diseases
Erythrocytes
Hemoglobin
Hemolytic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anemic patients

Brief summary: Anemia is a common pathology in geriatrics. According to the World Health Organization it affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in Europe. A prevalence that increases with the age and twice in individuals over 85 years.


Eligibility criteria: Inclusion criteria:

* Adult over 75 years old, male or female

Exclusion criteria:

* Transfusion within 3 months, acute anemia / deglobulisation

Primary outcomes:
measure: Laboratory tests
timeFrame: 1 hour after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Emmanuel ANDRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT00465699: Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Official title: Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eczema
Keywords: Eczema
Pediatric
Vitamin B12
Lead sponsor: Spartanburg Regional Healthcare System
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see in B12 applied to the skin will improve the symptoms of eczema in children compared to a placebo creme

Detailed description: INTRODUCTION: Atopic dermatitis is a prevalent disease process in children, affecting up to 20% of children in the United States. Various treatment options are available to treat atopic dermatitis to include topical emollients, topical steroids, and topical calcineurin inhibitors. Each treatment option has benefits and potential risks. This study was done to determine if topical B12 could be a tolerable and efficacious alternative treatment option in this population.

METHODS: The study was conducted as a placebo-controlled, double-blind, prospective, randomized clinical trial with intraindividual left ⁄ right comparison. Parents were given 2 containers of creams and instructed to apply the Vitamin B12 cream to one side of the body and the placebo cream to the contralateral side according to the randomization scheme.

Eligibility criteria: Inclusion Criteria:

* children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis

Exclusion Criteria:

* unwillingness of parent to consent to study protocol, pregnancy or lactation, eczema with superinfection present, known history of allergy to Vitamin B12 or components of the base cream, topical treatment with corticosteroids in the 4 weeks prior to enrollment

Primary outcomes:
measure: Reduction in SCORAD at 2 and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Center for Family Medicine
state: South Carolina
Study officials:
affiliation: Spartanburg Regional Healthcare System
name: Ronald P Januchowski, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stucker M, Pieck C, Stoerb C, Niedner R, Hartung J, Altmeyer P. Topical vitamin B12--a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial. Br J Dermatol. 2004 May;150(5):977-83. doi: 10.1111/j.1365-2133.2004.05866.x.