louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01198470: TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Official title: A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Keywords: Low back pain
Leg pain
Discogenic pain
Degenerative Disc Disease (DDD)
Herniated disc
Radiculopathy
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 20
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: The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.


Eligibility criteria: Inclusion Criteria:

* Degenerative Disc Disease in one vertebral level between L1 and S1
* Able to understand and sign informed consent
* Had at least 6 months of conservative treatment
* Oswestry Disability Index Score of at least 30 (one a 100 point scale)
* Other inclusion criteria as specified in approved IDE protocol

Exclusion Criteria:

* Bilateral leg pain
* Back or leg pain of unknown etiology
* Prior fusion surgery or another spinal device implanted at any other lumbar level
* Osteoporosis or osteopenia
* Other exclusion criteria as specified in approved IDE protocol

Primary outcomes:
measure: Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
timeFrame: 24 months
measure: Number of Participants With No Device Failures
timeFrame: 24 months
measure: Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage
timeFrame: 24 months
measure: Number of Participants Determined to Have a Normal Neurological Status
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
Study officials:
References:
Clinical trial NCT04036370: Continuous Pectoral Nerve Block in Breast Cancer Surgery
Official title: The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Blocks
Breast Surgery
Postoperative Pain
Keywords: pectoral nerve block (pecs block)
breast cancer
postoperative pain
numeric rating scale score (NRS score)
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-29
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.

Detailed description: Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II
* 18-65 years
* Body mass index (BMI) ≤40 kg/m2
* Elective breast cancer surgery

Exclusion Criteria:

* ASA ≥4
* under 18 years of age or over 65 years of age
* declining to give written informed consent
* history of allergy to the local anesthetics
* contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for chronic pain
* history of nerve blocks in order to treat postoperative pain

Primary outcomes:
measure: analgesia consumption
timeFrame: 12 hours
Secondary outcomes:
measure: analgesia consumption
timeFrame: during the surgery
measure: postoperative Numeric Rating Scale (NRS) score
timeFrame: 0, 1, 3, 6, 9, 12 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya TRH
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
citation: Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. No abstract available.
citation: Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Clinical trial NCT05328570: Comparing the Effects of Exercise on the Structure and Function of Fat Tissue
Official title: Effects of Exercise Training on the Structure and Metabolic Function of Fat Tissue
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adiposity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.


Eligibility criteria: Inclusion Criteria:

* Age: 18-40 years old
* Body Mass Index: 23-35 kg/m2
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism, or inflammation
* Weight instability ≥ ± 6 pounds in the last 6 months
* Tobacco or e-cigarette users
* Women must not be pregnant or actively lactating
* Blood pressure \> 140/90 mmHg

Primary outcomes:
measure: Blood Glucose Level
timeFrame: 2 hours at Experimental Trial
measure: Adipose tissue fibrosis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02608970: Safety and Tolerability Study of BMS-986177 in Healthy Subjects
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
* Other protocol-defined exclusion criteria could apply

Primary outcomes:
measure: Safety of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Approximately 3 days
measure: Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Approximately 16 days
measure: Tolerability of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Approximately 3 days
measure: Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Approximately 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Belgium NV
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01814670: Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Rhytides
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.


Eligibility criteria: Inclusion Criteria:

* moderate or severe frown lines
* facial laser treatment between 4 to 8 weeks prior to Day 1

Exclusion Criteria:

* previous use of botulinum toxin for any indication
* diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
* facial cosmetic procedures within the last 6 Months
* treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
* use of a new topical skin care product within 1 month of the screening
* any prior forehead or periorbital surgery or brow lift
* deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
* any facial skin infection or unhealed skin lesion
* pregnant or breast-feeding

Primary outcomes:
measure: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
timeFrame: Day 1, Day 30
Secondary outcomes:
measure: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
timeFrame: Day 1, Day 14, Day 90, Day 120
measure: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
timeFrame: Day 1, Day 14, Day 30, Day 90, Day 120
measure: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
timeFrame: Day 1, Day 14, Day 30, Day 90, Day 120
measure: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
timeFrame: Day 1, Day 14, Day 30, Day 90, Day 120
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2.
Clinical trial NCT03145870: Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
Official title: Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thrombosis
Multiple Myeloma
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.

The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.


Eligibility criteria: Inclusion Criteria:

* Patient major age ≥18 years
* Patients with symptomatic myeloma meeting the definition of the International Myeloma Working Group, regardless of the therapeutic line, including patients in remission and untreated.
* Patient having given informed consent, signed.
* Patient benefiting from a social security scheme

Exclusion Criteria:

* Patients with non-symptomatic myeloma (stage I) or gammapathy of unknown significance (MGUS).
* Patient undergoing antithrombotic treatment for deep or superficial venous thrombosis and / or pulmonary embolism at the time of inclusion.
* Patients with occlusive arterial disease of the lower limbs known at the time of inclusion.
* Minors, protected adults and patients deprived of liberty or not affiliated to a social security scheme
* Pregnant woman
* Patient unable to express consent.
* Patient under guardianship or curatorship or patient deprived of public liberty

Primary outcomes:
measure: Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02471170: Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Official title: Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic Diseases
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with pancreatic diseases

Brief summary: The purpose of this study is to collect blood samples to detect potential markers of pancreatic cancer in the blood and link these findings to medical and health information. Information from this study may help to provide insight into the detection of pancreas cancer in the blood before it can be found by other methods or provide a method of monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of this study is to collect blood to create a biobank.


Eligibility criteria: Inclusion Criteria:

1. The subject must be a patient at the Hospital of the University of Pennsylvania

   * The subject must be under evaluation and/or treatment for a pancreatic disease
   * The subject must be under evaluation and/or treatment for a non-pancreatic disease. For example, patients undergoing routine colonoscopy within the clinical practice will be asked to consent to provide control samples.
2. The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
3. The subject must be 18 years of age or older

Exclusion Criteria:

1. The subject or acceptable surrogate does not provide informed consent
2. Subject is a prisoner
3. Subject is under 18 years of age

Primary outcomes:
measure: Collection of blood and tissue samples from subjects with pancreatic diseases
timeFrame: 3 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: Peter O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05478070: Continuous Glucose Monitoring for Personal Protective Equipment Evaluation
Official title: The Use of Continuous Glucose Monitors in the Care of Pregnant and Postpartum Women to Limit Frequency of Staff Exposure and Preserve Staff Personal Protective Equipment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus (DM)
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-50 years with a viable singleton or twin intrauterine pregnancy between 8 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Diagnosis of pre-gestational or gestational diabetes mellitus A2, admitted to the hospital for labor or other antepartum admissions (besides DKA or glucoregulation)
* Able to understand the study, and having understood, provide written informed consent in English
* Infants who survive to hospital discharge who are born to women enrolled in the study

Exclusion Criteria:

* Participation in another trial that may influence the primary outcome, without prior approval
* Higher order pregnancy
* History of severe skin allergy to adhesive products or CGM
* DKA, admission for glucoregulation
* COVID-19 PUI or confirmed positive

Primary outcomes:
measure: Maternal outcomes
timeFrame: 1 year
measure: Neonatal outcomes
timeFrame: 1 year
measure: Maternal outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Elizabeth Buschur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03962270: Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
Official title: Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Cartilage Injury
Keywords: Extracorporeal Shock Wave Therapy
Knee Osteoarthritis
Cartilage Injury
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition


Eligibility criteria: Inclusion Criteria:

* Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
* MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
* Kellgren - Lawrence (K - L) grade II - III grade
* The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
* Informed consent and sign relevant documents
* Follow doctor's instructions and follow up on time

Exclusion Criteria:

* Metabolic arthritis
* Trauma of bone joint
* Inflammatory diseases
* Previous knee surgery history
* History of knee cavity injection in the past 6 months
* Serious cardiovascular diseases, pulmonary diseases or other serious diseases affecting survival, etc

Primary outcomes:
measure: magnetic resonance imaging of knee
timeFrame: Baseline (before treatment)
measure: magnetic resonance imaging of knee
timeFrame: Three months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univercity Third Hospital
state: No State Or Province
Study officials:
References: