louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06942819: MRI Outcomes of VersaWrap Verve Protector Following Surgery
Official title: Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lumbar Decompression
Keywords: VersaWrap
Decompression
Lead sponsor: Research Source
Sponsor class: NETWORK
First posted: 2025-04-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the following criteria and none of the exclusion will be enrolled in the study. A patient is considered enrolled upon successful placement of VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize VersaWrap then the patient will be considered a screen failure.

Brief summary: The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.

Detailed description: This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 and ≤65 at time of surgery
2. Patients undergoing lumbar decompression bilaterally at one level from L4-S1
3. Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.

Exclusion Criteria:

1. Non-English speaking
2. Known allergy or sensitivity to citrate, alginate or hyaluronate
3. Known allergy or sensitivity to MRI contrast dye
4. Known to experience claustrophobia
5. Pregnant or breastfeeding at time of surgery
6. Incarcerated at time of surgery
7. Prior lumbar surgery at the index level
8. Conjunction device use at index level (i.e., Barricade)\*
9. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol \*Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable

Primary outcomes:
measure: MRI
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Neurosurgeons
state: Texas
Study officials:
References:
Clinical trial NCT04034719: Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home
Official title: Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn, Disease
Keywords: Newborn
Parents
Carrying
Skin-to-skin
Scarf
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 80
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.

In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

Detailed description: This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).

Eligibility criteria: Inclusion Criteria:

For the child:

* Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne

For the parent (father or mother):

* Be a parent of a child eligible for the research protocol

Exclusion Criteria:

For the child:

* Need for sedation or analgesia for the duration of the study
* Orthopedic pathology incompatible with the practice of carrying
* Other medical contraindications to carriage
* Absence of parents

For the parent (father or mother):

* Family, social or psychological situation compromising the evaluation
* No fluency in the French language

Primary outcomes:
measure: Number of minuts with portage skin-to-skin
timeFrame: From inclusion to 2 months after exit
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882319: Irritation and Sensitization Study of HP-5000 Topical System
Official title: An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis of the Knee
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.

Detailed description: This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent prior to entering the study or undergoing any study procedures;
* Subject is a generally healthy male or female 18 to 65 years of age;
* Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.

Exclusion Criteria:

* Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
* Subject has severe cardiac, renal or hepatic impairment;
* Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.

Primary outcomes:
measure: Evaluating skin irritation with Mean Irritation Score (MIS)
timeFrame: 21 days
measure: Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: Noven Pharmaceuticals, Inc.
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01615419: An Observational Study of RoActemra/Actemra (Tocilizumab) in Rheumatoid Arthritis Patients
Official title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 60
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: Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra

Brief summary: This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
* Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or of any joint inflammatory disease other than RA

Primary outcomes:
measure: Proportion of patients on RoActemra/Actemra treatment at 6 months
timeFrame: approximately 2 years
Secondary outcomes:
measure: Rates of dose modifications/interruptions
timeFrame: approximately 2 years
measure: Clinical/demographic patient characteristics at initiation of treatment
timeFrame: approximately 2 years
measure: Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
timeFrame: approximately 2 years
measure: Efficacy: Monotherapy versus combination therapy
timeFrame: approximately 2 years
measure: Use of disease-modifying anti-rheumatic drugs (DMARDs)
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Larissa
country: Greece
city: Patras
country: Greece
city: Patras
country: Greece
city: Rhodes
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00705419: Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)
Official title: COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 180
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: The registry will enroll subjects who received vicriviroc or control in a Phase 2 or 3 clinical trial (with the exception of P03802 and ACTG A5211 \[and its rollover P04100\]), and are no longer receiving study medication.

Brief summary: Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.

Detailed description: A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.

Eligibility criteria: Inclusion Criteria:

* Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.

Exclusion Criteria:

* Unwillingness to participate in the registry or give informed consent.

Primary outcomes:
measure: Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
timeFrame: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.
Secondary outcomes:
measure: Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.
timeFrame: Every 6 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05908019: The Effects of Pulmonary Hypertension Web-Based Health Care Program on Symptom Management, Social Support, Activity Tolerance, and Quality of Life in Patients With Pulmonary Hypertension.
Official title: The Effects of Pulmonary Hypertension Web-Based Health Care Program on Symptom Management, Social Support, Activity Tolerance, and Quality of Life in Patients With Pulmonary Hypertension.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Web-based Health Care Program
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pulmonary arterial hypertension (PAH) is a chronic disease characterized by an elevation in pulmonary artery pressures and pulmonary vascular resistance. The condition most often is rarely detected, and patients frequently suffer symptoms for several years before being appropriately diagnosed. Patients with PH suffer from several symptoms, such as exertional dyspnea, fatigue, weakness, chest pain, fainting...et al. Pulmonary hypertension is an incurable and progressive disease with complex symptoms and treatments. Patients must learn to deal with their unpredictable future and manage the complex treatments associated with severe adverse effects and need significant changes in lifestyle.

Therefore, it is important to assist patients to develop the ability of symptom management.


Eligibility criteria: Inclusion Criteria:

1. At least 20 years old, diagnosed by clinical specialists as patients with pulmonary hypertension (Group1 and Group 4)
2. Clear consciousness, able to communicate in Mandarin and Taiwanese, with normal hearing
3. Those who have internet or mobile internet at home
4. Adults without mental illness
5. No alcohol or drug abusers.

Exclusion Criteria:

1. critical disease

Primary outcomes:
measure: Pulmonary Arterial Hypertension Symptom
timeFrame: Change from Baseline pulmonary Arterial Hypertension Symptom at six months
Secondary outcomes:
measure: Social support
timeFrame: Change from Baseline social support at six months
measure: Activity ability
timeFrame: Change from Baseline activity ability at six months
measure: Pulmonary Hypertension Quality of life
timeFrame: Change from Baseline quality of life at six months
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
Study officials:
References:
Clinical trial NCT03571919: Lidocaine Infusions for Rib Fractures
Official title: Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rib Fracture Multiple
Trauma Chest
Pain, Acute
Keywords: Lidocaine infusion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.


Eligibility criteria: Inclusion Criteria:

Patients aged 18 or older with 2+ rib fractures or \> 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI \> 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)

Exclusion Criteria:

Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS \< 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR \< 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic

Enrollment in other study that may affect the results of this study

Primary outcomes:
measure: Opioid pain medicine usage
timeFrame: Average per 24 hours
Secondary outcomes:
measure: PCA requirements
timeFrame: 5 days
measure: Pain score
timeFrame: 5 days
measure: Length of stay
timeFrame: 5 days
measure: Respiratory failure
timeFrame: 5 days
measure: Death
timeFrame: up to 30 days
measure: Mobility
timeFrame: 2 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Jeff Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Michael Y Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267419: Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
Official title: Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Oral Cancer
Leukoplakia
Oral Keratoses
Keywords: malondialdehyde
nitric oxide
salivary biomarkers
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: out patients

Brief summary: investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.

Detailed description: Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).

In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).

Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions

Eligibility criteria: Inclusion Criteria:

* healthy individuals with one of the following oral lesions :

  * keratosis
  * Oral lichen planus
  * oral squamous cell carcinoma
  * oral leukoplakia

Exclusion Criteria:

* subjects having systemic disorders
* pregnant or lactating females;
* subjects who suffered from any other mucosal lesions;
* severe periodontal inflammation.

Primary outcomes:
measure: Salivary MDA level in different oral lesions
timeFrame: 9 months
measure: Salivary NO level in different oral lesions
timeFrame: 9 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Abdelkawy, Phd
Study officials:
affiliation: Cairo University
name: weam Elbattawy, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844519: Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Cardiovascular Disease
Inflammation
HIV Infections
Keywords: Treatment Experienced
CCR5 receptor
maraviroc
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Pfizer
First posted: 2009-02-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
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 the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.


Eligibility criteria: Inclusion Criteria:

1. Stable antiretroviral therapy for at least 12 months
2. All plasma HIV RNA levels within the past year must be below level of detection (\< 50 copies RNA/mL), although isolated single values \> 50 but \< 200 copies will be allowed.
3. Screening plasma HIV RNA levels \< 50 copies RNA/mL
4. \>90% adherence to therapy within the preceding 30 days, as determined by self-report
5. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
4. Concurrent or recent exposure to any immunomodulatory drugs
5. Advanced liver disease or active hepatitis B or C
6. Patients with systolic blood pressure \<100/70
7. Starting or stopping statin therapy during the trial

Primary outcomes:
measure: Percent Change in FMD
timeFrame: Baseline, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References: