louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05022745: ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.
Official title: ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mobility
Opioid Use
Instable Spine
Keywords: Enhanced recovery after surgery (ERAS)
Posterior lumbar Interbody arthrodesis (PLIA)
length of hospital stay (LOS)
opioid use
Lead sponsor: AZ Nikolaas
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study in patients undergoing PLIA
Primary purpose: TREATMENT

Brief summary: Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.

Detailed description: Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent

Exclusion Criteria:

* Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).

Known kidney insufficiency: GFR \<30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux

Primary outcomes:
measure: Length of hospital stay
timeFrame: 2-3 days + 11 days
Secondary outcomes:
measure: Pain intensity
timeFrame: day of discharge
measure: Analgesic use, including opioids
timeFrame: 2-3
measure: 11-days readmission rate
timeFrame: discharge + 11 days
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
References:
Clinical trial NCT01563445: Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
Official title: Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Intracerebral Haemorrhage
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 40
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: This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).


Eligibility criteria: Inclusion Criteria:

* Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
* Signed informed consent form, or an exception from standard informed consent requirements

Exclusion Criteria:

* Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
* Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma
* Surgical haematoma evacuation planned or performed within 24 hours of onset

Primary outcomes:
measure: Occurrence of a treatment-related serious adverse event (SAE)
Secondary outcomes:
measure: Occurrence of adverse events
measure: Change in ICH volume as measured by CT head scans
Other outcomes:
Locations:
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Mayer SA, Brun NC, Broderick J, Diringer MN, Davis SM, Steiner T. Safety and Preliminary Efficacy of Recombinant Coagulation Factor VII in Patients with Acute Intracerebral Hemorrhage. Stroke 2004; 35: 322
citation: Diringer MN, Skolnick BE, Mayer SA, Steiner T, Davis SM, Brun NC, Broderick JP. Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage. Stroke. 2008 Mar;39(3):850-6. doi: 10.1161/STROKEAHA.107.493601. Epub 2008 Jan 31.
citation: Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care. 2006;4(3):206-14. doi: 10.1385/NCC:4:3:206.
Clinical trial NCT00000445: Use of Naltrexone in a Clinical Setting
Official title: Effectiveness of Naltrexone in a Community Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence (within the past 3 months).
* Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
* Must be able to provide an informed consent.
* Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
* Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.

Exclusion Criteria:

* Meets criteria for opiate dependence.
* Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease.
* Women who are pregnant, nursing, or not practicing an effective means of birth control.
* Currently being prescribed naltrexone.
* Known sensitivity or allergy to naltrexone.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Center for Drug and Alcohol Programs, Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT06041945: Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Official title: Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Neoplasms
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.


Eligibility criteria: Inclusion Criteria:

* All \>40 years-old patients undergoing colonoscopy for selected indications

Exclusion Criteria:

* patients with personal history of CRC, or IBD
* patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.

Primary outcomes:
measure: Non-inferiority in Adenoma Detection Rate
timeFrame: 4 years
Secondary outcomes:
measure: Negative Predictive Value for colorectal neoplasia
timeFrame: 4 years
measure: Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
timeFrame: 4 years
measure: Change in the cost of polypectomy and histology in screening programs
timeFrame: 4 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References:
Clinical trial NCT03540745: Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation as an Adjunctive Therapy for Substance Dependence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Insomnia
Substance Abuse
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Carrier Clinic
First posted: 2018-05-30
Enrollment: 14
Sex: ALL
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: Randomized Controlled Trial with block randomization
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical Stimulation (TES) is a viable adjunctive treatment of substance use treatments.

Detailed description: A Randomized Controlled Trial with block randomization. Inpatient subjects actively seeking substance abuse treatment at the Carrier Clinic who are diagnosed with a substance use disorder, including alcohol use disorder, tobacco use disorder, polysubstance use disorder, or other substance use disorder.

Eligibility criteria: Inclusion Criteria:

1. Be able to provide informed consent, assessed by the study clinician
2. Be able to speak, read and write fluently in English, assessed by the study clinician
3. Be committed to completion of the study. The subject will need to attest to availability for 10 to 15 treatments over a 5 to 8 day period for the treatment protocol.
4. Be adults over age 18 and under age 65
5. Be actively receiving substance use treatment for a substance use disorder

Exclusion Criteria:

1. Pregnant or at risk of becoming pregnant
2. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk

Primary outcomes:
measure: Treatment response
timeFrame: 5-8 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Belle Mead
country: United States
facility: Carrier Clinic
state: New Jersey
Study officials:
affiliation: University of Arizona
name: Michael R Grandner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920945: OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Official title: OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: New Daily Persistent Headache
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-08-12
Enrollment: 6
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: The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one that is difficult to treat and does not respond to preventive or abortive medications. Some patients experience migrainous features such as nausea, vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine, will be injected into specific muscles of the head and neck area by your study doctor, to evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been approved for NDPH and this is the first time it will be used for treatment of NDPH. All participants in this study will only receive BOTOX® and no other study drug.


Eligibility criteria: Inclusion Criteria:

Subjects aged 18 or older, male or female of any race with the diagnosis of NDPH meeting International Classification of Headache Disorders (ICHD-2) criteria will be included in the study. The criteria is as follows:

A. Persistent headache fulfilling criteria B and C B. Distinct and clearly remembered onset, with pain becoming continuous and unremitting within 24 hours C. Present for \>3 months D. Not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

1. Those with relevant physical or psychological illness, particularly conditions that might put them at risk if exposed to OnabotulinumtoxinA (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other neuromuscular disease).
2. Diagnosis of other primary/secondary headache disorder.
3. Psychiatric disorders that could interfere with study participation.
4. Subjects who abuse drugs, including headache treatments and alcohol (DSM IV criteria).
5. Those allergic to compounds similar to the study medication.
6. Those who are pregnant or breastfeeding, or who do not use adequate contraceptive methods.
7. Those who have had any prior exposure to any botulinum toxin serotype.

Primary outcomes:
measure: change from baseline in frequency of headache days
timeFrame: 29 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Roosevelt Hospital Headache Institute
state: New York
Study officials:
References:
Clinical trial NCT05533645: Food Frequency Questionnaire to Assess Sodium Intake
Official title: Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Renal Insufficiency
Keywords: natriuresis
Hypertension
Renal insufficiency
Sodium
Table salt
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram.

The objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients.

EvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.


Eligibility criteria: Inclusion Criteria:

* Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases
* Patients over 18 years old
* Patients in nephrology and cardiology consultation or recruited by CIC
* Patients with health insurance
* Patients willing to follow the full study

Exclusion Criteria:

* Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis
* Modification of the therapeutic management of patients during the study period
* Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis
* Pregnant or breastfeeding women
* Patients protected by law

Primary outcomes:
measure: Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values
timeFrame: through study completion an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: d GUYONNET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02945345: Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Official title: Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatomyositis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 300
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: Adult patients who have been diagnosed with dermatomyositis.

Brief summary: The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis.

The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL).

The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.


Eligibility criteria: Inclusion Criteria:

* Gender/Age: Males or females above 18 years old
* Diagnosis: Cutaneous Dermatomyositis
* Subjects able to give informed consent

Exclusion Criteria:

* Subjects without cutaneous DM
* Penn employees
* Penn students
* Cognitively impaired persons

Primary outcomes:
measure: Cutaneous Dermatomyositis Disease Area and Severity Index
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Skin quality of life tool
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: