louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03685370: PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique
Official title: PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Postoperative Complications
Pancreatic Cancer
Haemodynamic Instability
Keywords: Epidural catheter
postoperative pain
LOS
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.

Detailed description: About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.

Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.

Eligibility criteria: Inclusion Criteria:

* scheduled for open pancreatic surgery
* ASA \< = 3

Exclusion Criteria:

* scoliosis
* coagulation abnormalities
* antiplatelet drugs (except ASA)
* history of back surgery
* anticipated need of ICU stay

Primary outcomes:
measure: Incidence of catheters malfunctions in LOS and X-ray group
timeFrame: every day until 7th postoperative day
Secondary outcomes:
measure: Evaluate daily pain differences between groups: NRS (Numeric rating scale)
timeFrame: every day until 7th postoperative day
measure: Monitoring postoperative surgical complications between groups
timeFrame: at 30th postoperative day
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda ospedaliero-universitaria integrata Verona
state: Veneto
Study officials:
affiliation: AOUI Verona
name: Alvise Martini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06805370: Additional Mailed FIT Kits
Official title: Randomized Trial of Additional Mailed FIT Kits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: fecal immunochemical test (FIT)
cancer screening
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 1700
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, the health system mailed a random subset of patients ages 60 to 75 a FIT Kit in November 2024 in addition to sending patients an annual FIT Kit mailing. This work analyzes the return rate of mailed FIT Kits within 60-days of the November mailing.

Detailed description: This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, patients ages 60 to 75 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were randomized to be sent a FIT Kit in November of 2024 or to usual care. Usual care includes an annual FIT Kit mailing. We will analyze the successful return rate of mailed FIT Kits within 60-days of the November mailing.

Eligibility criteria: Inclusion Criteria:

* Age 60-74
* Due for colorectal cancer screening;
* Not sent a FIT Kit in the past 3-months;
* Previously successfully returned a FIT Kit.

Exclusion Criteria:

* Under age 60 or over age 74;
* Incarcerated;
* Not due for colorectal cancer screening;
* Sent a FIT Kit in the past 3-months.

Primary outcomes:
measure: FIT Kit return rate
timeFrame: 60-Days
Secondary outcomes:
Other outcomes:
Locations:
city: Martinez
country: United States
facility: Contra Costa Health
state: California
Study officials:
References:
Clinical trial NCT05877170: Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain
Official title: Evaluation of the Analgesic and Anti-inflammatory Activities of a Nutraceutical Agent Containing PEA in the Management of Patients With Orofacial Pain, Both Neuropathic and Nociceptive in Nature
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral-facial Pain
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is the most common symptom faced by dentists, whether acute (pulpitis, acute periodontitis, post-surgical, etc.) or chronic (chronic periodontitis, muscle pain, TMJ disorders, BMS, OLP, etc.). The success of therapy depends on the reduction and management of pain. Therefore, over the past few years, the need has emerged, also in relation to the aging population, to analyze new molecules with pain-relieving activity and with low risk of inducing side effects and interactions with other drugs; capable of bringing about the reduction of oro-facial pain; and that lend themselves to prolonged use. Palmitoylethanolamide (PEA) is a bioactive lipid mediator similar to endocannabinoids (eCBs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant, antimicrobial, antipyretic, antiepileptic, immunomodulatory, and neuroprotective activities.

The objective is to clinically study, through a clinical trial, the pain-relieving and anti-inflammatory properties of a PEA-containing nutraceutical agent in the management of patients with orofacial pain, both neuropathic and nociceptive in nature.

Detailed description: A double-blind placebo-controlled study was conducted to evaluate the efficacy of Palmitoyletinolamide (PEA) and determine the statistical significance of its action.

40 patients with both acute and chronic orofacial pain were divided into two groups: study group given a nutraceutical agent containing PEA and a control group given a placebo. A three-month follow-up will be conducted.

Eligibility criteria: Inclusion Criteria:

* good general health condition,
* presence of diffuse or localized oro-facial pain of nociceptive nature or postoperative pain,
* presence of diffuse or localized oro-facial pain of neuropathic nature for at least 1 month.

Exclusion Criteria:

* Allergies,
* debilitating systemic diseases,
* pregnancy status
* severe cognitive impairment

Primary outcomes:
measure: Reduction of oral-facial pain
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883270: Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome
Official title: Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GBS
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effects of Robotic-assisted gait training in non-ambulatory patients after Guillain-Barré syndrome.The participants are randomly divided into two groups.Patients of the treatment group receive robotic-assisted gait training,while the contorls receive conventional rehabilitation.

Detailed description: Guillain-Barré syndrome (GBS) is an acute autoimmune disease of the peripheral nervous system, which may lead to rapidly developing motor deficits, sensory deficits, autonomic dysfunction and respiratory failure. Approximately, 20.3% of patients cannot walk unaided at 4 weeks of symptom onset and 18.0% at 6 months. So, restoration and improvement of independent walk are one of major goals of GBS rehabilitation. For severely affected neurological patients, gait training using conventional therapy is technically difficult due to their motor weakness and balance problems. Robotic-assisted gait training （RAGT）is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation after some neuropathy. And the proven reliability and safety of RAGT suggest that it may be effective for treating non-ambulatory patients after some neuropathy. In our study, we investigated the anti-inflammatory effects of RAGT in non-ambulatory patients of GBS.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of GBS;
* Age between 18 and 65 years;
* Period of GBS is between 4 and 8 weeks;
* severe walking disabilities, defined as a GBS disability score of 2-4;

Exclusion Criteria:

* An unstable phase of disease;
* Disorders preventing RAGT(eg, unstable cardiovascular, respiratory disease ,orthopedic, or neurological condition, unhealed decubitus, orthostatic hypotension etc.) ;
* Severe cognitive impairment preventing meaningful communication;
* Body weight more than 100 kg;
* Pregnancy;

Primary outcomes:
measure: GBS disability score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: TianJin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00586170: A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
Official title: A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nonunion of Fracture of Fifth Metatarsal
Keywords: nonunion
fracture
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.

Detailed description: The investigators hypothesize:

1. That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
2. PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.

Eligibility criteria: Inclusion Criteria:

1. Subject has been diagnosed with a 5th metatarsal delayed or non-union.
2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
3. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

1. Subject has synovial pseudarthrosis.
2. Subject has a fracture gap of larger than 5mm as measured on CT Scan.
3. Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
4. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
5. Subject has an implanted unipolar pacemaker.
6. Subjects who have previous malignant or connective tissue disorder.
7. Subjects who use medication such as steroids or anticoagulants.
8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.

Primary outcomes:
measure: Percentage of Successful 5th Metatarsal Unions Achieved.
timeFrame: 24 Weeks
Secondary outcomes:
measure: Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Neurological Institute of NJ
state: New Jersey
city: Columbus
country: United States
facility: The Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Zimmer Biomet
name: John Evangelista
role: STUDY_DIRECTOR
References:
Clinical trial NCT06570070: AI-powered Chatbot vs. Human Counselors in Smoking Cessation
Official title: Effectiveness of Artificial Intelligence (AI)-Powered Chatbot vs. Human Counselors in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Mobile Health
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 300
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 study aims to explore the feasibility and preliminary effectiveness of AI-powered chatbot support in community smokers.

Detailed description: Smoking cessation remains one of the most significant public health challenges worldwide, with tobacco use being a leading cause of preventable death and disease. Despite extensive efforts, the success rates of smoking cessation programs remain low, necessitating innovative approaches to support individuals in their journey to quit smoking. Recently, artificial intelligence (AI) has opened new possibilities in healthcare, including the development of AI-powered chatbots that assist individuals in behavior change, such as quitting smoking.

This randomized controlled trial aims to investigate the effectiveness of AI-powered chatbot that simulates human counselors, compared to traditional human counseling in promoting smoking cessation among community smokers. The AI-powered chatbot, equipped with personalized interactions and real-time support, offers scalable and cost-effective assistance, potentially making it an accessible alternative to human counseling. However, human counselors provide empathy, tailored advice, and a nuanced understanding of human behavior that AI may not fully replicate. This study will explore which approach is more effective in helping individuals achieve long-term smoking cessation.

Eligibility criteria: Inclusion Criteria:

1. aged 18 and above, reside in Zhuhai for the next 6 months;
2. smoke at least 1 cigarette or use e-cigarettes daily;
3. Having a smartphone and a WeChat account, being able to use WeChat skillfully.

Exclusion Criteria:

1. Smokers who have communication barrier (either physically or cognitively);
2. Smokers who are currently participating in other SC programmes or services

Primary outcomes:
measure: Biochemical validated quit rate at 6 months follow-up
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Biochemical validated quit rate at 3 months follow-up
timeFrame: 3 months follow-up
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 3 and 6 months follow-up
measure: Smoking reduction rate
timeFrame: 3 and 6 months follow-up
measure: Eligibility rate
timeFrame: baseline
measure: Consent rate
timeFrame: baseline
measure: Percentage of Participant Engagement with E-Messages and Counselor Chats
timeFrame: 3 months follow-up
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Beijing Normal University
state: Guangdong
Study officials:
References:
Clinical trial NCT01354470: A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Official title: A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Keywords: Meth
Methamphetamine Addiction
Methamphetamine Treatment
Modafinil
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction \& Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form

Primary outcomes:
measure: Urine Samples Negative for Methamphetamine
timeFrame: Twice weekly for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: New Leaf Treatment Center
state: California
city: San Francisco
country: United States
facility: CPMC Research Institute, St.Luke's Hospital
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Gantt Galloway, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993070: Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
Official title: A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Polyneuropathy
Keywords: capsaicin
placebo
trial
diabetic polyneuropathy
neuropathic pain
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Bangkok Drug company
First posted: 2009-10-09
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Detailed description: Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.

Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Eligibility criteria: Inclusion Criteria:

* History of type 2 Diabetes mellitus
* Peripheral neuropathy
* Stabilized on pain medication for at least one month
* No previous invasive intervention for pain relief

Exclusion Criteria:

* Local wound or skin abnormality in the applicable area
* Allergic to capsaicin
* Refuse to participate or give consent
* Has other significant disease or receive medication that may worsen neuropathy

Primary outcomes:
measure: Pain relief from pain score reduction, using visual analog scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Thammasat University
name: Kongkiat Kulkantrakorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03840070: The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
Official title: A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penile Girth Enhancement
Penile Enhancement
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis.

This study will determine the long-term efficacy and safety of Potenfill.


Eligibility criteria: Inclusion Criteria:

* Male subjects aged above 19 and below 65. (20≤male≥65)
* Subjects will sign an informed consent form

Exclusion Criteria:

* Prior treatment for penile enhancement (e.g. fat, dermal graft).
* Allergic to hyalluronic acid.

Primary outcomes:
measure: Subject satisfaction on the penile appearance at 12 months after application of Potenfill
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university guro hospital
Study officials:
References: