louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01784653: Trial of Computerized MET for Adolescent Substance Use
Official title: Randomized Controlled Trial of Computerized MET for Adolescent Substance Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Drug Abuse
Alcohol Abuse
Nicotine Dependence
Keywords: Substance abuse
Drug abuse
Alcohol abuse
Tobacco
Adolescent
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.


Eligibility criteria: Inclusion Criteria:

* completed initial visit at the treatment program;
* be available to return for iMET/MET sessions (if assigned)
* be available to complete all follow-up measurements
* a past-12-month CRAFFT score \>1
* have used substances on \>6 days (not including tobacco use) during the 90 days preceding their visit

Exclusion Criteria:

* unable to speak and understand English, or read English at a 5th grade reading level
* youth deemed by the clinical team to require immediate hospitalization or referral to more intensive residential treatment

Primary outcomes:
measure: Treatment engagement
timeFrame: 12 months
Secondary outcomes:
measure: Days abstinent
timeFrame: past-90-days
measure: Driving/Riding Risk
timeFrame: past-90-days
measure: HIV Risk Behavior
timeFrame: past-90-days
Other outcomes:
measure: Treatment process/quality
timeFrame: 60 days
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sion K Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259253: Understanding Patient Experience Among Asians at MD Anderson
Official title: Understanding Patient Experience Among Asians at MD Anderson
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center Participants

Brief summary: The purpose of this research study is to understand barriers to and facilitators of a positive patient experience for Asian patients.

Detailed description: Primary Objective:

a. Identify critical aspects of inpatient experience among former Asian/Asian American patients at MD Anderson.

Secondary Objectives:

a. Determine MD Anderson health care providers' perceptions of Asian/Asian American inpatient experience.

Eligibility criteria: Inclusion criteria for former patients:

* Self-identify as Asian/Asian American
* Are 18 years or older
* Have been diagnosed with cancer, any type
* Received inpatient care at MD Anderson between 2019 and 2022
* Have a U.S. address
* Can read and write in English or simplified Chinese

Exclusion criteria for former patients:

• None

Inclusion criteria for healthcare providers:

* Self-report as a practicing inpatient provider (advanced practice provider, hospitalist, physician, nurse) at MD Anderson
* Treated patients diagnosed with breast, colon, prostate, thyroid, or lymphatic cancer
* Provided treatment services to Asian/Asian American patients between 2019 and 2022

Exclusion criteria for healthcare providers:

• None

Primary outcomes:
measure: Picker Patient Experience Questionnaire (PPE-15)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill, MPH,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386253: Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Official title: Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 and 64
* Smoked (on average) at least 5 cigarettes per day
* Be motivated to quit smoking

Exclusion Criteria:

* Unstable medical or psychiatric conditions
* Any medical conditions with neurological sequelae
* History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
* Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
* Are pregnant or planning to become pregnant during the study
* Current use of pacemaker, intracranial electrodes or implanted defibrillator

Primary outcomes:
measure: Number of Participants Willing to Complete 5 Days of tDCS or Sham
timeFrame: 5 days
Secondary outcomes:
measure: Change in Number of Cigarettes Smoked Per Day
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
References:
Clinical trial NCT02430753: Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency
Official title: Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms Accompanied by Respiratory Function Insufficiency
Keywords: irreversible electroporation
Lung Neoplasms
Respiratory Function Insufficiency
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Detailed description: By enrolling patients with Lung Neoplasms accompanied by Respiratory Function Insufficiency adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Eligibility criteria: Inclusion Criteria:

* Lung Neoplasms Accompanied by Respiratory Function Insufficiency diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01553253: From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy
Official title: From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Postcholecystectomy Pain
Chronic Postoperative Pain
Visceral Pain
Referred pain
Somatic pain
Quantitative Sensory Testing
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region of Southern Denmark
name: Vejle Hospital
name: Manufacturer Mads Clausen Foundation
name: DASAIMS Forskningsinitiativ
name: Fonden Else Poulsens Mindelegat
name: Oberstinde Kirsten Jensa la Cours Foundation
name: Læge Frk. K. Rasmussens Mindelegat
First posted: 2012-03-14
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: NON_PROBABILITY_SAMPLE
Study population: Consecutive Patients for elective cholecystectomy

Brief summary: Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.).

The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility criteria: Inclusion Criteria:

* Patients for elective cholecystectomy
* 18 years or older at the day of the operation
* Capable of speaking, reading and writing danish

Exclusion Criteria:

* Previous abdominal operation
* Patients with preoperative neuropathies
* Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.

Primary outcomes:
measure: Abdominal pain
timeFrame: 12 months
Secondary outcomes:
measure: Quantitative sensory testing values in referred pain area.
timeFrame: 12 Months
measure: Abdominal pain
timeFrame: 6 months
measure: Quantitative sensory testing values in referred pain area.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Lillebælt Hospital
Study officials:
References:
Clinical trial NCT01035853: Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Official title: Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
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 determine whether the nasal inhalation of Colistin is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.


Eligibility criteria: Inclusion Criteria:

* subject has a confirmed diagnosis of cystic fibrosis
* detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
* informed consent of the patients or parents
* subject \>= 6 years
* subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
* women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol

Exclusion Criteria:

* subject has a critical condition defined as: forced expiratory volume at one second \< 30% and / or arterial oxygen saturation \< 93% without O2-substitution; need of O2-substitution
* subject had an ear, nose, and throat surgery within 3 months prior to study
* subject shows signs of nasal bleeding
* subject has an ear drum perforation
* subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aeruginosa
* subject is unlikely to comply with the procedures scheduled in the protocol
* subject has a known allergic reaction to the medication
* subject is pregnant or breastfeeding
* subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
* systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study

Primary outcomes:
measure: Decrease of Pseudomonas aeruginosa in Nasal lavage fluid
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitäts-Kinderklinik
state: Baden-Würtemberg
city: Jena
country: Germany
facility: Mukoviszidosezentrum der Friedrich-Schiller-Universität
state: Thüringen
city: Hamburg
country: Germany
facility: CF-Zentrum
Study officials:
affiliation: University of Jena, Children's hospital
name: Jochen Mainz, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04354753: AiM COVID for Covid 19 Tracking and Prediction
Official title: AiM COVID for Covid 19 Tracking and Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: University of Warwick
name: Igor Sikorsky Kyiv Polytechnic Institute
name: ClickMedix LLC
First posted: 2020-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who registered or used any community support services in Leicester

Brief summary: University of Warwick (Coventry, UK) and NTUU "Igor Sikorsky" Kyiv Polytechnic Institute (Kyiv, Ukraine), together with ClickMedix LLC, have developed an app and a chatbot "AiM COVID" for efficient monitoring and mitigation of COVID-19. These products are available for free download on computers and mobile phones. These can be used by a wide range of users from various sectors - patients and people living with them, doctors, nurses, specialists, community health workers, hospitals, clinics, hospital IT staff, MHFA, and insurance companies.


Eligibility criteria: Inclusion Criteria:

* Participants 18 and above
* living in UK
* reported with or without symptoms from February 28 to March 28 with community support groups

Exclusion Criteria:

* below 18 years old

Primary outcomes:
measure: Physical symptoms
timeFrame: 1day
measure: Contact History
timeFrame: 14 days
measure: Travel History
timeFrame: 14 days
Secondary outcomes:
measure: Fever
timeFrame: 1 day
measure: Headache
timeFrame: 1 day
measure: Soar Throat
timeFrame: 1 day
measure: Runny nose
timeFrame: 1 day
measure: Cough
timeFrame: 1 day
measure: Shortness of breath
timeFrame: 1 day
measure: Nausea
timeFrame: 1 day
measure: Vomiting
timeFrame: 1 day
measure: Muscle pain
timeFrame: 1 day
measure: Joint pain
timeFrame: 1 day
measure: Diarrhoea
timeFrame: 1 day
measure: Other
timeFrame: 1 day
measure: Hospitalisation history
timeFrame: 1 day
measure: Co-morbid conditions
timeFrame: 1 day
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam (UK)
Study officials:
affiliation: University of Warwick
name: Vishwesh Kulkarni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364853: Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Official title: Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To compare in-person to remote video assessments in children to determine the reliability of remote evaluations for future neuropsychological assessments and set a precedent for future investigations.


Eligibility criteria: Inclusion Criteria:

1. Parents able to provide informed consent for themselves and their child
2. Access to computer and reliable internet connection for remote testing
3. Child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study
4. Child between the ages of 24 months and 30 months of age
5. Primary language is English

Exclusion Criteria:

1. Child unable to complete the cognitive assessment (e.g., expected IQ\<70)
2. Child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer)
3. Child who use centrally active medications

Primary outcomes:
measure: Developmental Assessment of Young Children-2nd edition (DAYC-2) Standard Scores of the Communication Domain as a Measure of Direct Comparison of the 2 Testing Conditions.
timeFrame: Change from the first, baseline assessment to the second assessment, 21 days later.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Kimford J Meador, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03903653: Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
Official title: Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Spastic Foot
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

Detailed description: The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.

Eligibility criteria: Inclusion Criteria

* Patients with Acquired Brain Injury (ABI) including but not limited to stroke, traumatic and anoxic brain injury in ABI unit of RRC
* Dorsiflexion limitation of \< 10 degrees from neutral and Modified Ashworth Score (MAS) of 2 or 3
* Patients that are on Oral Medication for Spasticity Tx are still allowed to participate (ie. Baclofen)
* Patients both with Bilateral or Unilateral Lower Limb Spasticity are included
* There will be no sex or age restrictions

Exclusion Criteria

* Patients cannot have had Botulinum Toxin A Injections in their Lower Extremities within the past 6 months
* Patients cannot have had any sort of custom bracing or serial casting previously
* Patients with MAS of 4
* Patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention
* Patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded.
* Patients whom have skin breakdown in their lower extremities prior to the study will be excluded
* Patients who develop Skin breakdown (Grade 2 or higher) during the course of the study will be removed automatically

Primary outcomes:
measure: Passive ankle dorsiflexion >10 degrees
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Seyed Hossein Hosseini, M.D.
role: PRINCIPAL_INVESTIGATOR
References: