louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05447156: QuitGuide for American Indians: Aims 2 & 3
Official title: QuitGuide for American Indians: Aims 2 & 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Tobacco Use Disorder
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
Primary purpose: PREVENTION

Brief summary: Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.


Eligibility criteria: Inclusion Criteria:

* American Indian person based on self-report
* Age ≥ 18 years
* Interested in quitting smoking
* Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days

  o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product
* Smartphone ownership with the ability to download applications and sufficient data to complete research procedures

Exclusion Criteria:

* New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month
* Does not speak or read English

Primary outcomes:
measure: Frequency of App Use
timeFrame: 5 weeks post enrollment and 1 week post randomization
Secondary outcomes:
measure: Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks
timeFrame: 5 weeks post enrollment aim 3
measure: Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview
timeFrame: 5 weeks post enrollment aim 3
measure: Usability of App Design Measured Using System Usability Scale (SUS)
timeFrame: 5 weeks post enrollment
measure: Acceptability of Overall App
timeFrame: 5 weeks post enrollment
measure: Fit of App With Culture
timeFrame: 5 weeks post enrollment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center - University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, Univeristy of Minnesota
name: Dana Caroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000356: Evaluation of L-alpha-acetylmethadol (LAAM) in Methadone Patients - 5
Official title: Pharmacokinetics of LAAM in Methadone Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00790309: Early Diabetes Resolution After Weight Loss Surgery
Official title: Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes
Keywords: Obesity
Diabetes
Bariatric surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study.

Brief summary: The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.


Eligibility criteria: Inclusion Criteria for surgery groups:

* BMI of 30 kg/m2 or higher
* Ages 18-65
* History of impaired glucose tolerance or T2DM

Inclusion Criteria for normal weight group:

* BMI of 30 kg/m2 or lower
* Ages 18-65

Exclusion Criteria:

* Development of an intercurrent infection
* Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
* Current use of thiazolidinediones
* Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)
* Any condition felt by the PI or co-investigators to interfere with ability to complete the study

Primary outcomes:
measure: Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery
timeFrame: 10 days post-op
Secondary outcomes:
measure: Determine changes in inflammatory markers after weight loss surgery
timeFrame: 10 days post-op
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
Clinical trial NCT01799109: Lung Function of Asthmatic Children by Nebulized MgSO4
Official title: Lung Function Changes of Mild to Moderate Asthmatic Children Treated by Nebulized MgSO4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: magnesium sulfate
nebulization
lung function
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.


Eligibility criteria: Inclusion Criteria:

* asthmatic children with controlled clinical manifestation

Exclusion Criteria:

* fever
* history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
* allergic to acetylcholine, albuterol or magnesium
* use any bronchodilator agents before the Clinic day

Primary outcomes:
measure: changes of lung function
timeFrame: 10minutes and 20minutes post-dose
Secondary outcomes:
measure: Nebulized magnesium sulfate alone effectively improve lung function
timeFrame: 10minutes and 20minutes post-dose
measure: the number of participants with adverse events as a measure of safety and tolerability
timeFrame: 20minutes
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Center of Respiratory Disorders,Children's Hospital,Chongqing medical university
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: Jihong Dai, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05385809: A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer
Official title: A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unresectable Gastric Cancer
Keywords: Unresectable Gastric Cancer
Conversion Therapy
Immunotherapy
Sintilimab
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Innovent Biologics, Inc.
First posted: 2022-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 pantients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received immunotherapy prior to surgical resection

Brief summary: This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.


Eligibility criteria: Inclusion Criteria:

* Ages: 18-75 Years (concluding 18 and 75 Years)
* Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
* Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
* Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
* Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
* At least 1 measurable lesion by RECIST v1.1 criteria
* ECOG PS: 0-2
* Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle

Exclusion Criteria:

* Known Her2 positive
* Patients with incomplete data or other factors affecting the judgment of efficacy and safety

Primary outcomes:
measure: Surgical conversion rate
timeFrame: two years
Secondary outcomes:
measure: R0 resection rate
timeFrame: two years
measure: Major pathological response (MPR)
timeFrame: two years
measure: Overall response rate ( ORR)
timeFrame: two years
measure: adverse event (AEs)
timeFrame: two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiangdong Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580809: CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy
Official title: CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy : a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced HCC Treated by Systemic Immunotherapy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HepatoCellular Carcinoma (HCC) treated by systemic immunotherapy

Brief summary: The purpose of this study is to compare CT perfusion parameters to RECIST 1.1 and mRECIST assessment for advanced HCC treated by systemic immunotherapy, and to evaluate perfusion parameters as predictive factors of response on baseline and on early follow-up


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Proved HCC
* Advanced HCC, defined as Barcelona Clinic Liver Classifications (BCLC) stage B non eligible for loco-regional therapy and stage C
* No prior systemic therapy
* Measurable disease per Response Evaluation Criteria for Solid Tumour (RECIST) v1.1
* Child-Pugh Score = A
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2

Exclusion Criteria:

* Absence of CT perfusion before treatment initiation more than a two-month delay between treatment initiation and first post-treatment CT perfusion
* Uninterpretable CT perfusion
* Definitive contraindication to CT perfusion (allergy or advanced renal disease)

Primary outcomes:
measure: Comparison of CT perfusion parameters between the responders and non-responders according to RECIST 1.1 assessment for advanced HCC treated by systemic immunotherapy
timeFrame: Through study completion, an average of 1 year
measure: Comparison of CT perfusion parameters between the responders and non-responders according to mRECIST assessment for advanced HCC treated by systemic immunotherapy
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluation of CT perfusion parameters as predictive factors of response on baseline and on early follow-up
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT06311409: Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient
Official title: Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fall Prevention
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 332
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children admitted as in-patients for whom the parents have given consent to the study, aged between 12 months and 16 years, of any gender, pathology and reason for admission. Population i

Brief summary: Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany.

The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve.


Eligibility criteria: Inclusion Criteria:

* children admitted as in-patients for whom the parents have given consent to the study, aged between 12 months and 16 years, of any gender, pathology and reason for admission.

Exclusion Criteria:

* not signed consent form

Primary outcomes:
measure: validation of the SMFS t
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: identification of patients high risk of falls
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: AUSL Toscana Sud Est
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Massa
country: Italy
facility: Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Daniele Ciofi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233909: A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
Official title: An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Myeloid
Keywords: Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
gemtuzumab ozogamicin (GO)
Lead sponsor: Kanisa Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description: Purpose:

Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.

Phase II: Determine the complete remission rate (CR+CRp)

Eligibility criteria: Inclusion Criteria:

1. Morphologic evidence of acute myeloid leukemia in first relapse.
2. Phase I: 18 years or older, Phase II: 50 years or older

Exclusion Criteria:

1. Prior treatment with zosuquidar
2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
3. History of stem cell transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02065609: 89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
Official title: Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Trastuzumab
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-19
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female patients 18 years of age or older
* Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 biopsy proven breast cancer
* Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer
* Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
* Able to give informed consent
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative
* Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.

Exclusion Criteria:

* Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
* Unable to tolerate 60 min of PET imaging per imaging session

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration
timeFrame: 30 Days following 89Zr-Trastuzumab Administration
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine @ Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Farrokh Dehdashti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598909: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty
Official title: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharoplasty
Upper Eyelid Blepharoplasty
Keywords: blepharoplasty
arnica
homeopathy
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 136
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: Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.


Eligibility criteria: Inclusion Criteria:

* patients undergoing primary blepharoplasty

Exclusion Criteria:

* use of anticoagulants

Primary outcomes:
measure: Surgical outcome
timeFrame: 7 days and 6 weeks postoperatively
Secondary outcomes:
measure: amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction
timeFrame: 3, 7 and 42 days postoperatively
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Isala
name: W Melenhorst, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: