louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01925781: e-Cigarettes Versus NRT Gum for Smoking Cessation
Official title: e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nicotine Addiction
Smoking Cessation
Keywords: Smoking Cessation
Nicotine Addiction
e-Cigarette
electronic nicotine delivery device
electronic cigarette
nicotine replacement therapy
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Smokes at least five cigarettes per day
* No current or previous regular use of e-cigarettes
* Ready to quit smoking

Exclusion Criteria:

* Use of smokeless or pipe tobacco
* Smoke more than 40 cigarettes per day
* Pregnant or breastfeeding
* Unable to chew gum due to dental or jaw problems
* Myocardial infarction (heart attack) within the previous 12 months
* Hypersensitivity to propylene glycol or nicotine gum

Primary outcomes:
measure: Sustained Abstinence
timeFrame: 12 weeks
Secondary outcomes:
measure: Point Prevalence Abstinence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Amy J Arouni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154681: World Digital Detox Program for Enhancing Youth and Family Well-being
Official title: Effectiveness of a World Digital Detox Program for Enhancing Youth and Family Well-being: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Well-Being
Adolescent Behavior
Family
Lead sponsor: Innowage Limited
Sponsor class: INDUSTRY
Collaborators: name: Zep Foundation
name: Aarogyam UK
First posted: 2023-12-04
Enrollment: 168
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The pervasive presence of digital devices and technology has reshaped contemporary society, providing numerous benefits but also prompting concerns about prolonged screen time, particularly with smartphones and social media. These concerns extend to their impact on interpersonal relationships and mental well-being. The Zep Foundation's World Digital Detox Program to address the challenges posed by excessive screen exposure, social media usage, and digital screen dependency.

This study aimed to assess the efficacy of the digital detox family intervention, endorsed by the World Digital Detox Day program, in curbing the use of digital devices-specifically smartphones and social media-and enhancing the overall well-being of youth and families.


Eligibility criteria: Inclusion Criteria:

for Caregivers:

* Age 18 or older at baseline assessment;
* Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household
* Able to speak English
* Agreement to participate in the program;
* Consent for self and child to participate in the study.

for Adolescents:

* Age 10-14 at baseline assessment;
* Agreed to participate in the study;
* Caregiver consent to participate in the study.

Exclusion Criteria:

* Serious Medical Conditions requiring frequent hospitalization
* Special Educational Need Children and Adolescents
* Substance abuse

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: From baseline to 4-week post intervention
Secondary outcomes:
measure: Media Multitasking-Revised (MMT-R) scale
timeFrame: From baseline to 4-week post intervention
measure: Family Communication Scale (FCS)
timeFrame: From baseline to 4-week post intervention
measure: Family Health Behaviours Scale (FHBS)
timeFrame: From baseline to 4-week post intervention
measure: Mental Health Continuum Short Form (MHC-SF)
timeFrame: From baseline to 4-week post intervention
Other outcomes:
Locations:
city: Mumbai
country: India
facility: World Digital Detox Day
state: Maharashtra
Study officials:
affiliation: World Digital Detox Day, Zep Foundation
name: Rekha Chaudhari, PhD
role: STUDY_DIRECTOR
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06114381: Physical Exercise and Diet Management in Vitamin D Deficient Females
Official title: Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females.

Detailed description: This is a randomized controlled trial to study the effect of home based physical exercises in comparison to Diet management, sun exposure and vitamin D supplements on functional performance and depression level in females with vitamin D deficiency.

Eligibility criteria: Inclusion Criteria:

* Subjects whose age ranged from 19-25 years.
* All participants have pre laboratory results with vitamin D deficiency less than 25 nmol/L and have been lasted for 6 months
* All participated subjects were female studying at Al-Jouf university, Al- Qurrayyat-Female Branch.

Exclusion Criteria:

* Chronic illness, liver, renal endocrine or autoimmune diseases.
* Patients who suffered from any cardiopulmonary diseases.
* History of fractures or any neuro-musculoskeletal disorders.

Primary outcomes:
measure: Vitamin D3 blood test
timeFrame: 6 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: 6 weeks
measure: 6 Minutes Walk Test
timeFrame: 6 weeks
measure: Dyspnea Borg scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia
state: Al Jouf
Study officials:
affiliation: Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.
name: Wael OA Abd El-Khalek, Dr.
role: STUDY_CHAIR
affiliation: Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.
name: Doaa Saeed, Dr.
role: STUDY_CHAIR
affiliation: Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.
name: Mina AG Elias, Dr.
role: STUDY_CHAIR
affiliation: Dept of PT & Health Rehabilitation, College of Applied Medical Sciences, Jouf University, KSA.
name: Heba A Bahey El-Deen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02649881: Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging
Official title: Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging : A Comparative Study With Coronary Artery of the Transplanted or Autopsy Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Plaque
Keywords: macrophage
vulnerable coronary plaque
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 20
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: This study is targeted at the isolated heart voluntarily donated from adult patients who receive heart transplantation

Brief summary: This study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration.


Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Patients who are to receive heart transplantation
* Patients or their legal representatives who gave a prior written consent

Exclusion Criteria:

* Impossible to OCT and IVUS analysis due to severe coronary stenosis

Primary outcomes:
measure: ROC curve of diagnosis
timeFrame: within 48 hours
Secondary outcomes:
measure: fibrin accumulation
timeFrame: within 48 hours
measure: neoatherosclerosis
timeFrame: within 48 hours
measure: elastic lamia
timeFrame: within 48 hours
measure: cholesterol crystal
timeFrame: within 48 hours
measure: microcalcification
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
References:
Clinical trial NCT01949181: Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease
Official title: Relationship Between Blood, Hair and Lung Metals/Metalloids Concentration (Cadmium, Iron, Copper, Nickel, Chrome, Arsenic, Vanadium, Beryllium, and Zinc) and Lung Cancer or Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Chronic Obstructive Pulmonary Disease
Emphysema
Lung Surgery
Keywords: Metals
Metalloids
Blood
Hair
Lung
Lung cancer
Chronic obstructive pulmonary disease
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Patients of 18 to 75 years of age.
* Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant

Exclusion Criteria:

* Patients with mental or physical conditions that prevent them giving their agreement for the study

Primary outcomes:
measure: Metals/metalloids concentration
timeFrame: Blood, hair and lung tissue are sampled during lung surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
city: Poitiers
country: France
facility: CHU de Poitiers, Chirurgie Cardiaque et Thoracique
Study officials:
affiliation: Hôpital Foch
name: Stanislas Grassin Delyle
role: STUDY_CHAIR
References:
Clinical trial NCT01293981: Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
Official title: Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Alphatec Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 6
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: Subjects diagnosed with symptomatic lumbar degenerative disc disease (DDD) at 1 or 2 contiguous levels between L1 and S1.

Brief summary: The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.


Eligibility criteria: Inclusion Criteria:

* Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
* Unresponsive to conservative treatment for at least 6 months
* Radiographic confirmation of primary diagnosis

Exclusion Criteria:

* More than 2 levels requiring lumbar interbody fusion
* Spondylolisthesis greater than Grade I
* Prior failed fusion surgery at any lumbar level(s)
* Local or systemic infection past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* BMI greater than 40
* Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
* Use of post operative Spinal Cord Stimulator (SCS)
* Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation related to the spine
* Pregnant or plans to become pregnant during the course of the study
* Insulin-dependent diabetes mellitus
* Known sensitivity to device materials
* Life expectancy less than duration of study
* Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
* Undergoing chemotherapy or radiation treatment
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

Primary outcomes:
measure: Fusion
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Middleton
country: United States
state: Connecticut
city: Greensboro
country: United States
state: North Carolina
Study officials:
References:
Clinical trial NCT02833181: Evaluation of Circadian Variation of EEG Using BIS Monitor in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EEG Circadian Variation of ICU Patients
Lead sponsor: Centro Hospitalar do Tâmega e Sousa
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index) monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency), bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute neurological disease.


Eligibility criteria: Inclusion Criteria:

* Admitted in the ICU
* Over 18 years old

Exclusion Criteria:

* Acute neurological disease

Primary outcomes:
measure: Circadian EEG variation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Penafiel
country: Portugal
facility: Centro Hospitalar Tâmega e Sousa
Study officials:
References:
Clinical trial NCT03797781: Protein Ingestion and Skeletal Muscle Atrophy
Official title: Understanding the Role of Protein Ingestion on Skeletal Muscle Atrophy During an Acute Period of Disuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Atrophy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.


Eligibility criteria: Inclusion Criteria:

* BMI \>18 and \<28 no prescription medications or current illness.

Exclusion Criteria:

* BMI \<18 and \>28 current prescription medication no history of leg injury.
* Smoker
* Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.

Primary outcomes:
measure: Muscle size
timeFrame: 3 days
Secondary outcomes:
measure: Muscle strength
timeFrame: 3 days
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport and Health Science
state: Devon
Study officials:
References:
citation: Kilroe SP, Fulford J, Jackman S, Holwerda A, Gijsen A, van Loon L, Wall BT. Dietary protein intake does not modulate daily myofibrillar protein synthesis rates or loss of muscle mass and function during short-term immobilization in young men: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):548-561. doi: 10.1093/ajcn/nqaa136.
Clinical trial NCT00775710: Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure
Official title: A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercapnic Respiratory Failure
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.


Eligibility criteria: Inclusion Criteria:

* Acute hypercapnic respiratory failure.
* Use of NIV to treat respiratory failure.
* Persistence of hypercapnia after discontinuation of NIV

Exclusion Criteria:

* Home NIV
* Facial or cranial trauma or surgery,
* Recent gastric or esophageal surgery,
* Active upper gastrointestinal bleeding,
* Excessive amount of respiratory secretions,
* Tracheostomy
* Lack of cooperation

Primary outcomes:
measure: New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
timeFrame: At the end of enrollment time
Secondary outcomes:
measure: Incidence of long term dependency on non-invasive ventilation
timeFrame: At the end of enrollment time
measure: Hospital and 6-month survival
timeFrame: At the end of enrollment time
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic
name: Jacobo Sellares, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sellares J, Ferrer M, Anton A, Loureiro H, Bencosme C, Alonso R, Martinez-Olondris P, Sayas J, Penacoba P, Torres A. Discontinuing noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations: a randomised controlled trial. Eur Respir J. 2017 Jul 5;50(1):1601448. doi: 10.1183/13993003.01448-2016. Print 2017 Jul.
Clinical trial NCT00184210: Magnetic Resonance (MR) Spectroscopy of Breast Cancer Tissue
Official title: HR MAS MR Spectroscopy of Breast Cancer Tissue
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: Magnetic Resonance Spectroscopy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: The Norwegian Women´s Public Health Association
First posted: 2005-09-16
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in surgery for breast cancer

Brief summary: Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer. The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can be analyzed by other methods, such as histopathology.

The MR spectral profiles are compared to clinical findings such as the patients diagnosis, lymph node status and tumor size.


Eligibility criteria: Inclusion Criteria:

* Palpable breast cancer lesion

Primary outcomes:
measure: MRimage of breast cancer tissue
timeFrame: 0 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Technology and Science
Study officials:
affiliation: Norwegian University of Technology and Science
name: Tone F Bathen, PhD
role: STUDY_CHAIR
References:
citation: Sitter B, Sonnewald U, Spraul M, Fjosne HE, Gribbestad IS. High-resolution magic angle spinning MRS of breast cancer tissue. NMR Biomed. 2002 Aug;15(5):327-37. doi: 10.1002/nbm.775.
citation: Sitter B, Lundgren S, Bathen TF, Halgunset J, Fjosne HE, Gribbestad IS. Comparison of HR MAS MR spectroscopic profiles of breast cancer tissue with clinical parameters. NMR Biomed. 2006 Feb;19(1):30-40. doi: 10.1002/nbm.992.
citation: Bathen TF, Jensen LR, Sitter B, Fjosne HE, Halgunset J, Axelson DE, Gribbestad IS, Lundgren S. MR-determined metabolic phenotype of breast cancer in prediction of lymphatic spread, grade, and hormone status. Breast Cancer Res Treat. 2007 Aug;104(2):181-9. doi: 10.1007/s10549-006-9400-z. Epub 2006 Oct 24.
citation: Sitter B, Bathen TF, Singstad TE, Fjosne HE, Lundgren S, Halgunset J, Gribbestad IS. Quantification of metabolites in breast cancer patients with different clinical prognosis using HR MAS MR spectroscopy. NMR Biomed. 2010 May;23(4):424-31. doi: 10.1002/nbm.1478. Epub 2010 Jan 25.
citation: Giskeodegard GF, Grinde MT, Sitter B, Axelson DE, Lundgren S, Fjosne HE, Dahl S, Gribbestad IS, Bathen TF. Multivariate modeling and prediction of breast cancer prognostic factors using MR metabolomics. J Proteome Res. 2010 Feb 5;9(2):972-9. doi: 10.1021/pr9008783.