louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02125032: Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 98
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: The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.

Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .


Eligibility criteria: Inclusion Criteria:

* Patients with Idiopathic Parkinson's disease H \& Y 1-3 (Hoehn\&Yahr)
* MMSE \> 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)
* Age \> 18 years.
* The patient is capable understanding, accepting and complete the planned procedures.

Exclusion Criteria:

* The patient has been using T-PEMF before.
* Changes in anti-parkinson drug treatment within the last 6 weeks
* Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient
* Psychosis, or other psychopathological conditions, which requires intervention
* The abuse of alcohol or drugs
* Treatment with Deep Brain stimulation.
* Pregnancy or nursing
* Epilepsy.
* Active implants such as pacemakers and others for example cochlear implants
* Active medical device for example insulin pumps, baclofen pumps.
* Participation in other trials in the intervention period
* Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer
* Autoimmune disease
* Wounds in the scalp

Primary outcomes:
measure: Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
timeFrame: At baseline and at endpoint at week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: OUH Odense University Hospital
state: Funen
Study officials:
References:
citation: Malling ASB, Morberg BM, Wermuth L, Gredal O, Bech P, Jensen BR. The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease. J Neuroeng Rehabil. 2019 Jan 31;16(1):19. doi: 10.1186/s12984-019-0491-2.
citation: Morberg BM, Malling AS, Jensen BR, Gredal O, Bech P, Wermuth L. Effects of transcranial pulsed electromagnetic field stimulation on quality of life in Parkinson's disease. Eur J Neurol. 2018 Jul;25(7):963-e74. doi: 10.1111/ene.13637. Epub 2018 Apr 17.
Clinical trial NCT03392532: Comparison of Two Silicone Hydrogel Toric Contact Lenses
Official title: Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Astigmatism
Axis orientation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.


Eligibility criteria: Inclusion Criteria:

* Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
* Astigmatism
* Requires contact lenses
* Best corrected visual acuity of 20/25 or better in each eye
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator
* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
timeFrame: Day 1, 10 minutes after lens insertion, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT03005132: Integrative Analysis of Human Glioblastoma Multiforme
Official title: Integrative Analysis of Human Glioblastoma Multiforme
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GBM
Keywords: GBM; Integrative Analysis; WES
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Jilin University
name: Ganzhou City People's Hospital
First posted: 2016-12-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with GBM

Brief summary: Integrative analysis of GBM

Detailed description: The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 75 years with histologically proven GBM
* No severe major organ dysfunction
* World Health Organization (WHO) performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy

Primary outcomes:
measure: 5 years overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 5 years disease-free survival
timeFrame: 5 years
measure: 10 years overall survival
timeFrame: 10 years
measure: 10 years disease-free survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Da Fu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganzhou City People's Hospital
name: Xiaoming Zhong, MD
role: STUDY_DIRECTOR
References:
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Clinical trial NCT03679832: A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients
Official title: Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University Medical Center, Vietnam
First posted: 2018-09-20
Enrollment: 1670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to a single-site in Vietnam meeting eligibility criteria for retrospective or prospective participation.

Brief summary: This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.


Eligibility criteria: Inclusion Criteria:

* Subject is at risk / malnourished, defined by an MST score ≥ 2 the first 24 hours post hospital admission
* Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal
* Patient is able to consume foods and beverages orally
* Patients with life expectancy ≥ 30 days
* Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF)

Exclusion Criteria:

* Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements
* Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject is known to be allergic or intolerant to any ingredient found in the study products
* Subject is pregnant
* Subject is intubated, receiving tube feeding or parenteral nutrition

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)
Secondary outcomes:
measure: Healthcare Resource Utilization
timeFrame: Hospital Admission to 30-day Post Discharge
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
Study officials:
affiliation: Abbott Nutrition
name: Suela Sulo, PhD,MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01034332: Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer
Official title: A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Esophagectomy
Paclitaxel
Induction chemotherapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 58
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: We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.

Detailed description: We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.in order to test this hypothesis, we thus propose this phase II clinical study to verify the role of "response to one-cycle induction chemotherapy"in the prediction of pathologic complete response rate to CCRT and tje outcomes for patients with loco-regional esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven esophageal cancer
* Locally advanced diseases T3 N0-1 M0; T1-3 N1 M0; T1-3 or N0-1 M1a
* Age ≥ 18 years old
* ECOG ≤ 2
* Creatinine \< 1.5 mg/dl AST, ALT \< 2.5 x upper normal limits Bilirubin \< 2.0 mg/dl
* WBC \> 4,000/μl or ANC\>2,000/μl
* Platelet \> 100,000//μl
* Informed consent

Exclusion Criteria:

* Invasion to surrounding organs (T4 disease)
* Distant mets (except M1a)
* Prior thoracic irradiation
* Presence of other squamous cell carcinoma of aerodigestive way
* Symptomatic co-morbid diseases
* Previous malignancy

Primary outcomes:
measure: To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospita
name: Chih-Hung Hsu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
Clinical trial NCT01967732: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Nicotine absorption
Modified risk tobacco product
Conventional cigarette
Nicotine replacement therapy
Nicotine nasal spray
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).


Eligibility criteria: Inclusion Criteria:

* Subject is Caucasian
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked at least 10 commercially available non menthol CCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS
timeFrame: 3 days
measure: Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion GB Ltd, 22-24 Lisburn Road
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Celerion GB Ltd.
name: Adrian Johnston Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259932: Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training
Official title: Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 0
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: After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* National health insurance cover
* 1st minor ischaemic stroke (initial NIH score ≤ 4)
* Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
* Patient living close to the participating centre (\<50 km)
* With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))

Exclusion Criteria:

* haemorrhagic stroke
* History of ischaemic or haemorrhagic stroke with clinical manifestations
* History of TIA
* MMS ≤ 24
* Pre-existing dementia (defined according to DSM IV criteria)
* Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
* Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
* Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
* Pre-stroke Rankin score ≥ 3
* Pregnant patient
* Patient under guardianship

Primary outcomes:
measure: Fatigue relief (assessed by the Fatigue Severity Scale)
timeFrame: 4 months after the stroke
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Clinical trial NCT04798937: Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
Official title: A RCT Using Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: type1diabetes
Keywords: adolescent
transition to adult care
type 1 diabetes
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 78 were screened and 66 youth were randomized to 2 groups of 33 each and followed for 6 months with data collection at time zero, 3 months and 6 months.
Primary purpose: OTHER

Brief summary: A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.

Detailed description: Introduction and Objectives: For youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. Effective interventions are needed to prepare youth for transition to adulthood and adult care. To prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with Type 1 diabetes (T1D).

Methods: After parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (MI) approach and goal setting based on responses to the Transition Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with type 1 diabetes
* Having an age between 13 and 18 years

Exclusion Criteria:

* Having a neurological disability (epilepsy, autism)
* Having a significant intellectual delay, which might have affected their ability to understand the content of the program

Primary outcomes:
measure: Transition Readiness Assessment Questionnaire (TRAQ) scores
timeFrame: Change from Baseline TRAQ score at 6 months
Secondary outcomes:
measure: Hemoglobin glycated values
timeFrame: Change from Baseline Hemoglobin glycated values at 6 months
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Farhat Hached University Hospital
Study officials:
affiliation: East Tennessee State University
name: David Wood, Dr
role: STUDY_DIRECTOR
References:
citation: Al Ksir K, Wood DL, Hasni Y, Sahli J, Quinn M, Ghardallou M. Motivational interviewing to improve self-management in youth with type 1 diabetes: A randomized clinical trial. J Pediatr Nurs. 2022 Sep-Oct;66:e116-e121. doi: 10.1016/j.pedn.2022.05.001. Epub 2022 May 12.
Clinical trial NCT00765037: Retrospective Encore Reverse Shoulder Prosthesis Study
Official title: Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Deficiency
Glenohumeral Arthritis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria

Brief summary: The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.


Eligibility criteria: Inclusion Criteria:

* The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
* The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
* The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion Criteria:

* Infection or sepsis
* Insufficient bone quality which may affect the stability of the implant, as determined by the physician
* Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
* Alcoholism or other addictions
* Materials (metals, etc) sensitivity
* Loss of ligamentous structures
* High levels of physical activity
* Non-functional deltoid muscle

Primary outcomes:
measure: Survivorship of the Encore Reverse Shoulder Prosthesis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Nashville Orthopedic Specialists
state: Tennessee
Study officials:
affiliation: Nashville Orthopedic Specialists
name: J. Michael Kioschos, M.D.
role: PRINCIPAL_INVESTIGATOR
References: