louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04079049: BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Official title: Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Liver Metastases
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Karolinska Institutet
name: Linkoeping University
name: Lund University
name: Göteborg University
First posted: 2019-09-06
Enrollment: 200
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: Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver.

The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* \>18 years old
* ECOG 0-1
* Breast cancer history
* Breast cancer liver metastasis verified by biopsy
* Patient amendable for liver surgery and pre- and postoperative oncological treatment
* 1-4 liver metastasis amendable to surgery with functional liver remnant volume \>30%
* Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment

Exclusion Criteria:

* Non-skeletal extrahepatic disease
* Non-resected primary tumour
* Pregnancy
* Progression of disease upon oncological treatment

Primary outcomes:
measure: Survival
timeFrame: Three years after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Oskar Hemmingsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03414749: Extremity Manipulation Impact on Postural Sway Characteristics
Official title: Assessment of Balance Changes After Extremity Manipulation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Chiropractic
postural sway
manipulation
Lead sponsor: Parker University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Whittier University
name: University of Houston
First posted: 2018-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study used a randomized, crossover experimental design over three days of testing.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the multi-segmental postural sway after upper versus lower extremity manipulation.

Detailed description: The focus of this study is to explore the effect of upper and lower extremity chiropractic adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on multisegmental postural control as represented by postural sway. Using a rocker (tilt) board, the participant cannot stand still, but has to adjust posture continuously to maintain balance. Body sways are considered to be self-induced because the design of the rocker board creates a natural instability without any external perturbation. This task provides a self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were considered separately on the device.

The investigators had the following hypotheses.

Hypothesis 1: Lower extremity adjustments will lead to reduced postural sway magnitude compared to upper extremity adjustments.

Hypothesis 2: Lower extremity adjustments will reduce sway variability of the rocker board, trunk and head compared to upper extremity adjustments.

Hypothesis 3: Lower extremity adjustments will facilitate the organization of sway behavior as assessed by the chaotic structure of sway.

Eligibility criteria: Inclusion Criteria:

* student in Parker University's Doctor of Chiropractic program and patient at the Parker University Wellness Clinic;
* available to take part in the study for all 3 test days;
* willing to forgo all non-normal daily activities and chiropractic treatments during the test days;

Exclusion Criteria:

* pregnant;
* previous major injury involving the extremities;
* previous surgeries to an extremity joint; and
* known neurological or systemic diseases.

Primary outcomes:
measure: Postural Assessment
timeFrame: Post Treatment on Day 1
measure: Postural Assessment
timeFrame: Pre Treatment on Day 2
measure: Postural Assessment
timeFrame: Post Treatment on Day 2
measure: Postural Assessment
timeFrame: Pre Treatment on Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker University
state: Texas
Study officials:
affiliation: Parker University
name: Katherine A Pohlman, DC, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05892549: COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
Official title: COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sars-CoV-2 Infection
COVID-19
Keywords: Voice
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of people coming to a hospital or to a COVID screening center.

Brief summary: In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a "cytokine storm" appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU).

At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation.

The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance.

Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.


Eligibility criteria: Inclusion Criteria:

* French speaking
* Affiliated to a social security system
* Owning a mobile phone capable of accessing the COVOICE application

Exclusion Criteria:

* Incapable adults
* People deprived of their liberty
* People under administrative or judicial supervision
* Patients intubated or hospitalized in intensive care unit

Primary outcomes:
measure: Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
timeFrame: Through study completion (36 months)
measure: Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
timeFrame: Through study completion (36 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
Study officials:
References:
Clinical trial NCT04041336: Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture
Official title: Optical Coherence Tomography Feasibility in Older People Following Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Imaging
Keywords: Older
Hip fracture surgery
Optical coherence tomography
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assess the feasibility of measuring the thickness of retinal layers using a handheld optical coherence tomography device in older patients after hips fracture surgery. Consecutively recruited consenting patients will be included.
Primary purpose: DIAGNOSTIC

Brief summary: Assessment of the feasibility of achieving retinal imaging in older people with recent hips fracture surgery using hand held optical coherence tomography device

Detailed description: Optical coherent tomography (OCT) is a device used to achieve cross-sectional imaging of tissues. It is often used in ophthalmology and also has application in dermatology, cardiology and other specialities. Usually, in adults, a table-top device is used necessitating the transfer of patients to the location of the device. In children a hand held device is used meaning the device can be taken to the patients' location. To facilitate/ help design a future study, this study's aim is to assess the feasibility of achieving retinal imaging in older people who are recovering from hip fracture surgery using a hand held device.

Eligibility criteria: Inclusion Criteria:

* Recent hip fracture surgery
* Age \> 64 years
* No cognitive impairment
* Able to understand instructions given in English
* Consent

Exclusion Criteria:

* Presence of degenerative eye disease e.g. age-related macula degeneration, glaucoma, diabetic retinopathy, hypertensive retinopathy
* Dementia, mild cognitive impairment, Parkinson,s disease, multiple sclerosis, current delirium

Primary outcomes:
measure: Ability to achieve good quality retinal images
timeFrame: 30 minutes
measure: Ability to achieve imaging without causing pain
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham, Nottingham, UK
name: Iain Moppett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643136: A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
Official title: Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Deprivation
Epilepsies, Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 17
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 purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.


Eligibility criteria: Inclusion Criteria:

* Partial epileptic seizures
* Not taking more than 1 background antiepileptic drug at study entry
* Disturbed sleep

Exclusion Criteria:

* More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
* Medical, psychological, or social conditions that could interfere with normal sleep

Primary outcomes:
measure: Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
timeFrame: Endpoint
Secondary outcomes:
measure: Change from baseline in total sleep time
timeFrame: Endpoint
measure: Change from baseline in sleep onset latency
timeFrame: Endpoint
measure: Change from baseline in wake after sleep onset
timeFrame: Endpoint
measure: Change from baseline in percent sleep spent in stages 3 and 4
timeFrame: Endpoint
measure: Change from baseline in percent sleep spent in REM stage
timeFrame: Endpoint
measure: Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)
timeFrame: Endpoint
measure: Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)
timeFrame: Endpoint
measure: Adverse events and laboratory value changes
timeFrame: Endpoint
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
city: Heeze
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06247436: Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period
Official title: Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tonsil Disease
Keywords: body composition
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The body composition of individuals undergoing tonsillectomy is assessed through bioimpedance-based measurements conducted immediately before the surgery, as well as on the 7th and 21st days during the postoperative period.

Detailed description: In the context of interventions affecting the upper alimentary canal-like tonsillectomy-, it is advisable to adhere to a gentle diet until complete wound healing. Additionally, patients may need to modify their eating habits due to discomfort during swallowing. Physical activity is strictly prohibited during this recovery phase, which poses a risk of muscle loss.

Branched-chain amino acids (BCAAs) play a crucial role in sports nutrition. Unlike other amino acids, BCAAs can be directly utilized by muscles without involving the liver. They serve as an immediate energy source for muscles or contribute to the synthesis of new muscle proteins, helping to prevent muscle loss.

At the same time, the investigators also examined the changes that could be detected in the blood and were possibly related to dietary habits.

Eligibility criteria: Inclusion Criteria:

* indication of tonsillectomy
* age between 20-40 years

Exclusion Criteria:

* metabolic diseases,
* haematologic disorders

Primary outcomes:
measure: The postoperative changes of body weight (kg) after tonsillectomy
timeFrame: 21 days
measure: The postoperative changes of skeletal muscle mass (kg) after tonsillectomy
timeFrame: 21 days
measure: The postoperative changes of Body Fat Mass (kg) after tonsillectomy
timeFrame: 21 days
measure: The postoperative changes of Body Mass Index (kg/m2) after tonsillectomy
timeFrame: 21 days
measure: The postoperative changes of Percent Body Fat (%) after tonsillectomy
timeFrame: 21 days
measure: The postoperative changes of Total Body Water (liter) after tonsillectomy
timeFrame: 21 days
measure: examination of changes in blood count (mmol/l)
timeFrame: 21 days
measure: determination of changes in blood parametersof Liver Function (U/l)
timeFrame: 21 days
Secondary outcomes:
measure: effects of branched chain amino acid consumption
timeFrame: 21 days
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Study officials:
affiliation: Szeged University
name: Agnes Kiricsi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333436: A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
Official title: A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.


Eligibility criteria: Inclusion criteria:

* Participant has an LDL-C ranging from ≥100 mg/dL to \<160 mg/dL.
* Patient has a triglyceride (TG) level of ≤500 mg/dL.

Exclusion Criteria:

* Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).
* Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal \[ULN\])
* Participant has increased creatine kinase (CK) (≥2 x ULN).
* Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.
* Participant has a history of alcohol and/or drug abuse.

Primary outcomes:
measure: Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
timeFrame: up to 6 hours after Test Meal
Secondary outcomes:
measure: Postprandial Mean ApoB-48 Peak Levels
timeFrame: up to 6 hours after Test Meal
measure: Fasting ApoB-48 Levels
timeFrame: Baseline (Hour 0)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: MSD Korea Ltd.
Study officials:
References:
citation: Park CY, Park JY, Choi J, Kim DJ, Park KS, Yoon KH, Lee MK, Park SW. Increased postprandial apolipoprotein B-48 level after a test meal in diabetic patients: A multicenter, cross-sectional study. Metabolism. 2016 Jun;65(6):843-51. doi: 10.1016/j.metabol.2016.02.008. Epub 2016 Feb 23.
Clinical trial NCT00757536: Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment
Official title: Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Primary Vitrectomy
Encircling Band
Endolaser Treatment
Keywords: Rhegmatogenous retinal detachment
primary vitrectomy
encircling band
endolaser treatment
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.

Detailed description: published

Eligibility criteria: Inclusion Criteria:

* Primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes
* Multiple breaks, inferior and posterior located breaks or unclear hole formation
* Proliferative vitreoretinopathy (PVR) stage A and B

Exclusion Criteria:

* Previous retinal detachment surgery
* Giant tears
* PVR stage C
* Age less than 18 years

Primary outcomes:
measure: Retinal redetachment rate
timeFrame: 6 months
Secondary outcomes:
measure: Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study officials:
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Susanne Binder, MD
role: STUDY_CHAIR
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Christiane I Falkner-Radler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falkner-Radler CI, Graf A, Binder S. Vitrectomy combined with endolaser or an encircling scleral buckle in primary retinal detachment surgery: a pilot study. Acta Ophthalmol. 2015 Aug;93(5):464-469. doi: 10.1111/aos.12663. Epub 2015 Jan 28.
Clinical trial NCT03089736: Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness
Official title: Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Head and Neck Cancer
Keywords: Pain
Head and neck cancer
depression
anxiety
health
catastrophizing
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-03-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.

Detailed description: The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer

Eligibility criteria: Inclusion Criteria:

All HNC patients who went through RT and were referred to the Pain and Rehabilitation Centre at the University Hospital (Linköping, Sweden) were invited to participate in the study which run from January 2015 - March 2017.

-

Exclusion Criteria:

Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions.

-

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Change from baseline pain intensity at 20 weeks
measure: Change in Pain Interference
timeFrame: Change from baseline pain interference at 20 weeks
measure: Change in Perceived health index
timeFrame: Change from baseline EQ-5D index at 20 weeks
measure: Change in Perceived health scale
timeFrame: Change from baseline EQ-VAS at 20 weeks
Secondary outcomes:
measure: Change in depression
timeFrame: Change from baseline depression at 20 weeks
measure: Change in anxiety
timeFrame: Change from baseline anxiety at 20 weeks
measure: Change in catastrophizing
timeFrame: Change from baseline catastrophizing at 20 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rehabilitation Medicine, Linkoeping University
name: Bjorn Gerdle, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: