louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02800629: Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Official title: Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind clinical trial
Primary purpose: TREATMENT

Brief summary: The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

1. Knee pain in at least one knee for more than half the days in the month prior to screening
2. X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments.
3. Willingness to maintain stable analgesic regimen throughout the study period

Exclusion Criteria:

1. Diagnosis of fibromyalgia
2. Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease.
3. Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them.
4. While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.

Primary outcomes:
measure: WOMAC-Knee
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: MGH
name: Mark Fisher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05984329: Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain
Official title: Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: Motor cortex stimulation
neuropathic pain
Burst DR(TM) waveform
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MCS patients.

Brief summary: Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

Detailed description: The main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for MCS with an internal pulse generator (IPG) capable of delivering both tonic and Burst DR(TM) stimulation waveforms.

Exclusion Criteria:

* Patients under 18 years old ; pregnancy

Primary outcomes:
measure: Percentage of pain relief
timeFrame: 6 months
Secondary outcomes:
measure: Antalgic drugs intake
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: François VASSAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06341829: Visuospatial and Affective Abilities in Parkinson Disease
Official title: Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Alexithymia
Visuospatial/Perceptual Abilities
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG).


Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Right-handed;
* Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
* Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) \<2,5;
* Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.

Exclusion Criteria:

* - Sensory-motor deficits that can hinder neuropsychological assessment;
* Visual system disorders (blindness, glaucoma);
* Atypical parkinsonisms;
* PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).

Primary outcomes:
measure: Improve visuospatial skills;
timeFrame: 2 years
measure: Modulate alexithymia;
timeFrame: 2 years
measure: Investigation of brain activity;
timeFrame: 2 years
Secondary outcomes:
measure: Improve the quality of life with PDQ-39 questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Laura Culicetto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560729: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
Official title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Denutrition
Keywords: elderly people
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 63
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients


Eligibility criteria: Inclusion Criteria:

* Hospitalization into a geriatric care unit
* age \> 70 years
* C reactive protein \> 30 mg/l
* 25 \< albumin \< 35 g/l
* 130 \< Na \< 145 mmol/l
* BMI \< 22
* weight loss \> 10 % within the last 6 months
* MNA \< 23.5

Exclusion Criteria:

* diabetes mellitus
* severe digestive failure
* enteral or parenteral nutrition
* renal,cardiac or digestive failure
* lactose intolerance
* terminal phase severe pathology
* MMS \< 15

Primary outcomes:
measure: Nutritional Risk Index
timeFrame: At J0, J21, J42
Secondary outcomes:
measure: Measure of body mass index (BMI), Mini Nutritional Assessment, Fat mass,lean mass, serum albumin and transthyretin,Activities of Daily Living (ADL), ingesta and morbidity.
measure: Tolerance
timeFrame: Daily
Other outcomes:
Locations:
city: Champcueil
country: France
facility: Hôpital Georges Clemenceau
city: Limeil Brevannes
country: France
facility: Hopital Emile Roux
city: Villiers Le Bel
country: France
facility: Hopital Charles RICHET
Study officials:
affiliation: University PARIS V
name: Christian Aussel, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06174129: Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes
Official title: Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Type 2 Diabetes
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 427
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with type 2 diabetes who visited the medical clinic at Burapha University Hospital, Chonburi province, Thailand between June 2022 and June 2023 were enrolled in the present study.

Brief summary: This case-control study was conducted at Burapha University Hospital. The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients.


Eligibility criteria: Inclusion Criteria:

* Outpatients with type 2 diabetes who visited the medical clinic between June 2022 and June 2023

Exclusion Criteria:

* Patients with missing information on the urinary albumin value and electrocardiograms at the latest date

Primary outcomes:
measure: Prevalence of atrial fibrillation
timeFrame: June 2022 and June 2023
measure: Factors associated with atrial fibrillation
timeFrame: June 2022 and June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: Burapha University Hospital
state: Chonburi
Study officials:
References:
Clinical trial NCT00168129: Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Official title: Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bone Neoplasms
Keywords: tomotherapy
bone metastases
radiotherapy
intensity modulated
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10
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: To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.


Eligibility criteria: Inclusion Criteria:

* painful metastatic bone disease from any malignancy

Exclusion Criteria:

* previous RT to same area
* contraindications to RT

Primary outcomes:
measure: To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
Secondary outcomes:
measure: To assess and quantify the acute toxicity of patients with bone metastases treated with helical tomotherapy.
measure: To measure invivo dosimetry and compare delivered doses to computer-reconstructed dose distribution.
measure: To determine the maximum tolerated does of palliative radiation give with helical tomotherapy in a single fraction.
measure: To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Rufus Scrimger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850329: A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
Official title: A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Informed Consent Process
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 67
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.


Eligibility criteria: Inclusion Criteria:

* Parents with patients under 18 years of age
* patients receive the procedural sedation and anesthesia in the emergency department

Exclusion Criteria:

* clinically unstable
* refuse to participate
* unable to understand the consent process for this study

Primary outcomes:
measure: structured questionnaire
timeFrame: before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT02096029: Tobacco Intervention in Primary Care Treatment Opportunities for Providers
Official title: Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
smoking cessation
nicotine replacement therapy
primary care
comparative effectiveness
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-03-26
Enrollment: 1278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.


Eligibility criteria: Inclusion Criteria:

* age \>=18
* daily (25+ days within past 30) cigarette smoker of \>5 cigs/day
* English speaking
* recruited through primary care sites aligned with study

Exclusion Criteria:

- no FDA contraindications for use of NRT:

1. not pregnant, breastfeeding, or planning to become pregnant
2. no recent (past 3 months) cardiovascular trauma: MI, stroke

Primary outcomes:
measure: Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
timeFrame: From study enrollment through end of six-month follow up
Secondary outcomes:
measure: Any Self-defined Attempt to Stop Smoking Cigarettes
timeFrame: From study enrollment through end of six-month follow up
measure: Use of Any Smoking Cessation Medication
timeFrame: From study enrollment through end of six-month follow up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Matthew J Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silvestri NJ, Dahne J, Wahlquist AE, Toll B, Carpenter MJ. Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial. J Smok Cessat. 2021;2021:6638872. doi: 10.1155/2021/6638872. Epub 2021 Mar 16.
Clinical trial NCT04772729: Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?
Official title: Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes type1
Diabetes Mellitus, Type 1
Keywords: CGM
continuous glucose monitoring system
TIR
Time In Range
insulin aspart
insulin faster aspart
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 77
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A cross-over, open-label, randomized study.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.


Eligibility criteria: Inclusion Criteria:

* ≥1 year of a history of type 1 diabetes;
* treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
* using continuous glucose monitoring system for at least 1 month;
* HbA1c\<8%;
* consent to participate in the study obtained from the parent and the patient (\>16 years of age).

Exclusion Criteria:

* diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
* concomitant medical problems which might significantly affect glucose levels;
* the withdrawal of the consent to participate in the study.

Primary outcomes:
measure: Glycaemia difference in time in range (TIR) 70-180mg/dl
timeFrame: at week 4 of the study
measure: Glycaemia difference in time in range (TIR) 70-180mg/dl
timeFrame: at week 8 of the study
Secondary outcomes:
measure: Glycaemia difference in time below range (TBR)
timeFrame: at weeks 4 and 8 of the study
measure: Glycaemia difference in time above range (TAR)
timeFrame: at weeks 4 and 8 of the study
measure: Glycaemia difference in the coefficient of variation (CV)
timeFrame: at weeks 4 and 8 of the study
measure: Difference in the average glycemia levels + standard deviation
timeFrame: at weeks 4 and 8 of the study
measure: Difference in Total Daily Dose (TDD) of insulin
timeFrame: at weeks 4 and 8 of the study
measure: Difference in the basal rate of insulin
timeFrame: at weeks 4 and 8 of the study
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland
name: Agnieszka Szypowska, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01516229: Special Survey for Long Term Application
Official title: Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Disorder
Achondroplasia
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 395
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being treated with somatropin for achondroplasia without epiphyseal line closure

Brief summary: This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Achondroplasia without epiphyseal line closure

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs)
Secondary outcomes:
measure: Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06512129: Defining Volume Status in Sepsis with Extracellular Water Measurement
Official title: Phenotypes in Sepsis - Extracellular Water for Volume Status Characterization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-07-22
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: Adult patients admitted to an ICU in Uppsala with suspected or confirmed sepsis.

Brief summary: The goal of this observational study is to learn about the influence of extracellular water on volume status in adult sepsis patients presenting with hemodynamic instability. The main question it aims to answer is:

• Can measurement of extracellular water (MoistureMeterD, Delfin Technologies Ltd, Kuopio, Finland) contribute to the description of hemodynamic instability in adult sepsis patients.

Patients with sepsis admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Detailed description: Adult patients with sepsis admitted to any of our ICUs will be recruited. During the first three days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility criteria: Inclusion Criteria:

* Adults with sepsis.

Exclusion Criteria:

* Pregnancy, palliative care, other than sepsis known cause of shock.

Primary outcomes:
measure: Phenotypes in sepsis - extracellular water for volume status characterization.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University, Region Uppsala
name: Annelie Barrueta Tenhunen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuutinen J, Ikaheimo R, Lahtinen T. Validation of a new dielectric device to assess changes of tissue water in skin and subcutaneous fat. Physiol Meas. 2004 Apr;25(2):447-54. doi: 10.1088/0967-3334/25/2/004.
citation: Toro C, Markarian B, Mayrovitz HN. Breast Cancer-Related Lymphedema Assessed via Tissue Dielectric Constant Measurements. Cureus. 2024 Apr 29;16(4):e59261. doi: 10.7759/cureus.59261. eCollection 2024 Apr.
citation: De Backer D, Cecconi M, Chew MS, Hajjar L, Monnet X, Ospina-Tascon GA, Ostermann M, Pinsky MR, Vincent JL. A plea for personalization of the hemodynamic management of septic shock. Crit Care. 2022 Dec 1;26(1):372. doi: 10.1186/s13054-022-04255-y.