louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06416826: Rhythmic Sensory Stimulation on Fibromyalgia
Official title: An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain, Widespread
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2024-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.


Eligibility criteria: Inclusion Criteria:

* patients with clinical diagnosis of fibromyalgia
* able to read and write English adequately
* have satisfactory hearing bilaterally (self-reported)
* have the ability to operate the supplied device

Exclusion Criteria:

* acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
* medical or psychiatric illness
* history of psychosis, epilepsy, seizures
* pregnancy or breast feeding
* hemorrhaging or active bleeding
* thrombosis, angina pectoris
* heart disease, such as hypotension, arrhythmia, pacemaker
* substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
* suffering from a recently prolapsed vertebral disc
* recovering from a recent accident with back or neck injury.

Primary outcomes:
measure: change in inflammatory cytokine levels
timeFrame: baseline, 1 month, 2 months
Secondary outcomes:
measure: change in pain severity
timeFrame: baseline, 1 month, 2 months
measure: change in EEG brain activity
timeFrame: baseline, 1 month, 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03788226: A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer
Official title: A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer Stage III
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-12-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years.
* Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
* Subjects must be able to take orally.
* R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
* Previously untreated except for the initial gastric resection for the primary lesion.
* ECOG performance status ≦ 1.
* Able to start chemotherapy with 42 days after gastrectomy.
* Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
* Creatine ≦ upper normal limit (UNL)
* Total bilirubin ≦ 1.5 X UNL
* AST, ALT and ALP ≦ 2.5 x UNL
* Life expectancy estimated than 3 months
* Written informed consent

Exclusion Criteria:

* Active double cancer
* Gastrointestinal bleeding
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Definite contraindications for the use of corticosteroids
* Any subject judged by the investigator to be unfit for any reason to participate in the study

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: From enrollment to 5 years after treatment
Secondary outcomes:
measure: overall survival
timeFrame: From enrollment to 5 years after treatment
measure: safety (The incidence of chemotherapy related adverse events)
timeFrame: From enrollment to 1 years after treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Rongbo Lin
Study officials:
References:
Clinical trial NCT00716326: The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Official title: The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Transcutaneous Electrical Nerve Stimulation
Chronic pain
Neuropathic pain
Short-term efficacy
Long-term efficacy
Lead sponsor: Norwegian Fund for Postgraduate Training in Physiotherapy
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."

Hypothesis:

An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.

0-hypothesis:

* TENS is not better than than placebo, medication or standard rehabilitation program.
* A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.

Detailed description: Setting:

Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.

Duration:

Until 18 months of intervention + 6 months of follow up and preparation.

Intervention:

Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.

Follow-up:

If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).

Eligibility criteria: Inclusion Criteria:

* Adult patients with chronic pain of predominantly neuropathic origin

Exclusion Criteria:

* Pain less than 3 months
* Surgery or lesion within 3 months
* Central neuropathic pain
* Fibromyalgia
* Primary headaches
* Primary psychiatric diagnosis
* Patients with pacemaker
* Formerly treated with TENS

Primary outcomes:
measure: Reduction of pain and/or functional improvement
timeFrame: 3-4 weeks, 2 and 4 months
Secondary outcomes:
measure: Compliance. Patient global impression of change
timeFrame: 3-4 weeks, 2 and 4 months
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Skogli helse- og rehabiliteringssenter
Study officials:
affiliation: University of Bergen
name: Jan M Bjordal, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01609426: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
Official title: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Nephrotic Syndrome
Keywords: Proteinuria
idiopathic
nephrotic syndrome
herpesvirus
epidemiology
immune response
interferon
steroid dependency
nephrotic disease: Idiopathic nephrotic syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 351
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any children below 16 years of age with a first manifestation of idiopathic nephrotic syndrome commencing or having commenced in the Paris area

Brief summary: The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

Detailed description: Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.

Eligibility criteria: Inclusion Criteria:

* children below 16 years
* first manifestation of nephrotic syndrome
* steroid sensitivity according to the recommendations of the french "pediatric society nephrology"

Exclusion Criteria:

* patients who don't stay in Paris during the study

Primary outcomes:
measure: define pharmacogenetic factors of steroid dependency
timeFrame: 28.5 months
Secondary outcomes:
measure: parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
timeFrame: 28.5 months
measure: Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
timeFrame: 28.5 months
measure: Analysis of cortico-dependence factors
timeFrame: Day 1
measure: Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Robert-Debré, Department of Pediatric Nephrology
Study officials:
affiliation: Assistance Publique
name: Georges Deschênes, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03736226: A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
Official title: A Post-Approval, Single-Arm Study of the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "all comers" study.

Brief summary: A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

Detailed description: This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.

Eligibility criteria: Inclusion Criteria:

* • Subject must be at least 18 years of age

  * Subject understands and provides written informed consent
  * Subject who is clinically indicated and will have an attempt of at least one SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent
  * Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Exclusion criteria are not required in this study which is an "all comers" study.

Primary outcomes:
measure: MACE rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Junbo Ge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925426: Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery
Official title: Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Keywords: Red Blood Cells
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing any spine surgery that utilizes Cell Saver and has blood to be given back.

Brief summary: The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?


Eligibility criteria: Inclusion Criteria:

* Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back.
* This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery.
* Only patients with the capacity to consent will be included.

Exclusion Criteria:

* Patients indicated for spinal surgery without the use of Cell Saver.

Primary outcomes:
measure: Lactate Dehydrogenase (LDH) Levels
timeFrame: Day 1 (Day of Surgery)
measure: Hemoglobin Levels
timeFrame: Day 1 (Day of Surgery)
measure: Elongation Index (Deformability)
timeFrame: Day 1 (Day of Surgery)
measure: Critical Shear Stress (Aggregation)
timeFrame: Day 1 (Day of Surgery)
Secondary outcomes:
measure: Standardized Quantified Blood Loss (mL)
timeFrame: Day 1 (Day of Surgery)
measure: Use of Cell Saver
timeFrame: Day 1 (Day of Surgery)
measure: Volume (mL) collected via Cell Saver
timeFrame: Day 1 (Day of Surgery)
measure: Units of autologous blood transfused intraoperatively
timeFrame: Day 1 (Day of Surgery)
measure: Units of allogeneic blood transfused intraoperatively
timeFrame: Day 1 (Day of Surgery)
measure: Units of allogeneic blood transfused postoperatively
timeFrame: Day 1 (Day of Surgery)
measure: Duration of pressor use
timeFrame: 1 Day (Day of Surgery)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Darryl Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04087226: Gingival Displacement by Polytetrafluoroethylene & Conventional Retraction Cord
Official title: Comparative Evaluation of Gingival Displacement by Polytetrafluoroethylene (PTFE) & Conventional Retraction Cord- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Pocket
Keywords: Polytetrafluoroethylene
Retraction
Soft tissue Management
Retraction cord
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To achieve harmony between restoration and surrounding periodontium, soft tissue management plays a pivotal role. Various Gingival displacement techniques show varying results in achieving the goals of displacement. The most preferred method of displacement by dental practitioners is through conventional retraction cord made up of cotton, which besides its advantages, poses certain drawbacks, including low tear strength, high friction, and fiber remnants within the sulcus.

Polytetrafluoroethylene (PTFE) retraction cord, is a fluoropolymer, known for its high tear strength, low friction, and bio-compatibility.

This study aims to determine the difference of horizontal gingival displacement between PTFE and conventional retraction cord.

Participants inducted in this study will be assessed for eligibility. qualifying subjects will receive crown preparation for Porcelain-fused to-metal crown. subjects will then be randomly allocated to either of the two arms of intervention. After making a pre-displacement impression, Retraction cord will be applied for 3 minutes, then removed to record post-displacement impression.

the difference in pre and post-displacement mean gingival sulcus width will be assessed by a stereomicroscope using image analysis software.


Eligibility criteria: Inclusion Criteria:

* Indication of full veneer crown

  * Age group: 18-60 years
  * Probing Depth 2-3mm and no bleeding on probing
  * No signs of gingival/periodontal disease

Exclusion Criteria:

* Indication of subgingival margin location

  * Developmental anomaly (anatomical) affecting abutment tooth
  * Bleeding disorder
  * Pregnancy

Primary outcomes:
measure: Difference between Mean Horizontal Gingival Displacement by PTFE retraction cord and Conventional retraction cord among sixty participants as assessed by Stereomicroscope.
timeFrame: 3 minutes after displacement
Secondary outcomes:
measure: Difference between Post-displacement Bleeding by PTFE and conventional retraction cord among sixty participants by visual assessment
timeFrame: immediately after cord removal
measure: Difference between ease of Application of PTFE and conventional retraction cord among sixty participants.
timeFrame: immediately after cord removal
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
References:
Clinical trial NCT04871126: Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction
Official title: Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for Left Ventricular Thrombus in Acute Anterior Myocardial Infarction With Left Ventricular Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Thrombus
Acute Anterior Myocardial Infarction
Left Ventricular Dysfunction
Keywords: left ventricular thrombus;anterior myocardial infarction
Risk factors
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included a total of 371 patients with anterior myocardial infarction (ANT-MI) treated with emergency prior percutaneous coronary intervention (pPCI) in our hospital betweenfrom January 2014 andto January 2021. Patients were eligible for enrollmentenrolment if they had a reduced left ventricularLV ejection fraction (LVEF) ( ≤40%). and if detailed data on demographic and clinical characteristics were documented. Exclusion criteria were end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity (Figure 1). Based on the study criteria, 123 patients were excluded from the study; thus, 248 patients were included in the analysis.

Brief summary: To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT).

Detailed description: The clinical data were collected from 371consecutive patients with ANT-MI in our hospital from January 2014 to January 2021.As a result,totally 62 patients with LVT were selected as the experimental group and 186 patients with non-LVT as the control group .The observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.Patients with severe organic disease and having previous history of left ventricular aneurysm( LVA) and LVT were excluded.Data was analyzed by software SPSS 22.0 for statistical analysis,and the logistic regression model was established.A P\<0.05 was considered statistically significant, and the risk factors of LVT formation were retrospectively analyzed.

Eligibility criteria: Inclusion Criteria:

acute anterior myocardial infarction with left ventricular dysfunction

Exclusion Criteria:

end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity

Primary outcomes:
measure: the predictive of the inflammatory indexes and CHA2DS2-VASc score in LVT
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: