louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06231264: Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Official title: A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 96
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 was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Ulcerative colitis diagnosed for at least 3 mouths.
3. Mayo score 4-10, Mayo endoscopic score 2-3 points
4. Resistant to at least one type of medical treatments

Exclusion Criteria:

1. Treatment-naive ulcerative colitis (no previous treatment)
2. Acute severe ulcerative colitis
3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
4. Other systemic diseases
5. Pregnancy and lactation
6. Allergic to the electrode patch

Primary outcomes:
measure: Clinical response
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in the Mayo score
timeFrame: 8 weeks
measure: Endoscopic remission
timeFrame: 8 weeks
measure: Clinical remission
timeFrame: 8 weeks
measure: Symptomatic remission
timeFrame: 2, 4, 6, and 8 weeks
measure: Fecal calprotectin
timeFrame: 4 and 8 weeks
measure: erythrocyte sedimentation rate
timeFrame: 4 and 8 weeks
measure: C reactive protein
timeFrame: 4 and 8 weeks
measure: pancreatic polypeptide
timeFrame: 4 and 8 weeks
measure: norepinephrine
timeFrame: 4 and 8 weeks
measure: acetyl choline
timeFrame: 4 and 8 weeks
measure: acetyl choline
timeFrame: 8 weeks
measure: alpha7 nicotinic acetylcholine receptor
timeFrame: 8 weeks
measure: Inflammatory Bowel Disease Questionnaire Score
timeFrame: 4 and 8 weeks
measure: Hospital Anxiety and Depression scale score
timeFrame: 4 and 8 weeks
measure: Pittsburgh sleep quality index
timeFrame: 4 and 8 weeks
measure: autonomic profile characteristics
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Honghui hospital
state: Shaanxi
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Kaichun Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246164: A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
Official title: A Randomized, Double-Blinded, Placebo Controlled Pilot Trial of the Feasibility of High Definition Transcranial Direct Current Stimulation and Cognitive Training in Patients With Mild Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Memory Disorders
Memory Loss
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo controlled
Primary purpose: TREATMENT

Brief summary: The primary objective of this project is to assess the feasibility of multi-field, extended HD-tDCS (MFE-HD-tDCS) with simultaneous computerized CT as a viable intervention to improve cognitive function in patients with MCI. This double-blinded, randomized pilot clinical trial of repetitive daily HD-tDCS/sham HD-tDCS, administered in combination with CT to subjects with MCI in 3 monthly blocks of 5 daily sessions for a total of 15 sessions will enroll 8 participants.


Eligibility criteria: Inclusion Criteria:

1. Age ≥50-90 years
2. Right handed
3. Willing and able to undergo all procedures
4. Retains decisional capacity at initial visit
5. Meets criteria for MCI, amnestic type (Petersen, 2004).

Exclusion Criteria:

1. Left handed patients
2. Significant kidney injury requiring hemodialysis
3. Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
4. Significant congestive heart failure
5. History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
6. History of thalamic lacunar stroke
7. Modified Hachinski Ischemia Score \>4 points
8. History of seizure disorder requiring medication
9. History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
10. History of HIV/AIDS
11. Severe untreated obstructive sleep apnea
12. Greater than three servings alcohol daily or illicit drug use
13. Major neurologic disorders other than dementia (e.g., MS, ALS)
14. Schizophrenia, bipolar disorder, other serious mental illnesses
15. Other significant medical conditions at investigators' discretion
16. Pregnancy

Primary outcomes:
measure: Treatment completion rates
timeFrame: 6 months
Secondary outcomes:
measure: Recruitment rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT01734564: Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
Official title: Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 15
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: In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

Detailed description: In this phase II study, patients with solid tumors will receive treatment with intratumoral hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and administered subcutaneously. A new cohort will explore the role of radiation therapy, looking for an abscopal effect.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of advanced solid tumors
* Measurable disease
* Performance status 0, 1 or 2.
* Adequate renal, hepatic and bone marrow function
* Availability of tumor tissue, for maturing dendritic cells

Exclusion Criteria:

* Clinically relevant diseases or infections.
* concurrent participation in other clinical trial or administration or other antitumoral treatment
* Concurrent cancer, with the exceptions allowed by the PI.
* Pregnant or breast feeding women
* immunosuppressant treatment
* known uncontrolled central nervous system metastasis

Primary outcomes:
measure: Response rate
timeFrame: 8-10 weeks
Secondary outcomes:
measure: Safety (Common Toxicity Criteria 4.0)
timeFrame: 8-10 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Jose Luis Perez Gracia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03503864: Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma
Official title: Clinical Research on Efficacy and Safety of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma：A Prospective，Single-arm, Open-label, Multi-center Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: Neuroblastoma
Arsenic Trioxide
Children
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 80
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combined induction chemotherapy with arsenic trioxide
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.

Detailed description: This study is a prospective, single-arm, open-lable, multi-center clinical trial. Children≤ 14 years old are eligible for this study if they were newly diagnosed with neuroblastoma and assessed as stage 4 according to the International Neuroblastoma Staging System (INSS) or stage M according to the International Neuroblastoma Risk Group (INRG) respectively. Patients enrolled in this study will receive combined induction chemotherapy with arsenic trioxide following an modifed protocol based on N7 and NB2004 protocols. Objective response rate (ORR) at 4 weeks after completing induction chemotherapy was defined as the main outcome and adverse events were monitored and graded in the meantime.

Eligibility criteria: Inclusion Criteria:

1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system;
2. Patients not more than 14 years old;
3. There are measurable lesions;
4. Guardians agreed and signed informed consent.

Exclusion Criteria:

1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.
2. Patients with one or more critical organs failure such as heart, brain, kidney failure.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Four weeks after ATO-combined induction chemotherapy
Secondary outcomes:
measure: Overall Survival Rate
timeFrame: 3 years.
measure: Progression Free Survival Rate
timeFrame: 3 years.
measure: Number of Participants With Adverse Events
timeFrame: From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yang Li, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03200964: OS Anesthesia Followup of All Bariatric Procedures at One Hospital
Official title: Retrospective Analysis of Anesthesia Delivering for Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia Recovery
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 20000
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: All patients undergoing bariatric surgery

Brief summary: Database registering demographic patient data, anesthesia and surgery information, post operative recovery and complications if any.

Detailed description: Every patient undergoing a bariatric procedure is entered in the data base after the procedure is finished, based on the information available in the medical records.

the study has no end point and keeps collecting data as long as procedures are performed.

The data is analyzed intermittent when medical questions arise on quality and outcome changes due to changes in clinical treatment taken in order to improve individual patient care.

Eligibility criteria: Inclusion Criteria:

* all bariatric procedures

Exclusion Criteria:

* none

Primary outcomes:
measure: Postoperative complications first month after surgery.
timeFrame: one month followup
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZ Sint-Jan AV
name: Marco lanckneus, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04263064: High Volume Caudal Study
Official title: Effect of Clonidine on High Volume-Low Concentration Caudals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Male Circumcision
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 129
Sex: MALE
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.


Eligibility criteria: Inclusion Criteria:

* 3 years old or less
* Weight \<= 13.3kg
* American Society of Anesthesiology Physical Status (ASA) 1 or 2
* Undergoing circumcision surgery
* Patients whose plan of care includes caudal block

Exclusion Criteria:

* Known allergy to clonidine, epinephrine, or amide local anesthetics
* Inability or unwillingness of parent or legal guardian to give informed consent

Primary outcomes:
measure: Presence of Pain
timeFrame: 24 hours
measure: Administration of Rescue Pain Medications
timeFrame: 24 hours
measure: Time to first Administration of Acetaminophen
timeFrame: 24 hours
Secondary outcomes:
measure: Hemodynamic Changes
timeFrame: 24 hours
measure: Incidence of Emergence Delirium
timeFrame: 24 hours
measure: Sedation Levels
timeFrame: 24 hours
measure: Average Time to Discharge
timeFrame: 24 hours
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: Christopher Heine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916864: Biomarker for Rapid Diagnosis of Hemispheric Stroke
Official title: Biomarker for Rapid Diagnosis of Hemispheric Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted with symptoms suspicious of acute hemispheric stroke to primary, secondary and tertiary care hospitals in Europe.

Brief summary: The aim of the study is to estimate the diagnostic accuracy of a combined biomarker test (including NMDA-Receptor fragments \[NR2-peptide\] and Glial fibrillary acidic protein) used to differentiate between cerebral ischemia and intracerebral hemorrhage in patients with acute hemispheric stroke.


Eligibility criteria: Inclusion Criteria:

* hemiparesis
* at least one sign of cortical involvement (e.g., aphasia, neglect, gaze deviation, reduced level of consciousness)
* hospital admission within 4.5 hours after symptom onset

Exclusion Criteria:

* stroke/TIA within the last 3 months
* traumatic brain injury within the last 3 months
* history of brain tumor

Primary outcomes:
measure: Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Neurology, Goethe-University
Study officials:
affiliation: Department of Neurology, Goethe-University, Frankfurt, Germany
name: Helmuth Steinmetz, MD
role: STUDY_CHAIR
References:
citation: Dvorak F, Haberer I, Sitzer M, Foerch C. Characterisation of the diagnostic window of serum glial fibrillary acidic protein for the differentiation of intracerebral haemorrhage and ischaemic stroke. Cerebrovasc Dis. 2009;27(1):37-41. doi: 10.1159/000172632. Epub 2008 Nov 15.
citation: Foerch C, Curdt I, Yan B, Dvorak F, Hermans M, Berkefeld J, Raabe A, Neumann-Haefelin T, Steinmetz H, Sitzer M. Serum glial fibrillary acidic protein as a biomarker for intracerebral haemorrhage in patients with acute stroke. J Neurol Neurosurg Psychiatry. 2006 Feb;77(2):181-4. doi: 10.1136/jnnp.2005.074823. Epub 2005 Sep 20.
citation: Dambinova SA, Khounteev GA, Izykenova GA, Zavolokov IG, Ilyukhina AY, Skoromets AA. Blood test detecting autoantibodies to N-methyl-D-aspartate neuroreceptors for evaluation of patients with transient ischemic attack and stroke. Clin Chem. 2003 Oct;49(10):1752-62. doi: 10.1373/49.10.1752.
Clinical trial NCT05902364: Systane® Ultra Preservative Free Lubricant Eye Drops
Official title: Systane® Ultra Preservative Free Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.

Detailed description: Subjects will participate in the study for approximately 30 days, with a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\] or Contact Lens Dry Eye Questionnaire \[CLDEQ-8\] and Comfortable Wear Time questions).

Eligibility criteria: Inclusion Criteria:

* Subject must be able to understand and sign an informed consent form
* Subject with mild to moderate dry eye
* Subject with CL-related dry eye symptoms
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 3 months prior to screening.
* Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean overall IDEEL-Symptom Bother(SB) score - Group 1
timeFrame: Visit 3 (Day 30)
measure: Resultant overall CLDEQ-8 score - Group 2
timeFrame: Visit 3 (Day 30)
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Integra Eye Care
state: British Columbia
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02496364: Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease
Official title: Topical and Intravenous Use of Tranexamic Acid in Posterior Lumbar Interbody Fusion - A Prospective, Double-blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lumbar Disc Degeneration
Surgical Procedure, Unspecified
Lead sponsor: Instituto Nacional de Traumatologia e Ortopedia
Sponsor class: OTHER_GOV
First posted: 2015-07-14
Enrollment: 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease



Primary outcomes:
measure: Observation
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03605290: Comparison Between Two Operational Techniques for Total Knee Replacement
Official title: Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Unsteady
Knee Arthropathy
Surgery
Keywords: total knee replacement
gait analysis
PROMS
mechanical aligment
kinematic alignment
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.

There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.

The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.


Eligibility criteria: Inclusion Criteria:

- Patients after total knee replacement which was performed in our ward.

Exclusion Criteria:

* Less than 6 months have passed after the procedure
* Inability to understand and fill out PROMS questionnaires.
* Inability to walk without aids for at least 20 meters.

Primary outcomes:
measure: PROMS
timeFrame: At least 6 months post operatively
measure: Gait analysis
timeFrame: At least 6 months post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: haemek MC
Study officials:
References: