louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04890418: Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
Official title: Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block. A Prospective Randomized Study in Ambulatory Patients Undergoing Upper Limb Bone Surgery Under Single Shot Axillary Plexus Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgery
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Risk factors and Prevention of severe Pain upon cessation of a peripheral nerve block. A prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.

Detailed description: Pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time.

Severe post-operative pain is a risk factor for chronic pain. Use of a well-known molecule, regularly used in anesthesiology. Prospective double-blind study on 120 patients. Pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients.

The anti-hyperalgesic properties of ketamine could be a benefit against this effect.

No studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release.

This may improve patients' post-operative comfort. The patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10mL saline or 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery.

Eligibility criteria: Inclusion Criteria:

* any ambulatory upper limb bone surgery carried out under axillary PNB

Exclusion Criteria:

* Refusal to participate
* Contraindication to the use of ketamine
* Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
* Pregnant woman
* Diabetic patient
* Vascular patient
* Cognitive disorders
* Inability to answer perioperative questionnaires (language problem)

Primary outcomes:
measure: incidence of severe postoperative rebound pain
timeFrame: from surgery to 30 days post operation
Secondary outcomes:
measure: To measure the impact of ketamine on the level of "rebound pain" in patients with central sensitivity using the Numerical Rating Scale
timeFrame: from surgery to 30 days postoperatively
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT04179318: the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Official title: A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Hangzhou Normal University
name: Korea University
First posted: 2019-11-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with hormone receptor positive (estrogen, ER + or progesterone PR +, HER2 negative, and pN0 or PN1) early breast cancer

Brief summary: Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.

This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.


Eligibility criteria: Inclusion Criteria:

* The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2)
* Axillary lymph node assessment : pN0 or PN1
* Women aged 18 and over
* Patients without chemotherapy after operation

Exclusion Criteria:

* Patients with negative hormone receptor （both estrogen and progesterone receptor are negative）
* Human epidermal growth factor receptor 2 （HER2） positive
* Pathological nodule evaluation: pN2 or pN3
* Male patients
* Patients receiving chemotherapy after surgery

Primary outcomes:
measure: Comparative assessment between risk groups
timeFrame: Month 9
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05955118: Hydrus Microstent as a Quality of Life Consideration
Official title: Hydrus Microstent as a Quality of Life Consideration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Angle Glaucoma
Lead sponsor: InSight Vision Center Medical Group, Inc
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation

Brief summary: The study aims to identify if Hydrus microstent implantation in patients with open angle glaucoma (OAG) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.

Detailed description: Prospective, interventional single arm study of patient-reported outcomes (PRO) via GSS with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and Hydrus implantation; Study will also explore other QOL factors that may motivate patients to accept Hydrus via Glauc-QOL36 and customized questions.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent
* Current treatment with one or more ocular hypotensive medication
* Corneal thickness between 470 to 610µm
* Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively

Exclusion Criteria:

* Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma)
* corneal opacity or angle abnormalities that make visualizing the angle difficult
* Past ocular surgery
* History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)
* Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts

Primary outcomes:
measure: Change in Glaucoma Symptom Score (GSS) Score
timeFrame: 3 months
Secondary outcomes:
measure: Number of Medication Reduction for Glaucoma
timeFrame: 3 months
measure: Ocular surface disease (OSD) assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Terri Smith
state: California
Study officials:
References:
Clinical trial NCT05913518: Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study
Official title: Training Metacognition by Means of Neurofeedback in Subjects With Alcohol Use Disorder Induces Neural Modifications: an Event-related Potentials Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Addressing cognitive deficits in alcohol use disorder (AUD) supports recovery. Impaired metacognitive functioning in AUD causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. By promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence.

The main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in AUD.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 65 years old undergoing a 3- to 4-week detoxification treatment program at the Alcohol Unit of CHU Brugmann hospital (Brussels, BELGIUM), who have been diagnosed with severe AUD (alcohol use disorder) according to the DSM-V-TR.

Exclusion Criteria:

* history of neurological disorders
* other serious medical conditions
* neuroleptic treatment are excluded.

Primary outcomes:
measure: Event related potential
timeFrame: Baseline T0
measure: Event related potential
timeFrame: Immediately after the last neurofeedback training session T1
measure: Metacognition questionnaire-30 (MCQ-30)
timeFrame: Baseline T0
measure: Metacognition questionnaire-30 (MCQ-30)
timeFrame: Immediately after the last neurofeedback training session T1
Secondary outcomes:
measure: Commission error rate
timeFrame: Baseline T0
measure: Commission error rate
timeFrame: Immediately after the last neurofeedback training session T1
measure: Reaction times
timeFrame: Baseline T0
measure: Abstinence
timeFrame: Immediately after the last neurofeedback training session T1
measure: Abstinence
timeFrame: 2 weeks post discharge
measure: Abstinence
timeFrame: 1 month post discharge
measure: Abstinence
timeFrame: 2 months post discharge
measure: Abstinence
timeFrame: 3 months post discharge
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Salvatore Campanella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04386018: A Registered Cohort Study of Inflammatory Demyelination Disease
Official title: A Registered Cohort Study on Natural Course and Drug Efficacy of Inflammatory Demyelination Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Demyelinating Autoimmune Diseases, CNS
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists

Brief summary: This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect


Eligibility criteria: Inclusion Criteria:

1. Outpatient or inpatient
2. Meet the diagnostic criteria of Inflammatory Demyelination Disease.
3. Voluntary participation and informed consent signed by the applicant or his/her family.

Exclusion Criteria:

1. Severe complications
2. Poor prognosis (\<1 year survival)
3. Severe mental disorder and inability to cooperate with the examination.

Primary outcomes:
measure: The correlation between clinical phenotypes and Serum antibodies
timeFrame: from date of enrollment until the date of death from any cause,assessed up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology,First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT03834441: Optimized Health-Related Social Needs Screening and Community Linkages
Official title: Optimized Health-Related Social Needs Screening and Community Linkages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Keywords: social needs
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED.

Detailed description: Bilingual research assistants (RA) will screen patients for eligibility based on the predetermined criteria and approach eligible patients with a brief description of the study and opportunity for participation. Interested participants will complete a verbal consent process to reduce the barriers to participation, a brief demographic questionnaire, and an assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN screener randomized to an oral v. iPad screening strategy.

After completion of the screening tool, participants will complete a secondary questionnaire asking about satisfaction with the process, the presence of additional HRSN not recorded by the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all participants will be provided with standardized, bilingual list of community resources to address each of the screening domains.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
2. triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
3. English- or Spanish-speaking, and
4. capable of informed consent.

Exclusion Criteria:

1. patients unwilling to have the interview audio-recorded,
2. medically unstable patients, and
3. Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.

Primary outcomes:
measure: Self-reported Satisfaction With the Screening Process
timeFrame: Immediately after completing survey
Secondary outcomes:
measure: Number of Health Related Social Needs Reported
timeFrame: Immediately after completing survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margaret Samuels-Kalow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371941: Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Detailed description: Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.

The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

* Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
* Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
* Evidence of pathologic eosinophilia in other locations in the GI tract.
* Participation in another research protocol
* Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

Primary outcomes:
measure: Peak Esophageal Eosinophil Count
timeFrame: 2 months
Secondary outcomes:
measure: Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score
timeFrame: Baseline as compared to 2 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: The University of Tennessee Health Science Center
name: Jay A Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lieberman JA, Zhang J, Whitworth J, Cavender C. A randomized, double-blinded, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2018 May;120(5):527-531. doi: 10.1016/j.anai.2018.03.006. Epub 2018 Mar 12.
Clinical trial NCT01789541: Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery?
Official title: Observational Prospective Case-control Study on Prevalence and Impact of Subclinical Hyperthyroidism in Patients Undergoing Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Subclinical Hyperthyroidism
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation (cases) or AV-nodal reentry tachycardia (controls)

Brief summary: Overt hyperthyroidism (so-called "goiter" in lay language) is a hormonal disturbance that is known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially severe consequences) in some patients. Previous research has indicated that even slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a patient, the hormonal imbalance must be treated first in order to later resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted for atrial fibrillation ablation than in the population as a whole, and 2) Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.

As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry Tachycardia at the same clinics as the cases. No correlation has ever been shown between AV-nodal Reentry Tachycardia and hyperthyroidism.


Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation or AV-nodal reentry tachycardia
* Fulfills criteria for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect)
* Admitted for ablation for the first time
* Has left blood samples for thyroid status (TSH, free T4, free T3)

Exclusion Criteria:

* Atrial flutter
* Overt hyperthyroidism

Primary outcomes:
measure: Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation
timeFrame: 1 day (Measured upon inclusion)
Secondary outcomes:
measure: Recurrent atrial fibrillation after ablation
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Arrhythmia Center
city: Stockholm
country: Sweden
facility: Hjärtkliniken, Karolinska Universitetssjukhuset Huddinge
Study officials:
affiliation: Karolinska Institutet, Institutionen för kliniska vetenskaper vid Danderyds sjukhus
name: Mårten Rosenqvist, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06365541: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients
Official title: Exploring the Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients: an Open, Prospective, and Self-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients
Lead sponsor: The People's Hospital of Gaozhou
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment
Primary purpose: TREATMENT

Brief summary: Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance.


Eligibility criteria: Inclusion Criteria:

* 1.Age between 20 and 70 years old; 2.Maintenance dialysis for longer than 3 months; 3.Diagnosis with chronic heart failure, Left ventricular ejection fraction (LVEF)≤40% or NT-proBNP\>12000pg/ml; 4.The patient signs an informed consent form.

Exclusion Criteria:

* 1.Patients with liver function impairment; 2.Patients with severe hypoglycemia/hypotension/ketoacidosis; 3.Patients with active pyelonephritis or symptomatic urinary tract infection; 4.Dapagliflozin allergies or severe adverse reactions; 5.Patients suffering from other severe diseases; 6.Patients participating in other clinical trials; 7.Pregnant or lactating women; 8.Failure to sign a written informed consent form; 9.Unable or unwilling to comply with the experimental protocol approved by the researcher

Primary outcomes:
measure: N-terminal B-type natriuretic peptide precursor (NT-proBNP)
timeFrame: Baseline, 3 months, 6 months
measure: Left ventricular ejection fraction (LVEF)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maoming
country: China
facility: The People's Hospital of Gaozhou
state: Guangdong
Study officials:
References: