louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02915965: A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
Official title: A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage II and III Esophageal Squamous Cell Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).


Eligibility criteria: Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. Karnofsky performance status (KPS) of 90 or more.
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
2. Patients with concomitant hemorrhagic disease.
3. Pregnant or breast feeding.
4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
5. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Primary outcomes:
measure: overall survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Pathologic response rate
timeFrame: 2 years
measure: Disease-free survival
timeFrame: 2 years
measure: Incidence of adverse event based on CTCAE 4.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Yanhong Deng, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564365: The Contemporary Role of Beta Blockers in Patients With Acute Myocardial Infarction
Official title: Influence of Beta-Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: left ventricular ejection fraction
acute myocardial infarction
beta-blocker
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient had normal left ventricular ejection fraction (LVEF≥50%) after acute myocardial infarction.

Brief summary: The use of beta blockers after acute myocardial infarction is a core component of drug therapy, but evidence is primarily derived from patients who did not receive reperfusion therapy and secondary prophylaxis.In contemporary times, the prognostic value of beta blockers in patients with acute myocardial infarction has been questioned, particularly in patients without reduced heart failure/ejection fraction after acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of acute myocardial infarction was clear and the left ventricular ejection fraction was normal

Exclusion Criteria:

* History of heart failure Died in hospital

Primary outcomes:
measure: mortality
timeFrame: the median time of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The first affiliated Hospital of Chongqing Medical University
Study officials:
References:
Clinical trial NCT06112665: ToFAcitinib in Early Active Axial SpondyloarThritis:
Official title: ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Axial Spondyloarthritis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2023-11-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation
Primary purpose: TREATMENT

Brief summary: This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria
* Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.
* Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels.

Exclusion criteria:

* active current infection, severe infections in the last 3 months
* history of recurrent Herpes zoster or disseminated Herpes simplex
* immunodeficiency
* chronic Hepatitis B, C or HIV infection
* women: pregnant or lactating (have to practice reliable method of contraception)
* other severe diseases conflicting with a clinical study, contraindications for MRI

Primary outcomes:
measure: Main trial endpoint
timeFrame: 16 weeks
Secondary outcomes:
measure: Change from baseline in the MRI SIJ SPARCC osteitis score at week 16
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charité Rheumatology
name: Denis Poddubbnyy, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535165: Effect of Red Beetroot Juice Intake in Adults With Long COVID-19
Official title: Effect of 14-day Red Beetroot Juice Intake on Physical Function, Gut Microbiota Composition, and Systemic Inflammation in Adults With Long COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID

Detailed description: A single-center, double-blind, placebo-controlled randomized trial to test the effects of 14 days of beetroot juice supplementation on functional and biological outcomes in adults with long-COVID.

Participants were randomized 1:1 to receive either daily oral supplementation with 200 mL beetroot juice or placebo for 14 days. The primary endpoint was the change from baseline to day 14 in the fatigue resistance test. Secondary outcomes included the distance walked on the 6-min walk test, handgrip strength, and flow-mediated dilation. Secondary endpoints also included changes from baseline in circulating inflammatory mediators, metagenomic and fecal water metabolomic profiles. Partial least squares discriminant analysis (PLS-DA) models were built to evaluate the differences in biological variables associated with the interventions.

Eligibility criteria: Inclusion Criteria:

* a certification of a previous SARS-CoV-2 infection
* a negative COVID-19 swab test at least four weeks prior to the screening visit
* meet the criteria for long-COVID diagnosis according to the World Health Organization criteria
* report persistent fatigue

Exclusion Criteria:

* intolerance to beetroot juice or its derivatives
* clinical conditions and/or use of medications that may interfere with trial outcomes (e.g., pregnancy or breastfeeding, diabetes, use of steroids or non-steroidal anti-inflammatory drugs, immunosuppressants, nitrates)
* participation in other intervention trials for long-COVID

Primary outcomes:
measure: Fatigue resistance
timeFrame: 14 days
Secondary outcomes:
measure: Six-minute walk test
timeFrame: 14 days
measure: Flow-mediated dilation
timeFrame: 14 days
measure: Changes in the concentration of gut microbial species
timeFrame: 14 days
measure: Fecal water metabolomics
timeFrame: 14 days
measure: Changes in the concentration of circulating inflammatory mediators
timeFrame: 14 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Center for Aging and Geriatrics Research - UCSC
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Francesco Landi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02663765: Lack of Antenatal Care in Primiparas
Official title: Impact of Lack of Antenatal Care in Primiparas on Maternal and Perinatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antenatal Care
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 512
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primiparas who will be delivered in Assiut Women Health Hospital

Brief summary: Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality rate because adequate utilization of antenatal health care services is associated with improved maternal and neonatal health outcomes. The trend of maternal mortality in developing countries has been increasing and various international organizations have reported that an important factor related to maternal and infant mortality has been linked to lack of antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to decrease these mortality rates, regular antenatal care has to be instituted or reinforced which can only be achieved through identifying factors causing poor utilization of antenatal care services


Eligibility criteria: Inclusion Criteria:

* Women who agree to participate in the study
* Primipara.

Exclusion Criteria:

* Multipara.
* Women who refuse to participate in the study.

Primary outcomes:
measure: number of morbidity cases due to lack of antenatal care
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02694666: Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
Official title: Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Falls Prevention
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to investigate the effects of controlled whole-body vibration training on reducing the likelihood of falls among healthy population and people with multiple sclerosis. (NOTE: research not covered by sponsored funding)

Detailed description: For each population, the participants will be randomized into two groups.

Eligibility criteria: Inclusion Criteria:

For healthy population:

* Aged between 18 and 75
* No known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment

For people with multiple sclerosis

* Self-reported multiple sclerosis and confirmed by the physician
* No significant relapse within the past 8 weeks
* To be able to walk independently a length of 25 feet
* Score on Patient Determined Disease Step \< 7

Exclusion Criteria:

* Subjects use any sedative of any type.
* The heel bone density is less than -2.0

Primary outcomes:
measure: Real life falls
timeFrame: Up to 12 months
Secondary outcomes:
measure: Berg Balance Scale test
timeFrame: Up to 12 months
measure: Slip-related falls on treadmill
timeFrame: Up to 12 months
measure: Functional mobility
timeFrame: Up to 12 months
measure: Sensation
timeFrame: Up to 12 months
measure: Muscle strength
timeFrame: Up to 12 months
measure: Range of motion
timeFrame: Up to 12 months
measure: Bone density
timeFrame: Up to 12 months
measure: Multiple Sclerosis Functional Composite score
timeFrame: Up to 12 months
measure: Equiscale balance test
timeFrame: Up to 12 months
measure: Symbol Digit Modalities test
timeFrame: Up to 12 months
measure: Selective Reminding test
timeFrame: Up to 12 months
measure: Behavior Rating Inventory of Executive Function
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Feng Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06399666: Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation
Official title: Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Inflammation
Genetic Predisposition to Disease
Lead sponsor: Vrinnevi Hospital
Sponsor class: OTHER
Collaborators: name: Ryhov County Hospital
First posted: 2024-05-06
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.

Brief summary: Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.

This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \&amp;gt;18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.

An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.


Eligibility criteria: Inclusion Criteria:

* Persistent atrial fibrillation (ICD-10 I48.1)
* Age over 18 years

Exclusion Criteria:

* Autoimmune disease
* Inflammatory diseases
* Acute or chronic liver dysfunction
* Ongoing infectious diseases
* Thyroid disorders
* Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Primary outcomes:
measure: Recurrence of AF
timeFrame: During follow-up (post ECV, day 7, 30, 90, and 180)
Secondary outcomes:
measure: Fluctuations of biomarkers and gene expression during follow-up
timeFrame: During follow-up (post ECV, day 7, 30, 90, and 180)
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Medical department
state: Småland
city: Norrköping
country: Sweden
facility: Cardiology Clinic
state: Östergötland
Study officials:
References:
Clinical trial NCT02779166: Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Official title: Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Labral Tears
Keywords: hip arthroscopy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.

Detailed description: This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.

Eligibility criteria: Inclusion Criteria:

* All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

Exclusion Criteria:

* Pregnant women and any patient under the age of 18 years.

Primary outcomes:
measure: Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period
timeFrame: Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively
measure: Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)
timeFrame: duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively
measure: Time to Discharge Following Surgery
timeFrame: time from OR to discharge, up to a maximum of 6 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Michael Terry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06516666: Psychophysiological Effects of Music
Official title: Psychophysiological Effects of Music on Sadness in Depressed and Non-Depressed Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sadness
Keywords: music
depression
emotion
heart rate variability
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study employed a repeated measure between-subjects design. Two groups (i.e., depressed group and non-depressed group) of participants were recruited. Each participant experienced four stages: baseline, neutral control, sadness induction, and music intervention. The outcome variables were self-reported emotion and Heart Rate Variability features. Emotions were reported at the end of every stage. Electrocardiogram signals were recorded throughout the experiment.


Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years
* Right-handed
* No recent illness or medication use
* No history of neurological or psychiatric disorders
* Normal or corrected-to-normal visual acuity (myopic participants wore glasses)
* Normal hearing

Exclusion Criteria:

* Incapable of giving written informed consent to this study
* Acute high suicide risk at baseline assessment
* Psychosis

Primary outcomes:
measure: Self-Assessment Manikin (SAM)
timeFrame: Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.
measure: Revision of Positive Affect and Negative Affect Scale (PANAS-R)
timeFrame: Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.
measure: Mean of Normal-to-Normal Intervals (MeanNN)
timeFrame: Throughout the whole experiment, an average of 6 minutes for each stage.
measure: Standard Deviation of Normal-to-Normal Intervals (SDNN)
timeFrame: Throughout the whole experiment, an average of 6 minutes for each stage.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Shulin Chen
state: Zhejiang
Study officials:
References:
citation: Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.