louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01705314: A Randomized Trial of Vitamin D to Reduce Respiratory Infection
Official title: Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infection
Keywords: human influenza children
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 1300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 3 and 17
* Residing in Thanh Liem District, Ha Nam Province, Vietnam

Exclusion Criteria:

* Born prematurely at less than 32 weeks gestation
* Any chronic illness (except asthma)
* Currently using medication known to interfere with vitamin D metabolism
* Children with a sibling participating in the study

Primary outcomes:
measure: Laboratory-confirmed non-influenza infection
timeFrame: 12 months
measure: Laboratory-confirmed influenza infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology
Study officials:
affiliation: McMaster University, Hamilton, ON, Canada
name: Mark Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916614: Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence
Official title: Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Stress, Psychological
Gunshot Wound
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that adult individuals who are victims of gun violence will have decreased symptoms of post-traumatic stress after an individual-level intervention with the Screening and Tool for Awareness and Relief of Trauma (START).

Detailed description: In response to the lack of targeted mental health intervention for gunshot wound survivors, the Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,\[30\] with input from focus groups, surveys and in-depth interviews with victims of violence and in particular, boys and young men of color. START has been shown to be effective at decreasing symptoms of PTSD in a one-month follow-up, but it has not been piloted on recently injured victims of gun violence specifically nor has it been tested in a randomized control trial design. A better understanding of the utility of this tool and others like it in victims of violent crime for relief of symptoms of post-traumatic stress and prevention of PTSD would contribute to the larger body of literature on PTSD prevention for victims of gun violence while simultaneously addressing a major need in this community.

Eligibility criteria: Inclusion Criteria:

* Survivors of gunshot wound presenting to the Emergency room and/or admitted as inpatient that are eligible for the Violence Prevention and Outreach Program (VPOP).

Exclusion Criteria:

* Patients with severe traumatic brain injury
* Children under the age of 18
* Patients otherwise unable to give consent
* Non-English speaking patients
* Victims of sexual assault
* Patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.

Primary outcomes:
measure: PTSD evaluation
timeFrame: baseline
measure: Change in PTSD evaluation test scores
timeFrame: 12 weeks
measure: Change PTSD evaluation test scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: James Dodington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951414: Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF
Official title: Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 600
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: Six hundred patients with knee osteoarthritis were treated in each participating research unit

Brief summary: To solve the existing Knee osteoarthritis;KOA) clinical norms and guidelines have low operability, Disconnection between treatment plan and specific evaluation results, difficulty in achieving individualized intervention and other problems, on the one hand, we need to develop Chinese expert consensus or clinical path based on evidence-based medicine to adapt to China's national conditions, on the other hand, is more important in The KOA clinical process introduces a set of tools to translate evidence-based medicine evidence into specific, actionable treatments, Thus, a more flexible, more comprehensive and three-dimensional, adaptable, targeted, more conducive to the promotion of the individual integration KOA rehabilitation intervention program.


Eligibility criteria: Inclusion Criteria:

* Neither knee had undergone knee replacement, and no knee replacement had been performed in recent half a year planning to have a knee replacement; Volunteered to participate in the study and signed the informed consent.

Exclusion Criteria:

* People with consciousness disorder, cognitive disorder, severe mental illness, unable to accurately express their own will, or unable to cooperate with the completion of various assessments and treatment

Primary outcomes:
measure: treatment compliance
timeFrame: 1month
measure: treatment compliance
timeFrame: 3month
measure: treatment compliance
timeFrame: 6month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital clinical characteristic applied research and achievement promotion
state: Beijing
city: Wuhan
country: China
facility: Huarunwugang general hospital
state: Hubei
Study officials:
affiliation: Peking University Third Hospital
name: YUANMINGFEI ZHANG
role: STUDY_DIRECTOR
References:
Clinical trial NCT00043914: Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy
Official title: A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: epilepsy
monotherapy conversion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-16
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.


Eligibility criteria: INCLUSION CRITERIA:

* 16 years old or older.
* Have confident diagnosis of epilepsy.
* Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
* Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.

EXCLUSION CRITERIA:

* A history of hypersensitivity to the drug being studied.
* Currently being treated with or has been treated in the past with the drug being studied.
* Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
* If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
* Has taken an investigational drug or the medication Felbatol within the previous 30 days.
* Is abusing alcohol and/or other substances.

Primary outcomes:
measure: Drug levels of lamotrigine.
Secondary outcomes:
measure: This study has no secondary outcome measures.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sale ME, Natarajan S, Biton V, Vuong A, Hammer AE, Messenheimer JA, Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy Behav. 2005 Feb;6(1):63-70. doi: 10.1016/j.yebeh.2004.11.002.
Clinical trial NCT01706614: Biochemical and Genetic Markers in Liver Diseases
Official title: Biochemical and Genetic Markers in Liver Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biochemical and Genetic Markers in Liver Diseases
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 500
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: patients with liver disease seen at department of Gastroenterology, University Hospital Heidelberg

Brief summary: Investigation of biochemical and genetic markers in liver disease that might have an influence on the course of the disease


Eligibility criteria: Inclusion Criteria:

* suffering from liver disease
* age of 18 years or older
* agreement to participate in study

Exclusion Criteria:

* younger than 18 years
* no consent to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Karolin J Hoeh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01939314: Sphenopalatine Nerve Block for Headache Tx360
Official title: A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Headache
Migraine
Keywords: Headache
Migraine
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 93
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: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.


Eligibility criteria: Inclusion Criteria:

* are 18 - 65 years of age
* present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
* have a normal neurological exams

Exclusion Criteria:

* are less than 18 years old or greater than 65
* have any focal neurological dysfunction signs or symptoms
* have a posterior/occipital/cervicogenic source predominance of headache
* are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
* have self treated with pain medication or anti-emetic 4 hours prior to arrival
* have a history of peripheral vascular disease, cancer, or HIV infection
* are known to be pregnant

Primary outcomes:
measure: Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
timeFrame: 15 minutes from dose
Secondary outcomes:
measure: Categorical Pain Relief
timeFrame: 15 minutes from dose
measure: Headache Free at 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Jason T Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06647914: Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management
Official title: Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Federico II University
name: Irccs Sdn
name: Marche Polytechnic university, Ancona, Italy
First posted: 2024-10-18
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited at the two Clinical Institution of I.R.C.C.S. Policlinico San Donato and Federico II University of Naples, with the same study protocol approved by the Institutional Board of the respective Institution.

Brief summary: This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Harnessing AI, we will extract and correlate hidden components within ECG-obtained P-wave data and echocardiographic studies with atrial fibrosis, culminating in an atrial fibrosis score (AFS). The AFS will non-invasively predict fibrosis extent and AF clinical progression, including metrics like rehospitalization, cardiac morbidity, and mortality. Ultimately, this endeavor aims to improve AF patient management, significantly reducing healthcare costs, and enhancing patient quality of life.


Eligibility criteria: Inclusion Criteria:

* History of paroxysmal or persistent atrial fibrillation
* Clinical indication for Atrial Fibrosis (AF) ablation according to the 2020 ESC Guidelines

Exclusion Criteria:

* Age below 18 years old
* Refusal to sign consent
* Noncompliance with the study protocol

Primary outcomes:
measure: A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability
timeFrame: Partecipants will be assessed at the baseline and at 6 months and 12 months time points. The AFS Prediction Model Testing will start at 9 months after the beginning of the patients enrollment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04590014: Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Official title: Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Hypercapnia
Respiratory Insufficiency
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: VA Pittsburgh Healthcare System
First posted: 2020-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the ability of a new High Velocity Nasal Insufflation \[HVNI\] device design to effect ventilation and related physiological responses relative to the current HVNI device design.

Detailed description: The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).

Eligibility criteria: Inclusion Criteria:

* Adult inpatients (18 years of age and older)
* Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea \[RPD\] (scale 0-10) of 3 or higher)
* Severe baseline hypercarbia/hypercapnia of 55 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas

Exclusion Criteria:

* Patient has unstable cardiovascular condition
* Significant unilateral or bilateral nasal occlusion
* Inability to provide informed consent
* Pregnancy
* Known contraindication to perform steps of the protocol
* Absence of spontaneous respiration or known contraindication to HVNI
* Inability to use HVNI therapy
* Agitation or uncooperativeness
* Determined by the clinician to be sufficiently unstable or unsuitable for this study

Primary outcomes:
measure: Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
timeFrame: Through study completion, an average of 1.6 hours
Secondary outcomes:
measure: Patient Vital Signs - Heart Rate [HR]
timeFrame: Through study completion, an average of 1.6 hours
measure: Patient Vital Signs - Respiratory Rate [RR]
timeFrame: Through study completion, an average of 1.6 hours
measure: Patient Vital Signs - Blood Pressure [BP]
timeFrame: Through study completion, an average of 1.6 hours
measure: Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
timeFrame: Through study completion, an average of 1.6 hours
measure: Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
timeFrame: Through study completion, an average of 1.6 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System
name: Charles Atwood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310514: Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
Official title: Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: biomarker
albuminuria
uric acid
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Rehydration during and after physical exercise is essential to avoid acute kidney injury.

Soft drinks are commonly used during exercise. High intake of carbohydrates is leading to obesity and metabolic disorders. Fructose intake is leading to uric acid abnormalities and kidney injury.

30 healthy soccer players will be studied. During four training sessions subjects will intake 500 ml 7% soft drinks containing glucose, fructose, saccharose or xylitol.

Changes in acute kidney injury markers, markers of kidney tubular function as well as changes in CRP, glucose, cholesterol and uric acid levels will be studied..


Eligibility criteria: Inclusion Criteria:

* age above 18 years
* well-trained soccer players
* informed consent

Exclusion Criteria:

* chronic diseases, especially kidney problems
* sigificant changes in urinalysis
* creatinine level above normal values

Primary outcomes:
measure: Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise
timeFrame: after 60-90 min of pysical exercise
measure: Changes in fractional uric acid excretion
timeFrame: after 60-90 min of pysical exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Medical University of Gdansk
name: Marcin Renke, prof
role: STUDY_CHAIR
References:
citation: Wolyniec W, Szwarc A, Kasprowicz K, Zorena K, Jaskulak M, Renke M, Naczyk M, Ratkowski W. Impact of hydration with beverages containing free sugars or xylitol on metabolic and acute kidney injury markers after physical exercise. Front Physiol. 2022 Oct 20;13:841056. doi: 10.3389/fphys.2022.841056. eCollection 2022.
Clinical trial NCT05078814: The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome
Official title: The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Occlusive Disease
Acute Coronary Syndrome
Keywords: Peripheral Artery Occlusive Disease or Acute Coronary Syndrome
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed as peripheral arterial obstruction or acute coronary syndrome.

Brief summary: Aldehyde dehydrogenase 2 (ALDH2) is an important enzyme protecting human from the accumulation of aldehyde, the main metabolites of alcohol. The deficiency of ALDH2 gene results in flush and hang over post drinking and most importantly it has been found associated with the incidence of cancer and post myocardial infarction (MI) heart failure. In the previous studies, ALDH2 decreased the ischemic territory post infarction and using a large scaled interaction of genetic variants and ALDH2 as an instrument, the threats of alcohol consumption on Asians' cardiovascular health was underscored. Furthermore, in a meta-analysis reviewing 12 case-control studies also indicated an increase of 48% risks in patients with ALDH2 deficiency. Notably, the genetic deficiency is most prevalent in Asians. In Taiwan one of every two individuals may be the victim and the high prevalence is counted as the top of the world. However, a large scaled prospective study focusing on the prevalence of ALDH2 deficiency in patients with peripheral artery occlusive disease (PAOD) or acute coronary syndrome （ACS）remains lacking.


Eligibility criteria: Inclusion Criteria:

1. Age≧20 y/o
2. Using ankle-brachial index (ABI)\< 0.9, angiography, vascular duplex, CAT scan or cardiologists'impression to confirm the diagnosis of PAOD
3. Clinical presentation of claudication
4. diagnosis of ACS

Exclusion Criteria:

* If the patient refuses to be included in this study

Primary outcomes:
measure: The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease.
timeFrame: 2 years
Secondary outcomes:
measure: The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease.
timeFrame: 2 years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Wei-Ting Chang
Study officials:
References: