louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01845311: ReZolve2 Clinical Investigation
Official title: RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Lead sponsor: REVA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.


Eligibility criteria: Primary Inclusion Criteria:

* Patient has evidence of myocardial ischemia or a positive functional study
* Patient has a normal CK-MB
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm
* Target lesion length must be ≤ 14mm

Primary Exclusion Criteria:

* Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
* Patient has a left ventricular ejection fraction \< 30%
* Patient has unprotected lest main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 6 Months
measure: Major Adverse Cardiac Events
timeFrame: 12 Months
measure: Late Lumen Loss
timeFrame: 9 Months
Secondary outcomes:
measure: QCA derived parameters
timeFrame: 9 Months
measure: Major Adverse Coronary Events
timeFrame: 24, 36, 48 & 60 Months
measure: TLR
timeFrame: 12,24,36,48 & 60 Months
measure: TVR
timeFrame: 12,24,36,48 & 60 Months
measure: TVF
timeFrame: 12, 24, 36, 48 & 60 Month
measure: Acute Procedural Success
timeFrame: Day 0
measure: Acute Technical Success
timeFrame: Day 0
measure: Clinical Procedural Success
timeFrame: 30 Days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cariologia
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Alexandre Abizaid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital, Sydney
name: David Muller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03648411: Drug Resistance Among Asymptomatic Infection
Official title: Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Resistant Malaria
Asymptomatic Infections
Migrant Workers
Keywords: malaria
falciparum
vivax
Myanmar
migrant workers
asymptomatic infection
drug resistance
Lead sponsor: Department of Medical Research, Lower Myanmar
Sponsor class: OTHER
Collaborators: name: National Malaria Control Program, Myanmar
First posted: 2018-08-27
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The activity will cover the migrant population of the Shwegyin Township (Bago Region) and Pinlebu Township (Sagaing Region).

Brief summary: A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.

Detailed description: Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.

In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.

Eligibility criteria: Inclusion Criteria:

* Age above 6 year
* Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
* Both sex
* Participant who give informed-consent to participate the study

Exclusion Criteria:

* Known clinical malaria cases regardless of the species detected
* Patients with clinical symptoms of malaria at the time of examination
* Known history of malaria within 14 days

Primary outcomes:
measure: Prevalence of the asymptomatic infection among the study population
timeFrame: 1 week
measure: Proportion of the drug resistance molecular markers among asymptomatic infections
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Dr. Myat Phone Kyaw
Study officials:
affiliation: Department of Medical Research
name: Myat H Nyunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02176811: Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease
Official title: The Cross Sectional Study to Investigate the Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Non-alcoholic Fatty Liver Disease
Betatrophin
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient clinics of gastroenterology

Brief summary: The study searched for answers to two questions:

1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.

2. Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven non-alcoholic fatty liver disease

Exclusion Criteria:

* Taking any drugs
* \>20 gr/day alcohol consumption
* chronic metabolic diseases
* morbid obesity

Primary outcomes:
measure: Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
Study officials:
References:
Clinical trial NCT05954611: The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers
Official title: A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

Detailed description: This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Eligibility criteria: Inclusion Criteria:

* 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion Criteria:

* 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.

Primary outcomes:
measure: Incidence of Adverse Events (AE)
timeFrame: 85 days
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
timeFrame: 85 days
measure: Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
timeFrame: 85 days
measure: Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration
timeFrame: 85 days
measure: Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
timeFrame: 85 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Yi Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01347411: Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
Official title: Effectiveness of the Treatment With CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Sleep Respiratory Disorders
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2011-05-04
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is enough scientific evidence that supports the association between apnea-hypopnea syndrome (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP) in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction and sleep disordered breathing during the sleep.


Eligibility criteria: Inclusion Criteria:

1. Ejection fraction\> 45%, which also ruled out significant left ventricular dilation
2. At least two abnormal indices of diastolic function.

Exclusion Criteria:

1. Not sinus rhytm
2. Severe lung disease (FEV1 or FVC less than 50%)
3. Significant valvular or congenital heart disease, primary
4. Unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion
5. Hypertrophic Cardiomyopathy
6. Presence of significant psychiatric disorders.
7. Severe Hypersomnia . (Epworth\> 20)
8. Severe pulmonary hypertension measured by Doppler,
9. Facial deformity and / or defect of nasal patency.

Primary outcomes:
measure: number of patients without diastolic dysfunction
timeFrame: One year
measure: number of hospital admissions for any cause
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03489811: The Effect of Aroma on Anxiety Among Children With Autism.
Official title: The Effect of Aroma on Anxiety Among Children With Autism.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Autism Spectrum Disorder
Keywords: Essential Oils
Aromatherapy
Anxiety
Autism Spectrum Disorder
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.

Detailed description: Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder.

The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils.

Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.

Eligibility criteria: Inclusion Criteria:

* age: 6-11 years old at enrollment
* diagnosed with an autism spectrum disorder

Exclusion Criteria:

* mast cell activation syndrome
* history of adverse response to essential oil inhalation

Primary outcomes:
measure: 39-Question Spence Children's Anxiety Scale (SCAS)
timeFrame: baseline and day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Institute of Wellness
state: Tennessee
Study officials:
References:
Clinical trial NCT06011811: Cluster Headache Treatment Survey
Official title: Cluster Headache Treatment Survey
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cluster Headache
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Clusterbusters, Inc.
First posted: 2023-08-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is patients with episodic or chronic cluster headache that has been diagnosed by a health care professional. The cluster headache diagnosis will be verified via the survey using a validated cluster headache diagnostic screen.

Brief summary: The objective of this study is to survey patients with cluster headache about treatment effectiveness and their views on treatments. Participants will complete one brief questionnaire online.


Eligibility criteria: Inclusion Criteria:

* Patients with episodic or chronic cluster headache that has been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed)

Exclusion Criteria:

* Unable to speak English (the survey is only in English)
* Unable to use a computer to take the online survey
* Unable to provide consent

Primary outcomes:
measure: Effectiveness of cluster headache treatment as assessed by a survey
timeFrame: at the time of survey completion, expected to be 6-12 months
Secondary outcomes:
measure: Opinions on new cluster headache treatment as assessed by a survey
timeFrame: at the time of survey completion, expected to be 6-12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mark J Burish, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03872011: Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock
Official title: Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Keywords: septic shock
vitamin C
thiamine
hydrocortisone
mortality
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 408
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 purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock.

Detailed description: Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.

A potential benefit of vitamin C with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(PMID 27940189) . The patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. The doses of vitamin C used in this trial are high, yet seemed to be safe and can be considered for use.

In this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin C,thiamine and hydrocortisone) on septic shock.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old or older
* Onset of septic shock within 12 hours

Exclusion Criteria:

* Systemic corticosteroid therapy within the last 3 months before septic shock
* High-dose steroid therapy
* Immunosuppression
* Pregnant
* Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
* Known hemachromatosis
* Known allergy to vitamin C, hydrocortisone, or thiamine
* Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician)
* Refusal of the attending staff or patient family

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days after randomization
Secondary outcomes:
measure: ICU mortality
timeFrame: 90 days after randomization
measure: Hospital mortality
timeFrame: 90 days after randomization
measure: 28-day mortality
timeFrame: 28 days after randomization
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu Province people's hospital
state: Jiangsu
Study officials:
affiliation: Northern Jiangsu People's Hospital
name: Qingquan Lyu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyu QQ, Zheng RQ, Chen QH, Yu JQ, Shao J, Gu XH. Early administration of hydrocortisone, vitamin C, and thiamine in adult patients with septic shock: a randomized controlled clinical trial. Crit Care. 2022 Sep 28;26(1):295. doi: 10.1186/s13054-022-04175-x.
Clinical trial NCT04650711: Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Official title: Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer Screening
p16 Protein
Cytology
High-risk Human Papillomavirus
Diagnostic Accuracy
Histology
Cervical Intraepithelial Neoplasia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
Primary purpose: DIAGNOSTIC

Brief summary: Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Signed an approved informed consents
* With sufficient cytology sample for p16 testing
* With definite results of cytology and/or high-risk human papillomavirus and cervical histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Diagnostic accuracy of p16 protein expression
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642211: IOP Changes Associated With SICS and Phako
Official title: An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cataract
Glaucoma
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
First posted: 2015-12-30
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Detailed description: Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.

Eligibility criteria: Inclusion Criteria:Age over 40 requiring cataract surgery -

Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma

-

Primary outcomes:
measure: Intraocular pressure lowering
timeFrame: 6 months
Secondary outcomes:
measure: Angle anatomy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: