louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03005028: Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
Official title: Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CAD - Coronary Artery Disease
Lead sponsor: CathWorks Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 184
Sex: ALL
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: This study will enroll male and female subjects above the age of 18, with stable angina who were referred to coronary angiography and have an FFR measurement in at least one coronary artery.

Brief summary: In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.


Eligibility criteria: Inclusion Criteria:

* Male and female above 18 years old age which undergo FFR as part of their standard care
* TIMI Grade Flow is equal to 3
* LVEF larger than 45%.
* Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.

Exclusion Criteria:

* Contraindicated for FFR examination or adenosine administration
* STEMI
* CTO
* TIMI Grade Flow below 3
* Arteries supplying akinetic or severe hypokinetic territories
* Prior CABG on the study vessel
* Left Main stenosis, In-stent restenosis and Collaterals
* Diffused atherosclerosis diseases and tandem lesions
* Aorto-ostial lesion

Primary outcomes:
measure: Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
citation: Pellicano M, Lavi I, De Bruyne B, Vaknin-Assa H, Assali A, Valtzer O, Lotringer Y, Weisz G, Almagor Y, Xaplanteris P, Kirtane AJ, Codner P, Leon MB, Kornowski R. Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography. Circ Cardiovasc Interv. 2017 Sep;10(9):e005259. doi: 10.1161/CIRCINTERVENTIONS.116.005259.
Clinical trial NCT03941028: Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant
Official title: Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Large Segmental Bone Defect
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.

Detailed description: The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.

Eligibility criteria: Inclusion Criteria:

* bone defects caused by trauma or infection or tumor
* the length of bone defect is more than 6cm
* more than 18 years old

Exclusion Criteria:

* malignant tumor
* patients with bad conditions failing to tolerate surgery

Primary outcomes:
measure: Bone reconstruction
timeFrame: 1 year
Secondary outcomes:
measure: Questionnaire of limb function
timeFrame: 1 year
Other outcomes:
measure: Questionnaire of patients' satisfaction degree
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yun Tian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03861728: Viral Conjunctivitis Treatment Study
Official title: Avenova for the Treatment of Viral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Viral Conjunctivitis
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: NovaBay Pharmaceuticals, Inc.
First posted: 2019-03-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis. The investigators hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis compared with artificial tears.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the Bascom Palmer Eye Institute
* Clinical diagnosis of viral conjunctivitis
* Symptoms less than 1 week duration

Exclusion Criteria:

* history of allergic conjunctivitis
* history of herpetic eye disease
* concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)
* Immunocompromised / Immunosuppressed patients
* Patients with HIV
* pregnant women
* prisoners
* adults who are unable to provide consent

Primary outcomes:
measure: Number of Participants With Clinical Resolution of Viral Conjunctivitis
timeFrame: Up to 8 days
Secondary outcomes:
measure: Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
timeFrame: Up to 8 days
measure: Number of Participants With Undetectable Adenoviral DNA
timeFrame: Up to 8 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute, University of Miami
name: Wendy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA
citation: Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.
Clinical trial NCT02929628: Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease
Official title: Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-10-11
Enrollment: 106
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: Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition\>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore \>1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years of age,male or female patients
* idiopathic Parkinson's disease
* had deep brain stimulaton implant
* H-Y\>2.0 in the absence of L-dopa
* UPDRSII-14 item ≥1
* UPDRSII-15 item ≥2
* an ability to walk at least 10 meters independently

Exclusion Criteria:

* Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
* epilepsy
* Pregnant female
* History of severe neuropsychiatric disease
* Patients are taking part in other clinical trials in recent several months

Primary outcomes:
measure: Changs in the score of Stand-Walk-Sit Test
timeFrame: 1、3、6 and 12 month
Secondary outcomes:
measure: Change of the score in UPDRS
timeFrame: 1,3,6,12 months of Various Frequency Stimulation
measure: Change of the score in PDQ-39
timeFrame: 1、3、6、12 months of Various Frequency Stimulation
measure: Change of the score in the FOG-Q
timeFrame: 1、3、6、12 month of Various Frequency Stimulation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06424028: Acute Right Ventricular Infarction Registry
Official title: Presentation, Management, Hospital-course, and Prognosis of Acute Right Ventricular Infarction: A Prospective Registry of Patients Presenting to the Largest Primary Percutaneous Coronary Intervention Centre of Pakistan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inferior Wall; Transmural Myocardial Infarction
Right Ventricular Dysfunction
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 1000
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 presented at a tertiary care hospital with Inferior and posterior wall MI with and without RV infarction undergoing PPCI who are fulfilling the eligibility criteria will be enrolled.

Brief summary: This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital and post-discharge (in 30 Days Prognosis).

Detailed description: After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity.Data will be collected for various patient, system, and procedure related characteristics with the help of a predefined structured proforma consisted of demographic data, clinical presentation, history and co-morbid conditions, and angiographic and procedural characteristics. All the recruited patients will be kept under observiton during the hospital stay and a telephonic follow-up will be carried out after 30-days of discharge and occurrence of the MACE will be recorded.

Univariate and multivariable binary logistic regression analysis will be performed to determine the clinical predictors of RVI. Odds ratio (OR) along with 95% confidence interval (CI) will be reported. The statistical significance criteria will be set as p-value\<0.05.

For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Eligibility criteria: Inclusion Criteria:

* Patients of Inferior, infero-lateral and infero-posterior wall MI with and without RV infarction undergoing PPCI.
* Both male and female patients.
* Patients of age ≥ 18 years.

Exclusion Criteria:

• Patients who will not give consent for participation.

Primary outcomes:
measure: Composite adverse clinical outcome
timeFrame: Upto 30 days from admission
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diaseses
name: Rajesh Kumar, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536328: What is the Predictive Value of the Reflux Impact Scale
Official title: What is the Value of the Use of Validated Questionnaire (Reflux Impact Scale) for Predicting Treatment Success With PPI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastroesophageal Reflux Disease
GERD
Heartburn
Acid Regurgitation
Retrosternal Pain
Keywords: Reflux Impact Scale (RIS)
predictive value
treatment success
patient satisfaction
proton pump inhibitor
gastro-esophageal reflux disease
PPU
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at general practitioner

Brief summary: Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44% of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for consulting a primary care physician and are an important reason for using OTC medication. A good diagnosis is important as functional GERD with possible complications such as strictures and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding \& perforations. The clinical diagnosis of reflux disease is mainly based on symptom evaluation. This, however, is hindered by the variety of complaints with different etiology. Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A major part of the patients with acid related stomach complaints indeed will experience symptom relief after starting PPI therapy. In this view, it is important to identify these patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire which asks for the presence \& impact of reflux symptoms. The RIS is developed for PCP to aid in the evaluation \& selection of these patient who will profit from treatment with PPI. The aim of this present study is to determine which questions of the RIS can be predictive for reaching treatment success with PPI. Treatment success is determined by asking for patients' satisfaction \& completion of the McMaster Overall Treatment Evaluation Heartburn questionnaire.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients with symptoms of reflux disease and or regurgitation and/or retrosternal pain probably caused by acid during the previous 7 days and for which treatment with a PPI is started.

Exclusion Criteria:

* Use of PPI and/or H2-receptor antagonist in the month prior to participation in this study.
* Presence of alarm symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: A Sellink
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: N van den Berk
role: STUDY_CHAIR
References:
Clinical trial NCT02869828: Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Surgery in Adult Patients
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.

Detailed description: Every patients undergoing heavy surgery had their central temperature monitoring, through an arterial catheter if the surgery required it (30 patients in this arm), otherwise the investigators used an oesophagus tube (20 patients). We also monitored every 50 patients with a non-invasive method 3M spot on (Zero-heath-flux technic) in order to measure its fiability and validity during the surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo general anaesthesia for gut surgery lasting more than 2 hours
* Patients with core temperature monitored with oesophagal probe only (30 patients) or with oesophagal probe and PICCO device (20 patients)
* Patients without opposition to this study after informations given

Exclusion Criteria:

* Patients with frontal cutaneous decay wich avoid using 3M Spot-on
* Patients whom oesophagal probe was prohibited (oesophagal varices, oesophagal surgery)
* Pregnant women or breast-feeding, women who may become pregnant unless adequate contraceptive measures

Primary outcomes:
measure: temperature monitoring with Zero-Heath-Flux (SpotOn)
timeFrame: 1 day
measure: temperature monitoring with oesophagal probe (Coviden)
timeFrame: 1 day
measure: temperature monitoring with arterial catheter (PICCO)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: BOISSON Matthieu
Study officials:
References:
citation: Boisson M, Alaux A, Kerforne T, Mimoz O, Debaene B, Dahyot-Fizelier C, Frasca D. Intra-operative cutaneous temperature monitoring with zero-heat-flux technique (3M SpotOn) in comparison with oesophageal and arterial temperature: A prospective observational study. Eur J Anaesthesiol. 2018 Nov;35(11):825-830. doi: 10.1097/EJA.0000000000000822.
Clinical trial NCT02699528: The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder
Official title: Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Enuresis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 5 - 10 years receiving a new diagnosis of attention deficit hyperactivity disorder

Brief summary: To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

Detailed description: Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of attention deficit hyperactivity disorder
* History of primary nocturnal enuresis
* Normal neurological examination

Exclusion Criteria:

* Anatomical abnormality of the genitourinary system
* Concommitant treatment, pharmacological/behavioral for enuresis
* Concommitant diurnal enuresis

Primary outcomes:
measure: A reduction in nocturnal enuresis frequency
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Nathan Watemberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149628: The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide
Official title: The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.

Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.

To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.

Secondarily, kidney protection effect of propofol over desflurane will be compared.


Eligibility criteria: Inclusion Criteria:

* patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia

Exclusion Criteria:

* chronic renal failure ( estimated glomerular filtration rate \<60 mL/min/1.73m2)
* allergy to propofol, nuts
* on diuretics, vitamin C or vitamin E within 5 days before surgery
* Body mass index \> 30 kg/m2
* older than 70 years
* who cannot read the patient consent form

Primary outcomes:
measure: changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation
timeFrame: 100 min after pneumoperitoneum, 10 min after decompression
Secondary outcomes:
measure: kidney function after anesthesia
timeFrame: 1 day after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University Gangnam Severance Hospital
name: Goun Roh, MD
role: PRINCIPAL_INVESTIGATOR
References: