louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01926353: Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux
Official title: Tissue Bulking Agent -Polyacrylate Polyalcohol Copolymer for Endoscopic Correction of Vesicoureteral Reflux in Children: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vesicoureteral Reflux (VUR)
Urinary Tract Infection
Keywords: Vesicoureteral Reflux (VUR)
Complicated Urinary Tract Infection
Vantris
Polyacrylate Polyalcohol Copolymer
Lead sponsor: St. Luke's Medical Center, Philippines
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children diagnosed with primary VUR grade 2-4 from 2006-2012 treated by a single urologist with different treatment modalities- conservative continuous antibiotic prophylaxis, endoscopic correction with PPC and open ureteral re-implantation with Cohen technique.

Brief summary: Endoscopic correction of VUR has gained its popularity due to its less invasiveness, associated low morbidity and short hospital stay. Although short term follow-up had justified their efficacy; however, long term recurrence and complications following endoscopic correction were also being reported in the literatures (6). Currently, there are insufficient evidences on the efficacy and safety of biocompatible tissue augmenting materials used for endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue augmenting biocompatible Acrylics used for endoscopic correction of VUR.


Eligibility criteria: Inclusion Criteria:

* Included patients for the study were only those who had 1- 3months and \>1year post-treatment follow-up study with voiding cystourethrogram (VCUG), kidney ultrasound, dimercaptosuccinic acid(DMSA) renal scan, and urine culture.

Exclusion Criteria:

* Excluded cases were patients who had VUR grade 1 and grade 5, no complete follow-up work ups, concomitant neurogenic bladder, anatomical malformation of the urinary tract (obstruction, complete duplicated pelvocaliceal system), previous surgical or endoscopic procedures, and suspected or confirmed dysfunctional voiding by clinical findings or abnormal results (irregular bladder wall, diverticulum) on VCUG or urodynamic study.

Primary outcomes:
measure: Rate of Treatment success
timeFrame: 3 months, 1 year
Secondary outcomes:
measure: Rate of renal scar development
timeFrame: at 3 months, 1 year
measure: Length of VUR treatment related hospital stay
timeFrame: 1 year
measure: Rate of failed treatment response
timeFrame: 3 months, 1 year
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: NCR
Study officials:
affiliation: Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines
name: Marcelino L Morales, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01979653: A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedation; Aged; Hemodynamics
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* aged ≥ 65 years
* ASA physical status class I-II
* the patients who want sedation during elective lower limb surgery under spinal anesthesia

Exclusion Criteria:

* contraindication to spinal anesthesia
* neurologic or cognitive dysfunction
* severe cardiovascular or pulmonary disease
* refusal to participation

Primary outcomes:
measure: hemodynamic stability
timeFrame: 4 hour
Secondary outcomes:
measure: Modified Observer Assessment of Alertness/Sedation (MOAAS) scale
timeFrame: 4 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03589053: Limb Remote Ischemic Conditioning and Cerebrovascular Reserve
Official title: Effects of Limb Remote Ischemic Conditioning (LRIC) on Cerebrovascular Reserve (CVR) in Ischemic Cerebrovascular Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Cerebrovascular Disease
Keywords: Limb remote ischemic conditioning
Cerebrovascular reserve
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 30
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: Cerebrovascular reserve (CVR), defined as the increase in cerebral blood flow (CBF)in response to a vasodilatory stimulus, is known to reflect the compensative capacity of the brain to maintain adequate blood flow in the face of decreased perfusion due to arterial stenosis. CVR dysfunction has been identified as an independent risk factor for ischemic stroke. Limb remote ischemic preconditioning （LRIC) has been suggested as a protective therapeutic modality against brain ischemia. So it is worth to detect whether LRIC can improve the CVR ability in ischemic cerebrovascular disease patients.


Eligibility criteria: Inclusion Criteria:

- (1)Symptomatic intracranial arterial stenosis measuring \>=50% by angiography or \>=70% by ultrasound, CT angiography (CTA), or magnetic resonance angiography (MRA);(2)Age range 18-80 years;(3)Compared with normal brain tissue, the reduction of cerebral glucose metabolism (CGM) and/ or cerebral blood flow (CBF) in the focal area\>=8%;(4)Stable vital signs, normal renal and hepatic functions; (5)No hemorrhagic tendency;(6)Subject or his or her legally authorized representative was able to provide an informed conised.

Exclusion Criteria:

-(1)Uncontrolled hypertension (defined as systolic blood pressure\>=200 mmHg despite medications at enrollment); (2)Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning;(3)Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion); (4)Hematologic disease;(5)Severe or unstable concomitant disease;(6)Can not tolerate LRIC treatment;(7)No informed consent.

Primary outcomes:
measure: Change of cerebrovascular reserve
timeFrame: 90 days
Secondary outcomes:
measure: Recurrence of stroke
timeFrame: 90 days
Other outcomes:
measure: Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]
timeFrame: 90 days
Locations:
city: Beijing
country: China
facility: Xunming Ji
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Xunming Ji
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740753: Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option
Official title: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Hepatoma
Keywords: liver tumor
cancer
hepatoma
yttrium
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Boston Scientific Corporation
First posted: 2008-08-25
Enrollment: 339
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: Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.

Detailed description: Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of HCC
* Cancer is unresectable
* ECOG Score 0-2
* Age of 18 yrs or over
* Able to give consent

Exclusion Criteria:

* Contraindication to angiography and selective visceral catheterization
* Portal hypertension with portal venous shunt away from the liver
* Evidence of potential delivery of \> 16.5 mCi of radiation to the lungs
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnancy

Primary outcomes:
measure: Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
timeFrame: 2 weeks, 1 month and then every 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kenneth Kolbeck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888753: Textbook Outcome in Adrenal Neoplasms
Official title: A Novel Study, Textbook Outcome in Adrenal Neoplasms: Observational Study in a Endocrine Surgical Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome Assessment
Adrenal Neoplasm
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective adrenal resection in the endorine surgical unit in public universitary hospital of alicante

Brief summary: BACKGROUND:

Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for adrenal neoplasms.

MATERIAL AND METHODS:

Retrospective study of all patients undergoing scheduled adrenal neoplasms surgery at a Spanish university hospital from September January 2010 to December 2022. Emergency surgeries were excluded. The variables included in the definition of TO were: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.

The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled adrenal neoplasms resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators compare the group of patients who achieve a TO result with the group of patients who do not. A univariable and multivariable analysis will be carry out in order to indentified the variables associated with TO.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective adrenal resection were eligible for the study

Exclusion Criteria:

* Age under 18 years
* Emergency surgery
* Resections of other organs in the same surgery.

Primary outcomes:
measure: Textbook Outcome
timeFrame: January 2010 to December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Juan Jesús Rubio García
Study officials:
References:
Clinical trial NCT01113853: Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients
Official title: Daily Monitoring of Exhaled Nitric Oxide in Asthmatic Patients Stopping Anti-inflammatory Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
exhaled nitric oxide
lung function
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Policlinico
First posted: 2010-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children with asthma visited in the outpatients clinic at University of Verona were invited to participate to the study

Brief summary: Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in asthmatic patients.

The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is possible, in relationship with symptoms and lung function.

Detailed description: All patients were evaluated with pulmonary lung function, exhaled nitric oxide and peak expiratory flow (PEF) and fill in a personal diary for the first two weeks when patients are in treatment; the same evaluation will be made for other four weeks without treatment.

Eligibility criteria: Inclusion Criteria:

* mild asthmatic treated with low dose inhaled steroids for whom it has to be considered stop of steroid treatment according to GINA guidelines

Exclusion Criteria:

* age \< 5 years
* chronic respiratory diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Pediatric Department University of Verona
Study officials:
affiliation: Universita di Verona
name: Giorgio L Piacentini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770053: Foraminal Enlargement and Postoperative Pain.
Official title: Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain Postoperative
Keywords: Foraminal enlargement
Root canal treatment
Lead sponsor: Isparta Military Hospital
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Detailed description: Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Eligibility criteria: Inclusion Criteria:

* Mature permenent teeth having pulpal necrosis and apical periodontitis.

Exclusion Criteria:

* Systemic disorders
* Diabetes
* Pregnancy
* Less than 18 years of age
* Immunocompromised
* Patients who had taken antibiotics in the past 1 month
* Patients who had a positive history of analgesic use within the past 3 days
* Previously accessed teeth

Primary outcomes:
measure: 4-step pain intensity measures using a Visual Analog Scale (VAS).
timeFrame: 7 days.
Secondary outcomes:
measure: The number of patients taking an analgesic following the endodontics treatment.
timeFrame: 7 days.
Other outcomes:
Locations:
Study officials:
affiliation: Isparta Military Hospital
name: Ibrahim E YAYLALI, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747953: Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Official title: An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 50
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 program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety information on gilotrif use.


Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
3. No further treatment option is available.
4. Male and female patients age ≥18 years.
5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.

Exclusion Criteria:

1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
5. Bilirubin ≥1.5 mg/dl
6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
8. Pregnancy or breast feeding.
9. Pre-existing Interstitial Lung Disease (ILD).
10. Patients suitable to be included into afatinib clinical trials

Primary outcomes:
measure: response rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04564053: Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
Official title: A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Knee
Keywords: osteoarthritis
knee
cartilage
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.
Primary purpose: TREATMENT

Brief summary: The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.

Detailed description: This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.

Eligibility criteria: Inclusion Criteria:

* Male and female Japanese participants aged 20 to 80 years at screening
* A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
* Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).

Exclusion Criteria:

* Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
* Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
* Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
* Malalignment \>10° in the target knee (varus/valgus)

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Day 22
Secondary outcomes:
measure: Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration
timeFrame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
measure: Observed maximum serum concentration of LNA043
timeFrame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
measure: Number of participants with anti-LNA043 antibodies in serum
timeFrame: Day 1 (pre-dose), 4, 8, 15, 22
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: