louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03107416: Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
Official title: Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Bumetanide
Diuretic
Transarterial Embolization (TAE)
17-141
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 30
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 purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.

  * Any virus status accepted (e.g. Hepatitis C etc.)
  * Any prior liver treatment
* Patients within unresectable HCC
* At least 18 years old
* ECOG performance status 0 or 1
* Radiographically measurable disease per mRECIST 1.1
* Meets standard of care to undergo embolization

Exclusion Criteria:

* Women who are pregnant or lactating
* Documented hypersensitivity to bumetanide or sulfonamides
* Patients with resectable HCC
* High risk for post-embolization hepatic failure:

  °Child's C cirrhosis

  °\> 80% liver involvement by tumor
* Contraindication to angiography/embolization including:

  * Patients cannot receive contrast:
  * Severe allergic reaction to contrast despite premedication
  * Poor renal function not on dialysis
  * Other, based on judgment of the investigator
* ECOG score 2
* Main portal vein tumor thrombus
* BCLC D = patients with distant metastasis

Primary outcomes:
measure: Maximum tolerated dose (MTD) (phase I)
timeFrame: 1 year
measure: estimate the local tumor progression (LTP) rates (phase II)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and follow-up only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and follow-up only)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and follow-up only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hooman Yarmohammadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191516: An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
Official title: An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 257
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
* Diagnosis of ADHD
* Normal intelligence

Exclusion Criteria:

* Weigh less than 20 kg or more than 60 kg at study entry
* Other relevant psychiatric diagnoses
* Are at serious suicidal risk as determined by the investigator
* Have a history of severe allergies
* Alcohol or drug abuse within the past 3 months

Primary outcomes:
measure: Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary outcomes:
measure: Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
measure: O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
Other outcomes:
Locations:
city: Koln
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References:
citation: Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Jun;2(2):73-85. doi: 10.1007/s12402-010-0022-2. Epub 2010 Mar 30.
Clinical trial NCT03649516: The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care
Official title: The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care: A Multicenter, Randomized, Open, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hypertension
Keywords: mHealth
Mobile application
Chronic Kidney Diseases
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: * Apply Mobile APP Intervention ( iCKD APP) to current chronic kidney disease care program.
* Conduct a randomized clinical trial to evaluate the clinical effectiveness of this mobile device on health behavior improvement in chronic kidney disease patients.

Detailed description: A mHealth app (iCKD APP) was designed to assist CKD patients to monitor their home bio-information data. Patients will be randomly assigned into the iCKD APP group(intervention) and traditional care group (control). Participants will be randomized into an 1:1 manner (intervention : control). Random assignment occurred after the consent and initial enrollment interview. Individuals randomized to the iCKD APP will provide with the equipment after randomization. Participants will follow for at least 6 months before the exit interview.

Eligibility criteria: Inclusion Criteria:

* Subjects are 20 years old and above, Chinese speaking, and able and willing to provide informed consent.
* Subjects own mobile devices such as cell phones and tablets.
* Subjects were diagnosed with Chronic Kidney Diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.

Exclusion Criteria:

* starting dialysis or having a kidney transplant (RRT)
* participating in other interventional study
* cognitively impaired
* unable to give consent
* life expectancy less than 1 year

Primary outcomes:
measure: Compare clinics and home blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Achievement of Blood pressure control target
timeFrame: 3 months
measure: The monitor rate of Home Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Shang-Jyh Hwang
role: STUDY_CHAIR
References:
Clinical trial NCT03979716: Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging
Official title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Polyposis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.

The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with nasal polyposis managed in the department of otorhinolaryngology and head and neck surgery of Nancy University Hospital,
* Adult Patients,
* Justifying a surgical treatment for nasal polyposis,
* Present hyposmia, anosmia or normosmia before surgery (confirmed by threshold and identification tests of the Sniffin' Stick kit),
* Affiliated with or beneficiary of a social security scheme,
* Having received complete information about the study and having signed an informed consent form.

Exclusion Criteria:

* General contraindications to Magnetic Resonance Imaging,
* Female of childbearing age without effective contraception,
* Persons referred in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code,
* Qualitative sense of smell disorder (cacosmia, hyperosmia, phantosmia, parosmia),
* Smell disorders with neurological, post-traumatic, or neurodegenerative origin.

Primary outcomes:
measure: Functional Brain activity
timeFrame: 6 months after the last inclusion
Secondary outcomes:
measure: Functional Brain activity
timeFrame: 6 months after the last inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: University Hospital, Nancy, France
name: Duc Trung NGUYEN, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106116: Efficacy of Enhanced External Counterpulsation on Ventricular Function
Official title: A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Ventricular Function
Vascular Endothelium
Counterpulsation, External
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease

Detailed description: Patients with coronary heart disease will be randomized into two groups:

standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.

Eligibility criteria: Inclusion Criteria:

* More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
* Or history of myocardial infarction
* Or history of prior revascularization
* Signed informed consent to participate in the study

Exclusion Criteria:

* Clinically significant valvular heart disease
* Aortic aneurysm
* Congenital heart disease
* Acute myocarditis
* Arrhythmias significantly interfere with the triggering of the EECP device
* History of cerebral hemorrhage
* Hemorrhagic disease
* Lower limb infection, phlebitis
* Deep venous thrombosis
* Malignant disease
* International normalized ratio (INR) \> 2.5
* Uncontrolled hypertension, defined as systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg
* Pregnancy

Primary outcomes:
measure: Change in heart function
timeFrame: 7 weeks
Secondary outcomes:
measure: Change in cardiac chamber diameter
timeFrame: 7 weeks
measure: Change in ventricular wall thickness
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat- sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yan Zhang, M. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Zhensheng Zheng, M. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04835116: Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
Official title: Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Postoperative Pain
Keywords: Local anesthesia, Percutaneous nephrolithotomy.
Lead sponsor: Armed Forces Institute of Urology, Rawalpindi
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Detailed description: The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing PCNL
* age from 12-65 years
* normal renal functions
* no history of chronic pain
* ASA I, II \& III
* Both genders

Exclusion Criteria:

* history of local anaesthesia allergy
* Redo PCNL
* Multiple punctures during PCNL
* Excessive intra-operative bleeding
* Diabetes mellitus
* Coagulopathy
* Mental disorder
* ASA IV \& V
* Active urinary tract infection.

Primary outcomes:
measure: Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Urology.
state: Punjab
Study officials:
affiliation: Armed Forces Institute of Urology.
name: Musab Umair, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220516: Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope
Official title: A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey
name: Siloam St.Trudpert Hospital
First posted: 2017-07-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

Detailed description: With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-70 years
2. American society of Anesthesiology (ASA) score 1 and 2
3. Renal or upper ureteral stone of diameter ≤ 2.0 cm

Exclusion Criteria:

1. Ureteral stricture, renal or ureteral deformity
2. Pregnancy
3. Patients with chronic kidney disease, CKD (serum creatine\> 177 umol/L)

Primary outcomes:
measure: cost of surgery
timeFrame: intraoperative
Secondary outcomes:
measure: Stone free rate
timeFrame: 1month after surgery
measure: stone free rate
timeFrame: 3months after surgery
measure: complication rates
timeFrame: upto 3months
measure: operative time
timeFrame: intraoperative
measure: operator's satisfaction with the scope
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05243316: Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology
Official title: Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Chest Tube
Pleural Diseases
Keywords: Chest tube
Pneumothorax
Pleural Diseases
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2022-02-17
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.

The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

Detailed description: Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).

Incidence of 24hour pneumothorax after chest tube removal will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients aged 16 years and more.
* Patients hospitalized in the National Institute of Respiratory Diseases.
* Patients who had a chest tube placement during their stay at the hospital, by any cause.

Exclusion Criteria:

* Patients who refuse to sign the informed consent and who refuse to participate in the study.
* Patients who die before randomization.
* Patients who gets chest tube removal before being randomized.

Primary outcomes:
measure: Incidence of pneumothorax after chest tube removal with chest tube clamping
timeFrame: After 24 hours of procedure
measure: Incidence of pneumothorax after chest tube removal without chest tube clamping
timeFrame: After 24 hours of procedure
Secondary outcomes:
measure: Hospital days of stay
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Respiratory Diseases
Study officials:
affiliation: National Institute of Respiratory Diseases
name: Sebastian Rodriguez, Doctor
role: STUDY_DIRECTOR
References: