louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03466619: Penile Prosthesis in Patients With Erectile Dysfunction
Official title: Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: inflatable penile prosthesis (IPP)
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

Detailed description: In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

Eligibility criteria: Inclusion Criteria:

* Patients complaining of ED with contraindication or failure of medical treatment

Exclusion Criteria:

* Patients lacking manual dexterity or mental abilities necessary to operate the pump
* General contraindications as uncorrectable bleeding tendency

Primary outcomes:
measure: Number of patients with improved erectile dysfunction
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university - faculty of medicine
state: Elgharbia
Study officials:
affiliation: Urology Department- Tanta University
name: Khaled Mohamed Hafez Morsy Almekaty, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology Department- Tanta University
name: Samir Abdelhakim Elgamal, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of urology University College London Hospital(UCLH)London, UK
name: Suks Minhas, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756119: Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology
Official title: Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Cardiac Surgery Patients
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: Russian Academy of Medical Sciences
First posted: 2008-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post cardiac surgery adult patients

Brief summary: Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency.

The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.


Eligibility criteria: Inclusion Criteria:

* Post cardiac surgery adult patients
* Patients with heart catheter and arterial catheter

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center of Surgery, Russian Academy of Medical Sciences
Study officials:
affiliation: Russian Academy of Medical Sciences
name: Alexsandr A Eremenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eremenko A, Balykov I, Chaus N, Kislukhin V, Krivitski N. Use of an extracorporeal arteriovenous tubing loop to measure cardiac output in intensive care unit patients by ultrasound velocity dilution. ASAIO J. 1998 Sep-Oct;44(5):M462-4. doi: 10.1097/00002480-199809000-00028.
citation: Eremenko AA, Chaus NI, Kislukhin VV, Balykov IV. [The determination of cardiac output by the dilution of ultrasonic blood density]. Anesteziol Reanimatol. 1998 Jul-Aug;(4):4-6. Russian.
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
Clinical trial NCT04221919: Different β -Blockers in STEMI and Primary PCI
Official title: Different β -Blockers in Patients With ST-segment Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary PCI
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 1200
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: Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

Detailed description: The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.

Eligibility criteria: Inclusion Criteria:

* Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
* Age ≥18 years;
* Informed consent from patient or next of kin.

Exclusion Criteria:

* Nonischaemic Cardiomyopathy;
* Cardiac surgery planed in the 6 months;
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
* Renal or hepatic failure;
* Malignancy, HIV, or central nervous system disorder;
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness;
* Cardiogenic shock;
* Current participation in any research study involving investigational drugs or devices;
* No written consensus;
* Previous myocardial infarction.

Primary outcomes:
measure: Change in LVEDV from baseline
timeFrame: 1 to 5 years
measure: Major adverse cardiovascular events (MACE)
timeFrame: 1 to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06031519: Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias
Official title: Impact of Percutaneous Intramyocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Arrhythmia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent Liwen Procedure in Xijing Hospital from 2016 to 2023.

Brief summary: The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation. The main questions it aims to answer are:

* To investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters
* To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation and their relationships with clinical characteristics and procedural parameters


Eligibility criteria: Inclusion Criteria:

1. Subject with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
2. Subject with a peak LVOT gradient≥50 mm Hg
3. Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

Exclusion Criteria:

1. Subject with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
2. Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
3. Subject has end-stage heart failure

Primary outcomes:
measure: All-cause and cardiovascular mortality
timeFrame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
Secondary outcomes:
measure: Ventricular tacharrhythmia composite outcome
timeFrame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
measure: Arrhythmia
timeFrame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT01159119: A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
Official title: Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Pancreatitis
Keywords: Chronic Abdominal Pain
Exocrine Pancreatic Insufficiency
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: University of Florida
First posted: 2010-07-09
Enrollment: 15
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: The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

Detailed description: To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chronic Pancreatitis
* Exocrine Pancreatic Insufficiency
* Chronic abdominal pain

Exclusion Criteria:

* Acute pancreatitis
* Active alcohol consumption
* Uncontrolled diabetes

Primary outcomes:
measure: Comparing frequency and severity of pain
timeFrame: up to 84 days
Secondary outcomes:
measure: Changes in fat malabsorption
timeFrame: up to 124 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Phillip Toskes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02611219: Deconditioning in Transplant
Official title: Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Stem Cell Transplant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this feasibility study is to test the potential for successful implementation of an intervention designed to study the effect of six hours out of bed time on the overall level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research has demonstrated that deconditioning occurs rapidly over the course of the hospitalization post-transplant and can negatively impact quality of life. By encouraging patients to be out of bed for six hours each day, it is anticipated that patients will experience less deconditioning than those patients who previously had no established minimum time out of the bed.


Eligibility criteria: Inclusion Criteria (Pediatric Patients)

* Ages 7-17 years
* Admitted to hospital for stem cell transplant
* Speaks English

Inclusion Criteria (Parents of pediatric patients)

* Parents of children ages 7-17 years
* Parents of children admitted to hospital for stem cell transplant
* Speaks English

Exclusion Criteria (Pediatric Patients) -Admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included

Exclusion Criteria (Parents of pediatric patients)

-Parents of children admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included

Primary outcomes:
measure: Recruitment and retention of participants throughout the study
timeFrame: Baseline through 6 week clinic visit (up to an estimated 82 days)
measure: Number of participants who achieve 6 hours out of bed through the 6 week clinic visit
timeFrame: Baseline through 6 week clinic visit (up to an estimated 82 days)
measure: Quality of life as measured by General Health Module questionnaires
timeFrame: Discharge from hospital (estimated to be 40 days)
measure: Quality of life as measured by General Health Module questionnaires
timeFrame: Baseline through 6 week clinic visit (up to an estimated 82 days)
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Heather Taylor, RN, BSN, CPHON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710619: Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX
Official title: Dosing Observational Study in Hemophilia Subjects With Inhibitors: A Phase IV Diary Study in Subjects Prescribed NovoSeven® as First Line on Demand Therapy for Acute Bleeding Episodes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 52
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male subjects with congenital haemophilia A or B with inhibitors with spontaneous bleeds requiring on-demand treatment

Brief summary: This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.


Eligibility criteria: Inclusion Criteria:

* Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
* Subjects prescribed NovoSeven® as the first line or recommended bypass agent
* History of on average at least 4 bleeds of any type over a 3 month period
* Subject or caregiver able and willing to complete daily journal for 3 months
* Informed consent obtained from all subjects or legal representative

Primary outcomes:
measure: Characterisation of dose and dosing intervals for each bleeding episode
timeFrame: after 3-6 months
Secondary outcomes:
measure: Effect of type of bleed on initial dose, dosing interval and total dose
timeFrame: after 3-6 months
measure: Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution
timeFrame: after 3-6 months
measure: Effect of time to first dose on dosing interval and total dose
timeFrame: after 3-6 months
measure: Effect of bleeds and drug administration time on planned daily activities
timeFrame: after 3-6 months
measure: Relationship of dose and dosing intervals to reported SAEs
timeFrame: after 3-6 months
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Gruppo RA, Kessler CM, Neufeld EJ, Cooper DL. Assessment of individual dose utilization vs. physician prescribing recommendations for recombinant activated factor VII (rFVIIa) in paediatric and adult patients with congenital haemophilia and alloantibody inhibitors (CHwI): the Dosing Observational Study in Hemophilia (DOSE). Haemophilia. 2013 Jul;19(4):524-32. doi: 10.1111/hae.12113. Epub 2013 Apr 1.
Clinical trial NCT06203119: Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
Official title: Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: PET/CT
TNBC
68Ga labeling
diagnosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at Being Cancer Hospital who are confirmed TNBC.

Brief summary: This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-DOTA-BPP in subjects with triple-negative breast cancer. The visual and semiquantitative methods will be used to assess the PET/CT images

Detailed description: ACE is expressed in triple-negative breast cancer cells. This project develops new type of 68GA-labeled DOTA-BPP, leveraging the inherent strengths of this nuclear medicine discipline, promoted the formulation of the production of this drug To obtain 68Ga-DOTA-BPP injection that can be used in preclinical studies and meets clinical standards. Join a group In clinical patients, 68Ga-DOTA-BPP PET/CT imaging of patients with ACE-positive TNBC was performed, and ACE was obtained To provide evidence for patient screening and efficacy evaluation before targeted therapy with high expression of TNBC, and preliminatively evaluate the level of ACE against high level of ACE. The effect of tumor development can provide a practical basis for the establishment of ACE-targeted PET imaging platform

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old;
2. ECOG score 0 or 1 point;
3. Participants with confirmed TNBC cancer who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

1. Pregnant or nursing;
2. Severe hepatic or renal dysfunction;
3. Low WBC (less than 3 x 10\^9/L);
4. Unable to comply with the PET/CT imaging procedures

Primary outcomes:
measure: Visual assessment of lesions
timeFrame: 1 year
measure: Semiquantitative assessment of lesions
timeFrame: 1 year
Secondary outcomes:
measure: ACE expression analysis of tumor tissues
timeFrame: 1 year
measure: Correlation analysis of 68Ga-DOTA-BPP uptake and lesion size changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ethics Committee of Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02728219: Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion
Official title: A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Hepatocellular Carcinoma
Keywords: Recurrent Hepatocellular Carcinoma
transcatheter arterial chemoembolization
AFP conversion
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 150
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 purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.

Detailed description: Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.

This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.

Eligibility criteria: Inclusion Criteria:

1. via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
2. age:18-70years
3. better liver function (Child-Pugh，class A or B)

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance;
5. serious heart、lung、kidney disease

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03997019: Erector Spinae Plane Block in Cardiac Surgery
Official title: Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A WILL RECEIVE OPOID analgesia group B will receive ESP block
Primary purpose: PREVENTION

Brief summary: ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery


Eligibility criteria: Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* emergency
* patient refusal
* infection at or near catheter insertion

Primary outcomes:
measure: pain score
timeFrame: 48 hours
Secondary outcomes:
measure: anaesthesia consumption
timeFrame: 6 hours
measure: ultrasound guided postoperative diaphragmatic excursion
timeFrame: 24 hours
measure: spirometric respiratory funtion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References: