louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01897558: Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Official title: Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradyarrhythmia
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 290
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: Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.


Eligibility criteria: Inclusion Criteria:

* de-novo implantation of a pacemaker system

Exclusion Criteria:

* AAI pacing or cardiac resynchronization therapy
* ICD indication
* temporary pacing
* lead revision
* right ventricular pacing aimed from alternative pacing sites (other than the apex)
* lead revision
* severe tricuspid valve regurgitation
* previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels
* dialysis

Primary outcomes:
measure: high-sensitive Troponin T
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Kempten
country: Germany
facility: Klinikum Kempten
city: Landhut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Mishima
country: Japan
facility: Kenri Hospital
Study officials:
affiliation: Deutsches Herzzentrum München
name: Christof Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blazek P, Ferri-Certic J, Vrazic H, Lennerz C, Grebmer C, Kaitani K, Karch M, Starcevic B, Semmler V, Kolb C. Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads. Sci Rep. 2018 Mar 20;8(1):4870. doi: 10.1038/s41598-018-23209-5.
Clinical trial NCT00676858: Gas Embolism With Use of Argon Plasma Coagulation
Official title: Gas Embolism With Use of Argon Plasma Coagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Embolism, Air
Keywords: Embolism
Argon
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referred to tertiary care center

Brief summary: The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).

Detailed description: Gas embolism is a rare but serious complication of APC. We will use TEE to monitor for gas bubbles during APC. APC will be terminated if gas bubbles are associated with ischemic heart rhythms, wall motion abnormalities, or if large gas bubbles are noted in the left ventricle.

Eligibility criteria: Inclusion Criteria:

* Adults (male and female) 18 years of age or older
* Clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance)
* Ability of the patient or proxy to read, comprehend, and sign informed consent document.

Exclusion Criteria:

* Presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery)
* Presence of coagulopathy or other bleeding diathesis
* Inability to tolerate brief periods of apnea
* Presence of pulmonary vascular disease
* Pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk.
* No exclusions will be made based on gender or race.

Primary outcomes:
measure: incidence of gas bubbles with use of APC
timeFrame: end of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Adnan Majid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080958: The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study
Official title: Negative Pressure Wound Therapy in Flap Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Flap
Negative-Pressure Dressings
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome

Detailed description: The cases will be divided into 3 major study groups:

1st group will be managed with high negative pressure wound therapy The 2nd group will be managed with low negative pressure wound therapy The 3rd group will be managed with conventional dressing

Eligibility criteria: Inclusion Criteria:

- Adult patients skin and soft tissue defects that need flap coverage

Exclusion Criteria:

* associated severe regional injuries uncontrolled comorbidities

Primary outcomes:
measure: Number of Participants with primary healing
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants with flap Edema
timeFrame: 1 week
measure: Number of Participants with flap Congestion
timeFrame: 1 week
measure: Number of Participants with flap Ischemia
timeFrame: 1 week
measure: Number of Participants with flap infection
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT01580358: Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy
Official title: Changhua Christian Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Patients Undergoing Chemotherapy or Radiotherapy
Keywords: cancer
radiotherapy
chemotherapy
Traditional Chinese Medicine
Safety
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Committee on Chinese Medicine and Pharmacy
First posted: 2012-04-19
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Detailed description: Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy
* age above 18 years old
* signed informed consent
* ability to read Chinese, ability for oral intake.

Exclusion Criteria:

* being pregnancy
* on breast feeding
* completed chemotherapy or radiotherapy
* brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four
* delusion or hallucination
* acute infection
* received medications for other clinical trials.

Primary outcomes:
measure: Change from baseline in EORTC QOL-C30 at four weeks
timeFrame: baseline and four weeks
Secondary outcomes:
measure: Change from baseline in BUN, Creatinine, GOT, GPT at four weeks
timeFrame: baseline and four weeks
measure: Change from baseline in Heart rate variability at four weeks
timeFrame: baseline and four weeks
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Lun Chien Lo, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo LC, Chen CY, Chen ST, Chen HC, Lee TC, Chang CS. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2012 Dec 3;13:232. doi: 10.1186/1745-6215-13-232.
Clinical trial NCT03583658: Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-07-11
Enrollment: 390
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: Primary Objective:

To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.

Secondary Objective:

To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.

Detailed description: Duration per participant is up to 4 days.

Eligibility criteria: Inclusion criteria:

* Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
* Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
* Signed written informed consent.

Exclusion criteria:

Patients suffering from pharyngitis of bacterial origin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in pain intensity difference (PID)
timeFrame: hour 3
Secondary outcomes:
measure: Change in SPID
timeFrame: hour 24
measure: 3-hour patient assessment of efficacy
timeFrame: hour 3
measure: 24-hour patient assessment of efficacy
timeFrame: hour 24
measure: Adverse events
timeFrame: baseline to day 4
measure: Patient assessment of tolerability
timeFrame: hour 3, hour 24 and day 2, day 3 or day 4
measure: Final assessment of tolerability
timeFrame: day 4
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7100005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18.
Clinical trial NCT03443258: Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation
Official title: Needs Assessment and Decision-making Tool (NEAT-decision) Integrated in a Clinical Practice to Enhance Patient Involvement in Head and Neck Cancer Rehabilitation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Danish Nurses Organisation
First posted: 2018-02-23
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: Patients are assigned to either intervention or control group. The intervention group receives a nursing consultation using a need assessment and decision making tool. The control group receives usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient involvement in decision-making.

Detailed description: The study tests a needs assessment and decision-making tool with patients surgically treated for Head and Neck Cancer. The tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. Half of the participants will receive nursing consultations using the tool and the other half will receive standard care.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Head and Neck Cancer
* Stage T3 or T4
* Surgically treated
* Must be able to speak and understand Danish

Exclusion Criteria:

* Treated surgically for thyroid or parotic cancers
* Referred to adjuvant radio - or chemotherapy
* Having an unstable psychiatric illness.

Primary outcomes:
measure: Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery
timeFrame: Baseline; 9; 21 and 67 days post-surgery
Secondary outcomes:
measure: Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery
timeFrame: Baseline, 2, 14 and 60 days post-surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology
Study officials:
affiliation: Rigshospitalet, Denmark
name: Annelise Mortensen, MSA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mortensen A, Wessel I, Rogers SN, Tolver A, Jarden M. Needs assessment in patients surgically treated for head and neck cancer-a randomized controlled trial. Support Care Cancer. 2022 May;30(5):4201-4218. doi: 10.1007/s00520-021-06759-9. Epub 2022 Jan 27.
Clinical trial NCT04888858: Effect of Epidural Analgesia During Labor on Force of Maternal Push
Official title: Effect of Epidural Analgesia During Labor on Force of Maternal Push
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Labor Pain
Analgesia
Maternal; Procedure
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions.

The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.


Eligibility criteria: Inclusion Criteria:

* Adult (18 years and older)
* Pregnant women in their third trimester
* Able to read and speak English
* Capacity to consent to participate
* Receiving a labor epidural catheter during their labor and delivery at HFH-Main

Exclusion Criteria:

* Severe cardiac disease
* People who are unable/medically recommended not to perform valsalva maneuvers
* People who are not undergoing labor epidural analgesia

Primary outcomes:
measure: The change in intraabdominal pressure (surrogate of maternal force)
timeFrame: 2 hours following initial administration of labor epidural
Secondary outcomes:
measure: Mode of delivery
timeFrame: Up to 72 hours after initial administration of labor epidural
measure: Duration of second stage of labor
timeFrame: Up to 72 hours after initial administration of labor epidural
measure: Apgar scores
timeFrame: Up to 72 hours after initial administration of labor epidural
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT04012658: A Registered Cohort Study on Wilson's Disease
Official title: A Registered Cohort Study on Wilson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson's Disease
Keywords: Wilson's Disease
Nature history
Genetics
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Wilson's Disease are diagnosed by the clinical and/or genetic features

Brief summary: The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management.


Eligibility criteria: Inclusion Criteria:

* Patients with the genetic diagnosis of Wilson's Disease
* Asymptomatic Wilson's Disease carriers
* Relatives of Wilson's Disease patients or carriers
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

\* Participants are unable to comply with study procedures and visit schedule

Primary outcomes:
measure: The change of Unified Wilson's Disease Rating Scale (UWDRS)
timeFrame: Up to 30years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
Study officials:
References:
Clinical trial NCT03119558: PET/MRI Evaluation of Cardiac Amyloid
Official title: 18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiac Amyloidosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. This makes it difficult for the heart to function properly. The investigators wish to evaluate if the radiopharmaceutical 18F-Florbetaben (Neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.

Detailed description: The use of hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. It is hypothesized that an increased PET signal of 18F-Florbetaben (Neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the MRI provides the anatomical information. The ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios:

1. Diagnosis of cardiac amyloidosis
2. Decreasing unnecessary invasive myocardial procedures.

The investigators believe this trial will help expand the use of current PET amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient with known or suspected cardiac amyloidosis.
* Patient is capable of complying with study procedures

Exclusion Criteria:

* Patient is pregnant or nursing
* Metallic implants (contraindicated for MRI)
* History of renal insufficiency (only for MRI contrast administration)

Primary outcomes:
measure: Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images
timeFrame: an estimated average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baratto L, Park SY, Hatami N, Gulaka P, Vasanawala S, Yohannan TK, Herfkens R, Witteles R, Iagaru A. 18F-florbetaben whole-body PET/MRI for evaluation of systemic amyloid deposition. EJNMMI Res. 2018 Jul 24;8(1):66. doi: 10.1186/s13550-018-0425-1.