louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01225484: Perioperative Analgesia After Knee Arthroplasty
Official title: Perioperative Analgetic Therapy After Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Arthroplasty
Keywords: Knee arthroplasty, perioperative analgesia
Lead sponsor: Landeskrankenhaus Feldbach
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2010-10-21
Enrollment: 123
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: The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of ropivacaine into an intraarticular catheter placed intraoperatively followed by a continuous intraarticular infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)


Eligibility criteria: Inclusion Criteria:

* Elective primary knee arthroplasty
* ASA I,II,\&III patients
* Spinal Anaesthesia

Exclusion Criteria:

* Patients refusing consent
* Contraindications to regional anaesthesia
* Preexisting neurological disease
* Alcohol or drug abuse
* Inability to use the outcome assessment tools
* Wheel chair or walker dependent
* Pregnancy

Primary outcomes:
measure: Static and dynamic pain scores (VAS)
timeFrame: 72 h
Secondary outcomes:
measure: Maximum knee flexion (active/passive)>= 90°
timeFrame: 72 h
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: LKH Feldbach
Study officials:
affiliation: LKH Feldbach
name: Karl Trauner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579084: Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Erythema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 64
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: This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.


Eligibility criteria: Inclusion Criteria:

* facial erythema associated with rosacea on both sides of the face

Exclusion Criteria:

* Laser light-source or other energy based therapy in the last 6 months
* Excessive hair around the treatment area

Primary outcomes:
measure: Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1
timeFrame: Baseline, Day 1-hour 6
measure: Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5
timeFrame: Baseline, Day 5-hour 6
Secondary outcomes:
measure: Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
timeFrame: Baseline, Day 1-hour 6, Day 5-hour 6
measure: Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
timeFrame: Baseline, Day1-hour 6, Day 5-hour 6
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00051584: Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
Official title: A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.


Eligibility criteria: Brief Overview of Inclusion Criteria:

* Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease
* Patients must have \> 20% Lewis-y antigen expression documented by immunohistochemistry
* LVEF \> 50% by echo or MUGA
* Must be platinum resistant as defined by:

  * Progression while on initial platinum therapy or
  * Progression while on retreatment with initial platinum regimen or
  * Relapse \< 6 months after initial therapy

Brief Overview of Exclusion Criteria:

* Patients who have had prior therapy with Gemzar®
* Cumulative anthracycline exposure \> 300 mg/m2
* More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Torrance
country: United States
facility: California Hematology Oncology Medical Group
state: California
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Arlington
country: United States
facility: Arlington Fairfax Hematology Oncology
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Andrew Sandler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01809184: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index 18.0-28.0 kg/m\^2
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as randomised
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve
timeFrame: From 0 to 648 hours after a single dose
measure: Area under the glucose infusion rate (GIR)-time curve
timeFrame: From 0 to 24 hours after a single dose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01970384: Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients
Official title: Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: transcranial direct current stimulation
stroke-related dysphagia
cortical plasticity
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2013-10-28
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: TREATMENT

Brief summary: The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.


Eligibility criteria: Inclusion Criteria:

- dysphagia due to acute stroke

Exclusion Criteria:

* preexisting dysphagia
* comorbidities that can possibly cause dysphagia
* psychiatric comorbidities
* pacemaker or other implanted electronic devices
* inability to give informed consent

Primary outcomes:
measure: FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score
timeFrame: Within three days after the last stimulation session
Secondary outcomes:
measure: Diet at discharge
timeFrame: by the time of discharge, an expected average of 2 weeks after the last stimulation session
measure: Dysphagia Severity Rating Score
timeFrame: within three days after the last stimulation session
measure: Endoscopically assessed swallow function
timeFrame: within three days after the last stimulation session
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Neurology, University of Muenster
Study officials:
affiliation: Department of Neurology, University of Muenster
name: Rainer Dziewas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suntrup S, Teismann I, Wollbrink A, Winkels M, Warnecke T, Floel A, Pantev C, Dziewas R. Magnetoencephalographic evidence for the modulation of cortical swallowing processing by transcranial direct current stimulation. Neuroimage. 2013 Dec;83:346-54. doi: 10.1016/j.neuroimage.2013.06.055. Epub 2013 Jun 23.
citation: Dziewas R, Warnecke T, Olenberg S, Teismann I, Zimmermann J, Kramer C, Ritter M, Ringelstein EB, Schabitz WR. Towards a basic endoscopic assessment of swallowing in acute stroke - development and evaluation of a simple dysphagia score. Cerebrovasc Dis. 2008;26(1):41-7. doi: 10.1159/000135652. Epub 2008 May 30.
Clinical trial NCT06608784: Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population
Official title: Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Epilepsy
Patients With First Seizure
Normal Population
Keywords: Electrocardiogram
Epilepsy
Seizure
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups enrolled the study. The first group: Patients with epilepsy who experienced a generalized tonic-clonic seizure within 24 hours before admission.

The second group: Patients who experienced a first time generalized tonic-clonic seizure within 24 hours before admission.

The third group: Patients without a history of generalized tonic-clonic seizure.

Brief summary: According to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ECG findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure.


Eligibility criteria: Inclusion Criteria for group 1:

* History of epilepsy for at least 2 years
* Taking antiseizure medications

Inclusion Criteria for group 2:

- Solid history of first seizure confirmed by a neurologist

Inclusion Criteria for group 3:

- No history of seizure

Exclusion Criteria:

* History of known cardiac disease or medical condition precipitating cardiac disease
* Electrolyte imbalance Taking medications with significant effect on ECG indexes

Primary outcomes:
measure: Differences between ECG indexes in study groups
timeFrame: The ECG in group 1 and 2 was performed for patients who were admitted within 24 hours of seizure occurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Mazandaran University of Medical Sciences
state: Mazandaran
Study officials:
References:
Clinical trial NCT02336984: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Official title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Ductal carcinoma in situ (DCIS)
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 0
Sex: FEMALE
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 the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.


Eligibility criteria: Inclusion Criteria:

* Women \>= 18 years.
* Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
* Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
* Women of childbearing age with a negative pregnancy test documented prior to enrollment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
* Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
* Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria

* Pregnant or lactating.
* Positive for HIV or hepatitis C at baseline by self-report.
* Potential participants with coagulopathies, including thrombocytopenia with platelet count \<75,000, INR\> 1.5 and partial thromboplastin time \> 50 sec
* Major cardiac illness MUGA or ECHO \<50% EF.
* Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).

Primary outcomes:
measure: Occurrence of Related Adverse Events (AEs)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Brian Czerniecki, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06919484: The Physiological Effect of RCexp on Ventilation/Perfusion Distribution
Official title: The Physiological Effect of RCexp on Ventilation/Perfusion Distribution in Patients With ARDS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Mechanical Ventilation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset

Brief summary: With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

Detailed description: With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

Eligibility criteria: Inclusion Criteria:

adult patients with ARDS receiving mechanical ventilation no more than 72 hours

Exclusion Criteria:

1. age \<18 years old
2. patient undergoing legal protection
3. contra-indications to EIT (e. g. severe chest trauma or wounds)
4. pneumothorax
5. patient undergoing ECMO
6. pregnancy

Primary outcomes:
measure: Difference in ventilation/perfusion mismatch
timeFrame: 4 hours
Secondary outcomes:
measure: Difference in dead space
timeFrame: 4 hours
measure: Difference in shunt
timeFrame: 4 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00758784: Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 38
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 investigate the safety and efficacy of an ophthalmic solution in dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older

Exclusion Criteria:

* No active ocular conditions of disease

Primary outcomes:
measure: Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
timeFrame: Baseline, Day 42
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: 52 days
Secondary outcomes:
measure: Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
timeFrame: Baseline, 42 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06274684: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
Official title: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Virtual Reality
VR
Anxiety
Prostate biopsies
Transperineal biopsies
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.

The main question it aims to answer:

- Is there a significant decrease on anxiety level thanks to VR-assistance?

Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.

Researchers will compare standardised anxiety scores with a control group.


Eligibility criteria: Inclusion Criteria:

* Indication for prostate biopsies
* Informed consent

Exclusion Criteria:

* Local anaesthesia contra-indication (allergy)
* Claustrophobia
* Major cognitive impairment and impossibility of answering the standardised questionnaires

Primary outcomes:
measure: Anxiety level
timeFrame: On the day of the biopsies (before the procedure) and one day after procedure
Secondary outcomes:
measure: Anxiety level of the surgeon
timeFrame: One day after procedure
measure: Biopsies complications
timeFrame: In the 30 days following prostate biopsies
Other outcomes:
Locations:
Study officials:
References: