louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785096: How do Patients, Nurses and Physicians Perceive Negative Postoperative Events?
Official title: Perception of Surgical Complications - Agreements Among Patients, Nurses and Physicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Perception, surgical complications, patients, nurses and physicians
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will admit for a minor or major surgical procedure Nurses from the University Hospital of Zurich Different physicians of the University Hospital of Zurich (surgeons, anesthesia, urologist ans ICU-care specialists)and other institutions.

Brief summary: The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years
* Capacity to act and no legal guardian
* Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
* German language as daily language.

Exclusion Criteria:

* Patients with cognitive difficulties and diseases, which may yield unreliable answers
* Patients unable to read and write

Primary outcomes:
measure: To assess how patients, nurses and physicians perceive negative events following surgical procedures
timeFrame: August 2008- December 2009
Secondary outcomes:
measure: Association to the Clavien Dindo Classification
timeFrame: August 2008 - December 2009
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Study officials:
References:
Clinical trial NCT04283396: Study for Novel Coronavirus Pneumonia (NCP)
Official title: Study for Clinical Epidemiology and Methods of Diagnosis and Treatment of Novel Coronavirus Pneumonia (NCP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Novel Coronavirus Pneumonia
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients confirmed with novel coronavirus pneumonia.

Brief summary: To develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

Detailed description: By retrospectively analyzing the clinical epidemiological characteristics of the novel coronavirus pneumonia and the current diagnosis and treatment schemes, as well as in-depth analyzing the disease development process and outcome trends of NCP patients to develop practical and effective clinical diagnosis and treatment schemes and provide guarantee for the rapid control of the epidemic.

Eligibility criteria: Inclusion Criteria:

* Patients confirmed with novel coronavirus pneumonia. The Diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)";

Exclusion Criteria:

* Physician judged the patient was not suitable for this clinical trial.

Primary outcomes:
measure: recovery
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital
state: Hubei
Study officials:
References:
Clinical trial NCT01810796: Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Official title: Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease,
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.

Detailed description: High-risk patients undergoing non cardiac surgery will be randomized to receive either Ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.

Eligibility criteria: Inclusion Criteria:

- All patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (PACU) or intensive care unit (ICU), and who either have known history of CAD or at least 3 of the following Revised Cardiac Risk Index (RCRI) criteria29F17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine \> 2mg/ml).

Exclusion Criteria:

* Pregnancy, LV ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate

Primary outcomes:
measure: Postoperative troponin
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah - Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Giora Landesberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00879996: Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Official title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opiate Addiction
Keywords: Opiate Addiction
Narcotic Addiction
Drug Addiction
Pain
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.

Detailed description: The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).

Eligibility criteria: Inclusion Criteria:

* chronic back pain
* opioid addiction
* not successful with abstinence
* at least 18 years old
* able to understand spoken English
* live in Western New York State (Erie or Niagara county)
* have health insurance or ability to pay for health care
* no methadone or buprenorphine treatment within past year
* not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

* homelessness
* unable to give consent (e.g., dementia, psychosis)
* serious heart or lung disease
* taking a medication that could interact with methadone or buprenorphine
* pregnancy

Primary outcomes:
measure: Number of Participants Retained in Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Numerical Rating Score for Pain
timeFrame: 6 months
measure: Numerical Rating Score for Functioning
timeFrame: 6 months
measure: Self-reported Illicit Opioid Use
timeFrame: 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Sheehan Memorial Hospital
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Richard D Blondell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
citation: Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872.
Clinical trial NCT00163696: Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
Official title: Measurements of Inhomogeneity of the Small Airway With Patients With Cystic Fibrosis, Asthma and Bronchiolitis Obliterans Syndrome (Post Transplant) Using the Multi Breath Nitrogen Washout Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Asthma
Bronchiolitis Obliterans
Lung Transplantation
Keywords: MBNW
Ventilation
small airways
Lung Transplant recipients (Bronchiolitis Obliterans syndrome)
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: The Alfred
First posted: 2005-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.

Detailed description: It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.

Eligibility criteria: Inclusion Criteria:

* Doctor diagnosed cystic fibrosis, asthma
* Lung transplant recipient

Exclusion Criteria:

* Smoke history of less than 10 pack years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Head of Physiology Services, Alfred Hospital
name: Bruce Thompson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00450996: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty
Official title: Phase 3: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Rejection
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 \>= 19 years; follow-up: 42 \>= 18months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months).

Detailed description: PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 \>= 19 years; follow-up: 42 \>= 18 months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months). \<=

Eligibility criteria: Inclusion Criteria:

* Low risk keratoplasty

Exclusion Criteria:

* High risk keratoplasty

Primary outcomes:
measure: Graft survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Erlangen-Nürnberg
name: friedrich Naumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg
name: claus Cursiefen, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT01529996: Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness
Official title: Comparison of the Efficacy Between Pulsed Dye Laser (PDL) and the Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness: A Pilot, Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG laser in the treatment of facial redness.


Eligibility criteria: Inclusion Criteria:

* Healthy patients 18-55 years of age with erythematotelangiectatic rosacea (as verified by the the PI).
* Subjects who are willing to provide informed consent for participation in the study.

Exclusion Criteria:

* Pregnant or lactating individuals
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a known history of photosensitive conditions (e.g. Systemic lupus, polymorphous light eruption)
* Subjects who have facial telangiectasia of diameter greater than 2 mm.
* Subject who have significant (as determined by the PI) acute inflammatory papules, pustules, and vesicle involving the central face.

Primary outcomes:
measure: Rating on global improvement scale
timeFrame: four months
measure: Spectrophotometer measurement
timeFrame: four months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: four months
measure: Recorded discomfort
timeFrame: four months
measure: Adverse events
timeFrame: four months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392196: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Official title: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Renal Impairment
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 39
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: This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.


Eligibility criteria: Inclusion Criteria:

* Heart Failure patients NYHA Class II or III
* Renal Impairment Left Ventricular Ejection Function \<40%
* GFR 30 to 75 mL/min/1.73m2
* Optimal stable medical therapy

Exclusion Criteria:

* Renal artery anatomy must be eligible for treatment as determined by Angiography, and
* History of prior renal artery intervention
* Single functioning kidney.
* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
* Systolic BP \< 90 mmHG

Primary outcomes:
measure: Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
timeFrame: 6 month
Secondary outcomes:
measure: Ventricular function as measured by Echocardiography
timeFrame: 6 month
measure: Renal function as measured by Glomerular Filtration Rate (GFR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Henry Krum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03910296: Acceptance and Commitment Therapy (ACT) - Based Treatment Development for Cancer Patients Treated for Pain
Official title: Acceptance and Commitment Therapy (ACT) - Based Treatment Development for Cancer Patients Treated for Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All potentially eligible patients will be identified through the DFCI ambulatory palliative care clinics.

Brief summary: The purpose of this research study is to develop a psychological treatment for patients with cancer, focused on the psychological symptoms they experience during opioid therapy.

Detailed description: This research study is a treatment development study, which is the first time investigators are developing this psychological intervention in patients with cancer, on opioid therapy. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures.

Eligibility criteria: Inclusion Criteria:

* must be at least 18 years of age
* speak and comprehend English sufficiently to be able to complete the study procedures and participate in psychotherapy in English
* have been diagnosed with cancer
* have an estimated survival time ≥6 months (as approximated by palliative care clinic staff)
* score ≥4 on the Opioid Risk Tool (Webster \& Webster, 2005) with psychosocial distress as one of the positive items.

Exclusion Criteria:

* untreated bipolar disorder
* untreated psychotic disorders
* untreated borderline personality disorder
* have an estimated survival time ≤6 months (as approximated by clinic staff).

Primary outcomes:
measure: Study feasibility
timeFrame: 2 years
Secondary outcomes:
measure: Intervention acceptability
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Miryam Yusufov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03589196: Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT
Official title: Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate For Management Of Benign Prostatic Enlargement: An Objective Evaluation Through a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ejaculation Abnormal
BPH With Urinary Obstruction
Prostatic Hyperplasia
Prostate Disease
Prostate Obstruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 84
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate and compare the outcome and coast of ejaculation sparing management of BPH using 3 different techniques: PVP, PKVP and TURP. Ejaculation sparing TURP group is considered the standard control group. Evaluation will be carried out through a prospective randomized powered trial


Eligibility criteria: Inclusion Criteria:

* 1. Age \>50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )\>15 and quality of life score (QOL)\< 3.

  4. Maximum flow rate of uroflometry \<10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation.

  6. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.

Exclusion Criteria:

1. Bleeding disorders and patients on anticoagulant treatment
2. Histologically proved cancer prostate
3. Neurogenic voiding dysfunction
4. Lower urinary tract malignancy
5. Preoperative ejaculation or sexual dysfunction
6. Presence of stricture urethra
7. Unfit for spinal anathesia -

Primary outcomes:
measure: estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
timeFrame: 1 years
Secondary outcomes:
measure: change in flow rate
timeFrame: 1 years
measure: postoperative complication
timeFrame: 1 year
measure: change in patients' symptoms.
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology & Nephrology Center
Study officials:
References: